News

The number of sexual assaults in the US military dropped for the first time in a decade, according an annual report from the Pentagon, while benefits claims for assault survivors are on the rise. 

     Records show that 29,000 active-duty members reported being sexually assaulted in 2023, or 7000 fewer than in 2021. A confidential survey also found the number of service members who experienced some type of unwanted sexual contact dropped nearly 20%, leaving the Pentagon “cautiously optimistic“ its investments in preventing sexual assault and building a healthy climate are having an impact.

     Despite these investments, issues persist. An Army anesthesiologist recently pleaded guilty to 41 charges of sexual misconduct involving 21 victims at Madigan Army Medical Center at Joint Base Lewis-McChord in Washington. The alleged incidents occurred between 2019 and 2022 and involved the doctor unnecessarily focusing on the genital area of patients during what he described as routine examinations. Maj. Michael Stockin faces nearly 14 years in prison, should the judge accept the plea agreement Stockin and his attorneys made with government prosecutors.

     Additionally, a report from the Watson Institute of International and Public Affairs at Brown University indicated that 24% of active-duty women and 1.9% of active-duty men experienced sexual assault from 2001 to 2021.During post-9/11 wars, “the prioritization of force readiness above all else allowed the problem of sexual assault to fester, papering over internal violence and gender inequalities within military institutions,” the report said. There was also a slight uptick in reports of military sexual assaults in 2020, when troops were largely on lockdown as a result of the COVID-19 pandemic.

     Efforts to address sexual assault in the military have increased in the past 10 years to the tune of 10 Department of Defense Inspector General engagements, 60 Government Accountability Office recommendations, > 200 government panel and task force recommendations, > 150 Congressional provisions, and > 50 Secretary of Defense initiatives. Additionally, the 2022 National Defense Authorization gave authority in sexual assault cases to independent prosecutors rather than commanders. Other reforms have included incorporating trauma-informed practices in the claims process.

     Meanwhile, the US Department of Veterans Affairs (VA) has also been attempting to convince more sexual assault survivors to file claims for benefits. Assistant Deputy Under Secretary for Field Operations Kenesha Britton said in December that the VA has held 3500 events in the past 14 months focused on benefits for victims of military sexual assault and harassment. It appears to be working, as the VA received 57,400 claims for military sexual trauma in fiscal year 2024 (an 18% increase from 2023), and approved > 63% of them, compared to 40% more than a decade ago. Prior to Oct. 1, VA staffers processed > 11,000 cases in a single day twice. Since that date, they have processed that amount on 9 separate occasions.

     “We recognize the remarkable courage it takes for survivors of military sexual trauma to seek the benefits and support they’ve earned,” Britton said. “Our mission is driven by a commitment to ensure survivors are met with care, dignity and sensitivity throughout the claims process.”

     The increase in trust is a byproduct of the outreach campaigns, VA Under Secretary for Benefits Josh Jacobs said: “[M]ore veterans are coming in to apply for benefits and I think that has to do with building trust because we are actively trying to reach veterans telling them we want to connect them with their earned benefits.”

The number of sexual assaults in the US military dropped for the first time in a decade, according an annual report from the Pentagon, while benefits claims for assault survivors are on the rise. 

     Records show that 29,000 active-duty members reported being sexually assaulted in 2023, or 7000 fewer than in 2021. A confidential survey also found the number of service members who experienced some type of unwanted sexual contact dropped nearly 20%, leaving the Pentagon “cautiously optimistic“ its investments in preventing sexual assault and building a healthy climate are having an impact.

     Despite these investments, issues persist. An Army anesthesiologist recently pleaded guilty to 41 charges of sexual misconduct involving 21 victims at Madigan Army Medical Center at Joint Base Lewis-McChord in Washington. The alleged incidents occurred between 2019 and 2022 and involved the doctor unnecessarily focusing on the genital area of patients during what he described as routine examinations. Maj. Michael Stockin faces nearly 14 years in prison, should the judge accept the plea agreement Stockin and his attorneys made with government prosecutors.

     Additionally, a report from the Watson Institute of International and Public Affairs at Brown University indicated that 24% of active-duty women and 1.9% of active-duty men experienced sexual assault from 2001 to 2021.During post-9/11 wars, “the prioritization of force readiness above all else allowed the problem of sexual assault to fester, papering over internal violence and gender inequalities within military institutions,” the report said. There was also a slight uptick in reports of military sexual assaults in 2020, when troops were largely on lockdown as a result of the COVID-19 pandemic.

     Efforts to address sexual assault in the military have increased in the past 10 years to the tune of 10 Department of Defense Inspector General engagements, 60 Government Accountability Office recommendations, > 200 government panel and task force recommendations, > 150 Congressional provisions, and > 50 Secretary of Defense initiatives. Additionally, the 2022 National Defense Authorization gave authority in sexual assault cases to independent prosecutors rather than commanders. Other reforms have included incorporating trauma-informed practices in the claims process.

     Meanwhile, the US Department of Veterans Affairs (VA) has also been attempting to convince more sexual assault survivors to file claims for benefits. Assistant Deputy Under Secretary for Field Operations Kenesha Britton said in December that the VA has held 3500 events in the past 14 months focused on benefits for victims of military sexual assault and harassment. It appears to be working, as the VA received 57,400 claims for military sexual trauma in fiscal year 2024 (an 18% increase from 2023), and approved > 63% of them, compared to 40% more than a decade ago. Prior to Oct. 1, VA staffers processed > 11,000 cases in a single day twice. Since that date, they have processed that amount on 9 separate occasions.

     “We recognize the remarkable courage it takes for survivors of military sexual trauma to seek the benefits and support they’ve earned,” Britton said. “Our mission is driven by a commitment to ensure survivors are met with care, dignity and sensitivity throughout the claims process.”

     The increase in trust is a byproduct of the outreach campaigns, VA Under Secretary for Benefits Josh Jacobs said: “[M]ore veterans are coming in to apply for benefits and I think that has to do with building trust because we are actively trying to reach veterans telling them we want to connect them with their earned benefits.”

The number of sexual assaults in the US military dropped for the first time in a decade, according an annual report from the Pentagon, while benefits claims for assault survivors are on the rise. 

     Records show that 29,000 active-duty members reported being sexually assaulted in 2023, or 7000 fewer than in 2021. A confidential survey also found the number of service members who experienced some type of unwanted sexual contact dropped nearly 20%, leaving the Pentagon “cautiously optimistic“ its investments in preventing sexual assault and building a healthy climate are having an impact.

