Oral induction therapy with obefazimod (Abivax) for 8 weeks led to clinically meaningful improvements across all efficacy endpoints in a highly refractory population of patients with moderately to severely active ulcerative colitis (UC).

The findings, from the ABTECT-1 and ABTECT-2 phase 3 induction trials, were presented in two separate late-breaking presentations at United European Gastroenterology (UEG) Week 2025 in Berlin, Germany.

“These trials enrolled a broad spectrum of participants, including one of the most severe and refractory populations evaluated to date in a phase 3 UC trial, with about 60% of patients across the pooled dataset having a Mayo endoscopic subscore of 3 — the highest level of UC endoscopic disease activity,” study investigator Marla Dubinsky, MD, gastroenterologist and co-director of the IBD Center at Mount Sinai in New York City, told GI & Hepatology News.

“Even within this challenging population, obefazimod achieved the primary endpoint of clinical remission and all key secondary endpoints, including endoscopic improvement, after just 8 weeks of therapy,” Dubinsky said.

This suggests that obefazimod may serve as both an early advanced therapy option and a much-needed alternative for patients with moderately to severely active UC who have failed multiple biologics and JAK inhibitors, with few choices left short of colectomy, she added.

 

Study Details

Obefazimod is an investigational oral, potentially first-in-class drug that enhances expression of microRNA-124, resulting in regulation of the inflammatory response and restoring mucosal homeostasis in UC.

The ABTECT-1 and ABTECT-2 were identically designed induction trials enrolling a total of 1272 patients with moderately to severely active UC who had inadequate response, loss of response, or intolerance to at least one prior therapy (with no upper limit), including corticosteroids, immunosuppressants, biologics, S1P receptor modulators, and/or JAK inhibitors. Participants were randomly assigned in a 2:1:1 ratio to receive obefazimod 50 mg or 25 mg or placebo once daily for 8 weeks.

In ABTECT-1, obefazimod 50 mg and 25 mg met the primary endpoint of clinical remission, with 22% of patients in the 50-mg group and 24% in the 25-mg group achieving clinical remission at 8 weeks compared with 2.5% of the placebo group.

The effect sizes for clinical remission were 21% for the 25-mg dose and 19% for the 50-mg dose, reported Bruce E. Sands, MD, MS, AGAF, professor of medicine at Icahn School of Medicine at Mount Sinai and chief in the Division of Gastroenterology at Mount Sinai Health System in New York City.

In ABTECT-2, the 50-mg dose met the primary endpoint of clinical remission, with 20% of patients achieving remission compared with 11% in the 25-mg group and 6.3% in the placebo group.

The effect sizes for clinical remission in ABTECT-2 were “a bit smaller” (13% for the 50-mg dose and 5% for the 25-mg dose) “because the absolute efficacy of 50 mg in this study was a little bit lower, and the placebo response rate was a little bit higher at 6.3%, and so accordingly, the 25-mg dose did not achieve statistical significance,” Sands explained.

Both doses of obefazimod met all secondary endpoints in ABTECT-1 and the 50-mg dose achieved all secondary endpoints in ABTECT-2. Secondary endpoints included clinical response, endoscopic improvement, symptomatic remission, and histo-endoscopic mucosal improvement.

Pooled data across the two studies showed that both doses achieved “clinically meaningful improvements across all efficacy points,” Sands noted.

Notably, obefazimod 50 mg once daily achieved “consistent and clinically meaningful improvements” regardless of prior failure of advanced therapy, and both doses performed similarly well in the subgroup with no prior failure of advanced therapy, Silvio Danese, MD, PhD, with Vita-Salute San Raffaele University, Milan, Italy, reported in a separate presentation.

 

Adverse Events ‘Not a Barrier to Treatment’

Pooled data across the two studies showed no signal for serious, severe, or opportunistic infections or malignancies.

The most commonly reported treatment-emergent adverse event was headache, reported in 24% and 16% of patients taking obefazimod 50 mg and 25 mg, respectively, vs 6% of those taking placebo. Headaches were mild, transient, and short-lasting and “not a barrier to treatment, as evidenced by the low discontinuation (< 1%),” Sands noted.

“Because this is a safe agent and it’s an oral agent and convenient, I think the drug could be used early in the course of the disease, before advanced therapy or after failure of advanced therapies, even multiple advanced therapies,” Sands said.

“Of course, we’ll have to see what the maintenance data show. But we have a long experience from the phase 2a and 2b long-term extension treatments, and the durability seems to be quite good,” Sands cautioned.

Abivax CEO Marc de Garidel, MBA, told GI & Hepatology News that the company will share “top-line data” from the 44-week maintenance study evaluating obefazimod in UC in the second quarter of 2026.

“If positive, the data will support a potential NDA [New Drug Application] submission in the second half of 2026,” de Garidel said.

 

‘Promising Data’

Ashwin Ananthakrishnan, MBBS, MPH, AGAF, associate professor of medicine at Harvard Medical School and a gastroenterologist at Massachusetts General Hospital, Boston, who wasn’t involved in the study, was impressed.

“I think this is very promising data from an important study. This is an entirely novel mechanism of action in ulcerative colitis,” Ananthakrishnan told GI & Hepatology News.

“While we have many treatments available, there are still a large number of patients who do not respond to existing treatment mechanisms,” he said. These trials “consisted of a large number of very refractory patients (severe endoscopic disease or multiple prior mechanism failures). That it works well in this population is very promising (and clinically impactful).”

It would be a “welcome addition to the armamentarium,” he added.

The study was funded by Abivax. Several study authors disclosed having financial relationships with the company. Ananthakrishnan reported having no disclosures.

 

A version of this article appeared on Medscape.com.

Oral induction therapy with obefazimod (Abivax) for 8 weeks led to clinically meaningful improvements across all efficacy endpoints in a highly refractory population of patients with moderately to severely active ulcerative colitis (UC).

The findings, from the ABTECT-1 and ABTECT-2 phase 3 induction trials, were presented in two separate late-breaking presentations at United European Gastroenterology (UEG) Week 2025 in Berlin, Germany.

“These trials enrolled a broad spectrum of participants, including one of the most severe and refractory populations evaluated to date in a phase 3 UC trial, with about 60% of patients across the pooled dataset having a Mayo endoscopic subscore of 3 — the highest level of UC endoscopic disease activity,” study investigator Marla Dubinsky, MD, gastroenterologist and co-director of the IBD Center at Mount Sinai in New York City, told GI & Hepatology News.

“Even within this challenging population, obefazimod achieved the primary endpoint of clinical remission and all key secondary endpoints, including endoscopic improvement, after just 8 weeks of therapy,” Dubinsky said.

This suggests that obefazimod may serve as both an early advanced therapy option and a much-needed alternative for patients with moderately to severely active UC who have failed multiple biologics and JAK inhibitors, with few choices left short of colectomy, she added.

 

Study Details

Obefazimod is an investigational oral, potentially first-in-class drug that enhances expression of microRNA-124, resulting in regulation of the inflammatory response and restoring mucosal homeostasis in UC.

The ABTECT-1 and ABTECT-2 were identically designed induction trials enrolling a total of 1272 patients with moderately to severely active UC who had inadequate response, loss of response, or intolerance to at least one prior therapy (with no upper limit), including corticosteroids, immunosuppressants, biologics, S1P receptor modulators, and/or JAK inhibitors. Participants were randomly assigned in a 2:1:1 ratio to receive obefazimod 50 mg or 25 mg or placebo once daily for 8 weeks.

In ABTECT-1, obefazimod 50 mg and 25 mg met the primary endpoint of clinical remission, with 22% of patients in the 50-mg group and 24% in the 25-mg group achieving clinical remission at 8 weeks compared with 2.5% of the placebo group.

The effect sizes for clinical remission were 21% for the 25-mg dose and 19% for the 50-mg dose, reported Bruce E. Sands, MD, MS, AGAF, professor of medicine at Icahn School of Medicine at Mount Sinai and chief in the Division of Gastroenterology at Mount Sinai Health System in New York City.

In ABTECT-2, the 50-mg dose met the primary endpoint of clinical remission, with 20% of patients achieving remission compared with 11% in the 25-mg group and 6.3% in the placebo group.

The effect sizes for clinical remission in ABTECT-2 were “a bit smaller” (13% for the 50-mg dose and 5% for the 25-mg dose) “because the absolute efficacy of 50 mg in this study was a little bit lower, and the placebo response rate was a little bit higher at 6.3%, and so accordingly, the 25-mg dose did not achieve statistical significance,” Sands explained.

Both doses of obefazimod met all secondary endpoints in ABTECT-1 and the 50-mg dose achieved all secondary endpoints in ABTECT-2. Secondary endpoints included clinical response, endoscopic improvement, symptomatic remission, and histo-endoscopic mucosal improvement.

Pooled data across the two studies showed that both doses achieved “clinically meaningful improvements across all efficacy points,” Sands noted.

Notably, obefazimod 50 mg once daily achieved “consistent and clinically meaningful improvements” regardless of prior failure of advanced therapy, and both doses performed similarly well in the subgroup with no prior failure of advanced therapy, Silvio Danese, MD, PhD, with Vita-Salute San Raffaele University, Milan, Italy, reported in a separate presentation.

 

Adverse Events ‘Not a Barrier to Treatment’

Pooled data across the two studies showed no signal for serious, severe, or opportunistic infections or malignancies.

The most commonly reported treatment-emergent adverse event was headache, reported in 24% and 16% of patients taking obefazimod 50 mg and 25 mg, respectively, vs 6% of those taking placebo. Headaches were mild, transient, and short-lasting and “not a barrier to treatment, as evidenced by the low discontinuation (< 1%),” Sands noted.

“Because this is a safe agent and it’s an oral agent and convenient, I think the drug could be used early in the course of the disease, before advanced therapy or after failure of advanced therapies, even multiple advanced therapies,” Sands said.

“Of course, we’ll have to see what the maintenance data show. But we have a long experience from the phase 2a and 2b long-term extension treatments, and the durability seems to be quite good,” Sands cautioned.

Abivax CEO Marc de Garidel, MBA, told GI & Hepatology News that the company will share “top-line data” from the 44-week maintenance study evaluating obefazimod in UC in the second quarter of 2026.

“If positive, the data will support a potential NDA [New Drug Application] submission in the second half of 2026,” de Garidel said.

 

‘Promising Data’

Ashwin Ananthakrishnan, MBBS, MPH, AGAF, associate professor of medicine at Harvard Medical School and a gastroenterologist at Massachusetts General Hospital, Boston, who wasn’t involved in the study, was impressed.

“I think this is very promising data from an important study. This is an entirely novel mechanism of action in ulcerative colitis,” Ananthakrishnan told GI & Hepatology News.

“While we have many treatments available, there are still a large number of patients who do not respond to existing treatment mechanisms,” he said. These trials “consisted of a large number of very refractory patients (severe endoscopic disease or multiple prior mechanism failures). That it works well in this population is very promising (and clinically impactful).”

It would be a “welcome addition to the armamentarium,” he added.

The study was funded by Abivax. Several study authors disclosed having financial relationships with the company. Ananthakrishnan reported having no disclosures.

 

A version of this article appeared on Medscape.com.

Oral induction therapy with obefazimod (Abivax) for 8 weeks led to clinically meaningful improvements across all efficacy endpoints in a highly refractory population of patients with moderately to severely active ulcerative colitis (UC).

The findings, from the ABTECT-1 and ABTECT-2 phase 3 induction trials, were presented in two separate late-breaking presentations at United European Gastroenterology (UEG) Week 2025 in Berlin, Germany.

“These trials enrolled a broad spectrum of participants, including one of the most severe and refractory populations evaluated to date in a phase 3 UC trial, with about 60% of patients across the pooled dataset having a Mayo endoscopic subscore of 3 — the highest level of UC endoscopic disease activity,” study investigator Marla Dubinsky, MD, gastroenterologist and co-director of the IBD Center at Mount Sinai in New York City, told GI & Hepatology News.

“Even within this challenging population, obefazimod achieved the primary endpoint of clinical remission and all key secondary endpoints, including endoscopic improvement, after just 8 weeks of therapy,” Dubinsky said.

This suggests that obefazimod may serve as both an early advanced therapy option and a much-needed alternative for patients with moderately to severely active UC who have failed multiple biologics and JAK inhibitors, with few choices left short of colectomy, she added.

 

Study Details

Obefazimod is an investigational oral, potentially first-in-class drug that enhances expression of microRNA-124, resulting in regulation of the inflammatory response and restoring mucosal homeostasis in UC.

The ABTECT-1 and ABTECT-2 were identically designed induction trials enrolling a total of 1272 patients with moderately to severely active UC who had inadequate response, loss of response, or intolerance to at least one prior therapy (with no upper limit), including corticosteroids, immunosuppressants, biologics, S1P receptor modulators, and/or JAK inhibitors. Participants were randomly assigned in a 2:1:1 ratio to receive obefazimod 50 mg or 25 mg or placebo once daily for 8 weeks.

In ABTECT-1, obefazimod 50 mg and 25 mg met the primary endpoint of clinical remission, with 22% of patients in the 50-mg group and 24% in the 25-mg group achieving clinical remission at 8 weeks compared with 2.5% of the placebo group.

The effect sizes for clinical remission were 21% for the 25-mg dose and 19% for the 50-mg dose, reported Bruce E. Sands, MD, MS, AGAF, professor of medicine at Icahn School of Medicine at Mount Sinai and chief in the Division of Gastroenterology at Mount Sinai Health System in New York City.

In ABTECT-2, the 50-mg dose met the primary endpoint of clinical remission, with 20% of patients achieving remission compared with 11% in the 25-mg group and 6.3% in the placebo group.

The effect sizes for clinical remission in ABTECT-2 were “a bit smaller” (13% for the 50-mg dose and 5% for the 25-mg dose) “because the absolute efficacy of 50 mg in this study was a little bit lower, and the placebo response rate was a little bit higher at 6.3%, and so accordingly, the 25-mg dose did not achieve statistical significance,” Sands explained.

Both doses of obefazimod met all secondary endpoints in ABTECT-1 and the 50-mg dose achieved all secondary endpoints in ABTECT-2. Secondary endpoints included clinical response, endoscopic improvement, symptomatic remission, and histo-endoscopic mucosal improvement.

Pooled data across the two studies showed that both doses achieved “clinically meaningful improvements across all efficacy points,” Sands noted.

Notably, obefazimod 50 mg once daily achieved “consistent and clinically meaningful improvements” regardless of prior failure of advanced therapy, and both doses performed similarly well in the subgroup with no prior failure of advanced therapy, Silvio Danese, MD, PhD, with Vita-Salute San Raffaele University, Milan, Italy, reported in a separate presentation.

 

Adverse Events ‘Not a Barrier to Treatment’

Pooled data across the two studies showed no signal for serious, severe, or opportunistic infections or malignancies.

