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Advancements help guide achalasia management, experts say
at a pace that has left the line-tracing technology considered to have debatable merit just 15 years ago “now as obsolete as a typewriter,” experts said recently in a review in Gastro Hep Advances.
“We have come to conceptualize esophageal motility disorders by specific aspects of physiological dysfunction,” wrote a trio of experts – Peter Kahrilas, MD, professor of medicine; Dustin Carlson, MD, MS, assistant professor of medicine, and John Pandolfino, MD, chief of gastroenterology and hepatology, all at Northwestern University, Chicago. “A major implication of this approach is a shift in management strategy toward rendering treatment in a phenotype-specific manner.”
High-resolution manometry (HRM) was trail-blazing, they said, as it replaced line-tracing manometry in evaluating the motility of the esophagus. HRM led to the subtyping of achalasia based on the three patterns of pressurization in the esophagus that are associated with obstruction at the esophagogastric junction. But the field has continued to advance.
“It has since become clear that obstructive physiology also occurs in syndromes besides achalasia involving the esophagogastric junction and/or distal esophagus,” Dr. Kahrilas, Dr. Carlson, and Dr. Pandolfino said. “In fact, obstructive physiology is increasingly recognized as the fundamental abnormality leading to the perception of dysphagia with esophageal motility disorders. This concept of obstructive physiology as the fundamental abnormality has substantially morphed the clinical management of esophageal motility disorders.”
HRM, has many limitations, but in cases of an uncertain achalasia diagnosis, functional luminal imaging probe (FLIP) technology can help, they said. FLIP can also help surgeons tailor myotomy procedures.
In FLIP, a probe is carefully filled with fluid, causing distension of the esophagus. In the test, the distensibility of the esophagogastric junction is measured. The procedure allows a more refined assessment of the movement of the esophagus, and the subtypes of achalasia.
Identifying the achalasia subtype is crucial to choosing the right treatment, data suggests. There have been no randomized controlled trials on achalasia management that prospectively consider achalasia subtype, but retrospective analysis of RCT data “suggests that achalasia subtypes are of great relevance in forecasting treatment effectiveness,” they said.
In one trial, pneumatic dilation was effective in 100% of type II achalasia, which involves panesophageal pressurization, significantly better than laparoscopic Heller myotomy (LHM). But it was much less effective than LHM in type III achalasia, the spastic form, although a significance couldn’t be established because of the number of cases. Data from a meta-analysis showed that peroral endoscopic myotomy, which allows for a longer myotomy if needed, was better than LHM for classic achalasia and spastic achalasia and was most efficacious overall.
The writers said that the diagnostic classifications for achalasia are likely to continue to evolve, pointing to the dynamic nature of the Chicago Classification for the disorder.
“The fact that it has now gone through four iterations since 2008 emphasizes that this is a work in progress and that no classification scheme of esophageal motility disorders based on a single test will ever be perfect,” they said. “After all, there are no biomarkers of esophageal motility disorders and, in the absence of a biomarker, there can be no ‘gold standard’ for diagnosis.”
Dr. Pandolfino, Dr. Kahrilas, and Northwestern University hold shared intellectual property rights and ownership surrounding FLIP Panometry systems, methods, and apparatus with Medtronic. Dr. Kahrilas reported consulting with Ironwood, Reckitt, and Phathom. Dr. Carlson reported conflicts of interest with Medtronic and Phathom Pharmaceuticals. Dr. Pandolfino reported conflicts of interest with Sandhill Scientific/Diversatek, Takeda, AstraZeneca, Medtronic, Torax, and Ironwood.
16% of the U.S. population experience dysphagia, only half of whom seek medical care and the others manage their symptoms by modifying diet.
X-ray barium swallow and endoscopy with biopsy to exclude eosinophilic esophagitis are the initial tests for dysphagia diagnosis. If the above are normal, a high-resolution esophageal manometry impedance (HRMZ) is recommended to diagnose primary and secondary esophageal motility disorder.
However, only in a minority of patients is it likely to cause dysphagia because uncontrolled studies show that therapeutic strategies to address EGJOO (botox, dilation, and myotomy) relieve dysphagia symptoms in a minority of patients. Hence, in significant number of patients the cause of dysphagia symptoms remains obscure. It might be that our testing is inadequate, or possibly, patients have functional dysphagia (sensory dysfunction of the esophagus). My opinion is that it is the former.
The esophagus has only one simple function, that is, to transfer the pharyngeal pump driven, that is, swallowed contents to the stomach, for which its luminal cross-sectional area must be larger than that of the swallowed bolus and contraction (measured by manometry) behind the bolus must be of adequate strength. The latter is likely less relevant because humans eat in the upright position and gravity provides propulsion for the bolus. Stated simply, as long as esophagus can distend well and there is no resistance to the outflow at the EGJ, esophagus can achieve its goal. However, until recently, there was no single test to determine the distension and contraction, the two essential elements of primary esophageal peristalsis.
Endoscopy and x-ray barium swallow are tests to determine the luminal diameter but have limitations. Endoflip measures the opening function of the EGJ and is useful when the HRM is normal. However, pressures that are currently being used to measure the EGJ distensibility by Endoflip are not physiological. Furthermore, esophageal body motor function assessed by a bag that distends a long segment of the esophagus under high pressure is unphysiological. The distension-contraction plots, which determines the luminal CSA and contraction simultaneously during primary peristalsis is ideally suited to study the pathophysiology of esophageal motility disorders. Several studies from my laboratory show that in patients with nutcracker esophagus, EGJOO and normal HRM, the esophagus distends significantly less than that of normal subjects during primary peristalsis. I suspect that an esophageal contraction pushing bolus through a narrow lumen esophagus is the cause of dysphagia sensation in many patients that have been labeled as functional dysphagia.
The last 2 decades have seen significant progress in the diagnosis of esophageal motility disorders using HRM, Endoflip, and distension-contraction plots of peristalsis. Furthermore, endoscopic treatment of achalasia and “achalasia-like syndromes” is revolutionary. What is desperately needed is an understanding of the pathogenesis of esophageal motor disorders, pharmacotherapy of esophageal symptoms, such as chest pain, proton pump inhibitor–resistant heartburn, and others because dysfunctional esophagus is a huge burden on health care expenditures worldwide.
Ravinder K. Mittal, MD, is a professor of medicine and gastroenterologist with UC San Diego Health. He has patent application pending on the computer software Dplots.
16% of the U.S. population experience dysphagia, only half of whom seek medical care and the others manage their symptoms by modifying diet.
X-ray barium swallow and endoscopy with biopsy to exclude eosinophilic esophagitis are the initial tests for dysphagia diagnosis. If the above are normal, a high-resolution esophageal manometry impedance (HRMZ) is recommended to diagnose primary and secondary esophageal motility disorder.
However, only in a minority of patients is it likely to cause dysphagia because uncontrolled studies show that therapeutic strategies to address EGJOO (botox, dilation, and myotomy) relieve dysphagia symptoms in a minority of patients. Hence, in significant number of patients the cause of dysphagia symptoms remains obscure. It might be that our testing is inadequate, or possibly, patients have functional dysphagia (sensory dysfunction of the esophagus). My opinion is that it is the former.
The esophagus has only one simple function, that is, to transfer the pharyngeal pump driven, that is, swallowed contents to the stomach, for which its luminal cross-sectional area must be larger than that of the swallowed bolus and contraction (measured by manometry) behind the bolus must be of adequate strength. The latter is likely less relevant because humans eat in the upright position and gravity provides propulsion for the bolus. Stated simply, as long as esophagus can distend well and there is no resistance to the outflow at the EGJ, esophagus can achieve its goal. However, until recently, there was no single test to determine the distension and contraction, the two essential elements of primary esophageal peristalsis.
Endoscopy and x-ray barium swallow are tests to determine the luminal diameter but have limitations. Endoflip measures the opening function of the EGJ and is useful when the HRM is normal. However, pressures that are currently being used to measure the EGJ distensibility by Endoflip are not physiological. Furthermore, esophageal body motor function assessed by a bag that distends a long segment of the esophagus under high pressure is unphysiological. The distension-contraction plots, which determines the luminal CSA and contraction simultaneously during primary peristalsis is ideally suited to study the pathophysiology of esophageal motility disorders. Several studies from my laboratory show that in patients with nutcracker esophagus, EGJOO and normal HRM, the esophagus distends significantly less than that of normal subjects during primary peristalsis. I suspect that an esophageal contraction pushing bolus through a narrow lumen esophagus is the cause of dysphagia sensation in many patients that have been labeled as functional dysphagia.
The last 2 decades have seen significant progress in the diagnosis of esophageal motility disorders using HRM, Endoflip, and distension-contraction plots of peristalsis. Furthermore, endoscopic treatment of achalasia and “achalasia-like syndromes” is revolutionary. What is desperately needed is an understanding of the pathogenesis of esophageal motor disorders, pharmacotherapy of esophageal symptoms, such as chest pain, proton pump inhibitor–resistant heartburn, and others because dysfunctional esophagus is a huge burden on health care expenditures worldwide.