     Despite these investments, issues persist. An Army anesthesiologist recently pleaded guilty to 41 charges of sexual misconduct involving 21 victims at Madigan Army Medical Center at Joint Base Lewis-McChord in Washington. The alleged incidents occurred between 2019 and 2022 and involved the doctor unnecessarily focusing on the genital area of patients during what he described as routine examinations. Maj. Michael Stockin faces nearly 14 years in prison, should the judge accept the plea agreement Stockin and his attorneys made with government prosecutors.

     Additionally, a report from the Watson Institute of International and Public Affairs at Brown University indicated that 24% of active-duty women and 1.9% of active-duty men experienced sexual assault from 2001 to 2021.During post-9/11 wars, “the prioritization of force readiness above all else allowed the problem of sexual assault to fester, papering over internal violence and gender inequalities within military institutions,” the report said. There was also a slight uptick in reports of military sexual assaults in 2020, when troops were largely on lockdown as a result of the COVID-19 pandemic.

     Efforts to address sexual assault in the military have increased in the past 10 years to the tune of 10 Department of Defense Inspector General engagements, 60 Government Accountability Office recommendations, > 200 government panel and task force recommendations, > 150 Congressional provisions, and > 50 Secretary of Defense initiatives. Additionally, the 2022 National Defense Authorization gave authority in sexual assault cases to independent prosecutors rather than commanders. Other reforms have included incorporating trauma-informed practices in the claims process.

     Meanwhile, the US Department of Veterans Affairs (VA) has also been attempting to convince more sexual assault survivors to file claims for benefits. Assistant Deputy Under Secretary for Field Operations Kenesha Britton said in December that the VA has held 3500 events in the past 14 months focused on benefits for victims of military sexual assault and harassment. It appears to be working, as the VA received 57,400 claims for military sexual trauma in fiscal year 2024 (an 18% increase from 2023), and approved > 63% of them, compared to 40% more than a decade ago. Prior to Oct. 1, VA staffers processed > 11,000 cases in a single day twice. Since that date, they have processed that amount on 9 separate occasions.

     “We recognize the remarkable courage it takes for survivors of military sexual trauma to seek the benefits and support they’ve earned,” Britton said. “Our mission is driven by a commitment to ensure survivors are met with care, dignity and sensitivity throughout the claims process.”

     The increase in trust is a byproduct of the outreach campaigns, VA Under Secretary for Benefits Josh Jacobs said: “[M]ore veterans are coming in to apply for benefits and I think that has to do with building trust because we are actively trying to reach veterans telling them we want to connect them with their earned benefits.”

MRI-invisible prostate lesions. It sounds like the stuff of science fiction and fantasy, a creation from the minds of H.G. Wells, who wrote The Invisible Man, or J.K. Rowling, who authored the Harry Potter series.

But MRI-invisible prostate lesions are real. And what these lesions may, or may not, indicate is the subject of intense debate.

MRI plays an increasingly important role in detecting and diagnosing prostate cancer, staging prostate cancer as well as monitoring disease progression. However, on occasion, a puzzling phenomenon arises. Certain prostate lesions that appear when pathologists examine biopsied tissue samples under a microscope are not visible on MRI. The prostate tissue will, instead, appear normal to a radiologist’s eye.

Why are certain lesions invisible with MRI? And is it dangerous for patients if these lesions are not detected? 

Some experts believe these MRI-invisible lesions are nothing to worry about.

If the clinician can’t see the cancer on MRI, then it simply isn’t a threat, according to Mark Emberton, MD, a pioneer in prostate MRIs and director of interventional oncology at University College London, England.

Laurence Klotz, MD, of the University of Toronto, Ontario, Canada, agreed, noting that “invisible cancers are clinically insignificant and don’t require systematic biopsies.”

Emberton and Klotz compared MRI-invisible lesions to grade group 1 prostate cancer (Gleason score ≤ 6) — the least aggressive category that indicates the cancer that is not likely to spread or kill. For patients on active surveillance, those with MRI-invisible cancers do drastically better than those with visible cancers, Klotz explained.

But other experts in the field are skeptical that MRI-invisible lesions are truly innocuous.

Although statistically an MRI-visible prostate lesion indicates a more aggressive tumor, that is not always the case for every individual, said Brian Helfand, MD, PhD, chief of urology at NorthShore University Health System, Evanston, Illinois.

MRIs can lead to false negatives in about 10%-20% of patients who have clinically significant prostate cancer, though estimates vary.

In one analysis, 16% of men with no suspicious lesions on MRI had clinically significant prostate cancer identified after undergoing a systematic biopsy. Another analysis found that about 35% of MRI-invisible prostate cancers identified via biopsy were clinically significant.

Other studies, however, have indicated that negative MRI results accurately indicate patients at low risk of developing clinically significant cancers. A recent JAMA Oncology analysis, for instance, found that only seven of 233 men (3%) with negative MRI results at baseline who completed 3 years of monitoring were diagnosed with clinically significant prostate cancer.

When a patient has an MRI-invisible prostate tumor, there are a couple of reasons the MRI may not be picking it up, said urologic oncologist Alexander Putnam Cole, MD, assistant professor of surgery, Harvard Medical School, Boston, Massachusetts. “One is that the cancer is aggressive but just very small,” said Cole.

“Another possibility is that the cancer looks very similar to background prostate tissue, which is something that you might expect if you think about more of a low-grade cancer,” he explained.

The experience level of the radiologist interpreting the MRI can also play into the accuracy of the reading.

But Cole agreed that “in general, MRI visibility is associated with molecular and histologic features of progression and aggressiveness and non-visible cancers are less likely to have aggressive features.”

The genomic profiles of MRI-visible and -invisible cancers bear this out.

According to Todd Morgan, MD, chief of urologic oncology at Michigan Medicine, University of Michigan, Ann Arbor, the gene expression in visible disease tends to be linked to more aggressive prostate tumors whereas gene expression in invisible disease does not.

In one analysis, for instance, researchers found that four genes — PHYHD1, CENPF, ALDH2, and GDF15 — associated with worse progression-free survival and metastasis-free survival in prostate cancer also predicted MRI visibility.

“Genes that are associated with visibility are essentially the same genes that are associated with aggressive cancers,” Klotz said.

 

Next Steps After Negative MRI Result

What do MRI-invisible lesions mean for patient care? If, for instance, a patient has elevated PSA levels but a normal MRI, is a targeted or systematic biopsy warranted?

The overarching message, according to Klotz, is that “you don’t need to find them.” Klotz noted, however, that patients with a negative MRI result should still be followed with periodic repeat imaging.

Several trials support this approach of using MRI to decide who needs a biopsy and delaying a biopsy in men with normal MRIs.