The most commonly reported treatment-emergent adverse event was headache, reported in 24% and 16% of patients taking obefazimod 50 mg and 25 mg, respectively, vs 6% of those taking placebo. Headaches were mild, transient, and short-lasting and “not a barrier to treatment, as evidenced by the low discontinuation (< 1%),” Sands noted.

“Because this is a safe agent and it’s an oral agent and convenient, I think the drug could be used early in the course of the disease, before advanced therapy or after failure of advanced therapies, even multiple advanced therapies,” Sands said.

“Of course, we’ll have to see what the maintenance data show. But we have a long experience from the phase 2a and 2b long-term extension treatments, and the durability seems to be quite good,” Sands cautioned.

Abivax CEO Marc de Garidel, MBA, told GI & Hepatology News that the company will share “top-line data” from the 44-week maintenance study evaluating obefazimod in UC in the second quarter of 2026.

“If positive, the data will support a potential NDA [New Drug Application] submission in the second half of 2026,” de Garidel said.

 

‘Promising Data’

Ashwin Ananthakrishnan, MBBS, MPH, AGAF, associate professor of medicine at Harvard Medical School and a gastroenterologist at Massachusetts General Hospital, Boston, who wasn’t involved in the study, was impressed.

“I think this is very promising data from an important study. This is an entirely novel mechanism of action in ulcerative colitis,” Ananthakrishnan told GI & Hepatology News.

“While we have many treatments available, there are still a large number of patients who do not respond to existing treatment mechanisms,” he said. These trials “consisted of a large number of very refractory patients (severe endoscopic disease or multiple prior mechanism failures). That it works well in this population is very promising (and clinically impactful).”

It would be a “welcome addition to the armamentarium,” he added.

The study was funded by Abivax. Several study authors disclosed having financial relationships with the company. Ananthakrishnan reported having no disclosures.

 

A version of this article appeared on Medscape.com.

A large real-world study found that fewer than half of adults who started colorectal cancer (CRC) screening with an at-home stool test completed the recommended repeat test, creating gaps in protection and potentially diminishing their benefits.

Among those who did repeat the test, the average delay was 3 months before COVID and increased to 5 months during the pandemic, the authors reported in BMJ Public Health.

“Stool tests are relatively easy to complete at home and mailed for testing, and they are inexpensive, but they must be completed annually. In contrast, colonoscopies are more invasive and require more time away from work but only need to be repeated every 5-10 years,” Staci J Wendt, PhD, director, health research accelerator, Providence Research Network, Providence, Rhode Island, told GI & Hepatology News.

In the end, “the best colorectal cancer screening test is the one that gets done,” Wendt said.

“This is why we stress the importance of patients and their doctor having these discussions together and deciding which screening is the most preferred method for the individual patient,” she added.

 

Stool Tests Gaining Traction

Adults are increasingly turning to at-home stool tests for CRC screening — a trend that accelerated during the pandemic. Yet, there is limited data on whether patients undergo repeat stool tests following initial negative test results.

Wendt and her colleagues documented rates of repeat preventative stool tests by analyzing electronic medical records from Providence St Joseph Health, a large health system with 51 hospitals and over 1000 clinics across seven western US states.

They divided their analysis into two periods based on the onset of the pandemic. The pre-COVID onset period spanned January 2018 to February 2020 and the post-COVID period spanned March 2020 to February 2022.

“The pandemic is a salient time to conduct this study because it resulted in a dramatic decrease in colonoscopies, which were partially replaced by stool tests. This partial replacement of colonoscopies by stool tests has led other studies to conclude that stool tests mitigated gaps in CRC screening during the pandemic. But gaps may persist if patients do not undergo repeat testing,” the study team explained.

Their sample included 403,085 patients. Among those with an initial negative stool test, the share who obtained a timely repeat screening ranged from 38% to 49% across the study years, confirming that “most patients do not undergo the recommended repeat screening after their initial stool test,” the researchers said.

Among adults who do a repeat test, delays were common. The average lag to the follow-up test was 3months on average, increasing to about 5 months amid COVID — almost half as long as the preventative screening period of stool tests (12 months).

“These gaps could delay detection of CRC and subsequent treatment, potentially resulting in higher mortality. These gaps are particularly important as more and more patients use stool tests instead of colonoscopes for CRC screening,” the researchers wrote.

Screening patterns shifted markedly during the pandemic.

Not surprisingly, the volume of colonoscopies declined substantially after the onset of the pandemic and stayed low through the study’s end. In contrast, the volume of at-home stool tests was increasing before the pandemic and accelerated during the pandemic.

“Given this increase in stool tests, it will be increasingly important to focus on improving long-term adherence to screening through outreach, policies and programs,” the researchers said.

 

A Multilevel Approach

Wendt said health systems that are incorporating proactive measures like sending stool kits to patients who are eligible for screening, should ensure that these screening kits and information are sent annually and that it is stressed that the screening must happen every year.

Reached for comment, Aasma Shaukat, MD, MPH, AGAF, director of outcomes research, Division of Gastroenterology and Hepatology, NYU Langone Health, New York City, who wasn’t involved in the study, said the poor adherence to repeat stool tests for CRC screening seen in this study is “not surprising.”

“We know that adherence goes down with each consecutive screening round and what is really needed is an organized program to keep the level of adherence up,” Shaukat told GI & Hepatology News.

Shaukat agreed that boosting adherence to stool tests requires a “multilevel approach.”

She cited the success of the CRC screening program implemented across Kaiser Permanente Northern California. The program includes proactive and targeted outreach to members who are overdue for screening and mailed fecal immunochemical test kits for at-home use.

As reported previously by GI & Hepatology News, the program has made a huge difference in CRC incidence, deaths, and racial disparities.

The program has doubled the proportion of people up to date with screening. And, within about 10 years, cancer rates were cut by a third, deaths were halved and largely eliminated long-standing differences by race and ethnicity.

The study had no commercial funding. Wendt and Shaukat declared having no relevant disclosures.

 

A version of this article appeared on Medscape.com.

A large real-world study found that fewer than half of adults who started colorectal cancer (CRC) screening with an at-home stool test completed the recommended repeat test, creating gaps in protection and potentially diminishing their benefits.

Among those who did repeat the test, the average delay was 3 months before COVID and increased to 5 months during the pandemic, the authors reported in BMJ Public Health.

“Stool tests are relatively easy to complete at home and mailed for testing, and they are inexpensive, but they must be completed annually. In contrast, colonoscopies are more invasive and require more time away from work but only need to be repeated every 5-10 years,” Staci J Wendt, PhD, director, health research accelerator, Providence Research Network, Providence, Rhode Island, told GI & Hepatology News.

In the end, “the best colorectal cancer screening test is the one that gets done,” Wendt said.

“This is why we stress the importance of patients and their doctor having these discussions together and deciding which screening is the most preferred method for the individual patient,” she added.

 

Stool Tests Gaining Traction

Adults are increasingly turning to at-home stool tests for CRC screening — a trend that accelerated during the pandemic. Yet, there is limited data on whether patients undergo repeat stool tests following initial negative test results.

Wendt and her colleagues documented rates of repeat preventative stool tests by analyzing electronic medical records from Providence St Joseph Health, a large health system with 51 hospitals and over 1000 clinics across seven western US states.

They divided their analysis into two periods based on the onset of the pandemic. The pre-COVID onset period spanned January 2018 to February 2020 and the post-COVID period spanned March 2020 to February 2022.

“The pandemic is a salient time to conduct this study because it resulted in a dramatic decrease in colonoscopies, which were partially replaced by stool tests. This partial replacement of colonoscopies by stool tests has led other studies to conclude that stool tests mitigated gaps in CRC screening during the pandemic. But gaps may persist if patients do not undergo repeat testing,” the study team explained.

Their sample included 403,085 patients. Among those with an initial negative stool test, the share who obtained a timely repeat screening ranged from 38% to 49% across the study years, confirming that “most patients do not undergo the recommended repeat screening after their initial stool test,” the researchers said.

Among adults who do a repeat test, delays were common. The average lag to the follow-up test was 3months on average, increasing to about 5 months amid COVID — almost half as long as the preventative screening period of stool tests (12 months).

“These gaps could delay detection of CRC and subsequent treatment, potentially resulting in higher mortality. These gaps are particularly important as more and more patients use stool tests instead of colonoscopes for CRC screening,” the researchers wrote.

Screening patterns shifted markedly during the pandemic.

Not surprisingly, the volume of colonoscopies declined substantially after the onset of the pandemic and stayed low through the study’s end. In contrast, the volume of at-home stool tests was increasing before the pandemic and accelerated during the pandemic.

“Given this increase in stool tests, it will be increasingly important to focus on improving long-term adherence to screening through outreach, policies and programs,” the researchers said.

 

A Multilevel Approach

Wendt said health systems that are incorporating proactive measures like sending stool kits to patients who are eligible for screening, should ensure that these screening kits and information are sent annually and that it is stressed that the screening must happen every year.

Reached for comment, Aasma Shaukat, MD, MPH, AGAF, director of outcomes research, Division of Gastroenterology and Hepatology, NYU Langone Health, New York City, who wasn’t involved in the study, said the poor adherence to repeat stool tests for CRC screening seen in this study is “not surprising.”

“We know that adherence goes down with each consecutive screening round and what is really needed is an organized program to keep the level of adherence up,” Shaukat told GI & Hepatology News.

Shaukat agreed that boosting adherence to stool tests requires a “multilevel approach.”

She cited the success of the CRC screening program implemented across Kaiser Permanente Northern California. The program includes proactive and targeted outreach to members who are overdue for screening and mailed fecal immunochemical test kits for at-home use.

As reported previously by GI & Hepatology News, the program has made a huge difference in CRC incidence, deaths, and racial disparities.

The program has doubled the proportion of people up to date with screening. And, within about 10 years, cancer rates were cut by a third, deaths were halved and largely eliminated long-standing differences by race and ethnicity.

The study had no commercial funding. Wendt and Shaukat declared having no relevant disclosures.

 

A version of this article appeared on Medscape.com.

A large real-world study found that fewer than half of adults who started colorectal cancer (CRC) screening with an at-home stool test completed the recommended repeat test, creating gaps in protection and potentially diminishing their benefits.

Among those who did repeat the test, the average delay was 3 months before COVID and increased to 5 months during the pandemic, the authors reported in BMJ Public Health.

“Stool tests are relatively easy to complete at home and mailed for testing, and they are inexpensive, but they must be completed annually. In contrast, colonoscopies are more invasive and require more time away from work but only need to be repeated every 5-10 years,” Staci J Wendt, PhD, director, health research accelerator, Providence Research Network, Providence, Rhode Island, told GI & Hepatology News.

In the end, “the best colorectal cancer screening test is the one that gets done,” Wendt said.

“This is why we stress the importance of patients and their doctor having these discussions together and deciding which screening is the most preferred method for the individual patient,” she added.

 

Stool Tests Gaining Traction

Adults are increasingly turning to at-home stool tests for CRC screening — a trend that accelerated during the pandemic. Yet, there is limited data on whether patients undergo repeat stool tests following initial negative test results.

Wendt and her colleagues documented rates of repeat preventative stool tests by analyzing electronic medical records from Providence St Joseph Health, a large health system with 51 hospitals and over 1000 clinics across seven western US states.

They divided their analysis into two periods based on the onset of the pandemic. The pre-COVID onset period spanned January 2018 to February 2020 and the post-COVID period spanned March 2020 to February 2022.

“The pandemic is a salient time to conduct this study because it resulted in a dramatic decrease in colonoscopies, which were partially replaced by stool tests. This partial replacement of colonoscopies by stool tests has led other studies to conclude that stool tests mitigated gaps in CRC screening during the pandemic. But gaps may persist if patients do not undergo repeat testing,” the study team explained.

Their sample included 403,085 patients. Among those with an initial negative stool test, the share who obtained a timely repeat screening ranged from 38% to 49% across the study years, confirming that “most patients do not undergo the recommended repeat screening after their initial stool test,” the researchers said.

Among adults who do a repeat test, delays were common. The average lag to the follow-up test was 3months on average, increasing to about 5 months amid COVID — almost half as long as the preventative screening period of stool tests (12 months).

“These gaps could delay detection of CRC and subsequent treatment, potentially resulting in higher mortality. These gaps are particularly important as more and more patients use stool tests instead of colonoscopes for CRC screening,” the researchers wrote.

Screening patterns shifted markedly during the pandemic.

Not surprisingly, the volume of colonoscopies declined substantially after the onset of the pandemic and stayed low through the study’s end. In contrast, the volume of at-home stool tests was increasing before the pandemic and accelerated during the pandemic.

“Given this increase in stool tests, it will be increasingly important to focus on improving long-term adherence to screening through outreach, policies and programs,” the researchers said.

 

A Multilevel Approach

Wendt said health systems that are incorporating proactive measures like sending stool kits to patients who are eligible for screening, should ensure that these screening kits and information are sent annually and that it is stressed that the screening must happen every year.

Reached for comment, Aasma Shaukat, MD, MPH, AGAF, director of outcomes research, Division of Gastroenterology and Hepatology, NYU Langone Health, New York City, who wasn’t involved in the study, said the poor adherence to repeat stool tests for CRC screening seen in this study is “not surprising.”

“We know that adherence goes down with each consecutive screening round and what is really needed is an organized program to keep the level of adherence up,” Shaukat told GI & Hepatology News.

Shaukat agreed that boosting adherence to stool tests requires a “multilevel approach.”

She cited the success of the CRC screening program implemented across Kaiser Permanente Northern California. The program includes proactive and targeted outreach to members who are overdue for screening and mailed fecal immunochemical test kits for at-home use.

As reported previously by GI & Hepatology News, the program has made a huge difference in CRC incidence, deaths, and racial disparities.

The program has doubled the proportion of people up to date with screening. And, within about 10 years, cancer rates were cut by a third, deaths were halved and largely eliminated long-standing differences by race and ethnicity.

The study had no commercial funding. Wendt and Shaukat declared having no relevant disclosures.

 

A version of this article appeared on Medscape.com.

In 2020, the US Multi-Society Task Force (USMSTF) on Colorectal Cancer (CRC) increased the recommended colon polyp surveillance interval for 1 to 2 subcentimeter tubular adenomas from 5 to 10 years to 7 to 10 years.¹ This change was prompted by emerging research indicating that rates of CRC and advanced neoplasia among patients with a history of only 1 to 2 subcentimeter tubular adenomas are lower than initially estimated.^2,3 This extension provides an opportunity to increase endoscopy capacity and improve access to colonoscopies by retroactively applying the 2020 guidelines to surveillance interval recommendations made before their introduction. For example, based on the updated guidelines, patients previously recommended to undergo colon polyp surveillance colonoscopy 5 years after an index colonoscopy could extend their surveillance interval by 2 to 5 years. Increasing endoscopic capacity could address the growing demand for colonoscopies from new screening guidelines that reduced the age of initial CRC screening from 50 years to 45 years and the backlog of procedures due to COVID-19 restrictions.⁴

As part of a project to increase endoscopic capacity at the US Department of Veterans Affairs (VA) Pittsburgh Healthcare System (VAPHS), this study assessed the potential impact of retroactively applying the 2020 USMSTF polyp surveillance guidelines on endoscopic capacity. These results may be informative for other VA and private-sector health care systems seeking to identify strategies to improve endoscopy capacity.

