PRECISE-DAPT Score Predicts GI Bleeding Risk Among Post-PCI Patients

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Fri, 11/15/2024 - 15:45

— Gastrointestinal (GI) bleeding after percutaneous coronary intervention (PCI) among patients on dual antiplatelet therapy (DAPT) remains risky in terms of morbidity and mortality, but the Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy (PRECISE-DAPT) score could help predict that risk, according to a study presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting.

In a predominantly Hispanic population in Texas, 2.5% of post-PCI patients on DAPT had GI bleeding in the first year. The PRECISE-DAPT score helped to predict GI bleeding among high-risk and moderate-risk patients.

“Our study established that the PRECISE-DAPT score possesses a moderate predictive accuracy not only for overall bleeding risk but also specifically for gastrointestinal bleeding,” said lead author Jesus Guzman, MD, a gastroenterology fellow at the Texas Tech University Health Sciences Center El Paso.

Current guidelines from the American College of Cardiology and American Heart Association recommend DAPT for 6-12 months post-PCI, with consideration for shorter durations in patients with lower ischemic risks but higher bleeding risks.

“Interestingly, some of these patients were on DAPT for more than 2 years, which goes beyond the guidelines,” he said. “In this patient population, this has to do with them being lost to follow-up and getting reestablished, and they kept refilling their prescriptions.”

Guzman and colleagues conducted a retrospective cohort study of patients receiving DAPT after PCI from 2014 to 2021. They looked for GI bleeding rates at 1 year and across the duration of the study period, as well as endoscopic indications, findings, concurrent antiplatelet therapy, and the primary cause of bleeding.

In addition, the research team evaluated the predictive value of the PRECISE-DAPT score, which categorizes patients based on low risk (≤ 17), moderate risk (18-24), and high risk (≥ 25) for bleeding. The score aims to optimize the balance between bleeding and ischemic risks, Guzman said, by incorporating five factors: Age, creatinine clearance, hemoglobin, white blood cell count, and history of spontaneous bleeding.

Among 1067 patients, 563 (57.9%) received clopidogrel and 409 (42%) received ticagrelor. The overall cohort was 66.6% men, 77.1% Hispanic, and had a mean age of 62 years.

The GI bleeding rate was 2.5% at 1-year post-PCI among 27 patients and 3.7% for the study duration among 39 patients, with a median follow-up of 2.2 years.

Among the 39 GI bleeds, 41% were lower GI bleeds, 28% were upper GI bleeds, 15% were small bowel bleeds, and 15% were undetermined. The most frequent etiology was colon cancer, accounting for 18% of bleeds, followed by 15% for gastric ulcers, 10% for diverticular bleeds, and 10% for hemorrhoidal bleeds.

In general, analyses indicated no significant differences in GI bleeding between patients on clopidogrel (21.2%) and those on ticagrelor (19.2%).

However, the odds of GI bleeding were significantly higher in patients with high-risk PRECISE-DAPT scores (odds ratio [OR], 2.5) and moderate-risk scores (OR, 2.8) than in those with low-risk scores. The majority of patients without GI bleeding had scores < 17, whereas the majority of patients with GI bleeding had scores > 24. An optimal threshold for the PRECISE-DAPT score was identified as ≥ 19.

“When patients on DAPT present with GI bleeding, it can be a clinical conundrum for gastroenterologists and cardiologists, especially when it can be a life-or-death event, and stopping DAPT can increase risk of thrombosis,” said Jeff Taclob, MD, a hepatology fellow at The University of Tennessee Health Science Center in Memphis. Taclob, who wasn’t involved with the study, attended the conference session.

“In this population in El Paso, in particular, many patients don’t have adequate healthcare, may be lost to follow-up, and get their prescriptions filled elsewhere, such as Juárez, Mexico,” he said. “Then they come in with this life-threatening bleed, so we need to focus more on their risks.”

Paying attention to specific patient populations, cultures, and values remains important for patient communication and clinical decision-making, Taclob noted.

“In this population of older men, there’s often a macho persona where they don’t want to seek help,” he said. “DAPT criteria could differ in other populations, but here, the PRECISE-DAPT score appeared to help.”

The study was awarded the ACG Outstanding Research Award in the GI Bleeding Category (Trainee). Guzman and Taclob reported no relevant disclosures.

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

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— Gastrointestinal (GI) bleeding after percutaneous coronary intervention (PCI) among patients on dual antiplatelet therapy (DAPT) remains risky in terms of morbidity and mortality, but the Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy (PRECISE-DAPT) score could help predict that risk, according to a study presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting.

In a predominantly Hispanic population in Texas, 2.5% of post-PCI patients on DAPT had GI bleeding in the first year. The PRECISE-DAPT score helped to predict GI bleeding among high-risk and moderate-risk patients.

“Our study established that the PRECISE-DAPT score possesses a moderate predictive accuracy not only for overall bleeding risk but also specifically for gastrointestinal bleeding,” said lead author Jesus Guzman, MD, a gastroenterology fellow at the Texas Tech University Health Sciences Center El Paso.

Current guidelines from the American College of Cardiology and American Heart Association recommend DAPT for 6-12 months post-PCI, with consideration for shorter durations in patients with lower ischemic risks but higher bleeding risks.

“Interestingly, some of these patients were on DAPT for more than 2 years, which goes beyond the guidelines,” he said. “In this patient population, this has to do with them being lost to follow-up and getting reestablished, and they kept refilling their prescriptions.”

Guzman and colleagues conducted a retrospective cohort study of patients receiving DAPT after PCI from 2014 to 2021. They looked for GI bleeding rates at 1 year and across the duration of the study period, as well as endoscopic indications, findings, concurrent antiplatelet therapy, and the primary cause of bleeding.

In addition, the research team evaluated the predictive value of the PRECISE-DAPT score, which categorizes patients based on low risk (≤ 17), moderate risk (18-24), and high risk (≥ 25) for bleeding. The score aims to optimize the balance between bleeding and ischemic risks, Guzman said, by incorporating five factors: Age, creatinine clearance, hemoglobin, white blood cell count, and history of spontaneous bleeding.

Among 1067 patients, 563 (57.9%) received clopidogrel and 409 (42%) received ticagrelor. The overall cohort was 66.6% men, 77.1% Hispanic, and had a mean age of 62 years.

The GI bleeding rate was 2.5% at 1-year post-PCI among 27 patients and 3.7% for the study duration among 39 patients, with a median follow-up of 2.2 years.

Among the 39 GI bleeds, 41% were lower GI bleeds, 28% were upper GI bleeds, 15% were small bowel bleeds, and 15% were undetermined. The most frequent etiology was colon cancer, accounting for 18% of bleeds, followed by 15% for gastric ulcers, 10% for diverticular bleeds, and 10% for hemorrhoidal bleeds.

In general, analyses indicated no significant differences in GI bleeding between patients on clopidogrel (21.2%) and those on ticagrelor (19.2%).

However, the odds of GI bleeding were significantly higher in patients with high-risk PRECISE-DAPT scores (odds ratio [OR], 2.5) and moderate-risk scores (OR, 2.8) than in those with low-risk scores. The majority of patients without GI bleeding had scores < 17, whereas the majority of patients with GI bleeding had scores > 24. An optimal threshold for the PRECISE-DAPT score was identified as ≥ 19.

“When patients on DAPT present with GI bleeding, it can be a clinical conundrum for gastroenterologists and cardiologists, especially when it can be a life-or-death event, and stopping DAPT can increase risk of thrombosis,” said Jeff Taclob, MD, a hepatology fellow at The University of Tennessee Health Science Center in Memphis. Taclob, who wasn’t involved with the study, attended the conference session.

“In this population in El Paso, in particular, many patients don’t have adequate healthcare, may be lost to follow-up, and get their prescriptions filled elsewhere, such as Juárez, Mexico,” he said. “Then they come in with this life-threatening bleed, so we need to focus more on their risks.”

Paying attention to specific patient populations, cultures, and values remains important for patient communication and clinical decision-making, Taclob noted.

“In this population of older men, there’s often a macho persona where they don’t want to seek help,” he said. “DAPT criteria could differ in other populations, but here, the PRECISE-DAPT score appeared to help.”

The study was awarded the ACG Outstanding Research Award in the GI Bleeding Category (Trainee). Guzman and Taclob reported no relevant disclosures.

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

— Gastrointestinal (GI) bleeding after percutaneous coronary intervention (PCI) among patients on dual antiplatelet therapy (DAPT) remains risky in terms of morbidity and mortality, but the Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy (PRECISE-DAPT) score could help predict that risk, according to a study presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting.

In a predominantly Hispanic population in Texas, 2.5% of post-PCI patients on DAPT had GI bleeding in the first year. The PRECISE-DAPT score helped to predict GI bleeding among high-risk and moderate-risk patients.

“Our study established that the PRECISE-DAPT score possesses a moderate predictive accuracy not only for overall bleeding risk but also specifically for gastrointestinal bleeding,” said lead author Jesus Guzman, MD, a gastroenterology fellow at the Texas Tech University Health Sciences Center El Paso.

Current guidelines from the American College of Cardiology and American Heart Association recommend DAPT for 6-12 months post-PCI, with consideration for shorter durations in patients with lower ischemic risks but higher bleeding risks.

“Interestingly, some of these patients were on DAPT for more than 2 years, which goes beyond the guidelines,” he said. “In this patient population, this has to do with them being lost to follow-up and getting reestablished, and they kept refilling their prescriptions.”

Guzman and colleagues conducted a retrospective cohort study of patients receiving DAPT after PCI from 2014 to 2021. They looked for GI bleeding rates at 1 year and across the duration of the study period, as well as endoscopic indications, findings, concurrent antiplatelet therapy, and the primary cause of bleeding.

In addition, the research team evaluated the predictive value of the PRECISE-DAPT score, which categorizes patients based on low risk (≤ 17), moderate risk (18-24), and high risk (≥ 25) for bleeding. The score aims to optimize the balance between bleeding and ischemic risks, Guzman said, by incorporating five factors: Age, creatinine clearance, hemoglobin, white blood cell count, and history of spontaneous bleeding.

Among 1067 patients, 563 (57.9%) received clopidogrel and 409 (42%) received ticagrelor. The overall cohort was 66.6% men, 77.1% Hispanic, and had a mean age of 62 years.

The GI bleeding rate was 2.5% at 1-year post-PCI among 27 patients and 3.7% for the study duration among 39 patients, with a median follow-up of 2.2 years.

Among the 39 GI bleeds, 41% were lower GI bleeds, 28% were upper GI bleeds, 15% were small bowel bleeds, and 15% were undetermined. The most frequent etiology was colon cancer, accounting for 18% of bleeds, followed by 15% for gastric ulcers, 10% for diverticular bleeds, and 10% for hemorrhoidal bleeds.

In general, analyses indicated no significant differences in GI bleeding between patients on clopidogrel (21.2%) and those on ticagrelor (19.2%).

However, the odds of GI bleeding were significantly higher in patients with high-risk PRECISE-DAPT scores (odds ratio [OR], 2.5) and moderate-risk scores (OR, 2.8) than in those with low-risk scores. The majority of patients without GI bleeding had scores < 17, whereas the majority of patients with GI bleeding had scores > 24. An optimal threshold for the PRECISE-DAPT score was identified as ≥ 19.

“When patients on DAPT present with GI bleeding, it can be a clinical conundrum for gastroenterologists and cardiologists, especially when it can be a life-or-death event, and stopping DAPT can increase risk of thrombosis,” said Jeff Taclob, MD, a hepatology fellow at The University of Tennessee Health Science Center in Memphis. Taclob, who wasn’t involved with the study, attended the conference session.

“In this population in El Paso, in particular, many patients don’t have adequate healthcare, may be lost to follow-up, and get their prescriptions filled elsewhere, such as Juárez, Mexico,” he said. “Then they come in with this life-threatening bleed, so we need to focus more on their risks.”

Paying attention to specific patient populations, cultures, and values remains important for patient communication and clinical decision-making, Taclob noted.

“In this population of older men, there’s often a macho persona where they don’t want to seek help,” he said. “DAPT criteria could differ in other populations, but here, the PRECISE-DAPT score appeared to help.”

The study was awarded the ACG Outstanding Research Award in the GI Bleeding Category (Trainee). Guzman and Taclob reported no relevant disclosures.

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

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Angiotensin Receptor Blockers May Lead to Worse Outcomes in Celiac Disease

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Fri, 11/08/2024 - 12:45

Patients with celiac disease who take an angiotensin receptor blocker (ARB) may experience worse outcomes, such as increased risk of iron deficiency, diarrhea, and abdominal pain, according to a study presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting.

The association may be related to the similar pathophysiology between ARB-associated enteropathy and celiac disease, though additional research is needed.

“Based on our findings, people should take caution when prescribing angiotensin receptor blockers to people with celiac disease,” said lead author Isabel Hujoel, MD, clinical assistant professor of gastroenterology and clinic director of the Celiac Disease Center at the University of Washington, Seattle.

University of Washington, Seattle
Dr. Isabel Hujoel

“When we see someone with nonresponsive celiac disease, meaning persistent symptoms despite a gluten-free diet, I do think we should review their medication list, and if they’re on an ARB, we should consider a trial off those medications to see if they respond,” she said. “A primary care provider may choose other hypertensives as well.”

Hujoel and co-author Margaux Hujoel, PhD, a postdoctoral research fellow at Brigham and Women’s Hospital, Boston; Broad Institute, Cambridge; and Harvard Medical School, Boston, analyzed data from the National Institutes of Health’s All of Us, a large publicly available US longitudinal dataset.

The researchers conducted a survival analysis of time-to-first event after celiac disease diagnosis, allowing patients to have a time-dependent covariate of ARB use. They looked at outcomes such as iron deficiency, diarrhea, abdominal pain, vitamin deficiency, vitamin D deficiency, malabsorption, low hemoglobin, and weight loss.

The analysis included 1849 patients with celiac disease, including 1460 women and 389 men, with a median age of nearly 50 years at diagnosis. While the vast majority of patients (nearly 1600) didn’t take an ARB, 120 started one before celiac disease diagnosis and 142 started one after diagnosis.

Overall, taking an ARB was associated with increased hazard ratios [HRs] for low hemoglobin, iron deficiency, diarrhea, and abdominal pain. There weren’t increased risks for weight loss, malabsorption, or vitamin deficiencies.

When excluding those who had an ARB prescription before diagnosis, the HRs remained significantly higher for low hemoglobin (HR, 1.98) and iron deficiency (HR, 1.72) for those who started an ARB after diagnosis.

“The use of angiotensin receptor blockers may be associated with worse outcomes in the setting of celiac disease, specifically persistent symptoms and possibly poor small bowel healing as evidenced by malabsorption,” Hujoel said.

Future studies could look specifically at losartan, which was the most common ARB prescribed in this analysis, she said. Other studies could also analyze different patient outcomes, whether patients were on a gluten-free diet, medication adherence, and recurrence or persistence of symptoms rather than initial occurrence. The associations between ARB use and celiac disease could shift among patients who are in remission, for instance.

“ARBs are some of the most widely used medications, so studies like these can help people to understand that they may have symptoms but not know it’s related to their medication. Public awareness of this fact is key,” said Patricia Jones, MD, a hepatologist and associate professor of clinical medicine at the University of Miami Miller School of Medicine, Miami. Jones co-moderated the plenary session on small intestine, functional, and liver research.

University of Miami
Dr. Patricia Jones

“There are many types of antihypertensives, so while ARBs are used often, other options are available if people have symptoms, especially if they have worsening symptoms with celiac disease,” she said. “It’s important to make changes in your practice.”

The study was named an ACG Newsworthy Abstract. Isabel Hujoel and Patricia Jones reported no relevant disclosures.

A version of this article appeared on Medscape.com.

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Patients with celiac disease who take an angiotensin receptor blocker (ARB) may experience worse outcomes, such as increased risk of iron deficiency, diarrhea, and abdominal pain, according to a study presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting.

The association may be related to the similar pathophysiology between ARB-associated enteropathy and celiac disease, though additional research is needed.

“Based on our findings, people should take caution when prescribing angiotensin receptor blockers to people with celiac disease,” said lead author Isabel Hujoel, MD, clinical assistant professor of gastroenterology and clinic director of the Celiac Disease Center at the University of Washington, Seattle.

University of Washington, Seattle
Dr. Isabel Hujoel

“When we see someone with nonresponsive celiac disease, meaning persistent symptoms despite a gluten-free diet, I do think we should review their medication list, and if they’re on an ARB, we should consider a trial off those medications to see if they respond,” she said. “A primary care provider may choose other hypertensives as well.”

Hujoel and co-author Margaux Hujoel, PhD, a postdoctoral research fellow at Brigham and Women’s Hospital, Boston; Broad Institute, Cambridge; and Harvard Medical School, Boston, analyzed data from the National Institutes of Health’s All of Us, a large publicly available US longitudinal dataset.

The researchers conducted a survival analysis of time-to-first event after celiac disease diagnosis, allowing patients to have a time-dependent covariate of ARB use. They looked at outcomes such as iron deficiency, diarrhea, abdominal pain, vitamin deficiency, vitamin D deficiency, malabsorption, low hemoglobin, and weight loss.

The analysis included 1849 patients with celiac disease, including 1460 women and 389 men, with a median age of nearly 50 years at diagnosis. While the vast majority of patients (nearly 1600) didn’t take an ARB, 120 started one before celiac disease diagnosis and 142 started one after diagnosis.

Overall, taking an ARB was associated with increased hazard ratios [HRs] for low hemoglobin, iron deficiency, diarrhea, and abdominal pain. There weren’t increased risks for weight loss, malabsorption, or vitamin deficiencies.

When excluding those who had an ARB prescription before diagnosis, the HRs remained significantly higher for low hemoglobin (HR, 1.98) and iron deficiency (HR, 1.72) for those who started an ARB after diagnosis.

“The use of angiotensin receptor blockers may be associated with worse outcomes in the setting of celiac disease, specifically persistent symptoms and possibly poor small bowel healing as evidenced by malabsorption,” Hujoel said.

Future studies could look specifically at losartan, which was the most common ARB prescribed in this analysis, she said. Other studies could also analyze different patient outcomes, whether patients were on a gluten-free diet, medication adherence, and recurrence or persistence of symptoms rather than initial occurrence. The associations between ARB use and celiac disease could shift among patients who are in remission, for instance.

“ARBs are some of the most widely used medications, so studies like these can help people to understand that they may have symptoms but not know it’s related to their medication. Public awareness of this fact is key,” said Patricia Jones, MD, a hepatologist and associate professor of clinical medicine at the University of Miami Miller School of Medicine, Miami. Jones co-moderated the plenary session on small intestine, functional, and liver research.

University of Miami
Dr. Patricia Jones

“There are many types of antihypertensives, so while ARBs are used often, other options are available if people have symptoms, especially if they have worsening symptoms with celiac disease,” she said. “It’s important to make changes in your practice.”

The study was named an ACG Newsworthy Abstract. Isabel Hujoel and Patricia Jones reported no relevant disclosures.

A version of this article appeared on Medscape.com.

Patients with celiac disease who take an angiotensin receptor blocker (ARB) may experience worse outcomes, such as increased risk of iron deficiency, diarrhea, and abdominal pain, according to a study presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting.

The association may be related to the similar pathophysiology between ARB-associated enteropathy and celiac disease, though additional research is needed.

“Based on our findings, people should take caution when prescribing angiotensin receptor blockers to people with celiac disease,” said lead author Isabel Hujoel, MD, clinical assistant professor of gastroenterology and clinic director of the Celiac Disease Center at the University of Washington, Seattle.

University of Washington, Seattle
Dr. Isabel Hujoel

“When we see someone with nonresponsive celiac disease, meaning persistent symptoms despite a gluten-free diet, I do think we should review their medication list, and if they’re on an ARB, we should consider a trial off those medications to see if they respond,” she said. “A primary care provider may choose other hypertensives as well.”

Hujoel and co-author Margaux Hujoel, PhD, a postdoctoral research fellow at Brigham and Women’s Hospital, Boston; Broad Institute, Cambridge; and Harvard Medical School, Boston, analyzed data from the National Institutes of Health’s All of Us, a large publicly available US longitudinal dataset.

The researchers conducted a survival analysis of time-to-first event after celiac disease diagnosis, allowing patients to have a time-dependent covariate of ARB use. They looked at outcomes such as iron deficiency, diarrhea, abdominal pain, vitamin deficiency, vitamin D deficiency, malabsorption, low hemoglobin, and weight loss.