The recent JAMA Oncology analysis found that, among men with negative MRI results, 86% avoided a biopsy over 3 years, with clinically significant prostate cancer detected in only 4% of men across the study period — four in the initial diagnostic phase and seven in the 3-year monitoring phase. However, during the initial diagnostic phase, more than half the men with positive MRI findings had clinically significant prostate cancer detected.

Another recent study found that patients with negative MRI results were much less likely to upgrade to higher Gleason scores over time. Among 522 patients who underwent a systematic and targeted biopsy within 18 months of their grade group 1 designation, 9.2% with negative MRI findings had tumors reclassified as grade group 2 or higher vs 27% with positive MRI findings, and 2.3% with negative MRI findings had tumors reclassified as grade group 3 or higher vs 7.8% with positive MRI findings.

These data suggest that men with grade group 1 cancer and negative MRI result “may be able to avoid confirmatory biopsies until a routine surveillance biopsy in 2-3 years,” according to study author Christian Pavlovich, MD, professor of urologic oncology at the Johns Hopkins University School of Medicine, Baltimore.

Cole used MRI findings to triage who gets a biopsy. When a biopsy is warranted, “I usually recommend adding in some systematic sampling of the other side to assess for nonvisible cancers,” he noted.

Sampling prostate tissue outside the target area “adds maybe 1-2 minutes to the procedure and doesn’t drastically increase the morbidity or risks,” Cole said. It also can help “confirm there is cancer in the MRI target and also confirm there is no cancer in the nonvisible areas.” 

According to Klotz, if imaging demonstrates progression, patients should receive a biopsy — in most cases, a targeted biopsy only. And, Klotz noted, skipping routine prostate biopsies in men with negative MRI results can save thousands of men from these procedures, which carry risks for infections and sepsis.

Looking beyond Gleason scores for risk prediction, MRI “visibility is a very powerful risk stratifier,” he said.

A version of this article appeared on Medscape.com.

MRI-invisible prostate lesions. It sounds like the stuff of science fiction and fantasy, a creation from the minds of H.G. Wells, who wrote The Invisible Man, or J.K. Rowling, who authored the Harry Potter series.

But MRI-invisible prostate lesions are real. And what these lesions may, or may not, indicate is the subject of intense debate.

MRI plays an increasingly important role in detecting and diagnosing prostate cancer, staging prostate cancer as well as monitoring disease progression. However, on occasion, a puzzling phenomenon arises. Certain prostate lesions that appear when pathologists examine biopsied tissue samples under a microscope are not visible on MRI. The prostate tissue will, instead, appear normal to a radiologist’s eye.

Why are certain lesions invisible with MRI? And is it dangerous for patients if these lesions are not detected? 

Some experts believe these MRI-invisible lesions are nothing to worry about.

If the clinician can’t see the cancer on MRI, then it simply isn’t a threat, according to Mark Emberton, MD, a pioneer in prostate MRIs and director of interventional oncology at University College London, England.

Laurence Klotz, MD, of the University of Toronto, Ontario, Canada, agreed, noting that “invisible cancers are clinically insignificant and don’t require systematic biopsies.”

Emberton and Klotz compared MRI-invisible lesions to grade group 1 prostate cancer (Gleason score ≤ 6) — the least aggressive category that indicates the cancer that is not likely to spread or kill. For patients on active surveillance, those with MRI-invisible cancers do drastically better than those with visible cancers, Klotz explained.

But other experts in the field are skeptical that MRI-invisible lesions are truly innocuous.

Although statistically an MRI-visible prostate lesion indicates a more aggressive tumor, that is not always the case for every individual, said Brian Helfand, MD, PhD, chief of urology at NorthShore University Health System, Evanston, Illinois.

MRIs can lead to false negatives in about 10%-20% of patients who have clinically significant prostate cancer, though estimates vary.

In one analysis, 16% of men with no suspicious lesions on MRI had clinically significant prostate cancer identified after undergoing a systematic biopsy. Another analysis found that about 35% of MRI-invisible prostate cancers identified via biopsy were clinically significant.

Other studies, however, have indicated that negative MRI results accurately indicate patients at low risk of developing clinically significant cancers. A recent JAMA Oncology analysis, for instance, found that only seven of 233 men (3%) with negative MRI results at baseline who completed 3 years of monitoring were diagnosed with clinically significant prostate cancer.

When a patient has an MRI-invisible prostate tumor, there are a couple of reasons the MRI may not be picking it up, said urologic oncologist Alexander Putnam Cole, MD, assistant professor of surgery, Harvard Medical School, Boston, Massachusetts. “One is that the cancer is aggressive but just very small,” said Cole.

“Another possibility is that the cancer looks very similar to background prostate tissue, which is something that you might expect if you think about more of a low-grade cancer,” he explained.

The experience level of the radiologist interpreting the MRI can also play into the accuracy of the reading.

But Cole agreed that “in general, MRI visibility is associated with molecular and histologic features of progression and aggressiveness and non-visible cancers are less likely to have aggressive features.”

The genomic profiles of MRI-visible and -invisible cancers bear this out.

According to Todd Morgan, MD, chief of urologic oncology at Michigan Medicine, University of Michigan, Ann Arbor, the gene expression in visible disease tends to be linked to more aggressive prostate tumors whereas gene expression in invisible disease does not.

In one analysis, for instance, researchers found that four genes — PHYHD1, CENPF, ALDH2, and GDF15 — associated with worse progression-free survival and metastasis-free survival in prostate cancer also predicted MRI visibility.

“Genes that are associated with visibility are essentially the same genes that are associated with aggressive cancers,” Klotz said.

 

Next Steps After Negative MRI Result

What do MRI-invisible lesions mean for patient care? If, for instance, a patient has elevated PSA levels but a normal MRI, is a targeted or systematic biopsy warranted?

The overarching message, according to Klotz, is that “you don’t need to find them.” Klotz noted, however, that patients with a negative MRI result should still be followed with periodic repeat imaging.

Several trials support this approach of using MRI to decide who needs a biopsy and delaying a biopsy in men with normal MRIs.

The recent JAMA Oncology analysis found that, among men with negative MRI results, 86% avoided a biopsy over 3 years, with clinically significant prostate cancer detected in only 4% of men across the study period — four in the initial diagnostic phase and seven in the 3-year monitoring phase. However, during the initial diagnostic phase, more than half the men with positive MRI findings had clinically significant prostate cancer detected.

Another recent study found that patients with negative MRI results were much less likely to upgrade to higher Gleason scores over time. Among 522 patients who underwent a systematic and targeted biopsy within 18 months of their grade group 1 designation, 9.2% with negative MRI findings had tumors reclassified as grade group 2 or higher vs 27% with positive MRI findings, and 2.3% with negative MRI findings had tumors reclassified as grade group 3 or higher vs 7.8% with positive MRI findings.