Methods

VAPHS is an integrated health care system in the Veterans Health Administration (VHA) serving 85,000 patients across 8 health care institutions in Pennsylvania, Ohio, and West Virginia. VAPHS manages colorectal screening recommendations for patients receiving medical care in the health care system regardless of whether their prior colonoscopy was performed at VAPHS or external facilities. The VA maintains a national CRC screening and surveillance electronic medical record reminder that prompts health care practitioners to order colon polyp surveillance based on interval recommendations from the index colonoscopy. This study reviewed all patients from the VAPHS panel with a reminder to undergo colonoscopy for screening for CRC or surveillance of colon polyps within 12 months from September 1, 2022.

Among patients with a reminder, 3 investigators reviewed index colonoscopy and pathology reports to identify CRC risk category, colonoscopy indication, procedural quality, and recommended repeat colonoscopy interval. Per the USMSTF guidelines, patients with incomplete colonoscopy or pathology records, high-risk indications (ie, personal history of inflammatory bowel disease, personal history of CRC, or family history of CRC), or inadequate bowel preparation (Boston Bowel Preparation Score < 6) were excluded. Additionally, patients who had CRC screening or surveillance discontinued due to age or comorbidities, had completed a subsequent follow-up colonoscopy, or were deceased at the time of review were excluded.

Retroactive Interval Reclassification

Among eligible patients, this study compared the repeat colonoscopy interval recommended by the prior endoscopist with those from the 2020 USMSTF guidelines. In cases where the interval was documented as a range of years, the lower end was considered the recommendation. Similarly, the lower end of the range from the 2020 USMSTF guidelines was used for the reclassified surveillance interval. Years extended per patient were quantified relative to September 1, 2023 (ie, 1 year after the review date). For example, if the index colonoscopy was completed on September 1, 2016, the initial surveillance recommendation was 5 years, and the reclassified recommendation was 7 years, the interval extension beyond September 1, 2023, was 0 years.

Furthermore, because index surveillance recommendations are not always guideline concordant, the years extended per patient were calculated by harmonizing the index endoscopist’s recommendations with the guidelines at the time of the index colonoscopy.⁵ For example, if the index colonoscopy was completed on September 1, 2018, and the endoscopist recommended a 5-year follow-up for a patient with average risk for CRC, adequate bowel preparation, and no colorectal polyps, that patient is eligible to extend their colonoscopy to September 1, 2028, based on guideline recommendations at the time of index endoscopy recommending that the next colonoscopy occur in 10 years. In this analysis the 2012 USMSTF guidelines were applied to all index colonoscopies completed in 2021 or earlier to allow time for adoption of the 2020 guidelines. 

This project fulfilled a facility mandate to increase capacity to conduct endoscopic procedures. Institutional review board approval was not required by VAPHS policy relating to clinical operations projects. Approval for publication of clinical operations activity was obtained from the VAPHS facility director.

Results

Within 1 year of the September 1, 2022, review date, 637 patients receiving care at VAPHS had clinical reminders for an upcoming colonoscopy. Of these, 54 (8.4%) were already up to date or were deceased at the time of review. Of the 583 eligible patients, 96% were male, the median age was 74 years, the median index colonoscopy year was 2016, and 178 (30.5%) had an average-risk CRC screening indication at the index colonoscopy (Table).

Of the 583 patients due for colonoscopy, 331 (56.7%) had both colonoscopy and pathology reports available. The majority of those with incomplete records had the index colonoscopy completed outside VAPHS. Among these patients, 222 (67.0%) had adequate bowel preparation. Of those with adequate bowel preparation, 43 were not eligible for interval extension because of high-risk conditions and 13 were not eligible because there was no index surveillance interval recommendation from the index endoscopist. Of the patients due for colonoscopy, 166 (28.4%) were potentially eligible for surveillance interval extension (Figure).  

Sixty-five (39.2%) of the 166 patients had 1 to 2 subcentimeter tubular adenomas on their index colonoscopy. Sixty-two patients were eligible for interval extension to 7 years, but this only resulted in ≥ 1 year of extension beyond the review date for 36 (6% of all 583 patients due for colonoscopy). The 36 patients were extended 63 years. By harmonizing the index endoscopists’ surveillance interval recommendation with the guideline at the time of the index colonoscopy, 29 additional patients could have their colonoscopy extended by ≥ 1 year. Harmonization extended colonoscopy intervals by 93 years. Retroactively applying the 2020 USMSTF polyp surveillance guidelines and harmonizing recommendations to guidelines extended the time of index colonoscopy by 153 years.

Discussion

With retroactive application of the 2020 USMSTF polyp surveillance guidelines, 6% of patients due for an upcoming colonoscopy could extend their follow-up by ≥ 1 year by extending the surveillance interval for 1 to 2 subcentimeter tubular adenomas to 7 years. An additional 5% of patients could extend their interval by harmonizing the index endoscopist’s interval recommendation with polyp surveillance guidelines at the time of the index colonoscopy. These findings are consistent with the results of 2 studies that demonstrated that about 14% of patients due for colonoscopy could have their interval extended.^6,7 The current study enhances those insights by separating the contribution of 2020 USMSTF polyp surveillance guidelines from the contribution of harmonizing surveillance intervals with guidelines for other polyp histologies. This study found that there is an opportunity to improve endoscopic capacity by harmonizing recommendations with guidelines. This complements a 2023 study showing that even when knowledgeable about guidelines, clinicians do not necessarily follow recommendations.⁸ While this and previous research have identified that 11% to 14% of patients are eligible for extension, these individuals would also have to be willing to have their polyp surveillance intervals extended for there to be a real-world impact on endoscopic capacity. A 2024 study found that only 19% to 37% of patients with 1 to 2 small tubular adenomas were willing to have polyps surveillance interval extension.⁹ This suggests the actual effect on capacity may be even lower than reported.

Limitations

The overall impact of the 2020 USMSTF polyp surveillance guidelines on endoscopic capacity was blunted by the high prevalence of incomplete index colonoscopy records among the study population. Without data on bowel preparation quality or procedure indications, this study could not assess whether 43% of patients were eligible for surveillance interval extension. Most index colonoscopies with incomplete documentation were completed at community-care gastroenterology facilities. This high rate of incomplete documentation is likely generalizable to other VA health care systems—especially in the era of the Veterans Access, Choice, and Accountability Act of 2014, which increased veteran access to non-VA community care.¹⁰ Veterans due for colon polyp surveillance colonoscopies are more likely to have had their prior colonoscopy in community care compared with prior eras.¹¹ Furthermore, because the VHA is among the most established integrated health care systems offering primary and subspecialty care in the US, private sector health care systems may have even greater rates of care fragmentation for longitudinal CRC screening and colon polyp surveillance, as these systems have only begun to regionally integrate recently.^12,13

Another limitation is that nearly one-third of the individuals with documentation had inadequate bowel preparation for surveillance recommendations. This results in shorter surveillance follow-up colonoscopies and increases downstream demand for future colonoscopies. The low yield of extending colon polyp surveillance interval in this study emphasizes that improved efforts to obtain colonoscopy and pathology reports from community care, right-sizing the colon polyp surveillance intervals recommended by endoscopists, and improving quality of bowel preparation could have downstream health care system benefits in the future. These efforts could increase colonoscopy capacity at VA health care systems, thereby shortening colonoscopy wait times, decreasing fragmentation of care, and increasing the number of veterans who receive high-quality colonoscopies at VA health care systems.¹⁴

Conclusions

Eleven percent of patients in this study due for a colonoscopy could extend their follow-up by ≥ 1 year. About half of these extensions were directly due to the 2020 USMSTF polyp surveillance interval extension for 1 to 2 subcentimeter tubular adenomas. The rest resulted from harmonizing recommendations with guidelines at the time of the procedure. To determine whether retroactively applying polyp surveillance guidelines to follow-up interval recommendations will result in improved endoscopic capacity, health care system administrators should consider the degree of CRC screening care fragmentation in their patient population. Greater long-term gains in endoscopic capacity may be achieved by proactively supporting endoscopists in making guideline-concordant screening recommendations at the time of colonoscopy.

In 2020, the US Multi-Society Task Force (USMSTF) on Colorectal Cancer (CRC) increased the recommended colon polyp surveillance interval for 1 to 2 subcentimeter tubular adenomas from 5 to 10 years to 7 to 10 years.¹ This change was prompted by emerging research indicating that rates of CRC and advanced neoplasia among patients with a history of only 1 to 2 subcentimeter tubular adenomas are lower than initially estimated.^2,3 This extension provides an opportunity to increase endoscopy capacity and improve access to colonoscopies by retroactively applying the 2020 guidelines to surveillance interval recommendations made before their introduction. For example, based on the updated guidelines, patients previously recommended to undergo colon polyp surveillance colonoscopy 5 years after an index colonoscopy could extend their surveillance interval by 2 to 5 years. Increasing endoscopic capacity could address the growing demand for colonoscopies from new screening guidelines that reduced the age of initial CRC screening from 50 years to 45 years and the backlog of procedures due to COVID-19 restrictions.⁴

As part of a project to increase endoscopic capacity at the US Department of Veterans Affairs (VA) Pittsburgh Healthcare System (VAPHS), this study assessed the potential impact of retroactively applying the 2020 USMSTF polyp surveillance guidelines on endoscopic capacity. These results may be informative for other VA and private-sector health care systems seeking to identify strategies to improve endoscopy capacity.

Methods

VAPHS is an integrated health care system in the Veterans Health Administration (VHA) serving 85,000 patients across 8 health care institutions in Pennsylvania, Ohio, and West Virginia. VAPHS manages colorectal screening recommendations for patients receiving medical care in the health care system regardless of whether their prior colonoscopy was performed at VAPHS or external facilities. The VA maintains a national CRC screening and surveillance electronic medical record reminder that prompts health care practitioners to order colon polyp surveillance based on interval recommendations from the index colonoscopy. This study reviewed all patients from the VAPHS panel with a reminder to undergo colonoscopy for screening for CRC or surveillance of colon polyps within 12 months from September 1, 2022.

Among patients with a reminder, 3 investigators reviewed index colonoscopy and pathology reports to identify CRC risk category, colonoscopy indication, procedural quality, and recommended repeat colonoscopy interval. Per the USMSTF guidelines, patients with incomplete colonoscopy or pathology records, high-risk indications (ie, personal history of inflammatory bowel disease, personal history of CRC, or family history of CRC), or inadequate bowel preparation (Boston Bowel Preparation Score < 6) were excluded. Additionally, patients who had CRC screening or surveillance discontinued due to age or comorbidities, had completed a subsequent follow-up colonoscopy, or were deceased at the time of review were excluded.

Retroactive Interval Reclassification

Among eligible patients, this study compared the repeat colonoscopy interval recommended by the prior endoscopist with those from the 2020 USMSTF guidelines. In cases where the interval was documented as a range of years, the lower end was considered the recommendation. Similarly, the lower end of the range from the 2020 USMSTF guidelines was used for the reclassified surveillance interval. Years extended per patient were quantified relative to September 1, 2023 (ie, 1 year after the review date). For example, if the index colonoscopy was completed on September 1, 2016, the initial surveillance recommendation was 5 years, and the reclassified recommendation was 7 years, the interval extension beyond September 1, 2023, was 0 years.

Furthermore, because index surveillance recommendations are not always guideline concordant, the years extended per patient were calculated by harmonizing the index endoscopist’s recommendations with the guidelines at the time of the index colonoscopy.⁵ For example, if the index colonoscopy was completed on September 1, 2018, and the endoscopist recommended a 5-year follow-up for a patient with average risk for CRC, adequate bowel preparation, and no colorectal polyps, that patient is eligible to extend their colonoscopy to September 1, 2028, based on guideline recommendations at the time of index endoscopy recommending that the next colonoscopy occur in 10 years. In this analysis the 2012 USMSTF guidelines were applied to all index colonoscopies completed in 2021 or earlier to allow time for adoption of the 2020 guidelines. 

This project fulfilled a facility mandate to increase capacity to conduct endoscopic procedures. Institutional review board approval was not required by VAPHS policy relating to clinical operations projects. Approval for publication of clinical operations activity was obtained from the VAPHS facility director.

Results

Within 1 year of the September 1, 2022, review date, 637 patients receiving care at VAPHS had clinical reminders for an upcoming colonoscopy. Of these, 54 (8.4%) were already up to date or were deceased at the time of review. Of the 583 eligible patients, 96% were male, the median age was 74 years, the median index colonoscopy year was 2016, and 178 (30.5%) had an average-risk CRC screening indication at the index colonoscopy (Table).

Of the 583 patients due for colonoscopy, 331 (56.7%) had both colonoscopy and pathology reports available. The majority of those with incomplete records had the index colonoscopy completed outside VAPHS. Among these patients, 222 (67.0%) had adequate bowel preparation. Of those with adequate bowel preparation, 43 were not eligible for interval extension because of high-risk conditions and 13 were not eligible because there was no index surveillance interval recommendation from the index endoscopist. Of the patients due for colonoscopy, 166 (28.4%) were potentially eligible for surveillance interval extension (Figure).  

Sixty-five (39.2%) of the 166 patients had 1 to 2 subcentimeter tubular adenomas on their index colonoscopy. Sixty-two patients were eligible for interval extension to 7 years, but this only resulted in ≥ 1 year of extension beyond the review date for 36 (6% of all 583 patients due for colonoscopy). The 36 patients were extended 63 years. By harmonizing the index endoscopists’ surveillance interval recommendation with the guideline at the time of the index colonoscopy, 29 additional patients could have their colonoscopy extended by ≥ 1 year. Harmonization extended colonoscopy intervals by 93 years. Retroactively applying the 2020 USMSTF polyp surveillance guidelines and harmonizing recommendations to guidelines extended the time of index colonoscopy by 153 years.

Discussion

With retroactive application of the 2020 USMSTF polyp surveillance guidelines, 6% of patients due for an upcoming colonoscopy could extend their follow-up by ≥ 1 year by extending the surveillance interval for 1 to 2 subcentimeter tubular adenomas to 7 years. An additional 5% of patients could extend their interval by harmonizing the index endoscopist’s interval recommendation with polyp surveillance guidelines at the time of the index colonoscopy. These findings are consistent with the results of 2 studies that demonstrated that about 14% of patients due for colonoscopy could have their interval extended.^6,7 The current study enhances those insights by separating the contribution of 2020 USMSTF polyp surveillance guidelines from the contribution of harmonizing surveillance intervals with guidelines for other polyp histologies. This study found that there is an opportunity to improve endoscopic capacity by harmonizing recommendations with guidelines. This complements a 2023 study showing that even when knowledgeable about guidelines, clinicians do not necessarily follow recommendations.⁸ While this and previous research have identified that 11% to 14% of patients are eligible for extension, these individuals would also have to be willing to have their polyp surveillance intervals extended for there to be a real-world impact on endoscopic capacity. A 2024 study found that only 19% to 37% of patients with 1 to 2 small tubular adenomas were willing to have polyps surveillance interval extension.⁹ This suggests the actual effect on capacity may be even lower than reported.