Ravinder K. Mittal, MD, is a professor of medicine and gastroenterologist with UC San Diego Health. He has patent application pending on the computer software Dplots.
16% of the U.S. population experience dysphagia, only half of whom seek medical care and the others manage their symptoms by modifying diet.
X-ray barium swallow and endoscopy with biopsy to exclude eosinophilic esophagitis are the initial tests for dysphagia diagnosis. If the above are normal, a high-resolution esophageal manometry impedance (HRMZ) is recommended to diagnose primary and secondary esophageal motility disorder.
However, only in a minority of patients is it likely to cause dysphagia because uncontrolled studies show that therapeutic strategies to address EGJOO (botox, dilation, and myotomy) relieve dysphagia symptoms in a minority of patients. Hence, in significant number of patients the cause of dysphagia symptoms remains obscure. It might be that our testing is inadequate, or possibly, patients have functional dysphagia (sensory dysfunction of the esophagus). My opinion is that it is the former.
The esophagus has only one simple function, that is, to transfer the pharyngeal pump driven, that is, swallowed contents to the stomach, for which its luminal cross-sectional area must be larger than that of the swallowed bolus and contraction (measured by manometry) behind the bolus must be of adequate strength. The latter is likely less relevant because humans eat in the upright position and gravity provides propulsion for the bolus. Stated simply, as long as esophagus can distend well and there is no resistance to the outflow at the EGJ, esophagus can achieve its goal. However, until recently, there was no single test to determine the distension and contraction, the two essential elements of primary esophageal peristalsis.
Endoscopy and x-ray barium swallow are tests to determine the luminal diameter but have limitations. Endoflip measures the opening function of the EGJ and is useful when the HRM is normal. However, pressures that are currently being used to measure the EGJ distensibility by Endoflip are not physiological. Furthermore, esophageal body motor function assessed by a bag that distends a long segment of the esophagus under high pressure is unphysiological. The distension-contraction plots, which determines the luminal CSA and contraction simultaneously during primary peristalsis is ideally suited to study the pathophysiology of esophageal motility disorders. Several studies from my laboratory show that in patients with nutcracker esophagus, EGJOO and normal HRM, the esophagus distends significantly less than that of normal subjects during primary peristalsis. I suspect that an esophageal contraction pushing bolus through a narrow lumen esophagus is the cause of dysphagia sensation in many patients that have been labeled as functional dysphagia.
The last 2 decades have seen significant progress in the diagnosis of esophageal motility disorders using HRM, Endoflip, and distension-contraction plots of peristalsis. Furthermore, endoscopic treatment of achalasia and “achalasia-like syndromes” is revolutionary. What is desperately needed is an understanding of the pathogenesis of esophageal motor disorders, pharmacotherapy of esophageal symptoms, such as chest pain, proton pump inhibitor–resistant heartburn, and others because dysfunctional esophagus is a huge burden on health care expenditures worldwide.
Ravinder K. Mittal, MD, is a professor of medicine and gastroenterologist with UC San Diego Health. He has patent application pending on the computer software Dplots.
at a pace that has left the line-tracing technology considered to have debatable merit just 15 years ago “now as obsolete as a typewriter,” experts said recently in a review in Gastro Hep Advances.
“We have come to conceptualize esophageal motility disorders by specific aspects of physiological dysfunction,” wrote a trio of experts – Peter Kahrilas, MD, professor of medicine; Dustin Carlson, MD, MS, assistant professor of medicine, and John Pandolfino, MD, chief of gastroenterology and hepatology, all at Northwestern University, Chicago. “A major implication of this approach is a shift in management strategy toward rendering treatment in a phenotype-specific manner.”
High-resolution manometry (HRM) was trail-blazing, they said, as it replaced line-tracing manometry in evaluating the motility of the esophagus. HRM led to the subtyping of achalasia based on the three patterns of pressurization in the esophagus that are associated with obstruction at the esophagogastric junction. But the field has continued to advance.
“It has since become clear that obstructive physiology also occurs in syndromes besides achalasia involving the esophagogastric junction and/or distal esophagus,” Dr. Kahrilas, Dr. Carlson, and Dr. Pandolfino said. “In fact, obstructive physiology is increasingly recognized as the fundamental abnormality leading to the perception of dysphagia with esophageal motility disorders. This concept of obstructive physiology as the fundamental abnormality has substantially morphed the clinical management of esophageal motility disorders.”
HRM, has many limitations, but in cases of an uncertain achalasia diagnosis, functional luminal imaging probe (FLIP) technology can help, they said. FLIP can also help surgeons tailor myotomy procedures.
In FLIP, a probe is carefully filled with fluid, causing distension of the esophagus. In the test, the distensibility of the esophagogastric junction is measured. The procedure allows a more refined assessment of the movement of the esophagus, and the subtypes of achalasia.
Identifying the achalasia subtype is crucial to choosing the right treatment, data suggests. There have been no randomized controlled trials on achalasia management that prospectively consider achalasia subtype, but retrospective analysis of RCT data “suggests that achalasia subtypes are of great relevance in forecasting treatment effectiveness,” they said.
In one trial, pneumatic dilation was effective in 100% of type II achalasia, which involves panesophageal pressurization, significantly better than laparoscopic Heller myotomy (LHM). But it was much less effective than LHM in type III achalasia, the spastic form, although a significance couldn’t be established because of the number of cases. Data from a meta-analysis showed that peroral endoscopic myotomy, which allows for a longer myotomy if needed, was better than LHM for classic achalasia and spastic achalasia and was most efficacious overall.
The writers said that the diagnostic classifications for achalasia are likely to continue to evolve, pointing to the dynamic nature of the Chicago Classification for the disorder.
“The fact that it has now gone through four iterations since 2008 emphasizes that this is a work in progress and that no classification scheme of esophageal motility disorders based on a single test will ever be perfect,” they said. “After all, there are no biomarkers of esophageal motility disorders and, in the absence of a biomarker, there can be no ‘gold standard’ for diagnosis.”
Dr. Pandolfino, Dr. Kahrilas, and Northwestern University hold shared intellectual property rights and ownership surrounding FLIP Panometry systems, methods, and apparatus with Medtronic. Dr. Kahrilas reported consulting with Ironwood, Reckitt, and Phathom. Dr. Carlson reported conflicts of interest with Medtronic and Phathom Pharmaceuticals. Dr. Pandolfino reported conflicts of interest with Sandhill Scientific/Diversatek, Takeda, AstraZeneca, Medtronic, Torax, and Ironwood.
at a pace that has left the line-tracing technology considered to have debatable merit just 15 years ago “now as obsolete as a typewriter,” experts said recently in a review in Gastro Hep Advances.
“We have come to conceptualize esophageal motility disorders by specific aspects of physiological dysfunction,” wrote a trio of experts – Peter Kahrilas, MD, professor of medicine; Dustin Carlson, MD, MS, assistant professor of medicine, and John Pandolfino, MD, chief of gastroenterology and hepatology, all at Northwestern University, Chicago. “A major implication of this approach is a shift in management strategy toward rendering treatment in a phenotype-specific manner.”
High-resolution manometry (HRM) was trail-blazing, they said, as it replaced line-tracing manometry in evaluating the motility of the esophagus. HRM led to the subtyping of achalasia based on the three patterns of pressurization in the esophagus that are associated with obstruction at the esophagogastric junction. But the field has continued to advance.
“It has since become clear that obstructive physiology also occurs in syndromes besides achalasia involving the esophagogastric junction and/or distal esophagus,” Dr. Kahrilas, Dr. Carlson, and Dr. Pandolfino said. “In fact, obstructive physiology is increasingly recognized as the fundamental abnormality leading to the perception of dysphagia with esophageal motility disorders. This concept of obstructive physiology as the fundamental abnormality has substantially morphed the clinical management of esophageal motility disorders.”
HRM, has many limitations, but in cases of an uncertain achalasia diagnosis, functional luminal imaging probe (FLIP) technology can help, they said. FLIP can also help surgeons tailor myotomy procedures.
In FLIP, a probe is carefully filled with fluid, causing distension of the esophagus. In the test, the distensibility of the esophagogastric junction is measured. The procedure allows a more refined assessment of the movement of the esophagus, and the subtypes of achalasia.
Identifying the achalasia subtype is crucial to choosing the right treatment, data suggests. There have been no randomized controlled trials on achalasia management that prospectively consider achalasia subtype, but retrospective analysis of RCT data “suggests that achalasia subtypes are of great relevance in forecasting treatment effectiveness,” they said.
In one trial, pneumatic dilation was effective in 100% of type II achalasia, which involves panesophageal pressurization, significantly better than laparoscopic Heller myotomy (LHM). But it was much less effective than LHM in type III achalasia, the spastic form, although a significance couldn’t be established because of the number of cases. Data from a meta-analysis showed that peroral endoscopic myotomy, which allows for a longer myotomy if needed, was better than LHM for classic achalasia and spastic achalasia and was most efficacious overall.
The writers said that the diagnostic classifications for achalasia are likely to continue to evolve, pointing to the dynamic nature of the Chicago Classification for the disorder.
