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Accurate neoplasia detection in patients with Barrett’s esophagus (BE) involves high-quality endoscopy, adequate biopsy sampling, careful examination, and appropriate recognition of neoplastic lesions, said Prateek Sharma, MD, in a presentation on the management of BE at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.

However, clinicians often make mistakes such as failing to remove debris such as saliva and bile from the esophagus prior to assessing a patient, said Sharma, professor of medicine and the Elaine Blaylock Endowed Professor at the University of Kansas School of Medicine and the Cancer Center, Kansas City, Kansas.

More than 90% of neoplasias in patients with BE are found on an index endoscopy or within 6 months, as shown by Sharma and his colleagues in a systematic review, which highlights the importance of a high-quality index endoscopy, he told meeting attendees.

To improve the index endoscopy, Sharma developed a new algorithm called “CLEAN.”

The algorithm is composed of five steps, he said, the first of which is Clear: clear the esophagus of debris, including saliva and bile. Adequate prep is essential to detecting clinically significant lesions in patients with BE, he explained. In a study published in 2024, Sharma and colleagues found adequate cleanliness of the upper gastrointestinal tract was associated with a significantly higher detection rate of clinically significant lesions.

The second step of the algorithm is Learn: pay attention to BE inspection time and learn slow withdrawal strategies.

It’s important not to shortchange inspection time, Sharma emphasized. He cited a previous study in which the percentage of patients with BE who had high-grade dysplasia or esophageal adenocarcinoma during a surveillance endoscopy was 15% with inspection times of 2 minutes or less but jumped to 69% with inspection times of 7 minutes or more.

The third step of CLEAN is Endoscope: conduct a high-definition white-light endoscopy, which should be coupled with the fourth step, Acquire: acquire education on BE-related neoplasia, to learn how to recognize neoplastic lesions, he stressed.

The final step of the algorithm is Neoplasia detection rate (NDR): follow a quality metric to measure NDR.

The algorithm emphasizes a comprehensive approach in conjunction with resection of visible lesions followed by ablation for complete eradication, Sharma told GI & Hepatology News.
 

After Identification: What’s Next?

If lesions are identified, the next step is resection and/or ablation, Sharma said.

“Resection is typically used for visible lesions, nodules, or masses, while ablation is used to treat the remaining underlying Barrett tissue,” he told GI & Hepatology News. “A combination of both is often necessary to fully treat advanced cases, such as when a nodule is resected and the surrounding area is subsequently ablated.”

“It’s important to understand why we need to resect,” he said.

“Resection removes the lesion” and “provides more accurate histopathology reading and staging of how deep the lesion is,” he explained. Options for resection of cancerous or precancerous lesions in patients with BE include endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD).

The treatment algorithm for BE continues to evolve, Sharma said in his presentation. Currently, evidence supports EMR for most cases, but ESD is based on factors including lesion size ≥ 25-30 mm and potential submucosal invasion, he said.

He cited a study of 1000 adults with early BE who were managed with EMR that showed a 96% curative response after 5 years. Similarly, a review of ESD for early BE neoplasia including 501 patients showed a 75% curative response rate overall and a 93% en bloc resection rate, he noted.
 

Ablation

In terms of ablation, radiofrequency ablation, hybrid argon plasma coagulation, and the multifocal cryoballoon procedure have shown significant effectiveness, Sharma said.

In a 2020 multicenter, prospective study of 120 adult patients with BE, 76% achieved complete eradication of dysplasia, and 72% achieved complete eradication of intestinal metaplasia. As for safety, data from nine European centers including 154 patients who underwent ablation after resection had an adverse event rate of 6%, said Sharma.
 

In the Clinic

“It is sometimes difficult to detect subtle nodularity and irregularity that would benefit more from resection therapy/EMR rather than ablation,” said Gyanprakash A. Ketwaroo, MD, associate professor of medicine (digestive diseases) at Yale University, New Haven, Connecticut.

“Lesions can be obscured by esophagitis, peristalsis, or the shape of the [gastroesophageal] GE junction,” he noted. Therefore, careful scope cleaning and inspection with high-definition white light and narrow band imaging are important, he said. “Using a cap on the scope to better distend or manipulate the gastroesophageal junction also helps identify obscured lesions,” he added.

“Any acronym or approach that reminds us to slow down, and examine carefully, is welcome,” Ketwaroo told GI & Hepatology News. The CLEAN algorithm provides a useful summary of some of the key steps all clinicians should incorporate into approaching BE and could be useful for teaching trainees, he added.

Sharma disclosed serving as a consultant for the Olympus Corporation and Exact Sciences and receiving grant support from Fujifilm, Erbe Medical, and Braintree Pharmaceuticals.
 

A version of this article appeared on Medscape.com.

Accurate neoplasia detection in patients with Barrett’s esophagus (BE) involves high-quality endoscopy, adequate biopsy sampling, careful examination, and appropriate recognition of neoplastic lesions, said Prateek Sharma, MD, in a presentation on the management of BE at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.

However, clinicians often make mistakes such as failing to remove debris such as saliva and bile from the esophagus prior to assessing a patient, said Sharma, professor of medicine and the Elaine Blaylock Endowed Professor at the University of Kansas School of Medicine and the Cancer Center, Kansas City, Kansas.

More than 90% of neoplasias in patients with BE are found on an index endoscopy or within 6 months, as shown by Sharma and his colleagues in a systematic review, which highlights the importance of a high-quality index endoscopy, he told meeting attendees.

To improve the index endoscopy, Sharma developed a new algorithm called “CLEAN.”

The algorithm is composed of five steps, he said, the first of which is Clear: clear the esophagus of debris, including saliva and bile. Adequate prep is essential to detecting clinically significant lesions in patients with BE, he explained. In a study published in 2024, Sharma and colleagues found adequate cleanliness of the upper gastrointestinal tract was associated with a significantly higher detection rate of clinically significant lesions.

The second step of the algorithm is Learn: pay attention to BE inspection time and learn slow withdrawal strategies.

It’s important not to shortchange inspection time, Sharma emphasized. He cited a previous study in which the percentage of patients with BE who had high-grade dysplasia or esophageal adenocarcinoma during a surveillance endoscopy was 15% with inspection times of 2 minutes or less but jumped to 69% with inspection times of 7 minutes or more.

The third step of CLEAN is Endoscope: conduct a high-definition white-light endoscopy, which should be coupled with the fourth step, Acquire: acquire education on BE-related neoplasia, to learn how to recognize neoplastic lesions, he stressed.

The final step of the algorithm is Neoplasia detection rate (NDR): follow a quality metric to measure NDR.

The algorithm emphasizes a comprehensive approach in conjunction with resection of visible lesions followed by ablation for complete eradication, Sharma told GI & Hepatology News.
 

After Identification: What’s Next?

If lesions are identified, the next step is resection and/or ablation, Sharma said.

“Resection is typically used for visible lesions, nodules, or masses, while ablation is used to treat the remaining underlying Barrett tissue,” he told GI & Hepatology News. “A combination of both is often necessary to fully treat advanced cases, such as when a nodule is resected and the surrounding area is subsequently ablated.”

“It’s important to understand why we need to resect,” he said.

“Resection removes the lesion” and “provides more accurate histopathology reading and staging of how deep the lesion is,” he explained. Options for resection of cancerous or precancerous lesions in patients with BE include endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD).

The treatment algorithm for BE continues to evolve, Sharma said in his presentation. Currently, evidence supports EMR for most cases, but ESD is based on factors including lesion size ≥ 25-30 mm and potential submucosal invasion, he said.

He cited a study of 1000 adults with early BE who were managed with EMR that showed a 96% curative response after 5 years. Similarly, a review of ESD for early BE neoplasia including 501 patients showed a 75% curative response rate overall and a 93% en bloc resection rate, he noted.
 

Ablation

In terms of ablation, radiofrequency ablation, hybrid argon plasma coagulation, and the multifocal cryoballoon procedure have shown significant effectiveness, Sharma said.

In a 2020 multicenter, prospective study of 120 adult patients with BE, 76% achieved complete eradication of dysplasia, and 72% achieved complete eradication of intestinal metaplasia. As for safety, data from nine European centers including 154 patients who underwent ablation after resection had an adverse event rate of 6%, said Sharma.
 

In the Clinic

“It is sometimes difficult to detect subtle nodularity and irregularity that would benefit more from resection therapy/EMR rather than ablation,” said Gyanprakash A. Ketwaroo, MD, associate professor of medicine (digestive diseases) at Yale University, New Haven, Connecticut.

“Lesions can be obscured by esophagitis, peristalsis, or the shape of the [gastroesophageal] GE junction,” he noted. Therefore, careful scope cleaning and inspection with high-definition white light and narrow band imaging are important, he said. “Using a cap on the scope to better distend or manipulate the gastroesophageal junction also helps identify obscured lesions,” he added.

“Any acronym or approach that reminds us to slow down, and examine carefully, is welcome,” Ketwaroo told GI & Hepatology News. The CLEAN algorithm provides a useful summary of some of the key steps all clinicians should incorporate into approaching BE and could be useful for teaching trainees, he added.

Sharma disclosed serving as a consultant for the Olympus Corporation and Exact Sciences and receiving grant support from Fujifilm, Erbe Medical, and Braintree Pharmaceuticals.
 

A version of this article appeared on Medscape.com.

Accurate neoplasia detection in patients with Barrett’s esophagus (BE) involves high-quality endoscopy, adequate biopsy sampling, careful examination, and appropriate recognition of neoplastic lesions, said Prateek Sharma, MD, in a presentation on the management of BE at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.

However, clinicians often make mistakes such as failing to remove debris such as saliva and bile from the esophagus prior to assessing a patient, said Sharma, professor of medicine and the Elaine Blaylock Endowed Professor at the University of Kansas School of Medicine and the Cancer Center, Kansas City, Kansas.

More than 90% of neoplasias in patients with BE are found on an index endoscopy or within 6 months, as shown by Sharma and his colleagues in a systematic review, which highlights the importance of a high-quality index endoscopy, he told meeting attendees.

To improve the index endoscopy, Sharma developed a new algorithm called “CLEAN.”

The algorithm is composed of five steps, he said, the first of which is Clear: clear the esophagus of debris, including saliva and bile. Adequate prep is essential to detecting clinically significant lesions in patients with BE, he explained. In a study published in 2024, Sharma and colleagues found adequate cleanliness of the upper gastrointestinal tract was associated with a significantly higher detection rate of clinically significant lesions.

The second step of the algorithm is Learn: pay attention to BE inspection time and learn slow withdrawal strategies.

It’s important not to shortchange inspection time, Sharma emphasized. He cited a previous study in which the percentage of patients with BE who had high-grade dysplasia or esophageal adenocarcinoma during a surveillance endoscopy was 15% with inspection times of 2 minutes or less but jumped to 69% with inspection times of 7 minutes or more.

The third step of CLEAN is Endoscope: conduct a high-definition white-light endoscopy, which should be coupled with the fourth step, Acquire: acquire education on BE-related neoplasia, to learn how to recognize neoplastic lesions, he stressed.

The final step of the algorithm is Neoplasia detection rate (NDR): follow a quality metric to measure NDR.

The algorithm emphasizes a comprehensive approach in conjunction with resection of visible lesions followed by ablation for complete eradication, Sharma told GI & Hepatology News.
 

After Identification: What’s Next?

If lesions are identified, the next step is resection and/or ablation, Sharma said.

“Resection is typically used for visible lesions, nodules, or masses, while ablation is used to treat the remaining underlying Barrett tissue,” he told GI & Hepatology News. “A combination of both is often necessary to fully treat advanced cases, such as when a nodule is resected and the surrounding area is subsequently ablated.”

“It’s important to understand why we need to resect,” he said.

“Resection removes the lesion” and “provides more accurate histopathology reading and staging of how deep the lesion is,” he explained. Options for resection of cancerous or precancerous lesions in patients with BE include endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD).

The treatment algorithm for BE continues to evolve, Sharma said in his presentation. Currently, evidence supports EMR for most cases, but ESD is based on factors including lesion size ≥ 25-30 mm and potential submucosal invasion, he said.

He cited a study of 1000 adults with early BE who were managed with EMR that showed a 96% curative response after 5 years. Similarly, a review of ESD for early BE neoplasia including 501 patients showed a 75% curative response rate overall and a 93% en bloc resection rate, he noted.
 

Ablation

In terms of ablation, radiofrequency ablation, hybrid argon plasma coagulation, and the multifocal cryoballoon procedure have shown significant effectiveness, Sharma said.

In a 2020 multicenter, prospective study of 120 adult patients with BE, 76% achieved complete eradication of dysplasia, and 72% achieved complete eradication of intestinal metaplasia. As for safety, data from nine European centers including 154 patients who underwent ablation after resection had an adverse event rate of 6%, said Sharma.
 

In the Clinic

“It is sometimes difficult to detect subtle nodularity and irregularity that would benefit more from resection therapy/EMR rather than ablation,” said Gyanprakash A. Ketwaroo, MD, associate professor of medicine (digestive diseases) at Yale University, New Haven, Connecticut.

“Lesions can be obscured by esophagitis, peristalsis, or the shape of the [gastroesophageal] GE junction,” he noted. Therefore, careful scope cleaning and inspection with high-definition white light and narrow band imaging are important, he said. “Using a cap on the scope to better distend or manipulate the gastroesophageal junction also helps identify obscured lesions,” he added.

“Any acronym or approach that reminds us to slow down, and examine carefully, is welcome,” Ketwaroo told GI & Hepatology News. The CLEAN algorithm provides a useful summary of some of the key steps all clinicians should incorporate into approaching BE and could be useful for teaching trainees, he added.

Sharma disclosed serving as a consultant for the Olympus Corporation and Exact Sciences and receiving grant support from Fujifilm, Erbe Medical, and Braintree Pharmaceuticals.
 

A version of this article appeared on Medscape.com.

The more than 2 million women US veterans are the fastest-growing military population. While research into women veterans has traditionally lagged, more recently studies have begun to focus on their needs impacts of combat and service on women. These studies have found that women veterans preferred tailored solutions focused on women veterans.

A November 2025 study is one of the first to examine the impact of combat on women veterans. It found that those in combat roles had higher levels of depression, posttraumatic stress disorder (PTSD), dissociation, and overall poorer health compared with civilians and noncombat women military personnel. Previous research had found that women veterans had higher rates of lifetime and past-year PTSD (13.4%) compared with female civilians (8.0%), male veterans (7.7%), and male civilians (3.4%). A 2020 US Department of Veterans (VA) study of 4,928,638 men and 448,455 women similarly found that women had nearly twice the rates of depression and anxiety compared with men.

For many veterans, mental health issues may develop or be exacerbated in their return to civilian life. That transition can be especially confusing and isolating for women veterans, according to a 2024 study: “They neither fit in the military due to gendered relations centered on masculinity, or civilian life where they are largely misunderstood as ‘veterans.’ This ‘no woman’s land’ is poorly understood.” Few programs for transitioning veterans have been found effective for women veterans because they’ve been developed for a largely male veteran population. That includes mental health support programs.