Limitations

The overall impact of the 2020 USMSTF polyp surveillance guidelines on endoscopic capacity was blunted by the high prevalence of incomplete index colonoscopy records among the study population. Without data on bowel preparation quality or procedure indications, this study could not assess whether 43% of patients were eligible for surveillance interval extension. Most index colonoscopies with incomplete documentation were completed at community-care gastroenterology facilities. This high rate of incomplete documentation is likely generalizable to other VA health care systems—especially in the era of the Veterans Access, Choice, and Accountability Act of 2014, which increased veteran access to non-VA community care.¹⁰ Veterans due for colon polyp surveillance colonoscopies are more likely to have had their prior colonoscopy in community care compared with prior eras.¹¹ Furthermore, because the VHA is among the most established integrated health care systems offering primary and subspecialty care in the US, private sector health care systems may have even greater rates of care fragmentation for longitudinal CRC screening and colon polyp surveillance, as these systems have only begun to regionally integrate recently.^12,13

Another limitation is that nearly one-third of the individuals with documentation had inadequate bowel preparation for surveillance recommendations. This results in shorter surveillance follow-up colonoscopies and increases downstream demand for future colonoscopies. The low yield of extending colon polyp surveillance interval in this study emphasizes that improved efforts to obtain colonoscopy and pathology reports from community care, right-sizing the colon polyp surveillance intervals recommended by endoscopists, and improving quality of bowel preparation could have downstream health care system benefits in the future. These efforts could increase colonoscopy capacity at VA health care systems, thereby shortening colonoscopy wait times, decreasing fragmentation of care, and increasing the number of veterans who receive high-quality colonoscopies at VA health care systems.¹⁴

Conclusions

Eleven percent of patients in this study due for a colonoscopy could extend their follow-up by ≥ 1 year. About half of these extensions were directly due to the 2020 USMSTF polyp surveillance interval extension for 1 to 2 subcentimeter tubular adenomas. The rest resulted from harmonizing recommendations with guidelines at the time of the procedure. To determine whether retroactively applying polyp surveillance guidelines to follow-up interval recommendations will result in improved endoscopic capacity, health care system administrators should consider the degree of CRC screening care fragmentation in their patient population. Greater long-term gains in endoscopic capacity may be achieved by proactively supporting endoscopists in making guideline-concordant screening recommendations at the time of colonoscopy.

In 2020, the US Multi-Society Task Force (USMSTF) on Colorectal Cancer (CRC) increased the recommended colon polyp surveillance interval for 1 to 2 subcentimeter tubular adenomas from 5 to 10 years to 7 to 10 years.¹ This change was prompted by emerging research indicating that rates of CRC and advanced neoplasia among patients with a history of only 1 to 2 subcentimeter tubular adenomas are lower than initially estimated.^2,3 This extension provides an opportunity to increase endoscopy capacity and improve access to colonoscopies by retroactively applying the 2020 guidelines to surveillance interval recommendations made before their introduction. For example, based on the updated guidelines, patients previously recommended to undergo colon polyp surveillance colonoscopy 5 years after an index colonoscopy could extend their surveillance interval by 2 to 5 years. Increasing endoscopic capacity could address the growing demand for colonoscopies from new screening guidelines that reduced the age of initial CRC screening from 50 years to 45 years and the backlog of procedures due to COVID-19 restrictions.⁴

As part of a project to increase endoscopic capacity at the US Department of Veterans Affairs (VA) Pittsburgh Healthcare System (VAPHS), this study assessed the potential impact of retroactively applying the 2020 USMSTF polyp surveillance guidelines on endoscopic capacity. These results may be informative for other VA and private-sector health care systems seeking to identify strategies to improve endoscopy capacity.

Methods

VAPHS is an integrated health care system in the Veterans Health Administration (VHA) serving 85,000 patients across 8 health care institutions in Pennsylvania, Ohio, and West Virginia. VAPHS manages colorectal screening recommendations for patients receiving medical care in the health care system regardless of whether their prior colonoscopy was performed at VAPHS or external facilities. The VA maintains a national CRC screening and surveillance electronic medical record reminder that prompts health care practitioners to order colon polyp surveillance based on interval recommendations from the index colonoscopy. This study reviewed all patients from the VAPHS panel with a reminder to undergo colonoscopy for screening for CRC or surveillance of colon polyps within 12 months from September 1, 2022.

Among patients with a reminder, 3 investigators reviewed index colonoscopy and pathology reports to identify CRC risk category, colonoscopy indication, procedural quality, and recommended repeat colonoscopy interval. Per the USMSTF guidelines, patients with incomplete colonoscopy or pathology records, high-risk indications (ie, personal history of inflammatory bowel disease, personal history of CRC, or family history of CRC), or inadequate bowel preparation (Boston Bowel Preparation Score < 6) were excluded. Additionally, patients who had CRC screening or surveillance discontinued due to age or comorbidities, had completed a subsequent follow-up colonoscopy, or were deceased at the time of review were excluded.

Retroactive Interval Reclassification

Among eligible patients, this study compared the repeat colonoscopy interval recommended by the prior endoscopist with those from the 2020 USMSTF guidelines. In cases where the interval was documented as a range of years, the lower end was considered the recommendation. Similarly, the lower end of the range from the 2020 USMSTF guidelines was used for the reclassified surveillance interval. Years extended per patient were quantified relative to September 1, 2023 (ie, 1 year after the review date). For example, if the index colonoscopy was completed on September 1, 2016, the initial surveillance recommendation was 5 years, and the reclassified recommendation was 7 years, the interval extension beyond September 1, 2023, was 0 years.

Furthermore, because index surveillance recommendations are not always guideline concordant, the years extended per patient were calculated by harmonizing the index endoscopist’s recommendations with the guidelines at the time of the index colonoscopy.⁵ For example, if the index colonoscopy was completed on September 1, 2018, and the endoscopist recommended a 5-year follow-up for a patient with average risk for CRC, adequate bowel preparation, and no colorectal polyps, that patient is eligible to extend their colonoscopy to September 1, 2028, based on guideline recommendations at the time of index endoscopy recommending that the next colonoscopy occur in 10 years. In this analysis the 2012 USMSTF guidelines were applied to all index colonoscopies completed in 2021 or earlier to allow time for adoption of the 2020 guidelines. 

This project fulfilled a facility mandate to increase capacity to conduct endoscopic procedures. Institutional review board approval was not required by VAPHS policy relating to clinical operations projects. Approval for publication of clinical operations activity was obtained from the VAPHS facility director.

Results

Within 1 year of the September 1, 2022, review date, 637 patients receiving care at VAPHS had clinical reminders for an upcoming colonoscopy. Of these, 54 (8.4%) were already up to date or were deceased at the time of review. Of the 583 eligible patients, 96% were male, the median age was 74 years, the median index colonoscopy year was 2016, and 178 (30.5%) had an average-risk CRC screening indication at the index colonoscopy (Table).

Of the 583 patients due for colonoscopy, 331 (56.7%) had both colonoscopy and pathology reports available. The majority of those with incomplete records had the index colonoscopy completed outside VAPHS. Among these patients, 222 (67.0%) had adequate bowel preparation. Of those with adequate bowel preparation, 43 were not eligible for interval extension because of high-risk conditions and 13 were not eligible because there was no index surveillance interval recommendation from the index endoscopist. Of the patients due for colonoscopy, 166 (28.4%) were potentially eligible for surveillance interval extension (Figure).  

Sixty-five (39.2%) of the 166 patients had 1 to 2 subcentimeter tubular adenomas on their index colonoscopy. Sixty-two patients were eligible for interval extension to 7 years, but this only resulted in ≥ 1 year of extension beyond the review date for 36 (6% of all 583 patients due for colonoscopy). The 36 patients were extended 63 years. By harmonizing the index endoscopists’ surveillance interval recommendation with the guideline at the time of the index colonoscopy, 29 additional patients could have their colonoscopy extended by ≥ 1 year. Harmonization extended colonoscopy intervals by 93 years. Retroactively applying the 2020 USMSTF polyp surveillance guidelines and harmonizing recommendations to guidelines extended the time of index colonoscopy by 153 years.

Discussion

With retroactive application of the 2020 USMSTF polyp surveillance guidelines, 6% of patients due for an upcoming colonoscopy could extend their follow-up by ≥ 1 year by extending the surveillance interval for 1 to 2 subcentimeter tubular adenomas to 7 years. An additional 5% of patients could extend their interval by harmonizing the index endoscopist’s interval recommendation with polyp surveillance guidelines at the time of the index colonoscopy. These findings are consistent with the results of 2 studies that demonstrated that about 14% of patients due for colonoscopy could have their interval extended.^6,7 The current study enhances those insights by separating the contribution of 2020 USMSTF polyp surveillance guidelines from the contribution of harmonizing surveillance intervals with guidelines for other polyp histologies. This study found that there is an opportunity to improve endoscopic capacity by harmonizing recommendations with guidelines. This complements a 2023 study showing that even when knowledgeable about guidelines, clinicians do not necessarily follow recommendations.⁸ While this and previous research have identified that 11% to 14% of patients are eligible for extension, these individuals would also have to be willing to have their polyp surveillance intervals extended for there to be a real-world impact on endoscopic capacity. A 2024 study found that only 19% to 37% of patients with 1 to 2 small tubular adenomas were willing to have polyps surveillance interval extension.⁹ This suggests the actual effect on capacity may be even lower than reported.

Limitations

The overall impact of the 2020 USMSTF polyp surveillance guidelines on endoscopic capacity was blunted by the high prevalence of incomplete index colonoscopy records among the study population. Without data on bowel preparation quality or procedure indications, this study could not assess whether 43% of patients were eligible for surveillance interval extension. Most index colonoscopies with incomplete documentation were completed at community-care gastroenterology facilities. This high rate of incomplete documentation is likely generalizable to other VA health care systems—especially in the era of the Veterans Access, Choice, and Accountability Act of 2014, which increased veteran access to non-VA community care.¹⁰ Veterans due for colon polyp surveillance colonoscopies are more likely to have had their prior colonoscopy in community care compared with prior eras.¹¹ Furthermore, because the VHA is among the most established integrated health care systems offering primary and subspecialty care in the US, private sector health care systems may have even greater rates of care fragmentation for longitudinal CRC screening and colon polyp surveillance, as these systems have only begun to regionally integrate recently.^12,13

Another limitation is that nearly one-third of the individuals with documentation had inadequate bowel preparation for surveillance recommendations. This results in shorter surveillance follow-up colonoscopies and increases downstream demand for future colonoscopies. The low yield of extending colon polyp surveillance interval in this study emphasizes that improved efforts to obtain colonoscopy and pathology reports from community care, right-sizing the colon polyp surveillance intervals recommended by endoscopists, and improving quality of bowel preparation could have downstream health care system benefits in the future. These efforts could increase colonoscopy capacity at VA health care systems, thereby shortening colonoscopy wait times, decreasing fragmentation of care, and increasing the number of veterans who receive high-quality colonoscopies at VA health care systems.¹⁴

Conclusions

Eleven percent of patients in this study due for a colonoscopy could extend their follow-up by ≥ 1 year. About half of these extensions were directly due to the 2020 USMSTF polyp surveillance interval extension for 1 to 2 subcentimeter tubular adenomas. The rest resulted from harmonizing recommendations with guidelines at the time of the procedure. To determine whether retroactively applying polyp surveillance guidelines to follow-up interval recommendations will result in improved endoscopic capacity, health care system administrators should consider the degree of CRC screening care fragmentation in their patient population. Greater long-term gains in endoscopic capacity may be achieved by proactively supporting endoscopists in making guideline-concordant screening recommendations at the time of colonoscopy.

The ongoing US government partial shutdown has unintended consequences for seniors and their doctors as most telehealth appointments are now no longer being covered by Medicare.

That's because without a budget deal, federal lawmakers did not renew some pandemic-era telehealth flexibilities allowing Medicare beneficiaries to have medical appointments with doctors over audio or video at home.

This policy was first put into place under the first Trump Administration in 2020 during the COVID-19 pandemic. Previously, Medicare covered very limited telehealth services for rural patients.

For the past 5 years, lawmakers have always managed to renew the telehealth flexibilities in every government funding bill before the expiration date. This year, however, they expired for the first time on October 1.

Federal lawmakers remain at odds on the 2026 federal funding bill, meaning the shutdown could last into more days and even weeks.

But with Congress in a standoff, clinicians and patients outside Washington, DC, are already grappling with the consequences of the funding impasse.

Clinicians, Patients Already Feeling Effects

For the South Dakota-based Sanford Health System, which is the largest rural health system in the country, the past week without the Medicare telehealth waivers being in place has caused a lot of anxiety and uncertainty for both patients and clinicians.

Dave Newman, an endocrinologist and chief medical officer of virtual care at Sanford, said the health system decided to keep providing Medicare telehealth appointments to patients for now.

"We're maintaining telehealth access because we know that's the best thing for our patients. We've got full confidence that reimbursement will follow, but patients can't wait for Congress to act at this point," Newman told Medscape Medical News. "They still need access to their specialists. They still need access to their primary care providers, and this is one of the only ways that a lot of our patients get access. For them, it's either virtual care or no care at all."

Newman said as the shutdown continues, Sanford may reconsidered whether it can keep providing these appointments without reimbursement.

Some health systems have stopped providing an Medicare telehealth appointments, said Alexis Apple, director of federal affairs at the American Telemedicine Association. That means patients must appear in person for their doctor's appointment or cancel.

NYU Langone Health system's website currently has a banner that reads: "Due to the federal government shutdown, Medicare and Medicaid patients are unable to schedule new telehealth/video visits. If you already have a visit scheduled, it will continue as planned. If not, contact your doctor's office to schedule an in-person appointment.

"It's creating lots of confusion in the industry from patients, providers, hospital systems. You know, what do we do next? How do we grapple with this shutdown?" said Apple. "Patients have been able to receive care within their homes over the past 5 years, and now, all of a sudden, they've been stripped of that access."

Medicare patients who continue telehealth after October 1 may find out they're on the hook for the bill, if Congress doesn't act, said Apple.

Some physicians worry that commercial insurance payers may follow suit and no longer cover virtual appointments. Medicare, which is the largest health care payer in the country, is often seen as the standard for what services should be covered.

Patients and doctors have come to rely on telehealth as an integral part of health care, said Richard Chou, an anesthesiologist at the US Department of Veterans Affairs (VA) in Sacramento, California.

"You're seeing that postpandemic, telehealth is kind of a new way of doing things. It's part of the day for us as doctors," said Chou. He said tha tmany of his VA patients do their preliminary surgery appointments via telehealth before coming into the facility.