“The fact that it has now gone through four iterations since 2008 emphasizes that this is a work in progress and that no classification scheme of esophageal motility disorders based on a single test will ever be perfect,” they said. “After all, there are no biomarkers of esophageal motility disorders and, in the absence of a biomarker, there can be no ‘gold standard’ for diagnosis.”
Dr. Pandolfino, Dr. Kahrilas, and Northwestern University hold shared intellectual property rights and ownership surrounding FLIP Panometry systems, methods, and apparatus with Medtronic. Dr. Kahrilas reported consulting with Ironwood, Reckitt, and Phathom. Dr. Carlson reported conflicts of interest with Medtronic and Phathom Pharmaceuticals. Dr. Pandolfino reported conflicts of interest with Sandhill Scientific/Diversatek, Takeda, AstraZeneca, Medtronic, Torax, and Ironwood.
FROM GASTRO HEP ADVANCES
Simpler method of adenoma detection rate might be possible, study suggests
The findings, published earlier this year in Gastroenterology, point to a potentially simpler approach to the ADR, an established colonoscopy quality metric that measures the percentage of colonoscopies in which at least one adenoma was found, the researchers said, because of the complexities posed by separating out screening colonoscopies from those for other indications.
“Methods for ascertaining colonoscopy indication include manual review, electronic medical record queries, and text string searches of colonoscopy reports, which are resource-intensive and subject to misclassification,” said the researchers, led by Douglas Corley, MD, PhD, MPH, and Christopher Jensen, PhD, researchers at Kaiser Permanente Northern California. “These barriers have impeded the universal adoption of screening ADR reporting and suggest the need for a simpler, valid alternative to screening ADR.”
The analysis included Kaiser Permanente Northern California, Kaiser Permanente Southern California, Kaiser Permanente Washington, and the University of Texas Southwestern’s Parkland Memorial Hospital – large, demographically diverse, community-based health systems with 45 endoscopy centers and covering about 3% of the U.S. population. The data that were assessed covered 487 endoscopists who performed 1,046,916 cancer-negative colonoscopies from January 2011 to June 2019.
The median overall ADR was 36.3%; the median screening, ADR 29.7%; the diagnostic ADR, 37.1%; and the surveillance ADR, 48.6%.
No matter the colonoscopy indication, the researchers found, ADRs were similarly inversely related to the risk of post-colonoscopy colorectal cancer (PCCRC) rate. For patients of physicians with ADRs of 45% or more, using the group with a less than 25% ADR as the reference group, the risk hazard ratio for the overall ADRs was 0.44, and for the screening ADRs, it was 0.43.
Researchers also found that the quartile of overall ADR had a similar overall predictive ability for PCCRC to the quartile of screening ADR – both with a C-statistic of 0.71.
The overall ADR did just about as well as the screening ADR in identifying physician performance quartile groupings – especially in the case of the lowest quartile. Among the 293 endoscopists who performed colonoscopies in 2017-2018, for instance, 62 of the 73 providers who were in the lowest quartile for screening ADR were also in the lowest quartile for the overall ADR, the researchers found. And there were no providers who differed by more than one quartile.
When considering all quartiles, 69.6% of endoscopists had identical quartile rankings for overall ADR and screening ADR, 29.4% differed by one quartile, and only 1% differed by two quartiles.
The inclination to use screening colonoscopies to compute ADR metrics was intended to promote uniformity in the field, but this might not be the best practice, the researchers suggest.
“Given the large differences in screening ADRs between settings and the potential for indication misclassification, it is not clear that restricting ADR calculations to screening colonoscopies allows for a more ‘apples-to-apples’ comparison across settings than methods that include all colonoscopies,” they said. “The current study found that overall ADR as a quality metric performed similarly to screening ADR for predicting PCCRC and identifying the same providers in the lowest quartile. In addition, it is simpler to calculate, not susceptible to indication misclassification or potential provider-related biases, and more precise because it includes many more colonoscopies.”
In an editorial that was published in Gastroenterology, Jill Tinmouth, MD, PhD, University of Toronto, and Catherine Dubé, MD, University of Ottawa, noted that measuring ADR is valuable only if it improves the quality of colonoscopies.
“Ultimately, this new approach to measuring ADR and identifying underperformance is only valuable if it leads to improvement in colonoscopy quality. The approach proposed by Corley et al. should make it easier for facilities, screening programs, and jurisdictions to measure ADR, and this is an important first step. However, to move the dial on quality, reporting ADR needs to be accompanied by physician uptake of strategies to improve their colonoscopy performance, that is, split-dose bowel preparation, proper insertion and withdrawal techniques ([e.g.], careful cleaning and inspection and turning the patient, when possible), and improved polypectomy skills,” they wrote.
The authors disclosed no conflicts of interest.
The findings, published earlier this year in Gastroenterology, point to a potentially simpler approach to the ADR, an established colonoscopy quality metric that measures the percentage of colonoscopies in which at least one adenoma was found, the researchers said, because of the complexities posed by separating out screening colonoscopies from those for other indications.
“Methods for ascertaining colonoscopy indication include manual review, electronic medical record queries, and text string searches of colonoscopy reports, which are resource-intensive and subject to misclassification,” said the researchers, led by Douglas Corley, MD, PhD, MPH, and Christopher Jensen, PhD, researchers at Kaiser Permanente Northern California. “These barriers have impeded the universal adoption of screening ADR reporting and suggest the need for a simpler, valid alternative to screening ADR.”
The analysis included Kaiser Permanente Northern California, Kaiser Permanente Southern California, Kaiser Permanente Washington, and the University of Texas Southwestern’s Parkland Memorial Hospital – large, demographically diverse, community-based health systems with 45 endoscopy centers and covering about 3% of the U.S. population. The data that were assessed covered 487 endoscopists who performed 1,046,916 cancer-negative colonoscopies from January 2011 to June 2019.
The median overall ADR was 36.3%; the median screening, ADR 29.7%; the diagnostic ADR, 37.1%; and the surveillance ADR, 48.6%.
No matter the colonoscopy indication, the researchers found, ADRs were similarly inversely related to the risk of post-colonoscopy colorectal cancer (PCCRC) rate. For patients of physicians with ADRs of 45% or more, using the group with a less than 25% ADR as the reference group, the risk hazard ratio for the overall ADRs was 0.44, and for the screening ADRs, it was 0.43.
Researchers also found that the quartile of overall ADR had a similar overall predictive ability for PCCRC to the quartile of screening ADR – both with a C-statistic of 0.71.
The overall ADR did just about as well as the screening ADR in identifying physician performance quartile groupings – especially in the case of the lowest quartile. Among the 293 endoscopists who performed colonoscopies in 2017-2018, for instance, 62 of the 73 providers who were in the lowest quartile for screening ADR were also in the lowest quartile for the overall ADR, the researchers found. And there were no providers who differed by more than one quartile.
When considering all quartiles, 69.6% of endoscopists had identical quartile rankings for overall ADR and screening ADR, 29.4% differed by one quartile, and only 1% differed by two quartiles.
The inclination to use screening colonoscopies to compute ADR metrics was intended to promote uniformity in the field, but this might not be the best practice, the researchers suggest.
“Given the large differences in screening ADRs between settings and the potential for indication misclassification, it is not clear that restricting ADR calculations to screening colonoscopies allows for a more ‘apples-to-apples’ comparison across settings than methods that include all colonoscopies,” they said. “The current study found that overall ADR as a quality metric performed similarly to screening ADR for predicting PCCRC and identifying the same providers in the lowest quartile. In addition, it is simpler to calculate, not susceptible to indication misclassification or potential provider-related biases, and more precise because it includes many more colonoscopies.”
In an editorial that was published in Gastroenterology, Jill Tinmouth, MD, PhD, University of Toronto, and Catherine Dubé, MD, University of Ottawa, noted that measuring ADR is valuable only if it improves the quality of colonoscopies.
“Ultimately, this new approach to measuring ADR and identifying underperformance is only valuable if it leads to improvement in colonoscopy quality. The approach proposed by Corley et al. should make it easier for facilities, screening programs, and jurisdictions to measure ADR, and this is an important first step. However, to move the dial on quality, reporting ADR needs to be accompanied by physician uptake of strategies to improve their colonoscopy performance, that is, split-dose bowel preparation, proper insertion and withdrawal techniques ([e.g.], careful cleaning and inspection and turning the patient, when possible), and improved polypectomy skills,” they wrote.
The authors disclosed no conflicts of interest.
The findings, published earlier this year in Gastroenterology, point to a potentially simpler approach to the ADR, an established colonoscopy quality metric that measures the percentage of colonoscopies in which at least one adenoma was found, the researchers said, because of the complexities posed by separating out screening colonoscopies from those for other indications.
“Methods for ascertaining colonoscopy indication include manual review, electronic medical record queries, and text string searches of colonoscopy reports, which are resource-intensive and subject to misclassification,” said the researchers, led by Douglas Corley, MD, PhD, MPH, and Christopher Jensen, PhD, researchers at Kaiser Permanente Northern California. “These barriers have impeded the universal adoption of screening ADR reporting and suggest the need for a simpler, valid alternative to screening ADR.”