The analysis included 1849 patients with celiac disease, including 1460 women and 389 men, with a median age of nearly 50 years at diagnosis. While the vast majority of patients (nearly 1600) didn’t take an ARB, 120 started one before celiac disease diagnosis and 142 started one after diagnosis.

Overall, taking an ARB was associated with increased hazard ratios [HRs] for low hemoglobin, iron deficiency, diarrhea, and abdominal pain. There weren’t increased risks for weight loss, malabsorption, or vitamin deficiencies.

When excluding those who had an ARB prescription before diagnosis, the HRs remained significantly higher for low hemoglobin (HR, 1.98) and iron deficiency (HR, 1.72) for those who started an ARB after diagnosis.

“The use of angiotensin receptor blockers may be associated with worse outcomes in the setting of celiac disease, specifically persistent symptoms and possibly poor small bowel healing as evidenced by malabsorption,” Hujoel said.

Future studies could look specifically at losartan, which was the most common ARB prescribed in this analysis, she said. Other studies could also analyze different patient outcomes, whether patients were on a gluten-free diet, medication adherence, and recurrence or persistence of symptoms rather than initial occurrence. The associations between ARB use and celiac disease could shift among patients who are in remission, for instance.

“ARBs are some of the most widely used medications, so studies like these can help people to understand that they may have symptoms but not know it’s related to their medication. Public awareness of this fact is key,” said Patricia Jones, MD, a hepatologist and associate professor of clinical medicine at the University of Miami Miller School of Medicine, Miami. Jones co-moderated the plenary session on small intestine, functional, and liver research.

University of Miami
Dr. Patricia Jones

“There are many types of antihypertensives, so while ARBs are used often, other options are available if people have symptoms, especially if they have worsening symptoms with celiac disease,” she said. “It’s important to make changes in your practice.”

The study was named an ACG Newsworthy Abstract. Isabel Hujoel and Patricia Jones reported no relevant disclosures.

A version of this article appeared on Medscape.com.

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AI-Assisted Colonoscopy Linked to Higher Rate of Benign Lesion Removal

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Thu, 11/07/2024 - 09:42

Artificial intelligence–assisted colonoscopy (AIAC) with computer-aided detection (CADe) technology may improve adenoma detection rate (ADR), but it’s also associated with higher detection and removal of non-neoplastic lesions, according to a study presented at the annual meeting of the American College of Gastroenterology (ACG).

In particular, AIAC led to a statistically and clinically significant increase in the proportion of exams that detected lesions that after resection were all found to be benign, compared with unassisted colonoscopy.

University of Minnesota
Dr. Tessa Herman

“The potential implications include increased procedural risks, as well as costs, such as pathology costs and other healthcare expenditures, without any additional colorectal cancer prevention benefit,” said lead author Tessa Herman, MD, chief resident of internal medicine at the University of Minnesota, Minneapolis, and Minneapolis Veterans Affairs Health Care System.

In a previous implementation trial at the Minneapolis VA Medical Center, Herman and colleagues compared ADR between a group of patients undergoing AIAC and a historical cohort of patients who had non–AI-assisted colonoscopy.

In this subsequent study, the research team conducted an ad hoc analysis of data from the previous trial to determine the proportion of colonoscopies for screening, surveillance, and positive fecal immunochemical tests which detect lesions that after resection are all found to be benign. They excluded colonoscopies conducted for diagnostic indications or inflammatory bowel disease, as well as incomplete colonoscopies, and for those with inadequate bowel preparation.

Overall, they studied 441 non-AIAC colonoscopies (between November 2022 and April 2023) and 599 AIAC colonoscopies (between May 2023 and October 2023). The groups were balanced, and there were no significant differences in patient demographics, endoscopists, AI technology, procedure time, or average number of polyps detected.

In the non-AIAC cohort, 37 cases (8.4%) had polypectomies that revealed only benign lesions, as compared with 74 cases (12.4%) in the AIAC cohort. The most common resected lesions were benign colonic mucosa, lymphoid aggregates, and hyperplastic polyps.

Applied to the 15 million colonoscopies conducted in the United States per year, the findings indicate that full adoption of AIAC could result in about 600,000 more colonoscopies in which only benign, nonadenomatous lesions are removed, compared with traditional colonoscopy, Herman said.

More study of AIAC is needed, said Daniel Pambianco, MD, managing partner of GastroHealth-Charlottesville in Virginia and the 2023 ACG president. “This technology is in a fledging stage, and the more data we have, the more helpful it’ll be to know if we’re removing the right lesions at a better rate.”

“There’s a hope that assistance will improve detection, removal of polyps, and ultimately, colon cancer,” added Pambianco, who comoderated the session on colorectal cancer prevention.

Future longitudinal studies should monitor both ADR and benign lesion resection rates with AIAC, and modeling studies could determine the benefits and costs of the technology, Herman said. In addition, development of hybrid CADe and computer-aided diagnosis systems could mitigate concerns about excessive benign lesion resection with AI tools.

Valley Medical Group
Dr. Sita Chokhavatia

Clinicians already are able to find colon mucosa that are polypoid or lymphoid aggregates during colonoscopy without AI assistance, said the session’s comoderator, Sita Chokhavatia, MD, AGAF, a gastroenterologist with Valley Medical Group in Ridgewood, New Jersey. 

“Instead, we need a tool that can help us to not remove these polyps that are not neoplastic,” she said. “With future developments, we may be able to take it to the next step where the algorithm tells us that it’s benign and not to touch it.”

The study was named an ACG Newsworthy Abstract. Herman, Pambianco, and Chokhavatia reported no relevant disclosures.

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

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Artificial intelligence–assisted colonoscopy (AIAC) with computer-aided detection (CADe) technology may improve adenoma detection rate (ADR), but it’s also associated with higher detection and removal of non-neoplastic lesions, according to a study presented at the annual meeting of the American College of Gastroenterology (ACG).

In particular, AIAC led to a statistically and clinically significant increase in the proportion of exams that detected lesions that after resection were all found to be benign, compared with unassisted colonoscopy.

University of Minnesota
Dr. Tessa Herman

“The potential implications include increased procedural risks, as well as costs, such as pathology costs and other healthcare expenditures, without any additional colorectal cancer prevention benefit,” said lead author Tessa Herman, MD, chief resident of internal medicine at the University of Minnesota, Minneapolis, and Minneapolis Veterans Affairs Health Care System.

In a previous implementation trial at the Minneapolis VA Medical Center, Herman and colleagues compared ADR between a group of patients undergoing AIAC and a historical cohort of patients who had non–AI-assisted colonoscopy.

In this subsequent study, the research team conducted an ad hoc analysis of data from the previous trial to determine the proportion of colonoscopies for screening, surveillance, and positive fecal immunochemical tests which detect lesions that after resection are all found to be benign. They excluded colonoscopies conducted for diagnostic indications or inflammatory bowel disease, as well as incomplete colonoscopies, and for those with inadequate bowel preparation.

Overall, they studied 441 non-AIAC colonoscopies (between November 2022 and April 2023) and 599 AIAC colonoscopies (between May 2023 and October 2023). The groups were balanced, and there were no significant differences in patient demographics, endoscopists, AI technology, procedure time, or average number of polyps detected.

In the non-AIAC cohort, 37 cases (8.4%) had polypectomies that revealed only benign lesions, as compared with 74 cases (12.4%) in the AIAC cohort. The most common resected lesions were benign colonic mucosa, lymphoid aggregates, and hyperplastic polyps.

Applied to the 15 million colonoscopies conducted in the United States per year, the findings indicate that full adoption of AIAC could result in about 600,000 more colonoscopies in which only benign, nonadenomatous lesions are removed, compared with traditional colonoscopy, Herman said.

More study of AIAC is needed, said Daniel Pambianco, MD, managing partner of GastroHealth-Charlottesville in Virginia and the 2023 ACG president. “This technology is in a fledging stage, and the more data we have, the more helpful it’ll be to know if we’re removing the right lesions at a better rate.”

“There’s a hope that assistance will improve detection, removal of polyps, and ultimately, colon cancer,” added Pambianco, who comoderated the session on colorectal cancer prevention.

Future longitudinal studies should monitor both ADR and benign lesion resection rates with AIAC, and modeling studies could determine the benefits and costs of the technology, Herman said. In addition, development of hybrid CADe and computer-aided diagnosis systems could mitigate concerns about excessive benign lesion resection with AI tools.

Valley Medical Group
Dr. Sita Chokhavatia

Clinicians already are able to find colon mucosa that are polypoid or lymphoid aggregates during colonoscopy without AI assistance, said the session’s comoderator, Sita Chokhavatia, MD, AGAF, a gastroenterologist with Valley Medical Group in Ridgewood, New Jersey. 

“Instead, we need a tool that can help us to not remove these polyps that are not neoplastic,” she said. “With future developments, we may be able to take it to the next step where the algorithm tells us that it’s benign and not to touch it.”

The study was named an ACG Newsworthy Abstract. Herman, Pambianco, and Chokhavatia reported no relevant disclosures.

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

Artificial intelligence–assisted colonoscopy (AIAC) with computer-aided detection (CADe) technology may improve adenoma detection rate (ADR), but it’s also associated with higher detection and removal of non-neoplastic lesions, according to a study presented at the annual meeting of the American College of Gastroenterology (ACG).

In particular, AIAC led to a statistically and clinically significant increase in the proportion of exams that detected lesions that after resection were all found to be benign, compared with unassisted colonoscopy.

University of Minnesota
Dr. Tessa Herman

“The potential implications include increased procedural risks, as well as costs, such as pathology costs and other healthcare expenditures, without any additional colorectal cancer prevention benefit,” said lead author Tessa Herman, MD, chief resident of internal medicine at the University of Minnesota, Minneapolis, and Minneapolis Veterans Affairs Health Care System.

In a previous implementation trial at the Minneapolis VA Medical Center, Herman and colleagues compared ADR between a group of patients undergoing AIAC and a historical cohort of patients who had non–AI-assisted colonoscopy.

In this subsequent study, the research team conducted an ad hoc analysis of data from the previous trial to determine the proportion of colonoscopies for screening, surveillance, and positive fecal immunochemical tests which detect lesions that after resection are all found to be benign. They excluded colonoscopies conducted for diagnostic indications or inflammatory bowel disease, as well as incomplete colonoscopies, and for those with inadequate bowel preparation.

Overall, they studied 441 non-AIAC colonoscopies (between November 2022 and April 2023) and 599 AIAC colonoscopies (between May 2023 and October 2023). The groups were balanced, and there were no significant differences in patient demographics, endoscopists, AI technology, procedure time, or average number of polyps detected.

In the non-AIAC cohort, 37 cases (8.4%) had polypectomies that revealed only benign lesions, as compared with 74 cases (12.4%) in the AIAC cohort. The most common resected lesions were benign colonic mucosa, lymphoid aggregates, and hyperplastic polyps.

Applied to the 15 million colonoscopies conducted in the United States per year, the findings indicate that full adoption of AIAC could result in about 600,000 more colonoscopies in which only benign, nonadenomatous lesions are removed, compared with traditional colonoscopy, Herman said.

More study of AIAC is needed, said Daniel Pambianco, MD, managing partner of GastroHealth-Charlottesville in Virginia and the 2023 ACG president. “This technology is in a fledging stage, and the more data we have, the more helpful it’ll be to know if we’re removing the right lesions at a better rate.”

“There’s a hope that assistance will improve detection, removal of polyps, and ultimately, colon cancer,” added Pambianco, who comoderated the session on colorectal cancer prevention.

Future longitudinal studies should monitor both ADR and benign lesion resection rates with AIAC, and modeling studies could determine the benefits and costs of the technology, Herman said. In addition, development of hybrid CADe and computer-aided diagnosis systems could mitigate concerns about excessive benign lesion resection with AI tools.

Valley Medical Group
Dr. Sita Chokhavatia

Clinicians already are able to find colon mucosa that are polypoid or lymphoid aggregates during colonoscopy without AI assistance, said the session’s comoderator, Sita Chokhavatia, MD, AGAF, a gastroenterologist with Valley Medical Group in Ridgewood, New Jersey. 

“Instead, we need a tool that can help us to not remove these polyps that are not neoplastic,” she said. “With future developments, we may be able to take it to the next step where the algorithm tells us that it’s benign and not to touch it.”

The study was named an ACG Newsworthy Abstract. Herman, Pambianco, and Chokhavatia reported no relevant disclosures.

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

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Semiannual Time Changes Linked to Accidents, Heart Attacks

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Fri, 11/01/2024 - 12:47

As people turn their clocks back an hour on November 3 to mark the end of daylight saving time and return to standard time, they should remain aware of their sleep health and of potential risks associated with shifts in sleep patterns, according to a University of Calgary psychology professor who researches circadian cycles.

Notably, previous studies have shown that the twice-yearly time change is associated with increases in car accidents and workplace injuries, as well as heart attacks and strokes, owing to disrupted sleep, said Michael Antle, PhD, head of the psychology department and member of the Hotchkiss Brain Institute at the Cumming School of Medicine, University of Calgary, Alberta, Canada.

In an interview, Antle explained the science behind the health risks associated with time changes, offered tips to prepare for the shift, and discussed scientists’ suggestion to move to year-round standard time. This interview has been condensed and edited for clarity.

Why is it important to pay attention to circadian rhythms?

Circadian rhythms are patterns of physiologic and behavioral changes that affect everything inside the body and everything we do, including when hormones are secreted, digestive juices are ready to digest, and growth hormones are released at night. The body is a carefully coordinated orchestra, and everything has to happen at the right time.

When we start messing with those rhythms, that’s when states of disease start coming on and we don’t feel well. You’ve probably experienced it — when you try to stay up late, eat at the wrong times, or have jet lag. Flying across one or two time zones is usually tolerable, but if you fly across the world, it can be profound and make you feel bad, even up to a week. Similar shifts happen with the time changes.

How do the time changes affect health risks?

The wintertime change is generally more tolerable, and you’ll hear people talk about “gaining an hour” of sleep. It’s better than that, because we’re realigning our social clocks — such as our work schedules and school schedules — with daylight. We tend to go to bed relative to the sun but wake up based on when our boss says to be at our desk, so an earlier sunset helps us to fall asleep earlier and is healthier for our body.

In the spring, the opposite happens, and the time change affects us much more than just one bad night of sleep. For some people, it can feel like losing an hour of sleep every day for weeks, and that abrupt change can lead to car accidents, workplace injuries, heart attacks, and strokes. Our body experiences extra strain when we’re not awake and ready for the day.

What does your research show?

Most of my work focuses on preclinical models to understand what’s going on in the brain and body. Because we can’t study this ethically in humans, we learn a lot from animal models, especially mice. In a recent study looking at mild circadian disruption — where we raised mice on days that were about 75 minutes shorter — we saw they started developing diabetes, heart disease, and insulin resistance within in a few months, or about the time they were a young adult.

 

 

Oftentimes, people think about their sleep rhythm as an arbitrary choice, but in fact, it does affect your health. We know that if your human circadian clock runs slow, morning light can help fix that and reset it, whereas evening light moves us in the other direction and makes it harder to get up in the morning. 

Some people want to switch to one year-round time. What do you advocate? 

In most cases, the standard time (or winter time) is the more natural time that fits better with our body cycle. If we follow a time where we get up before sunrise or have a later sunset, then it’s linked to more social jet lag, where people are less attentive at work, don’t learn as well at school, and have more accidents.

Instead of picking what sounds good or chasing the name — such as “daylight saving time” — we need to think about the right time for us and our circadian clock. Some places, such as Maine in the United States, would actually fit better with the Atlantic time zone or the Maritime provinces in Canada, whereas some parts of Alberta are geographically west of Los Angeles based on longitude and would fit better with the Pacific time zone. Sticking with a year-round daylight saving time in some cities in Alberta would mean people wouldn’t see the sun until 10:30 AM in the winter, which is really late and could affect activities such as skiing and hockey.

The Canadian Society for Chronobiology advocates for year-round standard time to align our social clocks with our biological clocks. Sleep and circadian rhythm experts in the US and globally have issued similar position statements.

What tips do you suggest to help people adjust their circadian clocks in November?

For people who know their bodies and that it will affect them more, give yourself extra time. If your schedule permits, plan ahead and change your clocks sooner, especially if you’re able to do so over the weekend. Don’t rush around while tired — rushing when you’re not ready leads to those increased accidents on the road or on the job. Know that the sun will still be mismatched for a bit and your body clock will take time to adjust, so you might feel out of sorts for a few days.

Antle reported no relevant financial relationships.

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

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As people turn their clocks back an hour on November 3 to mark the end of daylight saving time and return to standard time, they should remain aware of their sleep health and of potential risks associated with shifts in sleep patterns, according to a University of Calgary psychology professor who researches circadian cycles.

Notably, previous studies have shown that the twice-yearly time change is associated with increases in car accidents and workplace injuries, as well as heart attacks and strokes, owing to disrupted sleep, said Michael Antle, PhD, head of the psychology department and member of the Hotchkiss Brain Institute at the Cumming School of Medicine, University of Calgary, Alberta, Canada.

In an interview, Antle explained the science behind the health risks associated with time changes, offered tips to prepare for the shift, and discussed scientists’ suggestion to move to year-round standard time. This interview has been condensed and edited for clarity.

Why is it important to pay attention to circadian rhythms?

Circadian rhythms are patterns of physiologic and behavioral changes that affect everything inside the body and everything we do, including when hormones are secreted, digestive juices are ready to digest, and growth hormones are released at night. The body is a carefully coordinated orchestra, and everything has to happen at the right time.

When we start messing with those rhythms, that’s when states of disease start coming on and we don’t feel well. You’ve probably experienced it — when you try to stay up late, eat at the wrong times, or have jet lag. Flying across one or two time zones is usually tolerable, but if you fly across the world, it can be profound and make you feel bad, even up to a week. Similar shifts happen with the time changes.

How do the time changes affect health risks?

The wintertime change is generally more tolerable, and you’ll hear people talk about “gaining an hour” of sleep. It’s better than that, because we’re realigning our social clocks — such as our work schedules and school schedules — with daylight. We tend to go to bed relative to the sun but wake up based on when our boss says to be at our desk, so an earlier sunset helps us to fall asleep earlier and is healthier for our body.

In the spring, the opposite happens, and the time change affects us much more than just one bad night of sleep. For some people, it can feel like losing an hour of sleep every day for weeks, and that abrupt change can lead to car accidents, workplace injuries, heart attacks, and strokes. Our body experiences extra strain when we’re not awake and ready for the day.

What does your research show?

Most of my work focuses on preclinical models to understand what’s going on in the brain and body. Because we can’t study this ethically in humans, we learn a lot from animal models, especially mice. In a recent study looking at mild circadian disruption — where we raised mice on days that were about 75 minutes shorter — we saw they started developing diabetes, heart disease, and insulin resistance within in a few months, or about the time they were a young adult.

 

 

Oftentimes, people think about their sleep rhythm as an arbitrary choice, but in fact, it does affect your health. We know that if your human circadian clock runs slow, morning light can help fix that and reset it, whereas evening light moves us in the other direction and makes it harder to get up in the morning. 

Some people want to switch to one year-round time. What do you advocate? 

In most cases, the standard time (or winter time) is the more natural time that fits better with our body cycle. If we follow a time where we get up before sunrise or have a later sunset, then it’s linked to more social jet lag, where people are less attentive at work, don’t learn as well at school, and have more accidents.

Instead of picking what sounds good or chasing the name — such as “daylight saving time” — we need to think about the right time for us and our circadian clock. Some places, such as Maine in the United States, would actually fit better with the Atlantic time zone or the Maritime provinces in Canada, whereas some parts of Alberta are geographically west of Los Angeles based on longitude and would fit better with the Pacific time zone. Sticking with a year-round daylight saving time in some cities in Alberta would mean people wouldn’t see the sun until 10:30 AM in the winter, which is really late and could affect activities such as skiing and hockey.

The Canadian Society for Chronobiology advocates for year-round standard time to align our social clocks with our biological clocks. Sleep and circadian rhythm experts in the US and globally have issued similar position statements.

What tips do you suggest to help people adjust their circadian clocks in November?

For people who know their bodies and that it will affect them more, give yourself extra time. If your schedule permits, plan ahead and change your clocks sooner, especially if you’re able to do so over the weekend. Don’t rush around while tired — rushing when you’re not ready leads to those increased accidents on the road or on the job. Know that the sun will still be mismatched for a bit and your body clock will take time to adjust, so you might feel out of sorts for a few days.

Antle reported no relevant financial relationships.

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

As people turn their clocks back an hour on November 3 to mark the end of daylight saving time and return to standard time, they should remain aware of their sleep health and of potential risks associated with shifts in sleep patterns, according to a University of Calgary psychology professor who researches circadian cycles.