Some women may prefer women-only groups, and even that choice may be dependent on their background, service history, socioeconomic level, and other factors. They may feel more comfortable in women-only groups if they’ve experienced MST. Others who have served in combat may choose mixed-gender programs. One study found that some women benefited from being in a mixed-gender group because it enabled them to work on difficulties with men in a safe environment. Other research has found that women veterans with substance use disorders are reluctant to seek help alongside men in the same facilities. 

Accessing care may be especially challenging for rural women veterans. However, separate facilities and women-only groups are not always available, particularly in rural areas where there may be very few women veterans. And even if they are available, rural women are often up against barriers that urban women do not face, such as having to travel long distances to get care. Clinicians also may be hard to find in rural areas. Some participants in a 2025 study were hampered not only by a lack of female practitioners, but practitioners who were well trained to understand and treat the unique needs of female veterans: “[It’s] incredibly difficult to find a mental health practitioner that understands a veteran’s unique experience as a woman,” a participant said.

The more than 2 million women US veterans are the fastest-growing military population. While research into women veterans has traditionally lagged, more recently studies have begun to focus on their needs impacts of combat and service on women. These studies have found that women veterans preferred tailored solutions focused on women veterans.

A November 2025 study is one of the first to examine the impact of combat on women veterans. It found that those in combat roles had higher levels of depression, posttraumatic stress disorder (PTSD), dissociation, and overall poorer health compared with civilians and noncombat women military personnel. Previous research had found that women veterans had higher rates of lifetime and past-year PTSD (13.4%) compared with female civilians (8.0%), male veterans (7.7%), and male civilians (3.4%). A 2020 US Department of Veterans (VA) study of 4,928,638 men and 448,455 women similarly found that women had nearly twice the rates of depression and anxiety compared with men.

For many veterans, mental health issues may develop or be exacerbated in their return to civilian life. That transition can be especially confusing and isolating for women veterans, according to a 2024 study: “They neither fit in the military due to gendered relations centered on masculinity, or civilian life where they are largely misunderstood as ‘veterans.’ This ‘no woman’s land’ is poorly understood.” Few programs for transitioning veterans have been found effective for women veterans because they’ve been developed for a largely male veteran population. That includes mental health support programs.

Some women may prefer women-only groups, and even that choice may be dependent on their background, service history, socioeconomic level, and other factors. They may feel more comfortable in women-only groups if they’ve experienced MST. Others who have served in combat may choose mixed-gender programs. One study found that some women benefited from being in a mixed-gender group because it enabled them to work on difficulties with men in a safe environment. Other research has found that women veterans with substance use disorders are reluctant to seek help alongside men in the same facilities. 

Accessing care may be especially challenging for rural women veterans. However, separate facilities and women-only groups are not always available, particularly in rural areas where there may be very few women veterans. And even if they are available, rural women are often up against barriers that urban women do not face, such as having to travel long distances to get care. Clinicians also may be hard to find in rural areas. Some participants in a 2025 study were hampered not only by a lack of female practitioners, but practitioners who were well trained to understand and treat the unique needs of female veterans: “[It’s] incredibly difficult to find a mental health practitioner that understands a veteran’s unique experience as a woman,” a participant said.

The more than 2 million women US veterans are the fastest-growing military population. While research into women veterans has traditionally lagged, more recently studies have begun to focus on their needs impacts of combat and service on women. These studies have found that women veterans preferred tailored solutions focused on women veterans.

A November 2025 study is one of the first to examine the impact of combat on women veterans. It found that those in combat roles had higher levels of depression, posttraumatic stress disorder (PTSD), dissociation, and overall poorer health compared with civilians and noncombat women military personnel. Previous research had found that women veterans had higher rates of lifetime and past-year PTSD (13.4%) compared with female civilians (8.0%), male veterans (7.7%), and male civilians (3.4%). A 2020 US Department of Veterans (VA) study of 4,928,638 men and 448,455 women similarly found that women had nearly twice the rates of depression and anxiety compared with men.

For many veterans, mental health issues may develop or be exacerbated in their return to civilian life. That transition can be especially confusing and isolating for women veterans, according to a 2024 study: “They neither fit in the military due to gendered relations centered on masculinity, or civilian life where they are largely misunderstood as ‘veterans.’ This ‘no woman’s land’ is poorly understood.” Few programs for transitioning veterans have been found effective for women veterans because they’ve been developed for a largely male veteran population. That includes mental health support programs.

Some women may prefer women-only groups, and even that choice may be dependent on their background, service history, socioeconomic level, and other factors. They may feel more comfortable in women-only groups if they’ve experienced MST. Others who have served in combat may choose mixed-gender programs. One study found that some women benefited from being in a mixed-gender group because it enabled them to work on difficulties with men in a safe environment. Other research has found that women veterans with substance use disorders are reluctant to seek help alongside men in the same facilities. 

Accessing care may be especially challenging for rural women veterans. However, separate facilities and women-only groups are not always available, particularly in rural areas where there may be very few women veterans. And even if they are available, rural women are often up against barriers that urban women do not face, such as having to travel long distances to get care. Clinicians also may be hard to find in rural areas. Some participants in a 2025 study were hampered not only by a lack of female practitioners, but practitioners who were well trained to understand and treat the unique needs of female veterans: “[It’s] incredibly difficult to find a mental health practitioner that understands a veteran’s unique experience as a woman,” a participant said.

TOPLINE:

Message-based psychotherapy (MBP), which uses asynchronous emails or texts, showed effectiveness comparable with that of video-based psychotherapy (VBP) for the treatment of depression on a commercial digital mental health platform, a new study showed.

METHODOLOGY:

• Investigators conducted a pragmatic sequential multiple-assignment randomized clinical trial from 2022 to 2024 involving 850 adult patients with a diagnosis of depression (mean age, 34 years; 66% women; 60% White, 22% Black and 14% Hispanic).
• Patients were initially randomly assigned to receive weekly MBP (n = 423) or VBP (n = 427), with nonresponders randomly assigned at week 6 to receive combination therapy of MBP plus weekly or monthly VBP. All patients received treatment for up to 12 weeks.
• Primary outcomes included depression severity measured by the 9-item Patient Health Questionnaire (PHQ-9), social functioning measured by the Quality of Life in Neurological Disorders 8-item tool, response to treatment (≥ 50% reduction in PHQ-9 total score or Clinical Global Impressions-Improvement score ≤ 2), and remissions (PHQ-9 score < 5).
• Secondary outcomes were treating disengagement, therapeutic alliance measured on the Working Alliance Inventory-Short Revised, quality of care in the past 4 weeks, and treatment satisfaction.

TAKEAWAY:

• Rates of response (47.5% and 47.2%, respectively) and remission (31.4% and 30.3%, respectively) were not significantly different at week 12 between the MBP and VBP groups or for nonresponders rerandomized to either group.
• There were also no significant differences in depression change scores between the MBP and VBP groups or for nonresponders rerandomized to either group.
• Treatment disengagement by week 5 was significantly higher in the VBP vs MBP group (21.3% vs 13.2%; P = .003); VBP responders had stronger initial therapeutic alliance at week 4 than MBP responders (P < .001).
• No significant differences were observed in the quality of care among those who responded only after the second randomization to MBP or VBP.

IN PRACTICE:

"Findings reinforced MBP as viable alternative to VBP. Broader insurance reimbursement for MBP could improve access to evidence-based care," the investigators wrote.

SOURCE:

The study was led by Michael D. Pullmann, PhD, School of Medicine, University of Washington, Seattle. It was published online on October 30 in JAMA Network Open.

LIMITATIONS:

The absence of a waiting list or a no-treatment control group made it difficult to rule out regression to the mean as an explanation for improvements. Additionally, missing data may have affected the robustness of some findings.

DISCLOSURES:

The research was funded by the National Institute of Mental Health. Several investigators reported having financial ties with various sources. Details are provided in the original article.

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

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

TOPLINE:

Message-based psychotherapy (MBP), which uses asynchronous emails or texts, showed effectiveness comparable with that of video-based psychotherapy (VBP) for the treatment of depression on a commercial digital mental health platform, a new study showed.

METHODOLOGY:

• Investigators conducted a pragmatic sequential multiple-assignment randomized clinical trial from 2022 to 2024 involving 850 adult patients with a diagnosis of depression (mean age, 34 years; 66% women; 60% White, 22% Black and 14% Hispanic).
• Patients were initially randomly assigned to receive weekly MBP (n = 423) or VBP (n = 427), with nonresponders randomly assigned at week 6 to receive combination therapy of MBP plus weekly or monthly VBP. All patients received treatment for up to 12 weeks.
• Primary outcomes included depression severity measured by the 9-item Patient Health Questionnaire (PHQ-9), social functioning measured by the Quality of Life in Neurological Disorders 8-item tool, response to treatment (≥ 50% reduction in PHQ-9 total score or Clinical Global Impressions-Improvement score ≤ 2), and remissions (PHQ-9 score < 5).
• Secondary outcomes were treating disengagement, therapeutic alliance measured on the Working Alliance Inventory-Short Revised, quality of care in the past 4 weeks, and treatment satisfaction.

TAKEAWAY:

• Rates of response (47.5% and 47.2%, respectively) and remission (31.4% and 30.3%, respectively) were not significantly different at week 12 between the MBP and VBP groups or for nonresponders rerandomized to either group.
• There were also no significant differences in depression change scores between the MBP and VBP groups or for nonresponders rerandomized to either group.
• Treatment disengagement by week 5 was significantly higher in the VBP vs MBP group (21.3% vs 13.2%; P = .003); VBP responders had stronger initial therapeutic alliance at week 4 than MBP responders (P < .001).
• No significant differences were observed in the quality of care among those who responded only after the second randomization to MBP or VBP.

IN PRACTICE:

"Findings reinforced MBP as viable alternative to VBP. Broader insurance reimbursement for MBP could improve access to evidence-based care," the investigators wrote.

SOURCE:

The study was led by Michael D. Pullmann, PhD, School of Medicine, University of Washington, Seattle. It was published online on October 30 in JAMA Network Open.

LIMITATIONS:

The absence of a waiting list or a no-treatment control group made it difficult to rule out regression to the mean as an explanation for improvements. Additionally, missing data may have affected the robustness of some findings.

DISCLOSURES:

The research was funded by the National Institute of Mental Health. Several investigators reported having financial ties with various sources. Details are provided in the original article.

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

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

TOPLINE:

Message-based psychotherapy (MBP), which uses asynchronous emails or texts, showed effectiveness comparable with that of video-based psychotherapy (VBP) for the treatment of depression on a commercial digital mental health platform, a new study showed.

METHODOLOGY:

• Investigators conducted a pragmatic sequential multiple-assignment randomized clinical trial from 2022 to 2024 involving 850 adult patients with a diagnosis of depression (mean age, 34 years; 66% women; 60% White, 22% Black and 14% Hispanic).
• Patients were initially randomly assigned to receive weekly MBP (n = 423) or VBP (n = 427), with nonresponders randomly assigned at week 6 to receive combination therapy of MBP plus weekly or monthly VBP. All patients received treatment for up to 12 weeks.
• Primary outcomes included depression severity measured by the 9-item Patient Health Questionnaire (PHQ-9), social functioning measured by the Quality of Life in Neurological Disorders 8-item tool, response to treatment (≥ 50% reduction in PHQ-9 total score or Clinical Global Impressions-Improvement score ≤ 2), and remissions (PHQ-9 score < 5).
• Secondary outcomes were treating disengagement, therapeutic alliance measured on the Working Alliance Inventory-Short Revised, quality of care in the past 4 weeks, and treatment satisfaction.

TAKEAWAY:

• Rates of response (47.5% and 47.2%, respectively) and remission (31.4% and 30.3%, respectively) were not significantly different at week 12 between the MBP and VBP groups or for nonresponders rerandomized to either group.
• There were also no significant differences in depression change scores between the MBP and VBP groups or for nonresponders rerandomized to either group.
• Treatment disengagement by week 5 was significantly higher in the VBP vs MBP group (21.3% vs 13.2%; P = .003); VBP responders had stronger initial therapeutic alliance at week 4 than MBP responders (P < .001).
• No significant differences were observed in the quality of care among those who responded only after the second randomization to MBP or VBP.

IN PRACTICE:

"Findings reinforced MBP as viable alternative to VBP. Broader insurance reimbursement for MBP could improve access to evidence-based care," the investigators wrote.

SOURCE:

The study was led by Michael D. Pullmann, PhD, School of Medicine, University of Washington, Seattle. It was published online on October 30 in JAMA Network Open.

LIMITATIONS:

The absence of a waiting list or a no-treatment control group made it difficult to rule out regression to the mean as an explanation for improvements. Additionally, missing data may have affected the robustness of some findings.

DISCLOSURES:

The research was funded by the National Institute of Mental Health. Several investigators reported having financial ties with various sources. Details are provided in the original article.

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

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

Treatment with a GLP-1 receptor agonist (RA) may offer a survival advantage in patients with colon cancer and obesity.

In a real-world analysis of nearly 7000 patients with colon cancer, those taking a GLP-1 RA were less than half as likely to die within 5 years compared with those who weren’t on a GLP-1 drug.

The association between GLP-1 exposure and lower 5–year mortality in colon cancer was “robust” and appeared to be concentrated in patients with severe obesity (BMI ≥ 35), lead investigator Raphael E. Cuomo, PhD, with University of California San Diego, told this news organization.

The apparent protective effect “persisted after controlling for differences in disease severity and demographics, as well as differences in circulating carcinoembryonic antigen, a biomarker of disease aggressiveness,” Cuomo said.

The study was published online in Cancer Investigation.
 

Effects Beyond Glucose-Lowering

Colon cancer remains a major global cause of cancer-related deaths, and obesity is both a risk factor and a driver of worse outcomes.

Beyond regulating blood sugar, GLP-1 drugs reduce systemic inflammation, improve insulin sensitivity, and promote weight loss. Prior preclinical work has also suggested they may prevent cancer cell growth, trigger cancer cell death, and reshape the tumor microenvironment.

To investigate further, Cuomo analyzed electronic health records of 6871 patients diagnosed with primary colon cancer before 2019 — of which 103 had at least 1 documented prescription for a GLP-1 drug within 5 years of diagnosis.

Five–year mortality was significantly lower in GLP-1 RA users than in nonusers (15.5% vs 37.1%; P < .001). A significant reduction in 5–year mortality among GLP-1 RA users was evident in an unadjusted model (odds ratio [OR], 0.38; P < .001) and persisted in fully adjusted models (OR, 0.28; P < .001).

When stratified by BMI, the odds of 5-year mortality with GLP-1 use was reduced only in patients with Class II obesity (BMI ≥ 35: fully adjusted hazard ratio [HR], 0.051; P = .004). In this group, fully adjusted hazard ratios suggested markedly lower risk for death (HR, 0.07; P = .009).

Beyond mortality, GLP-1 users also experienced fewer late cardiovascular events and had fewer markers of advanced colon cancer progression in the final months of follow-up, “which suggests that GLP-1 drugs exert benefits through both oncologic and cardiometabolic pathways,” Cuomo told this news organization.
 

Intriguing and Promising — but Further Studies Needed

“To further study the potential of GLP-1 therapy as an adjunct to standard care in colon cancer, randomized trials should be conducted with stratification by BMI, diabetes status, and disease severity, with endpoints spanning overall and cancerspecific survival and major cardiovascular events,” Cuomo said.

“We also need prospective translational studies integrating dosing/timing, adherence, tumor genomics, and serial biomarkers (including ctDNA and metabolic panels) to elucidate mechanisms, assess the role of adiposity and insulin resistance, and identify the patient subgroups most likely to benefit,” he noted.

For now, GLP1 medications are an option in “eligible colon cancer patients with severe obesity or diabetes who meet standard metabolic indications,” Cuomo told this news organization.

Commenting on this study for this news organization, David Greenwald, MD, director of Clinical Gastroenterology and Endoscopy at Icahn School of Medicine at Mount Sinai Hospital in New York City, noted “other studies have showed a lower risk of developing colorectal cancer in the first place and then improved survival.”

Greenwald cited a recent study that found people with diabetes who took GLP-1 RAs had a 44% lower risk of developing colorectal cancer than those who took insulin, and a 25% lower risk than those who took metformin.

The effects of GLP-1s in colon cancer are “very intriguing and very promising but more research is needed to confirm whether this is really true and the mechanisms behind it,” said Greenwald.

In terms of the lowering risk of developing colorectal cancer, “probably first and foremost is that the drugs are really effective in promoting weight loss. And if you can reduce obesity in the population, you do all sorts of good things — reduce diabetes, reduce heart disease, and maybe reduce colorectal cancer,” Greenwald said.

This study had no specific funding. Cuomo and Greenwald had no relevant disclosures.

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

Treatment with a GLP-1 receptor agonist (RA) may offer a survival advantage in patients with colon cancer and obesity.

In a real-world analysis of nearly 7000 patients with colon cancer, those taking a GLP-1 RA were less than half as likely to die within 5 years compared with those who weren’t on a GLP-1 drug.

The association between GLP-1 exposure and lower 5–year mortality in colon cancer was “robust” and appeared to be concentrated in patients with severe obesity (BMI ≥ 35), lead investigator Raphael E. Cuomo, PhD, with University of California San Diego, told this news organization.

The apparent protective effect “persisted after controlling for differences in disease severity and demographics, as well as differences in circulating carcinoembryonic antigen, a biomarker of disease aggressiveness,” Cuomo said.

The study was published online in Cancer Investigation.
 

Effects Beyond Glucose-Lowering

Colon cancer remains a major global cause of cancer-related deaths, and obesity is both a risk factor and a driver of worse outcomes.

Beyond regulating blood sugar, GLP-1 drugs reduce systemic inflammation, improve insulin sensitivity, and promote weight loss. Prior preclinical work has also suggested they may prevent cancer cell growth, trigger cancer cell death, and reshape the tumor microenvironment.

To investigate further, Cuomo analyzed electronic health records of 6871 patients diagnosed with primary colon cancer before 2019 — of which 103 had at least 1 documented prescription for a GLP-1 drug within 5 years of diagnosis.

Five–year mortality was significantly lower in GLP-1 RA users than in nonusers (15.5% vs 37.1%; P < .001). A significant reduction in 5–year mortality among GLP-1 RA users was evident in an unadjusted model (odds ratio [OR], 0.38; P < .001) and persisted in fully adjusted models (OR, 0.28; P < .001).

When stratified by BMI, the odds of 5-year mortality with GLP-1 use was reduced only in patients with Class II obesity (BMI ≥ 35: fully adjusted hazard ratio [HR], 0.051; P = .004). In this group, fully adjusted hazard ratios suggested markedly lower risk for death (HR, 0.07; P = .009).

Beyond mortality, GLP-1 users also experienced fewer late cardiovascular events and had fewer markers of advanced colon cancer progression in the final months of follow-up, “which suggests that GLP-1 drugs exert benefits through both oncologic and cardiometabolic pathways,” Cuomo told this news organization.
 

Intriguing and Promising — but Further Studies Needed

“To further study the potential of GLP-1 therapy as an adjunct to standard care in colon cancer, randomized trials should be conducted with stratification by BMI, diabetes status, and disease severity, with endpoints spanning overall and cancerspecific survival and major cardiovascular events,” Cuomo said.

“We also need prospective translational studies integrating dosing/timing, adherence, tumor genomics, and serial biomarkers (including ctDNA and metabolic panels) to elucidate mechanisms, assess the role of adiposity and insulin resistance, and identify the patient subgroups most likely to benefit,” he noted.

For now, GLP1 medications are an option in “eligible colon cancer patients with severe obesity or diabetes who meet standard metabolic indications,” Cuomo told this news organization.

Commenting on this study for this news organization, David Greenwald, MD, director of Clinical Gastroenterology and Endoscopy at Icahn School of Medicine at Mount Sinai Hospital in New York City, noted “other studies have showed a lower risk of developing colorectal cancer in the first place and then improved survival.”

Greenwald cited a recent study that found people with diabetes who took GLP-1 RAs had a 44% lower risk of developing colorectal cancer than those who took insulin, and a 25% lower risk than those who took metformin.

The effects of GLP-1s in colon cancer are “very intriguing and very promising but more research is needed to confirm whether this is really true and the mechanisms behind it,” said Greenwald.

In terms of the lowering risk of developing colorectal cancer, “probably first and foremost is that the drugs are really effective in promoting weight loss. And if you can reduce obesity in the population, you do all sorts of good things — reduce diabetes, reduce heart disease, and maybe reduce colorectal cancer,” Greenwald said.

This study had no specific funding. Cuomo and Greenwald had no relevant disclosures.

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

Treatment with a GLP-1 receptor agonist (RA) may offer a survival advantage in patients with colon cancer and obesity.

In a real-world analysis of nearly 7000 patients with colon cancer, those taking a GLP-1 RA were less than half as likely to die within 5 years compared with those who weren’t on a GLP-1 drug.

The association between GLP-1 exposure and lower 5–year mortality in colon cancer was “robust” and appeared to be concentrated in patients with severe obesity (BMI ≥ 35), lead investigator Raphael E. Cuomo, PhD, with University of California San Diego, told this news organization.

The apparent protective effect “persisted after controlling for differences in disease severity and demographics, as well as differences in circulating carcinoembryonic antigen, a biomarker of disease aggressiveness,” Cuomo said.

The study was published online in Cancer Investigation.
 

Effects Beyond Glucose-Lowering

Colon cancer remains a major global cause of cancer-related deaths, and obesity is both a risk factor and a driver of worse outcomes.

Beyond regulating blood sugar, GLP-1 drugs reduce systemic inflammation, improve insulin sensitivity, and promote weight loss. Prior preclinical work has also suggested they may prevent cancer cell growth, trigger cancer cell death, and reshape the tumor microenvironment.

To investigate further, Cuomo analyzed electronic health records of 6871 patients diagnosed with primary colon cancer before 2019 — of which 103 had at least 1 documented prescription for a GLP-1 drug within 5 years of diagnosis.

Five–year mortality was significantly lower in GLP-1 RA users than in nonusers (15.5% vs 37.1%; P < .001). A significant reduction in 5–year mortality among GLP-1 RA users was evident in an unadjusted model (odds ratio [OR], 0.38; P < .001) and persisted in fully adjusted models (OR, 0.28; P < .001).

When stratified by BMI, the odds of 5-year mortality with GLP-1 use was reduced only in patients with Class II obesity (BMI ≥ 35: fully adjusted hazard ratio [HR], 0.051; P = .004). In this group, fully adjusted hazard ratios suggested markedly lower risk for death (HR, 0.07; P = .009).

Beyond mortality, GLP-1 users also experienced fewer late cardiovascular events and had fewer markers of advanced colon cancer progression in the final months of follow-up, “which suggests that GLP-1 drugs exert benefits through both oncologic and cardiometabolic pathways,” Cuomo told this news organization.
 

Intriguing and Promising — but Further Studies Needed

“To further study the potential of GLP-1 therapy as an adjunct to standard care in colon cancer, randomized trials should be conducted with stratification by BMI, diabetes status, and disease severity, with endpoints spanning overall and cancerspecific survival and major cardiovascular events,” Cuomo said.

“We also need prospective translational studies integrating dosing/timing, adherence, tumor genomics, and serial biomarkers (including ctDNA and metabolic panels) to elucidate mechanisms, assess the role of adiposity and insulin resistance, and identify the patient subgroups most likely to benefit,” he noted.

For now, GLP1 medications are an option in “eligible colon cancer patients with severe obesity or diabetes who meet standard metabolic indications,” Cuomo told this news organization.

Commenting on this study for this news organization, David Greenwald, MD, director of Clinical Gastroenterology and Endoscopy at Icahn School of Medicine at Mount Sinai Hospital in New York City, noted “other studies have showed a lower risk of developing colorectal cancer in the first place and then improved survival.”

Greenwald cited a recent study that found people with diabetes who took GLP-1 RAs had a 44% lower risk of developing colorectal cancer than those who took insulin, and a 25% lower risk than those who took metformin.

The effects of GLP-1s in colon cancer are “very intriguing and very promising but more research is needed to confirm whether this is really true and the mechanisms behind it,” said Greenwald.

In terms of the lowering risk of developing colorectal cancer, “probably first and foremost is that the drugs are really effective in promoting weight loss. And if you can reduce obesity in the population, you do all sorts of good things — reduce diabetes, reduce heart disease, and maybe reduce colorectal cancer,” Greenwald said.

This study had no specific funding. Cuomo and Greenwald had no relevant disclosures.

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

Recent studies have cited an alarming increase in early-onset colorectal cancer (CRC) rates, raising concern among gastroenterologists, public health experts, and patients alike. Approximately 10% of CRC cases now occur in those under age 50, and that proportion continues to grow. Between 2000 and 2016, colon cancer rose by 13% and rectal cancer by 16% among those aged 40–49.

According to recently published data from the Surveillance, Epidemiology and End Results Program, between 2019 and 2022, CRC incidence among patients aged 45–49 rose by approximately 12% per year. 
 

A Potential Bacterial Connection

What accounts for this disturbing spike? A research group from the University of California, San Diego, may have uncovered part of the answer.

In their study of 981 CRC genomes, most carried mutations suggestive of prior exposure to colibactin, a toxin produced by certain Escherichia coli (E coli) strains. Patients with extremely early-onset CRC (aged < 40 years) were 3 times more likely to have colibactin-suggestive mutations than patients older than 70. Crucially, colonic exposure to colibactin was linked to an adenomatous polyposis coli driver mutation. 

These findings suggest that colibactin-induced injury in the gut microbiome may accelerate cancer development in some individuals. Environmental factors may contribute to the rise in early-onset CRC as well, such as consuming red meats, carcinogens from grilling, and processed meats and other highly processed foods; low fiber intake; lack of fruits and vegetables; drinking alcohol; lack of exercise; obesity; and colibactin exposure. 

In this video, we will take a closer look at how E coli and colibactin may increase CRC risk.
 

Bacteria’s Cancer-Causing Properties

The idea that bacteria has cancer-causing properties isn’t new. In the 1970s, researchers linked Streptococcus bovis type 1 (now called Streptococcus gallolyticus) to CRC in a subset of patients with bacterial endocarditis stemming from right-sided colon cancer. Similarly, Helicobacter pylori infection has long been associated with increased gastric cancer risk. 

Today, E coli infection is emerging as another possible contributor to CRC, especially via certain pathogenic strains containing the polyketide synthase (pks) genomic island, which encodes the colibactin and is sometimes present in the colon mucosa of patients with CRC.
 

Colibactin and DNA Damage

Colibactin-producing pks+ E coli strains can cause DNA double-strand breaks, one pathway to carcinogenesis. In animal studies, pks+ E coli strains have been linked to both increased risk for CRC and CRC progression.

In an important study published in Nature, Pleguezuelos-Manzano and colleagues repeatedly exposed intestinal organoids to pks+ E coli over 5 months and then performed whole genome sequencing. The result was a concerning potential for short insertions and deletions and single–base substitutions. 

The authors concluded that their “study describes the distinct mutational signature in colorectal cancer and implies that the underlying mutational process results directly from past exposure to bacteria carrying the colibactin-producing pks pathogenicity island.”

Other E coli virulence factors may also contribute. For example, alpha-hemolysin may downregulate DNA mismatch repair proteins. In other words, E coli is probably just a contributing factor for the development of CRC, not the sole cause. 
 

Biofilms and Inflammation

Previous studies have associated dense bacterial biofilms, particularly antibiotic-resistant strains, with CRC. This raises the possibility that widespread antibiotic overuse could predispose certain individuals to CRC development.

Biofilms normally separate the colon mucosal epithelium from bacteria and are essential for protecting against inflammation. In a 2018 study in Science, Dejea and colleagues concluded that “tumor-prone mice colonized with E coli (expressing colibactin), and enterotoxigenic B fragilis showed increased interleukin-17 in the colon and DNA damage in colonic epithelium with faster tumor onset and greater mortality, compared to mice with either bacteria strain alone. These data suggest an unexpected link between early neoplasia of the colon and tumorigenic bacteria.” 

Additional research revealed that E coli can create a pro-carcinogenic environment by stimulating mucosal inflammation, hindering DNA and mismatch repair mechanisms, and altering immune responses.
 

Dysbiosis and Diet

Colibactin can also drive dysbiosis and imbalance in bacteria in the colon, which fuels inflammation and disrupts mucosal barrier integrity. This creates a vicious cycle in which chronic inflammation can further drive additional mucus deterioration and dysbiosis.

In mouse models where the colon mucosal barrier is damaged with dextrin sulfate sodium (DSS), pks+ E coli gains better access to colon epithelium, causes injury, and can even lead to chronic colitis. Colibactin can also hinder epithelial recovery after DSS treatment. 

Diet plays a central role in this process. Low fiber consumption can disrupt the barrier between the colon mucus layer and the colon’s exterior layer where bacteria live. A traditional Western diet may bolster bacteria that degrade the mucus layer when the bacteria consume the glycosylated portion as an energy source.

Fortunately, diet is modifiable. High–fiber diets (ideally 25-30 g/d) boost short–chain fatty acids in the colon. This is important because short-chain fatty acids can decrease intercellular pH and impede Enterobacteriaceae replication, yet another reason why we should encourage patients to eat a diet high in vegetables, fruits, and [green] salads. 
 

Two Types of Bacterial Drivers 

There appear to be two broad types of bacteria associated with CRC development. It’s been hypothesized that there are “driver” bacteria that might initiate the development of CRC, possibly by creating oxidative stress and causing DNA breaks. Several potential pathogenic bacteria have been identified, including E coli, Enterococcus faecalis, and Bacteroides fragilis. Unfortunately, there are also bacteria such as Fusobacterium species and Streptococcus gallolyticus with the potential to alter intestinal permeability, resulting in downstream effects that can allow colon cancers to expand. Fusobacterium species and Streptococcus gallolyticus have the potential to cause DNA double–strand breaks in the intestine, which can produce chromosomal precariousness. 