The analysis included Kaiser Permanente Northern California, Kaiser Permanente Southern California, Kaiser Permanente Washington, and the University of Texas Southwestern’s Parkland Memorial Hospital – large, demographically diverse, community-based health systems with 45 endoscopy centers and covering about 3% of the U.S. population. The data that were assessed covered 487 endoscopists who performed 1,046,916 cancer-negative colonoscopies from January 2011 to June 2019.
The median overall ADR was 36.3%; the median screening, ADR 29.7%; the diagnostic ADR, 37.1%; and the surveillance ADR, 48.6%.
No matter the colonoscopy indication, the researchers found, ADRs were similarly inversely related to the risk of post-colonoscopy colorectal cancer (PCCRC) rate. For patients of physicians with ADRs of 45% or more, using the group with a less than 25% ADR as the reference group, the risk hazard ratio for the overall ADRs was 0.44, and for the screening ADRs, it was 0.43.
Researchers also found that the quartile of overall ADR had a similar overall predictive ability for PCCRC to the quartile of screening ADR – both with a C-statistic of 0.71.
The overall ADR did just about as well as the screening ADR in identifying physician performance quartile groupings – especially in the case of the lowest quartile. Among the 293 endoscopists who performed colonoscopies in 2017-2018, for instance, 62 of the 73 providers who were in the lowest quartile for screening ADR were also in the lowest quartile for the overall ADR, the researchers found. And there were no providers who differed by more than one quartile.
When considering all quartiles, 69.6% of endoscopists had identical quartile rankings for overall ADR and screening ADR, 29.4% differed by one quartile, and only 1% differed by two quartiles.
The inclination to use screening colonoscopies to compute ADR metrics was intended to promote uniformity in the field, but this might not be the best practice, the researchers suggest.
“Given the large differences in screening ADRs between settings and the potential for indication misclassification, it is not clear that restricting ADR calculations to screening colonoscopies allows for a more ‘apples-to-apples’ comparison across settings than methods that include all colonoscopies,” they said. “The current study found that overall ADR as a quality metric performed similarly to screening ADR for predicting PCCRC and identifying the same providers in the lowest quartile. In addition, it is simpler to calculate, not susceptible to indication misclassification or potential provider-related biases, and more precise because it includes many more colonoscopies.”
In an editorial that was published in Gastroenterology, Jill Tinmouth, MD, PhD, University of Toronto, and Catherine Dubé, MD, University of Ottawa, noted that measuring ADR is valuable only if it improves the quality of colonoscopies.
“Ultimately, this new approach to measuring ADR and identifying underperformance is only valuable if it leads to improvement in colonoscopy quality. The approach proposed by Corley et al. should make it easier for facilities, screening programs, and jurisdictions to measure ADR, and this is an important first step. However, to move the dial on quality, reporting ADR needs to be accompanied by physician uptake of strategies to improve their colonoscopy performance, that is, split-dose bowel preparation, proper insertion and withdrawal techniques ([e.g.], careful cleaning and inspection and turning the patient, when possible), and improved polypectomy skills,” they wrote.
The authors disclosed no conflicts of interest.
FROM GASTROENTEROLOGY
Nearly 1 in 100 people diagnosed with IBD in the U.S.
(IBD), and up to 56,000 new cases are diagnosed each year.
“The prevalence of IBD in the United States has been gradually increasing over the last decade, and thus the burden of caring for IBD is likely to increase as life expectancy increases,” said co-principal investigator Andrés Hurtado-Lorenzo, PhD, senior vice president, Translational Research and IBD Ventures, Crohn’s & Colitis Foundation.
These data provide “an initial step toward optimizing health care resources allocation and improving care of individuals with IBD,” said Manasi Agrawal, MD, a gastroenterologist at Mount Sinai Hospital, New York, who wasn’t involved in the study.
The study was published online in Gastroenterology.
For the federally funded study, researchers pooled data from commercial, Medicare, and Medicaid insurance plans to derive a population-based estimate of the incidence and prevalence of IBD throughout the United States.
“In essence, we consider this to be the most extensive study of the incidence and prevalence of IBD in the United States based on physician-diagnosed IBD, which is representative of nearly the entire U.S. population with health insurance,” Dr. Hurtado-Lorenzo said.
Trends identified
Key findings from the study include the following.
- The age- and sex-standardized incidence of IBD was 10.9 per 100,000 person years.
- The incidence of IBD peaks in the third decade of life, decreases to a relatively stable level across the fourth to eighth decades, and declines further beyond age 80.
- Ulcerative colitis is slightly more common than Crohn’s disease in most age groups, except in children, among whom this trend is reversed.
- The adjusted prevalence data show that IBD has been diagnosed in more than 0.7% of Americans, with 721 cases per 100,000, or nearly 1 in 100.
- Historically, IBD was slightly more common in men. Now it’s slightly more common in adult women and male children.
- IBD prevalence is highest in the Northeast and lowest in the western region of the United States.
- The overall prevalence of IBD increased gradually from 2011 to 2020.
“Environmental variables, such as ultra-processed foods, pollution, and urbanization, to name a few, are implicated in IBD risk. Shifts in our modern environment and improving diagnostics may be two reasons why we see rising trends in IBD,” said Dr. Agrawal, assistant professor of medicine at the Icahn School of Medicine at Mount Sinai.
Prevalence highest among Whites
The data also point to significant differences in prevalence among different racial groups in the United States, with Whites having a rate of IBD that is seven times higher than Blacks, six times higher than Hispanics, and 21 times higher than Asians.
The prevalence of IBD per 100,000 population was 812 in Whites, 504 in Blacks, 403 in Asians, and 458 in Hispanics.
“It’s important to note that the reasons for ethnic disparities in IBD prevalence are complex and multifactorial, and further research is needed to better understand the specific mechanisms underlying these disparities,” said Dr. Hurtado-Lorenzo said.
Factors that could contribute to this disparity include genetic and environmental factors, socioeconomic factors, health care disparities, differences in disease awareness and reporting, and underdiagnosis in some populations.
The data suggest a lower prevalence of IBD among children with Medicaid insurance, “which underscores the need for further investigation into the influence of social determinants of health on IBD care,” Dr. Hurtado-Lorenzo said.
Insights important for planning
Because of the fragmented nature of the health care system, it’s been challenging to get an accurate estimate of how many patients in the United States have IBD, said Ashwin Ananthakrishnan, MD, MPH, a gastroenterologist with Massachusetts General Hospital and Harvard Medical School, Boston.
“The authors and involved organizations are to be fully complemented on this really ambitious and important study. Having an idea of how common IBD is and how it is likely to increase in prevalence is important for resource planning for organizations and health care systems,” said Dr. Ananthakrishnan, who was not involved in the study.
Although IBD incidence and prevalence is lower in non-White populations, there is still a “sizeable burden of IBD in those groups, and it’s important to understand the implications of that in terms of disease biology, treatment availability, disparities, and access to care,” he added.
“With the aging of the population and increasing prevalence, it is also important to understand that the ‘face of IBD’ in the coming decades may be different than what we traditionally have estimated it to be. This is also important to incorporate in decision-making,” Dr. Ananthakrishnan said.
Funding for the study was provided by the Centers for Disease Control and Prevention. Dr. Hurtado-Lorenzo, Dr. Agrawal, and Dr. Ananthakrishnan have declared no relevant disclosures.
A version of this article first appeared on Medscape.com.
(IBD), and up to 56,000 new cases are diagnosed each year.
“The prevalence of IBD in the United States has been gradually increasing over the last decade, and thus the burden of caring for IBD is likely to increase as life expectancy increases,” said co-principal investigator Andrés Hurtado-Lorenzo, PhD, senior vice president, Translational Research and IBD Ventures, Crohn’s & Colitis Foundation.
These data provide “an initial step toward optimizing health care resources allocation and improving care of individuals with IBD,” said Manasi Agrawal, MD, a gastroenterologist at Mount Sinai Hospital, New York, who wasn’t involved in the study.
The study was published online in Gastroenterology.
For the federally funded study, researchers pooled data from commercial, Medicare, and Medicaid insurance plans to derive a population-based estimate of the incidence and prevalence of IBD throughout the United States.
“In essence, we consider this to be the most extensive study of the incidence and prevalence of IBD in the United States based on physician-diagnosed IBD, which is representative of nearly the entire U.S. population with health insurance,” Dr. Hurtado-Lorenzo said.
Trends identified
Key findings from the study include the following.
- The age- and sex-standardized incidence of IBD was 10.9 per 100,000 person years.
- The incidence of IBD peaks in the third decade of life, decreases to a relatively stable level across the fourth to eighth decades, and declines further beyond age 80.
- Ulcerative colitis is slightly more common than Crohn’s disease in most age groups, except in children, among whom this trend is reversed.
- The adjusted prevalence data show that IBD has been diagnosed in more than 0.7% of Americans, with 721 cases per 100,000, or nearly 1 in 100.
- Historically, IBD was slightly more common in men. Now it’s slightly more common in adult women and male children.