"Telehealth is that bridge to making sure patients get the care they need, and when these patients don't get that preliminary care they need, this builds up and builds up," said Chou. "And next thing you know, you have people flooding the emergency rooms, and we can't have that."

Will Telehealth Reimbursement See a Permanent Fix?

With Congressional budget negotiations at an impasse, it remains unclear when the shutdown will end.

Health care spending disagreements weigh heavily in negotiations. Democrats are currently unwilling to give the votes to pass the 60-vote threshold in the Senate unless Republicans agree to extend Affordable Care Act subsidies that expire at the end of the year. Democrats also want to reverse the Medicaid cuts that were part of the large Republican domestic tax and spending bill passed by Congress earlier this year.

When lawmakers do reach an agreement and reopen the government, it's likely telehealth flexibilities will be included in any package but for how long remains in question.

A newly introduced bipartisan bill would permanently allow Medicare patients to access telehealth appointments in their homes. But the legislation has been estimated to be very costly.

Federal data does show that telehealth appointments have been popular with Medicare recipients and increased over time since telehealth became more accessible.

"I used to say that virtual care was the future of medicine, and now it's just kind of the present of medicine. It used to be like a cool technology that we used to advertise, now it's just the standard of care," said Newman. "We think that permanent coverage would mean stability for both patients and providers."

Victoria Knight is a freelance reporter based in Washington, DC.

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

The ongoing US government partial shutdown has unintended consequences for seniors and their doctors as most telehealth appointments are now no longer being covered by Medicare.

That's because without a budget deal, federal lawmakers did not renew some pandemic-era telehealth flexibilities allowing Medicare beneficiaries to have medical appointments with doctors over audio or video at home.

This policy was first put into place under the first Trump Administration in 2020 during the COVID-19 pandemic. Previously, Medicare covered very limited telehealth services for rural patients.

For the past 5 years, lawmakers have always managed to renew the telehealth flexibilities in every government funding bill before the expiration date. This year, however, they expired for the first time on October 1.

Federal lawmakers remain at odds on the 2026 federal funding bill, meaning the shutdown could last into more days and even weeks.

But with Congress in a standoff, clinicians and patients outside Washington, DC, are already grappling with the consequences of the funding impasse.

Clinicians, Patients Already Feeling Effects

For the South Dakota-based Sanford Health System, which is the largest rural health system in the country, the past week without the Medicare telehealth waivers being in place has caused a lot of anxiety and uncertainty for both patients and clinicians.

Dave Newman, an endocrinologist and chief medical officer of virtual care at Sanford, said the health system decided to keep providing Medicare telehealth appointments to patients for now.

"We're maintaining telehealth access because we know that's the best thing for our patients. We've got full confidence that reimbursement will follow, but patients can't wait for Congress to act at this point," Newman told Medscape Medical News. "They still need access to their specialists. They still need access to their primary care providers, and this is one of the only ways that a lot of our patients get access. For them, it's either virtual care or no care at all."

Newman said as the shutdown continues, Sanford may reconsidered whether it can keep providing these appointments without reimbursement.

Some health systems have stopped providing an Medicare telehealth appointments, said Alexis Apple, director of federal affairs at the American Telemedicine Association. That means patients must appear in person for their doctor's appointment or cancel.

NYU Langone Health system's website currently has a banner that reads: "Due to the federal government shutdown, Medicare and Medicaid patients are unable to schedule new telehealth/video visits. If you already have a visit scheduled, it will continue as planned. If not, contact your doctor's office to schedule an in-person appointment.

"It's creating lots of confusion in the industry from patients, providers, hospital systems. You know, what do we do next? How do we grapple with this shutdown?" said Apple. "Patients have been able to receive care within their homes over the past 5 years, and now, all of a sudden, they've been stripped of that access."

Medicare patients who continue telehealth after October 1 may find out they're on the hook for the bill, if Congress doesn't act, said Apple.

Some physicians worry that commercial insurance payers may follow suit and no longer cover virtual appointments. Medicare, which is the largest health care payer in the country, is often seen as the standard for what services should be covered.

Patients and doctors have come to rely on telehealth as an integral part of health care, said Richard Chou, an anesthesiologist at the US Department of Veterans Affairs (VA) in Sacramento, California.

"You're seeing that postpandemic, telehealth is kind of a new way of doing things. It's part of the day for us as doctors," said Chou. He said tha tmany of his VA patients do their preliminary surgery appointments via telehealth before coming into the facility.

"Telehealth is that bridge to making sure patients get the care they need, and when these patients don't get that preliminary care they need, this builds up and builds up," said Chou. "And next thing you know, you have people flooding the emergency rooms, and we can't have that."

Will Telehealth Reimbursement See a Permanent Fix?

With Congressional budget negotiations at an impasse, it remains unclear when the shutdown will end.

Health care spending disagreements weigh heavily in negotiations. Democrats are currently unwilling to give the votes to pass the 60-vote threshold in the Senate unless Republicans agree to extend Affordable Care Act subsidies that expire at the end of the year. Democrats also want to reverse the Medicaid cuts that were part of the large Republican domestic tax and spending bill passed by Congress earlier this year.

When lawmakers do reach an agreement and reopen the government, it's likely telehealth flexibilities will be included in any package but for how long remains in question.

A newly introduced bipartisan bill would permanently allow Medicare patients to access telehealth appointments in their homes. But the legislation has been estimated to be very costly.

Federal data does show that telehealth appointments have been popular with Medicare recipients and increased over time since telehealth became more accessible.

"I used to say that virtual care was the future of medicine, and now it's just kind of the present of medicine. It used to be like a cool technology that we used to advertise, now it's just the standard of care," said Newman. "We think that permanent coverage would mean stability for both patients and providers."

Victoria Knight is a freelance reporter based in Washington, DC.

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

The ongoing US government partial shutdown has unintended consequences for seniors and their doctors as most telehealth appointments are now no longer being covered by Medicare.

That's because without a budget deal, federal lawmakers did not renew some pandemic-era telehealth flexibilities allowing Medicare beneficiaries to have medical appointments with doctors over audio or video at home.

This policy was first put into place under the first Trump Administration in 2020 during the COVID-19 pandemic. Previously, Medicare covered very limited telehealth services for rural patients.

For the past 5 years, lawmakers have always managed to renew the telehealth flexibilities in every government funding bill before the expiration date. This year, however, they expired for the first time on October 1.

Federal lawmakers remain at odds on the 2026 federal funding bill, meaning the shutdown could last into more days and even weeks.

But with Congress in a standoff, clinicians and patients outside Washington, DC, are already grappling with the consequences of the funding impasse.

Clinicians, Patients Already Feeling Effects

For the South Dakota-based Sanford Health System, which is the largest rural health system in the country, the past week without the Medicare telehealth waivers being in place has caused a lot of anxiety and uncertainty for both patients and clinicians.

Dave Newman, an endocrinologist and chief medical officer of virtual care at Sanford, said the health system decided to keep providing Medicare telehealth appointments to patients for now.

"We're maintaining telehealth access because we know that's the best thing for our patients. We've got full confidence that reimbursement will follow, but patients can't wait for Congress to act at this point," Newman told Medscape Medical News. "They still need access to their specialists. They still need access to their primary care providers, and this is one of the only ways that a lot of our patients get access. For them, it's either virtual care or no care at all."

Newman said as the shutdown continues, Sanford may reconsidered whether it can keep providing these appointments without reimbursement.

Some health systems have stopped providing an Medicare telehealth appointments, said Alexis Apple, director of federal affairs at the American Telemedicine Association. That means patients must appear in person for their doctor's appointment or cancel.

NYU Langone Health system's website currently has a banner that reads: "Due to the federal government shutdown, Medicare and Medicaid patients are unable to schedule new telehealth/video visits. If you already have a visit scheduled, it will continue as planned. If not, contact your doctor's office to schedule an in-person appointment.

"It's creating lots of confusion in the industry from patients, providers, hospital systems. You know, what do we do next? How do we grapple with this shutdown?" said Apple. "Patients have been able to receive care within their homes over the past 5 years, and now, all of a sudden, they've been stripped of that access."

Medicare patients who continue telehealth after October 1 may find out they're on the hook for the bill, if Congress doesn't act, said Apple.

Some physicians worry that commercial insurance payers may follow suit and no longer cover virtual appointments. Medicare, which is the largest health care payer in the country, is often seen as the standard for what services should be covered.

Patients and doctors have come to rely on telehealth as an integral part of health care, said Richard Chou, an anesthesiologist at the US Department of Veterans Affairs (VA) in Sacramento, California.

"You're seeing that postpandemic, telehealth is kind of a new way of doing things. It's part of the day for us as doctors," said Chou. He said tha tmany of his VA patients do their preliminary surgery appointments via telehealth before coming into the facility.

"Telehealth is that bridge to making sure patients get the care they need, and when these patients don't get that preliminary care they need, this builds up and builds up," said Chou. "And next thing you know, you have people flooding the emergency rooms, and we can't have that."

Will Telehealth Reimbursement See a Permanent Fix?

With Congressional budget negotiations at an impasse, it remains unclear when the shutdown will end.

Health care spending disagreements weigh heavily in negotiations. Democrats are currently unwilling to give the votes to pass the 60-vote threshold in the Senate unless Republicans agree to extend Affordable Care Act subsidies that expire at the end of the year. Democrats also want to reverse the Medicaid cuts that were part of the large Republican domestic tax and spending bill passed by Congress earlier this year.

When lawmakers do reach an agreement and reopen the government, it's likely telehealth flexibilities will be included in any package but for how long remains in question.

A newly introduced bipartisan bill would permanently allow Medicare patients to access telehealth appointments in their homes. But the legislation has been estimated to be very costly.

Federal data does show that telehealth appointments have been popular with Medicare recipients and increased over time since telehealth became more accessible.

"I used to say that virtual care was the future of medicine, and now it's just kind of the present of medicine. It used to be like a cool technology that we used to advertise, now it's just the standard of care," said Newman. "We think that permanent coverage would mean stability for both patients and providers."

Victoria Knight is a freelance reporter based in Washington, DC.

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

The introduction of extended reality (XR) to the operating room (OR) has proved promising for enhancing surgical precision and improving patient outcomes. In the field of orthopedic surgery, precise alignment of implants is integral to maintaining functional range of motion and preventing impingement of adjacent neurovascular structures. XR systems have shown promise in arthroplasty including by improving precision and streamlining surgery by allowing surgeons to create 3D preoperative plans that are accessible intraoperatively. This article explores the current applications of XR in arthroplasty, highlights recent advancements and benefits, and describes limitations in comparison to traditional techniques.

Methods

A literature search identified studies involving the use of XR in arthroplasty and current US Food and Drug Administration (FDA)-approved XR systems. Multiple electronic databases were used, including PubMed, Google Scholar, and IEEE Xplore. Search terms included: extended reality, augmented reality, virtual reality, arthroplasty, joint replacement, total knee arthroplasty, total shoulder arthroplasty, and total hip arthroplasty. The study design, intervention details, outcomes, and comparisons with traditional surgical techniques were thematically analyzed, with identification of common ideas associated with XR use in arthroplasty. This narrative report highlights the integration of XR in arthroplasty.

Extended Reality Fundamentals

XR encompasses augmented reality (AR), virtual reality (VR), and mixed reality (MR). AR involves superimposing digitally rendered information and images onto the surgeon’s view of the real world, typically through the use of a headset and smart glasses.¹ AR allows the surgeon to move and interact freely within the OR, removing the need for additional screens or devices to display patient information or imaging. VR is a fully immersive simulation using a headset that obstructs the view of the real world but allows the user to move freely within this virtual setting, often with audio or other sensory stimuli. MR combines AR and VR to create a digital model that allows for real-world interaction, with the advantage of adapting information and models in real time.² Whereas in AR the surgeon can view the data projected from the headset, MR provides the ability to interact with and manipulate the digital content (Figure). Both AR and MR have been adapted for use in the OR, while VR has been adapted for use in surgical planning and training.

Extended Reality Use in Orthopedics

The HipNav system was introduced in 1995 to create preoperative plans that assist surgeons in accurately implanting the acetabular cup during total hip arthroplasty (THA).³ Although not commercially successful, this system spurred surgeons to experiment with XR to improve the accuracy and alignment of orthopedic implants. Systems capable of displaying the desired intraoperative implant placement have flourished, with applications in fracture reduction, arthroplasty, solid tumor resection, and hardware placement.^4-7 Accurate alignment has been linked to improvements in patient outcomes.^8-10 XR has great potential within the field of arthroplasty, with multiple new systems approved by the FDA and currently available in the US (Table).

Hip Arthroplasty

Orientation of the acetabular cup is a technically challenging part of THA. Accuracy in the anteversion and inclination angles of the acetabular cup is required to maintain implant stability, preserve functional range of motion (ROM), and prevent precocious wear.^11,12 Despite preoperative planning, surgeons often overestimate the inclination angle and underestimate anteversion.¹³ Improper implantation of the acetabular cup can lead to joint instability caused by aseptic loosening, increasing the risk of dislocation and the need for revision surgery.^14,15 Dislocations typically present to the emergency department, but primary care practitioners may encounter patients with pain or diminished sensation due to impingement or instability.¹⁶

The introduction of XR into the OR has provided the opportunity for real-time navigation and adjustment of the acetabular cup to maximize anteversion and inclination angles. Currently, 2 FDA-approved systems are available for THA: the Zimmer and Surgical Planning Associates HipInsight system, and the Insight Augmented Reality Visualization and Information System (ARVIS). The HipInsight system consists of a hologram projection using the Microsoft HoloLens2 device and optimizes preoperative planning, producing accuracy of anteversion and inclination angles within 3°.¹⁷ ARVIS employs existing surgical helmets and 2 mounted tracking cameras to provide navigation intraoperatively. ARVIS has also been approved for use in total knee arthroplasty (TKA) and unicompartmental knee arthroplasty.¹⁸

HipInsight has shown utility in increasing the accuracy of acetabular cup placement along with the use of biplanar radiographic scans.¹⁹ However, there are no studies validating the efficacy of ARVIS and HipInsight and assessing long-term disease-oriented or patient-oriented outcomes.