These data suggest that men with grade group 1 cancer and negative MRI result “may be able to avoid confirmatory biopsies until a routine surveillance biopsy in 2-3 years,” according to study author Christian Pavlovich, MD, professor of urologic oncology at the Johns Hopkins University School of Medicine, Baltimore.

Cole used MRI findings to triage who gets a biopsy. When a biopsy is warranted, “I usually recommend adding in some systematic sampling of the other side to assess for nonvisible cancers,” he noted.

Sampling prostate tissue outside the target area “adds maybe 1-2 minutes to the procedure and doesn’t drastically increase the morbidity or risks,” Cole said. It also can help “confirm there is cancer in the MRI target and also confirm there is no cancer in the nonvisible areas.” 

According to Klotz, if imaging demonstrates progression, patients should receive a biopsy — in most cases, a targeted biopsy only. And, Klotz noted, skipping routine prostate biopsies in men with negative MRI results can save thousands of men from these procedures, which carry risks for infections and sepsis.

Looking beyond Gleason scores for risk prediction, MRI “visibility is a very powerful risk stratifier,” he said.

A version of this article appeared on Medscape.com.

MRI-invisible prostate lesions. It sounds like the stuff of science fiction and fantasy, a creation from the minds of H.G. Wells, who wrote The Invisible Man, or J.K. Rowling, who authored the Harry Potter series.

But MRI-invisible prostate lesions are real. And what these lesions may, or may not, indicate is the subject of intense debate.

MRI plays an increasingly important role in detecting and diagnosing prostate cancer, staging prostate cancer as well as monitoring disease progression. However, on occasion, a puzzling phenomenon arises. Certain prostate lesions that appear when pathologists examine biopsied tissue samples under a microscope are not visible on MRI. The prostate tissue will, instead, appear normal to a radiologist’s eye.

Why are certain lesions invisible with MRI? And is it dangerous for patients if these lesions are not detected? 

Some experts believe these MRI-invisible lesions are nothing to worry about.

If the clinician can’t see the cancer on MRI, then it simply isn’t a threat, according to Mark Emberton, MD, a pioneer in prostate MRIs and director of interventional oncology at University College London, England.

Laurence Klotz, MD, of the University of Toronto, Ontario, Canada, agreed, noting that “invisible cancers are clinically insignificant and don’t require systematic biopsies.”

Emberton and Klotz compared MRI-invisible lesions to grade group 1 prostate cancer (Gleason score ≤ 6) — the least aggressive category that indicates the cancer that is not likely to spread or kill. For patients on active surveillance, those with MRI-invisible cancers do drastically better than those with visible cancers, Klotz explained.

But other experts in the field are skeptical that MRI-invisible lesions are truly innocuous.

Although statistically an MRI-visible prostate lesion indicates a more aggressive tumor, that is not always the case for every individual, said Brian Helfand, MD, PhD, chief of urology at NorthShore University Health System, Evanston, Illinois.

MRIs can lead to false negatives in about 10%-20% of patients who have clinically significant prostate cancer, though estimates vary.

In one analysis, 16% of men with no suspicious lesions on MRI had clinically significant prostate cancer identified after undergoing a systematic biopsy. Another analysis found that about 35% of MRI-invisible prostate cancers identified via biopsy were clinically significant.

Other studies, however, have indicated that negative MRI results accurately indicate patients at low risk of developing clinically significant cancers. A recent JAMA Oncology analysis, for instance, found that only seven of 233 men (3%) with negative MRI results at baseline who completed 3 years of monitoring were diagnosed with clinically significant prostate cancer.

When a patient has an MRI-invisible prostate tumor, there are a couple of reasons the MRI may not be picking it up, said urologic oncologist Alexander Putnam Cole, MD, assistant professor of surgery, Harvard Medical School, Boston, Massachusetts. “One is that the cancer is aggressive but just very small,” said Cole.

“Another possibility is that the cancer looks very similar to background prostate tissue, which is something that you might expect if you think about more of a low-grade cancer,” he explained.

The experience level of the radiologist interpreting the MRI can also play into the accuracy of the reading.

But Cole agreed that “in general, MRI visibility is associated with molecular and histologic features of progression and aggressiveness and non-visible cancers are less likely to have aggressive features.”

The genomic profiles of MRI-visible and -invisible cancers bear this out.

According to Todd Morgan, MD, chief of urologic oncology at Michigan Medicine, University of Michigan, Ann Arbor, the gene expression in visible disease tends to be linked to more aggressive prostate tumors whereas gene expression in invisible disease does not.

In one analysis, for instance, researchers found that four genes — PHYHD1, CENPF, ALDH2, and GDF15 — associated with worse progression-free survival and metastasis-free survival in prostate cancer also predicted MRI visibility.

“Genes that are associated with visibility are essentially the same genes that are associated with aggressive cancers,” Klotz said.

 

Next Steps After Negative MRI Result

What do MRI-invisible lesions mean for patient care? If, for instance, a patient has elevated PSA levels but a normal MRI, is a targeted or systematic biopsy warranted?

The overarching message, according to Klotz, is that “you don’t need to find them.” Klotz noted, however, that patients with a negative MRI result should still be followed with periodic repeat imaging.

Several trials support this approach of using MRI to decide who needs a biopsy and delaying a biopsy in men with normal MRIs.

The recent JAMA Oncology analysis found that, among men with negative MRI results, 86% avoided a biopsy over 3 years, with clinically significant prostate cancer detected in only 4% of men across the study period — four in the initial diagnostic phase and seven in the 3-year monitoring phase. However, during the initial diagnostic phase, more than half the men with positive MRI findings had clinically significant prostate cancer detected.

Another recent study found that patients with negative MRI results were much less likely to upgrade to higher Gleason scores over time. Among 522 patients who underwent a systematic and targeted biopsy within 18 months of their grade group 1 designation, 9.2% with negative MRI findings had tumors reclassified as grade group 2 or higher vs 27% with positive MRI findings, and 2.3% with negative MRI findings had tumors reclassified as grade group 3 or higher vs 7.8% with positive MRI findings.

These data suggest that men with grade group 1 cancer and negative MRI result “may be able to avoid confirmatory biopsies until a routine surveillance biopsy in 2-3 years,” according to study author Christian Pavlovich, MD, professor of urologic oncology at the Johns Hopkins University School of Medicine, Baltimore.

Cole used MRI findings to triage who gets a biopsy. When a biopsy is warranted, “I usually recommend adding in some systematic sampling of the other side to assess for nonvisible cancers,” he noted.

Sampling prostate tissue outside the target area “adds maybe 1-2 minutes to the procedure and doesn’t drastically increase the morbidity or risks,” Cole said. It also can help “confirm there is cancer in the MRI target and also confirm there is no cancer in the nonvisible areas.” 

According to Klotz, if imaging demonstrates progression, patients should receive a biopsy — in most cases, a targeted biopsy only. And, Klotz noted, skipping routine prostate biopsies in men with negative MRI results can save thousands of men from these procedures, which carry risks for infections and sepsis.

Looking beyond Gleason scores for risk prediction, MRI “visibility is a very powerful risk stratifier,” he said.

A version of this article appeared on Medscape.com.

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

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

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

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

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

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

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

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

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

 

Specific Wavelengths of Light Improve Cellular Function

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

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

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

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

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

 

More Study Is Needed

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

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

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

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

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

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

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

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

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

A version of this article appeared on WebMD.com.

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

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

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

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

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

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

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

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

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

 

Specific Wavelengths of Light Improve Cellular Function

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

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

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

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

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

 

More Study Is Needed

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

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

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

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

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

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

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

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

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

A version of this article appeared on WebMD.com.

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

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

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

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

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

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

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

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

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

 

Specific Wavelengths of Light Improve Cellular Function

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

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

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

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

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

 

More Study Is Needed

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

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

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

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

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

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

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

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

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

A version of this article appeared on WebMD.com.

TOPLINE:

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

METHODOLOGY:

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

TAKEAWAY:

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

IN PRACTICE:

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

SOURCE:

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

LIMITATIONS:

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

DISCLOSURES:

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

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

TOPLINE:

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

METHODOLOGY:

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

TAKEAWAY:

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

IN PRACTICE:

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

SOURCE:

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

LIMITATIONS:

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

DISCLOSURES:

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

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

TOPLINE:

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

METHODOLOGY:

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

TAKEAWAY:

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

IN PRACTICE:

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

SOURCE:

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

LIMITATIONS:

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

DISCLOSURES:

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

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

TOPLINE:

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

METHODOLOGY:

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

TAKEAWAY:

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

IN PRACTICE:

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

SOURCE:

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

LIMITATIONS:

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

DISCLOSURES:

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

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

TOPLINE:

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

METHODOLOGY:

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

TAKEAWAY:

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

IN PRACTICE:

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

SOURCE:

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

LIMITATIONS:

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

DISCLOSURES:

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

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

TOPLINE:

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

METHODOLOGY:

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

TAKEAWAY:

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

IN PRACTICE:

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

SOURCE:

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

LIMITATIONS:

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

DISCLOSURES:

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

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

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

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

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

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

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

 

Study Details

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

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

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

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

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

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

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

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

 

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

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

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

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

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

A version of this article appeared on Medscape.com.

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

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

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

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

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

 

Study Details

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

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

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

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

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

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

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

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

 

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

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

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

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

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

A version of this article appeared on Medscape.com.

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

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

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

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

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

 

Study Details

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

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

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

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

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

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

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

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

 

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

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

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

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

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

A version of this article appeared on Medscape.com.

TOPLINE:

In a multinational phase 3 trial, imipenem-cilastatin-relebactam demonstrated noninferiority to piperacillin-tazobactam in treating critically ill patients with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP), with a comparable safety profile.

METHODOLOGY:

• This multinational phase 3 trial, conducted between September 2018 and July 2022, compared imipenem-cilastatin-relebactam with piperacillin-tazobactam for HABP and VABP to support its use across multiple countries.
• Overall, 270 patients with HABP or VABP (mean age, 57.6 years; 73.3% men) were randomly assigned to receive either intravenous imipenem-cilastatin-relebactam (500 mg/250 mg) or piperacillin-tazobactam (4000 mg/500 mg) every 6 hours over 30 minutes for 7-14 days.
• Both treatment groups included critically ill patients, with 54.5% and 55.1% of patients in the imipenem-cilastatin-relebactam and piperacillin-tazobactam groups, respectively, having an Acute Physiology and Chronic Health Evaluation II score ≥ 15.
• The primary outcome was the 28-day all-cause mortality; secondary outcomes included the rates of clinical and microbiological responses, as well as the incidence of adverse events.

TAKEAWAY:

• Imipenem-cilastatin-relebactam was noninferior to piperacillin-tazobactam in terms of 28-day all-cause mortality (adjusted difference, 5.2%; 95% CI, −1.5-12.4; P = .024 for noninferiority).
• At the end of treatment, the rates of a favorable clinical response were comparable between the imipenem-cilastatin-relebactam (71.6%) and piperacillin-tazobactam (68.4%) groups.
• After treatment, microbiological response rates were 48.8% in the imipenem-cilastatin-relebactam group, whereas the rates were 47.9% in the piperacillin-tazobactam group.
• The incidence of drug-related adverse events was similar across the treatment groups, with diarrhea, increased levels of alanine aminotransferase and aspartate aminotransferase, and abnormal hepatic function being the most common events.

IN PRACTICE:

“These results support the use of IMI/REL [imipenem-cilastatin-relebactam] in MDR [multidrug-resistant] infections globally, including to expand the range of available treatments for critically ill patients with HABP/VABP in China, and provide additional data to inform the World Health Organization’s MDR pathogen strategy,” the authors wrote.

SOURCE:

This study was led by Junjie Li, Department of Pulmonary and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. It was published online on December 12, 2024, in the International Journal of Infectious Diseases.

LIMITATIONS:

This study excluded patients with immunosuppression and those on intermittent hemodialysis, limiting the generalizability of the results to these populations.

DISCLOSURES:

This study was funded by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co. Inc., Rahway, New Jersey. Some authors served as employees of Merck Sharp & Dohme LLC, New Jersey, and MSD, China.

 

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

TOPLINE:

In a multinational phase 3 trial, imipenem-cilastatin-relebactam demonstrated noninferiority to piperacillin-tazobactam in treating critically ill patients with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP), with a comparable safety profile.

METHODOLOGY:

• This multinational phase 3 trial, conducted between September 2018 and July 2022, compared imipenem-cilastatin-relebactam with piperacillin-tazobactam for HABP and VABP to support its use across multiple countries.
• Overall, 270 patients with HABP or VABP (mean age, 57.6 years; 73.3% men) were randomly assigned to receive either intravenous imipenem-cilastatin-relebactam (500 mg/250 mg) or piperacillin-tazobactam (4000 mg/500 mg) every 6 hours over 30 minutes for 7-14 days.
• Both treatment groups included critically ill patients, with 54.5% and 55.1% of patients in the imipenem-cilastatin-relebactam and piperacillin-tazobactam groups, respectively, having an Acute Physiology and Chronic Health Evaluation II score ≥ 15.
• The primary outcome was the 28-day all-cause mortality; secondary outcomes included the rates of clinical and microbiological responses, as well as the incidence of adverse events.

TAKEAWAY:

• Imipenem-cilastatin-relebactam was noninferior to piperacillin-tazobactam in terms of 28-day all-cause mortality (adjusted difference, 5.2%; 95% CI, −1.5-12.4; P = .024 for noninferiority).
• At the end of treatment, the rates of a favorable clinical response were comparable between the imipenem-cilastatin-relebactam (71.6%) and piperacillin-tazobactam (68.4%) groups.
• After treatment, microbiological response rates were 48.8% in the imipenem-cilastatin-relebactam group, whereas the rates were 47.9% in the piperacillin-tazobactam group.
• The incidence of drug-related adverse events was similar across the treatment groups, with diarrhea, increased levels of alanine aminotransferase and aspartate aminotransferase, and abnormal hepatic function being the most common events.

IN PRACTICE:

“These results support the use of IMI/REL [imipenem-cilastatin-relebactam] in MDR [multidrug-resistant] infections globally, including to expand the range of available treatments for critically ill patients with HABP/VABP in China, and provide additional data to inform the World Health Organization’s MDR pathogen strategy,” the authors wrote.

SOURCE:

This study was led by Junjie Li, Department of Pulmonary and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. It was published online on December 12, 2024, in the International Journal of Infectious Diseases.

LIMITATIONS:

This study excluded patients with immunosuppression and those on intermittent hemodialysis, limiting the generalizability of the results to these populations.

DISCLOSURES:

This study was funded by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co. Inc., Rahway, New Jersey. Some authors served as employees of Merck Sharp & Dohme LLC, New Jersey, and MSD, China.

 

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

TOPLINE:

In a multinational phase 3 trial, imipenem-cilastatin-relebactam demonstrated noninferiority to piperacillin-tazobactam in treating critically ill patients with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP), with a comparable safety profile.

METHODOLOGY:

• This multinational phase 3 trial, conducted between September 2018 and July 2022, compared imipenem-cilastatin-relebactam with piperacillin-tazobactam for HABP and VABP to support its use across multiple countries.
• Overall, 270 patients with HABP or VABP (mean age, 57.6 years; 73.3% men) were randomly assigned to receive either intravenous imipenem-cilastatin-relebactam (500 mg/250 mg) or piperacillin-tazobactam (4000 mg/500 mg) every 6 hours over 30 minutes for 7-14 days.
• Both treatment groups included critically ill patients, with 54.5% and 55.1% of patients in the imipenem-cilastatin-relebactam and piperacillin-tazobactam groups, respectively, having an Acute Physiology and Chronic Health Evaluation II score ≥ 15.
• The primary outcome was the 28-day all-cause mortality; secondary outcomes included the rates of clinical and microbiological responses, as well as the incidence of adverse events.

TAKEAWAY:

• Imipenem-cilastatin-relebactam was noninferior to piperacillin-tazobactam in terms of 28-day all-cause mortality (adjusted difference, 5.2%; 95% CI, −1.5-12.4; P = .024 for noninferiority).
• At the end of treatment, the rates of a favorable clinical response were comparable between the imipenem-cilastatin-relebactam (71.6%) and piperacillin-tazobactam (68.4%) groups.
• After treatment, microbiological response rates were 48.8% in the imipenem-cilastatin-relebactam group, whereas the rates were 47.9% in the piperacillin-tazobactam group.
• The incidence of drug-related adverse events was similar across the treatment groups, with diarrhea, increased levels of alanine aminotransferase and aspartate aminotransferase, and abnormal hepatic function being the most common events.

IN PRACTICE:

“These results support the use of IMI/REL [imipenem-cilastatin-relebactam] in MDR [multidrug-resistant] infections globally, including to expand the range of available treatments for critically ill patients with HABP/VABP in China, and provide additional data to inform the World Health Organization’s MDR pathogen strategy,” the authors wrote.

SOURCE:

This study was led by Junjie Li, Department of Pulmonary and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. It was published online on December 12, 2024, in the International Journal of Infectious Diseases.

LIMITATIONS:

This study excluded patients with immunosuppression and those on intermittent hemodialysis, limiting the generalizability of the results to these populations.

DISCLOSURES:

This study was funded by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co. Inc., Rahway, New Jersey. Some authors served as employees of Merck Sharp & Dohme LLC, New Jersey, and MSD, China.

 

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

TOPLINE:

Stem cell transplantation tames some refractory systemic juvenile idiopathic arthritis–related lung disease that does not respond to other treatment.

METHODOLOGY:

• Retrospective cohort study of 13 children with refractory systemic juvenile idiopathic arthritis–related lung disease (sJIA-LD) who had allogeneic hematopoietic stem cell transplantation (HSCT).
• Children whose median age was 9 years at transplantation underwent HSCT at nine hospitals in the United States and Europe between January 2018 and October 2022, with a median follow-up of 16 months.
• Outcomes included transplant-related complications, pulmonary outcomes (eg, oxygen dependence and chest CT findings), and overall outcomes (eg, complete response, partial response, and death).

TAKEAWAY:

• Five patients developed acute graft vs host disease of varying grades, but none experienced chronic disease.
• All nine surviving patients achieved a complete response at the last follow-up, with no sJIA characteristics or need for immunosuppressive therapy or supplemental oxygen.
• Four patients died from complications including cytomegalovirus pneumonitis (n = 2), intracranial hemorrhage (n = 1), and progressive sJIA-LD (n = 1).
• Of six patients who underwent posttransplant chest CT, three had improved lung health, two had stable lung disease, and one experienced worsening lung disease, ultimately resulting in death.

IN PRACTICE:

“Allogeneic HSCT should be considered for treatment-refractory sJIA-LD,” the authors wrote.

“Efforts are being pursued for earlier recognition of patients with sJIA-LD at risk of adverse reactions to biologics. Early detection should help to avoid repeated treatments that are less effective and possibly deleterious and consider therapeutic approaches (eg, anti–[interleukin]-18 or [interferon]-delta–targeted treatments) that might act as a bridge therapy to control disease activity before HSCT,” wrote the author of an accompanying editorial.

SOURCE:

Michael G. Matt, MD, and Daniel Drozdov, MD, led the study, which was published online on December 20, 2024, in The Lancet Rheumatology.

LIMITATIONS:

Limitations included sampling bias and heterogeneity in clinical follow-up. The small sample size made it difficult to identify variables affecting survival and the achievement of a complete response. Additionally, many patients had relatively short follow-up periods.

DISCLOSURES:

This study was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health. Several authors reported receiving advisory board fees, consulting fees, honoraria, grant funds, and stocks and shares from various research institutes and pharmaceutical organizations.

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:

Stem cell transplantation tames some refractory systemic juvenile idiopathic arthritis–related lung disease that does not respond to other treatment.

METHODOLOGY:

• Retrospective cohort study of 13 children with refractory systemic juvenile idiopathic arthritis–related lung disease (sJIA-LD) who had allogeneic hematopoietic stem cell transplantation (HSCT).
• Children whose median age was 9 years at transplantation underwent HSCT at nine hospitals in the United States and Europe between January 2018 and October 2022, with a median follow-up of 16 months.
• Outcomes included transplant-related complications, pulmonary outcomes (eg, oxygen dependence and chest CT findings), and overall outcomes (eg, complete response, partial response, and death).

TAKEAWAY:

• Five patients developed acute graft vs host disease of varying grades, but none experienced chronic disease.
• All nine surviving patients achieved a complete response at the last follow-up, with no sJIA characteristics or need for immunosuppressive therapy or supplemental oxygen.
• Four patients died from complications including cytomegalovirus pneumonitis (n = 2), intracranial hemorrhage (n = 1), and progressive sJIA-LD (n = 1).
• Of six patients who underwent posttransplant chest CT, three had improved lung health, two had stable lung disease, and one experienced worsening lung disease, ultimately resulting in death.

IN PRACTICE:

“Allogeneic HSCT should be considered for treatment-refractory sJIA-LD,” the authors wrote.

“Efforts are being pursued for earlier recognition of patients with sJIA-LD at risk of adverse reactions to biologics. Early detection should help to avoid repeated treatments that are less effective and possibly deleterious and consider therapeutic approaches (eg, anti–[interleukin]-18 or [interferon]-delta–targeted treatments) that might act as a bridge therapy to control disease activity before HSCT,” wrote the author of an accompanying editorial.

SOURCE:

Michael G. Matt, MD, and Daniel Drozdov, MD, led the study, which was published online on December 20, 2024, in The Lancet Rheumatology.

LIMITATIONS:

Limitations included sampling bias and heterogeneity in clinical follow-up. The small sample size made it difficult to identify variables affecting survival and the achievement of a complete response. Additionally, many patients had relatively short follow-up periods.

DISCLOSURES:

This study was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health. Several authors reported receiving advisory board fees, consulting fees, honoraria, grant funds, and stocks and shares from various research institutes and pharmaceutical organizations.

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:

Stem cell transplantation tames some refractory systemic juvenile idiopathic arthritis–related lung disease that does not respond to other treatment.

METHODOLOGY:

• Retrospective cohort study of 13 children with refractory systemic juvenile idiopathic arthritis–related lung disease (sJIA-LD) who had allogeneic hematopoietic stem cell transplantation (HSCT).
• Children whose median age was 9 years at transplantation underwent HSCT at nine hospitals in the United States and Europe between January 2018 and October 2022, with a median follow-up of 16 months.
• Outcomes included transplant-related complications, pulmonary outcomes (eg, oxygen dependence and chest CT findings), and overall outcomes (eg, complete response, partial response, and death).

TAKEAWAY:

• Five patients developed acute graft vs host disease of varying grades, but none experienced chronic disease.
• All nine surviving patients achieved a complete response at the last follow-up, with no sJIA characteristics or need for immunosuppressive therapy or supplemental oxygen.
• Four patients died from complications including cytomegalovirus pneumonitis (n = 2), intracranial hemorrhage (n = 1), and progressive sJIA-LD (n = 1).
• Of six patients who underwent posttransplant chest CT, three had improved lung health, two had stable lung disease, and one experienced worsening lung disease, ultimately resulting in death.

IN PRACTICE:

“Allogeneic HSCT should be considered for treatment-refractory sJIA-LD,” the authors wrote.

“Efforts are being pursued for earlier recognition of patients with sJIA-LD at risk of adverse reactions to biologics. Early detection should help to avoid repeated treatments that are less effective and possibly deleterious and consider therapeutic approaches (eg, anti–[interleukin]-18 or [interferon]-delta–targeted treatments) that might act as a bridge therapy to control disease activity before HSCT,” wrote the author of an accompanying editorial.

SOURCE:

Michael G. Matt, MD, and Daniel Drozdov, MD, led the study, which was published online on December 20, 2024, in The Lancet Rheumatology.

LIMITATIONS:

Limitations included sampling bias and heterogeneity in clinical follow-up. The small sample size made it difficult to identify variables affecting survival and the achievement of a complete response. Additionally, many patients had relatively short follow-up periods.

DISCLOSURES:

This study was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health. Several authors reported receiving advisory board fees, consulting fees, honoraria, grant funds, and stocks and shares from various research institutes and pharmaceutical organizations.

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:

Higher levels of environmental metals in urine are associated with poorer cognitive performance and an increased risk for dementia, new research suggests.

METHODOLOGY:

• This multicenter prospective cohort study included 6303 participants from six US study centers from 2000 to 2002, with follow-up through 2018.
• Participants were aged 45-84 years (median age at baseline, 60 years; 52% women) and were free of diagnosed cardiovascular disease.
• Researchers measured urinary levels of arsenic, cadmium, cobalt, copper, lead, manganese, tungsten, uranium, and zinc.
• Neuropsychological assessments included the Digit Symbol Coding, Cognitive Abilities Screening Instrument, and Digit Span tests.
• The median follow-up duration was 11.7 years for participants with dementia and 16.8 years for those without; 559 cases of dementia were identified during the study.

TAKEAWAY:

• Lower Digit Symbol Coding scores were associated with higher urinary concentrations of arsenic (mean difference [MD] in score per interquartile range [IQR] increase, –0.03), cobalt (MD per IQR increase, –0.05), copper (MD per IQR increase, –0.05), uranium (MD per IQR increase, –0.04), and zinc (MD per IQR increase, –0.03).
• Effects for cobalt, uranium, and zinc were stronger in apolipoprotein epsilon 4 allele (APOE4) carriers vs noncarriers.
• Higher urinary levels of copper were associated with lower Digit Span scores (MD, –0.043) and elevated levels of copper (MD, –0.028) and zinc (MD, –0.024) were associated with lower global cognitive scores.
• Individuals with urinary levels of the nine-metal mixture at the 95th percentile had a 71% higher risk for dementia compared to those with levels at the 25th percentile, with the risk more pronounced in APOE4 carriers than in noncarriers (MD, –0.30 vs –0.10, respectively).

IN PRACTICE:

“We found an inverse association of essential and nonessential metals in urine, both individually and as a mixture, with the speed of mental operations, as well as a positive association of urinary metal levels with dementia risk. As metal exposure and levels in the body are modifiable, these findings could inform early screening and precision interventions for dementia prevention based on individuals’ metal exposure and genetic profiles,” the investigators wrote.

 

SOURCE:

The study was led by Arce Domingo-Relloso, PhD, Columbia University Mailman School of Public Health, New York City. It was published online in JAMA Network Open.

 

LIMITATIONS:

Data may have been missed for patients with dementia who were never hospitalized, died, or were lost to follow-up. The dementia diagnosis included nonspecific International Classification of Diseases codes, potentially leading to false-positive reports. In addition, the sample size was not sufficient to evaluate the associations between metal exposure and cognitive test scores for carriers of two APOE4 alleles.

 

DISCLOSURES:

The study was supported by the National Heart, Lung, and Blood Institute. Several authors reported receiving grants from the National Institutes of Health and consulting fees, editorial stipends, teaching fees, or unrelated grant funding from various sources, which are fully listed in the original article.

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

TOPLINE:

Higher levels of environmental metals in urine are associated with poorer cognitive performance and an increased risk for dementia, new research suggests.

METHODOLOGY:

• This multicenter prospective cohort study included 6303 participants from six US study centers from 2000 to 2002, with follow-up through 2018.
• Participants were aged 45-84 years (median age at baseline, 60 years; 52% women) and were free of diagnosed cardiovascular disease.
• Researchers measured urinary levels of arsenic, cadmium, cobalt, copper, lead, manganese, tungsten, uranium, and zinc.
• Neuropsychological assessments included the Digit Symbol Coding, Cognitive Abilities Screening Instrument, and Digit Span tests.
• The median follow-up duration was 11.7 years for participants with dementia and 16.8 years for those without; 559 cases of dementia were identified during the study.

TAKEAWAY:

• Lower Digit Symbol Coding scores were associated with higher urinary concentrations of arsenic (mean difference [MD] in score per interquartile range [IQR] increase, –0.03), cobalt (MD per IQR increase, –0.05), copper (MD per IQR increase, –0.05), uranium (MD per IQR increase, –0.04), and zinc (MD per IQR increase, –0.03).
• Effects for cobalt, uranium, and zinc were stronger in apolipoprotein epsilon 4 allele (APOE4) carriers vs noncarriers.
• Higher urinary levels of copper were associated with lower Digit Span scores (MD, –0.043) and elevated levels of copper (MD, –0.028) and zinc (MD, –0.024) were associated with lower global cognitive scores.
• Individuals with urinary levels of the nine-metal mixture at the 95th percentile had a 71% higher risk for dementia compared to those with levels at the 25th percentile, with the risk more pronounced in APOE4 carriers than in noncarriers (MD, –0.30 vs –0.10, respectively).

IN PRACTICE:

“We found an inverse association of essential and nonessential metals in urine, both individually and as a mixture, with the speed of mental operations, as well as a positive association of urinary metal levels with dementia risk. As metal exposure and levels in the body are modifiable, these findings could inform early screening and precision interventions for dementia prevention based on individuals’ metal exposure and genetic profiles,” the investigators wrote.

 

SOURCE:

The study was led by Arce Domingo-Relloso, PhD, Columbia University Mailman School of Public Health, New York City. It was published online in JAMA Network Open.

 

LIMITATIONS:

Data may have been missed for patients with dementia who were never hospitalized, died, or were lost to follow-up. The dementia diagnosis included nonspecific International Classification of Diseases codes, potentially leading to false-positive reports. In addition, the sample size was not sufficient to evaluate the associations between metal exposure and cognitive test scores for carriers of two APOE4 alleles.

 

DISCLOSURES:

The study was supported by the National Heart, Lung, and Blood Institute. Several authors reported receiving grants from the National Institutes of Health and consulting fees, editorial stipends, teaching fees, or unrelated grant funding from various sources, which are fully listed in the original article.

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

TOPLINE:

Higher levels of environmental metals in urine are associated with poorer cognitive performance and an increased risk for dementia, new research suggests.

METHODOLOGY:

• This multicenter prospective cohort study included 6303 participants from six US study centers from 2000 to 2002, with follow-up through 2018.
• Participants were aged 45-84 years (median age at baseline, 60 years; 52% women) and were free of diagnosed cardiovascular disease.
• Researchers measured urinary levels of arsenic, cadmium, cobalt, copper, lead, manganese, tungsten, uranium, and zinc.
• Neuropsychological assessments included the Digit Symbol Coding, Cognitive Abilities Screening Instrument, and Digit Span tests.
• The median follow-up duration was 11.7 years for participants with dementia and 16.8 years for those without; 559 cases of dementia were identified during the study.

TAKEAWAY:

• Lower Digit Symbol Coding scores were associated with higher urinary concentrations of arsenic (mean difference [MD] in score per interquartile range [IQR] increase, –0.03), cobalt (MD per IQR increase, –0.05), copper (MD per IQR increase, –0.05), uranium (MD per IQR increase, –0.04), and zinc (MD per IQR increase, –0.03).
• Effects for cobalt, uranium, and zinc were stronger in apolipoprotein epsilon 4 allele (APOE4) carriers vs noncarriers.
• Higher urinary levels of copper were associated with lower Digit Span scores (MD, –0.043) and elevated levels of copper (MD, –0.028) and zinc (MD, –0.024) were associated with lower global cognitive scores.
• Individuals with urinary levels of the nine-metal mixture at the 95th percentile had a 71% higher risk for dementia compared to those with levels at the 25th percentile, with the risk more pronounced in APOE4 carriers than in noncarriers (MD, –0.30 vs –0.10, respectively).

IN PRACTICE:

“We found an inverse association of essential and nonessential metals in urine, both individually and as a mixture, with the speed of mental operations, as well as a positive association of urinary metal levels with dementia risk. As metal exposure and levels in the body are modifiable, these findings could inform early screening and precision interventions for dementia prevention based on individuals’ metal exposure and genetic profiles,” the investigators wrote.

 

SOURCE:

The study was led by Arce Domingo-Relloso, PhD, Columbia University Mailman School of Public Health, New York City. It was published online in JAMA Network Open.

 

LIMITATIONS:

Data may have been missed for patients with dementia who were never hospitalized, died, or were lost to follow-up. The dementia diagnosis included nonspecific International Classification of Diseases codes, potentially leading to false-positive reports. In addition, the sample size was not sufficient to evaluate the associations between metal exposure and cognitive test scores for carriers of two APOE4 alleles.

 

DISCLOSURES:

The study was supported by the National Heart, Lung, and Blood Institute. Several authors reported receiving grants from the National Institutes of Health and consulting fees, editorial stipends, teaching fees, or unrelated grant funding from various sources, which are fully listed in the original article.

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