- IBD prevalence is highest in the Northeast and lowest in the western region of the United States.
- The overall prevalence of IBD increased gradually from 2011 to 2020.
“Environmental variables, such as ultra-processed foods, pollution, and urbanization, to name a few, are implicated in IBD risk. Shifts in our modern environment and improving diagnostics may be two reasons why we see rising trends in IBD,” said Dr. Agrawal, assistant professor of medicine at the Icahn School of Medicine at Mount Sinai.
Prevalence highest among Whites
The data also point to significant differences in prevalence among different racial groups in the United States, with Whites having a rate of IBD that is seven times higher than Blacks, six times higher than Hispanics, and 21 times higher than Asians.
The prevalence of IBD per 100,000 population was 812 in Whites, 504 in Blacks, 403 in Asians, and 458 in Hispanics.
“It’s important to note that the reasons for ethnic disparities in IBD prevalence are complex and multifactorial, and further research is needed to better understand the specific mechanisms underlying these disparities,” said Dr. Hurtado-Lorenzo said.
Factors that could contribute to this disparity include genetic and environmental factors, socioeconomic factors, health care disparities, differences in disease awareness and reporting, and underdiagnosis in some populations.
The data suggest a lower prevalence of IBD among children with Medicaid insurance, “which underscores the need for further investigation into the influence of social determinants of health on IBD care,” Dr. Hurtado-Lorenzo said.
Insights important for planning
Because of the fragmented nature of the health care system, it’s been challenging to get an accurate estimate of how many patients in the United States have IBD, said Ashwin Ananthakrishnan, MD, MPH, a gastroenterologist with Massachusetts General Hospital and Harvard Medical School, Boston.
“The authors and involved organizations are to be fully complemented on this really ambitious and important study. Having an idea of how common IBD is and how it is likely to increase in prevalence is important for resource planning for organizations and health care systems,” said Dr. Ananthakrishnan, who was not involved in the study.
Although IBD incidence and prevalence is lower in non-White populations, there is still a “sizeable burden of IBD in those groups, and it’s important to understand the implications of that in terms of disease biology, treatment availability, disparities, and access to care,” he added.
“With the aging of the population and increasing prevalence, it is also important to understand that the ‘face of IBD’ in the coming decades may be different than what we traditionally have estimated it to be. This is also important to incorporate in decision-making,” Dr. Ananthakrishnan said.
Funding for the study was provided by the Centers for Disease Control and Prevention. Dr. Hurtado-Lorenzo, Dr. Agrawal, and Dr. Ananthakrishnan have declared no relevant disclosures.
A version of this article first appeared on Medscape.com.
(IBD), and up to 56,000 new cases are diagnosed each year.
“The prevalence of IBD in the United States has been gradually increasing over the last decade, and thus the burden of caring for IBD is likely to increase as life expectancy increases,” said co-principal investigator Andrés Hurtado-Lorenzo, PhD, senior vice president, Translational Research and IBD Ventures, Crohn’s & Colitis Foundation.
These data provide “an initial step toward optimizing health care resources allocation and improving care of individuals with IBD,” said Manasi Agrawal, MD, a gastroenterologist at Mount Sinai Hospital, New York, who wasn’t involved in the study.
The study was published online in Gastroenterology.
For the federally funded study, researchers pooled data from commercial, Medicare, and Medicaid insurance plans to derive a population-based estimate of the incidence and prevalence of IBD throughout the United States.
“In essence, we consider this to be the most extensive study of the incidence and prevalence of IBD in the United States based on physician-diagnosed IBD, which is representative of nearly the entire U.S. population with health insurance,” Dr. Hurtado-Lorenzo said.
Trends identified
Key findings from the study include the following.
- The age- and sex-standardized incidence of IBD was 10.9 per 100,000 person years.
- The incidence of IBD peaks in the third decade of life, decreases to a relatively stable level across the fourth to eighth decades, and declines further beyond age 80.
- Ulcerative colitis is slightly more common than Crohn’s disease in most age groups, except in children, among whom this trend is reversed.
- The adjusted prevalence data show that IBD has been diagnosed in more than 0.7% of Americans, with 721 cases per 100,000, or nearly 1 in 100.
- Historically, IBD was slightly more common in men. Now it’s slightly more common in adult women and male children.
- IBD prevalence is highest in the Northeast and lowest in the western region of the United States.
- The overall prevalence of IBD increased gradually from 2011 to 2020.
“Environmental variables, such as ultra-processed foods, pollution, and urbanization, to name a few, are implicated in IBD risk. Shifts in our modern environment and improving diagnostics may be two reasons why we see rising trends in IBD,” said Dr. Agrawal, assistant professor of medicine at the Icahn School of Medicine at Mount Sinai.
Prevalence highest among Whites
The data also point to significant differences in prevalence among different racial groups in the United States, with Whites having a rate of IBD that is seven times higher than Blacks, six times higher than Hispanics, and 21 times higher than Asians.
The prevalence of IBD per 100,000 population was 812 in Whites, 504 in Blacks, 403 in Asians, and 458 in Hispanics.
“It’s important to note that the reasons for ethnic disparities in IBD prevalence are complex and multifactorial, and further research is needed to better understand the specific mechanisms underlying these disparities,” said Dr. Hurtado-Lorenzo said.
Factors that could contribute to this disparity include genetic and environmental factors, socioeconomic factors, health care disparities, differences in disease awareness and reporting, and underdiagnosis in some populations.
The data suggest a lower prevalence of IBD among children with Medicaid insurance, “which underscores the need for further investigation into the influence of social determinants of health on IBD care,” Dr. Hurtado-Lorenzo said.
Insights important for planning
Because of the fragmented nature of the health care system, it’s been challenging to get an accurate estimate of how many patients in the United States have IBD, said Ashwin Ananthakrishnan, MD, MPH, a gastroenterologist with Massachusetts General Hospital and Harvard Medical School, Boston.
“The authors and involved organizations are to be fully complemented on this really ambitious and important study. Having an idea of how common IBD is and how it is likely to increase in prevalence is important for resource planning for organizations and health care systems,” said Dr. Ananthakrishnan, who was not involved in the study.
Although IBD incidence and prevalence is lower in non-White populations, there is still a “sizeable burden of IBD in those groups, and it’s important to understand the implications of that in terms of disease biology, treatment availability, disparities, and access to care,” he added.
“With the aging of the population and increasing prevalence, it is also important to understand that the ‘face of IBD’ in the coming decades may be different than what we traditionally have estimated it to be. This is also important to incorporate in decision-making,” Dr. Ananthakrishnan said.
Funding for the study was provided by the Centers for Disease Control and Prevention. Dr. Hurtado-Lorenzo, Dr. Agrawal, and Dr. Ananthakrishnan have declared no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM GASTROENTEROLOGY
Incidental hepatic steatosis
It is important to identify patients at risk of progressive fibrosis.
Calculation of the fibrosis-4 (FIB-4) score (based on age, alanine and aspartate aminotransferase [ALT and AST] levels, and platelet count by the primary care provider, using either an online calculator or the dot phrase “.fib4” in Epic) is a useful first step. If the value is low (with a high negative predictive value for advanced fibrosis), the patient does not need to be referred but can be managed for risk factors for nonalcoholic fatty liver disease. If the value is high, suggesting advanced fibrosis, the patient requires further evaluation. If the value is indeterminate, options for assessing liver stiffness include vibration-controlled transient elastography (with a controlled attenuation parameter to assess the degree of steatosis) and ultrasound elastography. A low liver stiffness score argues against the need for subspecialty management. An indeterminate score may be followed by magnetic resonance elastography, if available. An alternative to elastography is the enhanced liver fibrosis (ELF) blood test, based on serum levels of tissue inhibitor of metalloproteinases 1 (TIMP-1), amino-terminal propeptide of type III procollagen (PIIINP), and hyaluronic acid.
Dr. Friedman is the Anton R. Fried, MD, chair of the department of medicine at Newton-Wellesley Hospital in Newton, Mass., and assistant chief of medicine at Massachusetts General Hospital, and a professor of medicine at Harvard Medical School and Tufts University, Boston. Dr. Martin is chief of the division of digestive health and liver diseases at the University of Miami, where he is the Mandel Chair of Gastroenterology. The authors disclose no conflicts.
Published previously in Gastro Hep Advances (doi: 10.1016/j.gastha.2023.03.008).
It is important to identify patients at risk of progressive fibrosis.
Calculation of the fibrosis-4 (FIB-4) score (based on age, alanine and aspartate aminotransferase [ALT and AST] levels, and platelet count by the primary care provider, using either an online calculator or the dot phrase “.fib4” in Epic) is a useful first step. If the value is low (with a high negative predictive value for advanced fibrosis), the patient does not need to be referred but can be managed for risk factors for nonalcoholic fatty liver disease. If the value is high, suggesting advanced fibrosis, the patient requires further evaluation. If the value is indeterminate, options for assessing liver stiffness include vibration-controlled transient elastography (with a controlled attenuation parameter to assess the degree of steatosis) and ultrasound elastography. A low liver stiffness score argues against the need for subspecialty management. An indeterminate score may be followed by magnetic resonance elastography, if available. An alternative to elastography is the enhanced liver fibrosis (ELF) blood test, based on serum levels of tissue inhibitor of metalloproteinases 1 (TIMP-1), amino-terminal propeptide of type III procollagen (PIIINP), and hyaluronic acid.