Knee Arthroplasty

In the setting of TKA, XR is most effective in ensuring accurate resection of the tibial and femoral components. Achieving the planned femoral coronal, axial, and sagittal angles allows the prosthesis to be on the femoral axis of rotation, improving functional outcomes. XR systems for TKA have been shown to increase the accuracy of distal femoral resection with a limited increase in surgery duration.^20,21 For TKA in particular, patients are often less satisfied with the result than surgeons expect.²² Accurate alignment can improve patient satisfaction and reduce return-to-clinic rates for postoperative pain management, a factor that primary care practitioners should consider when recommending a patient for TKA.²³

Along with ARVIS, 3 additional XR systems are FDA-approved for use in TKA. The Pixee Medical Knee+ system uses smart glasses and trackers to aid in the positioning of instruments for improved accuracy while allowing real-time navigation.²⁴ The Medacta NextAR Knee’s single-use tracking system allows for intraoperative navigation with the use of AR glasses.²⁵ The Polaris STELLAR Knee uses MR and avoids the need for preoperative imaging by capturing real-time anatomic data.²⁶

The Pixee Medical Knee+ system was commercially available in Europe for several years prior to FDA approval, so more research exists on its efficacy. One study found that the Pixee Medical Knee+ system initially demonstrated an inferior clinical outcome, attributed to the learning curve associated with using the system.²⁷ However, more recent studies have shown its utility in improving alignment, regardless of implant specifications.^28,29 The Medacta NextAR Knee system has been shown to improve accuracy of tibial rotation and soft tissue balance and even increase OR efficiency.^30,31 The Polaris STELLAR Knee system received FDA approval in 2023; no published research exists on its accuracy and outcomes.²⁶

Shoulder Arthroplasty

Minimally invasive techniques are favored in total shoulder arthroplasty (TSA) due to the vitality of maintaining the surrounding soft tissue to maximize preservation of motility and strength.³² However, this complicates the procedure by decreasing the ability to effectively access and visualize key structures of the shoulder. Accordingly, issues with implant positioning and alignment are more common with TSA than other joint arthroplasties, making XR particularly promising.³³ Some studies report that up to 67% of patients experience glenohumeral instability, which can clinically present as weakness, decreased range of motion, and persistent shoulder pain.^34,35 The use of preoperative computed tomography to improve understanding of glenoid anatomy and glenohumeral subluxation is becoming increasingly common, and it can be combined with XR to improve accuracy.^36,37

Two FDA-approved systems are available. The Stryker Blueprint MR system is used for intraoperative guidance and integration for patient imaging used for preoperative planning. The Medacta NextAR Shoulder system is a parallel of the company’s TKA system. The Stryker Blueprint MR system combines the Microsoft HoloLens 2 headset to display preoperative plans with a secondary display for coordination with the rest of the surgical team.³⁸ Similar to the Medacta NextAR Knee, the Medacta NextAR Shoulder system uses the same single-use tracking system and AR glasses for intraoperative guidance.³⁹

Data on the long-term outcomes of using these systems are still limited, but the Stryker Blueprint MR system has not been shown to accurately predict postoperative ROM.⁴⁰ Cadaveric studies have demonstrated that the Medacta NextAR Shoulder system can provide accurate inclination, retroversion, entry point, depth, and rotation values based on the preoperative planned values.^41,42 However, this accuracy has yet to be confirmed in vivo, and the impact of using XR in TSA on long-term outcomes is still unknown.

Challenges and Limitations

Though XR has proven to be promising in arthroplasty, several limitations regarding widespread implementation exist. In particular, there is a steep learning curve associated with the use of XR systems, which can cause increased operative time and even initial inferior outcomes, as demonstrated with the Pixee Medical Knee+ system. The need for extensive practice and training prior to use could delay widespread adoption and may cause discrepancies in surgical outcomes. Unfamiliarity with the system and technological difficulties that may require troubleshooting can also increase operative time, particularly for surgeons new to using the XR system. Though intraoperative navigation is expected to improve accuracy of implant alignment, its added complexity may also result in longer surgeries.

In addition to the steep learning curve and increased operative time, there is a high upfront cost associated with XR systems. Exact costs of XR systems are not typically disclosed, but available estimates suggest an average sales price of about $1000 per case. Given the proprietary nature of these technologies, publicly available cost data are limited, making it challenging to fully assess the financial burden on health care institutions. Though some systems, such as ARVIS, can be integrated with existing surgical helmets, many require the purchase of AR glasses and secondary displays. This can cause further variation in the total expense for each system. In low-resource settings, this represents a significant challenge to widespread implementation. To justify this cost, additional research on long-term patient outcomes is needed to ensure the benefits of XR systems outweigh the cost. 

Although early studies on XR systems in arthroplasty have shown improvements in precision and short-term outcomes, long-term data regarding effectiveness remains. Even systems such as ARVIS and HipInsight have limited long-term follow-up, making it difficult to assess whether the improved accuracy with these XR systems translates into improved patient outcomes compared with traditional arthroplasty.

CONCLUSIONS

XR technologies have shown significant potential in enhancing precision and patient outcomes. Through the integration of XR in the OR, surgeons can visualize preoperative plans and even make intraoperative changes, with the benefit of improving implant alignment.

There are some disadvantages to its use, however, including high cost and increased operative time. Despite this, the integration of XR into surgical practice can deliver more precise implant alignment and address other challenges faced with conventional techniques. As these technologies evolve and studies on long-term outcomes validate their utility, XR has the potential to transform the field of arthroplasty.

The introduction of extended reality (XR) to the operating room (OR) has proved promising for enhancing surgical precision and improving patient outcomes. In the field of orthopedic surgery, precise alignment of implants is integral to maintaining functional range of motion and preventing impingement of adjacent neurovascular structures. XR systems have shown promise in arthroplasty including by improving precision and streamlining surgery by allowing surgeons to create 3D preoperative plans that are accessible intraoperatively. This article explores the current applications of XR in arthroplasty, highlights recent advancements and benefits, and describes limitations in comparison to traditional techniques.

Methods

A literature search identified studies involving the use of XR in arthroplasty and current US Food and Drug Administration (FDA)-approved XR systems. Multiple electronic databases were used, including PubMed, Google Scholar, and IEEE Xplore. Search terms included: extended reality, augmented reality, virtual reality, arthroplasty, joint replacement, total knee arthroplasty, total shoulder arthroplasty, and total hip arthroplasty. The study design, intervention details, outcomes, and comparisons with traditional surgical techniques were thematically analyzed, with identification of common ideas associated with XR use in arthroplasty. This narrative report highlights the integration of XR in arthroplasty.

Extended Reality Fundamentals

XR encompasses augmented reality (AR), virtual reality (VR), and mixed reality (MR). AR involves superimposing digitally rendered information and images onto the surgeon’s view of the real world, typically through the use of a headset and smart glasses.¹ AR allows the surgeon to move and interact freely within the OR, removing the need for additional screens or devices to display patient information or imaging. VR is a fully immersive simulation using a headset that obstructs the view of the real world but allows the user to move freely within this virtual setting, often with audio or other sensory stimuli. MR combines AR and VR to create a digital model that allows for real-world interaction, with the advantage of adapting information and models in real time.² Whereas in AR the surgeon can view the data projected from the headset, MR provides the ability to interact with and manipulate the digital content (Figure). Both AR and MR have been adapted for use in the OR, while VR has been adapted for use in surgical planning and training.

Extended Reality Use in Orthopedics

The HipNav system was introduced in 1995 to create preoperative plans that assist surgeons in accurately implanting the acetabular cup during total hip arthroplasty (THA).³ Although not commercially successful, this system spurred surgeons to experiment with XR to improve the accuracy and alignment of orthopedic implants. Systems capable of displaying the desired intraoperative implant placement have flourished, with applications in fracture reduction, arthroplasty, solid tumor resection, and hardware placement.^4-7 Accurate alignment has been linked to improvements in patient outcomes.^8-10 XR has great potential within the field of arthroplasty, with multiple new systems approved by the FDA and currently available in the US (Table).

Hip Arthroplasty

Orientation of the acetabular cup is a technically challenging part of THA. Accuracy in the anteversion and inclination angles of the acetabular cup is required to maintain implant stability, preserve functional range of motion (ROM), and prevent precocious wear.^11,12 Despite preoperative planning, surgeons often overestimate the inclination angle and underestimate anteversion.¹³ Improper implantation of the acetabular cup can lead to joint instability caused by aseptic loosening, increasing the risk of dislocation and the need for revision surgery.^14,15 Dislocations typically present to the emergency department, but primary care practitioners may encounter patients with pain or diminished sensation due to impingement or instability.¹⁶

The introduction of XR into the OR has provided the opportunity for real-time navigation and adjustment of the acetabular cup to maximize anteversion and inclination angles. Currently, 2 FDA-approved systems are available for THA: the Zimmer and Surgical Planning Associates HipInsight system, and the Insight Augmented Reality Visualization and Information System (ARVIS). The HipInsight system consists of a hologram projection using the Microsoft HoloLens2 device and optimizes preoperative planning, producing accuracy of anteversion and inclination angles within 3°.¹⁷ ARVIS employs existing surgical helmets and 2 mounted tracking cameras to provide navigation intraoperatively. ARVIS has also been approved for use in total knee arthroplasty (TKA) and unicompartmental knee arthroplasty.¹⁸

HipInsight has shown utility in increasing the accuracy of acetabular cup placement along with the use of biplanar radiographic scans.¹⁹ However, there are no studies validating the efficacy of ARVIS and HipInsight and assessing long-term disease-oriented or patient-oriented outcomes.

Knee Arthroplasty

In the setting of TKA, XR is most effective in ensuring accurate resection of the tibial and femoral components. Achieving the planned femoral coronal, axial, and sagittal angles allows the prosthesis to be on the femoral axis of rotation, improving functional outcomes. XR systems for TKA have been shown to increase the accuracy of distal femoral resection with a limited increase in surgery duration.^20,21 For TKA in particular, patients are often less satisfied with the result than surgeons expect.²² Accurate alignment can improve patient satisfaction and reduce return-to-clinic rates for postoperative pain management, a factor that primary care practitioners should consider when recommending a patient for TKA.²³

Along with ARVIS, 3 additional XR systems are FDA-approved for use in TKA. The Pixee Medical Knee+ system uses smart glasses and trackers to aid in the positioning of instruments for improved accuracy while allowing real-time navigation.²⁴ The Medacta NextAR Knee’s single-use tracking system allows for intraoperative navigation with the use of AR glasses.²⁵ The Polaris STELLAR Knee uses MR and avoids the need for preoperative imaging by capturing real-time anatomic data.²⁶

The Pixee Medical Knee+ system was commercially available in Europe for several years prior to FDA approval, so more research exists on its efficacy. One study found that the Pixee Medical Knee+ system initially demonstrated an inferior clinical outcome, attributed to the learning curve associated with using the system.²⁷ However, more recent studies have shown its utility in improving alignment, regardless of implant specifications.^28,29 The Medacta NextAR Knee system has been shown to improve accuracy of tibial rotation and soft tissue balance and even increase OR efficiency.^30,31 The Polaris STELLAR Knee system received FDA approval in 2023; no published research exists on its accuracy and outcomes.²⁶

Shoulder Arthroplasty

Minimally invasive techniques are favored in total shoulder arthroplasty (TSA) due to the vitality of maintaining the surrounding soft tissue to maximize preservation of motility and strength.³² However, this complicates the procedure by decreasing the ability to effectively access and visualize key structures of the shoulder. Accordingly, issues with implant positioning and alignment are more common with TSA than other joint arthroplasties, making XR particularly promising.³³ Some studies report that up to 67% of patients experience glenohumeral instability, which can clinically present as weakness, decreased range of motion, and persistent shoulder pain.^34,35 The use of preoperative computed tomography to improve understanding of glenoid anatomy and glenohumeral subluxation is becoming increasingly common, and it can be combined with XR to improve accuracy.^36,37

Two FDA-approved systems are available. The Stryker Blueprint MR system is used for intraoperative guidance and integration for patient imaging used for preoperative planning. The Medacta NextAR Shoulder system is a parallel of the company’s TKA system. The Stryker Blueprint MR system combines the Microsoft HoloLens 2 headset to display preoperative plans with a secondary display for coordination with the rest of the surgical team.³⁸ Similar to the Medacta NextAR Knee, the Medacta NextAR Shoulder system uses the same single-use tracking system and AR glasses for intraoperative guidance.³⁹

Data on the long-term outcomes of using these systems are still limited, but the Stryker Blueprint MR system has not been shown to accurately predict postoperative ROM.⁴⁰ Cadaveric studies have demonstrated that the Medacta NextAR Shoulder system can provide accurate inclination, retroversion, entry point, depth, and rotation values based on the preoperative planned values.^41,42 However, this accuracy has yet to be confirmed in vivo, and the impact of using XR in TSA on long-term outcomes is still unknown.

Challenges and Limitations

Though XR has proven to be promising in arthroplasty, several limitations regarding widespread implementation exist. In particular, there is a steep learning curve associated with the use of XR systems, which can cause increased operative time and even initial inferior outcomes, as demonstrated with the Pixee Medical Knee+ system. The need for extensive practice and training prior to use could delay widespread adoption and may cause discrepancies in surgical outcomes. Unfamiliarity with the system and technological difficulties that may require troubleshooting can also increase operative time, particularly for surgeons new to using the XR system. Though intraoperative navigation is expected to improve accuracy of implant alignment, its added complexity may also result in longer surgeries.

In addition to the steep learning curve and increased operative time, there is a high upfront cost associated with XR systems. Exact costs of XR systems are not typically disclosed, but available estimates suggest an average sales price of about $1000 per case. Given the proprietary nature of these technologies, publicly available cost data are limited, making it challenging to fully assess the financial burden on health care institutions. Though some systems, such as ARVIS, can be integrated with existing surgical helmets, many require the purchase of AR glasses and secondary displays. This can cause further variation in the total expense for each system. In low-resource settings, this represents a significant challenge to widespread implementation. To justify this cost, additional research on long-term patient outcomes is needed to ensure the benefits of XR systems outweigh the cost. 

Although early studies on XR systems in arthroplasty have shown improvements in precision and short-term outcomes, long-term data regarding effectiveness remains. Even systems such as ARVIS and HipInsight have limited long-term follow-up, making it difficult to assess whether the improved accuracy with these XR systems translates into improved patient outcomes compared with traditional arthroplasty.

CONCLUSIONS

XR technologies have shown significant potential in enhancing precision and patient outcomes. Through the integration of XR in the OR, surgeons can visualize preoperative plans and even make intraoperative changes, with the benefit of improving implant alignment.

There are some disadvantages to its use, however, including high cost and increased operative time. Despite this, the integration of XR into surgical practice can deliver more precise implant alignment and address other challenges faced with conventional techniques. As these technologies evolve and studies on long-term outcomes validate their utility, XR has the potential to transform the field of arthroplasty.

The introduction of extended reality (XR) to the operating room (OR) has proved promising for enhancing surgical precision and improving patient outcomes. In the field of orthopedic surgery, precise alignment of implants is integral to maintaining functional range of motion and preventing impingement of adjacent neurovascular structures. XR systems have shown promise in arthroplasty including by improving precision and streamlining surgery by allowing surgeons to create 3D preoperative plans that are accessible intraoperatively. This article explores the current applications of XR in arthroplasty, highlights recent advancements and benefits, and describes limitations in comparison to traditional techniques.

