Federal Practitioner

The US Department of Veterans Affairs (VA) mission is defined by President Abraham Lincoln’s promise “to care for him who shall have borne the battle, and for his widow, and his orphan.” Critically, the biopsychosocial needs of veterans differ from the needs of civilians due to the nature of military service.¹ Veterans commonly experience traumatic brain injury (TBI) due to combat- or training-related injuries.² Psychologically, veterans are disproportionately likely to be diagnosed with mental health conditions, such as posttraumatic stress disorder (PTSD), often linked to military exposures.³ Spiritually, veterans frequently express moral injury after living through circumstances when they perpetrate, fail to prevent, or witness events that contradict moral beliefs/ expectations.⁴ Veterans also have significant social challenges, including high rates of homelessness. ⁵ A critical strength of the VA mission is its awareness of these complex sequelae and its ability to provide well-informed treatment and social services to meet veterans’ unique needs.

Foundational to a well-informed health care system is a robust research and operational quality improvement infrastructure. The VA Office of Research and Development (ORD) has worked tirelessly to understand and address the unique, idiographic needs of veterans. In 2024 the ORD had a budget of $2.4 billion, excluding quality improvement initiatives enhancing VA operations.⁶

The integrated VA health care system is a major strength for providing state-of-the-science to inform veterans’ treatment and social service needs. The VA features medical centers and clinics capable of synergistically leveraging extant infrastructure to facilitate collaborations and centralized procedures across sites. The VA also has dedicated research centers, such as the National Center for PTSD, Centers of Excellence, Centers of Innovation, and Mental Illness, Research, Education and Clinical Centers that focus on PTSD, suicide prevention, TBI, and other high-priority areas. These centers recruit, train, and invest in experts dedicated to improving veterans’ lives. The VA Corporate Data Warehouse provides a national, system-wide repository for patient-level data, allowing for advanced analysis of large datasets.⁷

This special issue is a showcase of the strengths of VA mental health and social service research, aligning with the current strategic priorities of VA research. Topics focus on the unique needs of veterans, including sequelae (eg, PTSD, homelessness, moral injury), with particular attention to veterans. Manuscripts highlight the strengths of collaborations, including those between specialized research centers and national VA operational partners. Analyses highlight the VA research approach, leveraging data and perspectives from inside and outside the VA, and studying new and established approaches to care. This issue highlights the distinct advantages that VA research provides: experts with the tools, experience, and dedication to addressing the unique needs of veterans. Given the passion for veteran care among VA researchers, including those featured in this issue, we strongly believe the VA will continue to be a leader in this research.

The US Department of Veterans Affairs (VA) mission is defined by President Abraham Lincoln’s promise “to care for him who shall have borne the battle, and for his widow, and his orphan.” Critically, the biopsychosocial needs of veterans differ from the needs of civilians due to the nature of military service.¹ Veterans commonly experience traumatic brain injury (TBI) due to combat- or training-related injuries.² Psychologically, veterans are disproportionately likely to be diagnosed with mental health conditions, such as posttraumatic stress disorder (PTSD), often linked to military exposures.³ Spiritually, veterans frequently express moral injury after living through circumstances when they perpetrate, fail to prevent, or witness events that contradict moral beliefs/ expectations.⁴ Veterans also have significant social challenges, including high rates of homelessness. ⁵ A critical strength of the VA mission is its awareness of these complex sequelae and its ability to provide well-informed treatment and social services to meet veterans’ unique needs.

Foundational to a well-informed health care system is a robust research and operational quality improvement infrastructure. The VA Office of Research and Development (ORD) has worked tirelessly to understand and address the unique, idiographic needs of veterans. In 2024 the ORD had a budget of $2.4 billion, excluding quality improvement initiatives enhancing VA operations.⁶

The integrated VA health care system is a major strength for providing state-of-the-science to inform veterans’ treatment and social service needs. The VA features medical centers and clinics capable of synergistically leveraging extant infrastructure to facilitate collaborations and centralized procedures across sites. The VA also has dedicated research centers, such as the National Center for PTSD, Centers of Excellence, Centers of Innovation, and Mental Illness, Research, Education and Clinical Centers that focus on PTSD, suicide prevention, TBI, and other high-priority areas. These centers recruit, train, and invest in experts dedicated to improving veterans’ lives. The VA Corporate Data Warehouse provides a national, system-wide repository for patient-level data, allowing for advanced analysis of large datasets.⁷

This special issue is a showcase of the strengths of VA mental health and social service research, aligning with the current strategic priorities of VA research. Topics focus on the unique needs of veterans, including sequelae (eg, PTSD, homelessness, moral injury), with particular attention to veterans. Manuscripts highlight the strengths of collaborations, including those between specialized research centers and national VA operational partners. Analyses highlight the VA research approach, leveraging data and perspectives from inside and outside the VA, and studying new and established approaches to care. This issue highlights the distinct advantages that VA research provides: experts with the tools, experience, and dedication to addressing the unique needs of veterans. Given the passion for veteran care among VA researchers, including those featured in this issue, we strongly believe the VA will continue to be a leader in this research.

The US Department of Veterans Affairs (VA) mission is defined by President Abraham Lincoln’s promise “to care for him who shall have borne the battle, and for his widow, and his orphan.” Critically, the biopsychosocial needs of veterans differ from the needs of civilians due to the nature of military service.¹ Veterans commonly experience traumatic brain injury (TBI) due to combat- or training-related injuries.² Psychologically, veterans are disproportionately likely to be diagnosed with mental health conditions, such as posttraumatic stress disorder (PTSD), often linked to military exposures.³ Spiritually, veterans frequently express moral injury after living through circumstances when they perpetrate, fail to prevent, or witness events that contradict moral beliefs/ expectations.⁴ Veterans also have significant social challenges, including high rates of homelessness. ⁵ A critical strength of the VA mission is its awareness of these complex sequelae and its ability to provide well-informed treatment and social services to meet veterans’ unique needs.

Foundational to a well-informed health care system is a robust research and operational quality improvement infrastructure. The VA Office of Research and Development (ORD) has worked tirelessly to understand and address the unique, idiographic needs of veterans. In 2024 the ORD had a budget of $2.4 billion, excluding quality improvement initiatives enhancing VA operations.⁶

The integrated VA health care system is a major strength for providing state-of-the-science to inform veterans’ treatment and social service needs. The VA features medical centers and clinics capable of synergistically leveraging extant infrastructure to facilitate collaborations and centralized procedures across sites. The VA also has dedicated research centers, such as the National Center for PTSD, Centers of Excellence, Centers of Innovation, and Mental Illness, Research, Education and Clinical Centers that focus on PTSD, suicide prevention, TBI, and other high-priority areas. These centers recruit, train, and invest in experts dedicated to improving veterans’ lives. The VA Corporate Data Warehouse provides a national, system-wide repository for patient-level data, allowing for advanced analysis of large datasets.⁷

This special issue is a showcase of the strengths of VA mental health and social service research, aligning with the current strategic priorities of VA research. Topics focus on the unique needs of veterans, including sequelae (eg, PTSD, homelessness, moral injury), with particular attention to veterans. Manuscripts highlight the strengths of collaborations, including those between specialized research centers and national VA operational partners. Analyses highlight the VA research approach, leveraging data and perspectives from inside and outside the VA, and studying new and established approaches to care. This issue highlights the distinct advantages that VA research provides: experts with the tools, experience, and dedication to addressing the unique needs of veterans. Given the passion for veteran care among VA researchers, including those featured in this issue, we strongly believe the VA will continue to be a leader in this research.

On March 27, Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. said he planned to cut about 10,000 full-time jobs from the department in a sweeping “reorganization.” Less than a week later, the reduction in force (RIF) notifications were sent out, and in the very early hours of April 1, hundreds of employees found themselves locked out from their offices, often so abruptly their belongings were left behind. 

Most affected employees were told they would be placed on administrative leave; some were told to continue working until they can hand off their duties but they would be formally separated on June 2. Many of the email RIF notifications used the recommended wording provided by the US Office of Personnel Management: “This RIF action does not reflect directly on your service, performance, or conduct.” The HHS workforce is expected to be reduced from 82,000 full-time employees to 62,000. 

"The Trump Administration has launched an unprecedented attack on the federal health workforce," said House Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ), during an oversight and investigations hearing on medical device technology and cybersecurity.

The cuts in personnel and programs are broad and deep, and touch every aspect of public health. Alzheimer’s disease programs are being eliminated, measles vaccine clinics are being shuttered, and tuberculosis, HIV prevention, and cancer research are being stalled. A Reddit thread for RIF notices from HHS employees had nearly 750 postings, suggesting a broad cross-section of individuals and departments had received them. 

Secretary Kennedy stated the layoffs and restructuring will save $1.8 billion a year. “We aren’t just reducing bureaucratic sprawl," he said in a statement. "We are realigning the organization with its core mission and our new priorities in reversing the chronic disease epidemic.” On the social platform X, Kennedy acknowledged, “This will be a painful period for HHS.”

Entire offices devoted to Freedom of Information Act-related requests, communications, and human resources were also shut down, according to multiple reports.

The agency's 28 divisions will be reformatted into a “new, unified entity” of 15 divisions—the Administration for a Healthy America, or AHA, aimed at carrying out Kennedy's “Make America Healthy Again” agenda. The AHA will include the Substance Abuse and Mental Health Services Administration (SAMHSA), the Agency for Toxic Substances and Disease Registry, and the National Institute for Occupational Safety and Health. The Administration for Community Living's functions will shift into the Centers for Medicare and Medicaid Services, the Administration for Children and Families, and the Assistant Secretary for Planning and Evaluation (ASPE). ASPE will be combined with the Agency for Health Research and Quality into the Office of Strategy

 “This centralization,” HHS says, “will improve coordination of health resources for low-income Americans and will focus on areas including, Primary Care, Maternal and Child Health, Mental Health, Environmental Health, HIV/AIDS, and Workforce development.”

US Food and Drug Administration

An estimated 3500 full-time FDA employees are expected to receive RIF notices. The agency said reductions will not affect drug, medical device, or food reviewers or inspectors. 

Politico spoke with fired employees on condition of anonymity. According to them, Dr. Peter Stein, director of the FDA Office of New Drugs (OND), was let go. The policy office inside of OND was also eliminated. Another top FDA regulator, Dr. Brian King, the director of the Center for Tobacco Products (CTP), was placed on administrative leave, according to an email sent to his staff and obtained by Politico. “I encourage you to hold your heads high and never compromise the guiding tenets that CTP has held dear since its inception,” King wrote in the email to his staff. “We obeyed the law. We followed the science. We told the truth.” 

Julie Tierney, who was recently elevated to acting director of the FDA Center for Biologics Evaluation and Research, according to an agency website, was also placed on administrative leave, according to 2 people familiar with the decision. The FDA Office of Strategic Programs, including its director, Sridhar Mantha, has been completely shuttered. Mantha cochaired the Artificial Intelligence (AI) Council at the Center for Drug Evaluation and Research (CDER), which helped develop policy around AI use in drug development and assisted the FDA in using AI internally.

Centers for Disease Control and Prevention

About 2400 CDC employees are expected to receive RIF notices. According to Government Executive, the National Institute for Occupational Safety and Health (NIOSH) sustained more than one-third of the cuts at CDC. About 80% of the 1100 employees at the institute were laid off, including its director and deputy director. An HHS letter to a labor union said about 185 NIOSH employees would be let go in just the Morgantown, W. Va., location. However, NIOSH is apparently slated to be part of the newly created AHA.

Other layoffs hit the National Center for Chronic Disease Prevention and Health Promotion; National Center for Injury Prevention and Control; the National Center for HIV, Viral Hepatitis, STD, and Tuberculosis Prevention; the Global Health Center; the National Center on Birth Defects and Developmental Disabilities; and the National Center for Environmental Health. Two sources familiar with the firings said the Office on Smoking and Health was eliminated. The Administration for Strategic Preparedness and Response, currently part of the US Public Health Service, will move to the CDC. 

A compensation program for employees who developed cancer due to radiation exposure while working for the federal government was also eliminated. Similarly, a national registry that tracks rates of cancer among firefighters was cut. One employee said NIOSH laid off veterinarians despite the bureau having laboratory animals that need care. 

National Institutes of Health 

NIH will lose 1200 employees, due to "centralizing” procurement, human resources, and communications across its 27 institutes and centers. According to the employees who spoke with Politico, scientists were also targeted, including National Institute of Nursing Research Director Shannon Zenk; National Institute of Child Health and Human Development Director Diana Bianchi; Emily Erbelding, who leads the Division of Microbiology and Infectious Diseases at National Institutes of Allergy and Infectious Diseases; and National Institute on Minority Health and Health Disparities Director Eliseo Pérez-Stable. National Institute of Allergy and Infectious Diseases Director Jeanne Marrazzo, who replaced Anthony Fauci, was also put on leave.

In his “welcome” email to staff, the new NIH director, Dr. Jay Bhattacharya, wrote: “I recognize that I am joining NIH at a time of tremendous change. Every inch of the federal government is under scrutiny—and NIH is not exempt. These reductions in the workforce will have a profound impact on key NIH administrative functions, including communications, legislative affairs, procurement, and human resources, and will require an entirely new approach to how we carry them out.”

Deep Cuts at Other HHS Agencies

As many as 500 to 600 people were let go at the Health Resource and Services Administration (HRSA). Its Bureau of Primary Health Care, which oversees the national network of health care centers that collectively provide care to 31 million people, was “severely impacted,” and the agency lost much of its regional staff, according to an article in Government Executive. “This will have an enormous impact on the program and viability of health centers,” an HRSA employee said. 

About 50% of the nearly 900 SAMHSA employees were laid off and its 10 regional offices were closed. SAMHSA will be “hamstrung for data,” according to an agency employee, who added contracts may be cut en masse due the departure of the contract management staff. They added that even if funding remains for the agency, the support systems for grantees were being decimated.

More than 800 people lost their jobs at the CDER, according to an official who was laid off; this part of the agency had around 6,000 employees before the cuts.

Indian Health Service

The IHS offers a rare bright spot. Although it was also in line for massive cuts, it has been spared, for now. According to a statement emailed to Native News Online, Secretary Kennedy said the Trump administration intends to prioritize the IHS.

“The Indian Health Service has always been treated as the redheaded stepchild at HHS,” Secretary Kennedy wrote. “My father often complained that IHS was chronically understaffed and underfunded. President Trump wants me to rectify this sad history. Indians suffer at the highest level of chronic disease of any demographic. IHS will be a priority over the next 4 years. President Trump wants me to end the chronic disease epidemic beginning in Indian country.”

March layoffs that had been announced for 1000 IHS employees were rescinded.

“We can confirm the layoffs were rescinded thanks at least in part to advocacy by the many Tribal organizations,” a spokesperson for the National Indian Health Board told Native News Online.

In fact, top career executives across the department are now being offered reassignments to the IHS, which employees must accept to keep their jobs. One executive who received the offer told Native News Online that no details on positions or location were provided, and they doubted that everyone who got such a notice would ultimately be matched to a suitable position. 