Dr. Friedman is the Anton R. Fried, MD, chair of the department of medicine at Newton-Wellesley Hospital in Newton, Mass., and assistant chief of medicine at Massachusetts General Hospital, and a professor of medicine at Harvard Medical School and Tufts University, Boston. Dr. Martin is chief of the division of digestive health and liver diseases at the University of Miami, where he is the Mandel Chair of Gastroenterology. The authors disclose no conflicts.
Published previously in Gastro Hep Advances (doi: 10.1016/j.gastha.2023.03.008).
It is important to identify patients at risk of progressive fibrosis.
Calculation of the fibrosis-4 (FIB-4) score (based on age, alanine and aspartate aminotransferase [ALT and AST] levels, and platelet count by the primary care provider, using either an online calculator or the dot phrase “.fib4” in Epic) is a useful first step. If the value is low (with a high negative predictive value for advanced fibrosis), the patient does not need to be referred but can be managed for risk factors for nonalcoholic fatty liver disease. If the value is high, suggesting advanced fibrosis, the patient requires further evaluation. If the value is indeterminate, options for assessing liver stiffness include vibration-controlled transient elastography (with a controlled attenuation parameter to assess the degree of steatosis) and ultrasound elastography. A low liver stiffness score argues against the need for subspecialty management. An indeterminate score may be followed by magnetic resonance elastography, if available. An alternative to elastography is the enhanced liver fibrosis (ELF) blood test, based on serum levels of tissue inhibitor of metalloproteinases 1 (TIMP-1), amino-terminal propeptide of type III procollagen (PIIINP), and hyaluronic acid.
Dr. Friedman is the Anton R. Fried, MD, chair of the department of medicine at Newton-Wellesley Hospital in Newton, Mass., and assistant chief of medicine at Massachusetts General Hospital, and a professor of medicine at Harvard Medical School and Tufts University, Boston. Dr. Martin is chief of the division of digestive health and liver diseases at the University of Miami, where he is the Mandel Chair of Gastroenterology. The authors disclose no conflicts.
Published previously in Gastro Hep Advances (doi: 10.1016/j.gastha.2023.03.008).
FROM GASTRO HEP ADVANCES
Biologics, thiopurines, or methotrexate doesn’t affect fertility or birth outcomes in men with IBD
published in Clinical Gastroenterology and Hepatology.
The effort is the first meta-analysis to assess semen parameters and the risk of adverse outcomes in pregnancy for male patients with IBD who have taken biologics, thiopurines or methotrexate for the condition, the researchers said.
“We provide encouraging evidence that biologic, thiopurine, and methotrexate therapy among male patients with IBD are not associated with impairments in male fertility or with increased risk of adverse pregnancy outcomes,” said the researchers, led in part by John Gubatan, MD, instructor in medicine at Stanford (Calif.) University, who worked with investigators in Copenhagen and Toronto. “Taken together, our data support the safety of continuing biologics, thiopurines, or methotrexate across the reproductive spectrum.”
Questions of fertility and pregnancy outcomes are of particular importance in IBD, since patients are often diagnosed around the time of their reproductive years – about 30 years old for Crohn’s disease and 35 years old for ulcerative colitis. There has been far more research attention paid to female than male reproductive considerations, mainly the health of the fetus when the mother takes biologic therapy for IBD during pregnancy, which has generally found to be safe.
Their search found 13 studies with male IBD patients exposed to biologics, 10 exposed to thiopurines and 6 to methotrexate. Researchers extracted data on sperm count, sperm motility, and abnormal sperm morphology – three metrics considered a proxy for male fertility – as well as early pregnancy loss, preterm birth and congenital malformations.
Researchers found no differences between sperm count, motility or morphology between those exposed and not exposed to biologics, thiopurines and methotrexate, with a couple of exceptions. They actually found that sperm count was higher for thiopurine users, compared with nonusers, and there was only one study on methotrexate and abnormal sperm morphology, so there was no data to pool together for that comparison.
In a subgroup analysis, there was a trend toward higher sperm count in thiopurine users, compared with biologic or methotrexate users, but no differences were seen in the other parameters.
Similarly, there were no significant differences for users and nonusers of these medications for early pregnancy loss, preterm births or congenital malformations, the researchers found.
A prior systematic review suggested that azathioprine might be associated with low sperm count, but this new analysis calls that into question.
“Our results, which demonstrated that thiopurine use among male patients with IBD is associated with increased sperm count, refute this prior finding,” the researchers said. The previous finding, they noted, was only qualitative because the authors didn’t do an analysis to calculate effect size or determine statistical significance.
“Furthermore,” the researchers said, “our study included more updated studies and a greater number of patients.”
The authors disclosed no conflicts of interest.
Understanding the impact of inflammatory bowel disease therapies on fertility and pregnancy outcomes is key toward managing patients with IBD. While there is substantial research on the implications of maternal exposure to IBD medications with reassuring safety data, research in the context of paternal exposure to IBD medications is limited.
This study represents the largest report summarizing data across diverse populations on the topic with reassuring results. It carries important implications in clinical practice and provides further evidence in support of continuing IBD therapy among male patients through pregnancy planning. Certainly, active IBD in male patients is associated with adverse effects on sperm quality and conception likelihood, and it is important to achieve remission prior to pregnancy planning.
Further research on the impact of paternal exposure to newer biologics, including small molecule drugs, and additional analyses after adjusting for potential confounders will advance the field and provide further guidance in clinical practice.
Manasi Agrawal, MD, MS, is an assistant professor of medicine in the Dr. Henry D. Janowitz Division of Gastroenterology at the Icahn School of Medicine at Mount Sinai, New York. She is a research associate with the Center for Molecular Prediction of Inflammatory Bowel Disease. Aalborg University, Copenhagen. She reports no conflicts.
Understanding the impact of inflammatory bowel disease therapies on fertility and pregnancy outcomes is key toward managing patients with IBD. While there is substantial research on the implications of maternal exposure to IBD medications with reassuring safety data, research in the context of paternal exposure to IBD medications is limited.
This study represents the largest report summarizing data across diverse populations on the topic with reassuring results. It carries important implications in clinical practice and provides further evidence in support of continuing IBD therapy among male patients through pregnancy planning. Certainly, active IBD in male patients is associated with adverse effects on sperm quality and conception likelihood, and it is important to achieve remission prior to pregnancy planning.
Further research on the impact of paternal exposure to newer biologics, including small molecule drugs, and additional analyses after adjusting for potential confounders will advance the field and provide further guidance in clinical practice.
Manasi Agrawal, MD, MS, is an assistant professor of medicine in the Dr. Henry D. Janowitz Division of Gastroenterology at the Icahn School of Medicine at Mount Sinai, New York. She is a research associate with the Center for Molecular Prediction of Inflammatory Bowel Disease. Aalborg University, Copenhagen. She reports no conflicts.
Understanding the impact of inflammatory bowel disease therapies on fertility and pregnancy outcomes is key toward managing patients with IBD. While there is substantial research on the implications of maternal exposure to IBD medications with reassuring safety data, research in the context of paternal exposure to IBD medications is limited.
This study represents the largest report summarizing data across diverse populations on the topic with reassuring results. It carries important implications in clinical practice and provides further evidence in support of continuing IBD therapy among male patients through pregnancy planning. Certainly, active IBD in male patients is associated with adverse effects on sperm quality and conception likelihood, and it is important to achieve remission prior to pregnancy planning.
Further research on the impact of paternal exposure to newer biologics, including small molecule drugs, and additional analyses after adjusting for potential confounders will advance the field and provide further guidance in clinical practice.
Manasi Agrawal, MD, MS, is an assistant professor of medicine in the Dr. Henry D. Janowitz Division of Gastroenterology at the Icahn School of Medicine at Mount Sinai, New York. She is a research associate with the Center for Molecular Prediction of Inflammatory Bowel Disease. Aalborg University, Copenhagen. She reports no conflicts.
published in Clinical Gastroenterology and Hepatology.
The effort is the first meta-analysis to assess semen parameters and the risk of adverse outcomes in pregnancy for male patients with IBD who have taken biologics, thiopurines or methotrexate for the condition, the researchers said.
“We provide encouraging evidence that biologic, thiopurine, and methotrexate therapy among male patients with IBD are not associated with impairments in male fertility or with increased risk of adverse pregnancy outcomes,” said the researchers, led in part by John Gubatan, MD, instructor in medicine at Stanford (Calif.) University, who worked with investigators in Copenhagen and Toronto. “Taken together, our data support the safety of continuing biologics, thiopurines, or methotrexate across the reproductive spectrum.”
Questions of fertility and pregnancy outcomes are of particular importance in IBD, since patients are often diagnosed around the time of their reproductive years – about 30 years old for Crohn’s disease and 35 years old for ulcerative colitis. There has been far more research attention paid to female than male reproductive considerations, mainly the health of the fetus when the mother takes biologic therapy for IBD during pregnancy, which has generally found to be safe.