Methods

A literature search identified studies involving the use of XR in arthroplasty and current US Food and Drug Administration (FDA)-approved XR systems. Multiple electronic databases were used, including PubMed, Google Scholar, and IEEE Xplore. Search terms included: extended reality, augmented reality, virtual reality, arthroplasty, joint replacement, total knee arthroplasty, total shoulder arthroplasty, and total hip arthroplasty. The study design, intervention details, outcomes, and comparisons with traditional surgical techniques were thematically analyzed, with identification of common ideas associated with XR use in arthroplasty. This narrative report highlights the integration of XR in arthroplasty.

Extended Reality Fundamentals

XR encompasses augmented reality (AR), virtual reality (VR), and mixed reality (MR). AR involves superimposing digitally rendered information and images onto the surgeon’s view of the real world, typically through the use of a headset and smart glasses.¹ AR allows the surgeon to move and interact freely within the OR, removing the need for additional screens or devices to display patient information or imaging. VR is a fully immersive simulation using a headset that obstructs the view of the real world but allows the user to move freely within this virtual setting, often with audio or other sensory stimuli. MR combines AR and VR to create a digital model that allows for real-world interaction, with the advantage of adapting information and models in real time.² Whereas in AR the surgeon can view the data projected from the headset, MR provides the ability to interact with and manipulate the digital content (Figure). Both AR and MR have been adapted for use in the OR, while VR has been adapted for use in surgical planning and training.

Extended Reality Use in Orthopedics

The HipNav system was introduced in 1995 to create preoperative plans that assist surgeons in accurately implanting the acetabular cup during total hip arthroplasty (THA).³ Although not commercially successful, this system spurred surgeons to experiment with XR to improve the accuracy and alignment of orthopedic implants. Systems capable of displaying the desired intraoperative implant placement have flourished, with applications in fracture reduction, arthroplasty, solid tumor resection, and hardware placement.^4-7 Accurate alignment has been linked to improvements in patient outcomes.^8-10 XR has great potential within the field of arthroplasty, with multiple new systems approved by the FDA and currently available in the US (Table).

Hip Arthroplasty

Orientation of the acetabular cup is a technically challenging part of THA. Accuracy in the anteversion and inclination angles of the acetabular cup is required to maintain implant stability, preserve functional range of motion (ROM), and prevent precocious wear.^11,12 Despite preoperative planning, surgeons often overestimate the inclination angle and underestimate anteversion.¹³ Improper implantation of the acetabular cup can lead to joint instability caused by aseptic loosening, increasing the risk of dislocation and the need for revision surgery.^14,15 Dislocations typically present to the emergency department, but primary care practitioners may encounter patients with pain or diminished sensation due to impingement or instability.¹⁶

The introduction of XR into the OR has provided the opportunity for real-time navigation and adjustment of the acetabular cup to maximize anteversion and inclination angles. Currently, 2 FDA-approved systems are available for THA: the Zimmer and Surgical Planning Associates HipInsight system, and the Insight Augmented Reality Visualization and Information System (ARVIS). The HipInsight system consists of a hologram projection using the Microsoft HoloLens2 device and optimizes preoperative planning, producing accuracy of anteversion and inclination angles within 3°.¹⁷ ARVIS employs existing surgical helmets and 2 mounted tracking cameras to provide navigation intraoperatively. ARVIS has also been approved for use in total knee arthroplasty (TKA) and unicompartmental knee arthroplasty.¹⁸

HipInsight has shown utility in increasing the accuracy of acetabular cup placement along with the use of biplanar radiographic scans.¹⁹ However, there are no studies validating the efficacy of ARVIS and HipInsight and assessing long-term disease-oriented or patient-oriented outcomes.

Knee Arthroplasty

In the setting of TKA, XR is most effective in ensuring accurate resection of the tibial and femoral components. Achieving the planned femoral coronal, axial, and sagittal angles allows the prosthesis to be on the femoral axis of rotation, improving functional outcomes. XR systems for TKA have been shown to increase the accuracy of distal femoral resection with a limited increase in surgery duration.^20,21 For TKA in particular, patients are often less satisfied with the result than surgeons expect.²² Accurate alignment can improve patient satisfaction and reduce return-to-clinic rates for postoperative pain management, a factor that primary care practitioners should consider when recommending a patient for TKA.²³

Along with ARVIS, 3 additional XR systems are FDA-approved for use in TKA. The Pixee Medical Knee+ system uses smart glasses and trackers to aid in the positioning of instruments for improved accuracy while allowing real-time navigation.²⁴ The Medacta NextAR Knee’s single-use tracking system allows for intraoperative navigation with the use of AR glasses.²⁵ The Polaris STELLAR Knee uses MR and avoids the need for preoperative imaging by capturing real-time anatomic data.²⁶

The Pixee Medical Knee+ system was commercially available in Europe for several years prior to FDA approval, so more research exists on its efficacy. One study found that the Pixee Medical Knee+ system initially demonstrated an inferior clinical outcome, attributed to the learning curve associated with using the system.²⁷ However, more recent studies have shown its utility in improving alignment, regardless of implant specifications.^28,29 The Medacta NextAR Knee system has been shown to improve accuracy of tibial rotation and soft tissue balance and even increase OR efficiency.^30,31 The Polaris STELLAR Knee system received FDA approval in 2023; no published research exists on its accuracy and outcomes.²⁶

Shoulder Arthroplasty

Minimally invasive techniques are favored in total shoulder arthroplasty (TSA) due to the vitality of maintaining the surrounding soft tissue to maximize preservation of motility and strength.³² However, this complicates the procedure by decreasing the ability to effectively access and visualize key structures of the shoulder. Accordingly, issues with implant positioning and alignment are more common with TSA than other joint arthroplasties, making XR particularly promising.³³ Some studies report that up to 67% of patients experience glenohumeral instability, which can clinically present as weakness, decreased range of motion, and persistent shoulder pain.^34,35 The use of preoperative computed tomography to improve understanding of glenoid anatomy and glenohumeral subluxation is becoming increasingly common, and it can be combined with XR to improve accuracy.^36,37

Two FDA-approved systems are available. The Stryker Blueprint MR system is used for intraoperative guidance and integration for patient imaging used for preoperative planning. The Medacta NextAR Shoulder system is a parallel of the company’s TKA system. The Stryker Blueprint MR system combines the Microsoft HoloLens 2 headset to display preoperative plans with a secondary display for coordination with the rest of the surgical team.³⁸ Similar to the Medacta NextAR Knee, the Medacta NextAR Shoulder system uses the same single-use tracking system and AR glasses for intraoperative guidance.³⁹

Data on the long-term outcomes of using these systems are still limited, but the Stryker Blueprint MR system has not been shown to accurately predict postoperative ROM.⁴⁰ Cadaveric studies have demonstrated that the Medacta NextAR Shoulder system can provide accurate inclination, retroversion, entry point, depth, and rotation values based on the preoperative planned values.^41,42 However, this accuracy has yet to be confirmed in vivo, and the impact of using XR in TSA on long-term outcomes is still unknown.

Challenges and Limitations

Though XR has proven to be promising in arthroplasty, several limitations regarding widespread implementation exist. In particular, there is a steep learning curve associated with the use of XR systems, which can cause increased operative time and even initial inferior outcomes, as demonstrated with the Pixee Medical Knee+ system. The need for extensive practice and training prior to use could delay widespread adoption and may cause discrepancies in surgical outcomes. Unfamiliarity with the system and technological difficulties that may require troubleshooting can also increase operative time, particularly for surgeons new to using the XR system. Though intraoperative navigation is expected to improve accuracy of implant alignment, its added complexity may also result in longer surgeries.

In addition to the steep learning curve and increased operative time, there is a high upfront cost associated with XR systems. Exact costs of XR systems are not typically disclosed, but available estimates suggest an average sales price of about $1000 per case. Given the proprietary nature of these technologies, publicly available cost data are limited, making it challenging to fully assess the financial burden on health care institutions. Though some systems, such as ARVIS, can be integrated with existing surgical helmets, many require the purchase of AR glasses and secondary displays. This can cause further variation in the total expense for each system. In low-resource settings, this represents a significant challenge to widespread implementation. To justify this cost, additional research on long-term patient outcomes is needed to ensure the benefits of XR systems outweigh the cost. 

Although early studies on XR systems in arthroplasty have shown improvements in precision and short-term outcomes, long-term data regarding effectiveness remains. Even systems such as ARVIS and HipInsight have limited long-term follow-up, making it difficult to assess whether the improved accuracy with these XR systems translates into improved patient outcomes compared with traditional arthroplasty.

CONCLUSIONS

XR technologies have shown significant potential in enhancing precision and patient outcomes. Through the integration of XR in the OR, surgeons can visualize preoperative plans and even make intraoperative changes, with the benefit of improving implant alignment.

There are some disadvantages to its use, however, including high cost and increased operative time. Despite this, the integration of XR into surgical practice can deliver more precise implant alignment and address other challenges faced with conventional techniques. As these technologies evolve and studies on long-term outcomes validate their utility, XR has the potential to transform the field of arthroplasty.

BERLIN — Pairing a screening or surveillance colonoscopy with a same-day esophagogastroduodenoscopy (EGD) proved feasible and yielded clinically relevant upper gastrointestinal (GI) findings, including malignancies and lesions requiring ongoing surveillance, according to an interim analysis from the TOGAS study.

“There was an abundance of benign but clinically relevant findings,” said lead investigator Jan Bornschein, MD, gastroenterologist at Oxford University Hospitals NHS Foundation Trust, Oxford, England, who presented the interim resuts of the study at United European Gastroenterology (UEG) Week 2025.

While the study found upper GI neoplasia in only 1.4% of participants, 17.8% of individuals were marked for upper GI endoscopic surveillance.

The results may inform how Europe develops gastric cancer prevention programs alongside those for colorectal cancer, said Bornschein. “If we can combine the upper GI endoscopy with other modalities [colonoscopy], the more likelihood there is that you can have a one-stop test package,” he said. “A combination, particularly for bowel and stomach, is more feasible and also more cost-effective. So far, the findings show that it’s definitely a strategy that, in my opinion, is worth implementing.”

Bornschein and the TOGAS study group hope that the combined approach will prove workable across diverse European settings and will help identify a spectrum of upper GI pathology, from cancers and dysplasia to atrophy and intestinal metaplasia, that can meaningfully affect follow-up surveillance.

 

Mixed Rates of GI Cancers Across Europe and the US

These findings come amid data showing rising rates of early-onset (younger than 50 years) GI cancers in the US, including colorectal, gastric, pancreatic, and esophageal tumors. These trends, previously reported by this news organization, point to environmental and lifestyle drivers, strengthening the case for earlier detection and risk-tailored strategies for upper GI neoplasia and preneoplastic conditions detected during existing colorectal cancer screening pathways.

However, Bornschein noted that prevalence varies considerably across Europe. “There are areas, particularly in the Eastern regions, and in some parts of the West, for example, Portugal, that have a very high incidence of GI cancers. In the UK or in Germany, we have noticed a decline over the years, so the numbers are actually much better than they used to be.”

The study is the second in a series of three TOGAS pilot studies and was conducted across eight centers (France, Germany, Ireland, Latvia, Lithuania, the Netherlands, Portugal, and Spain) in adults aged 50-74 years attending screening or polyp-surveillance colonoscopy. 

A European Society of Gastrointestinal Endoscopy-aligned protocol defining image documentation, biopsy sampling, and quality parameters was followed to ensure a standardized approach. “Marked preneoplastic change” was defined as gastric glandular atrophy or intestinal metaplasia at the Operative Link on Gastritis Assessment/Operative Link on Gastric Intestinal Metaplasia Assessment stage III-IV and/or Endoscopic Grading of Gastric Intestinal Metaplasia > 5, triggering a need for endoscopic surveillance.

Data were gathered on colonoscopy findings (including polyp surveillance and family history), EGD findings plus biopsies, serum pepsinogen, and Helicobacter pylori serology. Outcome measures included the prevalence of gastric cancer and preneoplastic conditions, the diagnostic accuracy of pepsinogen testing, comparisons between national settings, the relevance of upper endoscopy in fecal immunochemical test-positive cases, and overall H pylori prevalence.

 

Neoplasia and Preneoplasia Found

A total of 846 participants were analyzed. At baseline, the mean age was 62 years, 52.2% were men, and 84.2% were White, despite efforts to recruit a more diverse population. Around 390 participants drank alcohol, and 190 smoked tobacco.

A total of 37.8% of participants had undergone prior EGD, of which 94.7% were performed more than 3 years before the study start. The history of GI surgery was 13.7%, and the history of cancer was 14.5%. Around 11% took aspirin, and 14% took proton pump inhibitors (PPIs). “We were surprised at the low prevalence of PPI use,” remarked Bornschein. “It was also good news that around half were never smokers.”

Key results for upper GI neoplasia included six patients (0.7%) with gastric cancers, three (0.4%) with esophageal cancers, and five (0.6%) with duodenal tumors. H pylori positivity was found in 303 patients (35.8%), with an additional 81 (9.6%) reporting a history of eradication.

Colorectal findings included 15 patients (1.8%) with cancers and colon polyps in 503 (59.5%) participants.

Regarding preneoplastic conditions, endoscopy identified intestinal metaplasia in 174 patients (20.6%), of which 65 (7.7%) were multifocal. Atrophy was observed in 220 patients (26.0%), with 59 (7.0%) showing multifocal atrophic changes. Both intestinal metaplasia and atrophy were found together in 105 (12.4%) patients. Barrett’s esophagus was detected in 31 (3.7%) patients.

“I’d really like to highlight these further benign gastric findings,” said Bornschein. These included gastric ulcers in 28 (3.3%) patients, erosive gastritis in 245 (29.0%) patients, esophageal ulcers in three (0.4%) patients, Los Angeles Community College District classification esophagitis in 13 (1.5%) patients, and duodenal ulcers in 10 (1.2%) patients. “These were asymptomatic, but we were able to identify them,” he noted.

“We’ve had a very low rate of complications (0.01%),” he added.” I don’t want to jinx that now. These were basically related to sedation.”

 

PROSPERO: Early Detection of Upper GI Conditions in a UK Population

Massimiliano di Pietro, MD, consultant gastroenterologist at Addenbrooke’s Hospital, Cambridge, England, and the principal investigator of the PROSPERO study, which aimed to determine the prevalence of premalignant upper GI conditions in routine endoscopy in the UK, commented on the findings. The TOGAS study focuses on asymptomatic individuals referred for colonoscopy and examines the value of performing an upper GI endoscopy at the same time, he explained. “This approach might identify upper GI conditions that require monitoring, in particular early cancer.”

“On the other hand, the PROSPERO study focuses on patients referred for upper GI symptoms and diagnosis,” he said. Preliminary data from that study, presented during the same session as the TOGAS trial, showed a 13.6% prevalence of premalignant upper GI conditions in a symptomatic UK patient population referred for endoscopy.

“In some respects, the findings were similar, particularly the rate of upper GI cancer at 1.4%, although there were differences in the prevalence of premalignant conditions,” he noted. “This may be explained by the fact that TOGAS is a European study, while PROSPERO is UK-based, where the distribution of upper GI cancers differs, with more esophageal adenocarcinoma vs gastric adenocarcinoma.”

Reflecting on both of the studies, Di Pietro said they are “really important in fulfilling an unmet need in the quality of upper GI endoscopy. Currently, there are no diagnostic quality indicators in upper GI endoscopy, so it’s difficult to rate the performance of endoscopists in the same way as we can in lower GI. It’s really important to understand the population prevalence, both in symptomatic and asymptomatic individuals, of premalignant and malignant upper GI conditions.”

TOGAS 2 is recruiting until February 2026, with 1200 of a potential 1600 participants recruited to date. The data will be used for implementation modeling and to inform quality indicators for future screening programs. Final results and plans for a follow-up study are expected in 2026.

Bornschein declared receiving advisory and speaker fees from Flynn Pharma and Juvisé Pharmaceuticals. Di Pietro reported having no disclosures relevant to the studies discussed.

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

BERLIN — Pairing a screening or surveillance colonoscopy with a same-day esophagogastroduodenoscopy (EGD) proved feasible and yielded clinically relevant upper gastrointestinal (GI) findings, including malignancies and lesions requiring ongoing surveillance, according to an interim analysis from the TOGAS study.

“There was an abundance of benign but clinically relevant findings,” said lead investigator Jan Bornschein, MD, gastroenterologist at Oxford University Hospitals NHS Foundation Trust, Oxford, England, who presented the interim resuts of the study at United European Gastroenterology (UEG) Week 2025.

While the study found upper GI neoplasia in only 1.4% of participants, 17.8% of individuals were marked for upper GI endoscopic surveillance.

The results may inform how Europe develops gastric cancer prevention programs alongside those for colorectal cancer, said Bornschein. “If we can combine the upper GI endoscopy with other modalities [colonoscopy], the more likelihood there is that you can have a one-stop test package,” he said. “A combination, particularly for bowel and stomach, is more feasible and also more cost-effective. So far, the findings show that it’s definitely a strategy that, in my opinion, is worth implementing.”

Bornschein and the TOGAS study group hope that the combined approach will prove workable across diverse European settings and will help identify a spectrum of upper GI pathology, from cancers and dysplasia to atrophy and intestinal metaplasia, that can meaningfully affect follow-up surveillance.

 

Mixed Rates of GI Cancers Across Europe and the US

These findings come amid data showing rising rates of early-onset (younger than 50 years) GI cancers in the US, including colorectal, gastric, pancreatic, and esophageal tumors. These trends, previously reported by this news organization, point to environmental and lifestyle drivers, strengthening the case for earlier detection and risk-tailored strategies for upper GI neoplasia and preneoplastic conditions detected during existing colorectal cancer screening pathways.

However, Bornschein noted that prevalence varies considerably across Europe. “There are areas, particularly in the Eastern regions, and in some parts of the West, for example, Portugal, that have a very high incidence of GI cancers. In the UK or in Germany, we have noticed a decline over the years, so the numbers are actually much better than they used to be.”

The study is the second in a series of three TOGAS pilot studies and was conducted across eight centers (France, Germany, Ireland, Latvia, Lithuania, the Netherlands, Portugal, and Spain) in adults aged 50-74 years attending screening or polyp-surveillance colonoscopy. 

A European Society of Gastrointestinal Endoscopy-aligned protocol defining image documentation, biopsy sampling, and quality parameters was followed to ensure a standardized approach. “Marked preneoplastic change” was defined as gastric glandular atrophy or intestinal metaplasia at the Operative Link on Gastritis Assessment/Operative Link on Gastric Intestinal Metaplasia Assessment stage III-IV and/or Endoscopic Grading of Gastric Intestinal Metaplasia > 5, triggering a need for endoscopic surveillance.

Data were gathered on colonoscopy findings (including polyp surveillance and family history), EGD findings plus biopsies, serum pepsinogen, and Helicobacter pylori serology. Outcome measures included the prevalence of gastric cancer and preneoplastic conditions, the diagnostic accuracy of pepsinogen testing, comparisons between national settings, the relevance of upper endoscopy in fecal immunochemical test-positive cases, and overall H pylori prevalence.

 

Neoplasia and Preneoplasia Found

A total of 846 participants were analyzed. At baseline, the mean age was 62 years, 52.2% were men, and 84.2% were White, despite efforts to recruit a more diverse population. Around 390 participants drank alcohol, and 190 smoked tobacco.

A total of 37.8% of participants had undergone prior EGD, of which 94.7% were performed more than 3 years before the study start. The history of GI surgery was 13.7%, and the history of cancer was 14.5%. Around 11% took aspirin, and 14% took proton pump inhibitors (PPIs). “We were surprised at the low prevalence of PPI use,” remarked Bornschein. “It was also good news that around half were never smokers.”

Key results for upper GI neoplasia included six patients (0.7%) with gastric cancers, three (0.4%) with esophageal cancers, and five (0.6%) with duodenal tumors. H pylori positivity was found in 303 patients (35.8%), with an additional 81 (9.6%) reporting a history of eradication.

Colorectal findings included 15 patients (1.8%) with cancers and colon polyps in 503 (59.5%) participants.

Regarding preneoplastic conditions, endoscopy identified intestinal metaplasia in 174 patients (20.6%), of which 65 (7.7%) were multifocal. Atrophy was observed in 220 patients (26.0%), with 59 (7.0%) showing multifocal atrophic changes. Both intestinal metaplasia and atrophy were found together in 105 (12.4%) patients. Barrett’s esophagus was detected in 31 (3.7%) patients.

“I’d really like to highlight these further benign gastric findings,” said Bornschein. These included gastric ulcers in 28 (3.3%) patients, erosive gastritis in 245 (29.0%) patients, esophageal ulcers in three (0.4%) patients, Los Angeles Community College District classification esophagitis in 13 (1.5%) patients, and duodenal ulcers in 10 (1.2%) patients. “These were asymptomatic, but we were able to identify them,” he noted.

“We’ve had a very low rate of complications (0.01%),” he added.” I don’t want to jinx that now. These were basically related to sedation.”

 

PROSPERO: Early Detection of Upper GI Conditions in a UK Population

Massimiliano di Pietro, MD, consultant gastroenterologist at Addenbrooke’s Hospital, Cambridge, England, and the principal investigator of the PROSPERO study, which aimed to determine the prevalence of premalignant upper GI conditions in routine endoscopy in the UK, commented on the findings. The TOGAS study focuses on asymptomatic individuals referred for colonoscopy and examines the value of performing an upper GI endoscopy at the same time, he explained. “This approach might identify upper GI conditions that require monitoring, in particular early cancer.”

“On the other hand, the PROSPERO study focuses on patients referred for upper GI symptoms and diagnosis,” he said. Preliminary data from that study, presented during the same session as the TOGAS trial, showed a 13.6% prevalence of premalignant upper GI conditions in a symptomatic UK patient population referred for endoscopy.

“In some respects, the findings were similar, particularly the rate of upper GI cancer at 1.4%, although there were differences in the prevalence of premalignant conditions,” he noted. “This may be explained by the fact that TOGAS is a European study, while PROSPERO is UK-based, where the distribution of upper GI cancers differs, with more esophageal adenocarcinoma vs gastric adenocarcinoma.”

Reflecting on both of the studies, Di Pietro said they are “really important in fulfilling an unmet need in the quality of upper GI endoscopy. Currently, there are no diagnostic quality indicators in upper GI endoscopy, so it’s difficult to rate the performance of endoscopists in the same way as we can in lower GI. It’s really important to understand the population prevalence, both in symptomatic and asymptomatic individuals, of premalignant and malignant upper GI conditions.”

TOGAS 2 is recruiting until February 2026, with 1200 of a potential 1600 participants recruited to date. The data will be used for implementation modeling and to inform quality indicators for future screening programs. Final results and plans for a follow-up study are expected in 2026.

Bornschein declared receiving advisory and speaker fees from Flynn Pharma and Juvisé Pharmaceuticals. Di Pietro reported having no disclosures relevant to the studies discussed.

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

BERLIN — Pairing a screening or surveillance colonoscopy with a same-day esophagogastroduodenoscopy (EGD) proved feasible and yielded clinically relevant upper gastrointestinal (GI) findings, including malignancies and lesions requiring ongoing surveillance, according to an interim analysis from the TOGAS study.

“There was an abundance of benign but clinically relevant findings,” said lead investigator Jan Bornschein, MD, gastroenterologist at Oxford University Hospitals NHS Foundation Trust, Oxford, England, who presented the interim resuts of the study at United European Gastroenterology (UEG) Week 2025.

While the study found upper GI neoplasia in only 1.4% of participants, 17.8% of individuals were marked for upper GI endoscopic surveillance.

The results may inform how Europe develops gastric cancer prevention programs alongside those for colorectal cancer, said Bornschein. “If we can combine the upper GI endoscopy with other modalities [colonoscopy], the more likelihood there is that you can have a one-stop test package,” he said. “A combination, particularly for bowel and stomach, is more feasible and also more cost-effective. So far, the findings show that it’s definitely a strategy that, in my opinion, is worth implementing.”

Bornschein and the TOGAS study group hope that the combined approach will prove workable across diverse European settings and will help identify a spectrum of upper GI pathology, from cancers and dysplasia to atrophy and intestinal metaplasia, that can meaningfully affect follow-up surveillance.

 

Mixed Rates of GI Cancers Across Europe and the US

These findings come amid data showing rising rates of early-onset (younger than 50 years) GI cancers in the US, including colorectal, gastric, pancreatic, and esophageal tumors. These trends, previously reported by this news organization, point to environmental and lifestyle drivers, strengthening the case for earlier detection and risk-tailored strategies for upper GI neoplasia and preneoplastic conditions detected during existing colorectal cancer screening pathways.

However, Bornschein noted that prevalence varies considerably across Europe. “There are areas, particularly in the Eastern regions, and in some parts of the West, for example, Portugal, that have a very high incidence of GI cancers. In the UK or in Germany, we have noticed a decline over the years, so the numbers are actually much better than they used to be.”

The study is the second in a series of three TOGAS pilot studies and was conducted across eight centers (France, Germany, Ireland, Latvia, Lithuania, the Netherlands, Portugal, and Spain) in adults aged 50-74 years attending screening or polyp-surveillance colonoscopy. 

A European Society of Gastrointestinal Endoscopy-aligned protocol defining image documentation, biopsy sampling, and quality parameters was followed to ensure a standardized approach. “Marked preneoplastic change” was defined as gastric glandular atrophy or intestinal metaplasia at the Operative Link on Gastritis Assessment/Operative Link on Gastric Intestinal Metaplasia Assessment stage III-IV and/or Endoscopic Grading of Gastric Intestinal Metaplasia > 5, triggering a need for endoscopic surveillance.

Data were gathered on colonoscopy findings (including polyp surveillance and family history), EGD findings plus biopsies, serum pepsinogen, and Helicobacter pylori serology. Outcome measures included the prevalence of gastric cancer and preneoplastic conditions, the diagnostic accuracy of pepsinogen testing, comparisons between national settings, the relevance of upper endoscopy in fecal immunochemical test-positive cases, and overall H pylori prevalence.

 

Neoplasia and Preneoplasia Found

A total of 846 participants were analyzed. At baseline, the mean age was 62 years, 52.2% were men, and 84.2% were White, despite efforts to recruit a more diverse population. Around 390 participants drank alcohol, and 190 smoked tobacco.

A total of 37.8% of participants had undergone prior EGD, of which 94.7% were performed more than 3 years before the study start. The history of GI surgery was 13.7%, and the history of cancer was 14.5%. Around 11% took aspirin, and 14% took proton pump inhibitors (PPIs). “We were surprised at the low prevalence of PPI use,” remarked Bornschein. “It was also good news that around half were never smokers.”

Key results for upper GI neoplasia included six patients (0.7%) with gastric cancers, three (0.4%) with esophageal cancers, and five (0.6%) with duodenal tumors. H pylori positivity was found in 303 patients (35.8%), with an additional 81 (9.6%) reporting a history of eradication.

Colorectal findings included 15 patients (1.8%) with cancers and colon polyps in 503 (59.5%) participants.

Regarding preneoplastic conditions, endoscopy identified intestinal metaplasia in 174 patients (20.6%), of which 65 (7.7%) were multifocal. Atrophy was observed in 220 patients (26.0%), with 59 (7.0%) showing multifocal atrophic changes. Both intestinal metaplasia and atrophy were found together in 105 (12.4%) patients. Barrett’s esophagus was detected in 31 (3.7%) patients.

“I’d really like to highlight these further benign gastric findings,” said Bornschein. These included gastric ulcers in 28 (3.3%) patients, erosive gastritis in 245 (29.0%) patients, esophageal ulcers in three (0.4%) patients, Los Angeles Community College District classification esophagitis in 13 (1.5%) patients, and duodenal ulcers in 10 (1.2%) patients. “These were asymptomatic, but we were able to identify them,” he noted.

“We’ve had a very low rate of complications (0.01%),” he added.” I don’t want to jinx that now. These were basically related to sedation.”

 

PROSPERO: Early Detection of Upper GI Conditions in a UK Population

Massimiliano di Pietro, MD, consultant gastroenterologist at Addenbrooke’s Hospital, Cambridge, England, and the principal investigator of the PROSPERO study, which aimed to determine the prevalence of premalignant upper GI conditions in routine endoscopy in the UK, commented on the findings. The TOGAS study focuses on asymptomatic individuals referred for colonoscopy and examines the value of performing an upper GI endoscopy at the same time, he explained. “This approach might identify upper GI conditions that require monitoring, in particular early cancer.”

“On the other hand, the PROSPERO study focuses on patients referred for upper GI symptoms and diagnosis,” he said. Preliminary data from that study, presented during the same session as the TOGAS trial, showed a 13.6% prevalence of premalignant upper GI conditions in a symptomatic UK patient population referred for endoscopy.

“In some respects, the findings were similar, particularly the rate of upper GI cancer at 1.4%, although there were differences in the prevalence of premalignant conditions,” he noted. “This may be explained by the fact that TOGAS is a European study, while PROSPERO is UK-based, where the distribution of upper GI cancers differs, with more esophageal adenocarcinoma vs gastric adenocarcinoma.”

Reflecting on both of the studies, Di Pietro said they are “really important in fulfilling an unmet need in the quality of upper GI endoscopy. Currently, there are no diagnostic quality indicators in upper GI endoscopy, so it’s difficult to rate the performance of endoscopists in the same way as we can in lower GI. It’s really important to understand the population prevalence, both in symptomatic and asymptomatic individuals, of premalignant and malignant upper GI conditions.”

TOGAS 2 is recruiting until February 2026, with 1200 of a potential 1600 participants recruited to date. The data will be used for implementation modeling and to inform quality indicators for future screening programs. Final results and plans for a follow-up study are expected in 2026.

Bornschein declared receiving advisory and speaker fees from Flynn Pharma and Juvisé Pharmaceuticals. Di Pietro reported having no disclosures relevant to the studies discussed.

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