"Streamline the Agency"

The dramatic actions at HHS were not unexpected. In fact, employees had been in an unsettling limbo since Kennedy was appointed Secretary, not knowing when the axe would fall, or where, or on whom. Kennedy, when describing the restructuring plans, said, “We're going to streamline our agency and eliminate the redundancies and invite everyone to align behind a simple, bold mission. I want every HHS employee to wake up every morning asking themselves, ‘What can I do to restore American Health?’ I want to empower everyone in the HHS family to have a sense of purpose and pride and a sense of personal agency and responsibility to this larger goal.”

“The FDA as we've known it is finished,” Dr. Robert M. Califf, who served as FDA commissioner twice, wrote on LinkedIn. In an interview with CNN, Califf said he was dismayed to see how federal workers were being treated. 

“This is a sad and inhumane way to treat people,” he said. “It’s different when you’re a company and you’re out of money and you can’t pay people, but the federal government can pay people and do things in an orderly, respectful fashion—and not have them end up in line trying to get to work and have their badges not work as a way to fire them.” 

But the fired HHS employees aren’t the only ones who will bear the brunt of the cuts. “Today’s announcement is not just a restructuring of the Department of Health and Human Services. It is a catastrophe for the health care of every American,” Senator Ed Markey (D-MA) said in a press briefing.

Calling the cuts “a recipe for disaster,” former CDC director Tom Frieden said, “[Secretary] Kennedy claims that health care services will not be harmed by the dramatic downsizing, but he is wrong, and everyone who is paying any attention knows it.”

Senators Bill Cassidy (R-LA) and Bernie Sanders (I-VT), of the Senate Health, Education, Labor, and Pensions Committee, announced Tuesday that they were inviting Kennedy to a hearing April 10 about the restructuring of HHS. “This will be a good opportunity,” Cassidy said in a statement, “for him to set the record straight and speak to the goals, structure and benefits of the proposed reorganization.”

On March 27, Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. said he planned to cut about 10,000 full-time jobs from the department in a sweeping “reorganization.” Less than a week later, the reduction in force (RIF) notifications were sent out, and in the very early hours of April 1, hundreds of employees found themselves locked out from their offices, often so abruptly their belongings were left behind. 

Most affected employees were told they would be placed on administrative leave; some were told to continue working until they can hand off their duties but they would be formally separated on June 2. Many of the email RIF notifications used the recommended wording provided by the US Office of Personnel Management: “This RIF action does not reflect directly on your service, performance, or conduct.” The HHS workforce is expected to be reduced from 82,000 full-time employees to 62,000. 

"The Trump Administration has launched an unprecedented attack on the federal health workforce," said House Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ), during an oversight and investigations hearing on medical device technology and cybersecurity.

The cuts in personnel and programs are broad and deep, and touch every aspect of public health. Alzheimer’s disease programs are being eliminated, measles vaccine clinics are being shuttered, and tuberculosis, HIV prevention, and cancer research are being stalled. A Reddit thread for RIF notices from HHS employees had nearly 750 postings, suggesting a broad cross-section of individuals and departments had received them. 

Secretary Kennedy stated the layoffs and restructuring will save $1.8 billion a year. “We aren’t just reducing bureaucratic sprawl," he said in a statement. "We are realigning the organization with its core mission and our new priorities in reversing the chronic disease epidemic.” On the social platform X, Kennedy acknowledged, “This will be a painful period for HHS.”

Entire offices devoted to Freedom of Information Act-related requests, communications, and human resources were also shut down, according to multiple reports.

The agency's 28 divisions will be reformatted into a “new, unified entity” of 15 divisions—the Administration for a Healthy America, or AHA, aimed at carrying out Kennedy's “Make America Healthy Again” agenda. The AHA will include the Substance Abuse and Mental Health Services Administration (SAMHSA), the Agency for Toxic Substances and Disease Registry, and the National Institute for Occupational Safety and Health. The Administration for Community Living's functions will shift into the Centers for Medicare and Medicaid Services, the Administration for Children and Families, and the Assistant Secretary for Planning and Evaluation (ASPE). ASPE will be combined with the Agency for Health Research and Quality into the Office of Strategy

 “This centralization,” HHS says, “will improve coordination of health resources for low-income Americans and will focus on areas including, Primary Care, Maternal and Child Health, Mental Health, Environmental Health, HIV/AIDS, and Workforce development.”

US Food and Drug Administration

An estimated 3500 full-time FDA employees are expected to receive RIF notices. The agency said reductions will not affect drug, medical device, or food reviewers or inspectors. 

Politico spoke with fired employees on condition of anonymity. According to them, Dr. Peter Stein, director of the FDA Office of New Drugs (OND), was let go. The policy office inside of OND was also eliminated. Another top FDA regulator, Dr. Brian King, the director of the Center for Tobacco Products (CTP), was placed on administrative leave, according to an email sent to his staff and obtained by Politico. “I encourage you to hold your heads high and never compromise the guiding tenets that CTP has held dear since its inception,” King wrote in the email to his staff. “We obeyed the law. We followed the science. We told the truth.” 

Julie Tierney, who was recently elevated to acting director of the FDA Center for Biologics Evaluation and Research, according to an agency website, was also placed on administrative leave, according to 2 people familiar with the decision. The FDA Office of Strategic Programs, including its director, Sridhar Mantha, has been completely shuttered. Mantha cochaired the Artificial Intelligence (AI) Council at the Center for Drug Evaluation and Research (CDER), which helped develop policy around AI use in drug development and assisted the FDA in using AI internally.

Centers for Disease Control and Prevention

About 2400 CDC employees are expected to receive RIF notices. According to Government Executive, the National Institute for Occupational Safety and Health (NIOSH) sustained more than one-third of the cuts at CDC. About 80% of the 1100 employees at the institute were laid off, including its director and deputy director. An HHS letter to a labor union said about 185 NIOSH employees would be let go in just the Morgantown, W. Va., location. However, NIOSH is apparently slated to be part of the newly created AHA.

Other layoffs hit the National Center for Chronic Disease Prevention and Health Promotion; National Center for Injury Prevention and Control; the National Center for HIV, Viral Hepatitis, STD, and Tuberculosis Prevention; the Global Health Center; the National Center on Birth Defects and Developmental Disabilities; and the National Center for Environmental Health. Two sources familiar with the firings said the Office on Smoking and Health was eliminated. The Administration for Strategic Preparedness and Response, currently part of the US Public Health Service, will move to the CDC. 

A compensation program for employees who developed cancer due to radiation exposure while working for the federal government was also eliminated. Similarly, a national registry that tracks rates of cancer among firefighters was cut. One employee said NIOSH laid off veterinarians despite the bureau having laboratory animals that need care. 

National Institutes of Health 

NIH will lose 1200 employees, due to "centralizing” procurement, human resources, and communications across its 27 institutes and centers. According to the employees who spoke with Politico, scientists were also targeted, including National Institute of Nursing Research Director Shannon Zenk; National Institute of Child Health and Human Development Director Diana Bianchi; Emily Erbelding, who leads the Division of Microbiology and Infectious Diseases at National Institutes of Allergy and Infectious Diseases; and National Institute on Minority Health and Health Disparities Director Eliseo Pérez-Stable. National Institute of Allergy and Infectious Diseases Director Jeanne Marrazzo, who replaced Anthony Fauci, was also put on leave.

In his “welcome” email to staff, the new NIH director, Dr. Jay Bhattacharya, wrote: “I recognize that I am joining NIH at a time of tremendous change. Every inch of the federal government is under scrutiny—and NIH is not exempt. These reductions in the workforce will have a profound impact on key NIH administrative functions, including communications, legislative affairs, procurement, and human resources, and will require an entirely new approach to how we carry them out.”

Deep Cuts at Other HHS Agencies

As many as 500 to 600 people were let go at the Health Resource and Services Administration (HRSA). Its Bureau of Primary Health Care, which oversees the national network of health care centers that collectively provide care to 31 million people, was “severely impacted,” and the agency lost much of its regional staff, according to an article in Government Executive. “This will have an enormous impact on the program and viability of health centers,” an HRSA employee said. 

About 50% of the nearly 900 SAMHSA employees were laid off and its 10 regional offices were closed. SAMHSA will be “hamstrung for data,” according to an agency employee, who added contracts may be cut en masse due the departure of the contract management staff. They added that even if funding remains for the agency, the support systems for grantees were being decimated.

More than 800 people lost their jobs at the CDER, according to an official who was laid off; this part of the agency had around 6,000 employees before the cuts.

Indian Health Service

The IHS offers a rare bright spot. Although it was also in line for massive cuts, it has been spared, for now. According to a statement emailed to Native News Online, Secretary Kennedy said the Trump administration intends to prioritize the IHS.

“The Indian Health Service has always been treated as the redheaded stepchild at HHS,” Secretary Kennedy wrote. “My father often complained that IHS was chronically understaffed and underfunded. President Trump wants me to rectify this sad history. Indians suffer at the highest level of chronic disease of any demographic. IHS will be a priority over the next 4 years. President Trump wants me to end the chronic disease epidemic beginning in Indian country.”

March layoffs that had been announced for 1000 IHS employees were rescinded.

“We can confirm the layoffs were rescinded thanks at least in part to advocacy by the many Tribal organizations,” a spokesperson for the National Indian Health Board told Native News Online.

In fact, top career executives across the department are now being offered reassignments to the IHS, which employees must accept to keep their jobs. One executive who received the offer told Native News Online that no details on positions or location were provided, and they doubted that everyone who got such a notice would ultimately be matched to a suitable position. 

"Streamline the Agency"

The dramatic actions at HHS were not unexpected. In fact, employees had been in an unsettling limbo since Kennedy was appointed Secretary, not knowing when the axe would fall, or where, or on whom. Kennedy, when describing the restructuring plans, said, “We're going to streamline our agency and eliminate the redundancies and invite everyone to align behind a simple, bold mission. I want every HHS employee to wake up every morning asking themselves, ‘What can I do to restore American Health?’ I want to empower everyone in the HHS family to have a sense of purpose and pride and a sense of personal agency and responsibility to this larger goal.”

“The FDA as we've known it is finished,” Dr. Robert M. Califf, who served as FDA commissioner twice, wrote on LinkedIn. In an interview with CNN, Califf said he was dismayed to see how federal workers were being treated. 

“This is a sad and inhumane way to treat people,” he said. “It’s different when you’re a company and you’re out of money and you can’t pay people, but the federal government can pay people and do things in an orderly, respectful fashion—and not have them end up in line trying to get to work and have their badges not work as a way to fire them.” 

But the fired HHS employees aren’t the only ones who will bear the brunt of the cuts. “Today’s announcement is not just a restructuring of the Department of Health and Human Services. It is a catastrophe for the health care of every American,” Senator Ed Markey (D-MA) said in a press briefing.

Calling the cuts “a recipe for disaster,” former CDC director Tom Frieden said, “[Secretary] Kennedy claims that health care services will not be harmed by the dramatic downsizing, but he is wrong, and everyone who is paying any attention knows it.”

Senators Bill Cassidy (R-LA) and Bernie Sanders (I-VT), of the Senate Health, Education, Labor, and Pensions Committee, announced Tuesday that they were inviting Kennedy to a hearing April 10 about the restructuring of HHS. “This will be a good opportunity,” Cassidy said in a statement, “for him to set the record straight and speak to the goals, structure and benefits of the proposed reorganization.”

On March 27, Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. said he planned to cut about 10,000 full-time jobs from the department in a sweeping “reorganization.” Less than a week later, the reduction in force (RIF) notifications were sent out, and in the very early hours of April 1, hundreds of employees found themselves locked out from their offices, often so abruptly their belongings were left behind. 

Most affected employees were told they would be placed on administrative leave; some were told to continue working until they can hand off their duties but they would be formally separated on June 2. Many of the email RIF notifications used the recommended wording provided by the US Office of Personnel Management: “This RIF action does not reflect directly on your service, performance, or conduct.” The HHS workforce is expected to be reduced from 82,000 full-time employees to 62,000. 

"The Trump Administration has launched an unprecedented attack on the federal health workforce," said House Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ), during an oversight and investigations hearing on medical device technology and cybersecurity.

The cuts in personnel and programs are broad and deep, and touch every aspect of public health. Alzheimer’s disease programs are being eliminated, measles vaccine clinics are being shuttered, and tuberculosis, HIV prevention, and cancer research are being stalled. A Reddit thread for RIF notices from HHS employees had nearly 750 postings, suggesting a broad cross-section of individuals and departments had received them. 

Secretary Kennedy stated the layoffs and restructuring will save $1.8 billion a year. “We aren’t just reducing bureaucratic sprawl," he said in a statement. "We are realigning the organization with its core mission and our new priorities in reversing the chronic disease epidemic.” On the social platform X, Kennedy acknowledged, “This will be a painful period for HHS.”

Entire offices devoted to Freedom of Information Act-related requests, communications, and human resources were also shut down, according to multiple reports.

The agency's 28 divisions will be reformatted into a “new, unified entity” of 15 divisions—the Administration for a Healthy America, or AHA, aimed at carrying out Kennedy's “Make America Healthy Again” agenda. The AHA will include the Substance Abuse and Mental Health Services Administration (SAMHSA), the Agency for Toxic Substances and Disease Registry, and the National Institute for Occupational Safety and Health. The Administration for Community Living's functions will shift into the Centers for Medicare and Medicaid Services, the Administration for Children and Families, and the Assistant Secretary for Planning and Evaluation (ASPE). ASPE will be combined with the Agency for Health Research and Quality into the Office of Strategy

 “This centralization,” HHS says, “will improve coordination of health resources for low-income Americans and will focus on areas including, Primary Care, Maternal and Child Health, Mental Health, Environmental Health, HIV/AIDS, and Workforce development.”

US Food and Drug Administration

An estimated 3500 full-time FDA employees are expected to receive RIF notices. The agency said reductions will not affect drug, medical device, or food reviewers or inspectors. 

Politico spoke with fired employees on condition of anonymity. According to them, Dr. Peter Stein, director of the FDA Office of New Drugs (OND), was let go. The policy office inside of OND was also eliminated. Another top FDA regulator, Dr. Brian King, the director of the Center for Tobacco Products (CTP), was placed on administrative leave, according to an email sent to his staff and obtained by Politico. “I encourage you to hold your heads high and never compromise the guiding tenets that CTP has held dear since its inception,” King wrote in the email to his staff. “We obeyed the law. We followed the science. We told the truth.” 

Julie Tierney, who was recently elevated to acting director of the FDA Center for Biologics Evaluation and Research, according to an agency website, was also placed on administrative leave, according to 2 people familiar with the decision. The FDA Office of Strategic Programs, including its director, Sridhar Mantha, has been completely shuttered. Mantha cochaired the Artificial Intelligence (AI) Council at the Center for Drug Evaluation and Research (CDER), which helped develop policy around AI use in drug development and assisted the FDA in using AI internally.

Centers for Disease Control and Prevention

About 2400 CDC employees are expected to receive RIF notices. According to Government Executive, the National Institute for Occupational Safety and Health (NIOSH) sustained more than one-third of the cuts at CDC. About 80% of the 1100 employees at the institute were laid off, including its director and deputy director. An HHS letter to a labor union said about 185 NIOSH employees would be let go in just the Morgantown, W. Va., location. However, NIOSH is apparently slated to be part of the newly created AHA.