Their search found 13 studies with male IBD patients exposed to biologics, 10 exposed to thiopurines and 6 to methotrexate. Researchers extracted data on sperm count, sperm motility, and abnormal sperm morphology – three metrics considered a proxy for male fertility – as well as early pregnancy loss, preterm birth and congenital malformations.
Researchers found no differences between sperm count, motility or morphology between those exposed and not exposed to biologics, thiopurines and methotrexate, with a couple of exceptions. They actually found that sperm count was higher for thiopurine users, compared with nonusers, and there was only one study on methotrexate and abnormal sperm morphology, so there was no data to pool together for that comparison.
In a subgroup analysis, there was a trend toward higher sperm count in thiopurine users, compared with biologic or methotrexate users, but no differences were seen in the other parameters.
Similarly, there were no significant differences for users and nonusers of these medications for early pregnancy loss, preterm births or congenital malformations, the researchers found.
A prior systematic review suggested that azathioprine might be associated with low sperm count, but this new analysis calls that into question.
“Our results, which demonstrated that thiopurine use among male patients with IBD is associated with increased sperm count, refute this prior finding,” the researchers said. The previous finding, they noted, was only qualitative because the authors didn’t do an analysis to calculate effect size or determine statistical significance.
“Furthermore,” the researchers said, “our study included more updated studies and a greater number of patients.”
The authors disclosed no conflicts of interest.
published in Clinical Gastroenterology and Hepatology.
The effort is the first meta-analysis to assess semen parameters and the risk of adverse outcomes in pregnancy for male patients with IBD who have taken biologics, thiopurines or methotrexate for the condition, the researchers said.
“We provide encouraging evidence that biologic, thiopurine, and methotrexate therapy among male patients with IBD are not associated with impairments in male fertility or with increased risk of adverse pregnancy outcomes,” said the researchers, led in part by John Gubatan, MD, instructor in medicine at Stanford (Calif.) University, who worked with investigators in Copenhagen and Toronto. “Taken together, our data support the safety of continuing biologics, thiopurines, or methotrexate across the reproductive spectrum.”
Questions of fertility and pregnancy outcomes are of particular importance in IBD, since patients are often diagnosed around the time of their reproductive years – about 30 years old for Crohn’s disease and 35 years old for ulcerative colitis. There has been far more research attention paid to female than male reproductive considerations, mainly the health of the fetus when the mother takes biologic therapy for IBD during pregnancy, which has generally found to be safe.
Their search found 13 studies with male IBD patients exposed to biologics, 10 exposed to thiopurines and 6 to methotrexate. Researchers extracted data on sperm count, sperm motility, and abnormal sperm morphology – three metrics considered a proxy for male fertility – as well as early pregnancy loss, preterm birth and congenital malformations.
Researchers found no differences between sperm count, motility or morphology between those exposed and not exposed to biologics, thiopurines and methotrexate, with a couple of exceptions. They actually found that sperm count was higher for thiopurine users, compared with nonusers, and there was only one study on methotrexate and abnormal sperm morphology, so there was no data to pool together for that comparison.
In a subgroup analysis, there was a trend toward higher sperm count in thiopurine users, compared with biologic or methotrexate users, but no differences were seen in the other parameters.
Similarly, there were no significant differences for users and nonusers of these medications for early pregnancy loss, preterm births or congenital malformations, the researchers found.
A prior systematic review suggested that azathioprine might be associated with low sperm count, but this new analysis calls that into question.
“Our results, which demonstrated that thiopurine use among male patients with IBD is associated with increased sperm count, refute this prior finding,” the researchers said. The previous finding, they noted, was only qualitative because the authors didn’t do an analysis to calculate effect size or determine statistical significance.
“Furthermore,” the researchers said, “our study included more updated studies and a greater number of patients.”
The authors disclosed no conflicts of interest.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Offering blood test ups CRC screening for people who first declined colonoscopy, FIT
, researchers report.
However, the number of people in the study who subsequently underwent timely colonoscopy after a positive blood test did not increase, signaling a continuing challenge in CRC prevention and treatment.
“The main message is that the blood test can do what it’s meant to do, which is increase screening uptake,” first author Peter Liang, MD, MPH, told this news organization. Dr. Liang is a gastroenterologist and researcher at NYU Langone Health and the VA New York Harbor Health Care System in New York.
The study was published online in Clinical Gastroenterology and Hepatology.
In the United States, the rate of use of first-line screening has for years been stuck at about 70% or lower for eligible people, Dr. Liang said. A different modality is needed to help raise the numbers.
The blood test is easy to perform and requires only a few tubes of blood, he noted. No diet restrictions, test prep, or contact with stool is necessary.
We are all searching for ways to get that first-line screening rate up from 60% to 70% to 80% to 90%, noted Folasade P. May, MD, PhD, who was not involved in the study.
“A lot of people think these blood tests are the promised land,” said Dr. May, associate professor of medicine at the University of California, Los Angeles, and director of the gastroenterology quality improvement program at UCLA Health. “We want to see that, when we offer these blood tests, the uptake is 20%-25% higher, which would get us closer to the national goal of 80% screened.”
Blood test as a second-line screening option
The study enrolled 359 veterans at a Veterans Affairs medical center. Participants were 50-75 years old and were eligible for screening but had declined a colonoscopy and a stool test within the previous 6 months.
They were randomly assigned to one of two groups. The control group received a letter and telephone outreach in which participants were again offered screening with colonoscopy or FIT only. The intervention group was additionally offered the blood test as a second-line option.
The primary outcome was completion of any screening test within 6 months. The secondary outcome was completion of a full screening strategy within 6 months, including colonoscopy for those with a positive noninvasive test result.
Of the people who had declined first-line tests and were reoffered first-line tests and the blood test, 17.1% completed screening within 6 months, compared with 9.6% of those who were only reoffered the first-line tests. The uptake of colonoscopy and FIT was similar between the two groups. The full-screening strategy was completed by 14.9% in the intervention group, compared with 9% in the control group.
At first glance, the results for uptake seem a bit disappointing, Dr. May said. However, the numbers in this study may not reflect the true potential of the blood tests – which are relatively new and have not yet been incorporated into routine care – because they had to be conducted in a separate appointment at a lab, she said.
If blood tests for CRC were part of the workflow, Dr. May explained, patients could undergo them with a routine blood draw already scheduled to check for diabetes or high cholesterol, for instance, and the numbers presumably would go up.
“I think this study underestimates the proportion of people who will participate,” she said. “We need a study that tests this strategy in a more real-world scenario.”
Nonetheless, “This is the first trial that’s looking at this question, and it’s an important question,” Dr. May added.
Dr. Liang and colleagues acknowledge that a limitation of the study is that it was performed in only one VA center among an older, predominantly male population, so it will be important to make the comparisons in more diverse study populations.
Blood test reliability
The septin 9 blood test is the only blood test approved by the U.S. Food and Drug Administration for CRC screening and is indicated for those who have declined first-line tests. However, the extent of usage of the blood test in this context is unclear, as it has only been approved since 2016.
Because the blood test is not covered by Medicare, Dr. Liang said, accessibility has been limited. One of the reasons for the lack of coverage is that the blood tests are less reliable than first-line tests, he said.
The test detects methylated septin 9 DNA, a biomarker for CRC. The FDA-approved version of the test has a sensitivity of 68% and a specificity of 79% for CRC.
Dr. May said she’d have more confidence in the blood tests if those numbers were higher, at 80%-90%.
Dr. Liang told this news organization that previous research has compared test use when colonoscopy, FIT, and a blood test are considered equally, but because the blood test is indicated only after a person declines first-line screening, his team designed an approach in which the blood test was a second-line option for its target population.
Other blood tests now on the market or under development appear to have higher sensitivity and specificity, he added.
“We think our results are actually applicable to a blood test in general,” Dr. Liang said.
Blood tests are only the first step, though. Getting people who screen positive to follow up with a diagnostic colonoscopy is critical, Dr. May and the authors agree.
“That’s something we, as a nation, just haven’t figured out,” Dr. May said. “It has to become a priority.”
The study was supported in part by the Veterans Health Administration and was funded by Epigenomics and a grant from the New York Society for Gastrointestinal Endoscopy’s Florence Lefcourt Endoscopy Research Award to Dr. Laing, who is also supported by the National Cancer Institute. Dr. Liang has received research support from Epigenomics and Freenome and is on the advisory board for Guardant Health. The remaining authors disclosed no relevant financial relationships. Dr. May is a consultant for Exact Sciences and Geneoscopy, both of which are developing stool tests, and for Freenome, which is developing stool and blood tests.
A version of this article originally appeared on Medscape.com.
, researchers report.
However, the number of people in the study who subsequently underwent timely colonoscopy after a positive blood test did not increase, signaling a continuing challenge in CRC prevention and treatment.
“The main message is that the blood test can do what it’s meant to do, which is increase screening uptake,” first author Peter Liang, MD, MPH, told this news organization. Dr. Liang is a gastroenterologist and researcher at NYU Langone Health and the VA New York Harbor Health Care System in New York.
The study was published online in Clinical Gastroenterology and Hepatology.
In the United States, the rate of use of first-line screening has for years been stuck at about 70% or lower for eligible people, Dr. Liang said. A different modality is needed to help raise the numbers.
The blood test is easy to perform and requires only a few tubes of blood, he noted. No diet restrictions, test prep, or contact with stool is necessary.
We are all searching for ways to get that first-line screening rate up from 60% to 70% to 80% to 90%, noted Folasade P. May, MD, PhD, who was not involved in the study.
“A lot of people think these blood tests are the promised land,” said Dr. May, associate professor of medicine at the University of California, Los Angeles, and director of the gastroenterology quality improvement program at UCLA Health. “We want to see that, when we offer these blood tests, the uptake is 20%-25% higher, which would get us closer to the national goal of 80% screened.”
Blood test as a second-line screening option
The study enrolled 359 veterans at a Veterans Affairs medical center. Participants were 50-75 years old and were eligible for screening but had declined a colonoscopy and a stool test within the previous 6 months.
They were randomly assigned to one of two groups. The control group received a letter and telephone outreach in which participants were again offered screening with colonoscopy or FIT only. The intervention group was additionally offered the blood test as a second-line option.
The primary outcome was completion of any screening test within 6 months. The secondary outcome was completion of a full screening strategy within 6 months, including colonoscopy for those with a positive noninvasive test result.
Of the people who had declined first-line tests and were reoffered first-line tests and the blood test, 17.1% completed screening within 6 months, compared with 9.6% of those who were only reoffered the first-line tests. The uptake of colonoscopy and FIT was similar between the two groups. The full-screening strategy was completed by 14.9% in the intervention group, compared with 9% in the control group.
At first glance, the results for uptake seem a bit disappointing, Dr. May said. However, the numbers in this study may not reflect the true potential of the blood tests – which are relatively new and have not yet been incorporated into routine care – because they had to be conducted in a separate appointment at a lab, she said.
If blood tests for CRC were part of the workflow, Dr. May explained, patients could undergo them with a routine blood draw already scheduled to check for diabetes or high cholesterol, for instance, and the numbers presumably would go up.
“I think this study underestimates the proportion of people who will participate,” she said. “We need a study that tests this strategy in a more real-world scenario.”
Nonetheless, “This is the first trial that’s looking at this question, and it’s an important question,” Dr. May added.
Dr. Liang and colleagues acknowledge that a limitation of the study is that it was performed in only one VA center among an older, predominantly male population, so it will be important to make the comparisons in more diverse study populations.
Blood test reliability
The septin 9 blood test is the only blood test approved by the U.S. Food and Drug Administration for CRC screening and is indicated for those who have declined first-line tests. However, the extent of usage of the blood test in this context is unclear, as it has only been approved since 2016.
Because the blood test is not covered by Medicare, Dr. Liang said, accessibility has been limited. One of the reasons for the lack of coverage is that the blood tests are less reliable than first-line tests, he said.
The test detects methylated septin 9 DNA, a biomarker for CRC. The FDA-approved version of the test has a sensitivity of 68% and a specificity of 79% for CRC.
Dr. May said she’d have more confidence in the blood tests if those numbers were higher, at 80%-90%.
Dr. Liang told this news organization that previous research has compared test use when colonoscopy, FIT, and a blood test are considered equally, but because the blood test is indicated only after a person declines first-line screening, his team designed an approach in which the blood test was a second-line option for its target population.
Other blood tests now on the market or under development appear to have higher sensitivity and specificity, he added.
“We think our results are actually applicable to a blood test in general,” Dr. Liang said.
Blood tests are only the first step, though. Getting people who screen positive to follow up with a diagnostic colonoscopy is critical, Dr. May and the authors agree.
“That’s something we, as a nation, just haven’t figured out,” Dr. May said. “It has to become a priority.”
The study was supported in part by the Veterans Health Administration and was funded by Epigenomics and a grant from the New York Society for Gastrointestinal Endoscopy’s Florence Lefcourt Endoscopy Research Award to Dr. Laing, who is also supported by the National Cancer Institute. Dr. Liang has received research support from Epigenomics and Freenome and is on the advisory board for Guardant Health. The remaining authors disclosed no relevant financial relationships. Dr. May is a consultant for Exact Sciences and Geneoscopy, both of which are developing stool tests, and for Freenome, which is developing stool and blood tests.
A version of this article originally appeared on Medscape.com.
, researchers report.
However, the number of people in the study who subsequently underwent timely colonoscopy after a positive blood test did not increase, signaling a continuing challenge in CRC prevention and treatment.
“The main message is that the blood test can do what it’s meant to do, which is increase screening uptake,” first author Peter Liang, MD, MPH, told this news organization. Dr. Liang is a gastroenterologist and researcher at NYU Langone Health and the VA New York Harbor Health Care System in New York.
The study was published online in Clinical Gastroenterology and Hepatology.
In the United States, the rate of use of first-line screening has for years been stuck at about 70% or lower for eligible people, Dr. Liang said. A different modality is needed to help raise the numbers.
The blood test is easy to perform and requires only a few tubes of blood, he noted. No diet restrictions, test prep, or contact with stool is necessary.
We are all searching for ways to get that first-line screening rate up from 60% to 70% to 80% to 90%, noted Folasade P. May, MD, PhD, who was not involved in the study.
“A lot of people think these blood tests are the promised land,” said Dr. May, associate professor of medicine at the University of California, Los Angeles, and director of the gastroenterology quality improvement program at UCLA Health. “We want to see that, when we offer these blood tests, the uptake is 20%-25% higher, which would get us closer to the national goal of 80% screened.”
Blood test as a second-line screening option
The study enrolled 359 veterans at a Veterans Affairs medical center. Participants were 50-75 years old and were eligible for screening but had declined a colonoscopy and a stool test within the previous 6 months.
They were randomly assigned to one of two groups. The control group received a letter and telephone outreach in which participants were again offered screening with colonoscopy or FIT only. The intervention group was additionally offered the blood test as a second-line option.
The primary outcome was completion of any screening test within 6 months. The secondary outcome was completion of a full screening strategy within 6 months, including colonoscopy for those with a positive noninvasive test result.
Of the people who had declined first-line tests and were reoffered first-line tests and the blood test, 17.1% completed screening within 6 months, compared with 9.6% of those who were only reoffered the first-line tests. The uptake of colonoscopy and FIT was similar between the two groups. The full-screening strategy was completed by 14.9% in the intervention group, compared with 9% in the control group.
At first glance, the results for uptake seem a bit disappointing, Dr. May said. However, the numbers in this study may not reflect the true potential of the blood tests – which are relatively new and have not yet been incorporated into routine care – because they had to be conducted in a separate appointment at a lab, she said.
If blood tests for CRC were part of the workflow, Dr. May explained, patients could undergo them with a routine blood draw already scheduled to check for diabetes or high cholesterol, for instance, and the numbers presumably would go up.
“I think this study underestimates the proportion of people who will participate,” she said. “We need a study that tests this strategy in a more real-world scenario.”
Nonetheless, “This is the first trial that’s looking at this question, and it’s an important question,” Dr. May added.
Dr. Liang and colleagues acknowledge that a limitation of the study is that it was performed in only one VA center among an older, predominantly male population, so it will be important to make the comparisons in more diverse study populations.
Blood test reliability
The septin 9 blood test is the only blood test approved by the U.S. Food and Drug Administration for CRC screening and is indicated for those who have declined first-line tests. However, the extent of usage of the blood test in this context is unclear, as it has only been approved since 2016.
Because the blood test is not covered by Medicare, Dr. Liang said, accessibility has been limited. One of the reasons for the lack of coverage is that the blood tests are less reliable than first-line tests, he said.
The test detects methylated septin 9 DNA, a biomarker for CRC. The FDA-approved version of the test has a sensitivity of 68% and a specificity of 79% for CRC.
Dr. May said she’d have more confidence in the blood tests if those numbers were higher, at 80%-90%.
Dr. Liang told this news organization that previous research has compared test use when colonoscopy, FIT, and a blood test are considered equally, but because the blood test is indicated only after a person declines first-line screening, his team designed an approach in which the blood test was a second-line option for its target population.
Other blood tests now on the market or under development appear to have higher sensitivity and specificity, he added.
“We think our results are actually applicable to a blood test in general,” Dr. Liang said.
Blood tests are only the first step, though. Getting people who screen positive to follow up with a diagnostic colonoscopy is critical, Dr. May and the authors agree.
“That’s something we, as a nation, just haven’t figured out,” Dr. May said. “It has to become a priority.”
The study was supported in part by the Veterans Health Administration and was funded by Epigenomics and a grant from the New York Society for Gastrointestinal Endoscopy’s Florence Lefcourt Endoscopy Research Award to Dr. Laing, who is also supported by the National Cancer Institute. Dr. Liang has received research support from Epigenomics and Freenome and is on the advisory board for Guardant Health. The remaining authors disclosed no relevant financial relationships. