News

The US Department of Veterans Affairs (VA) is earning high marks for the quality of care provided to veterans, according to multiple sources. For instance, systematic reviews published in 2023 found that VA health care is consistently as good as, or surpasses, non-VA health care. In the latest Centers for Medicare & Medicaid Services (CMS) annual Overall Hospital Quality Star Ratings, 67% of VA hospitals received either 4 or 5 stars, compared with only 41% of non-VA hospitals.

Veterans themselves are awarding high marks. According to the Medicare nationwide survey of patients, VA hospitals outperformed non-VA hospitals on all 10 core patient satisfaction metrics, including overall hospital rating, communication with doctors, communication about medications, and willingness to recommend the hospital. Furthermore, trust in VA outpatient care has reached an all-time record high of 92%, according to a survey of more than 440,000 veterans.

This year, in fact, the VA has broken a number of its own records. The VA cites other high points:

• More than 127.5 million health care appointments, a 6% increase over last year;
• Shorter wait times: new patients saw an 11% reduction in average wait times for VA primary care and a 7% reduction for mental health care compared to last year;
• $187 billion in benefits to 6.7 million veterans and survivors this year—an all-time record;
• 2,517,519 disability benefit claims processed, a 27% increase over 2023;
• No-cost emergency health care is provided to more than 50,000 veterans in acute suicidal crises; the Veterans Crisis Line supported 1,123,591 million calls, texts, and chats, up 12% from 2023;
• 47,925 veterans experiencing homelessness were housed in fiscal year 2024 and 96% remain housed long-term;
• 519,453 spouses and dependents received survivor benefits, a 4.5% increase from 2023;
• Services, resources, and assistance provided to a record 88,095 veteran family caregivers, an 18.6% increase over the 2023 record;
• A record 741,259 women veterans received compensation payments, 8.2% more than 2023;
• VA dental clinics provided > 6 million procedures to > 630,000 veterans; through community care, the VA delivered a record additional 3.4 million procedures to > 330,000 veterans.

Other actions this year include: expanding eligibility for VA healthcare to all toxin-exposed veterans years earlier than called for by the PACT Act; expanding access to care across the nation through VA Access Sprints, adding night and weekend clinics, and increasing the number of veterans scheduled into daily clinic schedules; removing copays for the first 3 outpatient mental health care and substance use disorder visits of each calendar year through 2027; expanding access to VA cancer care through establishing new cancer presumptive conditions, expanding access to genetic, lung, and colorectal cancer screening, and expanding the Close to Me cancer care program; expanding access to in vitro fertilization for eligible unmarried veterans and eligible veterans in same-sex marriages; expanding access to VA care and benefits for some former service members discharged under other than honorable conditions; and launching tele-emergency care for veterans nationwide.

The VA will continue to “aggressively reach out to and engage veterans to encourage them to come to VA for the care and benefits they have earned.”  

“Veterans deserve the very best from VA and our nation, and we will never settle for anything less,” said VA Secretary Denis McDonough. “We’re honored that more veterans are getting their earned health care and benefits from VA than ever before, but make no mistake: there is still work to do. We will continue to work each and every day to earn the trust of those we serve — and ensure that all Veterans, their families, and their survivors get the care and benefits they so rightly deserve.”

The US Department of Veterans Affairs (VA) is earning high marks for the quality of care provided to veterans, according to multiple sources. For instance, systematic reviews published in 2023 found that VA health care is consistently as good as, or surpasses, non-VA health care. In the latest Centers for Medicare & Medicaid Services (CMS) annual Overall Hospital Quality Star Ratings, 67% of VA hospitals received either 4 or 5 stars, compared with only 41% of non-VA hospitals.

Veterans themselves are awarding high marks. According to the Medicare nationwide survey of patients, VA hospitals outperformed non-VA hospitals on all 10 core patient satisfaction metrics, including overall hospital rating, communication with doctors, communication about medications, and willingness to recommend the hospital. Furthermore, trust in VA outpatient care has reached an all-time record high of 92%, according to a survey of more than 440,000 veterans.

This year, in fact, the VA has broken a number of its own records. The VA cites other high points:

• More than 127.5 million health care appointments, a 6% increase over last year;
• Shorter wait times: new patients saw an 11% reduction in average wait times for VA primary care and a 7% reduction for mental health care compared to last year;
• $187 billion in benefits to 6.7 million veterans and survivors this year—an all-time record;
• 2,517,519 disability benefit claims processed, a 27% increase over 2023;
• No-cost emergency health care is provided to more than 50,000 veterans in acute suicidal crises; the Veterans Crisis Line supported 1,123,591 million calls, texts, and chats, up 12% from 2023;
• 47,925 veterans experiencing homelessness were housed in fiscal year 2024 and 96% remain housed long-term;
• 519,453 spouses and dependents received survivor benefits, a 4.5% increase from 2023;
• Services, resources, and assistance provided to a record 88,095 veteran family caregivers, an 18.6% increase over the 2023 record;
• A record 741,259 women veterans received compensation payments, 8.2% more than 2023;
• VA dental clinics provided > 6 million procedures to > 630,000 veterans; through community care, the VA delivered a record additional 3.4 million procedures to > 330,000 veterans.

Other actions this year include: expanding eligibility for VA healthcare to all toxin-exposed veterans years earlier than called for by the PACT Act; expanding access to care across the nation through VA Access Sprints, adding night and weekend clinics, and increasing the number of veterans scheduled into daily clinic schedules; removing copays for the first 3 outpatient mental health care and substance use disorder visits of each calendar year through 2027; expanding access to VA cancer care through establishing new cancer presumptive conditions, expanding access to genetic, lung, and colorectal cancer screening, and expanding the Close to Me cancer care program; expanding access to in vitro fertilization for eligible unmarried veterans and eligible veterans in same-sex marriages; expanding access to VA care and benefits for some former service members discharged under other than honorable conditions; and launching tele-emergency care for veterans nationwide.

The VA will continue to “aggressively reach out to and engage veterans to encourage them to come to VA for the care and benefits they have earned.”  

“Veterans deserve the very best from VA and our nation, and we will never settle for anything less,” said VA Secretary Denis McDonough. “We’re honored that more veterans are getting their earned health care and benefits from VA than ever before, but make no mistake: there is still work to do. We will continue to work each and every day to earn the trust of those we serve — and ensure that all Veterans, their families, and their survivors get the care and benefits they so rightly deserve.”

The US Department of Veterans Affairs (VA) is earning high marks for the quality of care provided to veterans, according to multiple sources. For instance, systematic reviews published in 2023 found that VA health care is consistently as good as, or surpasses, non-VA health care. In the latest Centers for Medicare & Medicaid Services (CMS) annual Overall Hospital Quality Star Ratings, 67% of VA hospitals received either 4 or 5 stars, compared with only 41% of non-VA hospitals.

Veterans themselves are awarding high marks. According to the Medicare nationwide survey of patients, VA hospitals outperformed non-VA hospitals on all 10 core patient satisfaction metrics, including overall hospital rating, communication with doctors, communication about medications, and willingness to recommend the hospital. Furthermore, trust in VA outpatient care has reached an all-time record high of 92%, according to a survey of more than 440,000 veterans.

This year, in fact, the VA has broken a number of its own records. The VA cites other high points:

• More than 127.5 million health care appointments, a 6% increase over last year;
• Shorter wait times: new patients saw an 11% reduction in average wait times for VA primary care and a 7% reduction for mental health care compared to last year;
• $187 billion in benefits to 6.7 million veterans and survivors this year—an all-time record;
• 2,517,519 disability benefit claims processed, a 27% increase over 2023;
• No-cost emergency health care is provided to more than 50,000 veterans in acute suicidal crises; the Veterans Crisis Line supported 1,123,591 million calls, texts, and chats, up 12% from 2023;
• 47,925 veterans experiencing homelessness were housed in fiscal year 2024 and 96% remain housed long-term;
• 519,453 spouses and dependents received survivor benefits, a 4.5% increase from 2023;
• Services, resources, and assistance provided to a record 88,095 veteran family caregivers, an 18.6% increase over the 2023 record;
• A record 741,259 women veterans received compensation payments, 8.2% more than 2023;
• VA dental clinics provided > 6 million procedures to > 630,000 veterans; through community care, the VA delivered a record additional 3.4 million procedures to > 330,000 veterans.

Other actions this year include: expanding eligibility for VA healthcare to all toxin-exposed veterans years earlier than called for by the PACT Act; expanding access to care across the nation through VA Access Sprints, adding night and weekend clinics, and increasing the number of veterans scheduled into daily clinic schedules; removing copays for the first 3 outpatient mental health care and substance use disorder visits of each calendar year through 2027; expanding access to VA cancer care through establishing new cancer presumptive conditions, expanding access to genetic, lung, and colorectal cancer screening, and expanding the Close to Me cancer care program; expanding access to in vitro fertilization for eligible unmarried veterans and eligible veterans in same-sex marriages; expanding access to VA care and benefits for some former service members discharged under other than honorable conditions; and launching tele-emergency care for veterans nationwide.

The VA will continue to “aggressively reach out to and engage veterans to encourage them to come to VA for the care and benefits they have earned.”  

“Veterans deserve the very best from VA and our nation, and we will never settle for anything less,” said VA Secretary Denis McDonough. “We’re honored that more veterans are getting their earned health care and benefits from VA than ever before, but make no mistake: there is still work to do. We will continue to work each and every day to earn the trust of those we serve — and ensure that all Veterans, their families, and their survivors get the care and benefits they so rightly deserve.”