These secondary bacteria can also lead to DNA epigenetic changes and gene mutations. However, it should be emphasized that “the direct causation of imprinted DNA changes resulting from a direct interaction between bacteria and host cells is not so far established.”

E coli produces compounds called cyclomodulins, which can cause DNA breaks and potentially trigger cell cycle arrest and even cell death through activation of the DNA damage checkpoint pathway. The DNA damage checkpoint pathway is a cellular signaling network that helps detect DNA lesions and allows for genetic stability by stopping growth to allow for repair and simulating cell survival or apoptosis. A key cyclomodulin that E coli makes is colibactin, produced by the pks locus. Other cyclomodulins include cytolethal distending toxin, cytotoxic necrotizing factor, and cycle-inhibiting factor. 

Previous research has shown that E coli is the only culturable bacteria found near CRC. A groundbreaking 1998 study employing PCR technology found E coli in 60% of colon polyp adenomas and an alarming 77% of CRC biopsies. 

E coli’s capability to downregulate essential DNA mismatch repair proteins has been implicated in colorectal carcinogenesis. Interestingly, when the genetic region responsible for producing colibactin is deleted in animals, the bacteria aren’t able to promote cancer.

Mechanistically, colibactin causes double-stranded DNA breaks, eukaryotic cell cycle arrest, and chromosome abnormalities. It also alkylates DNA. This occurs when the cyclopropane ring of colibactin interacts with the N3 position of adenine in DNA, forming a covalent bond and creating a DNA adduct. DNA adducts occur when a chemical moiety from an environmental or dietary source binds to DNA base. Colibactin can cause DNA interstrand cross-links to form via alkalization of adenine residues on opposing DNA strands, a crucial step in DNA damage. DNA adducts can occur through carcinogens in N-nitroso compounds, such as in processed meats and in polycyclic aromatic hydrocarbons found in cigarette smoke. Colibactin-induced damage may also stimulate the senescence–associated secretory phenotype pathway, increasing proinflammatory cytokines.
 

E coli and Inflammatory Bowel Disease 

E coli, the primary colibactin producer in the human intestinal microbiome, is found at higher bacterial percentages in the microbiomes of patients with inflammatory bowel disease (IBD). In a study by Dubinsky and colleagues, “the medium relative levels of colibactin–encoding E. coli were about threefold higher in IBD.”

Researchers have also postulated that antibiotics and microbiome dysbiosis may create conditions that allow colibactin–producing bacteria to overpopulate.
 

Future Directions

Not every patient with CRC carries a colorectal mutational signature, but these findings underscore the need for continued vigilance and prevention. 

From a public health standpoint, our advice remains consistent: Promote high-fiber diets with more vegetables and less red meat; avoid highly processed foods; avoid alcohol; encourage exercise; and address overweight and obesity. Our goal is to create the best possible colon environment to prevent DNA damage from bacterial and environmental carcinogens.

In the future, we need more research to clarify exactly how E coli and colibactin increase early–onset CRC risk and whether antibiotics and dysbiosis facilitate their ability to damage the DNA of colon mucosa. It’s still unclear why younger patients are at greater risk. In time, we may be able to screen for colibactin–producing bacteria such as E coli and manipulate the fecal microbiome to prevent damage. 

A recent mouse study in Nature by Jans and colleagues suggests it might be possible to block bacterial adhesion and hopefully mitigate damage caused by colibactin. With continued work, colibactin–targeted strategies could become a part of CRC prevention.

Benjamin H. Levy III, MD, is a gastroenterologist at the University of Chicago. In 2017, Levy, a previous Fulbright Fellow in France, also started a gastroenterology clinic for refugees resettling in Chicago. His clinical projects focus on the development of colorectal cancer screening campaigns. Levy, who gave a TEDx Talk about building health education campaigns using music and concerts, organizes "Tune It Up: A Concert To Raise Colorectal Cancer Awareness" with the American College of Gastroenterology (ACG). He frequently publishes on a variety of gastroenterology topics and serves on ACG’s Public Relations Committee and FDA-Related Matters Committee.

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

Recent studies have cited an alarming increase in early-onset colorectal cancer (CRC) rates, raising concern among gastroenterologists, public health experts, and patients alike. Approximately 10% of CRC cases now occur in those under age 50, and that proportion continues to grow. Between 2000 and 2016, colon cancer rose by 13% and rectal cancer by 16% among those aged 40–49.

According to recently published data from the Surveillance, Epidemiology and End Results Program, between 2019 and 2022, CRC incidence among patients aged 45–49 rose by approximately 12% per year. 
 

A Potential Bacterial Connection

What accounts for this disturbing spike? A research group from the University of California, San Diego, may have uncovered part of the answer.

In their study of 981 CRC genomes, most carried mutations suggestive of prior exposure to colibactin, a toxin produced by certain Escherichia coli (E coli) strains. Patients with extremely early-onset CRC (aged < 40 years) were 3 times more likely to have colibactin-suggestive mutations than patients older than 70. Crucially, colonic exposure to colibactin was linked to an adenomatous polyposis coli driver mutation. 

These findings suggest that colibactin-induced injury in the gut microbiome may accelerate cancer development in some individuals. Environmental factors may contribute to the rise in early-onset CRC as well, such as consuming red meats, carcinogens from grilling, and processed meats and other highly processed foods; low fiber intake; lack of fruits and vegetables; drinking alcohol; lack of exercise; obesity; and colibactin exposure. 

In this video, we will take a closer look at how E coli and colibactin may increase CRC risk.
 

Bacteria’s Cancer-Causing Properties

The idea that bacteria has cancer-causing properties isn’t new. In the 1970s, researchers linked Streptococcus bovis type 1 (now called Streptococcus gallolyticus) to CRC in a subset of patients with bacterial endocarditis stemming from right-sided colon cancer. Similarly, Helicobacter pylori infection has long been associated with increased gastric cancer risk. 

Today, E coli infection is emerging as another possible contributor to CRC, especially via certain pathogenic strains containing the polyketide synthase (pks) genomic island, which encodes the colibactin and is sometimes present in the colon mucosa of patients with CRC.
 

Colibactin and DNA Damage

Colibactin-producing pks+ E coli strains can cause DNA double-strand breaks, one pathway to carcinogenesis. In animal studies, pks+ E coli strains have been linked to both increased risk for CRC and CRC progression.

In an important study published in Nature, Pleguezuelos-Manzano and colleagues repeatedly exposed intestinal organoids to pks+ E coli over 5 months and then performed whole genome sequencing. The result was a concerning potential for short insertions and deletions and single–base substitutions. 

The authors concluded that their “study describes the distinct mutational signature in colorectal cancer and implies that the underlying mutational process results directly from past exposure to bacteria carrying the colibactin-producing pks pathogenicity island.”

Other E coli virulence factors may also contribute. For example, alpha-hemolysin may downregulate DNA mismatch repair proteins. In other words, E coli is probably just a contributing factor for the development of CRC, not the sole cause. 
 

Biofilms and Inflammation

Previous studies have associated dense bacterial biofilms, particularly antibiotic-resistant strains, with CRC. This raises the possibility that widespread antibiotic overuse could predispose certain individuals to CRC development.

Biofilms normally separate the colon mucosal epithelium from bacteria and are essential for protecting against inflammation. In a 2018 study in Science, Dejea and colleagues concluded that “tumor-prone mice colonized with E coli (expressing colibactin), and enterotoxigenic B fragilis showed increased interleukin-17 in the colon and DNA damage in colonic epithelium with faster tumor onset and greater mortality, compared to mice with either bacteria strain alone. These data suggest an unexpected link between early neoplasia of the colon and tumorigenic bacteria.” 

Additional research revealed that E coli can create a pro-carcinogenic environment by stimulating mucosal inflammation, hindering DNA and mismatch repair mechanisms, and altering immune responses.
 

Dysbiosis and Diet

Colibactin can also drive dysbiosis and imbalance in bacteria in the colon, which fuels inflammation and disrupts mucosal barrier integrity. This creates a vicious cycle in which chronic inflammation can further drive additional mucus deterioration and dysbiosis.

In mouse models where the colon mucosal barrier is damaged with dextrin sulfate sodium (DSS), pks+ E coli gains better access to colon epithelium, causes injury, and can even lead to chronic colitis. Colibactin can also hinder epithelial recovery after DSS treatment. 

Diet plays a central role in this process. Low fiber consumption can disrupt the barrier between the colon mucus layer and the colon’s exterior layer where bacteria live. A traditional Western diet may bolster bacteria that degrade the mucus layer when the bacteria consume the glycosylated portion as an energy source.

Fortunately, diet is modifiable. High–fiber diets (ideally 25-30 g/d) boost short–chain fatty acids in the colon. This is important because short-chain fatty acids can decrease intercellular pH and impede Enterobacteriaceae replication, yet another reason why we should encourage patients to eat a diet high in vegetables, fruits, and [green] salads. 
 

Two Types of Bacterial Drivers 

There appear to be two broad types of bacteria associated with CRC development. It’s been hypothesized that there are “driver” bacteria that might initiate the development of CRC, possibly by creating oxidative stress and causing DNA breaks. Several potential pathogenic bacteria have been identified, including E coli, Enterococcus faecalis, and Bacteroides fragilis. Unfortunately, there are also bacteria such as Fusobacterium species and Streptococcus gallolyticus with the potential to alter intestinal permeability, resulting in downstream effects that can allow colon cancers to expand. Fusobacterium species and Streptococcus gallolyticus have the potential to cause DNA double–strand breaks in the intestine, which can produce chromosomal precariousness. 

These secondary bacteria can also lead to DNA epigenetic changes and gene mutations. However, it should be emphasized that “the direct causation of imprinted DNA changes resulting from a direct interaction between bacteria and host cells is not so far established.”

E coli produces compounds called cyclomodulins, which can cause DNA breaks and potentially trigger cell cycle arrest and even cell death through activation of the DNA damage checkpoint pathway. The DNA damage checkpoint pathway is a cellular signaling network that helps detect DNA lesions and allows for genetic stability by stopping growth to allow for repair and simulating cell survival or apoptosis. A key cyclomodulin that E coli makes is colibactin, produced by the pks locus. Other cyclomodulins include cytolethal distending toxin, cytotoxic necrotizing factor, and cycle-inhibiting factor. 

Previous research has shown that E coli is the only culturable bacteria found near CRC. A groundbreaking 1998 study employing PCR technology found E coli in 60% of colon polyp adenomas and an alarming 77% of CRC biopsies. 

E coli’s capability to downregulate essential DNA mismatch repair proteins has been implicated in colorectal carcinogenesis. Interestingly, when the genetic region responsible for producing colibactin is deleted in animals, the bacteria aren’t able to promote cancer.

Mechanistically, colibactin causes double-stranded DNA breaks, eukaryotic cell cycle arrest, and chromosome abnormalities. It also alkylates DNA. This occurs when the cyclopropane ring of colibactin interacts with the N3 position of adenine in DNA, forming a covalent bond and creating a DNA adduct. DNA adducts occur when a chemical moiety from an environmental or dietary source binds to DNA base. Colibactin can cause DNA interstrand cross-links to form via alkalization of adenine residues on opposing DNA strands, a crucial step in DNA damage. DNA adducts can occur through carcinogens in N-nitroso compounds, such as in processed meats and in polycyclic aromatic hydrocarbons found in cigarette smoke. Colibactin-induced damage may also stimulate the senescence–associated secretory phenotype pathway, increasing proinflammatory cytokines.
 

E coli and Inflammatory Bowel Disease 

E coli, the primary colibactin producer in the human intestinal microbiome, is found at higher bacterial percentages in the microbiomes of patients with inflammatory bowel disease (IBD). In a study by Dubinsky and colleagues, “the medium relative levels of colibactin–encoding E. coli were about threefold higher in IBD.”

Researchers have also postulated that antibiotics and microbiome dysbiosis may create conditions that allow colibactin–producing bacteria to overpopulate.
 

Future Directions

Not every patient with CRC carries a colorectal mutational signature, but these findings underscore the need for continued vigilance and prevention. 

From a public health standpoint, our advice remains consistent: Promote high-fiber diets with more vegetables and less red meat; avoid highly processed foods; avoid alcohol; encourage exercise; and address overweight and obesity. Our goal is to create the best possible colon environment to prevent DNA damage from bacterial and environmental carcinogens.

In the future, we need more research to clarify exactly how E coli and colibactin increase early–onset CRC risk and whether antibiotics and dysbiosis facilitate their ability to damage the DNA of colon mucosa. It’s still unclear why younger patients are at greater risk. In time, we may be able to screen for colibactin–producing bacteria such as E coli and manipulate the fecal microbiome to prevent damage. 

A recent mouse study in Nature by Jans and colleagues suggests it might be possible to block bacterial adhesion and hopefully mitigate damage caused by colibactin. With continued work, colibactin–targeted strategies could become a part of CRC prevention.

Benjamin H. Levy III, MD, is a gastroenterologist at the University of Chicago. In 2017, Levy, a previous Fulbright Fellow in France, also started a gastroenterology clinic for refugees resettling in Chicago. His clinical projects focus on the development of colorectal cancer screening campaigns. Levy, who gave a TEDx Talk about building health education campaigns using music and concerts, organizes "Tune It Up: A Concert To Raise Colorectal Cancer Awareness" with the American College of Gastroenterology (ACG). He frequently publishes on a variety of gastroenterology topics and serves on ACG’s Public Relations Committee and FDA-Related Matters Committee.

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

Recent studies have cited an alarming increase in early-onset colorectal cancer (CRC) rates, raising concern among gastroenterologists, public health experts, and patients alike. Approximately 10% of CRC cases now occur in those under age 50, and that proportion continues to grow. Between 2000 and 2016, colon cancer rose by 13% and rectal cancer by 16% among those aged 40–49.

According to recently published data from the Surveillance, Epidemiology and End Results Program, between 2019 and 2022, CRC incidence among patients aged 45–49 rose by approximately 12% per year. 
 

A Potential Bacterial Connection

What accounts for this disturbing spike? A research group from the University of California, San Diego, may have uncovered part of the answer.

In their study of 981 CRC genomes, most carried mutations suggestive of prior exposure to colibactin, a toxin produced by certain Escherichia coli (E coli) strains. Patients with extremely early-onset CRC (aged < 40 years) were 3 times more likely to have colibactin-suggestive mutations than patients older than 70. Crucially, colonic exposure to colibactin was linked to an adenomatous polyposis coli driver mutation. 

These findings suggest that colibactin-induced injury in the gut microbiome may accelerate cancer development in some individuals. Environmental factors may contribute to the rise in early-onset CRC as well, such as consuming red meats, carcinogens from grilling, and processed meats and other highly processed foods; low fiber intake; lack of fruits and vegetables; drinking alcohol; lack of exercise; obesity; and colibactin exposure. 

In this video, we will take a closer look at how E coli and colibactin may increase CRC risk.
 

Bacteria’s Cancer-Causing Properties

The idea that bacteria has cancer-causing properties isn’t new. In the 1970s, researchers linked Streptococcus bovis type 1 (now called Streptococcus gallolyticus) to CRC in a subset of patients with bacterial endocarditis stemming from right-sided colon cancer. Similarly, Helicobacter pylori infection has long been associated with increased gastric cancer risk. 

Today, E coli infection is emerging as another possible contributor to CRC, especially via certain pathogenic strains containing the polyketide synthase (pks) genomic island, which encodes the colibactin and is sometimes present in the colon mucosa of patients with CRC.
 

Colibactin and DNA Damage

Colibactin-producing pks+ E coli strains can cause DNA double-strand breaks, one pathway to carcinogenesis. In animal studies, pks+ E coli strains have been linked to both increased risk for CRC and CRC progression.

In an important study published in Nature, Pleguezuelos-Manzano and colleagues repeatedly exposed intestinal organoids to pks+ E coli over 5 months and then performed whole genome sequencing. The result was a concerning potential for short insertions and deletions and single–base substitutions. 

The authors concluded that their “study describes the distinct mutational signature in colorectal cancer and implies that the underlying mutational process results directly from past exposure to bacteria carrying the colibactin-producing pks pathogenicity island.”

Other E coli virulence factors may also contribute. For example, alpha-hemolysin may downregulate DNA mismatch repair proteins. In other words, E coli is probably just a contributing factor for the development of CRC, not the sole cause. 
 

Biofilms and Inflammation

Previous studies have associated dense bacterial biofilms, particularly antibiotic-resistant strains, with CRC. This raises the possibility that widespread antibiotic overuse could predispose certain individuals to CRC development.

Biofilms normally separate the colon mucosal epithelium from bacteria and are essential for protecting against inflammation. In a 2018 study in Science, Dejea and colleagues concluded that “tumor-prone mice colonized with E coli (expressing colibactin), and enterotoxigenic B fragilis showed increased interleukin-17 in the colon and DNA damage in colonic epithelium with faster tumor onset and greater mortality, compared to mice with either bacteria strain alone. These data suggest an unexpected link between early neoplasia of the colon and tumorigenic bacteria.” 

Additional research revealed that E coli can create a pro-carcinogenic environment by stimulating mucosal inflammation, hindering DNA and mismatch repair mechanisms, and altering immune responses.
 

Dysbiosis and Diet

Colibactin can also drive dysbiosis and imbalance in bacteria in the colon, which fuels inflammation and disrupts mucosal barrier integrity. This creates a vicious cycle in which chronic inflammation can further drive additional mucus deterioration and dysbiosis.

In mouse models where the colon mucosal barrier is damaged with dextrin sulfate sodium (DSS), pks+ E coli gains better access to colon epithelium, causes injury, and can even lead to chronic colitis. Colibactin can also hinder epithelial recovery after DSS treatment. 

Diet plays a central role in this process. Low fiber consumption can disrupt the barrier between the colon mucus layer and the colon’s exterior layer where bacteria live. A traditional Western diet may bolster bacteria that degrade the mucus layer when the bacteria consume the glycosylated portion as an energy source.

Fortunately, diet is modifiable. High–fiber diets (ideally 25-30 g/d) boost short–chain fatty acids in the colon. This is important because short-chain fatty acids can decrease intercellular pH and impede Enterobacteriaceae replication, yet another reason why we should encourage patients to eat a diet high in vegetables, fruits, and [green] salads. 
 

Two Types of Bacterial Drivers 

There appear to be two broad types of bacteria associated with CRC development. It’s been hypothesized that there are “driver” bacteria that might initiate the development of CRC, possibly by creating oxidative stress and causing DNA breaks. Several potential pathogenic bacteria have been identified, including E coli, Enterococcus faecalis, and Bacteroides fragilis. Unfortunately, there are also bacteria such as Fusobacterium species and Streptococcus gallolyticus with the potential to alter intestinal permeability, resulting in downstream effects that can allow colon cancers to expand. Fusobacterium species and Streptococcus gallolyticus have the potential to cause DNA double–strand breaks in the intestine, which can produce chromosomal precariousness. 

These secondary bacteria can also lead to DNA epigenetic changes and gene mutations. However, it should be emphasized that “the direct causation of imprinted DNA changes resulting from a direct interaction between bacteria and host cells is not so far established.”

E coli produces compounds called cyclomodulins, which can cause DNA breaks and potentially trigger cell cycle arrest and even cell death through activation of the DNA damage checkpoint pathway. The DNA damage checkpoint pathway is a cellular signaling network that helps detect DNA lesions and allows for genetic stability by stopping growth to allow for repair and simulating cell survival or apoptosis. A key cyclomodulin that E coli makes is colibactin, produced by the pks locus. Other cyclomodulins include cytolethal distending toxin, cytotoxic necrotizing factor, and cycle-inhibiting factor. 

Previous research has shown that E coli is the only culturable bacteria found near CRC. A groundbreaking 1998 study employing PCR technology found E coli in 60% of colon polyp adenomas and an alarming 77% of CRC biopsies. 

E coli’s capability to downregulate essential DNA mismatch repair proteins has been implicated in colorectal carcinogenesis. Interestingly, when the genetic region responsible for producing colibactin is deleted in animals, the bacteria aren’t able to promote cancer.

Mechanistically, colibactin causes double-stranded DNA breaks, eukaryotic cell cycle arrest, and chromosome abnormalities. It also alkylates DNA. This occurs when the cyclopropane ring of colibactin interacts with the N3 position of adenine in DNA, forming a covalent bond and creating a DNA adduct. DNA adducts occur when a chemical moiety from an environmental or dietary source binds to DNA base. Colibactin can cause DNA interstrand cross-links to form via alkalization of adenine residues on opposing DNA strands, a crucial step in DNA damage. DNA adducts can occur through carcinogens in N-nitroso compounds, such as in processed meats and in polycyclic aromatic hydrocarbons found in cigarette smoke. Colibactin-induced damage may also stimulate the senescence–associated secretory phenotype pathway, increasing proinflammatory cytokines.
 

E coli and Inflammatory Bowel Disease 

E coli, the primary colibactin producer in the human intestinal microbiome, is found at higher bacterial percentages in the microbiomes of patients with inflammatory bowel disease (IBD). In a study by Dubinsky and colleagues, “the medium relative levels of colibactin–encoding E. coli were about threefold higher in IBD.”

Researchers have also postulated that antibiotics and microbiome dysbiosis may create conditions that allow colibactin–producing bacteria to overpopulate.
 

Future Directions

Not every patient with CRC carries a colorectal mutational signature, but these findings underscore the need for continued vigilance and prevention. 

From a public health standpoint, our advice remains consistent: Promote high-fiber diets with more vegetables and less red meat; avoid highly processed foods; avoid alcohol; encourage exercise; and address overweight and obesity. Our goal is to create the best possible colon environment to prevent DNA damage from bacterial and environmental carcinogens.

In the future, we need more research to clarify exactly how E coli and colibactin increase early–onset CRC risk and whether antibiotics and dysbiosis facilitate their ability to damage the DNA of colon mucosa. It’s still unclear why younger patients are at greater risk. In time, we may be able to screen for colibactin–producing bacteria such as E coli and manipulate the fecal microbiome to prevent damage. 

A recent mouse study in Nature by Jans and colleagues suggests it might be possible to block bacterial adhesion and hopefully mitigate damage caused by colibactin. With continued work, colibactin–targeted strategies could become a part of CRC prevention.

Benjamin H. Levy III, MD, is a gastroenterologist at the University of Chicago. In 2017, Levy, a previous Fulbright Fellow in France, also started a gastroenterology clinic for refugees resettling in Chicago. His clinical projects focus on the development of colorectal cancer screening campaigns. Levy, who gave a TEDx Talk about building health education campaigns using music and concerts, organizes "Tune It Up: A Concert To Raise Colorectal Cancer Awareness" with the American College of Gastroenterology (ACG). He frequently publishes on a variety of gastroenterology topics and serves on ACG’s Public Relations Committee and FDA-Related Matters Committee.

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

TOPLINE: 

Electronic health records patient portal signup rates were lower among vulnerable oncology patients at 64%, compared with 87% in nonvulnerable patients. Once adopted, both groups showed comparable meaningful use patterns. Non-English language emerged as a significant barrier to initial portal signup.

METHODOLOGY:

• Portal usage disparities persist across age, race, ethnicity, and health literacy groups, particularly at the initial signup stage.
• Oral anticancer medications represent a new frontier in cancer therapy, offering convenience but requiring high medication adherence and vigilant self-monitoring of symptoms.
• Researchers conducted a retrospective analysis of 280 patients who had recently started taking an oral anticancer medication at Tufts Medical Center, Boston, between October 2022 and March 2024.
• Vulnerability criteria included having an age ≥ 75 years, a non-English language preference, or subsidized insurance (Medicaid only or Medicare with Medicaid as secondary insurance).
• Analysis defined active portal use as having at least one message, while meaningful use was characterized by patient-provider bidirectional messaging.
• Portal messaging proxy use was determined through message content screening, particularly when non-English speaking patients sent messages in English or when message content indicated proxy use.

TAKEAWAY:

• Among the study population, 56% met vulnerability criteria, with 20% aged at least 75 years, 26% having a non-English language, and 30% having subsidized insurance.
• Non-English language was associated with lower portal signup rates (odds ratio [OR], 0.27; 95% CI, 0.15-0.49; P < .0001), whereas age and insurance status showed no significant association.
• Proxy messaging was utilized by 17% of vulnerable patients who signed up for the portal compared to 2.8% of nonvulnerable patients.
• Among patients who signed up for the portal, 31% used it specifically for communication about oral anticancer medications.

IN PRACTICE:

“Although patient portal signup was lower among vulnerable patients, once adopted, vulnerable patients demonstrated comparable meaningful use and greater proxy engagement. Fostering patient portal adoption requires a targeted approach with patient navigation and patient proxy engagement,” wrote the authors of the study.

SOURCE:

The study was led by Yenong Cao, MD, PhD, Boston Medical Center, Boston. It was published online on November 19 in JCO Oncology Practice.

LIMITATIONS:

The study was limited by its retrospective single-center design at Tufts Medical Center, which serves a large number of non-English, Chinese-speaking patients, potentially affecting the generalizability of findings. Additionally, formal proxy login identification was lacking in the Epic documentation during the study period, which may have led to underestimation of proxy portal use.

DISCLOSURES:

Cao reported being employed at Tufts Medical Center. Johnson Ching, PharmD, CSP, disclosed being employed at Duke University Hospital and SpeciaRx, LLC. Additional disclosures are noted in the original article. 

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

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

TOPLINE: 

Electronic health records patient portal signup rates were lower among vulnerable oncology patients at 64%, compared with 87% in nonvulnerable patients. Once adopted, both groups showed comparable meaningful use patterns. Non-English language emerged as a significant barrier to initial portal signup.

METHODOLOGY:

• Portal usage disparities persist across age, race, ethnicity, and health literacy groups, particularly at the initial signup stage.
• Oral anticancer medications represent a new frontier in cancer therapy, offering convenience but requiring high medication adherence and vigilant self-monitoring of symptoms.
• Researchers conducted a retrospective analysis of 280 patients who had recently started taking an oral anticancer medication at Tufts Medical Center, Boston, between October 2022 and March 2024.
• Vulnerability criteria included having an age ≥ 75 years, a non-English language preference, or subsidized insurance (Medicaid only or Medicare with Medicaid as secondary insurance).
• Analysis defined active portal use as having at least one message, while meaningful use was characterized by patient-provider bidirectional messaging.
• Portal messaging proxy use was determined through message content screening, particularly when non-English speaking patients sent messages in English or when message content indicated proxy use.

TAKEAWAY:

• Among the study population, 56% met vulnerability criteria, with 20% aged at least 75 years, 26% having a non-English language, and 30% having subsidized insurance.
• Non-English language was associated with lower portal signup rates (odds ratio [OR], 0.27; 95% CI, 0.15-0.49; P < .0001), whereas age and insurance status showed no significant association.
• Proxy messaging was utilized by 17% of vulnerable patients who signed up for the portal compared to 2.8% of nonvulnerable patients.
• Among patients who signed up for the portal, 31% used it specifically for communication about oral anticancer medications.

IN PRACTICE:

“Although patient portal signup was lower among vulnerable patients, once adopted, vulnerable patients demonstrated comparable meaningful use and greater proxy engagement. Fostering patient portal adoption requires a targeted approach with patient navigation and patient proxy engagement,” wrote the authors of the study.

SOURCE:

The study was led by Yenong Cao, MD, PhD, Boston Medical Center, Boston. It was published online on November 19 in JCO Oncology Practice.

LIMITATIONS:

The study was limited by its retrospective single-center design at Tufts Medical Center, which serves a large number of non-English, Chinese-speaking patients, potentially affecting the generalizability of findings. Additionally, formal proxy login identification was lacking in the Epic documentation during the study period, which may have led to underestimation of proxy portal use.

DISCLOSURES:

Cao reported being employed at Tufts Medical Center. Johnson Ching, PharmD, CSP, disclosed being employed at Duke University Hospital and SpeciaRx, LLC. Additional disclosures are noted in the original article. 

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

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

TOPLINE: 

Electronic health records patient portal signup rates were lower among vulnerable oncology patients at 64%, compared with 87% in nonvulnerable patients. Once adopted, both groups showed comparable meaningful use patterns. Non-English language emerged as a significant barrier to initial portal signup.

METHODOLOGY:

• Portal usage disparities persist across age, race, ethnicity, and health literacy groups, particularly at the initial signup stage.
• Oral anticancer medications represent a new frontier in cancer therapy, offering convenience but requiring high medication adherence and vigilant self-monitoring of symptoms.
• Researchers conducted a retrospective analysis of 280 patients who had recently started taking an oral anticancer medication at Tufts Medical Center, Boston, between October 2022 and March 2024.
• Vulnerability criteria included having an age ≥ 75 years, a non-English language preference, or subsidized insurance (Medicaid only or Medicare with Medicaid as secondary insurance).
• Analysis defined active portal use as having at least one message, while meaningful use was characterized by patient-provider bidirectional messaging.
• Portal messaging proxy use was determined through message content screening, particularly when non-English speaking patients sent messages in English or when message content indicated proxy use.

TAKEAWAY:

• Among the study population, 56% met vulnerability criteria, with 20% aged at least 75 years, 26% having a non-English language, and 30% having subsidized insurance.
• Non-English language was associated with lower portal signup rates (odds ratio [OR], 0.27; 95% CI, 0.15-0.49; P < .0001), whereas age and insurance status showed no significant association.
• Proxy messaging was utilized by 17% of vulnerable patients who signed up for the portal compared to 2.8% of nonvulnerable patients.
• Among patients who signed up for the portal, 31% used it specifically for communication about oral anticancer medications.

IN PRACTICE:

“Although patient portal signup was lower among vulnerable patients, once adopted, vulnerable patients demonstrated comparable meaningful use and greater proxy engagement. Fostering patient portal adoption requires a targeted approach with patient navigation and patient proxy engagement,” wrote the authors of the study.