Notably, previous studies have shown that the twice-yearly time change is associated with increases in car accidents and workplace injuries, as well as heart attacks and strokes, owing to disrupted sleep, said Michael Antle, PhD, head of the psychology department and member of the Hotchkiss Brain Institute at the Cumming School of Medicine, University of Calgary, Alberta, Canada.

In an interview, Antle explained the science behind the health risks associated with time changes, offered tips to prepare for the shift, and discussed scientists’ suggestion to move to year-round standard time. This interview has been condensed and edited for clarity.

Why is it important to pay attention to circadian rhythms?

Circadian rhythms are patterns of physiologic and behavioral changes that affect everything inside the body and everything we do, including when hormones are secreted, digestive juices are ready to digest, and growth hormones are released at night. The body is a carefully coordinated orchestra, and everything has to happen at the right time.

When we start messing with those rhythms, that’s when states of disease start coming on and we don’t feel well. You’ve probably experienced it — when you try to stay up late, eat at the wrong times, or have jet lag. Flying across one or two time zones is usually tolerable, but if you fly across the world, it can be profound and make you feel bad, even up to a week. Similar shifts happen with the time changes.

How do the time changes affect health risks?

The wintertime change is generally more tolerable, and you’ll hear people talk about “gaining an hour” of sleep. It’s better than that, because we’re realigning our social clocks — such as our work schedules and school schedules — with daylight. We tend to go to bed relative to the sun but wake up based on when our boss says to be at our desk, so an earlier sunset helps us to fall asleep earlier and is healthier for our body.

In the spring, the opposite happens, and the time change affects us much more than just one bad night of sleep. For some people, it can feel like losing an hour of sleep every day for weeks, and that abrupt change can lead to car accidents, workplace injuries, heart attacks, and strokes. Our body experiences extra strain when we’re not awake and ready for the day.

What does your research show?

Most of my work focuses on preclinical models to understand what’s going on in the brain and body. Because we can’t study this ethically in humans, we learn a lot from animal models, especially mice. In a recent study looking at mild circadian disruption — where we raised mice on days that were about 75 minutes shorter — we saw they started developing diabetes, heart disease, and insulin resistance within in a few months, or about the time they were a young adult.

 

 

Oftentimes, people think about their sleep rhythm as an arbitrary choice, but in fact, it does affect your health. We know that if your human circadian clock runs slow, morning light can help fix that and reset it, whereas evening light moves us in the other direction and makes it harder to get up in the morning. 

Some people want to switch to one year-round time. What do you advocate? 

In most cases, the standard time (or winter time) is the more natural time that fits better with our body cycle. If we follow a time where we get up before sunrise or have a later sunset, then it’s linked to more social jet lag, where people are less attentive at work, don’t learn as well at school, and have more accidents.

Instead of picking what sounds good or chasing the name — such as “daylight saving time” — we need to think about the right time for us and our circadian clock. Some places, such as Maine in the United States, would actually fit better with the Atlantic time zone or the Maritime provinces in Canada, whereas some parts of Alberta are geographically west of Los Angeles based on longitude and would fit better with the Pacific time zone. Sticking with a year-round daylight saving time in some cities in Alberta would mean people wouldn’t see the sun until 10:30 AM in the winter, which is really late and could affect activities such as skiing and hockey.

The Canadian Society for Chronobiology advocates for year-round standard time to align our social clocks with our biological clocks. Sleep and circadian rhythm experts in the US and globally have issued similar position statements.

What tips do you suggest to help people adjust their circadian clocks in November?

For people who know their bodies and that it will affect them more, give yourself extra time. If your schedule permits, plan ahead and change your clocks sooner, especially if you’re able to do so over the weekend. Don’t rush around while tired — rushing when you’re not ready leads to those increased accidents on the road or on the job. Know that the sun will still be mismatched for a bit and your body clock will take time to adjust, so you might feel out of sorts for a few days.

Antle reported no relevant financial relationships.

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

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Low-Volume Bowel Prep Easier, as Effective as Standard Prep in Hospitalized Patients

Article Type
Changed
Thu, 10/31/2024 - 10:17

Low-volume bowel preparation is noninferior in adequacy to standard-volume prep in hospitalized patients undergoing colonoscopy, according to a study presented at the annual meeting of the American College of Gastroenterology (ACG).

Patients who received MoviPrep (2L of polyethylene glycol and ascorbic acid) reported higher tolerability and willingness to repeat colonoscopy preparation in the future than those taking GoLYTELY (4L of polyethylene glycol and electrolytes). In addition, the rates of electrolyte abnormalities and acute kidney injury were low and similar between the two groups.

Yale School of Medicine
Dr. Karen Xiao

“Bowel preparation remains a challenge in the inpatient setting, where 20%-50% of all colonoscopies can have inadequate bowel preparation,” said lead author Karen Xiao, MD, assistant professor in the section of digestive diseases at Yale School of Medicine, New Haven, Connecticut.

Previous studies have indicated that low-volume (2L), split-dose preparations are noninferior to high-volume (4L), split-dose regimens, and patients generally prefer low-volume options, she said. However, the current standard of care for inpatients continues to include high-volume polyethylene glycol electrocyte lavage, which may be less tolerable.

“Similar to prior studies, our study supports that MoviPrep may be a suitable alternative to traditional high-volume bowel preparation in hospitalized patients undergoing colonoscopy,” she said.

In a single-blind, multi-site, randomized controlled trial, Xiao and colleagues in the Yale–New Haven Health System randomly assigned inpatients undergoing colonoscopy to MoviPrep or GoLYTELY between January 2022 and July 2024. They excluded patients with prior small or large bowel resection, foreign body removal, or medical contraindications, such as obstruction, pregnancy, phenylketonuria, or glucose-6-phosphate dehydrogenase deficiency.

After bowel prep but before colonoscopy, patients took the Mayo Clinic Bowel Preparation survey. Colonoscopies were then recorded, and videos were scored by a single-blinded central reviewer. The primary outcome included the adequacy of bowel prep as defined by a Boston Bowel Preparation Scale score of 6 or higher, with each segment scoring 2 or higher.

In the final analysis, 202 patients received MoviPrep and 210 received GoLYTELY. In both groups, the average age was 62; about 60% were men; and 66% were White, about 22% Black, and 13%-15% Hispanic. About 65% of patients in both arms had an American Society of Anesthesiologists (ASA) score of 3, with another 20% in each group having an ASA score of 4, “reflective of a sicker inpatient population,” Xiao said.

Inpatient colonoscopy was indicated for gastrointestinal bleeding (55%), diarrhea (15%-20%), abnormal imaging (10%-13%), inflammatory bowel disease (4%), or other (35%-41%). Patients could have more than one indication for colonoscopy.

Overall, bowel preparation was scored as adequate in 111 patients with MoviPrep (55%) and 111 patients with GoLYTELY (52.9%), and was inadequate in 91 patients with MoviPrep (45%) and 99 patients with GoLYTELY (47.1%). With a rate difference of 2.1% and a P value of .007, MoviPrep was considered noninferior to GoLYTELY for adequate bowel preparation.

In terms of secondary outcomes, there wasn’t a significant difference in the length of hospital stay, with a median stay of 6 days. Similarly, there were no differences in the rates of adverse events, including acute kidney injury and electrolyte abnormalities, with rates ranging from 1% to 9%. MoviPrep patients were slightly more likely to need additional bowel prep but also had a slightly shorter time to colonoscopy.
 

 

 

Ease of Use Is a Plus

On the basis of the Mayo Clinic Bowel Preparation survey, there wasn’t a difference between the groups in how much bowel prep solution was left in the bottle. However, more than twice as many patients who took MoviPrep said the prep was “easy,” and more MoviPrep patients called it “acceptable,” whereas more GoLYTELY patients said prep was “somewhat difficult” or “very difficult.”

In addition, significantly more MoviPrep patients (49.7% vs 33.7%) said they were “mostly willing” to drink the same prep again if they needed another colonoscopy in the future, while more GoLYTELY patients said they were “somewhat willing” (44.7% vs 34.6%) or “not willing at all” (21.6% vs 15.7%).

“Bowel prep, particularly in hospitals, is important because we do it so often. When you think about what our patients in the hospital are going through, they’re very sick and often have multiple comorbidities, so how can we give them a bowel prep that is safe for them, easiest for them, easy for our nursing staff who are experiencing shortages, and as good as the traditional bowel prep,” said the session’s moderator, Amy Oxentenko, MD, AGAF, professor of medicine and gastroenterologist at Mayo Clinic, Rochester, Minnesota.

Mayo Clinic
Dr. Amy Oxentenko

“Here we’ve seen great data that we can provide half the volume of the prep, still get amazing results in terms of adequacy of preparation, and the patients had a better experience,” said Oxentenko, the incoming ACG president. “That’s important because they likely may need another colonoscopy in the future, and we would hate for the bowel prep in the hospital to potentially dissuade them from a future colonoscopy.”

Future studies could stratify patients on the basis of colonoscopy indication or patient history, including conditions such as chronic constipation or neurogenic bowel, where some patients may still need a high-volume prep, Oxentenko said.

“Also, in the hospital setting, we don’t always know when a patient is going to the endoscopy suite due to other patient cases that may get prolonged or pushed in,” she said. “So how do you time the second dose of the split dose in anticipation of when that patient will go to the endoscopy suite to maintain that great preparation with a smaller volume prep?”

The study was awarded the ACG Governors Award for Excellence in Clinical Research (Trainee). Xiao and Oxentenko reported no relevant disclosures.

A version of this article appeared on Medscape.com.

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Low-volume bowel preparation is noninferior in adequacy to standard-volume prep in hospitalized patients undergoing colonoscopy, according to a study presented at the annual meeting of the American College of Gastroenterology (ACG).

Patients who received MoviPrep (2L of polyethylene glycol and ascorbic acid) reported higher tolerability and willingness to repeat colonoscopy preparation in the future than those taking GoLYTELY (4L of polyethylene glycol and electrolytes). In addition, the rates of electrolyte abnormalities and acute kidney injury were low and similar between the two groups.

Yale School of Medicine
Dr. Karen Xiao

“Bowel preparation remains a challenge in the inpatient setting, where 20%-50% of all colonoscopies can have inadequate bowel preparation,” said lead author Karen Xiao, MD, assistant professor in the section of digestive diseases at Yale School of Medicine, New Haven, Connecticut.

Previous studies have indicated that low-volume (2L), split-dose preparations are noninferior to high-volume (4L), split-dose regimens, and patients generally prefer low-volume options, she said. However, the current standard of care for inpatients continues to include high-volume polyethylene glycol electrocyte lavage, which may be less tolerable.

“Similar to prior studies, our study supports that MoviPrep may be a suitable alternative to traditional high-volume bowel preparation in hospitalized patients undergoing colonoscopy,” she said.

In a single-blind, multi-site, randomized controlled trial, Xiao and colleagues in the Yale–New Haven Health System randomly assigned inpatients undergoing colonoscopy to MoviPrep or GoLYTELY between January 2022 and July 2024. They excluded patients with prior small or large bowel resection, foreign body removal, or medical contraindications, such as obstruction, pregnancy, phenylketonuria, or glucose-6-phosphate dehydrogenase deficiency.

After bowel prep but before colonoscopy, patients took the Mayo Clinic Bowel Preparation survey. Colonoscopies were then recorded, and videos were scored by a single-blinded central reviewer. The primary outcome included the adequacy of bowel prep as defined by a Boston Bowel Preparation Scale score of 6 or higher, with each segment scoring 2 or higher.

In the final analysis, 202 patients received MoviPrep and 210 received GoLYTELY. In both groups, the average age was 62; about 60% were men; and 66% were White, about 22% Black, and 13%-15% Hispanic. About 65% of patients in both arms had an American Society of Anesthesiologists (ASA) score of 3, with another 20% in each group having an ASA score of 4, “reflective of a sicker inpatient population,” Xiao said.

Inpatient colonoscopy was indicated for gastrointestinal bleeding (55%), diarrhea (15%-20%), abnormal imaging (10%-13%), inflammatory bowel disease (4%), or other (35%-41%). Patients could have more than one indication for colonoscopy.

Overall, bowel preparation was scored as adequate in 111 patients with MoviPrep (55%) and 111 patients with GoLYTELY (52.9%), and was inadequate in 91 patients with MoviPrep (45%) and 99 patients with GoLYTELY (47.1%). With a rate difference of 2.1% and a P value of .007, MoviPrep was considered noninferior to GoLYTELY for adequate bowel preparation.

In terms of secondary outcomes, there wasn’t a significant difference in the length of hospital stay, with a median stay of 6 days. Similarly, there were no differences in the rates of adverse events, including acute kidney injury and electrolyte abnormalities, with rates ranging from 1% to 9%. MoviPrep patients were slightly more likely to need additional bowel prep but also had a slightly shorter time to colonoscopy.
 

 

 

Ease of Use Is a Plus

On the basis of the Mayo Clinic Bowel Preparation survey, there wasn’t a difference between the groups in how much bowel prep solution was left in the bottle. However, more than twice as many patients who took MoviPrep said the prep was “easy,” and more MoviPrep patients called it “acceptable,” whereas more GoLYTELY patients said prep was “somewhat difficult” or “very difficult.”

In addition, significantly more MoviPrep patients (49.7% vs 33.7%) said they were “mostly willing” to drink the same prep again if they needed another colonoscopy in the future, while more GoLYTELY patients said they were “somewhat willing” (44.7% vs 34.6%) or “not willing at all” (21.6% vs 15.7%).

“Bowel prep, particularly in hospitals, is important because we do it so often. When you think about what our patients in the hospital are going through, they’re very sick and often have multiple comorbidities, so how can we give them a bowel prep that is safe for them, easiest for them, easy for our nursing staff who are experiencing shortages, and as good as the traditional bowel prep,” said the session’s moderator, Amy Oxentenko, MD, AGAF, professor of medicine and gastroenterologist at Mayo Clinic, Rochester, Minnesota.

Mayo Clinic
Dr. Amy Oxentenko

“Here we’ve seen great data that we can provide half the volume of the prep, still get amazing results in terms of adequacy of preparation, and the patients had a better experience,” said Oxentenko, the incoming ACG president. “That’s important because they likely may need another colonoscopy in the future, and we would hate for the bowel prep in the hospital to potentially dissuade them from a future colonoscopy.”

Future studies could stratify patients on the basis of colonoscopy indication or patient history, including conditions such as chronic constipation or neurogenic bowel, where some patients may still need a high-volume prep, Oxentenko said.

“Also, in the hospital setting, we don’t always know when a patient is going to the endoscopy suite due to other patient cases that may get prolonged or pushed in,” she said. “So how do you time the second dose of the split dose in anticipation of when that patient will go to the endoscopy suite to maintain that great preparation with a smaller volume prep?”

The study was awarded the ACG Governors Award for Excellence in Clinical Research (Trainee). Xiao and Oxentenko reported no relevant disclosures.

A version of this article appeared on Medscape.com.

Low-volume bowel preparation is noninferior in adequacy to standard-volume prep in hospitalized patients undergoing colonoscopy, according to a study presented at the annual meeting of the American College of Gastroenterology (ACG).

Patients who received MoviPrep (2L of polyethylene glycol and ascorbic acid) reported higher tolerability and willingness to repeat colonoscopy preparation in the future than those taking GoLYTELY (4L of polyethylene glycol and electrolytes). In addition, the rates of electrolyte abnormalities and acute kidney injury were low and similar between the two groups.

Yale School of Medicine
Dr. Karen Xiao

“Bowel preparation remains a challenge in the inpatient setting, where 20%-50% of all colonoscopies can have inadequate bowel preparation,” said lead author Karen Xiao, MD, assistant professor in the section of digestive diseases at Yale School of Medicine, New Haven, Connecticut.

Previous studies have indicated that low-volume (2L), split-dose preparations are noninferior to high-volume (4L), split-dose regimens, and patients generally prefer low-volume options, she said. However, the current standard of care for inpatients continues to include high-volume polyethylene glycol electrocyte lavage, which may be less tolerable.

“Similar to prior studies, our study supports that MoviPrep may be a suitable alternative to traditional high-volume bowel preparation in hospitalized patients undergoing colonoscopy,” she said.

In a single-blind, multi-site, randomized controlled trial, Xiao and colleagues in the Yale–New Haven Health System randomly assigned inpatients undergoing colonoscopy to MoviPrep or GoLYTELY between January 2022 and July 2024. They excluded patients with prior small or large bowel resection, foreign body removal, or medical contraindications, such as obstruction, pregnancy, phenylketonuria, or glucose-6-phosphate dehydrogenase deficiency.

After bowel prep but before colonoscopy, patients took the Mayo Clinic Bowel Preparation survey. Colonoscopies were then recorded, and videos were scored by a single-blinded central reviewer. The primary outcome included the adequacy of bowel prep as defined by a Boston Bowel Preparation Scale score of 6 or higher, with each segment scoring 2 or higher.

In the final analysis, 202 patients received MoviPrep and 210 received GoLYTELY. In both groups, the average age was 62; about 60% were men; and 66% were White, about 22% Black, and 13%-15% Hispanic. About 65% of patients in both arms had an American Society of Anesthesiologists (ASA) score of 3, with another 20% in each group having an ASA score of 4, “reflective of a sicker inpatient population,” Xiao said.

Inpatient colonoscopy was indicated for gastrointestinal bleeding (55%), diarrhea (15%-20%), abnormal imaging (10%-13%), inflammatory bowel disease (4%), or other (35%-41%). Patients could have more than one indication for colonoscopy.

Overall, bowel preparation was scored as adequate in 111 patients with MoviPrep (55%) and 111 patients with GoLYTELY (52.9%), and was inadequate in 91 patients with MoviPrep (45%) and 99 patients with GoLYTELY (47.1%). With a rate difference of 2.1% and a P value of .007, MoviPrep was considered noninferior to GoLYTELY for adequate bowel preparation.

In terms of secondary outcomes, there wasn’t a significant difference in the length of hospital stay, with a median stay of 6 days. Similarly, there were no differences in the rates of adverse events, including acute kidney injury and electrolyte abnormalities, with rates ranging from 1% to 9%. MoviPrep patients were slightly more likely to need additional bowel prep but also had a slightly shorter time to colonoscopy.
 

 

 

Ease of Use Is a Plus

On the basis of the Mayo Clinic Bowel Preparation survey, there wasn’t a difference between the groups in how much bowel prep solution was left in the bottle. However, more than twice as many patients who took MoviPrep said the prep was “easy,” and more MoviPrep patients called it “acceptable,” whereas more GoLYTELY patients said prep was “somewhat difficult” or “very difficult.”

In addition, significantly more MoviPrep patients (49.7% vs 33.7%) said they were “mostly willing” to drink the same prep again if they needed another colonoscopy in the future, while more GoLYTELY patients said they were “somewhat willing” (44.7% vs 34.6%) or “not willing at all” (21.6% vs 15.7%).

“Bowel prep, particularly in hospitals, is important because we do it so often. When you think about what our patients in the hospital are going through, they’re very sick and often have multiple comorbidities, so how can we give them a bowel prep that is safe for them, easiest for them, easy for our nursing staff who are experiencing shortages, and as good as the traditional bowel prep,” said the session’s moderator, Amy Oxentenko, MD, AGAF, professor of medicine and gastroenterologist at Mayo Clinic, Rochester, Minnesota.

Mayo Clinic
Dr. Amy Oxentenko

“Here we’ve seen great data that we can provide half the volume of the prep, still get amazing results in terms of adequacy of preparation, and the patients had a better experience,” said Oxentenko, the incoming ACG president. “That’s important because they likely may need another colonoscopy in the future, and we would hate for the bowel prep in the hospital to potentially dissuade them from a future colonoscopy.”

Future studies could stratify patients on the basis of colonoscopy indication or patient history, including conditions such as chronic constipation or neurogenic bowel, where some patients may still need a high-volume prep, Oxentenko said.

“Also, in the hospital setting, we don’t always know when a patient is going to the endoscopy suite due to other patient cases that may get prolonged or pushed in,” she said. “So how do you time the second dose of the split dose in anticipation of when that patient will go to the endoscopy suite to maintain that great preparation with a smaller volume prep?”

The study was awarded the ACG Governors Award for Excellence in Clinical Research (Trainee). Xiao and Oxentenko reported no relevant disclosures.

A version of this article appeared on Medscape.com.

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One-Dose HPV Vaccine Program Would Be Efficient in Canada

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Thu, 11/07/2024 - 05:42

In Canada, switching to a one-dose, gender-neutral vaccination program for human papillomavirus (HPV) could use vaccine doses more efficiently and prevent a similar number of cervical cancer cases, compared with a two-dose program, according to a new modeling analysis.

If vaccine protection remains high during the ages of peak sexual activity, all one-dose vaccination options are projected to be “substantially more efficient” than two-dose programs, even in the most pessimistic scenarios, the study authors wrote.

In addition, the scenarios projected the elimination of cervical cancer in Canada between 2032 and 2040. HPV can also lead to oral, throat, and penile cancers, and most are preventable through vaccination.

“The COVID-19 pandemic has impacted HPV vaccination in Canada, particularly among vulnerable population subgroups,” said study author Chantal Sauvageau, MD, a consultant in infectious diseases at the National Institute of Public Health of Quebec and associate professor of social and preventive medicine at the University of Laval, Quebec City, Canada.

Switching to one-dose vaccination would offer potential economic savings and programmatic flexibility, she added. The change also could enable investments aimed at increasing vaccination rates in regions where coverage is suboptimal, as well as in subgroups with a high HPV burden. Such initiatives could mitigate the pandemic’s impact on health programs and reduce inequalities.

The study was published online in CMAJ.
 

Vaccination Program Changes

Globally, countries have been investigating whether to shift from a two-dose to a one-dose HPV vaccine strategy since the World Health Organization’s Strategic Advisory Group of Experts on Immunization issued a single-dose recommendation in 2022.

In July, Canada’s National Advisory Committee on Immunization (NACI) updated its guidelines to recommend the single-dose approach for ages 9-20 years. The change aligns Canada with 35 other countries, including Australia and the United Kingdom. Canada›s vaccine advisory group still recommends two doses for ages 21-26 years and three doses for patients who are immunocompromised or have HIV.

To help inform new NACI policies, Sauvageau and colleagues modeled several one-dose and two-dose strategies using HPV-ADVISE, an individual-based transmission-dynamic model of HPV infections and diseases. They looked at vaccination programs in Quebec, which has a high HPV vaccine coverage rate of around 85%, and Ontario, which has lower coverage of around 65%.

For one-dose programs, the researchers analyzed noninferior (98% efficacy) and pessimistic (90% efficacy) scenarios and different average vaccine duration periods, including lifelong, 30-year, and 25-year coverage. They compared the scenarios with a two-dose program with 98% efficacy and lifelong duration, estimating the relative reduction in HPV-16 infection and cervical cancer incidence and the number of doses needed to prevent one cervical cancer case.

Overall, the model projected that gender-neutral HPV vaccine programs with either two doses or a noninferior one dose would nearly eliminate HPV-16 infection by 2040-2045 in Quebec and reduce infection by more than 90% in Ontario. Under a one-dose strategy with 90% vaccine efficacy, rebounds in HPV-16 infection would start more than 25-30 years after a switch to a lower-dose strategy, thus providing time for officials to detect any signs of waning efficacy and change policies, if needed, the authors wrote.

In addition, the model projected that a noninferior one-dose, gender-neutral HPV vaccination program would avert a similar number of cervical cancer cases, compared with a two-dose program. The reduction would be about 60% in Quebec and 55% in Ontario, compared with no vaccination. Under the most pessimistic scenario with 25-year vaccine duration, a one-dose program would be slightly less effective in averting cancer: about 3% lower than a two-dose program over 100 years.

All one-dose scenarios were projected to lead to the elimination of cervical cancer in 8-16 years — at fewer than four cervical cancer cases per 100,000 female-years.

One-dose programs would also lead to more efficient use of vaccine doses, with about 800-1000 doses needed to prevent one cervical cancer case in a one-dose program and more than 10,000 incremental doses needed to prevent one additional cervical cancer case in a two-dose program.
 

 

 

What Next?

In Canada, the HPV vaccine is authorized for patients aged 9-45 years. Current immunization coverage among adolescents and young adults varies across provinces and falls below the national target of 90%. In its July 2024 update, NACI estimated that 76% of 14-year-olds of both genders received at least one vaccine dose and that 67% received two doses in 2023. Vaccine uptake was slightly higher among girls than boys.

To boost the coverage rate, shifting to a one-dose schedule could appeal to young people, as well as maintain vaccination efficacy.

“When you look at the studies that have been published worldwide, the effectiveness of one dose of the HPV vaccine is actually quite high,” said Caroline Quach-Thanh, MD, professor of microbiology, infectious diseases, immunology, and pediatrics at the University of Montreal, Quebec, Canada.

Quach-Thanh, who wasn’t involved with this study, previously served as NACI chair and now serves as chair of the Quebec Immunization Committee.

“In terms of prevention of HPV infections that may lead to cancer, whether you give one dose or two doses basically gives you the same amount of protection,” she said.

However, not all physicians agree about the switch in vaccination approaches. In early October, the Federation of Medical Women of Canada released a report with 12 recommendations to increase HPV vaccination rates, including a call for healthcare providers to continue with multidose immunization schedules for now.

“Vaccination is the most powerful action we can take in preventing HPV-related cancers. Canada is falling behind, but we can get back on track if we act quickly,” said Vivien Brown, MD, chair of the group’s HPV Immunization Task Force, chair and cofounder of HPV Prevention Week in Canada, and a past president of the federation.

After the NACI update in July, the task force evaluated the risks and benefits of a single-dose vaccine regimen, she said. They concluded that a multidose schedule should continue at this time because of its proven effectiveness.

“Until more research on the efficacy of a single-dose schedule becomes available, healthcare providers and public health agencies should continue to offer patients a multidose schedule,” said Brown. “This is the only way to ensure individuals are protected against HPV infection and cancer over the long term.”

The study was supported by the Public Health Agency of Canada, the Canadian Institutes of Health Research, the Bill & Melinda Gates Foundation, and Canadian Immunization Research Network. Sauvageau, Quach-Thanh, and Brown declared no relevant financial disclosures.

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

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In Canada, switching to a one-dose, gender-neutral vaccination program for human papillomavirus (HPV) could use vaccine doses more efficiently and prevent a similar number of cervical cancer cases, compared with a two-dose program, according to a new modeling analysis.

If vaccine protection remains high during the ages of peak sexual activity, all one-dose vaccination options are projected to be “substantially more efficient” than two-dose programs, even in the most pessimistic scenarios, the study authors wrote.

In addition, the scenarios projected the elimination of cervical cancer in Canada between 2032 and 2040. HPV can also lead to oral, throat, and penile cancers, and most are preventable through vaccination.

“The COVID-19 pandemic has impacted HPV vaccination in Canada, particularly among vulnerable population subgroups,” said study author Chantal Sauvageau, MD, a consultant in infectious diseases at the National Institute of Public Health of Quebec and associate professor of social and preventive medicine at the University of Laval, Quebec City, Canada.

Switching to one-dose vaccination would offer potential economic savings and programmatic flexibility, she added. The change also could enable investments aimed at increasing vaccination rates in regions where coverage is suboptimal, as well as in subgroups with a high HPV burden. Such initiatives could mitigate the pandemic’s impact on health programs and reduce inequalities.

The study was published online in CMAJ.
 

Vaccination Program Changes

Globally, countries have been investigating whether to shift from a two-dose to a one-dose HPV vaccine strategy since the World Health Organization’s Strategic Advisory Group of Experts on Immunization issued a single-dose recommendation in 2022.

In July, Canada’s National Advisory Committee on Immunization (NACI) updated its guidelines to recommend the single-dose approach for ages 9-20 years. The change aligns Canada with 35 other countries, including Australia and the United Kingdom. Canada›s vaccine advisory group still recommends two doses for ages 21-26 years and three doses for patients who are immunocompromised or have HIV.

To help inform new NACI policies, Sauvageau and colleagues modeled several one-dose and two-dose strategies using HPV-ADVISE, an individual-based transmission-dynamic model of HPV infections and diseases. They looked at vaccination programs in Quebec, which has a high HPV vaccine coverage rate of around 85%, and Ontario, which has lower coverage of around 65%.

For one-dose programs, the researchers analyzed noninferior (98% efficacy) and pessimistic (90% efficacy) scenarios and different average vaccine duration periods, including lifelong, 30-year, and 25-year coverage. They compared the scenarios with a two-dose program with 98% efficacy and lifelong duration, estimating the relative reduction in HPV-16 infection and cervical cancer incidence and the number of doses needed to prevent one cervical cancer case.

Overall, the model projected that gender-neutral HPV vaccine programs with either two doses or a noninferior one dose would nearly eliminate HPV-16 infection by 2040-2045 in Quebec and reduce infection by more than 90% in Ontario. Under a one-dose strategy with 90% vaccine efficacy, rebounds in HPV-16 infection would start more than 25-30 years after a switch to a lower-dose strategy, thus providing time for officials to detect any signs of waning efficacy and change policies, if needed, the authors wrote.

In addition, the model projected that a noninferior one-dose, gender-neutral HPV vaccination program would avert a similar number of cervical cancer cases, compared with a two-dose program. The reduction would be about 60% in Quebec and 55% in Ontario, compared with no vaccination. Under the most pessimistic scenario with 25-year vaccine duration, a one-dose program would be slightly less effective in averting cancer: about 3% lower than a two-dose program over 100 years.

All one-dose scenarios were projected to lead to the elimination of cervical cancer in 8-16 years — at fewer than four cervical cancer cases per 100,000 female-years.

One-dose programs would also lead to more efficient use of vaccine doses, with about 800-1000 doses needed to prevent one cervical cancer case in a one-dose program and more than 10,000 incremental doses needed to prevent one additional cervical cancer case in a two-dose program.
 

 

 

What Next?

In Canada, the HPV vaccine is authorized for patients aged 9-45 years. Current immunization coverage among adolescents and young adults varies across provinces and falls below the national target of 90%. In its July 2024 update, NACI estimated that 76% of 14-year-olds of both genders received at least one vaccine dose and that 67% received two doses in 2023. Vaccine uptake was slightly higher among girls than boys.

To boost the coverage rate, shifting to a one-dose schedule could appeal to young people, as well as maintain vaccination efficacy.

“When you look at the studies that have been published worldwide, the effectiveness of one dose of the HPV vaccine is actually quite high,” said Caroline Quach-Thanh, MD, professor of microbiology, infectious diseases, immunology, and pediatrics at the University of Montreal, Quebec, Canada.

Quach-Thanh, who wasn’t involved with this study, previously served as NACI chair and now serves as chair of the Quebec Immunization Committee.

“In terms of prevention of HPV infections that may lead to cancer, whether you give one dose or two doses basically gives you the same amount of protection,” she said.

However, not all physicians agree about the switch in vaccination approaches. In early October, the Federation of Medical Women of Canada released a report with 12 recommendations to increase HPV vaccination rates, including a call for healthcare providers to continue with multidose immunization schedules for now.

“Vaccination is the most powerful action we can take in preventing HPV-related cancers. Canada is falling behind, but we can get back on track if we act quickly,” said Vivien Brown, MD, chair of the group’s HPV Immunization Task Force, chair and cofounder of HPV Prevention Week in Canada, and a past president of the federation.

After the NACI update in July, the task force evaluated the risks and benefits of a single-dose vaccine regimen, she said. They concluded that a multidose schedule should continue at this time because of its proven effectiveness.

“Until more research on the efficacy of a single-dose schedule becomes available, healthcare providers and public health agencies should continue to offer patients a multidose schedule,” said Brown. “This is the only way to ensure individuals are protected against HPV infection and cancer over the long term.”

The study was supported by the Public Health Agency of Canada, the Canadian Institutes of Health Research, the Bill & Melinda Gates Foundation, and Canadian Immunization Research Network. Sauvageau, Quach-Thanh, and Brown declared no relevant financial disclosures.

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

In Canada, switching to a one-dose, gender-neutral vaccination program for human papillomavirus (HPV) could use vaccine doses more efficiently and prevent a similar number of cervical cancer cases, compared with a two-dose program, according to a new modeling analysis.

If vaccine protection remains high during the ages of peak sexual activity, all one-dose vaccination options are projected to be “substantially more efficient” than two-dose programs, even in the most pessimistic scenarios, the study authors wrote.

In addition, the scenarios projected the elimination of cervical cancer in Canada between 2032 and 2040. HPV can also lead to oral, throat, and penile cancers, and most are preventable through vaccination.

“The COVID-19 pandemic has impacted HPV vaccination in Canada, particularly among vulnerable population subgroups,” said study author Chantal Sauvageau, MD, a consultant in infectious diseases at the National Institute of Public Health of Quebec and associate professor of social and preventive medicine at the University of Laval, Quebec City, Canada.

Switching to one-dose vaccination would offer potential economic savings and programmatic flexibility, she added. The change also could enable investments aimed at increasing vaccination rates in regions where coverage is suboptimal, as well as in subgroups with a high HPV burden. Such initiatives could mitigate the pandemic’s impact on health programs and reduce inequalities.

The study was published online in CMAJ.
 

Vaccination Program Changes

Globally, countries have been investigating whether to shift from a two-dose to a one-dose HPV vaccine strategy since the World Health Organization’s Strategic Advisory Group of Experts on Immunization issued a single-dose recommendation in 2022.

In July, Canada’s National Advisory Committee on Immunization (NACI) updated its guidelines to recommend the single-dose approach for ages 9-20 years. The change aligns Canada with 35 other countries, including Australia and the United Kingdom. Canada›s vaccine advisory group still recommends two doses for ages 21-26 years and three doses for patients who are immunocompromised or have HIV.

To help inform new NACI policies, Sauvageau and colleagues modeled several one-dose and two-dose strategies using HPV-ADVISE, an individual-based transmission-dynamic model of HPV infections and diseases. They looked at vaccination programs in Quebec, which has a high HPV vaccine coverage rate of around 85%, and Ontario, which has lower coverage of around 65%.

For one-dose programs, the researchers analyzed noninferior (98% efficacy) and pessimistic (90% efficacy) scenarios and different average vaccine duration periods, including lifelong, 30-year, and 25-year coverage. They compared the scenarios with a two-dose program with 98% efficacy and lifelong duration, estimating the relative reduction in HPV-16 infection and cervical cancer incidence and the number of doses needed to prevent one cervical cancer case.

Overall, the model projected that gender-neutral HPV vaccine programs with either two doses or a noninferior one dose would nearly eliminate HPV-16 infection by 2040-2045 in Quebec and reduce infection by more than 90% in Ontario. Under a one-dose strategy with 90% vaccine efficacy, rebounds in HPV-16 infection would start more than 25-30 years after a switch to a lower-dose strategy, thus providing time for officials to detect any signs of waning efficacy and change policies, if needed, the authors wrote.

In addition, the model projected that a noninferior one-dose, gender-neutral HPV vaccination program would avert a similar number of cervical cancer cases, compared with a two-dose program. The reduction would be about 60% in Quebec and 55% in Ontario, compared with no vaccination. Under the most pessimistic scenario with 25-year vaccine duration, a one-dose program would be slightly less effective in averting cancer: about 3% lower than a two-dose program over 100 years.

All one-dose scenarios were projected to lead to the elimination of cervical cancer in 8-16 years — at fewer than four cervical cancer cases per 100,000 female-years.

One-dose programs would also lead to more efficient use of vaccine doses, with about 800-1000 doses needed to prevent one cervical cancer case in a one-dose program and more than 10,000 incremental doses needed to prevent one additional cervical cancer case in a two-dose program.
 

 

 

What Next?

In Canada, the HPV vaccine is authorized for patients aged 9-45 years. Current immunization coverage among adolescents and young adults varies across provinces and falls below the national target of 90%. In its July 2024 update, NACI estimated that 76% of 14-year-olds of both genders received at least one vaccine dose and that 67% received two doses in 2023. Vaccine uptake was slightly higher among girls than boys.

To boost the coverage rate, shifting to a one-dose schedule could appeal to young people, as well as maintain vaccination efficacy.

“When you look at the studies that have been published worldwide, the effectiveness of one dose of the HPV vaccine is actually quite high,” said Caroline Quach-Thanh, MD, professor of microbiology, infectious diseases, immunology, and pediatrics at the University of Montreal, Quebec, Canada.

Quach-Thanh, who wasn’t involved with this study, previously served as NACI chair and now serves as chair of the Quebec Immunization Committee.

“In terms of prevention of HPV infections that may lead to cancer, whether you give one dose or two doses basically gives you the same amount of protection,” she said.

However, not all physicians agree about the switch in vaccination approaches. In early October, the Federation of Medical Women of Canada released a report with 12 recommendations to increase HPV vaccination rates, including a call for healthcare providers to continue with multidose immunization schedules for now.

“Vaccination is the most powerful action we can take in preventing HPV-related cancers. Canada is falling behind, but we can get back on track if we act quickly,” said Vivien Brown, MD, chair of the group’s HPV Immunization Task Force, chair and cofounder of HPV Prevention Week in Canada, and a past president of the federation.

After the NACI update in July, the task force evaluated the risks and benefits of a single-dose vaccine regimen, she said. They concluded that a multidose schedule should continue at this time because of its proven effectiveness.

“Until more research on the efficacy of a single-dose schedule becomes available, healthcare providers and public health agencies should continue to offer patients a multidose schedule,” said Brown. “This is the only way to ensure individuals are protected against HPV infection and cancer over the long term.”

The study was supported by the Public Health Agency of Canada, the Canadian Institutes of Health Research, the Bill & Melinda Gates Foundation, and Canadian Immunization Research Network. Sauvageau, Quach-Thanh, and Brown declared no relevant financial disclosures.

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

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A CRC Blood Test Is Here. What Does it Mean for Screening?

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Mon, 10/07/2024 - 02:33

In July, the US Food and Drug Administration (FDA) approved the first blood-based test to screen for colorectal cancer (CRC).

The FDA’s approval of Shield (Guardant Health) marks a notable achievement, as individuals at average risk now have the option to receive a simple blood test for CRC screening, starting at age 45.

“No one has an excuse anymore not to be screened,” said John Marshall, MD, director of The Ruesch Center for the Cure of Gastrointestinal Cancers and chief medical officer of the Lombardi Comprehensive Cancer Center at the Georgetown University Medical Center in Washington, DC.

The approval was based on findings from the ECLIPSE study, which reported that Shield had 83% sensitivity for CRC and 90% specificity for advanced neoplasia, though only 13% sensitivity for advanced precancerous lesions.

While an exciting option, the test has its pros and cons.

A major plus for Shield is it provides a noninvasive, convenient way for patients to be screened for CRC, especially among the approximately 30% Americans who are either not being screened or not up to date with their screening.

The bad news, however, is that it does a poor job of detecting precancerous lesions. This could snowball if patients decide to replace a colonoscopy — which helps both detect and prevent CRC — with the blood test.

This news organization spoke to experts across three core specialties involved in the screening and treatment of CRC — primary care, gastroenterology, and oncology — to better understand both the potential value and potential pitfalls of this new option.

The interview responses have been condensed and edited for clarity.
 

What does this FDA approval mean for CRC screening?

David Lieberman, MD, gastroenterologist and professor emeritus at Oregon Health & Science University:
Detecting circulating-free DNA associated with CRC in blood is a major scientific breakthrough. The ease of blood testing will appeal to patients and providers.

Folasade May, MD, director of the gastroenterology quality improvement program at the University of California, Los Angeles: The FDA approval means that we continue to broaden the scope of available tools to help reduce the impact of this largely preventable disease.

Dr. Marshall: Colonoscopy is still the gold standard, but we have to recognize that not everyone does it. And that not everyone wants to send their poop in the mail (with a stool-based test). Now there are no more excuses.

Alan Venook, MD, gastrointestinal medical oncologist at the University of California, San Francisco: Although it’s good to have a blood test that’s approved for CRC screening, I don’t think it moves the bar much in terms of screening. I worry about it overpromising and under-delivering. If it could find polyps or premalignant lesions, that would make a big difference; however, at 13%, that doesn’t really register, so this doesn’t really change anything.

Kenny Lin, MD, a family physician at Penn Medicine Lancaster General Health: I see this test as a good option for the 30% people of CRC screening age who are either not being screened or out of date for screening. I’m a little concerned about the people who are already getting recommended screening and may try to switch to this option.

William Golden, MD, internist and professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock, Arkansas: On a scale of 1-10, I give it a 2. It’s expensive ($900 per test without insurance). It’s also not sensitive for early cancers, which would be its main value. Frankly, there are better strategies to get patients engaged.
 

 

 

What do you see as the pros and cons of this test?

Dr. Lin:
The pros are that it’s very convenient for patients, and it’s especially easy for physicians if they have a lab in their office and can avoid a referral where patients may never get the test. However, the data I saw were disappointing, with sensitivity and specificity falling short of the stool-based Cologuard test, which is also not invasive and less likely to miss early cancers, precancerous lesions, and polyps.

Dr. Lieberman: A major con is the detection rate of only 13% for advanced precancerous lesions, which means that this test is not likely to result in much cancer prevention. There is good evidence that if advanced precancerous lesions are detected and removed, many — if not most — CRCs can be prevented.

Dr. Marshall: Another issue is the potential for a false-positive result (which occurs for 1 in every 10 tests). With this result, you would do a scope but can’t find what’s going on. This is a big deal. It’s the first of the blood tests that will be used for cancer screening, and it could be scary for a patient to receive a positive result but not be able to figure out where it’s coming from.
 

Will you be recommending this test or relying on its results?

Dr. Lieberman:
Patients need to understand that the blood test is inferior to every other screening test and, if selected, would result in less protection against developing CRC or dying from CRC than other screening tests. But models suggest that this test will perform better than no screening. Therefore, it is reasonable to offer the test to individuals who decline any other form of screening.

Dr. May: I will do what I’ve always done — after the FDA approval, I wait for the US Preventive Services Task Force (USPSTF) to endorse it. If it does, then I feel it’s my responsibility to tell my patients about all the options they have and stay up to date on how the tests perform, what the pros and cons are, and what reliable information will help patients make the best decision.

Dr. Venook: No, but I could potentially see us moving it into surveillance mode, where CRC survivors or patients undergoing therapy could take it, which might give us a unique second bite of the apple. The test could potentially be of value in identifying early relapse or recurrence, which might give us a heads-up or jump start on follow-up.
 

Are you concerned that patients won’t return for a colonoscopy after a positive result?

Dr. Golden:
This concern is relevant for all tests, including fecal immunochemical test (FIT), but I’ve found that if the patient is willing to do the initial test and it comes back positive, most are willing to do the follow-up. Of course, some folks have issues with this, but now we’ll have a marker in their medical records and can re-engage them through outreach.

Dr. Lieberman: I am concerned that a patient who previously declined to have a colonoscopy may not follow up an abnormal blood test with a colonoscopy. If this occurs, it will render a blood test program ineffective for those patients. Patients should be told upfront that if the test is abnormal, a colonoscopy would be recommended.

Dr. May: This is a big concern that I have. We already have two-step screening processes with FIT, Cologuard, and CT colonography, and strong data show there is attrition. All doctors and companies will need to make it clear that if patients have an abnormal test result, they must undergo a colonoscopy. We must have activated and involved systems of patient follow-up and navigation.

Dr. Lin: I already have some concerns, given that some patients with positive FIT tests don’t get timely follow-up. I see it in my own practice where we call patients to get a colonoscopy, but they don’t take it seriously or their initial counseling wasn’t clear about the possibility of needing a follow-up colonoscopy. If people aren’t being screened for whatever reason in the first place and they get a positive result on the Shield blood test, they might be even less likely to get the necessary follow-up testing afterward.
 

 

 

What might this mean for insurance coverage and costs for patients?

Dr. May:
This is an important question because if we don’t have equal access, we create or widen disparities. For insurers to cover Shield, it’ll need to be endorsed by major medical societies, including USPSTF. But what will happen in the beginning is that wealthy patients who can pay out of pocket will use it, while lower-income individuals won’t have access until insurers cover it.

Dr. Golden: I could do 70 (or more) FIT tests for the cost of this one blood test. A FIT test should be offered first. We’re advising the Medicaid program that physicians should be required to explain why a patient doesn’t want a FIT test, prior to covering this blood test.

Dr. Venook: It’s too early to say. Although it’s approved, we now have to look at the monetization factor. At the end of the day, we still need a colonoscopy. The science is impressive, but it doesn’t mean we need to spend $900 doing a blood test.

Dr. Lin: I could see the coverage trajectory being similar to that for Cologuard, which had little coverage when it came out 10 years ago, but eventually, Medicare and commercial coverage happened. With Shield, initially, there will be some coverage gaps, especially with commercial insurance, and I can see insurance companies having concerns, especially because the test is expensive compared with other tests and the return isn’t well known. It could also be a waste of money if people with positive tests don’t receive follow-up colonoscopies.
 

What else would you like to share that people may not have considered?

Dr. Marshall: These tests could pick up other genes from other cancers. My worry is that people could have another cancer detected but not find it on a colonoscopy and think the blood test must be wrong. Or they’ll do a scan, which could lead to more scans and tests.

Dr. Golden: This test has received a lot of attention and coverage that didn’t discuss other screening options, limitations, or nuances. Let’s face it — we’ll see lots of TV ads about it, but once we start dealing with the total cost of care and alternate payment models, it’s going to be hard for this test to find a niche.

Dr. Venook: This test has only been validated in a population of ages 45 years or older, which is the conventional screening population. We desperately need something that can work in younger people, where CRC rates are increasing. I’d like to see the research move in that direction.

Dr. Lin: I thought it was unique that the FDA Advisory Panel clearly stated this was better than nothing but also should be used as second-line screening. The agency took pains to say this is not a colonoscopy or even equivalent to the fecal tests in use. But they appropriately did approve it because a lot of people aren’t getting anything at all, which is the biggest problem with CRC screening.
 

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

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In July, the US Food and Drug Administration (FDA) approved the first blood-based test to screen for colorectal cancer (CRC).

The FDA’s approval of Shield (Guardant Health) marks a notable achievement, as individuals at average risk now have the option to receive a simple blood test for CRC screening, starting at age 45.

“No one has an excuse anymore not to be screened,” said John Marshall, MD, director of The Ruesch Center for the Cure of Gastrointestinal Cancers and chief medical officer of the Lombardi Comprehensive Cancer Center at the Georgetown University Medical Center in Washington, DC.

The approval was based on findings from the ECLIPSE study, which reported that Shield had 83% sensitivity for CRC and 90% specificity for advanced neoplasia, though only 13% sensitivity for advanced precancerous lesions.

While an exciting option, the test has its pros and cons.

A major plus for Shield is it provides a noninvasive, convenient way for patients to be screened for CRC, especially among the approximately 30% Americans who are either not being screened or not up to date with their screening.

The bad news, however, is that it does a poor job of detecting precancerous lesions. This could snowball if patients decide to replace a colonoscopy — which helps both detect and prevent CRC — with the blood test.

This news organization spoke to experts across three core specialties involved in the screening and treatment of CRC — primary care, gastroenterology, and oncology — to better understand both the potential value and potential pitfalls of this new option.

The interview responses have been condensed and edited for clarity.
 

What does this FDA approval mean for CRC screening?

David Lieberman, MD, gastroenterologist and professor emeritus at Oregon Health & Science University:
Detecting circulating-free DNA associated with CRC in blood is a major scientific breakthrough. The ease of blood testing will appeal to patients and providers.

Folasade May, MD, director of the gastroenterology quality improvement program at the University of California, Los Angeles: The FDA approval means that we continue to broaden the scope of available tools to help reduce the impact of this largely preventable disease.

Dr. Marshall: Colonoscopy is still the gold standard, but we have to recognize that not everyone does it. And that not everyone wants to send their poop in the mail (with a stool-based test). Now there are no more excuses.

Alan Venook, MD, gastrointestinal medical oncologist at the University of California, San Francisco: Although it’s good to have a blood test that’s approved for CRC screening, I don’t think it moves the bar much in terms of screening. I worry about it overpromising and under-delivering. If it could find polyps or premalignant lesions, that would make a big difference; however, at 13%, that doesn’t really register, so this doesn’t really change anything.

Kenny Lin, MD, a family physician at Penn Medicine Lancaster General Health: I see this test as a good option for the 30% people of CRC screening age who are either not being screened or out of date for screening. I’m a little concerned about the people who are already getting recommended screening and may try to switch to this option.

William Golden, MD, internist and professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock, Arkansas: On a scale of 1-10, I give it a 2. It’s expensive ($900 per test without insurance). It’s also not sensitive for early cancers, which would be its main value. Frankly, there are better strategies to get patients engaged.
 

 

 

What do you see as the pros and cons of this test?

Dr. Lin:
The pros are that it’s very convenient for patients, and it’s especially easy for physicians if they have a lab in their office and can avoid a referral where patients may never get the test. However, the data I saw were disappointing, with sensitivity and specificity falling short of the stool-based Cologuard test, which is also not invasive and less likely to miss early cancers, precancerous lesions, and polyps.

Dr. Lieberman: A major con is the detection rate of only 13% for advanced precancerous lesions, which means that this test is not likely to result in much cancer prevention. There is good evidence that if advanced precancerous lesions are detected and removed, many — if not most — CRCs can be prevented.

Dr. Marshall: Another issue is the potential for a false-positive result (which occurs for 1 in every 10 tests). With this result, you would do a scope but can’t find what’s going on. This is a big deal. It’s the first of the blood tests that will be used for cancer screening, and it could be scary for a patient to receive a positive result but not be able to figure out where it’s coming from.
 

Will you be recommending this test or relying on its results?

Dr. Lieberman:
Patients need to understand that the blood test is inferior to every other screening test and, if selected, would result in less protection against developing CRC or dying from CRC than other screening tests. But models suggest that this test will perform better than no screening. Therefore, it is reasonable to offer the test to individuals who decline any other form of screening.

Dr. May: I will do what I’ve always done — after the FDA approval, I wait for the US Preventive Services Task Force (USPSTF) to endorse it. If it does, then I feel it’s my responsibility to tell my patients about all the options they have and stay up to date on how the tests perform, what the pros and cons are, and what reliable information will help patients make the best decision.

Dr. Venook: No, but I could potentially see us moving it into surveillance mode, where CRC survivors or patients undergoing therapy could take it, which might give us a unique second bite of the apple. The test could potentially be of value in identifying early relapse or recurrence, which might give us a heads-up or jump start on follow-up.
 

Are you concerned that patients won’t return for a colonoscopy after a positive result?

Dr. Golden:
This concern is relevant for all tests, including fecal immunochemical test (FIT), but I’ve found that if the patient is willing to do the initial test and it comes back positive, most are willing to do the follow-up. Of course, some folks have issues with this, but now we’ll have a marker in their medical records and can re-engage them through outreach.

Dr. Lieberman: I am concerned that a patient who previously declined to have a colonoscopy may not follow up an abnormal blood test with a colonoscopy. If this occurs, it will render a blood test program ineffective for those patients. Patients should be told upfront that if the test is abnormal, a colonoscopy would be recommended.

Dr. May: This is a big concern that I have. We already have two-step screening processes with FIT, Cologuard, and CT colonography, and strong data show there is attrition. All doctors and companies will need to make it clear that if patients have an abnormal test result, they must undergo a colonoscopy. We must have activated and involved systems of patient follow-up and navigation.

Dr. Lin: I already have some concerns, given that some patients with positive FIT tests don’t get timely follow-up. I see it in my own practice where we call patients to get a colonoscopy, but they don’t take it seriously or their initial counseling wasn’t clear about the possibility of needing a follow-up colonoscopy. If people aren’t being screened for whatever reason in the first place and they get a positive result on the Shield blood test, they might be even less likely to get the necessary follow-up testing afterward.
 

 

 

What might this mean for insurance coverage and costs for patients?

Dr. May:
This is an important question because if we don’t have equal access, we create or widen disparities. For insurers to cover Shield, it’ll need to be endorsed by major medical societies, including USPSTF. But what will happen in the beginning is that wealthy patients who can pay out of pocket will use it, while lower-income individuals won’t have access until insurers cover it.

Dr. Golden: I could do 70 (or more) FIT tests for the cost of this one blood test. A FIT test should be offered first. We’re advising the Medicaid program that physicians should be required to explain why a patient doesn’t want a FIT test, prior to covering this blood test.

Dr. Venook: It’s too early to say. Although it’s approved, we now have to look at the monetization factor. At the end of the day, we still need a colonoscopy. The science is impressive, but it doesn’t mean we need to spend $900 doing a blood test.

Dr. Lin: I could see the coverage trajectory being similar to that for Cologuard, which had little coverage when it came out 10 years ago, but eventually, Medicare and commercial coverage happened. With Shield, initially, there will be some coverage gaps, especially with commercial insurance, and I can see insurance companies having concerns, especially because the test is expensive compared with other tests and the return isn’t well known. It could also be a waste of money if people with positive tests don’t receive follow-up colonoscopies.
 

What else would you like to share that people may not have considered?

Dr. Marshall: These tests could pick up other genes from other cancers. My worry is that people could have another cancer detected but not find it on a colonoscopy and think the blood test must be wrong. Or they’ll do a scan, which could lead to more scans and tests.

Dr. Golden: This test has received a lot of attention and coverage that didn’t discuss other screening options, limitations, or nuances. Let’s face it — we’ll see lots of TV ads about it, but once we start dealing with the total cost of care and alternate payment models, it’s going to be hard for this test to find a niche.

Dr. Venook: This test has only been validated in a population of ages 45 years or older, which is the conventional screening population. We desperately need something that can work in younger people, where CRC rates are increasing. I’d like to see the research move in that direction.

Dr. Lin: I thought it was unique that the FDA Advisory Panel clearly stated this was better than nothing but also should be used as second-line screening. The agency took pains to say this is not a colonoscopy or even equivalent to the fecal tests in use. But they appropriately did approve it because a lot of people aren’t getting anything at all, which is the biggest problem with CRC screening.
 

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

In July, the US Food and Drug Administration (FDA) approved the first blood-based test to screen for colorectal cancer (CRC).

The FDA’s approval of Shield (Guardant Health) marks a notable achievement, as individuals at average risk now have the option to receive a simple blood test for CRC screening, starting at age 45.

“No one has an excuse anymore not to be screened,” said John Marshall, MD, director of The Ruesch Center for the Cure of Gastrointestinal Cancers and chief medical officer of the Lombardi Comprehensive Cancer Center at the Georgetown University Medical Center in Washington, DC.

The approval was based on findings from the ECLIPSE study, which reported that Shield had 83% sensitivity for CRC and 90% specificity for advanced neoplasia, though only 13% sensitivity for advanced precancerous lesions.

While an exciting option, the test has its pros and cons.

A major plus for Shield is it provides a noninvasive, convenient way for patients to be screened for CRC, especially among the approximately 30% Americans who are either not being screened or not up to date with their screening.

The bad news, however, is that it does a poor job of detecting precancerous lesions. This could snowball if patients decide to replace a colonoscopy — which helps both detect and prevent CRC — with the blood test.

This news organization spoke to experts across three core specialties involved in the screening and treatment of CRC — primary care, gastroenterology, and oncology — to better understand both the potential value and potential pitfalls of this new option.

The interview responses have been condensed and edited for clarity.
 

What does this FDA approval mean for CRC screening?

David Lieberman, MD, gastroenterologist and professor emeritus at Oregon Health & Science University:
Detecting circulating-free DNA associated with CRC in blood is a major scientific breakthrough. The ease of blood testing will appeal to patients and providers.

Folasade May, MD, director of the gastroenterology quality improvement program at the University of California, Los Angeles: The FDA approval means that we continue to broaden the scope of available tools to help reduce the impact of this largely preventable disease.

Dr. Marshall: Colonoscopy is still the gold standard, but we have to recognize that not everyone does it. And that not everyone wants to send their poop in the mail (with a stool-based test). Now there are no more excuses.

Alan Venook, MD, gastrointestinal medical oncologist at the University of California, San Francisco: Although it’s good to have a blood test that’s approved for CRC screening, I don’t think it moves the bar much in terms of screening. I worry about it overpromising and under-delivering. If it could find polyps or premalignant lesions, that would make a big difference; however, at 13%, that doesn’t really register, so this doesn’t really change anything.

Kenny Lin, MD, a family physician at Penn Medicine Lancaster General Health: I see this test as a good option for the 30% people of CRC screening age who are either not being screened or out of date for screening. I’m a little concerned about the people who are already getting recommended screening and may try to switch to this option.

William Golden, MD, internist and professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock, Arkansas: On a scale of 1-10, I give it a 2. It’s expensive ($900 per test without insurance). It’s also not sensitive for early cancers, which would be its main value. Frankly, there are better strategies to get patients engaged.
 

 

 

What do you see as the pros and cons of this test?

Dr. Lin:
The pros are that it’s very convenient for patients, and it’s especially easy for physicians if they have a lab in their office and can avoid a referral where patients may never get the test. However, the data I saw were disappointing, with sensitivity and specificity falling short of the stool-based Cologuard test, which is also not invasive and less likely to miss early cancers, precancerous lesions, and polyps.

Dr. Lieberman: A major con is the detection rate of only 13% for advanced precancerous lesions, which means that this test is not likely to result in much cancer prevention. There is good evidence that if advanced precancerous lesions are detected and removed, many — if not most — CRCs can be prevented.

Dr. Marshall: Another issue is the potential for a false-positive result (which occurs for 1 in every 10 tests). With this result, you would do a scope but can’t find what’s going on. This is a big deal. It’s the first of the blood tests that will be used for cancer screening, and it could be scary for a patient to receive a positive result but not be able to figure out where it’s coming from.
 

Will you be recommending this test or relying on its results?

Dr. Lieberman:
Patients need to understand that the blood test is inferior to every other screening test and, if selected, would result in less protection against developing CRC or dying from CRC than other screening tests. But models suggest that this test will perform better than no screening. Therefore, it is reasonable to offer the test to individuals who decline any other form of screening.

Dr. May: I will do what I’ve always done — after the FDA approval, I wait for the US Preventive Services Task Force (USPSTF) to endorse it. If it does, then I feel it’s my responsibility to tell my patients about all the options they have and stay up to date on how the tests perform, what the pros and cons are, and what reliable information will help patients make the best decision.

Dr. Venook: No, but I could potentially see us moving it into surveillance mode, where CRC survivors or patients undergoing therapy could take it, which might give us a unique second bite of the apple. The test could potentially be of value in identifying early relapse or recurrence, which might give us a heads-up or jump start on follow-up.
 

Are you concerned that patients won’t return for a colonoscopy after a positive result?

Dr. Golden:
This concern is relevant for all tests, including fecal immunochemical test (FIT), but I’ve found that if the patient is willing to do the initial test and it comes back positive, most are willing to do the follow-up. Of course, some folks have issues with this, but now we’ll have a marker in their medical records and can re-engage them through outreach.

Dr. Lieberman: I am concerned that a patient who previously declined to have a colonoscopy may not follow up an abnormal blood test with a colonoscopy. If this occurs, it will render a blood test program ineffective for those patients. Patients should be told upfront that if the test is abnormal, a colonoscopy would be recommended.

Dr. May: This is a big concern that I have. We already have two-step screening processes with FIT, Cologuard, and CT colonography, and strong data show there is attrition. All doctors and companies will need to make it clear that if patients have an abnormal test result, they must undergo a colonoscopy. We must have activated and involved systems of patient follow-up and navigation.

Dr. Lin: I already have some concerns, given that some patients with positive FIT tests don’t get timely follow-up. I see it in my own practice where we call patients to get a colonoscopy, but they don’t take it seriously or their initial counseling wasn’t clear about the possibility of needing a follow-up colonoscopy. If people aren’t being screened for whatever reason in the first place and they get a positive result on the Shield blood test, they might be even less likely to get the necessary follow-up testing afterward.
 

 

 

What might this mean for insurance coverage and costs for patients?

Dr. May:
This is an important question because if we don’t have equal access, we create or widen disparities. For insurers to cover Shield, it’ll need to be endorsed by major medical societies, including USPSTF. But what will happen in the beginning is that wealthy patients who can pay out of pocket will use it, while lower-income individuals won’t have access until insurers cover it.

Dr. Golden: I could do 70 (or more) FIT tests for the cost of this one blood test. A FIT test should be offered first. We’re advising the Medicaid program that physicians should be required to explain why a patient doesn’t want a FIT test, prior to covering this blood test.

Dr. Venook: It’s too early to say. Although it’s approved, we now have to look at the monetization factor. At the end of the day, we still need a colonoscopy. The science is impressive, but it doesn’t mean we need to spend $900 doing a blood test.

Dr. Lin: I could see the coverage trajectory being similar to that for Cologuard, which had little coverage when it came out 10 years ago, but eventually, Medicare and commercial coverage happened. With Shield, initially, there will be some coverage gaps, especially with commercial insurance, and I can see insurance companies having concerns, especially because the test is expensive compared with other tests and the return isn’t well known. It could also be a waste of money if people with positive tests don’t receive follow-up colonoscopies.
 

What else would you like to share that people may not have considered?

Dr. Marshall: These tests could pick up other genes from other cancers. My worry is that people could have another cancer detected but not find it on a colonoscopy and think the blood test must be wrong. Or they’ll do a scan, which could lead to more scans and tests.

Dr. Golden: This test has received a lot of attention and coverage that didn’t discuss other screening options, limitations, or nuances. Let’s face it — we’ll see lots of TV ads about it, but once we start dealing with the total cost of care and alternate payment models, it’s going to be hard for this test to find a niche.

Dr. Venook: This test has only been validated in a population of ages 45 years or older, which is the conventional screening population. We desperately need something that can work in younger people, where CRC rates are increasing. I’d like to see the research move in that direction.

Dr. Lin: I thought it was unique that the FDA Advisory Panel clearly stated this was better than nothing but also should be used as second-line screening. The agency took pains to say this is not a colonoscopy or even equivalent to the fecal tests in use. But they appropriately did approve it because a lot of people aren’t getting anything at all, which is the biggest problem with CRC screening.
 

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

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Five Steps to Improved Colonoscopy Performance

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Thu, 11/07/2024 - 10:53

As quality indicators and benchmarks for colonoscopy increase in coming years, gastroenterologists must think about ways to improve performance across the procedure continuum.

According to several experts who spoke at the American Gastroenterological Association’s Postgraduate Course this spring, which was offered at Digestive Disease Week (DDW), gastroenterologists can take these five steps to improve their performance: Addressing poor bowel prep, improving polyp detection, following the best intervals for polyp surveillance, reducing the environmental impact of gastrointestinal (GI) practice, and implementing artificial intelligence (AI) tools for efficiency and quality.
 

Addressing Poor Prep

To improve bowel preparation rates, clinicians may consider identifying those at high risk for inadequate prep, which could include known risk factors such as age, body mass index, inpatient status, constipation, tobacco use, and hypertension. However, other variables tend to serve as bigger predictors of inadequate prep, such as the patient’s status regarding cirrhosis, Parkinson’s disease, dementia, diabetes, opioid use, gastroparesis, tricyclics, and colorectal surgery.

Although several prediction models are based on some of these factors — looking at comorbidities, antidepressant use, constipation, and prior abdominal or pelvic surgery — the data don’t indicate whether knowing about or addressing these risks actually leads to better bowel prep, said Brian Jacobson, MD, associate professor of medicine at Harvard Medical School, Boston, and director of program development for gastroenterology at Massachusetts General Hospital in Boston.

Instead, the biggest return-on-investment option is to maximize prep for all patients, he said, especially since every patient has at least some risk of poor prep, either due to the required diet changes, medication considerations, or purgative solution and timing.

Massachusetts General Hospital
Dr. Brian Jacobson


To create a state-of-the-art bowel prep process, Dr. Jacobson recommended numerous tactics for all patients: Verbal and written instructions for all components of prep, patient navigation with phone or virtual messaging to guide patients through the process, a low-fiber or all-liquid diet on the day before colonoscopy, and a split-dose 2-L prep regimen. Patients should begin the second half of the split-dose regimen 4-6 hours before colonoscopy and complete it at least 2 hours before the procedure starts, and clinicians should use an irrigation pump during colonoscopy to improve visibility. 

Beyond that, Dr. Jacobson noted, higher risk patients can take a split-dose 4-L prep regimen with bisacodyl, a low-fiber diet 2-3 days before colonoscopy, and a clear liquid diet the day before colonoscopy. Using simethicone as an adjunct solution can also reduce bubbles in the colon.

Future tech developments may help clinicians as well, he said, such as using AI to identify patients at high risk and modifying their prep process, creating a personalized prep on a digital platform with videos that guide patients through the process, and using a phone checklist tool to indicate when they’re ready for colonoscopy.
 

Improving Polyp Detection

Adenoma detection rates (ADR) can be highly variable due to different techniques, technical skills, pattern recognition, interpretation, and experience. New adjunct and AI-based tools can help improve ADR, especially if clinicians want to improve, receive training, and use best-practice techniques.

“In colonoscopy, it’s tricky because it’s not just a blood test or an x-ray. There’s really a lot of technique involved, both cognitive awareness and pattern recognition, as well as our technical skills,” said Tonya Kaltenbach, MD, professor of clinical medicine at the University of California San Francisco and director of advanced endoscopy at the San Francisco VA Health Care System in San Francisco.

For instance, multiple tools and techniques may be needed in real time to interpret a lesion, such as washing, retroflexing, and using better lighting, while paying attention to alerts and noting areas for further inspection and resection.

Dr. Tonya Kaltenbach, University of California San Francisco and the San Francisco VA Health Care System
San Francisco VA Health Care System
Dr. Tonya Kaltenbach


“This is not innate. It’s a learned skill,” she said. “It’s something we need to intentionally make efforts on and get feedback to improve.”

Improvement starts with using the right mindset for lesion detection, Dr. Kaltenbach said, by having a “reflexive recognition of deconstructed patterns of normal” — following the lines, vessels, and folds and looking for interruptions, abnormal thickness, and mucus caps. On top of that, adjunctive tools such as caps/cuffs and dye chromoendoscopy can help with proper ergonomics, irrigation, and mucosa exposure.

In the past 3 years, real-world studies using AI and computer-assisted detection have shown mixed results, with some demonstrating significant increases in ADR, while others haven’t, she said. However, being willing to try AI and other tools, such as the Endocuff cap, may help improve ADR, standardize interpretation, improve efficiency, and increase reproducibility.

“We’re always better with intentional feedback and deliberate practice,” she said. “Remember that if you improve, you’re protecting the patient from death and reducing interval cancer.”
 

Following Polyp Surveillance Intervals

The US Multi-Society Task Force on Colorectal Cancer’s recommendations for follow-up after colonoscopy and polypectomy provide valuable information and rationale for how to determine surveillance intervals for patients. However, clinicians still may be unsure what to recommend for some patients — or tell them to come back too soon, leading to unnecessary colonoscopy. 

For instance, a 47-year-old woman who presents for her initial screening and has a single 6-mm polyp, which pathology returns as a single adenoma may be considered to be at average risk and suggested to return in 7-10 years. The guidelines seem more obvious for patients with one or two adenomas under 10 mm removed en bloc. 

However, once the case details shift into gray areas and include three or four adenomas between 10 and 20 mm, or piecemeal removal, clinicians may differ on their recommendations, said Rajesh N. Keswani, MD, associate professor of medicine at the Northwestern University Feinberg School of Medicine and director of endoscopy for Northwestern Medicine in Chicago. At DDW 2024, Dr. Keswani presented several case examples, often finding various audience opinions.

Dr. Rajesh N. Keswani


In addition, he noted, recent studies have found that clinicians may estimate imprecise polyp measurements, struggle to identify sessile serrated polyposis syndrome, and often don’t follow evidence-based guidelines.

“Why do we ignore the guidelines? There’s this perception that a patient has risk factors that aren’t addressed by the guidelines, with regards to family history or a distant history of a large polyp that we don’t want to leave to the usual intervals,” he said. “We feel uncomfortable, even with our meticulous colonoscopy, telling people to come back in 10 years.”

To improve guideline adherence, Dr. Keswani suggested providing additional education, implementing an automated surveillance calculator, and using guidelines at the point of care. At Northwestern, for instance, clinicians use a hyperlink with an interpreted version of the guidelines with prior colonoscopy considerations. Overall though, practitioners should feel comfortable leaning toward longer surveillance intervals, he noted.

“More effort should be spent on getting unscreened patients in for colonoscopy than bringing back low-risk patients too early,” he said.
 

 

 

Reducing Environmental Effects

In recent waste audits of endoscopy rooms, providers generate 1-3 kg of waste per procedure, which would fill 117 soccer fields to a depth of 1 m, based on 18 million procedures in the United States per year. This waste comes from procedure-related equipment, administration, medications, travel of patients and staff, and infrastructure with systems such as air conditioning. Taking steps toward a green practice can reduce waste and the carbon footprint of healthcare.

“When we think about improving colonoscopy performance, the goal is to prevent colon cancer death, but when we expand that, we have to apply sustainable practices as a domain of quality,” said Heiko Pohl, MD, professor of medicine at the Geisel School of Medicine at Dartmouth in Hanover, New Hampshire, and a gastroenterologist at White River Junction VA Medical Center in White River Junction, Vermont.

The GI Multisociety Strategic Plan on Environmental Sustainability suggests a 5-year initiative to improve sustainability and reduce waste across seven domains — clinical setting, education, research, society efforts, intersociety efforts, industry, and advocacy.

Dr. Heiko Pohl


For instance, clinicians can take the biggest step toward sustainability by avoiding unneeded colonoscopies, Dr. Pohl said, noting that between 20% and 30% aren’t appropriate or indicated. Instead, practitioners can implement longer surveillance intervals, adhere to guidelines, and consider alternative tests, such as the fecal immunochemical test, fecal DNA, blood-based tests, and CT colonography, where relevant.

Clinicians can also rethink their approach to resection, such as using a snare first instead of forceps to reduce single-instrument use, using clip closure only when it’s truly indicated, and implementing AI-assisted optical diagnosis to help with leaving rectosigmoid polyps in place.

In terms of physical waste, practices may also reconsider how they sort bins and biohazards, looking at new ways to dispose of regulated medical waste, sharps, recyclables, and typical trash. Waste audits can help find ways to reduce paper, combine procedures, and create more efficient use of endoscopy rooms.

“We are really in a very precarious situation,” Dr. Pohl said. “It’s our generation that has a responsibility to change the course for our children’s and grandchildren’s sake.”
 

AI for Quality And Efficiency

Moving forward, AI tools will likely become more popular in various parts of GI practice, by assisting with documentation, spotting polyps, tracking mucosal surfaces, providing optical histopathology, and supervising performance through high-quality feedback.

“Endoscopy has reached the limits of human visual capacity, where seeing more pixels won’t necessarily improve clinical diagnosis. What’s next for elevating the care of patients really is AI,” said Jason B. Samarasena, MD, professor of medicine and program director of the interventional endoscopy training program at the University of California Irvine in Irvine, California.

As practices adopt AI-based systems, however, clinicians should be cautious about a false sense of comfort or “alarm fatigue” if bounding boxes become distracting. Instead, new tools need to be adopted as a “physician-AI hybrid,” with the endoscopist in mind, particularly if helpful for performing a better exam by watching withdrawal time or endoscope slippage.

Dr. Jason B. Samarasena


“In real-world practice, this is being implemented without attention to endoscopist inclination and behavior,” he said. “Having a better understanding of physician attitudes could yield more optimal results.”

Notably, AI-assisted tools should be viewed akin to spell-check, which signals to the endoscopist when to pay attention and double-check an area — but primarily relies on the expert to do a high-quality exam, said Aasma Shaukat, MD, professor of medicine and director of GI outcomes research at the NYU Grossman School of Medicine, New York City. 

“This should be an adjunct or an additional tool, not a replacement tool,” she added. “This doesn’t mean to stop doing astute observation.”

New York University
Dr. Aasma Shaukat


Future tools show promise in terms of tracking additional data related to prep quality, cecal landmarks, polyp size, mucosa exposure, histology prediction, and complete resection. These automated reports could also link to real-time dashboards, hospital or national registries, and reimbursement systems, Dr. Shaukat noted.

“At the end of the day, our interests are aligned,” she said. “Everybody cares about quality, patient satisfaction, and reimbursement, and with that goal in mind, I think some of the tools can be applied to show how we can achieve those principles together.”

Dr. Jacobson, Dr. Kaltenbach, Dr. Keswani, Dr. Pohl, Dr. Samarasena, and Dr. Shaukat reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

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As quality indicators and benchmarks for colonoscopy increase in coming years, gastroenterologists must think about ways to improve performance across the procedure continuum.

According to several experts who spoke at the American Gastroenterological Association’s Postgraduate Course this spring, which was offered at Digestive Disease Week (DDW), gastroenterologists can take these five steps to improve their performance: Addressing poor bowel prep, improving polyp detection, following the best intervals for polyp surveillance, reducing the environmental impact of gastrointestinal (GI) practice, and implementing artificial intelligence (AI) tools for efficiency and quality.
 

Addressing Poor Prep

To improve bowel preparation rates, clinicians may consider identifying those at high risk for inadequate prep, which could include known risk factors such as age, body mass index, inpatient status, constipation, tobacco use, and hypertension. However, other variables tend to serve as bigger predictors of inadequate prep, such as the patient’s status regarding cirrhosis, Parkinson’s disease, dementia, diabetes, opioid use, gastroparesis, tricyclics, and colorectal surgery.

Although several prediction models are based on some of these factors — looking at comorbidities, antidepressant use, constipation, and prior abdominal or pelvic surgery — the data don’t indicate whether knowing about or addressing these risks actually leads to better bowel prep, said Brian Jacobson, MD, associate professor of medicine at Harvard Medical School, Boston, and director of program development for gastroenterology at Massachusetts General Hospital in Boston.

Instead, the biggest return-on-investment option is to maximize prep for all patients, he said, especially since every patient has at least some risk of poor prep, either due to the required diet changes, medication considerations, or purgative solution and timing.

Massachusetts General Hospital
Dr. Brian Jacobson


To create a state-of-the-art bowel prep process, Dr. Jacobson recommended numerous tactics for all patients: Verbal and written instructions for all components of prep, patient navigation with phone or virtual messaging to guide patients through the process, a low-fiber or all-liquid diet on the day before colonoscopy, and a split-dose 2-L prep regimen. Patients should begin the second half of the split-dose regimen 4-6 hours before colonoscopy and complete it at least 2 hours before the procedure starts, and clinicians should use an irrigation pump during colonoscopy to improve visibility. 

Beyond that, Dr. Jacobson noted, higher risk patients can take a split-dose 4-L prep regimen with bisacodyl, a low-fiber diet 2-3 days before colonoscopy, and a clear liquid diet the day before colonoscopy. Using simethicone as an adjunct solution can also reduce bubbles in the colon.

Future tech developments may help clinicians as well, he said, such as using AI to identify patients at high risk and modifying their prep process, creating a personalized prep on a digital platform with videos that guide patients through the process, and using a phone checklist tool to indicate when they’re ready for colonoscopy.
 

Improving Polyp Detection

Adenoma detection rates (ADR) can be highly variable due to different techniques, technical skills, pattern recognition, interpretation, and experience. New adjunct and AI-based tools can help improve ADR, especially if clinicians want to improve, receive training, and use best-practice techniques.

“In colonoscopy, it’s tricky because it’s not just a blood test or an x-ray. There’s really a lot of technique involved, both cognitive awareness and pattern recognition, as well as our technical skills,” said Tonya Kaltenbach, MD, professor of clinical medicine at the University of California San Francisco and director of advanced endoscopy at the San Francisco VA Health Care System in San Francisco.

For instance, multiple tools and techniques may be needed in real time to interpret a lesion, such as washing, retroflexing, and using better lighting, while paying attention to alerts and noting areas for further inspection and resection.

Dr. Tonya Kaltenbach, University of California San Francisco and the San Francisco VA Health Care System
San Francisco VA Health Care System
Dr. Tonya Kaltenbach


“This is not innate. It’s a learned skill,” she said. “It’s something we need to intentionally make efforts on and get feedback to improve.”

Improvement starts with using the right mindset for lesion detection, Dr. Kaltenbach said, by having a “reflexive recognition of deconstructed patterns of normal” — following the lines, vessels, and folds and looking for interruptions, abnormal thickness, and mucus caps. On top of that, adjunctive tools such as caps/cuffs and dye chromoendoscopy can help with proper ergonomics, irrigation, and mucosa exposure.

In the past 3 years, real-world studies using AI and computer-assisted detection have shown mixed results, with some demonstrating significant increases in ADR, while others haven’t, she said. However, being willing to try AI and other tools, such as the Endocuff cap, may help improve ADR, standardize interpretation, improve efficiency, and increase reproducibility.

“We’re always better with intentional feedback and deliberate practice,” she said. “Remember that if you improve, you’re protecting the patient from death and reducing interval cancer.”
 

Following Polyp Surveillance Intervals

The US Multi-Society Task Force on Colorectal Cancer’s recommendations for follow-up after colonoscopy and polypectomy provide valuable information and rationale for how to determine surveillance intervals for patients. However, clinicians still may be unsure what to recommend for some patients — or tell them to come back too soon, leading to unnecessary colonoscopy. 

For instance, a 47-year-old woman who presents for her initial screening and has a single 6-mm polyp, which pathology returns as a single adenoma may be considered to be at average risk and suggested to return in 7-10 years. The guidelines seem more obvious for patients with one or two adenomas under 10 mm removed en bloc. 

However, once the case details shift into gray areas and include three or four adenomas between 10 and 20 mm, or piecemeal removal, clinicians may differ on their recommendations, said Rajesh N. Keswani, MD, associate professor of medicine at the Northwestern University Feinberg School of Medicine and director of endoscopy for Northwestern Medicine in Chicago. At DDW 2024, Dr. Keswani presented several case examples, often finding various audience opinions.

Dr. Rajesh N. Keswani


In addition, he noted, recent studies have found that clinicians may estimate imprecise polyp measurements, struggle to identify sessile serrated polyposis syndrome, and often don’t follow evidence-based guidelines.

“Why do we ignore the guidelines? There’s this perception that a patient has risk factors that aren’t addressed by the guidelines, with regards to family history or a distant history of a large polyp that we don’t want to leave to the usual intervals,” he said. “We feel uncomfortable, even with our meticulous colonoscopy, telling people to come back in 10 years.”

To improve guideline adherence, Dr. Keswani suggested providing additional education, implementing an automated surveillance calculator, and using guidelines at the point of care. At Northwestern, for instance, clinicians use a hyperlink with an interpreted version of the guidelines with prior colonoscopy considerations. Overall though, practitioners should feel comfortable leaning toward longer surveillance intervals, he noted.

“More effort should be spent on getting unscreened patients in for colonoscopy than bringing back low-risk patients too early,” he said.
 

 

 

Reducing Environmental Effects

In recent waste audits of endoscopy rooms, providers generate 1-3 kg of waste per procedure, which would fill 117 soccer fields to a depth of 1 m, based on 18 million procedures in the United States per year. This waste comes from procedure-related equipment, administration, medications, travel of patients and staff, and infrastructure with systems such as air conditioning. Taking steps toward a green practice can reduce waste and the carbon footprint of healthcare.

“When we think about improving colonoscopy performance, the goal is to prevent colon cancer death, but when we expand that, we have to apply sustainable practices as a domain of quality,” said Heiko Pohl, MD, professor of medicine at the Geisel School of Medicine at Dartmouth in Hanover, New Hampshire, and a gastroenterologist at White River Junction VA Medical Center in White River Junction, Vermont.

The GI Multisociety Strategic Plan on Environmental Sustainability suggests a 5-year initiative to improve sustainability and reduce waste across seven domains — clinical setting, education, research, society efforts, intersociety efforts, industry, and advocacy.

Dr. Heiko Pohl


For instance, clinicians can take the biggest step toward sustainability by avoiding unneeded colonoscopies, Dr. Pohl said, noting that between 20% and 30% aren’t appropriate or indicated. Instead, practitioners can implement longer surveillance intervals, adhere to guidelines, and consider alternative tests, such as the fecal immunochemical test, fecal DNA, blood-based tests, and CT colonography, where relevant.

Clinicians can also rethink their approach to resection, such as using a snare first instead of forceps to reduce single-instrument use, using clip closure only when it’s truly indicated, and implementing AI-assisted optical diagnosis to help with leaving rectosigmoid polyps in place.

In terms of physical waste, practices may also reconsider how they sort bins and biohazards, looking at new ways to dispose of regulated medical waste, sharps, recyclables, and typical trash. Waste audits can help find ways to reduce paper, combine procedures, and create more efficient use of endoscopy rooms.

“We are really in a very precarious situation,” Dr. Pohl said. “It’s our generation that has a responsibility to change the course for our children’s and grandchildren’s sake.”
 

AI for Quality And Efficiency

Moving forward, AI tools will likely become more popular in various parts of GI practice, by assisting with documentation, spotting polyps, tracking mucosal surfaces, providing optical histopathology, and supervising performance through high-quality feedback.

“Endoscopy has reached the limits of human visual capacity, where seeing more pixels won’t necessarily improve clinical diagnosis. What’s next for elevating the care of patients really is AI,” said Jason B. Samarasena, MD, professor of medicine and program director of the interventional endoscopy training program at the University of California Irvine in Irvine, California.

As practices adopt AI-based systems, however, clinicians should be cautious about a false sense of comfort or “alarm fatigue” if bounding boxes become distracting. Instead, new tools need to be adopted as a “physician-AI hybrid,” with the endoscopist in mind, particularly if helpful for performing a better exam by watching withdrawal time or endoscope slippage.

Dr. Jason B. Samarasena


“In real-world practice, this is being implemented without attention to endoscopist inclination and behavior,” he said. “Having a better understanding of physician attitudes could yield more optimal results.”

Notably, AI-assisted tools should be viewed akin to spell-check, which signals to the endoscopist when to pay attention and double-check an area — but primarily relies on the expert to do a high-quality exam, said Aasma Shaukat, MD, professor of medicine and director of GI outcomes research at the NYU Grossman School of Medicine, New York City. 

“This should be an adjunct or an additional tool, not a replacement tool,” she added. “This doesn’t mean to stop doing astute observation.”

New York University
Dr. Aasma Shaukat


Future tools show promise in terms of tracking additional data related to prep quality, cecal landmarks, polyp size, mucosa exposure, histology prediction, and complete resection. These automated reports could also link to real-time dashboards, hospital or national registries, and reimbursement systems, Dr. Shaukat noted.

“At the end of the day, our interests are aligned,” she said. “Everybody cares about quality, patient satisfaction, and reimbursement, and with that goal in mind, I think some of the tools can be applied to show how we can achieve those principles together.”

Dr. Jacobson, Dr. Kaltenbach, Dr. Keswani, Dr. Pohl, Dr. Samarasena, and Dr. Shaukat reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

As quality indicators and benchmarks for colonoscopy increase in coming years, gastroenterologists must think about ways to improve performance across the procedure continuum.

According to several experts who spoke at the American Gastroenterological Association’s Postgraduate Course this spring, which was offered at Digestive Disease Week (DDW), gastroenterologists can take these five steps to improve their performance: Addressing poor bowel prep, improving polyp detection, following the best intervals for polyp surveillance, reducing the environmental impact of gastrointestinal (GI) practice, and implementing artificial intelligence (AI) tools for efficiency and quality.
 

Addressing Poor Prep

To improve bowel preparation rates, clinicians may consider identifying those at high risk for inadequate prep, which could include known risk factors such as age, body mass index, inpatient status, constipation, tobacco use, and hypertension. However, other variables tend to serve as bigger predictors of inadequate prep, such as the patient’s status regarding cirrhosis, Parkinson’s disease, dementia, diabetes, opioid use, gastroparesis, tricyclics, and colorectal surgery.

Although several prediction models are based on some of these factors — looking at comorbidities, antidepressant use, constipation, and prior abdominal or pelvic surgery — the data don’t indicate whether knowing about or addressing these risks actually leads to better bowel prep, said Brian Jacobson, MD, associate professor of medicine at Harvard Medical School, Boston, and director of program development for gastroenterology at Massachusetts General Hospital in Boston.

Instead, the biggest return-on-investment option is to maximize prep for all patients, he said, especially since every patient has at least some risk of poor prep, either due to the required diet changes, medication considerations, or purgative solution and timing.

Massachusetts General Hospital
Dr. Brian Jacobson


To create a state-of-the-art bowel prep process, Dr. Jacobson recommended numerous tactics for all patients: Verbal and written instructions for all components of prep, patient navigation with phone or virtual messaging to guide patients through the process, a low-fiber or all-liquid diet on the day before colonoscopy, and a split-dose 2-L prep regimen. Patients should begin the second half of the split-dose regimen 4-6 hours before colonoscopy and complete it at least 2 hours before the procedure starts, and clinicians should use an irrigation pump during colonoscopy to improve visibility. 

Beyond that, Dr. Jacobson noted, higher risk patients can take a split-dose 4-L prep regimen with bisacodyl, a low-fiber diet 2-3 days before colonoscopy, and a clear liquid diet the day before colonoscopy. Using simethicone as an adjunct solution can also reduce bubbles in the colon.

Future tech developments may help clinicians as well, he said, such as using AI to identify patients at high risk and modifying their prep process, creating a personalized prep on a digital platform with videos that guide patients through the process, and using a phone checklist tool to indicate when they’re ready for colonoscopy.
 

Improving Polyp Detection

Adenoma detection rates (ADR) can be highly variable due to different techniques, technical skills, pattern recognition, interpretation, and experience. New adjunct and AI-based tools can help improve ADR, especially if clinicians want to improve, receive training, and use best-practice techniques.

“In colonoscopy, it’s tricky because it’s not just a blood test or an x-ray. There’s really a lot of technique involved, both cognitive awareness and pattern recognition, as well as our technical skills,” said Tonya Kaltenbach, MD, professor of clinical medicine at the University of California San Francisco and director of advanced endoscopy at the San Francisco VA Health Care System in San Francisco.

For instance, multiple tools and techniques may be needed in real time to interpret a lesion, such as washing, retroflexing, and using better lighting, while paying attention to alerts and noting areas for further inspection and resection.

Dr. Tonya Kaltenbach, University of California San Francisco and the San Francisco VA Health Care System
San Francisco VA Health Care System
Dr. Tonya Kaltenbach


“This is not innate. It’s a learned skill,” she said. “It’s something we need to intentionally make efforts on and get feedback to improve.”

Improvement starts with using the right mindset for lesion detection, Dr. Kaltenbach said, by having a “reflexive recognition of deconstructed patterns of normal” — following the lines, vessels, and folds and looking for interruptions, abnormal thickness, and mucus caps. On top of that, adjunctive tools such as caps/cuffs and dye chromoendoscopy can help with proper ergonomics, irrigation, and mucosa exposure.

In the past 3 years, real-world studies using AI and computer-assisted detection have shown mixed results, with some demonstrating significant increases in ADR, while others haven’t, she said. However, being willing to try AI and other tools, such as the Endocuff cap, may help improve ADR, standardize interpretation, improve efficiency, and increase reproducibility.

“We’re always better with intentional feedback and deliberate practice,” she said. “Remember that if you improve, you’re protecting the patient from death and reducing interval cancer.”
 

Following Polyp Surveillance Intervals

The US Multi-Society Task Force on Colorectal Cancer’s recommendations for follow-up after colonoscopy and polypectomy provide valuable information and rationale for how to determine surveillance intervals for patients. However, clinicians still may be unsure what to recommend for some patients — or tell them to come back too soon, leading to unnecessary colonoscopy. 

For instance, a 47-year-old woman who presents for her initial screening and has a single 6-mm polyp, which pathology returns as a single adenoma may be considered to be at average risk and suggested to return in 7-10 years. The guidelines seem more obvious for patients with one or two adenomas under 10 mm removed en bloc. 

However, once the case details shift into gray areas and include three or four adenomas between 10 and 20 mm, or piecemeal removal, clinicians may differ on their recommendations, said Rajesh N. Keswani, MD, associate professor of medicine at the Northwestern University Feinberg School of Medicine and director of endoscopy for Northwestern Medicine in Chicago. At DDW 2024, Dr. Keswani presented several case examples, often finding various audience opinions.

Dr. Rajesh N. Keswani


In addition, he noted, recent studies have found that clinicians may estimate imprecise polyp measurements, struggle to identify sessile serrated polyposis syndrome, and often don’t follow evidence-based guidelines.

“Why do we ignore the guidelines? There’s this perception that a patient has risk factors that aren’t addressed by the guidelines, with regards to family history or a distant history of a large polyp that we don’t want to leave to the usual intervals,” he said. “We feel uncomfortable, even with our meticulous colonoscopy, telling people to come back in 10 years.”

To improve guideline adherence, Dr. Keswani suggested providing additional education, implementing an automated surveillance calculator, and using guidelines at the point of care. At Northwestern, for instance, clinicians use a hyperlink with an interpreted version of the guidelines with prior colonoscopy considerations. Overall though, practitioners should feel comfortable leaning toward longer surveillance intervals, he noted.

“More effort should be spent on getting unscreened patients in for colonoscopy than bringing back low-risk patients too early,” he said.
 

 

 

Reducing Environmental Effects

In recent waste audits of endoscopy rooms, providers generate 1-3 kg of waste per procedure, which would fill 117 soccer fields to a depth of 1 m, based on 18 million procedures in the United States per year. This waste comes from procedure-related equipment, administration, medications, travel of patients and staff, and infrastructure with systems such as air conditioning. Taking steps toward a green practice can reduce waste and the carbon footprint of healthcare.

“When we think about improving colonoscopy performance, the goal is to prevent colon cancer death, but when we expand that, we have to apply sustainable practices as a domain of quality,” said Heiko Pohl, MD, professor of medicine at the Geisel School of Medicine at Dartmouth in Hanover, New Hampshire, and a gastroenterologist at White River Junction VA Medical Center in White River Junction, Vermont.

The GI Multisociety Strategic Plan on Environmental Sustainability suggests a 5-year initiative to improve sustainability and reduce waste across seven domains — clinical setting, education, research, society efforts, intersociety efforts, industry, and advocacy.

Dr. Heiko Pohl


For instance, clinicians can take the biggest step toward sustainability by avoiding unneeded colonoscopies, Dr. Pohl said, noting that between 20% and 30% aren’t appropriate or indicated. Instead, practitioners can implement longer surveillance intervals, adhere to guidelines, and consider alternative tests, such as the fecal immunochemical test, fecal DNA, blood-based tests, and CT colonography, where relevant.

Clinicians can also rethink their approach to resection, such as using a snare first instead of forceps to reduce single-instrument use, using clip closure only when it’s truly indicated, and implementing AI-assisted optical diagnosis to help with leaving rectosigmoid polyps in place.

In terms of physical waste, practices may also reconsider how they sort bins and biohazards, looking at new ways to dispose of regulated medical waste, sharps, recyclables, and typical trash. Waste audits can help find ways to reduce paper, combine procedures, and create more efficient use of endoscopy rooms.

“We are really in a very precarious situation,” Dr. Pohl said. “It’s our generation that has a responsibility to change the course for our children’s and grandchildren’s sake.”
 

AI for Quality And Efficiency

Moving forward, AI tools will likely become more popular in various parts of GI practice, by assisting with documentation, spotting polyps, tracking mucosal surfaces, providing optical histopathology, and supervising performance through high-quality feedback.

“Endoscopy has reached the limits of human visual capacity, where seeing more pixels won’t necessarily improve clinical diagnosis. What’s next for elevating the care of patients really is AI,” said Jason B. Samarasena, MD, professor of medicine and program director of the interventional endoscopy training program at the University of California Irvine in Irvine, California.

As practices adopt AI-based systems, however, clinicians should be cautious about a false sense of comfort or “alarm fatigue” if bounding boxes become distracting. Instead, new tools need to be adopted as a “physician-AI hybrid,” with the endoscopist in mind, particularly if helpful for performing a better exam by watching withdrawal time or endoscope slippage.

Dr. Jason B. Samarasena


“In real-world practice, this is being implemented without attention to endoscopist inclination and behavior,” he said. “Having a better understanding of physician attitudes could yield more optimal results.”

Notably, AI-assisted tools should be viewed akin to spell-check, which signals to the endoscopist when to pay attention and double-check an area — but primarily relies on the expert to do a high-quality exam, said Aasma Shaukat, MD, professor of medicine and director of GI outcomes research at the NYU Grossman School of Medicine, New York City. 

“This should be an adjunct or an additional tool, not a replacement tool,” she added. “This doesn’t mean to stop doing astute observation.”

New York University
Dr. Aasma Shaukat


Future tools show promise in terms of tracking additional data related to prep quality, cecal landmarks, polyp size, mucosa exposure, histology prediction, and complete resection. These automated reports could also link to real-time dashboards, hospital or national registries, and reimbursement systems, Dr. Shaukat noted.

“At the end of the day, our interests are aligned,” she said. “Everybody cares about quality, patient satisfaction, and reimbursement, and with that goal in mind, I think some of the tools can be applied to show how we can achieve those principles together.”

Dr. Jacobson, Dr. Kaltenbach, Dr. Keswani, Dr. Pohl, Dr. Samarasena, and Dr. Shaukat reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

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Baveno VI Criteria Appear Cost-Effective for Detecting Varices in Cirrhosis

Article Type
Changed
Fri, 09/13/2024 - 14:06

 

Compared with endoscopy, the Baveno VI criteria present a noninvasive and cost-effective method to detect high-risk varices in patients with Child-Pugh A cirrhosis, according to new research.

Although upper gastrointestinal endoscopy continues to be the gold standard for detecting varices, the Baveno VI criteria combine liver stiffness and platelet count values to rule out high-risk varices, which can save on endoscopy costs.

“The Baveno VI criteria can reduce the need for endoscopies in patients with cirrhosis, but it is important to ascertain if they are also cost-effective,” said senior author Emmanuel Tsochatzis, MD, professor of hepatology at the University College London Institute for Liver and Digestive Health and Royal Free Hospital in London.

Andrew McConnell/EASL
Dr. Emmanuel Tsochatzis

“Our findings confirm that the application of these criteria is highly cost-effective, and given the fact that they are also safe, should be considered for widespread implementation,” he said.

The study was published online in Clinical Gastroenterology and Hepatology.
 

Baveno VI Criteria Analysis

On the basis of the Baveno VI Consensus, endoscopy screening can be avoided in patients with compensated advanced chronic liver disease and Child-Pugh A cirrhosis who have a platelet count > 150,000/mm3 and a liver stiffness measurement < 20 kPa. 

In addition, expanded Baveno VI criteria have suggested optimized cut-off values to avoid even more endoscopies — at a platelet value of > 110,000/mm3 and a liver stiffness < 25 kPa.

Previous research indicates that the expanded criteria could avoid double the number of endoscopies, the authors wrote, with a risk of missing high-risk varices in 1.6% of patients with the criteria and 0.6% of overall study participants. Both criteria have been validated in large groups of patients with compensated cirrhosis of different etiologies, but the cost-effectiveness hasn’t been analyzed.

Dr. Tsochatzis and colleagues created an analytical decision model to estimate the costs and benefits of using the Baveno VI criteria as compared with endoscopy as the standard of care among a hypothetical cohort of 1000 patients with Child-Pugh A cirrhosis. The research team looked at costs and clinical outcomes based on the United Kingdom National Health Service perspective at 1 year from diagnosis and then estimated the expected costs and outcomes at 5 years and 20 years, including factors such as liver disease progression and variceal bleeding.

As part of the model, the Baveno VI criteria were implemented at annual screenings with targeted endoscopy for patients who met the criteria, as compared with endoscopy as a biannual screening using esophagogastroduodenoscopy for everyone.

In general, the Baveno VI criteria were cost-effective compared with endoscopy in all analyses, including all time points, as well as deterministic and probabilistic sensitivity analyses. The cost of using the criteria was £67 per patient, as compared with £411 per patient for esophagogastroduodenoscopy.

For the 1000 patients, the criteria produced 0.16 additional quality-adjusted life years (QALYs) per patient at an incremental cost of £326, or about $443, over 5 years. This resulted in an incremental cost-effectiveness ratio (ICER) of £2081, or $2830, per additional QALY gained.

In addition, the incremental net monetary benefit of the Baveno VI criteria was £2808, or $3819, over 5 years per patient.

The results were also consistent and cost-effective in Canada and Spain using relevant cost inputs from those countries. In Canada, the ICER per QALY estimates were €3535, or $3712, over 5 years and €4610, or $4841, over 20 years. In Spain, the ICER per QALY estimates were €1966, or $2064, over 5 years and €2225, or $2336, over 20 years.
 

 

 

Baveno VI Considerations

Despite the small risk of false negatives, the Baveno VI criteria could avoid unnecessary endoscopies and provide significant cost savings, the study authors wrote.

“It should be mentioned, however, that sparing endoscopies could result in missing the incidental detection of esophageal and gastric cancers, particularly in patients with higher risk, such as those who misuse alcohol,” Dr. Tsochatzis said.

Future studies could investigate ways to broaden the applicability of the Baveno VI criteria to other patient subgroups, identify optimal cut-off points, and incorporate patients with systemic therapies.

“Baveno VI criteria can be safely used to avoid endoscopy in a substantial proportion of patients with compensated cirrhosis,” said Wayne Bai, MBChB, a gastroenterologist at Waikato Hospital and the University of Auckland in New Zealand.

Dr. Bai, who wasn’t involved with this study, has researched the Baveno VI criteria and participated in Baveno VII criteria meetings. In an analysis of more than two dozen studies, he and colleagues found that the Baveno VI criteria had a pooled 99% negative predictive value for ruling out high-risk varices and weren’t affected by the cause of cirrhosis. However, expanding the criteria had suboptimal performance in some cases.

Waikato Hospital
Dr. Wayne Bai


“The progressive change in approach to the management of compensated cirrhosis, progressively focusing on treating portal hypertension with beta-blockers independently of the presence of varices, might render these criteria less relevant,” he said.

The authors were supported by funds from the National Institute for Health and Care Research Applied Research Collaboration North Thames, the Instituto de Salud Carlos III, and the European Union’s European Regional Development Fund and European Social Fund. Dr Bai reported no relevant disclosures.
 

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

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Compared with endoscopy, the Baveno VI criteria present a noninvasive and cost-effective method to detect high-risk varices in patients with Child-Pugh A cirrhosis, according to new research.

Although upper gastrointestinal endoscopy continues to be the gold standard for detecting varices, the Baveno VI criteria combine liver stiffness and platelet count values to rule out high-risk varices, which can save on endoscopy costs.

“The Baveno VI criteria can reduce the need for endoscopies in patients with cirrhosis, but it is important to ascertain if they are also cost-effective,” said senior author Emmanuel Tsochatzis, MD, professor of hepatology at the University College London Institute for Liver and Digestive Health and Royal Free Hospital in London.

Andrew McConnell/EASL
Dr. Emmanuel Tsochatzis

“Our findings confirm that the application of these criteria is highly cost-effective, and given the fact that they are also safe, should be considered for widespread implementation,” he said.

The study was published online in Clinical Gastroenterology and Hepatology.
 

Baveno VI Criteria Analysis

On the basis of the Baveno VI Consensus, endoscopy screening can be avoided in patients with compensated advanced chronic liver disease and Child-Pugh A cirrhosis who have a platelet count > 150,000/mm3 and a liver stiffness measurement < 20 kPa. 

In addition, expanded Baveno VI criteria have suggested optimized cut-off values to avoid even more endoscopies — at a platelet value of > 110,000/mm3 and a liver stiffness < 25 kPa.

Previous research indicates that the expanded criteria could avoid double the number of endoscopies, the authors wrote, with a risk of missing high-risk varices in 1.6% of patients with the criteria and 0.6% of overall study participants. Both criteria have been validated in large groups of patients with compensated cirrhosis of different etiologies, but the cost-effectiveness hasn’t been analyzed.

Dr. Tsochatzis and colleagues created an analytical decision model to estimate the costs and benefits of using the Baveno VI criteria as compared with endoscopy as the standard of care among a hypothetical cohort of 1000 patients with Child-Pugh A cirrhosis. The research team looked at costs and clinical outcomes based on the United Kingdom National Health Service perspective at 1 year from diagnosis and then estimated the expected costs and outcomes at 5 years and 20 years, including factors such as liver disease progression and variceal bleeding.

As part of the model, the Baveno VI criteria were implemented at annual screenings with targeted endoscopy for patients who met the criteria, as compared with endoscopy as a biannual screening using esophagogastroduodenoscopy for everyone.

In general, the Baveno VI criteria were cost-effective compared with endoscopy in all analyses, including all time points, as well as deterministic and probabilistic sensitivity analyses. The cost of using the criteria was £67 per patient, as compared with £411 per patient for esophagogastroduodenoscopy.

For the 1000 patients, the criteria produced 0.16 additional quality-adjusted life years (QALYs) per patient at an incremental cost of £326, or about $443, over 5 years. This resulted in an incremental cost-effectiveness ratio (ICER) of £2081, or $2830, per additional QALY gained.

In addition, the incremental net monetary benefit of the Baveno VI criteria was £2808, or $3819, over 5 years per patient.

The results were also consistent and cost-effective in Canada and Spain using relevant cost inputs from those countries. In Canada, the ICER per QALY estimates were €3535, or $3712, over 5 years and €4610, or $4841, over 20 years. In Spain, the ICER per QALY estimates were €1966, or $2064, over 5 years and €2225, or $2336, over 20 years.
 

 

 

Baveno VI Considerations

Despite the small risk of false negatives, the Baveno VI criteria could avoid unnecessary endoscopies and provide significant cost savings, the study authors wrote.

“It should be mentioned, however, that sparing endoscopies could result in missing the incidental detection of esophageal and gastric cancers, particularly in patients with higher risk, such as those who misuse alcohol,” Dr. Tsochatzis said.

Future studies could investigate ways to broaden the applicability of the Baveno VI criteria to other patient subgroups, identify optimal cut-off points, and incorporate patients with systemic therapies.

“Baveno VI criteria can be safely used to avoid endoscopy in a substantial proportion of patients with compensated cirrhosis,” said Wayne Bai, MBChB, a gastroenterologist at Waikato Hospital and the University of Auckland in New Zealand.

Dr. Bai, who wasn’t involved with this study, has researched the Baveno VI criteria and participated in Baveno VII criteria meetings. In an analysis of more than two dozen studies, he and colleagues found that the Baveno VI criteria had a pooled 99% negative predictive value for ruling out high-risk varices and weren’t affected by the cause of cirrhosis. However, expanding the criteria had suboptimal performance in some cases.

Waikato Hospital
Dr. Wayne Bai


“The progressive change in approach to the management of compensated cirrhosis, progressively focusing on treating portal hypertension with beta-blockers independently of the presence of varices, might render these criteria less relevant,” he said.

The authors were supported by funds from the National Institute for Health and Care Research Applied Research Collaboration North Thames, the Instituto de Salud Carlos III, and the European Union’s European Regional Development Fund and European Social Fund. Dr Bai reported no relevant disclosures.
 

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

 

Compared with endoscopy, the Baveno VI criteria present a noninvasive and cost-effective method to detect high-risk varices in patients with Child-Pugh A cirrhosis, according to new research.

Although upper gastrointestinal endoscopy continues to be the gold standard for detecting varices, the Baveno VI criteria combine liver stiffness and platelet count values to rule out high-risk varices, which can save on endoscopy costs.

“The Baveno VI criteria can reduce the need for endoscopies in patients with cirrhosis, but it is important to ascertain if they are also cost-effective,” said senior author Emmanuel Tsochatzis, MD, professor of hepatology at the University College London Institute for Liver and Digestive Health and Royal Free Hospital in London.

Andrew McConnell/EASL
Dr. Emmanuel Tsochatzis

“Our findings confirm that the application of these criteria is highly cost-effective, and given the fact that they are also safe, should be considered for widespread implementation,” he said.

The study was published online in Clinical Gastroenterology and Hepatology.
 

Baveno VI Criteria Analysis

On the basis of the Baveno VI Consensus, endoscopy screening can be avoided in patients with compensated advanced chronic liver disease and Child-Pugh A cirrhosis who have a platelet count > 150,000/mm3 and a liver stiffness measurement < 20 kPa. 

In addition, expanded Baveno VI criteria have suggested optimized cut-off values to avoid even more endoscopies — at a platelet value of > 110,000/mm3 and a liver stiffness < 25 kPa.

Previous research indicates that the expanded criteria could avoid double the number of endoscopies, the authors wrote, with a risk of missing high-risk varices in 1.6% of patients with the criteria and 0.6% of overall study participants. Both criteria have been validated in large groups of patients with compensated cirrhosis of different etiologies, but the cost-effectiveness hasn’t been analyzed.

Dr. Tsochatzis and colleagues created an analytical decision model to estimate the costs and benefits of using the Baveno VI criteria as compared with endoscopy as the standard of care among a hypothetical cohort of 1000 patients with Child-Pugh A cirrhosis. The research team looked at costs and clinical outcomes based on the United Kingdom National Health Service perspective at 1 year from diagnosis and then estimated the expected costs and outcomes at 5 years and 20 years, including factors such as liver disease progression and variceal bleeding.

As part of the model, the Baveno VI criteria were implemented at annual screenings with targeted endoscopy for patients who met the criteria, as compared with endoscopy as a biannual screening using esophagogastroduodenoscopy for everyone.

In general, the Baveno VI criteria were cost-effective compared with endoscopy in all analyses, including all time points, as well as deterministic and probabilistic sensitivity analyses. The cost of using the criteria was £67 per patient, as compared with £411 per patient for esophagogastroduodenoscopy.

For the 1000 patients, the criteria produced 0.16 additional quality-adjusted life years (QALYs) per patient at an incremental cost of £326, or about $443, over 5 years. This resulted in an incremental cost-effectiveness ratio (ICER) of £2081, or $2830, per additional QALY gained.

In addition, the incremental net monetary benefit of the Baveno VI criteria was £2808, or $3819, over 5 years per patient.

The results were also consistent and cost-effective in Canada and Spain using relevant cost inputs from those countries. In Canada, the ICER per QALY estimates were €3535, or $3712, over 5 years and €4610, or $4841, over 20 years. In Spain, the ICER per QALY estimates were €1966, or $2064, over 5 years and €2225, or $2336, over 20 years.
 

 

 

Baveno VI Considerations

Despite the small risk of false negatives, the Baveno VI criteria could avoid unnecessary endoscopies and provide significant cost savings, the study authors wrote.

“It should be mentioned, however, that sparing endoscopies could result in missing the incidental detection of esophageal and gastric cancers, particularly in patients with higher risk, such as those who misuse alcohol,” Dr. Tsochatzis said.

Future studies could investigate ways to broaden the applicability of the Baveno VI criteria to other patient subgroups, identify optimal cut-off points, and incorporate patients with systemic therapies.

“Baveno VI criteria can be safely used to avoid endoscopy in a substantial proportion of patients with compensated cirrhosis,” said Wayne Bai, MBChB, a gastroenterologist at Waikato Hospital and the University of Auckland in New Zealand.

Dr. Bai, who wasn’t involved with this study, has researched the Baveno VI criteria and participated in Baveno VII criteria meetings. In an analysis of more than two dozen studies, he and colleagues found that the Baveno VI criteria had a pooled 99% negative predictive value for ruling out high-risk varices and weren’t affected by the cause of cirrhosis. However, expanding the criteria had suboptimal performance in some cases.

Waikato Hospital
Dr. Wayne Bai


“The progressive change in approach to the management of compensated cirrhosis, progressively focusing on treating portal hypertension with beta-blockers independently of the presence of varices, might render these criteria less relevant,” he said.

The authors were supported by funds from the National Institute for Health and Care Research Applied Research Collaboration North Thames, the Instituto de Salud Carlos III, and the European Union’s European Regional Development Fund and European Social Fund. Dr Bai reported no relevant disclosures.
 

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

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Parents’ Technology Use May Shape Adolescents’ Mental Health

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Wed, 09/04/2024 - 10:38

When parents are perceived as distracted by their phones or other technology during social or family interactions, it can affect the mental health of children between ages 9 and 11 years, according to a new study based in Canada.

In fact, this parental “technoference” is associated with higher levels of inattention and hyperactivity symptoms later in the child’s development, the researchers found.

“We hear a lot about children’s and adolescents’ screen time in the media, but we forget that parents are also on their screens a lot. In fact, past research shows that when parents are with their children, they spend 1 in 3 minutes on a screen,” said lead author Audrey-Ann Deneault, PhD, assistant professor of social psychology at the University of Montreal, Montreal, Quebec, Canada.

“We’ve all experienced moments when we’re on the phone and not hearing someone call us or don’t notice something happening right before our eyes,” she said. “We think that’s why it’s important to look at technoference. When parents use screens, they are more likely to miss when their child needs them.”

The study was published online in JAMA Network Open.
 

Analyzing Parental Technoference

As part of the All Our Families study, Dr. Deneault and colleagues analyzed a cohort of mothers and 1303 emerging adolescents between ages 9 and 11 years in Calgary, with the aim of understanding long-term associations between perceived parental interruptions (or technoference) and their children’s mental health.

Women were recruited during pregnancy between May 2008 and December 2010. For this study, the adolescents were assessed three times — at ages 9 years (in 2020), 10 years (in 2021), and 11 years (in 2021 and 2022). The mothers gave consent for their children to participate, and the children gave assent as well.

During the assessments, the adolescents completed questionnaires about their perceptions of parental technoference and their mental health symptoms, such as anxiety, depression, inattention, and hyperactivity. The study focused on the magnitude of effect sizes rather than statistical significance.

Overall, higher levels of anxiety symptoms at ages 9 and 10 years were prospectively associated with higher levels of perceived parental technoference at ages 10 and 11 years. The effect size was small.

In addition, higher levels of perceived parental technoference at ages 9 and 10 years were prospectively associated with higher levels of hyperactivity at ages 10 and 11 years and higher levels of inattention at age 11 years. There were no significant differences by gender.

“Technoference and youth mental health interact in complex ways. We found that when emerging adolescents have higher rates of anxiety, this can prompt parents to engage in more technoference,” Dr. Deneault said. “This latter bit highlights that parents may be struggling when their youths have mental health difficulties.”
 

Considering Healthy Changes

The findings call for a multitiered approach, Dr. Deneault said, in which adolescents and parents receive support related to mental health concerns, technology use, and healthy parent-child interactions.

“The key takeaway is that parents’ screen time matters and should begin to be a part of the conversation when we think about child and adolescent mental health,” she said.

Future research should look at the direction of associations between adolescent mental health and parental technoference, as well as underlying mechanisms, specific activities linked to technoference, and different age groups and stages of development, the study authors wrote.

“As a society, we need to understand how parents’ use of technology can interfere or not with youths’ mental health,” said Nicole Letourneau, PhD, a research professor of pediatrics, psychiatry, and community health sciences focused on parent and child health at the University of Calgary, Calgary, Alberta, Canada.

Dr. Letourneau, who wasn’t involved in this study, has researched the effects of parental technoference on parent-child relationships and child health and developmental outcomes. She and her colleagues found that parents recognized changes in their child’s behavior.

“Parental support is important for healthy development, and if parents are distracted by their devices, they can miss important but subtle cues that youth are using to signal their needs,” she said. “Given the troubling rise in youth mental health problems, we need to understand potential contributors so we can offer ways to reduce risks and promote youth mental health.”

Communication with parents should be considered as well. For instance, healthcare providers can address the positive and negative aspects of technology use.

“There is enough research out now that we should be more concerned than we currently are about how parents’ own technology habits might influence child and teen well-being. Yet, taking an overall negative lens to parent technology and smartphone habits may not prove very fruitful,” said Brandon McDaniel, PhD, a senior research scientist at the Parkview Mirro Center for Research & Innovation in Fort Wayne, Indiana.

Dr. McDaniel, who also wasn’t involved with this study, has researched technoference and associations with child behavior problems, as well as parents’ desires to change phone use. He noted that parents may use their devices for positive reasons, such as finding support from others, regulating their own emotions, and escaping from stress, so they can be more emotionally available for their children soon after using their phone.

“Many parents already feel an immense amount of guilt surrounding smartphone use in the presence of their child,” he said. “I suggest that practitioners address parent technology use in ways that validate parents in their positive uses of technology while helping them identify areas of their tech habits that may be counterproductive for their own or their child’s health and mental health.”

The All Our Families study was supported by an Alberta Innovates–Health Solutions Interdisciplinary Team Grant and the Alberta Children’s Hospital Foundation. The current analysis received funding from the Canadian Institutes of Health Research, a Children and Screens: Institute of Digital Media and Child Development COVID-19 grant, an Alberta Innovates grant, and a Banting Postdoctoral Fellowship. Dr. Deneault, Dr. Letourneau, and Dr. McDaniel reported no relevant financial relationships.

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

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When parents are perceived as distracted by their phones or other technology during social or family interactions, it can affect the mental health of children between ages 9 and 11 years, according to a new study based in Canada.

In fact, this parental “technoference” is associated with higher levels of inattention and hyperactivity symptoms later in the child’s development, the researchers found.

“We hear a lot about children’s and adolescents’ screen time in the media, but we forget that parents are also on their screens a lot. In fact, past research shows that when parents are with their children, they spend 1 in 3 minutes on a screen,” said lead author Audrey-Ann Deneault, PhD, assistant professor of social psychology at the University of Montreal, Montreal, Quebec, Canada.

“We’ve all experienced moments when we’re on the phone and not hearing someone call us or don’t notice something happening right before our eyes,” she said. “We think that’s why it’s important to look at technoference. When parents use screens, they are more likely to miss when their child needs them.”

The study was published online in JAMA Network Open.
 

Analyzing Parental Technoference

As part of the All Our Families study, Dr. Deneault and colleagues analyzed a cohort of mothers and 1303 emerging adolescents between ages 9 and 11 years in Calgary, with the aim of understanding long-term associations between perceived parental interruptions (or technoference) and their children’s mental health.

Women were recruited during pregnancy between May 2008 and December 2010. For this study, the adolescents were assessed three times — at ages 9 years (in 2020), 10 years (in 2021), and 11 years (in 2021 and 2022). The mothers gave consent for their children to participate, and the children gave assent as well.

During the assessments, the adolescents completed questionnaires about their perceptions of parental technoference and their mental health symptoms, such as anxiety, depression, inattention, and hyperactivity. The study focused on the magnitude of effect sizes rather than statistical significance.

Overall, higher levels of anxiety symptoms at ages 9 and 10 years were prospectively associated with higher levels of perceived parental technoference at ages 10 and 11 years. The effect size was small.

In addition, higher levels of perceived parental technoference at ages 9 and 10 years were prospectively associated with higher levels of hyperactivity at ages 10 and 11 years and higher levels of inattention at age 11 years. There were no significant differences by gender.

“Technoference and youth mental health interact in complex ways. We found that when emerging adolescents have higher rates of anxiety, this can prompt parents to engage in more technoference,” Dr. Deneault said. “This latter bit highlights that parents may be struggling when their youths have mental health difficulties.”
 

Considering Healthy Changes

The findings call for a multitiered approach, Dr. Deneault said, in which adolescents and parents receive support related to mental health concerns, technology use, and healthy parent-child interactions.

“The key takeaway is that parents’ screen time matters and should begin to be a part of the conversation when we think about child and adolescent mental health,” she said.

Future research should look at the direction of associations between adolescent mental health and parental technoference, as well as underlying mechanisms, specific activities linked to technoference, and different age groups and stages of development, the study authors wrote.

“As a society, we need to understand how parents’ use of technology can interfere or not with youths’ mental health,” said Nicole Letourneau, PhD, a research professor of pediatrics, psychiatry, and community health sciences focused on parent and child health at the University of Calgary, Calgary, Alberta, Canada.

Dr. Letourneau, who wasn’t involved in this study, has researched the effects of parental technoference on parent-child relationships and child health and developmental outcomes. She and her colleagues found that parents recognized changes in their child’s behavior.

“Parental support is important for healthy development, and if parents are distracted by their devices, they can miss important but subtle cues that youth are using to signal their needs,” she said. “Given the troubling rise in youth mental health problems, we need to understand potential contributors so we can offer ways to reduce risks and promote youth mental health.”

Communication with parents should be considered as well. For instance, healthcare providers can address the positive and negative aspects of technology use.

“There is enough research out now that we should be more concerned than we currently are about how parents’ own technology habits might influence child and teen well-being. Yet, taking an overall negative lens to parent technology and smartphone habits may not prove very fruitful,” said Brandon McDaniel, PhD, a senior research scientist at the Parkview Mirro Center for Research & Innovation in Fort Wayne, Indiana.

Dr. McDaniel, who also wasn’t involved with this study, has researched technoference and associations with child behavior problems, as well as parents’ desires to change phone use. He noted that parents may use their devices for positive reasons, such as finding support from others, regulating their own emotions, and escaping from stress, so they can be more emotionally available for their children soon after using their phone.

“Many parents already feel an immense amount of guilt surrounding smartphone use in the presence of their child,” he said. “I suggest that practitioners address parent technology use in ways that validate parents in their positive uses of technology while helping them identify areas of their tech habits that may be counterproductive for their own or their child’s health and mental health.”

The All Our Families study was supported by an Alberta Innovates–Health Solutions Interdisciplinary Team Grant and the Alberta Children’s Hospital Foundation. The current analysis received funding from the Canadian Institutes of Health Research, a Children and Screens: Institute of Digital Media and Child Development COVID-19 grant, an Alberta Innovates grant, and a Banting Postdoctoral Fellowship. Dr. Deneault, Dr. Letourneau, and Dr. McDaniel reported no relevant financial relationships.

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

When parents are perceived as distracted by their phones or other technology during social or family interactions, it can affect the mental health of children between ages 9 and 11 years, according to a new study based in Canada.

In fact, this parental “technoference” is associated with higher levels of inattention and hyperactivity symptoms later in the child’s development, the researchers found.

“We hear a lot about children’s and adolescents’ screen time in the media, but we forget that parents are also on their screens a lot. In fact, past research shows that when parents are with their children, they spend 1 in 3 minutes on a screen,” said lead author Audrey-Ann Deneault, PhD, assistant professor of social psychology at the University of Montreal, Montreal, Quebec, Canada.

“We’ve all experienced moments when we’re on the phone and not hearing someone call us or don’t notice something happening right before our eyes,” she said. “We think that’s why it’s important to look at technoference. When parents use screens, they are more likely to miss when their child needs them.”

The study was published online in JAMA Network Open.
 

Analyzing Parental Technoference

As part of the All Our Families study, Dr. Deneault and colleagues analyzed a cohort of mothers and 1303 emerging adolescents between ages 9 and 11 years in Calgary, with the aim of understanding long-term associations between perceived parental interruptions (or technoference) and their children’s mental health.

Women were recruited during pregnancy between May 2008 and December 2010. For this study, the adolescents were assessed three times — at ages 9 years (in 2020), 10 years (in 2021), and 11 years (in 2021 and 2022). The mothers gave consent for their children to participate, and the children gave assent as well.

During the assessments, the adolescents completed questionnaires about their perceptions of parental technoference and their mental health symptoms, such as anxiety, depression, inattention, and hyperactivity. The study focused on the magnitude of effect sizes rather than statistical significance.

Overall, higher levels of anxiety symptoms at ages 9 and 10 years were prospectively associated with higher levels of perceived parental technoference at ages 10 and 11 years. The effect size was small.

In addition, higher levels of perceived parental technoference at ages 9 and 10 years were prospectively associated with higher levels of hyperactivity at ages 10 and 11 years and higher levels of inattention at age 11 years. There were no significant differences by gender.

“Technoference and youth mental health interact in complex ways. We found that when emerging adolescents have higher rates of anxiety, this can prompt parents to engage in more technoference,” Dr. Deneault said. “This latter bit highlights that parents may be struggling when their youths have mental health difficulties.”
 

Considering Healthy Changes

The findings call for a multitiered approach, Dr. Deneault said, in which adolescents and parents receive support related to mental health concerns, technology use, and healthy parent-child interactions.

“The key takeaway is that parents’ screen time matters and should begin to be a part of the conversation when we think about child and adolescent mental health,” she said.

Future research should look at the direction of associations between adolescent mental health and parental technoference, as well as underlying mechanisms, specific activities linked to technoference, and different age groups and stages of development, the study authors wrote.

“As a society, we need to understand how parents’ use of technology can interfere or not with youths’ mental health,” said Nicole Letourneau, PhD, a research professor of pediatrics, psychiatry, and community health sciences focused on parent and child health at the University of Calgary, Calgary, Alberta, Canada.

Dr. Letourneau, who wasn’t involved in this study, has researched the effects of parental technoference on parent-child relationships and child health and developmental outcomes. She and her colleagues found that parents recognized changes in their child’s behavior.

“Parental support is important for healthy development, and if parents are distracted by their devices, they can miss important but subtle cues that youth are using to signal their needs,” she said. “Given the troubling rise in youth mental health problems, we need to understand potential contributors so we can offer ways to reduce risks and promote youth mental health.”

Communication with parents should be considered as well. For instance, healthcare providers can address the positive and negative aspects of technology use.

“There is enough research out now that we should be more concerned than we currently are about how parents’ own technology habits might influence child and teen well-being. Yet, taking an overall negative lens to parent technology and smartphone habits may not prove very fruitful,” said Brandon McDaniel, PhD, a senior research scientist at the Parkview Mirro Center for Research & Innovation in Fort Wayne, Indiana.

Dr. McDaniel, who also wasn’t involved with this study, has researched technoference and associations with child behavior problems, as well as parents’ desires to change phone use. He noted that parents may use their devices for positive reasons, such as finding support from others, regulating their own emotions, and escaping from stress, so they can be more emotionally available for their children soon after using their phone.

“Many parents already feel an immense amount of guilt surrounding smartphone use in the presence of their child,” he said. “I suggest that practitioners address parent technology use in ways that validate parents in their positive uses of technology while helping them identify areas of their tech habits that may be counterproductive for their own or their child’s health and mental health.”

The All Our Families study was supported by an Alberta Innovates–Health Solutions Interdisciplinary Team Grant and the Alberta Children’s Hospital Foundation. The current analysis received funding from the Canadian Institutes of Health Research, a Children and Screens: Institute of Digital Media and Child Development COVID-19 grant, an Alberta Innovates grant, and a Banting Postdoctoral Fellowship. Dr. Deneault, Dr. Letourneau, and Dr. McDaniel reported no relevant financial relationships.

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

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