Other layoffs hit the National Center for Chronic Disease Prevention and Health Promotion; National Center for Injury Prevention and Control; the National Center for HIV, Viral Hepatitis, STD, and Tuberculosis Prevention; the Global Health Center; the National Center on Birth Defects and Developmental Disabilities; and the National Center for Environmental Health. Two sources familiar with the firings said the Office on Smoking and Health was eliminated. The Administration for Strategic Preparedness and Response, currently part of the US Public Health Service, will move to the CDC. 

A compensation program for employees who developed cancer due to radiation exposure while working for the federal government was also eliminated. Similarly, a national registry that tracks rates of cancer among firefighters was cut. One employee said NIOSH laid off veterinarians despite the bureau having laboratory animals that need care. 

National Institutes of Health 

NIH will lose 1200 employees, due to "centralizing” procurement, human resources, and communications across its 27 institutes and centers. According to the employees who spoke with Politico, scientists were also targeted, including National Institute of Nursing Research Director Shannon Zenk; National Institute of Child Health and Human Development Director Diana Bianchi; Emily Erbelding, who leads the Division of Microbiology and Infectious Diseases at National Institutes of Allergy and Infectious Diseases; and National Institute on Minority Health and Health Disparities Director Eliseo Pérez-Stable. National Institute of Allergy and Infectious Diseases Director Jeanne Marrazzo, who replaced Anthony Fauci, was also put on leave.

In his “welcome” email to staff, the new NIH director, Dr. Jay Bhattacharya, wrote: “I recognize that I am joining NIH at a time of tremendous change. Every inch of the federal government is under scrutiny—and NIH is not exempt. These reductions in the workforce will have a profound impact on key NIH administrative functions, including communications, legislative affairs, procurement, and human resources, and will require an entirely new approach to how we carry them out.”

Deep Cuts at Other HHS Agencies

As many as 500 to 600 people were let go at the Health Resource and Services Administration (HRSA). Its Bureau of Primary Health Care, which oversees the national network of health care centers that collectively provide care to 31 million people, was “severely impacted,” and the agency lost much of its regional staff, according to an article in Government Executive. “This will have an enormous impact on the program and viability of health centers,” an HRSA employee said. 

About 50% of the nearly 900 SAMHSA employees were laid off and its 10 regional offices were closed. SAMHSA will be “hamstrung for data,” according to an agency employee, who added contracts may be cut en masse due the departure of the contract management staff. They added that even if funding remains for the agency, the support systems for grantees were being decimated.

More than 800 people lost their jobs at the CDER, according to an official who was laid off; this part of the agency had around 6,000 employees before the cuts.

Indian Health Service

The IHS offers a rare bright spot. Although it was also in line for massive cuts, it has been spared, for now. According to a statement emailed to Native News Online, Secretary Kennedy said the Trump administration intends to prioritize the IHS.

“The Indian Health Service has always been treated as the redheaded stepchild at HHS,” Secretary Kennedy wrote. “My father often complained that IHS was chronically understaffed and underfunded. President Trump wants me to rectify this sad history. Indians suffer at the highest level of chronic disease of any demographic. IHS will be a priority over the next 4 years. President Trump wants me to end the chronic disease epidemic beginning in Indian country.”

March layoffs that had been announced for 1000 IHS employees were rescinded.

“We can confirm the layoffs were rescinded thanks at least in part to advocacy by the many Tribal organizations,” a spokesperson for the National Indian Health Board told Native News Online.

In fact, top career executives across the department are now being offered reassignments to the IHS, which employees must accept to keep their jobs. One executive who received the offer told Native News Online that no details on positions or location were provided, and they doubted that everyone who got such a notice would ultimately be matched to a suitable position. 

"Streamline the Agency"

The dramatic actions at HHS were not unexpected. In fact, employees had been in an unsettling limbo since Kennedy was appointed Secretary, not knowing when the axe would fall, or where, or on whom. Kennedy, when describing the restructuring plans, said, “We're going to streamline our agency and eliminate the redundancies and invite everyone to align behind a simple, bold mission. I want every HHS employee to wake up every morning asking themselves, ‘What can I do to restore American Health?’ I want to empower everyone in the HHS family to have a sense of purpose and pride and a sense of personal agency and responsibility to this larger goal.”

“The FDA as we've known it is finished,” Dr. Robert M. Califf, who served as FDA commissioner twice, wrote on LinkedIn. In an interview with CNN, Califf said he was dismayed to see how federal workers were being treated. 

“This is a sad and inhumane way to treat people,” he said. “It’s different when you’re a company and you’re out of money and you can’t pay people, but the federal government can pay people and do things in an orderly, respectful fashion—and not have them end up in line trying to get to work and have their badges not work as a way to fire them.” 

But the fired HHS employees aren’t the only ones who will bear the brunt of the cuts. “Today’s announcement is not just a restructuring of the Department of Health and Human Services. It is a catastrophe for the health care of every American,” Senator Ed Markey (D-MA) said in a press briefing.

Calling the cuts “a recipe for disaster,” former CDC director Tom Frieden said, “[Secretary] Kennedy claims that health care services will not be harmed by the dramatic downsizing, but he is wrong, and everyone who is paying any attention knows it.”

Senators Bill Cassidy (R-LA) and Bernie Sanders (I-VT), of the Senate Health, Education, Labor, and Pensions Committee, announced Tuesday that they were inviting Kennedy to a hearing April 10 about the restructuring of HHS. “This will be a good opportunity,” Cassidy said in a statement, “for him to set the record straight and speak to the goals, structure and benefits of the proposed reorganization.”

Late last year, the Health Resources and Services Administration projected a shortage of nearly 190,000 physicians across specialties by 2037. They noted, however, that we could mitigate the lack of doctors in some specialties by increasing the use of physician associates (PAs), especially with new and pending legislation expanding PAs’ scope of practice. A new survey conducted by Morning Consult, a business intelligence company, and the American Academy of Physician Associates (AAPA) found that doctors mostly agree with this assessment.

Lisa Gables, CPA, chief executive officer of the AAPA, said, “anecdotally,” physicians have long heralded the value of PAs. But, with organizations like the American Medical Association (AMA) campaigning to end PA “scope creep,” the AAPA thought it was important to do a direct study. Most (90%) of physicians see PAs as important to enhancing care delivery.

“For change to happen — and to make sure we can continue to provide the best possible care for patients — all healthcare providers must work together to find solutions,” Gables told this news organization. “The doctors who work with PAs appreciate the work they do and recognize the barriers they face. But anecdotes aren’t data. We thought it was important to do a formal survey so physicians across the nation could share how they work with PAs and where we can find common ground to address the challenges healthcare is facing.”

The survey included a national sample of 999 physicians. It found that 86% of respondents, even those who do not work directly with PAs, believe that PAs can help expand access to care. Moreover, 68% of respondents said that they support modernizing PA laws and regulations to ease provider shortages and reduce wait times for patients.

 

Physicians Trust PAs

Currently, most laws dictate that physicians must supervise PAs as they work — yet, what constitutes supervision varies. The physicians surveyed said their PAs often see patients on their own in primary and specialty care settings. And 63% of the respondents reported never or rarely being physically present in the room while a PA delivers care. Gables said that while she is well aware of PAs’ strong skills and capabilities, she was surprised to see that this percentage was so high.

“The supervising agreement and supervision language that you see in so many state laws suggests that constant physician oversight is necessary. But in day-to-day practice, that’s not what is happening,” she said. “Physicians report they are rarely in the room with PAs during patient interactions and spend little time monitoring the care they provide. Physicians really trust their PAs — and it would be good to see laws that reflect that.”

 

PAs Improve Care Delivery

One of the AMA’s arguments about the dangers of scope creep is that patients may come to harm if a physician is not directly involved with patient care. They say PAs may not have the training or experience to identify some issues or to understand when a referral is required. Yet, a significant number of physicians surveyed in the AAPA study stated that they believed PAs are trained to perform comprehensive history and physical exams (61%), make referrals (59%), diagnose conditions and other disease states (50%), and develop and implement treatment plans (48%).

This is important, said Gables, because those same physicians reported there aren’t enough healthcare providers available, and they are struggling with current patient loads. The survey highlights the need to find ways to improve not just access to care but care delivery itself — and, given their skill sets, PAs are in a prime position to help.

“Most healthcare providers today will tell you that they are overworked. There are shortages everywhere,” said Gables. “Physicians see that patients are having a hard time accessing healthcare. There are long waits for appointments. And they also see that PAs have the skills necessary to help alleviate those shortages. More than three quarters of the doctors who work with PAs say they provide safe, effective care to patients — and they know when they need to consult with a physician or make a referral,” she said.

 

Autonomy Leads to Access

The AAPA has long called for policy changes to lessen the barriers that make it harder for PAs to serve the needs of patients. Gables said that what they are advocating for is not what the AMA calls scope creep but rather to lessen different barriers that interfere with PAs helping to deliver care. And it appears that physicians also see the value in loosening PA-related practice policies. About 68% of respondents said they support removing mandatory physician agreements to help ease provider shortages and improve care delivery for patients. Gables hopes that the AMA will see these results and think about ways providers can come together to make healthcare more accessible and equitable across the country.

“Looking at these results, I see that there’s the AMA, and then there’s the physicians who work with PAs. Those physicians know what PAs can do. And they know that we should all work together to solve the problems we share,” she said. “A previous survey shows that patients understand who PAs are and the value they bring to healthcare teams. Now we see that physicians understand that, too…So when we are thinking about how to make healthcare better, we all have a role to play in helping patients get the care they need and deserve.” Gables thinks we will be closer to achieving that when PAs practice at the highest levels of their training.

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

Late last year, the Health Resources and Services Administration projected a shortage of nearly 190,000 physicians across specialties by 2037. They noted, however, that we could mitigate the lack of doctors in some specialties by increasing the use of physician associates (PAs), especially with new and pending legislation expanding PAs’ scope of practice. A new survey conducted by Morning Consult, a business intelligence company, and the American Academy of Physician Associates (AAPA) found that doctors mostly agree with this assessment.

Lisa Gables, CPA, chief executive officer of the AAPA, said, “anecdotally,” physicians have long heralded the value of PAs. But, with organizations like the American Medical Association (AMA) campaigning to end PA “scope creep,” the AAPA thought it was important to do a direct study. Most (90%) of physicians see PAs as important to enhancing care delivery.

“For change to happen — and to make sure we can continue to provide the best possible care for patients — all healthcare providers must work together to find solutions,” Gables told this news organization. “The doctors who work with PAs appreciate the work they do and recognize the barriers they face. But anecdotes aren’t data. We thought it was important to do a formal survey so physicians across the nation could share how they work with PAs and where we can find common ground to address the challenges healthcare is facing.”

The survey included a national sample of 999 physicians. It found that 86% of respondents, even those who do not work directly with PAs, believe that PAs can help expand access to care. Moreover, 68% of respondents said that they support modernizing PA laws and regulations to ease provider shortages and reduce wait times for patients.

 

Physicians Trust PAs

Currently, most laws dictate that physicians must supervise PAs as they work — yet, what constitutes supervision varies. The physicians surveyed said their PAs often see patients on their own in primary and specialty care settings. And 63% of the respondents reported never or rarely being physically present in the room while a PA delivers care. Gables said that while she is well aware of PAs’ strong skills and capabilities, she was surprised to see that this percentage was so high.

“The supervising agreement and supervision language that you see in so many state laws suggests that constant physician oversight is necessary. But in day-to-day practice, that’s not what is happening,” she said. “Physicians report they are rarely in the room with PAs during patient interactions and spend little time monitoring the care they provide. Physicians really trust their PAs — and it would be good to see laws that reflect that.”

 

PAs Improve Care Delivery

One of the AMA’s arguments about the dangers of scope creep is that patients may come to harm if a physician is not directly involved with patient care. They say PAs may not have the training or experience to identify some issues or to understand when a referral is required. Yet, a significant number of physicians surveyed in the AAPA study stated that they believed PAs are trained to perform comprehensive history and physical exams (61%), make referrals (59%), diagnose conditions and other disease states (50%), and develop and implement treatment plans (48%).

This is important, said Gables, because those same physicians reported there aren’t enough healthcare providers available, and they are struggling with current patient loads. The survey highlights the need to find ways to improve not just access to care but care delivery itself — and, given their skill sets, PAs are in a prime position to help.

“Most healthcare providers today will tell you that they are overworked. There are shortages everywhere,” said Gables. “Physicians see that patients are having a hard time accessing healthcare. There are long waits for appointments. And they also see that PAs have the skills necessary to help alleviate those shortages. More than three quarters of the doctors who work with PAs say they provide safe, effective care to patients — and they know when they need to consult with a physician or make a referral,” she said.

 

Autonomy Leads to Access

The AAPA has long called for policy changes to lessen the barriers that make it harder for PAs to serve the needs of patients. Gables said that what they are advocating for is not what the AMA calls scope creep but rather to lessen different barriers that interfere with PAs helping to deliver care. And it appears that physicians also see the value in loosening PA-related practice policies. About 68% of respondents said they support removing mandatory physician agreements to help ease provider shortages and improve care delivery for patients. Gables hopes that the AMA will see these results and think about ways providers can come together to make healthcare more accessible and equitable across the country.

“Looking at these results, I see that there’s the AMA, and then there’s the physicians who work with PAs. Those physicians know what PAs can do. And they know that we should all work together to solve the problems we share,” she said. “A previous survey shows that patients understand who PAs are and the value they bring to healthcare teams. Now we see that physicians understand that, too…So when we are thinking about how to make healthcare better, we all have a role to play in helping patients get the care they need and deserve.” Gables thinks we will be closer to achieving that when PAs practice at the highest levels of their training.

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

Late last year, the Health Resources and Services Administration projected a shortage of nearly 190,000 physicians across specialties by 2037. They noted, however, that we could mitigate the lack of doctors in some specialties by increasing the use of physician associates (PAs), especially with new and pending legislation expanding PAs’ scope of practice. A new survey conducted by Morning Consult, a business intelligence company, and the American Academy of Physician Associates (AAPA) found that doctors mostly agree with this assessment.

Lisa Gables, CPA, chief executive officer of the AAPA, said, “anecdotally,” physicians have long heralded the value of PAs. But, with organizations like the American Medical Association (AMA) campaigning to end PA “scope creep,” the AAPA thought it was important to do a direct study. Most (90%) of physicians see PAs as important to enhancing care delivery.

“For change to happen — and to make sure we can continue to provide the best possible care for patients — all healthcare providers must work together to find solutions,” Gables told this news organization. “The doctors who work with PAs appreciate the work they do and recognize the barriers they face. But anecdotes aren’t data. We thought it was important to do a formal survey so physicians across the nation could share how they work with PAs and where we can find common ground to address the challenges healthcare is facing.”

The survey included a national sample of 999 physicians. It found that 86% of respondents, even those who do not work directly with PAs, believe that PAs can help expand access to care. Moreover, 68% of respondents said that they support modernizing PA laws and regulations to ease provider shortages and reduce wait times for patients.

 

Physicians Trust PAs

Currently, most laws dictate that physicians must supervise PAs as they work — yet, what constitutes supervision varies. The physicians surveyed said their PAs often see patients on their own in primary and specialty care settings. And 63% of the respondents reported never or rarely being physically present in the room while a PA delivers care. Gables said that while she is well aware of PAs’ strong skills and capabilities, she was surprised to see that this percentage was so high.

“The supervising agreement and supervision language that you see in so many state laws suggests that constant physician oversight is necessary. But in day-to-day practice, that’s not what is happening,” she said. “Physicians report they are rarely in the room with PAs during patient interactions and spend little time monitoring the care they provide. Physicians really trust their PAs — and it would be good to see laws that reflect that.”

 

PAs Improve Care Delivery

One of the AMA’s arguments about the dangers of scope creep is that patients may come to harm if a physician is not directly involved with patient care. They say PAs may not have the training or experience to identify some issues or to understand when a referral is required. Yet, a significant number of physicians surveyed in the AAPA study stated that they believed PAs are trained to perform comprehensive history and physical exams (61%), make referrals (59%), diagnose conditions and other disease states (50%), and develop and implement treatment plans (48%).

This is important, said Gables, because those same physicians reported there aren’t enough healthcare providers available, and they are struggling with current patient loads. The survey highlights the need to find ways to improve not just access to care but care delivery itself — and, given their skill sets, PAs are in a prime position to help.

“Most healthcare providers today will tell you that they are overworked. There are shortages everywhere,” said Gables. “Physicians see that patients are having a hard time accessing healthcare. There are long waits for appointments. And they also see that PAs have the skills necessary to help alleviate those shortages. More than three quarters of the doctors who work with PAs say they provide safe, effective care to patients — and they know when they need to consult with a physician or make a referral,” she said.

 

Autonomy Leads to Access

The AAPA has long called for policy changes to lessen the barriers that make it harder for PAs to serve the needs of patients. Gables said that what they are advocating for is not what the AMA calls scope creep but rather to lessen different barriers that interfere with PAs helping to deliver care. And it appears that physicians also see the value in loosening PA-related practice policies. About 68% of respondents said they support removing mandatory physician agreements to help ease provider shortages and improve care delivery for patients. Gables hopes that the AMA will see these results and think about ways providers can come together to make healthcare more accessible and equitable across the country.

“Looking at these results, I see that there’s the AMA, and then there’s the physicians who work with PAs. Those physicians know what PAs can do. And they know that we should all work together to solve the problems we share,” she said. “A previous survey shows that patients understand who PAs are and the value they bring to healthcare teams. Now we see that physicians understand that, too…So when we are thinking about how to make healthcare better, we all have a role to play in helping patients get the care they need and deserve.” Gables thinks we will be closer to achieving that when PAs practice at the highest levels of their training.

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

In the largest head-to-head randomized trial of its kind, UK researchers found transperineal prostate biopsies using local anesthesia (LATP) superior to the transrectal approach in detecting clinically significant cancers.

The TRANSLATE study, with more than 1100 patients, found LATP identified 5.7% more cases of clinically significant prostate cancer, defined as Grade Group 2 or higher, than biopsies using transrectal ultrasonography (TRUS).

Previous research comparing the two techniques has focused mainly on rates of infection rather than cancer detection, said Richard Bryant, PhD, a consultant urologist at Nuffield Department of Surgical Sciences, University of Oxford in Oxford, England, who led the trial.

“We decided that the most important thing to look at is the detection rate of clinically significant prostate cancer, because that is why the man is having the biopsy in the first place, rather than to avoid infection, although avoiding infection is of course also important,” Bryant said.

Bryant presented the findings at the 2025 annual congress of the European Association of Urology and his group published the results in The Lancet Oncology.

The TRANSLATE trial was powered to identify a difference in the rate of cancer detection but not factors such as pain and sepsis. Hospitalization after biopsies served as a proxy for sepsis.

Men in the trial were nearly twice as likely to report LATP to be problematic immediately after the procedure than those who underwent transrectal biopsies. These issues included pain, discomfort, and embarrassment.

Two of the 562 men in the LATP group were hospitalized within 35 days of the procedure compared with nine of the 564 in the TRUS group. Bryant said this trend favored LATP, but the difference did not reach statistical significance.

The data on infection and other secondary outcomes were encouraging, but not conclusive, Bryant’s group reported.

Richard Szabo, MD, a prostate biopsy researcher at University of California Irvine, said the reduction in post-biopsy sepsis has been “an additional major advantage” of transperineal over transrectal prostate biopsy.

Almost 90% of men who received LATP had the biopsies without antibiotics — a “bonus,” Bryant said.

Antibiotic stewardship is a major factor in research and policies regarding biopsies in Europe. Transperineal biopsies avoid the rectum and pass needles through the perineum between the anus and the testicles, reducing risk for infection.

Jim Hu, MD, a urologic oncology researcher at Weill Cornell in New York City and the principal investigator on the 2024 PREVENT trial, said three of four randomized trials reported in the past year, including PREVENT and TRANSLATE, have found transperineal biopsies resulted in fewer infections than the transrectal method.

European guidelines call transperineal biopsy the preferred approach based on infection concerns, whereas guidance from the American Urological Association gives equal weight to transperineal and transrectal biopsies.

Badar Mian, MD, a urologist at Albany Med Health System in Albany, New York, said the field should “shift our focus from picking a winner to instead focus on whether prostate biopsy procedures are safe and effective. Patients should be reassured that, while there are trade-offs, both procedures can be performed safely and with a high degree of accuracy.”

The UK’s National Institute for Health and Care Research funded TRANSLATE. Bryant received support from BXTAccelyon to attend biopsy training provided by Guys’ Hospital, in London, England.

Howard Wolinsky is a Chicago-based freelance writer.

A version of this article appeared at Medscape.com.

In the largest head-to-head randomized trial of its kind, UK researchers found transperineal prostate biopsies using local anesthesia (LATP) superior to the transrectal approach in detecting clinically significant cancers.

The TRANSLATE study, with more than 1100 patients, found LATP identified 5.7% more cases of clinically significant prostate cancer, defined as Grade Group 2 or higher, than biopsies using transrectal ultrasonography (TRUS).

Previous research comparing the two techniques has focused mainly on rates of infection rather than cancer detection, said Richard Bryant, PhD, a consultant urologist at Nuffield Department of Surgical Sciences, University of Oxford in Oxford, England, who led the trial.

“We decided that the most important thing to look at is the detection rate of clinically significant prostate cancer, because that is why the man is having the biopsy in the first place, rather than to avoid infection, although avoiding infection is of course also important,” Bryant said.

Bryant presented the findings at the 2025 annual congress of the European Association of Urology and his group published the results in The Lancet Oncology.

The TRANSLATE trial was powered to identify a difference in the rate of cancer detection but not factors such as pain and sepsis. Hospitalization after biopsies served as a proxy for sepsis.

Men in the trial were nearly twice as likely to report LATP to be problematic immediately after the procedure than those who underwent transrectal biopsies. These issues included pain, discomfort, and embarrassment.

Two of the 562 men in the LATP group were hospitalized within 35 days of the procedure compared with nine of the 564 in the TRUS group. Bryant said this trend favored LATP, but the difference did not reach statistical significance.

The data on infection and other secondary outcomes were encouraging, but not conclusive, Bryant’s group reported.

Richard Szabo, MD, a prostate biopsy researcher at University of California Irvine, said the reduction in post-biopsy sepsis has been “an additional major advantage” of transperineal over transrectal prostate biopsy.

Almost 90% of men who received LATP had the biopsies without antibiotics — a “bonus,” Bryant said.

Antibiotic stewardship is a major factor in research and policies regarding biopsies in Europe. Transperineal biopsies avoid the rectum and pass needles through the perineum between the anus and the testicles, reducing risk for infection.

Jim Hu, MD, a urologic oncology researcher at Weill Cornell in New York City and the principal investigator on the 2024 PREVENT trial, said three of four randomized trials reported in the past year, including PREVENT and TRANSLATE, have found transperineal biopsies resulted in fewer infections than the transrectal method.

European guidelines call transperineal biopsy the preferred approach based on infection concerns, whereas guidance from the American Urological Association gives equal weight to transperineal and transrectal biopsies.

Badar Mian, MD, a urologist at Albany Med Health System in Albany, New York, said the field should “shift our focus from picking a winner to instead focus on whether prostate biopsy procedures are safe and effective. Patients should be reassured that, while there are trade-offs, both procedures can be performed safely and with a high degree of accuracy.”

The UK’s National Institute for Health and Care Research funded TRANSLATE. Bryant received support from BXTAccelyon to attend biopsy training provided by Guys’ Hospital, in London, England.

Howard Wolinsky is a Chicago-based freelance writer.

A version of this article appeared at Medscape.com.

In the largest head-to-head randomized trial of its kind, UK researchers found transperineal prostate biopsies using local anesthesia (LATP) superior to the transrectal approach in detecting clinically significant cancers.

The TRANSLATE study, with more than 1100 patients, found LATP identified 5.7% more cases of clinically significant prostate cancer, defined as Grade Group 2 or higher, than biopsies using transrectal ultrasonography (TRUS).

Previous research comparing the two techniques has focused mainly on rates of infection rather than cancer detection, said Richard Bryant, PhD, a consultant urologist at Nuffield Department of Surgical Sciences, University of Oxford in Oxford, England, who led the trial.

“We decided that the most important thing to look at is the detection rate of clinically significant prostate cancer, because that is why the man is having the biopsy in the first place, rather than to avoid infection, although avoiding infection is of course also important,” Bryant said.

Bryant presented the findings at the 2025 annual congress of the European Association of Urology and his group published the results in The Lancet Oncology.

The TRANSLATE trial was powered to identify a difference in the rate of cancer detection but not factors such as pain and sepsis. Hospitalization after biopsies served as a proxy for sepsis.

Men in the trial were nearly twice as likely to report LATP to be problematic immediately after the procedure than those who underwent transrectal biopsies. These issues included pain, discomfort, and embarrassment.

Two of the 562 men in the LATP group were hospitalized within 35 days of the procedure compared with nine of the 564 in the TRUS group. Bryant said this trend favored LATP, but the difference did not reach statistical significance.

The data on infection and other secondary outcomes were encouraging, but not conclusive, Bryant’s group reported.

Richard Szabo, MD, a prostate biopsy researcher at University of California Irvine, said the reduction in post-biopsy sepsis has been “an additional major advantage” of transperineal over transrectal prostate biopsy.

Almost 90% of men who received LATP had the biopsies without antibiotics — a “bonus,” Bryant said.

Antibiotic stewardship is a major factor in research and policies regarding biopsies in Europe. Transperineal biopsies avoid the rectum and pass needles through the perineum between the anus and the testicles, reducing risk for infection.

Jim Hu, MD, a urologic oncology researcher at Weill Cornell in New York City and the principal investigator on the 2024 PREVENT trial, said three of four randomized trials reported in the past year, including PREVENT and TRANSLATE, have found transperineal biopsies resulted in fewer infections than the transrectal method.

European guidelines call transperineal biopsy the preferred approach based on infection concerns, whereas guidance from the American Urological Association gives equal weight to transperineal and transrectal biopsies.

Badar Mian, MD, a urologist at Albany Med Health System in Albany, New York, said the field should “shift our focus from picking a winner to instead focus on whether prostate biopsy procedures are safe and effective. Patients should be reassured that, while there are trade-offs, both procedures can be performed safely and with a high degree of accuracy.”

The UK’s National Institute for Health and Care Research funded TRANSLATE. Bryant received support from BXTAccelyon to attend biopsy training provided by Guys’ Hospital, in London, England.

Howard Wolinsky is a Chicago-based freelance writer.

A version of this article appeared at Medscape.com.

Micro-ultrasound–guided biopsies were found for the first time to be “noninferior” to MRI-guided procedures, according to new research presented at the 2025 annual congress of the European Association of Urology.

The OPTIMUM study found 4.5% more clinically significant cancers among men who underwent micro-ultrasound–guided biopsies of the prostate than in those scanned using MRI.

“The take-home message is that men being worked up for an elevated PSA [prostate-specific antigen] or an abnormal digital rectal examination who are at increased risk of prostate cancer may safely undergo a micro-ultrasound–guided biopsy rather than an MRI-guided biopsy,” said Adam Kinnaird, MD, PhD, the Frank and Carla Sojonky Chair in Prostate Cancer Research at the University of Alberta, Edmonton, Alberta, Canada, and principal investigator of the study.

Micro-ultrasound can image to as small as 70 μm, ie, the width of a human hair.

OPTIMUM was an international, open-label, randomized, noninferiority trial in 20 centers in eight countries of men with clinical suspicion of prostate cancer, elevated PSAs, abnormal digital rectal exams, or a combination of these risk factors. None of the men previously had undergone biopsies.

The study had three arms to which men were assigned randomly: Micro-ultrasound–guided biopsy (n = 121); biopsies guided by micro-ultrasound and fusion MRI (n = 226), and MRI plus conventional ultrasound–guided biopsy (n = 331).

Subjects had a median age of 65 years and a median PSA level of 6.9 ng/mL; 83% self-identified as White individuals.

“Micro-ultrasound was found to be no worse than MRI at the detection of clinically significant prostate cancer. We don’t show it is equivalent. We don’t show it better. We show it is not worse,” Kinnaird said.

The study, funded by Exact Imaging, which makes the ExactVu micro-ultrasound platform, appeared simultaneously in JAMA.

Laurence Klotz, MD, the Sunnybrook Chair of Prostate Cancer Research at the University of Toronto Sunnybrook Health Sciences Centre, and senior researcher on the OPTIMUM trial, said as the incidence of prostate cancer rises globally, micro-ultrasound may be of particular value in low-income and middle-income countries where MRI is not widely available. 

“It’s extremely appealing in places that can’t offer MRI to everyone, but I think it also will have a role going forward in regions where there is no problem about getting access to MRI,” Klotz told Medscape Medical News.

This group is next studying the financial aspects of the technology, he added.

Gerald Andriole, MD, then urology chief at Washington University in St. Louis, St. Louis, Missouri, designed the original studies of the ExactVu system, which the US Food and Drug Administration approved in 2017.

Andriole, now chief medical officer of Prostatype Genomics, said MRIs are costly, subjective, and uncomfortable for many patients, due to claustrophobia and obesity, requiring complicated co-registration procedures to perform an accurate targeted biopsy into the most worrisome regions of the prostate. “Proceeding directly to a micro-ultrasound study avoids these impediments to discovering whether the patient has clinically significant cancer,” he said.

Micro-ultrasound testing involves a single visit to a urologist whereas MRI requires two trips for the patient — one to the urologist and the other to a radiologist, Klotz said. “It’s one-stop shopping,” he said. “So, the patient has his micro-ultrasound. If there’s a target found, he then does the targeted biopsy.”

Klotz said micro-ultrasound helps patients avoid the expense and health risks of gadolinium in contrast with MRIs.

“I don’t think micro-ultrasound is going to replace MRIs,” he said. “I think they’re somewhat complementary. You get cases where they’re visible on MRI and not visible on micro-ultrasound and vice versa.”

The researchers received a grant from Exact Imaging. 

A version of this article appeared at Medscape.com.

Howard Wolinsky is a Chicago-based freelance writer.

Micro-ultrasound–guided biopsies were found for the first time to be “noninferior” to MRI-guided procedures, according to new research presented at the 2025 annual congress of the European Association of Urology.

The OPTIMUM study found 4.5% more clinically significant cancers among men who underwent micro-ultrasound–guided biopsies of the prostate than in those scanned using MRI.

“The take-home message is that men being worked up for an elevated PSA [prostate-specific antigen] or an abnormal digital rectal examination who are at increased risk of prostate cancer may safely undergo a micro-ultrasound–guided biopsy rather than an MRI-guided biopsy,” said Adam Kinnaird, MD, PhD, the Frank and Carla Sojonky Chair in Prostate Cancer Research at the University of Alberta, Edmonton, Alberta, Canada, and principal investigator of the study.

Micro-ultrasound can image to as small as 70 μm, ie, the width of a human hair.

OPTIMUM was an international, open-label, randomized, noninferiority trial in 20 centers in eight countries of men with clinical suspicion of prostate cancer, elevated PSAs, abnormal digital rectal exams, or a combination of these risk factors. None of the men previously had undergone biopsies.

The study had three arms to which men were assigned randomly: Micro-ultrasound–guided biopsy (n = 121); biopsies guided by micro-ultrasound and fusion MRI (n = 226), and MRI plus conventional ultrasound–guided biopsy (n = 331).

Subjects had a median age of 65 years and a median PSA level of 6.9 ng/mL; 83% self-identified as White individuals.

“Micro-ultrasound was found to be no worse than MRI at the detection of clinically significant prostate cancer. We don’t show it is equivalent. We don’t show it better. We show it is not worse,” Kinnaird said.

The study, funded by Exact Imaging, which makes the ExactVu micro-ultrasound platform, appeared simultaneously in JAMA.

Laurence Klotz, MD, the Sunnybrook Chair of Prostate Cancer Research at the University of Toronto Sunnybrook Health Sciences Centre, and senior researcher on the OPTIMUM trial, said as the incidence of prostate cancer rises globally, micro-ultrasound may be of particular value in low-income and middle-income countries where MRI is not widely available. 

“It’s extremely appealing in places that can’t offer MRI to everyone, but I think it also will have a role going forward in regions where there is no problem about getting access to MRI,” Klotz told Medscape Medical News.

This group is next studying the financial aspects of the technology, he added.

Gerald Andriole, MD, then urology chief at Washington University in St. Louis, St. Louis, Missouri, designed the original studies of the ExactVu system, which the US Food and Drug Administration approved in 2017.

Andriole, now chief medical officer of Prostatype Genomics, said MRIs are costly, subjective, and uncomfortable for many patients, due to claustrophobia and obesity, requiring complicated co-registration procedures to perform an accurate targeted biopsy into the most worrisome regions of the prostate. “Proceeding directly to a micro-ultrasound study avoids these impediments to discovering whether the patient has clinically significant cancer,” he said.

Micro-ultrasound testing involves a single visit to a urologist whereas MRI requires two trips for the patient — one to the urologist and the other to a radiologist, Klotz said. “It’s one-stop shopping,” he said. “So, the patient has his micro-ultrasound. If there’s a target found, he then does the targeted biopsy.”

Klotz said micro-ultrasound helps patients avoid the expense and health risks of gadolinium in contrast with MRIs.

“I don’t think micro-ultrasound is going to replace MRIs,” he said. “I think they’re somewhat complementary. You get cases where they’re visible on MRI and not visible on micro-ultrasound and vice versa.”

The researchers received a grant from Exact Imaging. 

A version of this article appeared at Medscape.com.

Howard Wolinsky is a Chicago-based freelance writer.

Micro-ultrasound–guided biopsies were found for the first time to be “noninferior” to MRI-guided procedures, according to new research presented at the 2025 annual congress of the European Association of Urology.

The OPTIMUM study found 4.5% more clinically significant cancers among men who underwent micro-ultrasound–guided biopsies of the prostate than in those scanned using MRI.

“The take-home message is that men being worked up for an elevated PSA [prostate-specific antigen] or an abnormal digital rectal examination who are at increased risk of prostate cancer may safely undergo a micro-ultrasound–guided biopsy rather than an MRI-guided biopsy,” said Adam Kinnaird, MD, PhD, the Frank and Carla Sojonky Chair in Prostate Cancer Research at the University of Alberta, Edmonton, Alberta, Canada, and principal investigator of the study.

Micro-ultrasound can image to as small as 70 μm, ie, the width of a human hair.

OPTIMUM was an international, open-label, randomized, noninferiority trial in 20 centers in eight countries of men with clinical suspicion of prostate cancer, elevated PSAs, abnormal digital rectal exams, or a combination of these risk factors. None of the men previously had undergone biopsies.

The study had three arms to which men were assigned randomly: Micro-ultrasound–guided biopsy (n = 121); biopsies guided by micro-ultrasound and fusion MRI (n = 226), and MRI plus conventional ultrasound–guided biopsy (n = 331).

Subjects had a median age of 65 years and a median PSA level of 6.9 ng/mL; 83% self-identified as White individuals.

“Micro-ultrasound was found to be no worse than MRI at the detection of clinically significant prostate cancer. We don’t show it is equivalent. We don’t show it better. We show it is not worse,” Kinnaird said.

The study, funded by Exact Imaging, which makes the ExactVu micro-ultrasound platform, appeared simultaneously in JAMA.

Laurence Klotz, MD, the Sunnybrook Chair of Prostate Cancer Research at the University of Toronto Sunnybrook Health Sciences Centre, and senior researcher on the OPTIMUM trial, said as the incidence of prostate cancer rises globally, micro-ultrasound may be of particular value in low-income and middle-income countries where MRI is not widely available. 

“It’s extremely appealing in places that can’t offer MRI to everyone, but I think it also will have a role going forward in regions where there is no problem about getting access to MRI,” Klotz told Medscape Medical News.

This group is next studying the financial aspects of the technology, he added.

Gerald Andriole, MD, then urology chief at Washington University in St. Louis, St. Louis, Missouri, designed the original studies of the ExactVu system, which the US Food and Drug Administration approved in 2017.

Andriole, now chief medical officer of Prostatype Genomics, said MRIs are costly, subjective, and uncomfortable for many patients, due to claustrophobia and obesity, requiring complicated co-registration procedures to perform an accurate targeted biopsy into the most worrisome regions of the prostate. “Proceeding directly to a micro-ultrasound study avoids these impediments to discovering whether the patient has clinically significant cancer,” he said.

Micro-ultrasound testing involves a single visit to a urologist whereas MRI requires two trips for the patient — one to the urologist and the other to a radiologist, Klotz said. “It’s one-stop shopping,” he said. “So, the patient has his micro-ultrasound. If there’s a target found, he then does the targeted biopsy.”

Klotz said micro-ultrasound helps patients avoid the expense and health risks of gadolinium in contrast with MRIs.

“I don’t think micro-ultrasound is going to replace MRIs,” he said. “I think they’re somewhat complementary. You get cases where they’re visible on MRI and not visible on micro-ultrasound and vice versa.”

The researchers received a grant from Exact Imaging. 

A version of this article appeared at Medscape.com.

Howard Wolinsky is a Chicago-based freelance writer.

BOSTON — Solid intraductal carcinoma of the prostate (IDC-P) is associated with significantly worse outcomes compared with conventional Gleason grade 5 prostate cancers and is more commonly present in metastatic than nonmetastatic cancers, according to two studies presented this week at the United States and Canadian Academy of Pathology (USCAP) 2025 Annual Meeting.

“Our findings suggest that solid IDC-P is more aggressive than Gleason grade 5 conventional prostate adenocarcinoma or cribriform IDC-P,” and it may therefore be better not to consider it as a grade 5 pattern, said first author of one of the studies, Hangchuan Shi, MD, PhD, of the University of Rochester Medical Center, in Rochester, New York.

Although IDC-P — reported in about 20% of men with prostate cancer — is known to be associated with poorer response to treatment, there is a debate over whether to grade the entity with Gleason scoring or not.

The International Society of Urological Pathology recommends incorporating IDC-P into the Gleason score, while the Genitourinary Pathology Society does not.

To evaluate the prognostic significance of solid IDC-P compared with Gleason grade 5 conventional prostate cancer, Shi and his colleagues identified 115 cases in the surgical pathology database at the University of Rochester Medical Center between 2008 and 2015 involving Gleason grade 5 conventional prostatic adenocarcinoma as a primary, secondary, or tertiary pattern, as well as cribriform IDC-P.

The researchers excluded cases showing comedonecrosis within IDC-P, due to the potential for worse outcomes.

Of the grade 5 conventional prostate cancer cases with cribriform carcinoma, 28 (24.3%) had solid nest pattern IDC-P. Patients with and without solid IDC-P had a matching mean age of about 64 years, and their mean preoperative PSA was about 12.27 ng/mL.

Adjuvant therapy prior to recurrence was significantly more common in those who had solid IDC-P (60.7% vs 34.5%; P = .016).

Compared with the conventional prostate cancer cases, those with solid IDC-P had a significantly higher incidence of lymph node metastasis (P = .014) and had larger estimated tumor volume (P = .011).

There were no significant differences in other clinicopathologic features, such as preoperative prostate-specific antigen, grade group, pT stage, and surgical margin status.

After adjustment for key factors in a multivariable analysis, solid IDC-P was significantly associated with poorer recurrence-free survival (P = .007), and poorer cancer-specific survival (P = .004).

Finally, solid IDC-P was an independent predictor of recurrence (hazard ratio [HR] 1.960; P = .031), whereas other measures, including prostate-specific antigen (PSA), cancer grade, pT, lymph node metastasis, surgical and tumor volume were not significant factors.

“We found the solid IDC-P patients had almost two-times the risk of recurrence compared with the patients without solid IDC-P in our study,” Shi said.

The findings underscore the importance of accurately identifying IDC-P, senior author Hiroshi Miyamoto, MD, PhD, director of Genitourinary Pathology at School of Medicine and Dentistry, University of Rochester, Rochester, New York, told Medscape Medical News.

“It may be difficult for some pathologists, especially those who have no specific training in genitourinary pathology, to adequately recognize” this form of cancer, he said.

Although it is recognized as an aggressive form of prostate cancer, “based on our studies, we believe that it is inadequate to grade IDC-P” as a Gleason grade 5 cancer, Miyamoto added.

IDC More Common in Metastases 

Poorer outcomes associated with IDC-P were further described in a post hoc sub-analysis of the phase 3, prospective PATRON clinical trial that is evaluating prostate-specific membrane antigen (PSMA) PET-CT–guided intensification of therapy.

In the multicenter trial, 825 patients were stratified into three cohorts: High-risk patients receiving radiation therapy (45%), high-risk patients receiving salvage radiation therapy post-radical prostatectomy (47%), and those receiving a radical prostatectomy (8%).

The patients in all three cohorts were randomized 1:1 to receive imaging with or without PSMA PET-CT.

IDC-P and/or cribriform carcinoma were present among 342 patients in the PSMA PET-CT group including 48% of high-risk patients receiving radiotherapy, 42% of high-risk patients receiving salvage radiation therapy post-radical prostatectomy, and 40% of those receiving a radical prostatectomy.

IDC-P was reported in 64% of cases with metastases detected by PSMA PET-CT compared with just 36% of cases without metastasis (P = .008), with the ratios being similar in each individual patient cohort.

Of note, the association between the presence of IDC-P and metastases was not observed when IDC-P and cribriform carcinoma were combined — IDC-P and/or cribriform carcinoma was detected in 54% of cases with PSMA PET-CT–detectable metastasis and in 46% of cases without metastasis (P = .362).

The first author Dominique Trudel, MD, PhD, of the Centre Hospitalier de l’Université de Montréal, Montreal, Quebec, Canada, said the findings add to understanding of IDC-P’s relationship with poorer outcomes.

“As pathologists, we know that IDC is associated with poor outcomes and that men with IDC who are treated with standard therapies do benefit from them, but they never benefit as much as men without IDC,” she told Medscape Medical News.

As the study is ongoing, “in approximately 4-5 years, we will know how much of a difference IDC-P makes in outcomes after treatment,” Trudel noted.

The take-home message from the collective research should be that “IDC-P matters,” she said.

“I think that if your patient has IDC-P and [cribriform carcinoma], it is worth at least asking someone from an academic center to see what the treatment options are. We know that some radiation oncologists are increasing doses for IDC-P. It is empiric, but they’re doing it,” she explained.

The authors had no disclosures to report.

The article first appeared in Medscape.com.

BOSTON — Solid intraductal carcinoma of the prostate (IDC-P) is associated with significantly worse outcomes compared with conventional Gleason grade 5 prostate cancers and is more commonly present in metastatic than nonmetastatic cancers, according to two studies presented this week at the United States and Canadian Academy of Pathology (USCAP) 2025 Annual Meeting.

“Our findings suggest that solid IDC-P is more aggressive than Gleason grade 5 conventional prostate adenocarcinoma or cribriform IDC-P,” and it may therefore be better not to consider it as a grade 5 pattern, said first author of one of the studies, Hangchuan Shi, MD, PhD, of the University of Rochester Medical Center, in Rochester, New York.

Although IDC-P — reported in about 20% of men with prostate cancer — is known to be associated with poorer response to treatment, there is a debate over whether to grade the entity with Gleason scoring or not.

The International Society of Urological Pathology recommends incorporating IDC-P into the Gleason score, while the Genitourinary Pathology Society does not.

To evaluate the prognostic significance of solid IDC-P compared with Gleason grade 5 conventional prostate cancer, Shi and his colleagues identified 115 cases in the surgical pathology database at the University of Rochester Medical Center between 2008 and 2015 involving Gleason grade 5 conventional prostatic adenocarcinoma as a primary, secondary, or tertiary pattern, as well as cribriform IDC-P.

The researchers excluded cases showing comedonecrosis within IDC-P, due to the potential for worse outcomes.

Of the grade 5 conventional prostate cancer cases with cribriform carcinoma, 28 (24.3%) had solid nest pattern IDC-P. Patients with and without solid IDC-P had a matching mean age of about 64 years, and their mean preoperative PSA was about 12.27 ng/mL.

Adjuvant therapy prior to recurrence was significantly more common in those who had solid IDC-P (60.7% vs 34.5%; P = .016).

Compared with the conventional prostate cancer cases, those with solid IDC-P had a significantly higher incidence of lymph node metastasis (P = .014) and had larger estimated tumor volume (P = .011).

There were no significant differences in other clinicopathologic features, such as preoperative prostate-specific antigen, grade group, pT stage, and surgical margin status.

After adjustment for key factors in a multivariable analysis, solid IDC-P was significantly associated with poorer recurrence-free survival (P = .007), and poorer cancer-specific survival (P = .004).

Finally, solid IDC-P was an independent predictor of recurrence (hazard ratio [HR] 1.960; P = .031), whereas other measures, including prostate-specific antigen (PSA), cancer grade, pT, lymph node metastasis, surgical and tumor volume were not significant factors.

“We found the solid IDC-P patients had almost two-times the risk of recurrence compared with the patients without solid IDC-P in our study,” Shi said.

The findings underscore the importance of accurately identifying IDC-P, senior author Hiroshi Miyamoto, MD, PhD, director of Genitourinary Pathology at School of Medicine and Dentistry, University of Rochester, Rochester, New York, told Medscape Medical News.

“It may be difficult for some pathologists, especially those who have no specific training in genitourinary pathology, to adequately recognize” this form of cancer, he said.

Although it is recognized as an aggressive form of prostate cancer, “based on our studies, we believe that it is inadequate to grade IDC-P” as a Gleason grade 5 cancer, Miyamoto added.

IDC More Common in Metastases 

Poorer outcomes associated with IDC-P were further described in a post hoc sub-analysis of the phase 3, prospective PATRON clinical trial that is evaluating prostate-specific membrane antigen (PSMA) PET-CT–guided intensification of therapy.

In the multicenter trial, 825 patients were stratified into three cohorts: High-risk patients receiving radiation therapy (45%), high-risk patients receiving salvage radiation therapy post-radical prostatectomy (47%), and those receiving a radical prostatectomy (8%).

The patients in all three cohorts were randomized 1:1 to receive imaging with or without PSMA PET-CT.

IDC-P and/or cribriform carcinoma were present among 342 patients in the PSMA PET-CT group including 48% of high-risk patients receiving radiotherapy, 42% of high-risk patients receiving salvage radiation therapy post-radical prostatectomy, and 40% of those receiving a radical prostatectomy.

IDC-P was reported in 64% of cases with metastases detected by PSMA PET-CT compared with just 36% of cases without metastasis (P = .008), with the ratios being similar in each individual patient cohort.

Of note, the association between the presence of IDC-P and metastases was not observed when IDC-P and cribriform carcinoma were combined — IDC-P and/or cribriform carcinoma was detected in 54% of cases with PSMA PET-CT–detectable metastasis and in 46% of cases without metastasis (P = .362).

The first author Dominique Trudel, MD, PhD, of the Centre Hospitalier de l’Université de Montréal, Montreal, Quebec, Canada, said the findings add to understanding of IDC-P’s relationship with poorer outcomes.

“As pathologists, we know that IDC is associated with poor outcomes and that men with IDC who are treated with standard therapies do benefit from them, but they never benefit as much as men without IDC,” she told Medscape Medical News.

As the study is ongoing, “in approximately 4-5 years, we will know how much of a difference IDC-P makes in outcomes after treatment,” Trudel noted.

The take-home message from the collective research should be that “IDC-P matters,” she said.

“I think that if your patient has IDC-P and [cribriform carcinoma], it is worth at least asking someone from an academic center to see what the treatment options are. We know that some radiation oncologists are increasing doses for IDC-P. It is empiric, but they’re doing it,” she explained.

The authors had no disclosures to report.

The article first appeared in Medscape.com.

BOSTON — Solid intraductal carcinoma of the prostate (IDC-P) is associated with significantly worse outcomes compared with conventional Gleason grade 5 prostate cancers and is more commonly present in metastatic than nonmetastatic cancers, according to two studies presented this week at the United States and Canadian Academy of Pathology (USCAP) 2025 Annual Meeting.

“Our findings suggest that solid IDC-P is more aggressive than Gleason grade 5 conventional prostate adenocarcinoma or cribriform IDC-P,” and it may therefore be better not to consider it as a grade 5 pattern, said first author of one of the studies, Hangchuan Shi, MD, PhD, of the University of Rochester Medical Center, in Rochester, New York.

Although IDC-P — reported in about 20% of men with prostate cancer — is known to be associated with poorer response to treatment, there is a debate over whether to grade the entity with Gleason scoring or not.

The International Society of Urological Pathology recommends incorporating IDC-P into the Gleason score, while the Genitourinary Pathology Society does not.

To evaluate the prognostic significance of solid IDC-P compared with Gleason grade 5 conventional prostate cancer, Shi and his colleagues identified 115 cases in the surgical pathology database at the University of Rochester Medical Center between 2008 and 2015 involving Gleason grade 5 conventional prostatic adenocarcinoma as a primary, secondary, or tertiary pattern, as well as cribriform IDC-P.

The researchers excluded cases showing comedonecrosis within IDC-P, due to the potential for worse outcomes.

Of the grade 5 conventional prostate cancer cases with cribriform carcinoma, 28 (24.3%) had solid nest pattern IDC-P. Patients with and without solid IDC-P had a matching mean age of about 64 years, and their mean preoperative PSA was about 12.27 ng/mL.

Adjuvant therapy prior to recurrence was significantly more common in those who had solid IDC-P (60.7% vs 34.5%; P = .016).

Compared with the conventional prostate cancer cases, those with solid IDC-P had a significantly higher incidence of lymph node metastasis (P = .014) and had larger estimated tumor volume (P = .011).

There were no significant differences in other clinicopathologic features, such as preoperative prostate-specific antigen, grade group, pT stage, and surgical margin status.

After adjustment for key factors in a multivariable analysis, solid IDC-P was significantly associated with poorer recurrence-free survival (P = .007), and poorer cancer-specific survival (P = .004).

Finally, solid IDC-P was an independent predictor of recurrence (hazard ratio [HR] 1.960; P = .031), whereas other measures, including prostate-specific antigen (PSA), cancer grade, pT, lymph node metastasis, surgical and tumor volume were not significant factors.

“We found the solid IDC-P patients had almost two-times the risk of recurrence compared with the patients without solid IDC-P in our study,” Shi said.

The findings underscore the importance of accurately identifying IDC-P, senior author Hiroshi Miyamoto, MD, PhD, director of Genitourinary Pathology at School of Medicine and Dentistry, University of Rochester, Rochester, New York, told Medscape Medical News.

“It may be difficult for some pathologists, especially those who have no specific training in genitourinary pathology, to adequately recognize” this form of cancer, he said.

Although it is recognized as an aggressive form of prostate cancer, “based on our studies, we believe that it is inadequate to grade IDC-P” as a Gleason grade 5 cancer, Miyamoto added.

IDC More Common in Metastases 

Poorer outcomes associated with IDC-P were further described in a post hoc sub-analysis of the phase 3, prospective PATRON clinical trial that is evaluating prostate-specific membrane antigen (PSMA) PET-CT–guided intensification of therapy.

In the multicenter trial, 825 patients were stratified into three cohorts: High-risk patients receiving radiation therapy (45%), high-risk patients receiving salvage radiation therapy post-radical prostatectomy (47%), and those receiving a radical prostatectomy (8%).

The patients in all three cohorts were randomized 1:1 to receive imaging with or without PSMA PET-CT.

IDC-P and/or cribriform carcinoma were present among 342 patients in the PSMA PET-CT group including 48% of high-risk patients receiving radiotherapy, 42% of high-risk patients receiving salvage radiation therapy post-radical prostatectomy, and 40% of those receiving a radical prostatectomy.

IDC-P was reported in 64% of cases with metastases detected by PSMA PET-CT compared with just 36% of cases without metastasis (P = .008), with the ratios being similar in each individual patient cohort.

Of note, the association between the presence of IDC-P and metastases was not observed when IDC-P and cribriform carcinoma were combined — IDC-P and/or cribriform carcinoma was detected in 54% of cases with PSMA PET-CT–detectable metastasis and in 46% of cases without metastasis (P = .362).

The first author Dominique Trudel, MD, PhD, of the Centre Hospitalier de l’Université de Montréal, Montreal, Quebec, Canada, said the findings add to understanding of IDC-P’s relationship with poorer outcomes.

“As pathologists, we know that IDC is associated with poor outcomes and that men with IDC who are treated with standard therapies do benefit from them, but they never benefit as much as men without IDC,” she told Medscape Medical News.

As the study is ongoing, “in approximately 4-5 years, we will know how much of a difference IDC-P makes in outcomes after treatment,” Trudel noted.

The take-home message from the collective research should be that “IDC-P matters,” she said.

“I think that if your patient has IDC-P and [cribriform carcinoma], it is worth at least asking someone from an academic center to see what the treatment options are. We know that some radiation oncologists are increasing doses for IDC-P. It is empiric, but they’re doing it,” she explained.

The authors had no disclosures to report.

The article first appeared in Medscape.com.

SAN FRANCISCO (Reuters) — Joey Cortez, who served 24 years in the US Air Force, had been waiting since August to see a mental health specialist from the Department of Veterans’ Affairs, when he experienced a fresh jolt of anxiety.

Cortez was fired last month from his human resources job at the agency - one of about 2400 employees who lost their jobs at Veterans’ Affairs (VA) in the first wave of President Donald Trump’s efforts to shrink the federal workforce.

“Once the firings happened and I was terminated, I started having panic attacks to the point where I black out,” Cortez, who suffers from post-traumatic stress disorder, told Reuters. The layoff is also making it harder to maintain his sobriety, as a recovering alcoholic.

“Not a day has gone by since I was fired that I haven’t thought about picking up a bottle,” said Cortez.

After losing his job, Cortez asked the VA to expedite his wait for a therapist and was told there was no record of his request, he said. After a month of calls to the agency, he got an appointment for this August, one year after he started the process. Then the VA offered him an appointment next week because another patient had canceled.

The VA provides health care to 9.31 million US veterans at hundreds of medical centers, clinics, and nursing homes across the country.

It also faces complex problems.

“The VA has bloat. There are redundancies. There are places where we have questioned the administration of care and asked, does it need to be the way it is?” Pat Murray, the legislative director for the Veterans of Foreign Wars, which represents Americans who have fought overseas, said in an interview.

The Trump administration plans additional cuts to the VA of more than 80,000 personnel, according to an internal memo obtained by Reuters. The agency has also announced it is phasing out telework.

Reuters spoke to nine current and former VA employees in California, Oregon, Texas, and the Washington D.C. area who said the changes were further disrupting some mental health services and fueling anxieties among those who provide and rely on them.

The VA employees — who include six mental health professionals and three people in leadership positions — described cancellations of some in-person and telehealth appointments; confusion over staffing of a crisis hot-line; and professionals conducting telehealth visits in makeshift meeting rooms inside VA buildings.

They spoke on the condition of anonymity, because they were not authorized to speak with the media.

 

STAFFING SHORTAGES

A former employee at the VA’s Office of Inspector General, who is also a veteran, said any future large-scale staffing cuts would likely worsen shortages and impact the quality of care.

“There’s no way to take a scalpel and do it appropriately that quickly,” he said.

VA spokesperson Peter Kasperowicz told Reuters mental health professionals, such as psychologists and social workers, were not included in February’s staffing cuts, and the agency is working to recruit mental health providers and improve wait times.

He did not specify how many support staff for these providers had been affected.

Last week, two federal judges ordered the VA and other federal agencies to reinstate thousands of fired probationary workers. Cortez’s pay was reinstated but he was told not to return to work.

The Veterans Health Administration, the branch of the VA that provides healthcare, has experienced severe staffing shortages since 2015, especially among mental health professionals, according to an OIG report last year.

Veterans often benefit from specialized services to treat anxiety, trauma, depression and substance abuse. The proportion of veterans receiving mental health services rose to 31% in 2022 from 20% in 2007, according to the VA. Suicide among veterans is twice the rate of Americans overall.

The VFW’s Murray said his organization supports a thorough review of the VA’s mental health services, but it needs to be done carefully, “not with a chainsaw.”

 

‘THE MOOD IS SO LOW’

In recent years, the agency had encouraged remote work to help expand access to telehealth services and reduce wait times, especially in rural areas where recruiting providers is difficult.

The VA’s Kasperowicz said that, while providers will need to return to VA facilities, veterans will be able to access telehealth appointments.

He did not directly address questions about why mental health providers needed to return to the office.

“The VA will make accommodations as needed to ensure employees have enough space to work and will always ensure that Veterans’ access to benefits and services remains uninterrupted as employees return to in-person work,” Kasperowicz said.

In the last few weeks, demand for services among veterans who are VA employees has also risen, one of the mental health professionals, a social worker, told Reuters. A quarter of VA employees are veterans.

The social worker said he is meeting with two to three VA employees a week who are seeking access to mental health care, citing stress and the fear that they will lose their jobs.

“People are calling out sick. People are ill with stress and worry. The mood is so low.”

A mental health supervisor in California described scrambling to cover the caseload of a remote worker who had to cancel appointments with more than a dozen veterans, because she could not access a VA facility.

VA employees in the Washington area and in Oregon said mental health professionals were unsure if they were allowed to answer calls from the VA’s crisis hot-line if they were not physically in an office, because they had been instructed not to conduct work outside of a facility.

“People are nervous to be on-call,” said a supervisor of mental health providers in the Washington area. “The system is under a lot of duress.”

The VA told Reuters that crisis line workers are exempt from the return-to-office policy, and that staff continue to respond quickly to nearly 3000 calls daily.

Therapists returning to the office are struggling to find private meeting rooms at some VA facilities, according to four of the mental health professionals interviewed by Reuters.

They described medical and mental health professionals converting closets and conference rooms into offices to comply with the mandate to conduct telehealth visits from VA facilities. They expressed concerns that the crowded rooms could violate patient privacy rights.

“We are scrambling to find space,” said a provider in California. “Veterans are going without until we can find spaces for these providers.”

Reuters was unable to independently verify the accounts of overcrowding. Kasperowicz said the agency’s “policy is to bring as many employees back to the office as space permits.”

(Reporting by Robin Respaut in San Francisco; additional reporting by Julia Harte in New York and Gabriella Borter in D.C.; Editing by Michele Gershberg and Suzanne Goldenberg)

SAN FRANCISCO (Reuters) — Joey Cortez, who served 24 years in the US Air Force, had been waiting since August to see a mental health specialist from the Department of Veterans’ Affairs, when he experienced a fresh jolt of anxiety.

Cortez was fired last month from his human resources job at the agency - one of about 2400 employees who lost their jobs at Veterans’ Affairs (VA) in the first wave of President Donald Trump’s efforts to shrink the federal workforce.

“Once the firings happened and I was terminated, I started having panic attacks to the point where I black out,” Cortez, who suffers from post-traumatic stress disorder, told Reuters. The layoff is also making it harder to maintain his sobriety, as a recovering alcoholic.

“Not a day has gone by since I was fired that I haven’t thought about picking up a bottle,” said Cortez.

After losing his job, Cortez asked the VA to expedite his wait for a therapist and was told there was no record of his request, he said. After a month of calls to the agency, he got an appointment for this August, one year after he started the process. Then the VA offered him an appointment next week because another patient had canceled.

The VA provides health care to 9.31 million US veterans at hundreds of medical centers, clinics, and nursing homes across the country.

It also faces complex problems.

“The VA has bloat. There are redundancies. There are places where we have questioned the administration of care and asked, does it need to be the way it is?” Pat Murray, the legislative director for the Veterans of Foreign Wars, which represents Americans who have fought overseas, said in an interview.

The Trump administration plans additional cuts to the VA of more than 80,000 personnel, according to an internal memo obtained by Reuters. The agency has also announced it is phasing out telework.

Reuters spoke to nine current and former VA employees in California, Oregon, Texas, and the Washington D.C. area who said the changes were further disrupting some mental health services and fueling anxieties among those who provide and rely on them.

The VA employees — who include six mental health professionals and three people in leadership positions — described cancellations of some in-person and telehealth appointments; confusion over staffing of a crisis hot-line; and professionals conducting telehealth visits in makeshift meeting rooms inside VA buildings.

They spoke on the condition of anonymity, because they were not authorized to speak with the media.

 

STAFFING SHORTAGES

A former employee at the VA’s Office of Inspector General, who is also a veteran, said any future large-scale staffing cuts would likely worsen shortages and impact the quality of care.

“There’s no way to take a scalpel and do it appropriately that quickly,” he said.

VA spokesperson Peter Kasperowicz told Reuters mental health professionals, such as psychologists and social workers, were not included in February’s staffing cuts, and the agency is working to recruit mental health providers and improve wait times.

He did not specify how many support staff for these providers had been affected.

Last week, two federal judges ordered the VA and other federal agencies to reinstate thousands of fired probationary workers. Cortez’s pay was reinstated but he was told not to return to work.

The Veterans Health Administration, the branch of the VA that provides healthcare, has experienced severe staffing shortages since 2015, especially among mental health professionals, according to an OIG report last year.

Veterans often benefit from specialized services to treat anxiety, trauma, depression and substance abuse. The proportion of veterans receiving mental health services rose to 31% in 2022 from 20% in 2007, according to the VA. Suicide among veterans is twice the rate of Americans overall.

The VFW’s Murray said his organization supports a thorough review of the VA’s mental health services, but it needs to be done carefully, “not with a chainsaw.”

 

‘THE MOOD IS SO LOW’

In recent years, the agency had encouraged remote work to help expand access to telehealth services and reduce wait times, especially in rural areas where recruiting providers is difficult.

The VA’s Kasperowicz said that, while providers will need to return to VA facilities, veterans will be able to access telehealth appointments.

He did not directly address questions about why mental health providers needed to return to the office.

“The VA will make accommodations as needed to ensure employees have enough space to work and will always ensure that Veterans’ access to benefits and services remains uninterrupted as employees return to in-person work,” Kasperowicz said.

In the last few weeks, demand for services among veterans who are VA employees has also risen, one of the mental health professionals, a social worker, told Reuters. A quarter of VA employees are veterans.

The social worker said he is meeting with two to three VA employees a week who are seeking access to mental health care, citing stress and the fear that they will lose their jobs.

“People are calling out sick. People are ill with stress and worry. The mood is so low.”

A mental health supervisor in California described scrambling to cover the caseload of a remote worker who had to cancel appointments with more than a dozen veterans, because she could not access a VA facility.

VA employees in the Washington area and in Oregon said mental health professionals were unsure if they were allowed to answer calls from the VA’s crisis hot-line if they were not physically in an office, because they had been instructed not to conduct work outside of a facility.

“People are nervous to be on-call,” said a supervisor of mental health providers in the Washington area. “The system is under a lot of duress.”

The VA told Reuters that crisis line workers are exempt from the return-to-office policy, and that staff continue to respond quickly to nearly 3000 calls daily.

Therapists returning to the office are struggling to find private meeting rooms at some VA facilities, according to four of the mental health professionals interviewed by Reuters.

They described medical and mental health professionals converting closets and conference rooms into offices to comply with the mandate to conduct telehealth visits from VA facilities. They expressed concerns that the crowded rooms could violate patient privacy rights.

“We are scrambling to find space,” said a provider in California. “Veterans are going without until we can find spaces for these providers.”

Reuters was unable to independently verify the accounts of overcrowding. Kasperowicz said the agency’s “policy is to bring as many employees back to the office as space permits.”

(Reporting by Robin Respaut in San Francisco; additional reporting by Julia Harte in New York and Gabriella Borter in D.C.; Editing by Michele Gershberg and Suzanne Goldenberg)

SAN FRANCISCO (Reuters) — Joey Cortez, who served 24 years in the US Air Force, had been waiting since August to see a mental health specialist from the Department of Veterans’ Affairs, when he experienced a fresh jolt of anxiety.

Cortez was fired last month from his human resources job at the agency - one of about 2400 employees who lost their jobs at Veterans’ Affairs (VA) in the first wave of President Donald Trump’s efforts to shrink the federal workforce.

“Once the firings happened and I was terminated, I started having panic attacks to the point where I black out,” Cortez, who suffers from post-traumatic stress disorder, told Reuters. The layoff is also making it harder to maintain his sobriety, as a recovering alcoholic.

“Not a day has gone by since I was fired that I haven’t thought about picking up a bottle,” said Cortez.

After losing his job, Cortez asked the VA to expedite his wait for a therapist and was told there was no record of his request, he said. After a month of calls to the agency, he got an appointment for this August, one year after he started the process. Then the VA offered him an appointment next week because another patient had canceled.

The VA provides health care to 9.31 million US veterans at hundreds of medical centers, clinics, and nursing homes across the country.

It also faces complex problems.

“The VA has bloat. There are redundancies. There are places where we have questioned the administration of care and asked, does it need to be the way it is?” Pat Murray, the legislative director for the Veterans of Foreign Wars, which represents Americans who have fought overseas, said in an interview.

The Trump administration plans additional cuts to the VA of more than 80,000 personnel, according to an internal memo obtained by Reuters. The agency has also announced it is phasing out telework.

Reuters spoke to nine current and former VA employees in California, Oregon, Texas, and the Washington D.C. area who said the changes were further disrupting some mental health services and fueling anxieties among those who provide and rely on them.

The VA employees — who include six mental health professionals and three people in leadership positions — described cancellations of some in-person and telehealth appointments; confusion over staffing of a crisis hot-line; and professionals conducting telehealth visits in makeshift meeting rooms inside VA buildings.

They spoke on the condition of anonymity, because they were not authorized to speak with the media.

 

STAFFING SHORTAGES

A former employee at the VA’s Office of Inspector General, who is also a veteran, said any future large-scale staffing cuts would likely worsen shortages and impact the quality of care.

“There’s no way to take a scalpel and do it appropriately that quickly,” he said.

VA spokesperson Peter Kasperowicz told Reuters mental health professionals, such as psychologists and social workers, were not included in February’s staffing cuts, and the agency is working to recruit mental health providers and improve wait times.

He did not specify how many support staff for these providers had been affected.

Last week, two federal judges ordered the VA and other federal agencies to reinstate thousands of fired probationary workers. Cortez’s pay was reinstated but he was told not to return to work.

The Veterans Health Administration, the branch of the VA that provides healthcare, has experienced severe staffing shortages since 2015, especially among mental health professionals, according to an OIG report last year.

Veterans often benefit from specialized services to treat anxiety, trauma, depression and substance abuse. The proportion of veterans receiving mental health services rose to 31% in 2022 from 20% in 2007, according to the VA. Suicide among veterans is twice the rate of Americans overall.

The VFW’s Murray said his organization supports a thorough review of the VA’s mental health services, but it needs to be done carefully, “not with a chainsaw.”

 

‘THE MOOD IS SO LOW’

In recent years, the agency had encouraged remote work to help expand access to telehealth services and reduce wait times, especially in rural areas where recruiting providers is difficult.

The VA’s Kasperowicz said that, while providers will need to return to VA facilities, veterans will be able to access telehealth appointments.

He did not directly address questions about why mental health providers needed to return to the office.

“The VA will make accommodations as needed to ensure employees have enough space to work and will always ensure that Veterans’ access to benefits and services remains uninterrupted as employees return to in-person work,” Kasperowicz said.

In the last few weeks, demand for services among veterans who are VA employees has also risen, one of the mental health professionals, a social worker, told Reuters. A quarter of VA employees are veterans.

The social worker said he is meeting with two to three VA employees a week who are seeking access to mental health care, citing stress and the fear that they will lose their jobs.

“People are calling out sick. People are ill with stress and worry. The mood is so low.”

A mental health supervisor in California described scrambling to cover the caseload of a remote worker who had to cancel appointments with more than a dozen veterans, because she could not access a VA facility.

VA employees in the Washington area and in Oregon said mental health professionals were unsure if they were allowed to answer calls from the VA’s crisis hot-line if they were not physically in an office, because they had been instructed not to conduct work outside of a facility.

“People are nervous to be on-call,” said a supervisor of mental health providers in the Washington area. “The system is under a lot of duress.”

The VA told Reuters that crisis line workers are exempt from the return-to-office policy, and that staff continue to respond quickly to nearly 3000 calls daily.

Therapists returning to the office are struggling to find private meeting rooms at some VA facilities, according to four of the mental health professionals interviewed by Reuters.

They described medical and mental health professionals converting closets and conference rooms into offices to comply with the mandate to conduct telehealth visits from VA facilities. They expressed concerns that the crowded rooms could violate patient privacy rights.

“We are scrambling to find space,” said a provider in California. “Veterans are going without until we can find spaces for these providers.”

Reuters was unable to independently verify the accounts of overcrowding. Kasperowicz said the agency’s “policy is to bring as many employees back to the office as space permits.”

(Reporting by Robin Respaut in San Francisco; additional reporting by Julia Harte in New York and Gabriella Borter in D.C.; Editing by Michele Gershberg and Suzanne Goldenberg)

TOPLINE:

A single dose of the recombinant respiratory syncytial virus (RSV) vaccine demonstrates effectiveness against infections and associated hospitalizations in veterans aged 60 years or older during the 2023-2024 respiratory illness season. This protection extends across age groups and immunocompromised individuals.

METHODOLOGY:

• Researchers conducted a target trial emulation study to evaluate the real-world effectiveness of a single dose of recombinant RSV vaccine (RSVPreF3 or RSVpreF) among veterans enrolled in the Veterans Health Administration in the United States between September 1 and December 31, 2023.

• They analyzed 146,852 vaccinated veterans (69.2%, RSVPreF; 29.9%, RSVPreF3) propensity matched with 582,936 unvaccinated ones (median age, ~76 years; ~94% men; immunocompromised individuals, 11.2%) who were followed up for a median of 124 days.

• The primary outcome was any positive RSV test result obtained from day 14 after vaccination.

• The secondary outcomes were RSV-associated emergency department or urgent care visits, hospitalizations, intensive care unit (ICU) admissions, and death.

TAKEAWAY:

• Vaccine effectiveness against documented RSV infections was 78.1% (95% CI, 72.6-83.5), with incidence rates of infections lower in the vaccinated group than in the unvaccinated group (1.7 vs 7.3 per 1000 person-years).

• Likewise, vaccine effectiveness against RSV-associated emergency department or urgent care visits was 78.7% (95% CI, 72.2-84.8), with rates of infections lower in the vaccinated group than in the unvaccinated group (1.3 vs 5.7 per 1000 person-years).

• Immunocompromised veterans demonstrated a lower vaccine effectiveness of 71.6% (95% CI, 55.4-85.2); however, infection rates remained lower in the vaccinated group than in the unvaccinated group (5.8 vs 19.9 per 1000 person-years).

• Hospitalizations, ICU admission rates, and mortality rates were also lower in the vaccinated group than in the unvaccinated group.

IN PRACTICE:

“These results give confidence that an RSV vaccine for older adults is likely to provide protection against RSV infection and RSV disease, at least in the first season following vaccination,” wrote the author of an accompanying comment.

SOURCE:

The study was funded by the US Department of Veterans Affairs Cooperative Studies Program. It was published online on January 20, 2025, in The Lancet Infectious Diseases (2025 Jan 20. doi:10.1016/S1473-3099(24)00796-5)

LIMITATIONS:

This study did not account for veterans who sought care outside of the Veterans Health Administration. While the study employed rigorous matching to ensure the similarity of demographic, geographic, and clinical characteristics, there could still have been residual confounding. Also, the study was not designed to estimate the protective effect of the vaccine against mild RSV illness.

DISCLOSURES:

This study was supported by the US Department of Veterans Affairs Cooperative Studies Program and funded in part by the US Department of Health and Human Services Biomedical Advanced Research and Development Authority and US Food and Drug Administration. One of the authors reported receiving consulting support from Van-Breemen & Hynes and having a subcontract at Oregon State University for a Patient-Centered Outcomes Research Institute grant. Others reported 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 first appeared on Medscape.com.

TOPLINE:

A single dose of the recombinant respiratory syncytial virus (RSV) vaccine demonstrates effectiveness against infections and associated hospitalizations in veterans aged 60 years or older during the 2023-2024 respiratory illness season. This protection extends across age groups and immunocompromised individuals.

METHODOLOGY:

• Researchers conducted a target trial emulation study to evaluate the real-world effectiveness of a single dose of recombinant RSV vaccine (RSVPreF3 or RSVpreF) among veterans enrolled in the Veterans Health Administration in the United States between September 1 and December 31, 2023.

• They analyzed 146,852 vaccinated veterans (69.2%, RSVPreF; 29.9%, RSVPreF3) propensity matched with 582,936 unvaccinated ones (median age, ~76 years; ~94% men; immunocompromised individuals, 11.2%) who were followed up for a median of 124 days.

• The primary outcome was any positive RSV test result obtained from day 14 after vaccination.

• The secondary outcomes were RSV-associated emergency department or urgent care visits, hospitalizations, intensive care unit (ICU) admissions, and death.

TAKEAWAY:

• Vaccine effectiveness against documented RSV infections was 78.1% (95% CI, 72.6-83.5), with incidence rates of infections lower in the vaccinated group than in the unvaccinated group (1.7 vs 7.3 per 1000 person-years).

• Likewise, vaccine effectiveness against RSV-associated emergency department or urgent care visits was 78.7% (95% CI, 72.2-84.8), with rates of infections lower in the vaccinated group than in the unvaccinated group (1.3 vs 5.7 per 1000 person-years).

• Immunocompromised veterans demonstrated a lower vaccine effectiveness of 71.6% (95% CI, 55.4-85.2); however, infection rates remained lower in the vaccinated group than in the unvaccinated group (5.8 vs 19.9 per 1000 person-years).

• Hospitalizations, ICU admission rates, and mortality rates were also lower in the vaccinated group than in the unvaccinated group.

IN PRACTICE:

“These results give confidence that an RSV vaccine for older adults is likely to provide protection against RSV infection and RSV disease, at least in the first season following vaccination,” wrote the author of an accompanying comment.

SOURCE:

The study was funded by the US Department of Veterans Affairs Cooperative Studies Program. It was published online on January 20, 2025, in The Lancet Infectious Diseases (2025 Jan 20. doi:10.1016/S1473-3099(24)00796-5)

LIMITATIONS:

This study did not account for veterans who sought care outside of the Veterans Health Administration. While the study employed rigorous matching to ensure the similarity of demographic, geographic, and clinical characteristics, there could still have been residual confounding. Also, the study was not designed to estimate the protective effect of the vaccine against mild RSV illness.

DISCLOSURES:

This study was supported by the US Department of Veterans Affairs Cooperative Studies Program and funded in part by the US Department of Health and Human Services Biomedical Advanced Research and Development Authority and US Food and Drug Administration. One of the authors reported receiving consulting support from Van-Breemen & Hynes and having a subcontract at Oregon State University for a Patient-Centered Outcomes Research Institute grant. Others reported 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 first appeared on Medscape.com.

TOPLINE:

A single dose of the recombinant respiratory syncytial virus (RSV) vaccine demonstrates effectiveness against infections and associated hospitalizations in veterans aged 60 years or older during the 2023-2024 respiratory illness season. This protection extends across age groups and immunocompromised individuals.

METHODOLOGY:

• Researchers conducted a target trial emulation study to evaluate the real-world effectiveness of a single dose of recombinant RSV vaccine (RSVPreF3 or RSVpreF) among veterans enrolled in the Veterans Health Administration in the United States between September 1 and December 31, 2023.

• They analyzed 146,852 vaccinated veterans (69.2%, RSVPreF; 29.9%, RSVPreF3) propensity matched with 582,936 unvaccinated ones (median age, ~76 years; ~94% men; immunocompromised individuals, 11.2%) who were followed up for a median of 124 days.

• The primary outcome was any positive RSV test result obtained from day 14 after vaccination.

• The secondary outcomes were RSV-associated emergency department or urgent care visits, hospitalizations, intensive care unit (ICU) admissions, and death.

TAKEAWAY:

• Vaccine effectiveness against documented RSV infections was 78.1% (95% CI, 72.6-83.5), with incidence rates of infections lower in the vaccinated group than in the unvaccinated group (1.7 vs 7.3 per 1000 person-years).

• Likewise, vaccine effectiveness against RSV-associated emergency department or urgent care visits was 78.7% (95% CI, 72.2-84.8), with rates of infections lower in the vaccinated group than in the unvaccinated group (1.3 vs 5.7 per 1000 person-years).

• Immunocompromised veterans demonstrated a lower vaccine effectiveness of 71.6% (95% CI, 55.4-85.2); however, infection rates remained lower in the vaccinated group than in the unvaccinated group (5.8 vs 19.9 per 1000 person-years).

• Hospitalizations, ICU admission rates, and mortality rates were also lower in the vaccinated group than in the unvaccinated group.

IN PRACTICE:

“These results give confidence that an RSV vaccine for older adults is likely to provide protection against RSV infection and RSV disease, at least in the first season following vaccination,” wrote the author of an accompanying comment.

SOURCE:

The study was funded by the US Department of Veterans Affairs Cooperative Studies Program. It was published online on January 20, 2025, in The Lancet Infectious Diseases (2025 Jan 20. doi:10.1016/S1473-3099(24)00796-5)

LIMITATIONS:

This study did not account for veterans who sought care outside of the Veterans Health Administration. While the study employed rigorous matching to ensure the similarity of demographic, geographic, and clinical characteristics, there could still have been residual confounding. Also, the study was not designed to estimate the protective effect of the vaccine against mild RSV illness.

DISCLOSURES:

This study was supported by the US Department of Veterans Affairs Cooperative Studies Program and funded in part by the US Department of Health and Human Services Biomedical Advanced Research and Development Authority and US Food and Drug Administration. One of the authors reported receiving consulting support from Van-Breemen & Hynes and having a subcontract at Oregon State University for a Patient-Centered Outcomes Research Institute grant. Others reported 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 first appeared on Medscape.com.

Electronic health records (EHRs) are an integral part of modern health care. The 2009, Health Information Technology for Economic and Clinical Health Act established financial incentives for US hospitals to adopt EHRs. In 2009 only 12% of nonfederal acute care hospitals had adopted a certified EHR system, which increased to 96% by 2021.¹

EHRs have transformed the way patient data are stored and accessed, streamlining the process of providing quality patient care with improvements in efficiency, effectiveness, patient satisfaction, and safety.² Despite their widespread adoption and benefits, EHRs have generally been met with mixed physician satisfaction.³ Interactions with EHRs are linked to disproportionate time at the computer and physician burnout.^4-6

The US Department of Veterans Affairs (VA) was at the forefront of EHR development, establishing the Veterans Health Information Systems and Technology Architecture (VistA) in the 1970s. The VA released the Computerized Patient Record System (CPRS) in 1997, the first clinical user interface for VistA. In May 2018, the VA signed a $10 billion contract with Cerner (now Oracle Health) to modernize its EHR.⁷ This was later revised to $16.1 billion, and the Institute for Defense Analyses estimates it will cost $49.8 billion.⁸ The transition to Oracle Health has been faced with significant challenges, including patient safety risks and workflow inefficiencies, leading to a pause in rollout.⁹

Due to the known challenges with EHRs and the aging CPRS system (without a scheduled replacement date), innovations that facilitate the synthesis and display of clinical information are needed. To address this gap, the VA Ann Arbor Healthcare System (VAAAHS) developed the Inpatient Dashboard, an online EHR companion tool. The Inpatient Dashboard was designed to draw data from VistA to reduce time spent at the computer by streamlining clinical information presentation, standardizing inpatient notes, improving safety measures, and enhancing overall clinician satisfaction. This study evaluated the adoption and user experience with the Inpatient Dashboard.

INPATIENT DASHBOARD

The Inpatient Dashboard consists of several modules created by a contractor for the VAAAHS that is housed on VA servers with access restricted to individuals with patient health data privileges. As the Inpatient Dashboard draws data from VistA, it can display laboratory information, studies, and notes from all VA sites.

The main dashboard is a snapshot summary of patient information, including patient location, code status, last vital sign readings, vital sign ranges over the previous 24 hours, intake/output, deep vein thrombosis (DVT) prophylaxis, the presence of telemetry orders, or use of Foley or central catheters (Figure). It also includes a customizable to-do list and contact information for the patient’s clinician and nurse. Significant events, such as abnormal vital signs or speciation/sensitivities for blood cultures, are automatically populated on the to-do list. From this main dashboard overview, clinicians can customize which patients are displayed, create and print a rounding list, print a sign-out sheet, or select individual patients to open a progress note module.

Notes can be written in the patient history and physical module, progress note module, and discharge summary module. The patient history and physical module has text blocks allocated to the traditional components of a history and physical note (ie, chief complaint, history of present illness, review of systems, past medical history, family history, social history, allergies, medications, physical examination, assessment, and plan) (eAppendix 1). Some elements, such as past medical history, family history, and social history are prepopulated if the patient was previously admitted. Vital signs, laboratory results, studies, microbiology/ pathology reports, and other CPRS notes are displayed in this module.

The progress note module contains text blocks allocated to the traditional components of a progress note, such as subjective/interval events, physical examination, assessment, and plan (eAppendix 2). Vital signs, laboratory results, studies, microbiology/ pathology reports, other CPRS notes, and the patient’s medication administration record are also displayed in this module. Lastly, the discharge summary module includes patient follow-up, patient instructions, hospitalization summary, medication reconciliation, laboratory results, and studies/procedures, ensuring a comprehensive discharge summary for patients and clinicians (eAppendix 3).

A medication reconciliation tool was embedded within the history and physical and discharge summary modules. This tool has been shown to reduce medication errors in patients admitted from the emergency department to the hospital (eAppendix 4).¹⁰ The handoff/sign-out tool (eAppendix 5) accessible through the main dashboard page is modeled on the I-PASS handoff framework.^11,12 This includes the patient identifier, interval events, inpatient medications, specific sign-out guidance, sign-out tasks/to-dos, and any other pertinent information.

The Inpatient Dashboard is a team-based construct shared by the attending physicians, residents, and medical students. Each team (eg, general medicine, general surgery) is its own entity; only team members can change the content or add to the documentation. Each facility can have multiple teams caring for the same patient (eg, primary and consulting teams). Additional care members can also be incorporated (eg, pharmacists assist with medication reconciliation for admission and discharge at VAAAHS). The Inpatient Dashboard can export information directly to CPRS for clinicians to review and sign. It can also generate a note that can be pasted into CPRS.

Clinician Feedback and Satisfaction

A survey was developed to evaluate clinician experiences with using the Inpatient Dashboard as an adjunct to the CPRS. The Inpatient Dashboard was made available to general medicine teams in November 2018. The survey was conducted from December 2018 to September 2019. The study was conducted at the VAAAHS and included 4 general medicine teams. Each team included an attending physician, a senior resident, 2 to 3 interns, and 3 to 4 medical students. Eligibility was extended to any team member who used both the CPRS and Inpatient Dashboard. Participation in the survey was voluntary. All respondents were informed of the study’s purpose and encouraged to provide candid feedback to ensure the reliability and validity of the findings.

Data were collected through a semistructured survey administered via the Qualtrics platform. The questionnaire was designed to capture multidimensional insights into clinician experience, with particular focus on satisfaction, efficiency, and perceived safety when using the tool as an adjunct to CPRS compared to using CPRS alone. The questionnaire primarily used a Likert scale for responses. Surveys were emailed at the completion of a team’s 1-month inpatient block. An answer was not required for every question, resulting in slightly different response numbers for some questions.

A question regarding the tool’s impact on workload stress was added halfway through the study period, which resulted in fewer responses. Adoption was assessed by counting the Inpatient Dashboard unique users. Descriptive statistics were used within individual survey responses to report the distribution of responses. Differences in response between levels of training were assessed using a X² test of independence.

Survey Results

From September 2023 through November 2023, there were 1549 rounding printouts across 144 unique users (5 nurses, 40 medical students, 87 residents, and 12 attending physicians) and 1468 handoff printouts across 148 unique users (5 nurses, 10 medical students, 111 residents, and 22 attending physicians). The clinician survey received 68 responses from users at various levels of medical training: 23 medical students, 31 interns, 12 senior residents, and 2 attending physicians. All 68 participants confirmed they had used the Inpatient Dashboard.

User satisfaction and preference for the Inpatient Dashboard vs CPRS were assessed. Sixty-one respondents (90%) expressed overall satisfaction with the Inpatient Dashboard; 22 (32%) were extremely satisfied, and 39 (57%) were somewhat satisfied (Table 1). Three respondents (4%) were neutral, 2 (3%) were somewhat dissatisfied, and 2 (3%) were extremely dissatisfied with the Inpatient Dashboard. Responses differed by level of training (P = .03), with medical students trending towards higher satisfaction.

Respondents preferred the Inpatient Dashboard over CPRS for gathering information and writing progress notes; 42 (64%) respondents mostly favored the Inpatient Dashboard, 15 (23%) slightly favored the Inpatient Dashboard over CPRS, and 8 (12%) were neutral. One respondent (2%) slightly favored CPRS to the Inpatient Dashboard (Table 2).

Sixty-five respondents (100%) found the Inpatient Dashboard’s ability to summarize patient information in a central place helpful (Table 3). Among them, 53 (82%) respondents reported it was very or extremely helpful, 10 (15%) respondents reported it was moderately helpful, and 2 (3%) respondents reported it was slightly helpful. This feature positively impacted users’ awareness of patients with DVT prophylaxis or a Foley catheter. Ten (15%) respondents reported being much more aware, and 29 (45%) respondents reporting they were slightly more aware. The remaining 26 (40%) respondents reported no change in awareness.

The Inpatient Dashboard was reported to save time preparing for physician rounds by 52 (80%) respondents, contributing to much greater efficiency for 29 (45%) respondents and slightly more efficiency for 23 (35%) respondents. However, 10 (15%) respondents reported no change in efficiency, and 3 (5%) respondents reduced efficiency, with 1 (2%) respondent reporting it slightly less efficient and 2 (3%) respondents reporting it much less efficient. Responses differed by level of training (P = .01), with medical students trending towards higher efficiency. Of the 23 respondents who reported on the Inpatient Dashboard’s impact on daily workload stress level, 22 (96%) indicated the tool had a stress-reducing effect, with 9 (39%) experiencing a major reduction in stress level, and 13 (57%) experiencing somewhat reduced stress level. Only 1 participant (4%) reported no change in stress. No participants reported an increase in stress.

DISCUSSION

The adoption of EHRs has transformed operational modalities in contemporary health care systems, heralding advancements in patient satisfaction, safety, and overall quality and efficiency of care.^1,2 However, EHRs still present challenges, predominantly around clinician satisfaction, marked by instances of burnout and increased time spent on computers.^2-6 In this context, the Inpatient Dashboard, an online companion to the CPRS, exemplifies how user-centered innovations in EHRs can address and mitigate associated challenges.

The Inpatient Dashboard has been well received with most respondents of the survey conducted in this study indicating they were both satisfied with the instrument and preferring it to CPRS. This high approval aligns with existing literature on the potential advantages of user-centered design in health care technology.¹³ The tool has gained widespread acceptance at the VAAAHS even in the absence of obligatory usage or institutional incentives. The appeal of the Inpatient Dashboard may stem from its increased efficiency, with most users affirming its timesaving nature. While CPRS can only display local notes, laboratory results, and studies, the Inpatient Dashboard can display data from across all VA sites. The VA Joint Longitudinal Viewer can similarly display data from across all sites, but the display is not streamlined as it is in the Inpatient Dashboard. The Inpatient Dashboard incorporates this clinical information into a single page to facilitate day-to-day workflow and dynamic documentation (ie, reviewing laboratory results, medications, writing notes, and signing out patients). This increased efficiency allows clinicians to counter 2 common barriers to EHR implementation: productivity loss and insufficient time.¹⁴

The association between EHRs and improved quality and safety in health care is well-documented.³ The Inpatient Dashboard fortifies this association by enhancing awareness around patient status, evidenced by a majority of respondents, and by integrating a medication reconciliation tool to decrease medication errors on transition from the emergency department to inpatient hospitalization.¹⁰

The Inpatient Dashboard’s impact on alleviating daily workload stress is noteworthy, with almost all respondents experiencing reduced stress levels and physician burnout, which has been linked to deteriorating well-being, compromised patient safety, and escalated health care costs.^15,16 The heightened susceptibility of physicians to burnout compared to other professionals underscores the imperative for incorporating stress-mitigating interventions in the EHR.^17,18

While responses to most questions did not significantly differ by training levels, overall satisfaction with the Inpatient Dashboard and its ability to save time preparing for rounds were rated higher by medical students. This may be attributable to a greater derived benefit from collating and presenting data to learners with less familiarity with the native EHR. It is also notable that the Inpatient Dashboard allows medical students to directly contribute to a patient’s note, which could be another driver in satisfaction. While most interns still felt the Inpatient Dashboard enabled them to save time preparing for rounds, there were a considerable number of ‘no change’ responses, which suggests some interns may not have modified their existing prerounding strategies. These associations are limited by the relatively small number of respondents by learner category, with senior medical residents and attending physicians being underrepresented.

While there are a multitude of dashboards available at the VA, most are made to track certain quality metrics and are used more by administrative and leadership staff. The Inpatient Dashboard was created specifically for frontline clinicians to facilitate their day-to-day workflow and dynamic documentation. This tool can additionally help with quality metrics, though its main purpose was and is to make clinician workflow easier and more efficient.

These results are especially timely because the VA is modernizing its EHR by transitioning to Oracle Health.⁷ Due to the numerous reports both from veterans and VA clinicians that the Oracle Health EHR is not meeting expectations, deployment at further sites has been halted while improving the experience of the 5 institutions using Oracle Health is prioritized.⁹ The Inpatient Dashboard, instead of being merely an enhancement to CPRS, could emerge as a potential bridge to Oracle Health if adapted to display data from Oracle Health as it does VistA. This would facilitate a smoother, more integrated transition for those health care institutions employing the Inpatient Dashboard.

Limitations

The reliance on self-reported data inherently carries the risk of bias, and the absence of objective measures, like time-tracking studies, limits the quantifiable assessment of the Inpatient Dashboard efficacy. The single-center nature of the study also may restrict the generalizability of the results.

CONCLUSIONS

Optimal integration of EHRs into health care delivery is critical to high-quality patient care and operational efficiency. The Inpatient Dashboard is an example of an innovative, user-centric solution that integrated and presented clinical information in a way that produced high satisfaction and adoption by users at a VA hospital.