SOURCE:

The study was led by Yenong Cao, MD, PhD, Boston Medical Center, Boston. It was published online on November 19 in JCO Oncology Practice.

LIMITATIONS:

The study was limited by its retrospective single-center design at Tufts Medical Center, which serves a large number of non-English, Chinese-speaking patients, potentially affecting the generalizability of findings. Additionally, formal proxy login identification was lacking in the Epic documentation during the study period, which may have led to underestimation of proxy portal use.

DISCLOSURES:

Cao reported being employed at Tufts Medical Center. Johnson Ching, PharmD, CSP, disclosed being employed at Duke University Hospital and SpeciaRx, LLC. Additional disclosures are noted in the original article. 

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

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

Jerome Winegarden, MD, had bad news to deliver. A patient’s cancer was progressing, and the patient would need to stop his oral cancer medication. 

That would normally mean tossing a 30-day supply of pills, said Winegarden, an oncologist with Trinity Health, a statewide health system in Michigan.

But not in this case. 

Winegarden pointed to a sign on his exam room wall from YesRx, a nonprofit cancer drug repository program, that read: “Thank you, Michiganders! Donating cancer medication and supportive medication helps patients in Michigan.”

When Winegarden suggested donating the pills to YesRx, the patient was grateful. Turning a bad situation into hope for somebody else is “very powerful for patients,” Winegarden said. “We were going to be able to do something with [the medication], not just destroy it.”

In just 2 years of operation, YesRx has accepted donations and provided oral cancer or supportive care medications worth millions of dollars to nearly 1200 patients, at no cost to them, according to a recent analysis assessing the Michigan-based program. These patients couldn’t afford their prescribed medications or required immediate access and couldn’t wait for insurance approval, the researchers reported. The donated unopened or unused medications would otherwise have been wasted.

“This program is exactly what patients need: a safe way of recycling their unused prescriptions that actually benefits others with cancer,” said Fumiko Chino, MD, associate professor at MD Anderson Cancer Center, Houston, Texas, in a statement on YesRx.
 

Filling a Need

A growing body of research shows that patients with cancer face an increased risk for financial toxicity, given the high costs of oral cancer drugs as well as changes to insurance coverage that may require greater cost sharing by the patient. The financial burden on patients can be significant, with more than half reporting trouble affording their medications, an issue that can lead to persistent medical debt as well as gaps or delays in care that may impact patient outcomes. 

Alongside the affordability problem is one of waste. A 2023 analysis found that the mean cost of drug waste associated with dose reductions or discontinuations of oral anticancer drugs came to $4290 per patient. 

The YesRx program, however, turns that negative into a positive.

If YesRx has a relevant drug in stock, “we can get the medication into the patient’s hands within 24-to-48 hours,” said Maja Gibbons, PharmD, an oncology pharmacy specialist with Corewell Health in Grand Rapids, Michigan.

Facilitating quick access is one key goal of the program, said YesRx co-founder and chief medical officer Emily Mackler, PharmD, who led the recent analysis. “All the things we’re trying to do are to make sure that the patient doesn’t experience those gaps that can really be critical for their outcomes,” Mackler this news organization. 

The drug repository concept has been around for decades. While there is no federal program, 29 states have general drug repository programs, according to the National Conference of State Legislatures. 

One of the oldest repositories, Iowa’s SafeNetRx, which started in 2001, reports that it has given free medications worth $155 million to almost 161,000 patients. SafeNetRx also began a partnership with state cancer centers to boost oral anticancer drug donations. From 2016 to 2022, the repository donated 84,000 chemotherapy doses worth $15 million to patients in need, reported Natalie K. Heater and colleagues at Northwestern University in Health Affairs Scholar.

In addition to Iowa, four other states have cancer drug repositories: Florida, Montana, Nebraska, and Michigan.

Michigan enacted a drug repository law in 2006, but YesRx did not start until 2023. The Michigan Oncology Quality Consortium, Blue Cross Blue Shield of Michigan, Trinity Health, and the Michigan Society of Hematology and Oncology provided funding to get YesRx off the ground. YesRx, which grew from nine sites in 2023 to 105 in July 2025, helps new sites get certified as a repository by the state. 

The program accepts donations of any room-temperature oral cancer or supportive care medication that is in its original, sealed manufacturer packaging and has at least 6 months before it expires. Controlled substances are not eligible, but medications such as anticoagulants and antiemetics are. Donations are sent by overnight delivery to Trinity Pharmacy at Reichert Health. Trinity receives and inspects donations, and redispenses medications for all YesRx participants. 

Nearly 1600 people have donated oral cancer medications, valued at $28.6 million, according to the 2-year look at the program. “I am blown away by how many donations come in,” Mackler this news organization.

In the first 24 months, 1171 patients received, on average, a 1-month supply of a medication worth $18.4 million, at no cost. Slightly more than half (53%) were age 65 or older. The most common diagnoses among recipients were breast cancer (28%), leukemia (18%), lung cancer (12%), and prostate cancer (9%). 

A survey about the program revealed that recipients spanned about 90% of Michigan counties, with around 40% living in rural areas. Survey respondents highlighted the value of YesRx, with most saying it was easy to use and that they could not have provided this assistance without support from the program. 

“YesRx can kind of swoop in,” said Winegarden. When a new prescription presents an issue for a patient, Winegarden checks if YesRx has a 30-day supply of the drug. If it does, patients “can get started on their treatment while we figure out the financial piece of it.”

Gibbons connects with patients in need through oncologists and financial navigators, as well as education sessions she runs for patients starting treatment. The Corewell location in Grand Rapids also holds “YesRx Donation Days,” when patients and caregivers can drop off medications. 

In just over a year, Corewell has provided “more than half a million dollars’ worth of medication to our cancer patients,” she said. “It’s just a large relief for patients to know that this is going to be able to help someone else out,” said Gibbons. 

Many of the cancer drugs “can be challenging for patients to get rid of,” Gibbons said. YesRx “is helping make sure that these medications don’t end up in things like landfills and water systems where they should not be.”

Mackler says she has big plans for expanding access. Next on the agenda is to enlist more practices in rural areas, especially in Michigan’s Upper Peninsula.

“We want to be accessible to anyone in the state with cancer,” said Mackler. “We would love to be able to help other states get to this point as well.”

Winegarden and Gibbons have reported no relevant financial relationships.

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

Jerome Winegarden, MD, had bad news to deliver. A patient’s cancer was progressing, and the patient would need to stop his oral cancer medication. 

That would normally mean tossing a 30-day supply of pills, said Winegarden, an oncologist with Trinity Health, a statewide health system in Michigan.

But not in this case. 

Winegarden pointed to a sign on his exam room wall from YesRx, a nonprofit cancer drug repository program, that read: “Thank you, Michiganders! Donating cancer medication and supportive medication helps patients in Michigan.”

When Winegarden suggested donating the pills to YesRx, the patient was grateful. Turning a bad situation into hope for somebody else is “very powerful for patients,” Winegarden said. “We were going to be able to do something with [the medication], not just destroy it.”

In just 2 years of operation, YesRx has accepted donations and provided oral cancer or supportive care medications worth millions of dollars to nearly 1200 patients, at no cost to them, according to a recent analysis assessing the Michigan-based program. These patients couldn’t afford their prescribed medications or required immediate access and couldn’t wait for insurance approval, the researchers reported. The donated unopened or unused medications would otherwise have been wasted.

“This program is exactly what patients need: a safe way of recycling their unused prescriptions that actually benefits others with cancer,” said Fumiko Chino, MD, associate professor at MD Anderson Cancer Center, Houston, Texas, in a statement on YesRx.
 

Filling a Need

A growing body of research shows that patients with cancer face an increased risk for financial toxicity, given the high costs of oral cancer drugs as well as changes to insurance coverage that may require greater cost sharing by the patient. The financial burden on patients can be significant, with more than half reporting trouble affording their medications, an issue that can lead to persistent medical debt as well as gaps or delays in care that may impact patient outcomes. 

Alongside the affordability problem is one of waste. A 2023 analysis found that the mean cost of drug waste associated with dose reductions or discontinuations of oral anticancer drugs came to $4290 per patient. 

The YesRx program, however, turns that negative into a positive.

If YesRx has a relevant drug in stock, “we can get the medication into the patient’s hands within 24-to-48 hours,” said Maja Gibbons, PharmD, an oncology pharmacy specialist with Corewell Health in Grand Rapids, Michigan.

Facilitating quick access is one key goal of the program, said YesRx co-founder and chief medical officer Emily Mackler, PharmD, who led the recent analysis. “All the things we’re trying to do are to make sure that the patient doesn’t experience those gaps that can really be critical for their outcomes,” Mackler this news organization. 

The drug repository concept has been around for decades. While there is no federal program, 29 states have general drug repository programs, according to the National Conference of State Legislatures. 

One of the oldest repositories, Iowa’s SafeNetRx, which started in 2001, reports that it has given free medications worth $155 million to almost 161,000 patients. SafeNetRx also began a partnership with state cancer centers to boost oral anticancer drug donations. From 2016 to 2022, the repository donated 84,000 chemotherapy doses worth $15 million to patients in need, reported Natalie K. Heater and colleagues at Northwestern University in Health Affairs Scholar.

In addition to Iowa, four other states have cancer drug repositories: Florida, Montana, Nebraska, and Michigan.

Michigan enacted a drug repository law in 2006, but YesRx did not start until 2023. The Michigan Oncology Quality Consortium, Blue Cross Blue Shield of Michigan, Trinity Health, and the Michigan Society of Hematology and Oncology provided funding to get YesRx off the ground. YesRx, which grew from nine sites in 2023 to 105 in July 2025, helps new sites get certified as a repository by the state. 

The program accepts donations of any room-temperature oral cancer or supportive care medication that is in its original, sealed manufacturer packaging and has at least 6 months before it expires. Controlled substances are not eligible, but medications such as anticoagulants and antiemetics are. Donations are sent by overnight delivery to Trinity Pharmacy at Reichert Health. Trinity receives and inspects donations, and redispenses medications for all YesRx participants. 

Nearly 1600 people have donated oral cancer medications, valued at $28.6 million, according to the 2-year look at the program. “I am blown away by how many donations come in,” Mackler this news organization.

In the first 24 months, 1171 patients received, on average, a 1-month supply of a medication worth $18.4 million, at no cost. Slightly more than half (53%) were age 65 or older. The most common diagnoses among recipients were breast cancer (28%), leukemia (18%), lung cancer (12%), and prostate cancer (9%). 

A survey about the program revealed that recipients spanned about 90% of Michigan counties, with around 40% living in rural areas. Survey respondents highlighted the value of YesRx, with most saying it was easy to use and that they could not have provided this assistance without support from the program. 

“YesRx can kind of swoop in,” said Winegarden. When a new prescription presents an issue for a patient, Winegarden checks if YesRx has a 30-day supply of the drug. If it does, patients “can get started on their treatment while we figure out the financial piece of it.”

Gibbons connects with patients in need through oncologists and financial navigators, as well as education sessions she runs for patients starting treatment. The Corewell location in Grand Rapids also holds “YesRx Donation Days,” when patients and caregivers can drop off medications. 

In just over a year, Corewell has provided “more than half a million dollars’ worth of medication to our cancer patients,” she said. “It’s just a large relief for patients to know that this is going to be able to help someone else out,” said Gibbons. 

Many of the cancer drugs “can be challenging for patients to get rid of,” Gibbons said. YesRx “is helping make sure that these medications don’t end up in things like landfills and water systems where they should not be.”

Mackler says she has big plans for expanding access. Next on the agenda is to enlist more practices in rural areas, especially in Michigan’s Upper Peninsula.

“We want to be accessible to anyone in the state with cancer,” said Mackler. “We would love to be able to help other states get to this point as well.”

Winegarden and Gibbons have reported no relevant financial relationships.

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

Jerome Winegarden, MD, had bad news to deliver. A patient’s cancer was progressing, and the patient would need to stop his oral cancer medication. 

That would normally mean tossing a 30-day supply of pills, said Winegarden, an oncologist with Trinity Health, a statewide health system in Michigan.

But not in this case. 

Winegarden pointed to a sign on his exam room wall from YesRx, a nonprofit cancer drug repository program, that read: “Thank you, Michiganders! Donating cancer medication and supportive medication helps patients in Michigan.”

When Winegarden suggested donating the pills to YesRx, the patient was grateful. Turning a bad situation into hope for somebody else is “very powerful for patients,” Winegarden said. “We were going to be able to do something with [the medication], not just destroy it.”

In just 2 years of operation, YesRx has accepted donations and provided oral cancer or supportive care medications worth millions of dollars to nearly 1200 patients, at no cost to them, according to a recent analysis assessing the Michigan-based program. These patients couldn’t afford their prescribed medications or required immediate access and couldn’t wait for insurance approval, the researchers reported. The donated unopened or unused medications would otherwise have been wasted.

“This program is exactly what patients need: a safe way of recycling their unused prescriptions that actually benefits others with cancer,” said Fumiko Chino, MD, associate professor at MD Anderson Cancer Center, Houston, Texas, in a statement on YesRx.
 

Filling a Need

A growing body of research shows that patients with cancer face an increased risk for financial toxicity, given the high costs of oral cancer drugs as well as changes to insurance coverage that may require greater cost sharing by the patient. The financial burden on patients can be significant, with more than half reporting trouble affording their medications, an issue that can lead to persistent medical debt as well as gaps or delays in care that may impact patient outcomes. 

Alongside the affordability problem is one of waste. A 2023 analysis found that the mean cost of drug waste associated with dose reductions or discontinuations of oral anticancer drugs came to $4290 per patient. 

The YesRx program, however, turns that negative into a positive.

If YesRx has a relevant drug in stock, “we can get the medication into the patient’s hands within 24-to-48 hours,” said Maja Gibbons, PharmD, an oncology pharmacy specialist with Corewell Health in Grand Rapids, Michigan.

Facilitating quick access is one key goal of the program, said YesRx co-founder and chief medical officer Emily Mackler, PharmD, who led the recent analysis. “All the things we’re trying to do are to make sure that the patient doesn’t experience those gaps that can really be critical for their outcomes,” Mackler this news organization. 

The drug repository concept has been around for decades. While there is no federal program, 29 states have general drug repository programs, according to the National Conference of State Legislatures. 

One of the oldest repositories, Iowa’s SafeNetRx, which started in 2001, reports that it has given free medications worth $155 million to almost 161,000 patients. SafeNetRx also began a partnership with state cancer centers to boost oral anticancer drug donations. From 2016 to 2022, the repository donated 84,000 chemotherapy doses worth $15 million to patients in need, reported Natalie K. Heater and colleagues at Northwestern University in Health Affairs Scholar.

In addition to Iowa, four other states have cancer drug repositories: Florida, Montana, Nebraska, and Michigan.

Michigan enacted a drug repository law in 2006, but YesRx did not start until 2023. The Michigan Oncology Quality Consortium, Blue Cross Blue Shield of Michigan, Trinity Health, and the Michigan Society of Hematology and Oncology provided funding to get YesRx off the ground. YesRx, which grew from nine sites in 2023 to 105 in July 2025, helps new sites get certified as a repository by the state. 

The program accepts donations of any room-temperature oral cancer or supportive care medication that is in its original, sealed manufacturer packaging and has at least 6 months before it expires. Controlled substances are not eligible, but medications such as anticoagulants and antiemetics are. Donations are sent by overnight delivery to Trinity Pharmacy at Reichert Health. Trinity receives and inspects donations, and redispenses medications for all YesRx participants. 

Nearly 1600 people have donated oral cancer medications, valued at $28.6 million, according to the 2-year look at the program. “I am blown away by how many donations come in,” Mackler this news organization.

In the first 24 months, 1171 patients received, on average, a 1-month supply of a medication worth $18.4 million, at no cost. Slightly more than half (53%) were age 65 or older. The most common diagnoses among recipients were breast cancer (28%), leukemia (18%), lung cancer (12%), and prostate cancer (9%). 

A survey about the program revealed that recipients spanned about 90% of Michigan counties, with around 40% living in rural areas. Survey respondents highlighted the value of YesRx, with most saying it was easy to use and that they could not have provided this assistance without support from the program. 

“YesRx can kind of swoop in,” said Winegarden. When a new prescription presents an issue for a patient, Winegarden checks if YesRx has a 30-day supply of the drug. If it does, patients “can get started on their treatment while we figure out the financial piece of it.”

Gibbons connects with patients in need through oncologists and financial navigators, as well as education sessions she runs for patients starting treatment. The Corewell location in Grand Rapids also holds “YesRx Donation Days,” when patients and caregivers can drop off medications. 

In just over a year, Corewell has provided “more than half a million dollars’ worth of medication to our cancer patients,” she said. “It’s just a large relief for patients to know that this is going to be able to help someone else out,” said Gibbons. 

Many of the cancer drugs “can be challenging for patients to get rid of,” Gibbons said. YesRx “is helping make sure that these medications don’t end up in things like landfills and water systems where they should not be.”

Mackler says she has big plans for expanding access. Next on the agenda is to enlist more practices in rural areas, especially in Michigan’s Upper Peninsula.

“We want to be accessible to anyone in the state with cancer,” said Mackler. “We would love to be able to help other states get to this point as well.”

Winegarden and Gibbons have reported no relevant financial relationships.

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

Beth Cavanaugh, 79, was starting a new medication when she ran into a modern hurdle: Her doctor’s office required all follow–up questions, even those about side effects of the drug, to go through the patient portal.

Cavanaugh said she did not know how to set up or use the system.

“I tried to explain that, but the receptionist said that was the only way to contact the doctor. I felt lost,” said Cavanaugh, a retired psychotherapist near Albany, New York.

Cavanaugh is far from alone. Many older people balk at the idea of communicating with their physicians over the internet. They may have limited digital skills, have physical challenges, or simply prefer human connection.

As medicine leans harder on electronic portals and telehealth, these patients are finding themselves shut out of their own care. Experts warn this approach deepens inequities in access to care and can worsen health outcomes.

Clinicians should “offer options for various types of communication, such as phone calls or texts, because whenever an older adult — or anyone, for that matter — is given a choice, they feel more empowered and more committed to their care,” said Susan Wehry, MD, associate clinical professor at the University of New England College of Osteopathic Medicine in Biddeford, Maine.
 

Tech Support

Use of medical communication tools varies among older adults. One study in JAMA Network Open found nearly two thirds of those older than 65 years who filled out surveys via phone or internet had used a patient portal, while a little under half used telehealth, and only 44% used a medical health application.

Older patients tend to fall into two camps, said Neela Patel, MD, MPH, CMD, chief of the Division of Geriatrics and Supportive Care at the UT Health San Antonio.

Her patients “are at two extremes of the spectrum — some technologically savvy and others with limited digital literacy or limited or no access to the Internet,” Patel, who is also the vice chair of the Health Systems Innovations and Technology Committee of the American Geriatric Society, said.

Patel’s practice has dedicated staff to help patients master certain technologies. For example, a pharmacist teaches patients how to use a glucometer and a blood pressure cuff. Other staff teach them how to use smartphone apps that track blood pressure or glucose.

She usually sees patients in person before offering telehealth as an option, ensuring the person has “enough digital literacy to utilize them and that the patient can see and hear the visit.”

If technological limitations impede a telehealth appointment, clinicians can help patients navigate their computer screen. Patel recounted the story of an older woman who was unable to come to the clinic in person, so had a telehealth visit instead.

“She had trouble hearing me, so I asked her to share her screen with me. I walked her through how to do that. Then I showed her where the ‘volume’ button was located. It turns out her volume was at zero,” Patel said. “Once that was adjusted, we were able to proceed with the appointment.”

Educating older adults on how to use health technology does not have to fall upon clinicians and their staff, according to Wehry. She routinely refers her patients to community resources to help them develop digital skills.

Local libraries and community centers often offer digital education. Some retirement communities and assisted living facilities also have tech support personnel or classes available to residents.

Wehry refers some of her patients to the National Digital Equity Center which teaches older adults how to hold a telehealth visit.

Roughly 90% of Patel’s patients are signed up for the patient portal, but they may not be operating the technology, she said. She advises these patients to ask their children or caregivers for help as appropriate. 

Teaching patients to use the communication technology early on can also be helpful in other ways. If patients who have been technologically proficient start having difficulty, “it’s a clue there may be cognitive changes, and we follow up on those,” Patel said.

Additional resources to help older adults develop digital competence include Cyber Seniors, Older Adults Technology Services, AARP, AARP Find Digital Courses, Area Agencies on Aging, and Senior Navigator.
 

Human Touch

Some older adults may simply want a more traditional means of communicating with their clinician. A review of 29 papers, encompassing over 6200 adults older than 60 years, identified several domains affecting the adoption of healthcare technology, two of which were resistance to new technology and having family or friends that could help with.

Wehry said many older adults “don’t resist this technology because they’re unable to figure out how to use it. Instead, they see the technology as too impersonal.”

One study found many older adults fear technologies may end up replacing face-to-face contact.

“I’m beginning to encourage primary care providers to take a step back and refocus on the doctor-patient relationship. When communication is limited to the technological approach, it can erode trust in that relationship,” Wehry said.

The American Medical Association recommends clinicians “provide a method other than electronic communication for patients who are without technological proficiency or access.”

Some busy clinicians might be concerned phone calls will be too time-consuming, Wehry said. Patients should be informed of hours of phone availability, how much time is allotted to calls, and how many days or hours a response may take. Clinicians might also use tools that allow patients to use their cell phone to text their practice with medical questions.

Cavanaugh ended up finding technological help from a professional organizer whom she hired to help rearrange her closets.

“She’s knowledgeable and patient, and she’s helping me with the portal,” she said. “If I hadn’t serendipitously found the organizer, I’d still be struggling and unable to access proper medical care.”

Wehry and Patel disclosed no relevant financial relationships.

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

Beth Cavanaugh, 79, was starting a new medication when she ran into a modern hurdle: Her doctor’s office required all follow–up questions, even those about side effects of the drug, to go through the patient portal.

Cavanaugh said she did not know how to set up or use the system.

“I tried to explain that, but the receptionist said that was the only way to contact the doctor. I felt lost,” said Cavanaugh, a retired psychotherapist near Albany, New York.

Cavanaugh is far from alone. Many older people balk at the idea of communicating with their physicians over the internet. They may have limited digital skills, have physical challenges, or simply prefer human connection.

As medicine leans harder on electronic portals and telehealth, these patients are finding themselves shut out of their own care. Experts warn this approach deepens inequities in access to care and can worsen health outcomes.

Clinicians should “offer options for various types of communication, such as phone calls or texts, because whenever an older adult — or anyone, for that matter — is given a choice, they feel more empowered and more committed to their care,” said Susan Wehry, MD, associate clinical professor at the University of New England College of Osteopathic Medicine in Biddeford, Maine.
 

Tech Support

Use of medical communication tools varies among older adults. One study in JAMA Network Open found nearly two thirds of those older than 65 years who filled out surveys via phone or internet had used a patient portal, while a little under half used telehealth, and only 44% used a medical health application.

Older patients tend to fall into two camps, said Neela Patel, MD, MPH, CMD, chief of the Division of Geriatrics and Supportive Care at the UT Health San Antonio.

Her patients “are at two extremes of the spectrum — some technologically savvy and others with limited digital literacy or limited or no access to the Internet,” Patel, who is also the vice chair of the Health Systems Innovations and Technology Committee of the American Geriatric Society, said.

Patel’s practice has dedicated staff to help patients master certain technologies. For example, a pharmacist teaches patients how to use a glucometer and a blood pressure cuff. Other staff teach them how to use smartphone apps that track blood pressure or glucose.

She usually sees patients in person before offering telehealth as an option, ensuring the person has “enough digital literacy to utilize them and that the patient can see and hear the visit.”

If technological limitations impede a telehealth appointment, clinicians can help patients navigate their computer screen. Patel recounted the story of an older woman who was unable to come to the clinic in person, so had a telehealth visit instead.

“She had trouble hearing me, so I asked her to share her screen with me. I walked her through how to do that. Then I showed her where the ‘volume’ button was located. It turns out her volume was at zero,” Patel said. “Once that was adjusted, we were able to proceed with the appointment.”

Educating older adults on how to use health technology does not have to fall upon clinicians and their staff, according to Wehry. She routinely refers her patients to community resources to help them develop digital skills.

Local libraries and community centers often offer digital education. Some retirement communities and assisted living facilities also have tech support personnel or classes available to residents.

Wehry refers some of her patients to the National Digital Equity Center which teaches older adults how to hold a telehealth visit.

Roughly 90% of Patel’s patients are signed up for the patient portal, but they may not be operating the technology, she said. She advises these patients to ask their children or caregivers for help as appropriate. 

Teaching patients to use the communication technology early on can also be helpful in other ways. If patients who have been technologically proficient start having difficulty, “it’s a clue there may be cognitive changes, and we follow up on those,” Patel said.

Additional resources to help older adults develop digital competence include Cyber Seniors, Older Adults Technology Services, AARP, AARP Find Digital Courses, Area Agencies on Aging, and Senior Navigator.
 

Human Touch

Some older adults may simply want a more traditional means of communicating with their clinician. A review of 29 papers, encompassing over 6200 adults older than 60 years, identified several domains affecting the adoption of healthcare technology, two of which were resistance to new technology and having family or friends that could help with.

Wehry said many older adults “don’t resist this technology because they’re unable to figure out how to use it. Instead, they see the technology as too impersonal.”

One study found many older adults fear technologies may end up replacing face-to-face contact.

“I’m beginning to encourage primary care providers to take a step back and refocus on the doctor-patient relationship. When communication is limited to the technological approach, it can erode trust in that relationship,” Wehry said.

The American Medical Association recommends clinicians “provide a method other than electronic communication for patients who are without technological proficiency or access.”

Some busy clinicians might be concerned phone calls will be too time-consuming, Wehry said. Patients should be informed of hours of phone availability, how much time is allotted to calls, and how many days or hours a response may take. Clinicians might also use tools that allow patients to use their cell phone to text their practice with medical questions.

Cavanaugh ended up finding technological help from a professional organizer whom she hired to help rearrange her closets.

“She’s knowledgeable and patient, and she’s helping me with the portal,” she said. “If I hadn’t serendipitously found the organizer, I’d still be struggling and unable to access proper medical care.”

Wehry and Patel disclosed no relevant financial relationships.

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

Beth Cavanaugh, 79, was starting a new medication when she ran into a modern hurdle: Her doctor’s office required all follow–up questions, even those about side effects of the drug, to go through the patient portal.

Cavanaugh said she did not know how to set up or use the system.

“I tried to explain that, but the receptionist said that was the only way to contact the doctor. I felt lost,” said Cavanaugh, a retired psychotherapist near Albany, New York.

Cavanaugh is far from alone. Many older people balk at the idea of communicating with their physicians over the internet. They may have limited digital skills, have physical challenges, or simply prefer human connection.

As medicine leans harder on electronic portals and telehealth, these patients are finding themselves shut out of their own care. Experts warn this approach deepens inequities in access to care and can worsen health outcomes.

Clinicians should “offer options for various types of communication, such as phone calls or texts, because whenever an older adult — or anyone, for that matter — is given a choice, they feel more empowered and more committed to their care,” said Susan Wehry, MD, associate clinical professor at the University of New England College of Osteopathic Medicine in Biddeford, Maine.
 

Tech Support

Use of medical communication tools varies among older adults. One study in JAMA Network Open found nearly two thirds of those older than 65 years who filled out surveys via phone or internet had used a patient portal, while a little under half used telehealth, and only 44% used a medical health application.

Older patients tend to fall into two camps, said Neela Patel, MD, MPH, CMD, chief of the Division of Geriatrics and Supportive Care at the UT Health San Antonio.

Her patients “are at two extremes of the spectrum — some technologically savvy and others with limited digital literacy or limited or no access to the Internet,” Patel, who is also the vice chair of the Health Systems Innovations and Technology Committee of the American Geriatric Society, said.

Patel’s practice has dedicated staff to help patients master certain technologies. For example, a pharmacist teaches patients how to use a glucometer and a blood pressure cuff. Other staff teach them how to use smartphone apps that track blood pressure or glucose.

She usually sees patients in person before offering telehealth as an option, ensuring the person has “enough digital literacy to utilize them and that the patient can see and hear the visit.”

If technological limitations impede a telehealth appointment, clinicians can help patients navigate their computer screen. Patel recounted the story of an older woman who was unable to come to the clinic in person, so had a telehealth visit instead.

“She had trouble hearing me, so I asked her to share her screen with me. I walked her through how to do that. Then I showed her where the ‘volume’ button was located. It turns out her volume was at zero,” Patel said. “Once that was adjusted, we were able to proceed with the appointment.”

Educating older adults on how to use health technology does not have to fall upon clinicians and their staff, according to Wehry. She routinely refers her patients to community resources to help them develop digital skills.

Local libraries and community centers often offer digital education. Some retirement communities and assisted living facilities also have tech support personnel or classes available to residents.

Wehry refers some of her patients to the National Digital Equity Center which teaches older adults how to hold a telehealth visit.

Roughly 90% of Patel’s patients are signed up for the patient portal, but they may not be operating the technology, she said. She advises these patients to ask their children or caregivers for help as appropriate. 

Teaching patients to use the communication technology early on can also be helpful in other ways. If patients who have been technologically proficient start having difficulty, “it’s a clue there may be cognitive changes, and we follow up on those,” Patel said.

Additional resources to help older adults develop digital competence include Cyber Seniors, Older Adults Technology Services, AARP, AARP Find Digital Courses, Area Agencies on Aging, and Senior Navigator.
 

Human Touch

Some older adults may simply want a more traditional means of communicating with their clinician. A review of 29 papers, encompassing over 6200 adults older than 60 years, identified several domains affecting the adoption of healthcare technology, two of which were resistance to new technology and having family or friends that could help with.

Wehry said many older adults “don’t resist this technology because they’re unable to figure out how to use it. Instead, they see the technology as too impersonal.”

One study found many older adults fear technologies may end up replacing face-to-face contact.

“I’m beginning to encourage primary care providers to take a step back and refocus on the doctor-patient relationship. When communication is limited to the technological approach, it can erode trust in that relationship,” Wehry said.

The American Medical Association recommends clinicians “provide a method other than electronic communication for patients who are without technological proficiency or access.”

Some busy clinicians might be concerned phone calls will be too time-consuming, Wehry said. Patients should be informed of hours of phone availability, how much time is allotted to calls, and how many days or hours a response may take. Clinicians might also use tools that allow patients to use their cell phone to text their practice with medical questions.

Cavanaugh ended up finding technological help from a professional organizer whom she hired to help rearrange her closets.

“She’s knowledgeable and patient, and she’s helping me with the portal,” she said. “If I hadn’t serendipitously found the organizer, I’d still be struggling and unable to access proper medical care.”

Wehry and Patel disclosed no relevant financial relationships.

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

Fresenius Kabi USA has initiated a voluntary nationwide recall of three lots of famotidine injection, USP 20 mg/2 mL (10 mg/mL, 2 mL vial), according to a company announcement posted on the FDA website. 

The recall affects the following lot numbers 6133156 and 6133194, with expiration dates of August 2026, and lot number 6133388, with an expiration date of October 2026.

The recall stems from “out-of-specification endotoxin results in certain reserve samples of one lot,” the company said. The two additional lots are being recalled as a precaution. 

Elevated endotoxin levels may lead to severe systemic reactions, including sepsis, septic shock, inflammatory and life-threatening immune responses, and potentially death. 

Nonserious adverse events have been reported in association with lot 6133156, including chills, altered mental status, changes in respiratory status, fever/increased body temperature, shivering, and shaking. 

Famotidine injection is indicated in some hospitalized patients with pathological hypersecretory conditions or intractable ulcers or as an alternative to the oral dosage forms for short-term use in patients unable to take oral medication for certain conditions, including active duodenal ulcer, benign gastric ulcer or gastroesophageal reflux disease, or maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer.

Clinicians should be alert for symptoms potentially related to endotoxin exposure in patients who have received the affected product; document use of the product in affected lots (if already administered) and monitor patients carefully; and inform prescribing clinicians and nursing staff so they can monitor for signs of endotoxin-related reaction.

Patients should be advised to contact their physician or healthcare provider if they experienced any problems that may be related to receiving the affected drug. 

Clinicians should check their inventory for famotidine injection USP 20 mg/2 mL vials; discontinue use, dispensing, and distribution of affected lots; and segregate and quarantine any affected units to prevent inadvertent use. 

For questions or product return coordination, contact Fresenius Kabi USA Quality Assurance at 1-866-716-2459 or email at [email protected].

Adverse events or quality issues related to this recall should be reported to Fresenius Kabi (1-800-551-7176) and to the FDA MedWatch program. 
 

A version of this article appeared on Medscape.com.

Fresenius Kabi USA has initiated a voluntary nationwide recall of three lots of famotidine injection, USP 20 mg/2 mL (10 mg/mL, 2 mL vial), according to a company announcement posted on the FDA website. 

The recall affects the following lot numbers 6133156 and 6133194, with expiration dates of August 2026, and lot number 6133388, with an expiration date of October 2026.

The recall stems from “out-of-specification endotoxin results in certain reserve samples of one lot,” the company said. The two additional lots are being recalled as a precaution. 

Elevated endotoxin levels may lead to severe systemic reactions, including sepsis, septic shock, inflammatory and life-threatening immune responses, and potentially death. 

Nonserious adverse events have been reported in association with lot 6133156, including chills, altered mental status, changes in respiratory status, fever/increased body temperature, shivering, and shaking. 

Famotidine injection is indicated in some hospitalized patients with pathological hypersecretory conditions or intractable ulcers or as an alternative to the oral dosage forms for short-term use in patients unable to take oral medication for certain conditions, including active duodenal ulcer, benign gastric ulcer or gastroesophageal reflux disease, or maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer.

Clinicians should be alert for symptoms potentially related to endotoxin exposure in patients who have received the affected product; document use of the product in affected lots (if already administered) and monitor patients carefully; and inform prescribing clinicians and nursing staff so they can monitor for signs of endotoxin-related reaction.

Patients should be advised to contact their physician or healthcare provider if they experienced any problems that may be related to receiving the affected drug. 

Clinicians should check their inventory for famotidine injection USP 20 mg/2 mL vials; discontinue use, dispensing, and distribution of affected lots; and segregate and quarantine any affected units to prevent inadvertent use. 

For questions or product return coordination, contact Fresenius Kabi USA Quality Assurance at 1-866-716-2459 or email at [email protected].

Adverse events or quality issues related to this recall should be reported to Fresenius Kabi (1-800-551-7176) and to the FDA MedWatch program. 
 

A version of this article appeared on Medscape.com.

Fresenius Kabi USA has initiated a voluntary nationwide recall of three lots of famotidine injection, USP 20 mg/2 mL (10 mg/mL, 2 mL vial), according to a company announcement posted on the FDA website. 

The recall affects the following lot numbers 6133156 and 6133194, with expiration dates of August 2026, and lot number 6133388, with an expiration date of October 2026.

The recall stems from “out-of-specification endotoxin results in certain reserve samples of one lot,” the company said. The two additional lots are being recalled as a precaution. 

Elevated endotoxin levels may lead to severe systemic reactions, including sepsis, septic shock, inflammatory and life-threatening immune responses, and potentially death. 

Nonserious adverse events have been reported in association with lot 6133156, including chills, altered mental status, changes in respiratory status, fever/increased body temperature, shivering, and shaking. 

Famotidine injection is indicated in some hospitalized patients with pathological hypersecretory conditions or intractable ulcers or as an alternative to the oral dosage forms for short-term use in patients unable to take oral medication for certain conditions, including active duodenal ulcer, benign gastric ulcer or gastroesophageal reflux disease, or maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer.

Clinicians should be alert for symptoms potentially related to endotoxin exposure in patients who have received the affected product; document use of the product in affected lots (if already administered) and monitor patients carefully; and inform prescribing clinicians and nursing staff so they can monitor for signs of endotoxin-related reaction.

Patients should be advised to contact their physician or healthcare provider if they experienced any problems that may be related to receiving the affected drug. 

Clinicians should check their inventory for famotidine injection USP 20 mg/2 mL vials; discontinue use, dispensing, and distribution of affected lots; and segregate and quarantine any affected units to prevent inadvertent use. 

For questions or product return coordination, contact Fresenius Kabi USA Quality Assurance at 1-866-716-2459 or email at [email protected].

Adverse events or quality issues related to this recall should be reported to Fresenius Kabi (1-800-551-7176) and to the FDA MedWatch program. 
 

A version of this article appeared on Medscape.com.

Duodenal mucosal resurfacing (DMR) — an investigational endoscopic procedure — helped patients maintain weight loss, and in some cases, even lose additional weight, 3 months after discontinuing GLP-1 receptor agonist therapy, initial results of the open-label, multistage REMAIN-1 trial showed.

In addition, “the procedure was well tolerated, with only minor, transient TEAEs [treatment-emergent adverse events] consistent with routine upper endoscopy,” said Shailendra Singh, MD, of West Virginia University in Morgantown, West Virginia, who presented the findings at The Obesity Society’s Obesity Week 2025 meeting in Atlanta.

DMR uses hydrothermal ablation to treat the duodenal mucosa, which may be dysfunctional in both obesity and impaired glucose tolerance. A previous pooled clinical trial analysis of more than 100 patients with type 2 diabetes demonstrated that DMR helped patients maintain body weight loss up to 48 weeks post-procedure.

Metabolic therapeutics company Fractyl Health, Burlington, Massachusetts, developed the procedure, called Revita, and is sponsoring the current study. The trial’s aim is to determine the effect of DMR on weight-loss maintenance in patients with ≥ 15% total body weight loss using a GLP-1 RA in both an open-label arm and a prospective, randomized, double-blind, sham-controlled multicenter arm.
 

‘Encouraging Preliminary Findings’

The open-label arm included 15 DMR-treated participants (mean age, 49 years, 87% female ), all of whom had taken tirzepatide for a minimum of 5 months and a maximum of 3 years prior to DMR and had lost at least 15% of their total body weight.

Participants had a mean pre-GLP-1 RA weight of 104.8 kg and a mean weight prior to DMR of 79.4 kg, for a mean total body weight loss from the start of GLP-1 RA of 23.8%. Weight loss was heterogeneous and reflective of the real-world patient population taking GLP-1 medications, according to the poster presentation.

Participants discontinued their GLP-1 medication, underwent the DMR procedure, and were followed for 3 months. A total of 12 of 13 patients maintained or lost weight at that point, with 6 of 13 losing additional weight.

Specifically, participants experienced a median of 0.46% weight change (approximately 1 lb) compared with the 5%-6% weight regain (10-15 lb) observed after GLP-1 discontinuation in the literature.

The procedure was well tolerated, with most patients experiencing no TEAEs and none experiencing an event greater than grade 1. Grade 1 events occurred in three patients; 23% were transient in nature, lasting 2-5 days, and were similar to those typically seen with a routine upper endoscopy.

“These encouraging preliminary findings suggest that DMR may safely achieve durable weight maintenance for patients who wish to discontinue GLP-1 RA therapy,” the study authors stated.

Randomization is anticipated in early 2026, with 6-month topline data and a potential premarket approval filing expected in the second half of 2026.
 

A version of this article appeared on Medscape.com.

Duodenal mucosal resurfacing (DMR) — an investigational endoscopic procedure — helped patients maintain weight loss, and in some cases, even lose additional weight, 3 months after discontinuing GLP-1 receptor agonist therapy, initial results of the open-label, multistage REMAIN-1 trial showed.

In addition, “the procedure was well tolerated, with only minor, transient TEAEs [treatment-emergent adverse events] consistent with routine upper endoscopy,” said Shailendra Singh, MD, of West Virginia University in Morgantown, West Virginia, who presented the findings at The Obesity Society’s Obesity Week 2025 meeting in Atlanta.

DMR uses hydrothermal ablation to treat the duodenal mucosa, which may be dysfunctional in both obesity and impaired glucose tolerance. A previous pooled clinical trial analysis of more than 100 patients with type 2 diabetes demonstrated that DMR helped patients maintain body weight loss up to 48 weeks post-procedure.

Metabolic therapeutics company Fractyl Health, Burlington, Massachusetts, developed the procedure, called Revita, and is sponsoring the current study. The trial’s aim is to determine the effect of DMR on weight-loss maintenance in patients with ≥ 15% total body weight loss using a GLP-1 RA in both an open-label arm and a prospective, randomized, double-blind, sham-controlled multicenter arm.
 

‘Encouraging Preliminary Findings’

The open-label arm included 15 DMR-treated participants (mean age, 49 years, 87% female ), all of whom had taken tirzepatide for a minimum of 5 months and a maximum of 3 years prior to DMR and had lost at least 15% of their total body weight.

Participants had a mean pre-GLP-1 RA weight of 104.8 kg and a mean weight prior to DMR of 79.4 kg, for a mean total body weight loss from the start of GLP-1 RA of 23.8%. Weight loss was heterogeneous and reflective of the real-world patient population taking GLP-1 medications, according to the poster presentation.

Participants discontinued their GLP-1 medication, underwent the DMR procedure, and were followed for 3 months. A total of 12 of 13 patients maintained or lost weight at that point, with 6 of 13 losing additional weight.

Specifically, participants experienced a median of 0.46% weight change (approximately 1 lb) compared with the 5%-6% weight regain (10-15 lb) observed after GLP-1 discontinuation in the literature.

The procedure was well tolerated, with most patients experiencing no TEAEs and none experiencing an event greater than grade 1. Grade 1 events occurred in three patients; 23% were transient in nature, lasting 2-5 days, and were similar to those typically seen with a routine upper endoscopy.

“These encouraging preliminary findings suggest that DMR may safely achieve durable weight maintenance for patients who wish to discontinue GLP-1 RA therapy,” the study authors stated.

Randomization is anticipated in early 2026, with 6-month topline data and a potential premarket approval filing expected in the second half of 2026.
 

A version of this article appeared on Medscape.com.

Duodenal mucosal resurfacing (DMR) — an investigational endoscopic procedure — helped patients maintain weight loss, and in some cases, even lose additional weight, 3 months after discontinuing GLP-1 receptor agonist therapy, initial results of the open-label, multistage REMAIN-1 trial showed.

In addition, “the procedure was well tolerated, with only minor, transient TEAEs [treatment-emergent adverse events] consistent with routine upper endoscopy,” said Shailendra Singh, MD, of West Virginia University in Morgantown, West Virginia, who presented the findings at The Obesity Society’s Obesity Week 2025 meeting in Atlanta.

DMR uses hydrothermal ablation to treat the duodenal mucosa, which may be dysfunctional in both obesity and impaired glucose tolerance. A previous pooled clinical trial analysis of more than 100 patients with type 2 diabetes demonstrated that DMR helped patients maintain body weight loss up to 48 weeks post-procedure.

Metabolic therapeutics company Fractyl Health, Burlington, Massachusetts, developed the procedure, called Revita, and is sponsoring the current study. The trial’s aim is to determine the effect of DMR on weight-loss maintenance in patients with ≥ 15% total body weight loss using a GLP-1 RA in both an open-label arm and a prospective, randomized, double-blind, sham-controlled multicenter arm.
 

‘Encouraging Preliminary Findings’

The open-label arm included 15 DMR-treated participants (mean age, 49 years, 87% female ), all of whom had taken tirzepatide for a minimum of 5 months and a maximum of 3 years prior to DMR and had lost at least 15% of their total body weight.

Participants had a mean pre-GLP-1 RA weight of 104.8 kg and a mean weight prior to DMR of 79.4 kg, for a mean total body weight loss from the start of GLP-1 RA of 23.8%. Weight loss was heterogeneous and reflective of the real-world patient population taking GLP-1 medications, according to the poster presentation.

Participants discontinued their GLP-1 medication, underwent the DMR procedure, and were followed for 3 months. A total of 12 of 13 patients maintained or lost weight at that point, with 6 of 13 losing additional weight.

Specifically, participants experienced a median of 0.46% weight change (approximately 1 lb) compared with the 5%-6% weight regain (10-15 lb) observed after GLP-1 discontinuation in the literature.

The procedure was well tolerated, with most patients experiencing no TEAEs and none experiencing an event greater than grade 1. Grade 1 events occurred in three patients; 23% were transient in nature, lasting 2-5 days, and were similar to those typically seen with a routine upper endoscopy.

“These encouraging preliminary findings suggest that DMR may safely achieve durable weight maintenance for patients who wish to discontinue GLP-1 RA therapy,” the study authors stated.

Randomization is anticipated in early 2026, with 6-month topline data and a potential premarket approval filing expected in the second half of 2026.
 

A version of this article appeared on Medscape.com.