More than one third of patients with cancer visited an emergency department (ED) in the 90 days before their diagnosis, according to a study of medical records from Ontario, Canada.

Researchers examined Institute for Clinical Evaluative Sciences (ICES) data that had been gathered from January 1, 2014, to December 31, 2021. The study focused on patients aged 18 years or older with confirmed primary cancer diagnoses.

Factors associated with an increased likelihood of an ED visit ahead of diagnosis included having certain cancers, living in rural areas, and having less access to primary care, according to study author Keerat Grewal, MD, an emergency physician and clinician scientist at the Schwartz/Reisman Emergency Medicine Institute at Sinai Health in Toronto, Ontario, Canada, and coauthors.

“The ED is a distressing environment for patients to receive a possible cancer diagnosis,” the authors wrote. “Moreover, it is frequently ill equipped to provide ongoing continuity of care, which can lead patients down a poorly defined diagnostic pathway before receiving a confirmed diagnosis based on tissue and a subsequent treatment plan.”

The findings were published online on November 4 in CMAJ).
 

Neurologic Cancers Prominent

In an interview, Grewal said in an interview that the study reflects her desire as an emergency room physician to understand why so many patients with cancer get the initial reports about their disease from clinicians whom they often have just met for the first time.

Among patients with an ED visit before cancer diagnosis, 51.4% were admitted to hospital from the most recent visit.

Compared with patients with a family physician on whom they could rely for routine care, those who had no outpatient visits (odds ratio [OR], 2.09) or fewer than three outpatient visits (OR, 1.41) in the 6-30 months before cancer diagnosis were more likely to have an ED visit before their cancer diagnosis.

Other factors associated with increased odds of ED use before cancer diagnosis included rurality (OR, 1.15), residence in northern Ontario (northeast region: OR, 1.14 and northwest region: OR, 1.27 vs Toronto region), and living in the most marginalized areas (material resource deprivation: OR, 1.37 and housing stability: OR, 1.09 vs least marginalized area).

The researchers also found that patients with certain cancers were more likely to have sought care in the ED. They compared these cancers with breast cancer, which is often detected through screening.

“Patients with neurologic cancers had extremely high odds of ED use before cancer diagnosis,” the authors wrote. “This is likely because of the emergent nature of presentation, with acute neurologic symptoms such as weakness, confusion, or seizures, which require urgent assessment.” On the other hand, pancreatic, liver, or thoracic cancer can trigger nonspecific symptoms that may be ignored until they reach a crisis level that prompts an ED visit.

The limitations of the study included its inability to identify cancer-related ED visits and its narrow focus on patients in Ontario, according to the researchers. But the use of the ICES databases also allowed researchers access to a broader pool of data than are available in many other cases.

The findings in the new paper echo those of previous research, the authors noted. Research in the United Kingdom found that 24%-31% of cancer diagnoses involved the ED. In addition, a study of people enrolled in the US Medicare program, which serves patients aged 65 years or older, found that 23% were seen in the ED in the 30 days before diagnosis.
 

‘Unpacking the Data’

The current findings also are consistent with those of an International Cancer Benchmarking Partnership study that was published in 2022 in The Lancet Oncology, said Erika Nicholson, MHS, vice president of cancer systems and innovation at the Canadian Partnership Against Cancer. The latter study analyzed cancer registration and linked hospital admissions data from 14 jurisdictions in Australia, Canada, Denmark, New Zealand, Norway, and the United Kingdom.

“We see similar trends in terms of people visiting EDs and being diagnosed through EDs internationally,” Nicholson said. “We’re working with partners to put in place different strategies to address the challenges” that this phenomenon presents in terms of improving screening and follow-up care.

“Cancer is not one disease, but many diseases,” she said. “They present differently. We’re focused on really unpacking the data and understanding them.”

All this research highlights the need for more services and personnel to address cancer, including people who are trained to help patients cope after getting concerning news through emergency care, she said.

“That means having a system that fully supports you and helps you navigate through that diagnostic process,” Nicholson said. Addressing the added challenges for patients who don’t have secure housing is a special need, she added.

This study was supported by the Canadian Institutes of Health Research (CIHR). Grewal reported receiving grants from CIHR and the Canadian Association of Emergency Physicians. Nicholson reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

More than one third of patients with cancer visited an emergency department (ED) in the 90 days before their diagnosis, according to a study of medical records from Ontario, Canada.

Researchers examined Institute for Clinical Evaluative Sciences (ICES) data that had been gathered from January 1, 2014, to December 31, 2021. The study focused on patients aged 18 years or older with confirmed primary cancer diagnoses.

Factors associated with an increased likelihood of an ED visit ahead of diagnosis included having certain cancers, living in rural areas, and having less access to primary care, according to study author Keerat Grewal, MD, an emergency physician and clinician scientist at the Schwartz/Reisman Emergency Medicine Institute at Sinai Health in Toronto, Ontario, Canada, and coauthors.

“The ED is a distressing environment for patients to receive a possible cancer diagnosis,” the authors wrote. “Moreover, it is frequently ill equipped to provide ongoing continuity of care, which can lead patients down a poorly defined diagnostic pathway before receiving a confirmed diagnosis based on tissue and a subsequent treatment plan.”

The findings were published online on November 4 in CMAJ).
 

Neurologic Cancers Prominent

In an interview, Grewal said in an interview that the study reflects her desire as an emergency room physician to understand why so many patients with cancer get the initial reports about their disease from clinicians whom they often have just met for the first time.

Among patients with an ED visit before cancer diagnosis, 51.4% were admitted to hospital from the most recent visit.

Compared with patients with a family physician on whom they could rely for routine care, those who had no outpatient visits (odds ratio [OR], 2.09) or fewer than three outpatient visits (OR, 1.41) in the 6-30 months before cancer diagnosis were more likely to have an ED visit before their cancer diagnosis.

Other factors associated with increased odds of ED use before cancer diagnosis included rurality (OR, 1.15), residence in northern Ontario (northeast region: OR, 1.14 and northwest region: OR, 1.27 vs Toronto region), and living in the most marginalized areas (material resource deprivation: OR, 1.37 and housing stability: OR, 1.09 vs least marginalized area).

The researchers also found that patients with certain cancers were more likely to have sought care in the ED. They compared these cancers with breast cancer, which is often detected through screening.

“Patients with neurologic cancers had extremely high odds of ED use before cancer diagnosis,” the authors wrote. “This is likely because of the emergent nature of presentation, with acute neurologic symptoms such as weakness, confusion, or seizures, which require urgent assessment.” On the other hand, pancreatic, liver, or thoracic cancer can trigger nonspecific symptoms that may be ignored until they reach a crisis level that prompts an ED visit.

The limitations of the study included its inability to identify cancer-related ED visits and its narrow focus on patients in Ontario, according to the researchers. But the use of the ICES databases also allowed researchers access to a broader pool of data than are available in many other cases.

The findings in the new paper echo those of previous research, the authors noted. Research in the United Kingdom found that 24%-31% of cancer diagnoses involved the ED. In addition, a study of people enrolled in the US Medicare program, which serves patients aged 65 years or older, found that 23% were seen in the ED in the 30 days before diagnosis.
 

‘Unpacking the Data’

The current findings also are consistent with those of an International Cancer Benchmarking Partnership study that was published in 2022 in The Lancet Oncology, said Erika Nicholson, MHS, vice president of cancer systems and innovation at the Canadian Partnership Against Cancer. The latter study analyzed cancer registration and linked hospital admissions data from 14 jurisdictions in Australia, Canada, Denmark, New Zealand, Norway, and the United Kingdom.

“We see similar trends in terms of people visiting EDs and being diagnosed through EDs internationally,” Nicholson said. “We’re working with partners to put in place different strategies to address the challenges” that this phenomenon presents in terms of improving screening and follow-up care.

“Cancer is not one disease, but many diseases,” she said. “They present differently. We’re focused on really unpacking the data and understanding them.”

All this research highlights the need for more services and personnel to address cancer, including people who are trained to help patients cope after getting concerning news through emergency care, she said.

“That means having a system that fully supports you and helps you navigate through that diagnostic process,” Nicholson said. Addressing the added challenges for patients who don’t have secure housing is a special need, she added.

This study was supported by the Canadian Institutes of Health Research (CIHR). Grewal reported receiving grants from CIHR and the Canadian Association of Emergency Physicians. Nicholson reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

More than one third of patients with cancer visited an emergency department (ED) in the 90 days before their diagnosis, according to a study of medical records from Ontario, Canada.

Researchers examined Institute for Clinical Evaluative Sciences (ICES) data that had been gathered from January 1, 2014, to December 31, 2021. The study focused on patients aged 18 years or older with confirmed primary cancer diagnoses.

Factors associated with an increased likelihood of an ED visit ahead of diagnosis included having certain cancers, living in rural areas, and having less access to primary care, according to study author Keerat Grewal, MD, an emergency physician and clinician scientist at the Schwartz/Reisman Emergency Medicine Institute at Sinai Health in Toronto, Ontario, Canada, and coauthors.

“The ED is a distressing environment for patients to receive a possible cancer diagnosis,” the authors wrote. “Moreover, it is frequently ill equipped to provide ongoing continuity of care, which can lead patients down a poorly defined diagnostic pathway before receiving a confirmed diagnosis based on tissue and a subsequent treatment plan.”

The findings were published online on November 4 in CMAJ).
 

Neurologic Cancers Prominent

In an interview, Grewal said in an interview that the study reflects her desire as an emergency room physician to understand why so many patients with cancer get the initial reports about their disease from clinicians whom they often have just met for the first time.

Among patients with an ED visit before cancer diagnosis, 51.4% were admitted to hospital from the most recent visit.

Compared with patients with a family physician on whom they could rely for routine care, those who had no outpatient visits (odds ratio [OR], 2.09) or fewer than three outpatient visits (OR, 1.41) in the 6-30 months before cancer diagnosis were more likely to have an ED visit before their cancer diagnosis.

Other factors associated with increased odds of ED use before cancer diagnosis included rurality (OR, 1.15), residence in northern Ontario (northeast region: OR, 1.14 and northwest region: OR, 1.27 vs Toronto region), and living in the most marginalized areas (material resource deprivation: OR, 1.37 and housing stability: OR, 1.09 vs least marginalized area).

The researchers also found that patients with certain cancers were more likely to have sought care in the ED. They compared these cancers with breast cancer, which is often detected through screening.

“Patients with neurologic cancers had extremely high odds of ED use before cancer diagnosis,” the authors wrote. “This is likely because of the emergent nature of presentation, with acute neurologic symptoms such as weakness, confusion, or seizures, which require urgent assessment.” On the other hand, pancreatic, liver, or thoracic cancer can trigger nonspecific symptoms that may be ignored until they reach a crisis level that prompts an ED visit.

The limitations of the study included its inability to identify cancer-related ED visits and its narrow focus on patients in Ontario, according to the researchers. But the use of the ICES databases also allowed researchers access to a broader pool of data than are available in many other cases.

The findings in the new paper echo those of previous research, the authors noted. Research in the United Kingdom found that 24%-31% of cancer diagnoses involved the ED. In addition, a study of people enrolled in the US Medicare program, which serves patients aged 65 years or older, found that 23% were seen in the ED in the 30 days before diagnosis.
 

‘Unpacking the Data’

The current findings also are consistent with those of an International Cancer Benchmarking Partnership study that was published in 2022 in The Lancet Oncology, said Erika Nicholson, MHS, vice president of cancer systems and innovation at the Canadian Partnership Against Cancer. The latter study analyzed cancer registration and linked hospital admissions data from 14 jurisdictions in Australia, Canada, Denmark, New Zealand, Norway, and the United Kingdom.

“We see similar trends in terms of people visiting EDs and being diagnosed through EDs internationally,” Nicholson said. “We’re working with partners to put in place different strategies to address the challenges” that this phenomenon presents in terms of improving screening and follow-up care.

“Cancer is not one disease, but many diseases,” she said. “They present differently. We’re focused on really unpacking the data and understanding them.”

All this research highlights the need for more services and personnel to address cancer, including people who are trained to help patients cope after getting concerning news through emergency care, she said.

“That means having a system that fully supports you and helps you navigate through that diagnostic process,” Nicholson said. Addressing the added challenges for patients who don’t have secure housing is a special need, she added.

This study was supported by the Canadian Institutes of Health Research (CIHR). Grewal reported receiving grants from CIHR and the Canadian Association of Emergency Physicians. Nicholson reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

Veterans Health Administration cancer centers are lacking registered dieticians (RDs), and patients are more likely to be diagnosed with malnutrition when they are on staff, according to a new study.

The average number of full-time RDs across 13 cancer centers was just 1 per 1,065 patients, advanced practice oncology dietitian Katherine Petersen, MS, RDN, CSO, of the Phoenix VA Health Care System, reported at the AVAHO annual meeting.

However, patients treated by RDs were more likely to be diagnosed with malnutrition (odds ratio [OR], 2.9, 95% CI, 1.6-5.1). And patients were more likely to maintain weight if their clinic had a higher ratio of RDs to oncologists (OR, 1.6 for each 10% increase in ratio, 95% CI, 2.0-127.5).

Petersen told Federal Practitioner that dieticians came up with the idea for the study after attending AVAHO meetings. “A lot of the questions we were getting from physicians and other providers were: How do we get dietitians in our clinic?”

There is currently no standard staffing model for dieticians in oncology centers, Petersen said, and they are not reimbursed through Medicare or Medicaid. “We thought, ‘What do we add to the cancer center by having adequate staffing levels and seeing cancer patients?’ We designed a study to try and get to the heart of that.”

Petersen and her team focused on malnutrition. Nutrition impairment impacts an estimated 40% to 80% of patients with gastrointestinal, head and neck, pancreas, and colorectal cancer at diagnosis, she said.

Petersen discussed the published evidence that outlines how physicians recognize malnutrition at a lower rate than RDs. Dietary counseling from an RD is linked to better nutritional outcomes, physical function, and quality of life.

The study authors examined 2016 and 2017 VA registry data and reviewed charts of 681 veterans treated by 207 oncologists. Oncology clinics had a mean of 0.5 full-time equivalent (FTE) RD. The mean ratio of full-time RDs to oncologists was 1 per 48.5 and ranged from 1 per 4 to 1 per 850.

“It's almost like somebody randomly assigned [RDs] to cancer centers, and it has nothing to do with how many patients are seen in that particular center,” Petersen said. “Some clinics only have .1 or .2 FTEs assigned, and that may be a larger cancer center where they have maybe 85 cancer oncology providers, which includes surgical, medical, and radiation oncology and trainees.”

Why would a clinic have a .1 FTE RD, which suggests someone may be working 4 hours a week? In this kind of situation, an RD may cover a variety of areas and only work in cancer care when they receive a referral, Petersen said.

“That is just vastly underserving veterans,” she said. “You're missing so many veterans whom you could help with preventative care if you're only getting patients referred based on consults.”

As for the findings regarding higher RD staffing and higher detection of malnutrition, the study text notes “there was not a ‘high enough’ level of RD staffing at which we stopped seeing this trend. This is probably because – at least at the time of this study – no VA cancer center was adequately staffed for nutrition.”

Petersen hopes the findings will convince VA cancer center leadership to boost better patient outcomes by prioritizing the hiring of RDs.

Katherine Petersen, MS, RDN, CSO has no disclosures.

Veterans Health Administration cancer centers are lacking registered dieticians (RDs), and patients are more likely to be diagnosed with malnutrition when they are on staff, according to a new study.

The average number of full-time RDs across 13 cancer centers was just 1 per 1,065 patients, advanced practice oncology dietitian Katherine Petersen, MS, RDN, CSO, of the Phoenix VA Health Care System, reported at the AVAHO annual meeting.

However, patients treated by RDs were more likely to be diagnosed with malnutrition (odds ratio [OR], 2.9, 95% CI, 1.6-5.1). And patients were more likely to maintain weight if their clinic had a higher ratio of RDs to oncologists (OR, 1.6 for each 10% increase in ratio, 95% CI, 2.0-127.5).

Petersen told Federal Practitioner that dieticians came up with the idea for the study after attending AVAHO meetings. “A lot of the questions we were getting from physicians and other providers were: How do we get dietitians in our clinic?”

There is currently no standard staffing model for dieticians in oncology centers, Petersen said, and they are not reimbursed through Medicare or Medicaid. “We thought, ‘What do we add to the cancer center by having adequate staffing levels and seeing cancer patients?’ We designed a study to try and get to the heart of that.”

Petersen and her team focused on malnutrition. Nutrition impairment impacts an estimated 40% to 80% of patients with gastrointestinal, head and neck, pancreas, and colorectal cancer at diagnosis, she said.

Petersen discussed the published evidence that outlines how physicians recognize malnutrition at a lower rate than RDs. Dietary counseling from an RD is linked to better nutritional outcomes, physical function, and quality of life.

The study authors examined 2016 and 2017 VA registry data and reviewed charts of 681 veterans treated by 207 oncologists. Oncology clinics had a mean of 0.5 full-time equivalent (FTE) RD. The mean ratio of full-time RDs to oncologists was 1 per 48.5 and ranged from 1 per 4 to 1 per 850.

“It's almost like somebody randomly assigned [RDs] to cancer centers, and it has nothing to do with how many patients are seen in that particular center,” Petersen said. “Some clinics only have .1 or .2 FTEs assigned, and that may be a larger cancer center where they have maybe 85 cancer oncology providers, which includes surgical, medical, and radiation oncology and trainees.”

Why would a clinic have a .1 FTE RD, which suggests someone may be working 4 hours a week? In this kind of situation, an RD may cover a variety of areas and only work in cancer care when they receive a referral, Petersen said.

“That is just vastly underserving veterans,” she said. “You're missing so many veterans whom you could help with preventative care if you're only getting patients referred based on consults.”

As for the findings regarding higher RD staffing and higher detection of malnutrition, the study text notes “there was not a ‘high enough’ level of RD staffing at which we stopped seeing this trend. This is probably because – at least at the time of this study – no VA cancer center was adequately staffed for nutrition.”

Petersen hopes the findings will convince VA cancer center leadership to boost better patient outcomes by prioritizing the hiring of RDs.

Katherine Petersen, MS, RDN, CSO has no disclosures.

Veterans Health Administration cancer centers are lacking registered dieticians (RDs), and patients are more likely to be diagnosed with malnutrition when they are on staff, according to a new study.

The average number of full-time RDs across 13 cancer centers was just 1 per 1,065 patients, advanced practice oncology dietitian Katherine Petersen, MS, RDN, CSO, of the Phoenix VA Health Care System, reported at the AVAHO annual meeting.

However, patients treated by RDs were more likely to be diagnosed with malnutrition (odds ratio [OR], 2.9, 95% CI, 1.6-5.1). And patients were more likely to maintain weight if their clinic had a higher ratio of RDs to oncologists (OR, 1.6 for each 10% increase in ratio, 95% CI, 2.0-127.5).

Petersen told Federal Practitioner that dieticians came up with the idea for the study after attending AVAHO meetings. “A lot of the questions we were getting from physicians and other providers were: How do we get dietitians in our clinic?”

There is currently no standard staffing model for dieticians in oncology centers, Petersen said, and they are not reimbursed through Medicare or Medicaid. “We thought, ‘What do we add to the cancer center by having adequate staffing levels and seeing cancer patients?’ We designed a study to try and get to the heart of that.”

Petersen and her team focused on malnutrition. Nutrition impairment impacts an estimated 40% to 80% of patients with gastrointestinal, head and neck, pancreas, and colorectal cancer at diagnosis, she said.

Petersen discussed the published evidence that outlines how physicians recognize malnutrition at a lower rate than RDs. Dietary counseling from an RD is linked to better nutritional outcomes, physical function, and quality of life.

The study authors examined 2016 and 2017 VA registry data and reviewed charts of 681 veterans treated by 207 oncologists. Oncology clinics had a mean of 0.5 full-time equivalent (FTE) RD. The mean ratio of full-time RDs to oncologists was 1 per 48.5 and ranged from 1 per 4 to 1 per 850.

“It's almost like somebody randomly assigned [RDs] to cancer centers, and it has nothing to do with how many patients are seen in that particular center,” Petersen said. “Some clinics only have .1 or .2 FTEs assigned, and that may be a larger cancer center where they have maybe 85 cancer oncology providers, which includes surgical, medical, and radiation oncology and trainees.”

Why would a clinic have a .1 FTE RD, which suggests someone may be working 4 hours a week? In this kind of situation, an RD may cover a variety of areas and only work in cancer care when they receive a referral, Petersen said.

“That is just vastly underserving veterans,” she said. “You're missing so many veterans whom you could help with preventative care if you're only getting patients referred based on consults.”

As for the findings regarding higher RD staffing and higher detection of malnutrition, the study text notes “there was not a ‘high enough’ level of RD staffing at which we stopped seeing this trend. This is probably because – at least at the time of this study – no VA cancer center was adequately staffed for nutrition.”

Petersen hopes the findings will convince VA cancer center leadership to boost better patient outcomes by prioritizing the hiring of RDs.

Katherine Petersen, MS, RDN, CSO has no disclosures.

TOPLINE:

Higher plasma levels of omega-6 and omega-3 fatty acids are associated with a lower incidence of cancer. However, omega-3 fatty acids are linked to an increased risk for prostate cancer, specifically.

METHODOLOGY:

• Researchers looked for associations of plasma omega-3 and omega-6 polyunsaturated fatty acids (PUFAs) with the incidence of cancer overall and 19 site-specific cancers in the large population-based prospective UK Biobank cohort.
• They included 253,138 participants aged 37-73 years who were followed for an average of 12.9 years, with 29,838 diagnosed with cancer.
• Plasma levels of omega-3 and omega-6 fatty acids were measured using nuclear magnetic resonance and expressed as percentages of total fatty acids.
• Participants with cancer diagnoses at baseline, those who withdrew from the study, and those with missing data on plasma PUFAs were excluded.
• The study adjusted for multiple covariates, including age, sex, ethnicity, socioeconomic status, lifestyle behaviors, and family history of diseases.

TAKEAWAY:

• Higher plasma levels of omega-6 and omega-3 fatty acids were associated with a 2% and 1% reduction in overall cancer risk per SD increase, respectively (P = .001 and P = .03).
• Omega-6 fatty acids were inversely associated with 14 site-specific cancers, whereas omega-3 fatty acids were inversely associated with five site-specific cancers.
• Prostate cancer was positively associated with omega-3 fatty acids, with a 3% increased risk per SD increase (P = .049).
• A higher omega-6/omega-3 ratio was associated with an increased risk for overall cancer, and three site-specific cancers showed positive associations with the ratio. “Each standard deviation increase, corresponding to a 13.13 increase in the omega ratio, was associated with a 2% increase in the risk of rectum cancer,” for example, the authors wrote.

IN PRACTICE:

“Overall, our findings provide support for possible small net protective roles of omega-3 and omega-6 PUFAs in the development of new cancer incidence. Our study also suggests that the usage of circulating blood biomarkers captures different aspects of dietary intake, reduces measurement errors, and thus enhances statistical power. The differential effects of omega-6% and omega-3% in age and sex subgroups warrant future investigation,” wrote the authors of the study.

SOURCE:

The study was led by Yuchen Zhang of the University of Georgia in Athens, Georgia. It was published online in the International Journal of Cancer.

LIMITATIONS:

The study’s potential for selective bias persists due to the participant sample skewing heavily toward European ancestry and White ethnicity. The number of events was small for some specific cancer sites, which may have limited the statistical power. The study focused on total omega-3 and omega-6 PUFAs, with only two individual fatty acids measured. Future studies are needed to examine the roles of other individual PUFAs and specific genetic variants. 

DISCLOSURES:

This study was supported by grants from the National Institute of General Medical Sciences of the National Institutes of Health. No relevant conflicts of interest were disclosed by the authors.
 

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

TOPLINE:

Higher plasma levels of omega-6 and omega-3 fatty acids are associated with a lower incidence of cancer. However, omega-3 fatty acids are linked to an increased risk for prostate cancer, specifically.

METHODOLOGY:

• Researchers looked for associations of plasma omega-3 and omega-6 polyunsaturated fatty acids (PUFAs) with the incidence of cancer overall and 19 site-specific cancers in the large population-based prospective UK Biobank cohort.
• They included 253,138 participants aged 37-73 years who were followed for an average of 12.9 years, with 29,838 diagnosed with cancer.
• Plasma levels of omega-3 and omega-6 fatty acids were measured using nuclear magnetic resonance and expressed as percentages of total fatty acids.
• Participants with cancer diagnoses at baseline, those who withdrew from the study, and those with missing data on plasma PUFAs were excluded.
• The study adjusted for multiple covariates, including age, sex, ethnicity, socioeconomic status, lifestyle behaviors, and family history of diseases.

TAKEAWAY:

• Higher plasma levels of omega-6 and omega-3 fatty acids were associated with a 2% and 1% reduction in overall cancer risk per SD increase, respectively (P = .001 and P = .03).
• Omega-6 fatty acids were inversely associated with 14 site-specific cancers, whereas omega-3 fatty acids were inversely associated with five site-specific cancers.
• Prostate cancer was positively associated with omega-3 fatty acids, with a 3% increased risk per SD increase (P = .049).
• A higher omega-6/omega-3 ratio was associated with an increased risk for overall cancer, and three site-specific cancers showed positive associations with the ratio. “Each standard deviation increase, corresponding to a 13.13 increase in the omega ratio, was associated with a 2% increase in the risk of rectum cancer,” for example, the authors wrote.

IN PRACTICE:

“Overall, our findings provide support for possible small net protective roles of omega-3 and omega-6 PUFAs in the development of new cancer incidence. Our study also suggests that the usage of circulating blood biomarkers captures different aspects of dietary intake, reduces measurement errors, and thus enhances statistical power. The differential effects of omega-6% and omega-3% in age and sex subgroups warrant future investigation,” wrote the authors of the study.

SOURCE:

The study was led by Yuchen Zhang of the University of Georgia in Athens, Georgia. It was published online in the International Journal of Cancer.

LIMITATIONS:

The study’s potential for selective bias persists due to the participant sample skewing heavily toward European ancestry and White ethnicity. The number of events was small for some specific cancer sites, which may have limited the statistical power. The study focused on total omega-3 and omega-6 PUFAs, with only two individual fatty acids measured. Future studies are needed to examine the roles of other individual PUFAs and specific genetic variants. 

DISCLOSURES:

This study was supported by grants from the National Institute of General Medical Sciences of the National Institutes of Health. No relevant conflicts of interest were disclosed by the authors.
 

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

TOPLINE:

Higher plasma levels of omega-6 and omega-3 fatty acids are associated with a lower incidence of cancer. However, omega-3 fatty acids are linked to an increased risk for prostate cancer, specifically.

METHODOLOGY:

• Researchers looked for associations of plasma omega-3 and omega-6 polyunsaturated fatty acids (PUFAs) with the incidence of cancer overall and 19 site-specific cancers in the large population-based prospective UK Biobank cohort.
• They included 253,138 participants aged 37-73 years who were followed for an average of 12.9 years, with 29,838 diagnosed with cancer.
• Plasma levels of omega-3 and omega-6 fatty acids were measured using nuclear magnetic resonance and expressed as percentages of total fatty acids.
• Participants with cancer diagnoses at baseline, those who withdrew from the study, and those with missing data on plasma PUFAs were excluded.
• The study adjusted for multiple covariates, including age, sex, ethnicity, socioeconomic status, lifestyle behaviors, and family history of diseases.

TAKEAWAY:

• Higher plasma levels of omega-6 and omega-3 fatty acids were associated with a 2% and 1% reduction in overall cancer risk per SD increase, respectively (P = .001 and P = .03).
• Omega-6 fatty acids were inversely associated with 14 site-specific cancers, whereas omega-3 fatty acids were inversely associated with five site-specific cancers.
• Prostate cancer was positively associated with omega-3 fatty acids, with a 3% increased risk per SD increase (P = .049).
• A higher omega-6/omega-3 ratio was associated with an increased risk for overall cancer, and three site-specific cancers showed positive associations with the ratio. “Each standard deviation increase, corresponding to a 13.13 increase in the omega ratio, was associated with a 2% increase in the risk of rectum cancer,” for example, the authors wrote.

IN PRACTICE:

“Overall, our findings provide support for possible small net protective roles of omega-3 and omega-6 PUFAs in the development of new cancer incidence. Our study also suggests that the usage of circulating blood biomarkers captures different aspects of dietary intake, reduces measurement errors, and thus enhances statistical power. The differential effects of omega-6% and omega-3% in age and sex subgroups warrant future investigation,” wrote the authors of the study.

SOURCE:

The study was led by Yuchen Zhang of the University of Georgia in Athens, Georgia. It was published online in the International Journal of Cancer.

LIMITATIONS:

The study’s potential for selective bias persists due to the participant sample skewing heavily toward European ancestry and White ethnicity. The number of events was small for some specific cancer sites, which may have limited the statistical power. The study focused on total omega-3 and omega-6 PUFAs, with only two individual fatty acids measured. Future studies are needed to examine the roles of other individual PUFAs and specific genetic variants. 

DISCLOSURES:

This study was supported by grants from the National Institute of General Medical Sciences of the National Institutes of Health. No relevant conflicts of interest were disclosed by the authors.
 

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

The US Department of Veterans Affairs (VA) is awarding $15.9 million in grants to fund adaptive sports, recreational activities, and equine therapy for > 15,000 veterans and service members living with disabilities.

Marine Corps veteran Jataya Taylor — who competed in wheelchair fencing at the 2024 Paralympics — experienced mental health symptoms until she began participating in adaptive sports through an organization supported by the VA Adaptive Sports Grant Program.

“Getting involved in adaptive sports was a saving grace for me,” Taylor said. “Participating in these programs got me on the bike to start with, then got me climbing, and eventually it became an important part of my mental health to participate. I found my people. I found my new network of friends.”

Adaptive sports, which are customized to fit the needs of veterans with disabilities, include paralympic sports, archery, cycling, skiing, hunting, rock climbing, and sky diving. Mike Gooler, another Marine Corps veteran, praised the Adaptive Sports Center’s facilities in Crested Butte, Colorado, calling it “nothing short of amazing.”

“[S]ki therapy has been instrumental in helping me navigate through my experiences and injuries,” Gooler said. “Skiing provides me with sense of freedom and empowerment … and having my family by my side, witnessing my progress and sharing the joy of skiing, was truly special.”

The grant program is facilitated and managed by the National Veterans Sports Programs and Special Events Office and will provide grants to 91 national, regional, and community-based programs for fiscal year 2024 across all 50 states, the District of Columbia, Guam, and Puerto Rico.

“These grants give veterans life-changing opportunities,” Secretary of VA Denis McDonough said. “We know adaptive sports and recreational activities can be transformational for veterans living with disabilities, improving their overall physical and mental health, and also giving them important community with fellow heroes who served.”

Information about the awardees and details of the program are available at www.va.gov/adaptivesports and on Facebook at Sports4Vets.

The US Department of Veterans Affairs (VA) is awarding $15.9 million in grants to fund adaptive sports, recreational activities, and equine therapy for > 15,000 veterans and service members living with disabilities.

Marine Corps veteran Jataya Taylor — who competed in wheelchair fencing at the 2024 Paralympics — experienced mental health symptoms until she began participating in adaptive sports through an organization supported by the VA Adaptive Sports Grant Program.

“Getting involved in adaptive sports was a saving grace for me,” Taylor said. “Participating in these programs got me on the bike to start with, then got me climbing, and eventually it became an important part of my mental health to participate. I found my people. I found my new network of friends.”

Adaptive sports, which are customized to fit the needs of veterans with disabilities, include paralympic sports, archery, cycling, skiing, hunting, rock climbing, and sky diving. Mike Gooler, another Marine Corps veteran, praised the Adaptive Sports Center’s facilities in Crested Butte, Colorado, calling it “nothing short of amazing.”

“[S]ki therapy has been instrumental in helping me navigate through my experiences and injuries,” Gooler said. “Skiing provides me with sense of freedom and empowerment … and having my family by my side, witnessing my progress and sharing the joy of skiing, was truly special.”

The grant program is facilitated and managed by the National Veterans Sports Programs and Special Events Office and will provide grants to 91 national, regional, and community-based programs for fiscal year 2024 across all 50 states, the District of Columbia, Guam, and Puerto Rico.

“These grants give veterans life-changing opportunities,” Secretary of VA Denis McDonough said. “We know adaptive sports and recreational activities can be transformational for veterans living with disabilities, improving their overall physical and mental health, and also giving them important community with fellow heroes who served.”

Information about the awardees and details of the program are available at www.va.gov/adaptivesports and on Facebook at Sports4Vets.

The US Department of Veterans Affairs (VA) is awarding $15.9 million in grants to fund adaptive sports, recreational activities, and equine therapy for > 15,000 veterans and service members living with disabilities.

Marine Corps veteran Jataya Taylor — who competed in wheelchair fencing at the 2024 Paralympics — experienced mental health symptoms until she began participating in adaptive sports through an organization supported by the VA Adaptive Sports Grant Program.

“Getting involved in adaptive sports was a saving grace for me,” Taylor said. “Participating in these programs got me on the bike to start with, then got me climbing, and eventually it became an important part of my mental health to participate. I found my people. I found my new network of friends.”

Adaptive sports, which are customized to fit the needs of veterans with disabilities, include paralympic sports, archery, cycling, skiing, hunting, rock climbing, and sky diving. Mike Gooler, another Marine Corps veteran, praised the Adaptive Sports Center’s facilities in Crested Butte, Colorado, calling it “nothing short of amazing.”

“[S]ki therapy has been instrumental in helping me navigate through my experiences and injuries,” Gooler said. “Skiing provides me with sense of freedom and empowerment … and having my family by my side, witnessing my progress and sharing the joy of skiing, was truly special.”

The grant program is facilitated and managed by the National Veterans Sports Programs and Special Events Office and will provide grants to 91 national, regional, and community-based programs for fiscal year 2024 across all 50 states, the District of Columbia, Guam, and Puerto Rico.

“These grants give veterans life-changing opportunities,” Secretary of VA Denis McDonough said. “We know adaptive sports and recreational activities can be transformational for veterans living with disabilities, improving their overall physical and mental health, and also giving them important community with fellow heroes who served.”

Information about the awardees and details of the program are available at www.va.gov/adaptivesports and on Facebook at Sports4Vets.

The Food and Drug Administration (FDA) has approved a 10-mg dose of Roxybond (Protega Pharmaceuticals), an opioid analgesic indicated for the management of severe pain in cases where other treatments are not well-tolerated or prove ineffective.

Roxybond, an immediate-release (IR) formulation of oxycodone hydrochloride, is made with Protega’s SentryBond technology, which makes it harder for people to crush, inject, or snort, according to the company.

In a statement from Protega, Paul Howe, the company’s chief commercial officer, said the drug meets an “unmet need for an IR opioid with abuse-deterrent technology that may reduce misuse and abuse while providing pain relief to medically appropriate patients when used as indicated.”

To determine the tablet’s ability to withstand manipulation, more than 2000 in vitro tests were conducted, according to the release. The findings indicate Roxybond reduces — but does not entirely negate — the potential for intranasal and intravenous abuse.

Roxybond was previously approved in 5-, 15-, and 30-mg doses. The 10 mg option provides clinicians with the ability to better modify side effects, manage titration, and provide precision care for patients on opioid therapy, according to Protega.

“For patients, the range of doses can provide better pain control, reduce the risk of side effects, and provide a smoother transition during dosing transitions,” the company stated.

Roxybond is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma, gastrointestinal obstruction, or hypersensitivity to oxycodone. The drug is not intended for long-term use unless otherwise determined by a clinician. Roxybond also is subject to the FDA’s Risk Evaluation and Mitigation Strategies for opioids.

“The development of Roxybond with SentryBond is a step forward in fighting the national epidemic of prescription opioid overdose,” said Eric Kinzler, PhD, vice president of medical and regulatory affairs for Protega, in a release. “Protega is dedicated to our mission to block the path to abuse and work with healthcare professionals across the continuum of care to reduce misuse and abuse.”

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

The Food and Drug Administration (FDA) has approved a 10-mg dose of Roxybond (Protega Pharmaceuticals), an opioid analgesic indicated for the management of severe pain in cases where other treatments are not well-tolerated or prove ineffective.

Roxybond, an immediate-release (IR) formulation of oxycodone hydrochloride, is made with Protega’s SentryBond technology, which makes it harder for people to crush, inject, or snort, according to the company.

In a statement from Protega, Paul Howe, the company’s chief commercial officer, said the drug meets an “unmet need for an IR opioid with abuse-deterrent technology that may reduce misuse and abuse while providing pain relief to medically appropriate patients when used as indicated.”

To determine the tablet’s ability to withstand manipulation, more than 2000 in vitro tests were conducted, according to the release. The findings indicate Roxybond reduces — but does not entirely negate — the potential for intranasal and intravenous abuse.

Roxybond was previously approved in 5-, 15-, and 30-mg doses. The 10 mg option provides clinicians with the ability to better modify side effects, manage titration, and provide precision care for patients on opioid therapy, according to Protega.

“For patients, the range of doses can provide better pain control, reduce the risk of side effects, and provide a smoother transition during dosing transitions,” the company stated.

Roxybond is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma, gastrointestinal obstruction, or hypersensitivity to oxycodone. The drug is not intended for long-term use unless otherwise determined by a clinician. Roxybond also is subject to the FDA’s Risk Evaluation and Mitigation Strategies for opioids.

“The development of Roxybond with SentryBond is a step forward in fighting the national epidemic of prescription opioid overdose,” said Eric Kinzler, PhD, vice president of medical and regulatory affairs for Protega, in a release. “Protega is dedicated to our mission to block the path to abuse and work with healthcare professionals across the continuum of care to reduce misuse and abuse.”

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

The Food and Drug Administration (FDA) has approved a 10-mg dose of Roxybond (Protega Pharmaceuticals), an opioid analgesic indicated for the management of severe pain in cases where other treatments are not well-tolerated or prove ineffective.

Roxybond, an immediate-release (IR) formulation of oxycodone hydrochloride, is made with Protega’s SentryBond technology, which makes it harder for people to crush, inject, or snort, according to the company.

In a statement from Protega, Paul Howe, the company’s chief commercial officer, said the drug meets an “unmet need for an IR opioid with abuse-deterrent technology that may reduce misuse and abuse while providing pain relief to medically appropriate patients when used as indicated.”

To determine the tablet’s ability to withstand manipulation, more than 2000 in vitro tests were conducted, according to the release. The findings indicate Roxybond reduces — but does not entirely negate — the potential for intranasal and intravenous abuse.

Roxybond was previously approved in 5-, 15-, and 30-mg doses. The 10 mg option provides clinicians with the ability to better modify side effects, manage titration, and provide precision care for patients on opioid therapy, according to Protega.

“For patients, the range of doses can provide better pain control, reduce the risk of side effects, and provide a smoother transition during dosing transitions,” the company stated.

Roxybond is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma, gastrointestinal obstruction, or hypersensitivity to oxycodone. The drug is not intended for long-term use unless otherwise determined by a clinician. Roxybond also is subject to the FDA’s Risk Evaluation and Mitigation Strategies for opioids.

“The development of Roxybond with SentryBond is a step forward in fighting the national epidemic of prescription opioid overdose,” said Eric Kinzler, PhD, vice president of medical and regulatory affairs for Protega, in a release. “Protega is dedicated to our mission to block the path to abuse and work with healthcare professionals across the continuum of care to reduce misuse and abuse.”

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

A group of researchers from the University of Pennsylvania, Philadelphia, has developed a messenger RNA (mRNA) vaccine, delivered via lipid nanoparticles (LNPs) — the same type as the COVID-19 vaccine produced by Moderna and Pfizer — targeting Clostridioides difficile (formerly Clostridium difficile). According to the authors, the results of their preclinical study, published in Science, demonstrated this technology as a promising platform for C difficile vaccine development and could be the starting point for curbing intestinal infections that, in their most severe forms (pseudomembranous colitis, toxic megacolon), can be fatal.

An Increasingly Pressing Issue

C difficile is the leading cause of infectious diarrhea acquired in healthcare settings. In recent years, community-acquired C difficile infections have also become more frequent. The increase in infections has been attributed to the emergence of highly virulent and antibiotic-resistant strains.

A 2019 study reported a global incidence of C difficile infections at 2.2 per 1000 hospital admissions per year and 3.5 per 10,000 patient-days per year.
 

The Vaccine Candidate

Vaccine candidates tested so far have used toxoids or recombinant proteins targeting the combined repetitive oligopeptide (CROP) or receptor-binding domain (RBD) of the two primary C difficile toxins, TcdA and TcdB. The US researchers are now exploring the mRNA-LNP vaccine approach to target multiple antigens simultaneously. They developed a bivalent vaccine (including the CROP and RBD domains of both toxins) and a trivalent vaccine (with an additional virulence factor, the metalloprotease Pro-Pro endopeptidase-1).

Mice vaccinated with the bivalent and trivalent vaccines produced immunoglobulin G antibody titers two to four times higher than those elicited by recombinant protein with an adjuvant. The vaccination stimulated the proliferation of follicular T helper cells and the antigen-specific response of B lymphocytes, laying the foundation for a strong and long-lasting humoral response. The vaccines were also immunogenic in hamsters.

Vaccinated mice not only survived a toxin dose five times higher than the 100% lethal dose but also demonstrated the vaccine’s protective effect through serum transfer; unvaccinated mice given serum from vaccinated mice survived the lethal challenge. More importantly, when exposed to a lethal dose of the bacterium itself, all vaccinated mice survived.

To demonstrate the vaccine’s efficacy in patients with a history of C difficile infection and high recurrence risk — ideal candidates for vaccination — the researchers vaccinated mice that had previously survived a sublethal infection. Six months after the initial infection and vaccination, these mice remained protected against mortality when reexposed to the bacterium.

Additionally, a quadrivalent vaccine that included an immunogen targeting C difficile spores — key agents in transmission — also proved effective. Low levels of bacteria and toxins in the feces of mice vaccinated in this way suggested that spore vaccination could limit initial colonization.

In tests with nonhuman primates, two doses of the vaccines targeting either the vegetative form or the spores elicited strong immune responses against bacterial toxins and virulence factors. Human trials may indeed be on the horizon.
 

This story was translated from Univadis Italy 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.

A group of researchers from the University of Pennsylvania, Philadelphia, has developed a messenger RNA (mRNA) vaccine, delivered via lipid nanoparticles (LNPs) — the same type as the COVID-19 vaccine produced by Moderna and Pfizer — targeting Clostridioides difficile (formerly Clostridium difficile). According to the authors, the results of their preclinical study, published in Science, demonstrated this technology as a promising platform for C difficile vaccine development and could be the starting point for curbing intestinal infections that, in their most severe forms (pseudomembranous colitis, toxic megacolon), can be fatal.

An Increasingly Pressing Issue

C difficile is the leading cause of infectious diarrhea acquired in healthcare settings. In recent years, community-acquired C difficile infections have also become more frequent. The increase in infections has been attributed to the emergence of highly virulent and antibiotic-resistant strains.

A 2019 study reported a global incidence of C difficile infections at 2.2 per 1000 hospital admissions per year and 3.5 per 10,000 patient-days per year.
 

The Vaccine Candidate

Vaccine candidates tested so far have used toxoids or recombinant proteins targeting the combined repetitive oligopeptide (CROP) or receptor-binding domain (RBD) of the two primary C difficile toxins, TcdA and TcdB. The US researchers are now exploring the mRNA-LNP vaccine approach to target multiple antigens simultaneously. They developed a bivalent vaccine (including the CROP and RBD domains of both toxins) and a trivalent vaccine (with an additional virulence factor, the metalloprotease Pro-Pro endopeptidase-1).

Mice vaccinated with the bivalent and trivalent vaccines produced immunoglobulin G antibody titers two to four times higher than those elicited by recombinant protein with an adjuvant. The vaccination stimulated the proliferation of follicular T helper cells and the antigen-specific response of B lymphocytes, laying the foundation for a strong and long-lasting humoral response. The vaccines were also immunogenic in hamsters.

Vaccinated mice not only survived a toxin dose five times higher than the 100% lethal dose but also demonstrated the vaccine’s protective effect through serum transfer; unvaccinated mice given serum from vaccinated mice survived the lethal challenge. More importantly, when exposed to a lethal dose of the bacterium itself, all vaccinated mice survived.

To demonstrate the vaccine’s efficacy in patients with a history of C difficile infection and high recurrence risk — ideal candidates for vaccination — the researchers vaccinated mice that had previously survived a sublethal infection. Six months after the initial infection and vaccination, these mice remained protected against mortality when reexposed to the bacterium.

Additionally, a quadrivalent vaccine that included an immunogen targeting C difficile spores — key agents in transmission — also proved effective. Low levels of bacteria and toxins in the feces of mice vaccinated in this way suggested that spore vaccination could limit initial colonization.

In tests with nonhuman primates, two doses of the vaccines targeting either the vegetative form or the spores elicited strong immune responses against bacterial toxins and virulence factors. Human trials may indeed be on the horizon.
 

This story was translated from Univadis Italy 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.

A group of researchers from the University of Pennsylvania, Philadelphia, has developed a messenger RNA (mRNA) vaccine, delivered via lipid nanoparticles (LNPs) — the same type as the COVID-19 vaccine produced by Moderna and Pfizer — targeting Clostridioides difficile (formerly Clostridium difficile). According to the authors, the results of their preclinical study, published in Science, demonstrated this technology as a promising platform for C difficile vaccine development and could be the starting point for curbing intestinal infections that, in their most severe forms (pseudomembranous colitis, toxic megacolon), can be fatal.

An Increasingly Pressing Issue

C difficile is the leading cause of infectious diarrhea acquired in healthcare settings. In recent years, community-acquired C difficile infections have also become more frequent. The increase in infections has been attributed to the emergence of highly virulent and antibiotic-resistant strains.

A 2019 study reported a global incidence of C difficile infections at 2.2 per 1000 hospital admissions per year and 3.5 per 10,000 patient-days per year.
 

The Vaccine Candidate

Vaccine candidates tested so far have used toxoids or recombinant proteins targeting the combined repetitive oligopeptide (CROP) or receptor-binding domain (RBD) of the two primary C difficile toxins, TcdA and TcdB. The US researchers are now exploring the mRNA-LNP vaccine approach to target multiple antigens simultaneously. They developed a bivalent vaccine (including the CROP and RBD domains of both toxins) and a trivalent vaccine (with an additional virulence factor, the metalloprotease Pro-Pro endopeptidase-1).

Mice vaccinated with the bivalent and trivalent vaccines produced immunoglobulin G antibody titers two to four times higher than those elicited by recombinant protein with an adjuvant. The vaccination stimulated the proliferation of follicular T helper cells and the antigen-specific response of B lymphocytes, laying the foundation for a strong and long-lasting humoral response. The vaccines were also immunogenic in hamsters.

Vaccinated mice not only survived a toxin dose five times higher than the 100% lethal dose but also demonstrated the vaccine’s protective effect through serum transfer; unvaccinated mice given serum from vaccinated mice survived the lethal challenge. More importantly, when exposed to a lethal dose of the bacterium itself, all vaccinated mice survived.

To demonstrate the vaccine’s efficacy in patients with a history of C difficile infection and high recurrence risk — ideal candidates for vaccination — the researchers vaccinated mice that had previously survived a sublethal infection. Six months after the initial infection and vaccination, these mice remained protected against mortality when reexposed to the bacterium.

Additionally, a quadrivalent vaccine that included an immunogen targeting C difficile spores — key agents in transmission — also proved effective. Low levels of bacteria and toxins in the feces of mice vaccinated in this way suggested that spore vaccination could limit initial colonization.

In tests with nonhuman primates, two doses of the vaccines targeting either the vegetative form or the spores elicited strong immune responses against bacterial toxins and virulence factors. Human trials may indeed be on the horizon.
 

This story was translated from Univadis Italy 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.

TOPLINE:

The extended-release fluticasone propionate injection (EP-104IAR) significantly reduces knee osteoarthritis (OA) pain over 12 weeks, compared with a vehicle control, with no serious treatment-related adverse events.

METHODOLOGY:

• EP-104IAR utilizes a novel diffusion-based extended-release technology to optimize the action of fluticasone propionate.
• The researchers conducted a phase 2 trial at 12 research sites in Denmark, Poland, and the Czech Republic to assess the clinical efficacy, pharmacokinetics, and safety of EP-104IAR in 318 participants (58% women; 99% White) with a diagnosis of primary knee OA.
• Eligible patients, with a score of at least 4 out of 10 on the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain rating scale, were randomly assigned to receive either 25 mg EP-104IAR (n = 163; mean age, 64 years) or a vehicle control (n = 155; mean age, 63.2 years).
• The primary outcome was the between-group difference in the change in the WOMAC pain score from baseline to week 12.

TAKEAWAY:

• The reduction in WOMAC pain scores from baseline to week 12 was significantly higher with EP-104IAR than with a vehicle control (between-group difference, −0.66; P = .0044), with the difference maintained through week 14.
• The treatment resulted in a significant improvement in WOMAC function scores (P = .014) and the area under the curve for changes in the WOMAC pain score (P < .0001) over 12 weeks.
• Treatment-emergent adverse events were noted in 9% of participants in the EP-104IAR group and 7% of participants in the vehicle control group. No serious treatment-related adverse events or discontinuations related to EP-104IAR were reported.
• Fluticasone propionate levels were maintained at around 66% to 33% of peak values between weeks 2 and 24 at near-constant levels. The effects on glucose and cortisol levels were minimal and transient.

IN PRACTICE:

“The results of this trial show that EP-104IAR has the potential for clinically meaningful benefit in reducing knee osteoarthritis pain, addressing a substantial unmet medical need,” the authors wrote. “Additionally, the stable delivery of fluticasone propionate over an extended period with fewer systemic and local side effects than other corticosteroid treatments for knee osteoarthritis support the possibility of bilateral and repeat dosing.”

SOURCE:

The study was led by Amanda Malone, PhD, Eupraxia Pharmaceuticals, Victoria, British Columbia, Canada. It was published online in The Lancet Rheumatology.

LIMITATIONS:

The study’s generalizability may be limited because of the predominantly White participant population. The success of masking was not evaluated, and the treatment was administered by an unmasked injector. Efficacy outcomes were patient-reported, with no objective measurement of knee function.

DISCLOSURES:

This study was supported by Eupraxia Pharmaceuticals. Some authors disclosed their employment with Eupraxia Pharmaceuticals or with companies contracted by Eupraxia Pharmaceuticals for clinical research and trial and data management. One author reported serving as a consultant or participating in a speakers’ bureau. Another reported being on the board of directors for Eupraxia Pharmaceuticals and receiving royalties from a medical technology company.

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

TOPLINE:

The extended-release fluticasone propionate injection (EP-104IAR) significantly reduces knee osteoarthritis (OA) pain over 12 weeks, compared with a vehicle control, with no serious treatment-related adverse events.

METHODOLOGY:

• EP-104IAR utilizes a novel diffusion-based extended-release technology to optimize the action of fluticasone propionate.
• The researchers conducted a phase 2 trial at 12 research sites in Denmark, Poland, and the Czech Republic to assess the clinical efficacy, pharmacokinetics, and safety of EP-104IAR in 318 participants (58% women; 99% White) with a diagnosis of primary knee OA.
• Eligible patients, with a score of at least 4 out of 10 on the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain rating scale, were randomly assigned to receive either 25 mg EP-104IAR (n = 163; mean age, 64 years) or a vehicle control (n = 155; mean age, 63.2 years).
• The primary outcome was the between-group difference in the change in the WOMAC pain score from baseline to week 12.

TAKEAWAY:

• The reduction in WOMAC pain scores from baseline to week 12 was significantly higher with EP-104IAR than with a vehicle control (between-group difference, −0.66; P = .0044), with the difference maintained through week 14.
• The treatment resulted in a significant improvement in WOMAC function scores (P = .014) and the area under the curve for changes in the WOMAC pain score (P < .0001) over 12 weeks.
• Treatment-emergent adverse events were noted in 9% of participants in the EP-104IAR group and 7% of participants in the vehicle control group. No serious treatment-related adverse events or discontinuations related to EP-104IAR were reported.
• Fluticasone propionate levels were maintained at around 66% to 33% of peak values between weeks 2 and 24 at near-constant levels. The effects on glucose and cortisol levels were minimal and transient.

IN PRACTICE:

“The results of this trial show that EP-104IAR has the potential for clinically meaningful benefit in reducing knee osteoarthritis pain, addressing a substantial unmet medical need,” the authors wrote. “Additionally, the stable delivery of fluticasone propionate over an extended period with fewer systemic and local side effects than other corticosteroid treatments for knee osteoarthritis support the possibility of bilateral and repeat dosing.”

SOURCE:

The study was led by Amanda Malone, PhD, Eupraxia Pharmaceuticals, Victoria, British Columbia, Canada. It was published online in The Lancet Rheumatology.

LIMITATIONS:

The study’s generalizability may be limited because of the predominantly White participant population. The success of masking was not evaluated, and the treatment was administered by an unmasked injector. Efficacy outcomes were patient-reported, with no objective measurement of knee function.

DISCLOSURES:

This study was supported by Eupraxia Pharmaceuticals. Some authors disclosed their employment with Eupraxia Pharmaceuticals or with companies contracted by Eupraxia Pharmaceuticals for clinical research and trial and data management. One author reported serving as a consultant or participating in a speakers’ bureau. Another reported being on the board of directors for Eupraxia Pharmaceuticals and receiving royalties from a medical technology company.

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

TOPLINE:

The extended-release fluticasone propionate injection (EP-104IAR) significantly reduces knee osteoarthritis (OA) pain over 12 weeks, compared with a vehicle control, with no serious treatment-related adverse events.

METHODOLOGY:

• EP-104IAR utilizes a novel diffusion-based extended-release technology to optimize the action of fluticasone propionate.
• The researchers conducted a phase 2 trial at 12 research sites in Denmark, Poland, and the Czech Republic to assess the clinical efficacy, pharmacokinetics, and safety of EP-104IAR in 318 participants (58% women; 99% White) with a diagnosis of primary knee OA.
• Eligible patients, with a score of at least 4 out of 10 on the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain rating scale, were randomly assigned to receive either 25 mg EP-104IAR (n = 163; mean age, 64 years) or a vehicle control (n = 155; mean age, 63.2 years).
• The primary outcome was the between-group difference in the change in the WOMAC pain score from baseline to week 12.

TAKEAWAY:

• The reduction in WOMAC pain scores from baseline to week 12 was significantly higher with EP-104IAR than with a vehicle control (between-group difference, −0.66; P = .0044), with the difference maintained through week 14.
• The treatment resulted in a significant improvement in WOMAC function scores (P = .014) and the area under the curve for changes in the WOMAC pain score (P < .0001) over 12 weeks.
• Treatment-emergent adverse events were noted in 9% of participants in the EP-104IAR group and 7% of participants in the vehicle control group. No serious treatment-related adverse events or discontinuations related to EP-104IAR were reported.
• Fluticasone propionate levels were maintained at around 66% to 33% of peak values between weeks 2 and 24 at near-constant levels. The effects on glucose and cortisol levels were minimal and transient.

IN PRACTICE:

“The results of this trial show that EP-104IAR has the potential for clinically meaningful benefit in reducing knee osteoarthritis pain, addressing a substantial unmet medical need,” the authors wrote. “Additionally, the stable delivery of fluticasone propionate over an extended period with fewer systemic and local side effects than other corticosteroid treatments for knee osteoarthritis support the possibility of bilateral and repeat dosing.”

SOURCE:

The study was led by Amanda Malone, PhD, Eupraxia Pharmaceuticals, Victoria, British Columbia, Canada. It was published online in The Lancet Rheumatology.

LIMITATIONS:

The study’s generalizability may be limited because of the predominantly White participant population. The success of masking was not evaluated, and the treatment was administered by an unmasked injector. Efficacy outcomes were patient-reported, with no objective measurement of knee function.

DISCLOSURES:

This study was supported by Eupraxia Pharmaceuticals. Some authors disclosed their employment with Eupraxia Pharmaceuticals or with companies contracted by Eupraxia Pharmaceuticals for clinical research and trial and data management. One author reported serving as a consultant or participating in a speakers’ bureau. Another reported being on the board of directors for Eupraxia Pharmaceuticals and receiving royalties from a medical technology company.

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

TOPLINE:

Allogeneic bone marrow–derived mesenchymal stromal cells (BM-MSCs) are safe but do not show efficacy in treating intervertebral disc degeneration (IDD) in patients with chronic low back pain.

METHODOLOGY:

• The RESPINE trial assessed the efficacy and safety of a single intradiscal injection of allogeneic BM-MSCs in the treatment of chronic low back pain caused by single-level IDD.
• Overall, 114 patients (mean age, 40.9 years; 35% women) with IDD-associated chronic low back pain that was persistent for 3 months or more despite conventional medical therapy and without previous surgery, were recruited across four European countries from April 2018 to April 2021 and randomly assigned to receive either intradiscal injections of allogeneic BM-MSCs (n = 58) or sham injections (n = 56).
• The first co-primary endpoint was the rate of response to BM-MSC injections at 12 months after treatment, defined as improvement of at least 20% or 20 mm in the Visual Analog Scale for pain or improvement of at least 20% in the Oswestry Disability Index for functional status.
• The secondary co-primary endpoint was structural efficacy, based on disc fluid content measured by quantitative T2 MRI between baseline and month 12.

TAKEAWAY:

• At 12 months post-intervention, 74% of patients in the BM-MSC group were classified as responders compared with 68.8% in the placebo group. However, the difference between the groups was not statistically significant.
• The probability of being a responder was higher in the BM-MSC group than in the sham group; however, the findings did not reach statistical significance.
• The average change in disc fluid content, indicative of disc regeneration, from baseline to 12 months was 37.9% in the BM-MSC group and 41.7% in the placebo group, with no significant difference between the groups.
• The incidence of adverse events and serious adverse events was not significantly different between the treatment groups.

IN PRACTICE:

“BM-MSC represents a promising opportunity for the biological treatment of IDD, but only high-quality randomized controlled trials, comparing it to standard care, can determine whether it is a truly effective alternative to spine fusion or disc replacement,” the authors wrote.

SOURCE:

The study was led by Yves-Marie Pers, MD, PhD, Clinical Immunology and Osteoarticular Diseases Therapeutic Unit, CHRU Lapeyronie, Montpellier, France. It was published online on October 11, 2024, in Annals of the Rheumatic Diseases.

LIMITATIONS:

MRI results were collected from only 55 patients across both trial arms, which may have affected the statistical power of the findings. Although patients were monitored for up to 24 months, the long-term efficacy and safety of BM-MSC therapy for IDD may not have been fully captured. Selection bias could not be excluded because of the difficulty in accurately identifying patients with chronic low back pain caused by single-level IDD.

DISCLOSURES:

The study was funded by the European Union’s Horizon 2020 Research and Innovation Programme. The authors declared no conflicts of interest.

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

TOPLINE:

Allogeneic bone marrow–derived mesenchymal stromal cells (BM-MSCs) are safe but do not show efficacy in treating intervertebral disc degeneration (IDD) in patients with chronic low back pain.

METHODOLOGY:

• The RESPINE trial assessed the efficacy and safety of a single intradiscal injection of allogeneic BM-MSCs in the treatment of chronic low back pain caused by single-level IDD.
• Overall, 114 patients (mean age, 40.9 years; 35% women) with IDD-associated chronic low back pain that was persistent for 3 months or more despite conventional medical therapy and without previous surgery, were recruited across four European countries from April 2018 to April 2021 and randomly assigned to receive either intradiscal injections of allogeneic BM-MSCs (n = 58) or sham injections (n = 56).
• The first co-primary endpoint was the rate of response to BM-MSC injections at 12 months after treatment, defined as improvement of at least 20% or 20 mm in the Visual Analog Scale for pain or improvement of at least 20% in the Oswestry Disability Index for functional status.
• The secondary co-primary endpoint was structural efficacy, based on disc fluid content measured by quantitative T2 MRI between baseline and month 12.

TAKEAWAY:

• At 12 months post-intervention, 74% of patients in the BM-MSC group were classified as responders compared with 68.8% in the placebo group. However, the difference between the groups was not statistically significant.
• The probability of being a responder was higher in the BM-MSC group than in the sham group; however, the findings did not reach statistical significance.
• The average change in disc fluid content, indicative of disc regeneration, from baseline to 12 months was 37.9% in the BM-MSC group and 41.7% in the placebo group, with no significant difference between the groups.
• The incidence of adverse events and serious adverse events was not significantly different between the treatment groups.

IN PRACTICE:

“BM-MSC represents a promising opportunity for the biological treatment of IDD, but only high-quality randomized controlled trials, comparing it to standard care, can determine whether it is a truly effective alternative to spine fusion or disc replacement,” the authors wrote.

SOURCE:

The study was led by Yves-Marie Pers, MD, PhD, Clinical Immunology and Osteoarticular Diseases Therapeutic Unit, CHRU Lapeyronie, Montpellier, France. It was published online on October 11, 2024, in Annals of the Rheumatic Diseases.

LIMITATIONS:

MRI results were collected from only 55 patients across both trial arms, which may have affected the statistical power of the findings. Although patients were monitored for up to 24 months, the long-term efficacy and safety of BM-MSC therapy for IDD may not have been fully captured. Selection bias could not be excluded because of the difficulty in accurately identifying patients with chronic low back pain caused by single-level IDD.

DISCLOSURES:

The study was funded by the European Union’s Horizon 2020 Research and Innovation Programme. The authors declared no conflicts of interest.

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

TOPLINE:

Allogeneic bone marrow–derived mesenchymal stromal cells (BM-MSCs) are safe but do not show efficacy in treating intervertebral disc degeneration (IDD) in patients with chronic low back pain.

METHODOLOGY:

• The RESPINE trial assessed the efficacy and safety of a single intradiscal injection of allogeneic BM-MSCs in the treatment of chronic low back pain caused by single-level IDD.
• Overall, 114 patients (mean age, 40.9 years; 35% women) with IDD-associated chronic low back pain that was persistent for 3 months or more despite conventional medical therapy and without previous surgery, were recruited across four European countries from April 2018 to April 2021 and randomly assigned to receive either intradiscal injections of allogeneic BM-MSCs (n = 58) or sham injections (n = 56).
• The first co-primary endpoint was the rate of response to BM-MSC injections at 12 months after treatment, defined as improvement of at least 20% or 20 mm in the Visual Analog Scale for pain or improvement of at least 20% in the Oswestry Disability Index for functional status.
• The secondary co-primary endpoint was structural efficacy, based on disc fluid content measured by quantitative T2 MRI between baseline and month 12.

TAKEAWAY:

• At 12 months post-intervention, 74% of patients in the BM-MSC group were classified as responders compared with 68.8% in the placebo group. However, the difference between the groups was not statistically significant.
• The probability of being a responder was higher in the BM-MSC group than in the sham group; however, the findings did not reach statistical significance.
• The average change in disc fluid content, indicative of disc regeneration, from baseline to 12 months was 37.9% in the BM-MSC group and 41.7% in the placebo group, with no significant difference between the groups.
• The incidence of adverse events and serious adverse events was not significantly different between the treatment groups.

IN PRACTICE:

“BM-MSC represents a promising opportunity for the biological treatment of IDD, but only high-quality randomized controlled trials, comparing it to standard care, can determine whether it is a truly effective alternative to spine fusion or disc replacement,” the authors wrote.

SOURCE:

The study was led by Yves-Marie Pers, MD, PhD, Clinical Immunology and Osteoarticular Diseases Therapeutic Unit, CHRU Lapeyronie, Montpellier, France. It was published online on October 11, 2024, in Annals of the Rheumatic Diseases.

LIMITATIONS:

MRI results were collected from only 55 patients across both trial arms, which may have affected the statistical power of the findings. Although patients were monitored for up to 24 months, the long-term efficacy and safety of BM-MSC therapy for IDD may not have been fully captured. Selection bias could not be excluded because of the difficulty in accurately identifying patients with chronic low back pain caused by single-level IDD.

DISCLOSURES:

The study was funded by the European Union’s Horizon 2020 Research and Innovation Programme. The authors declared no conflicts of interest.

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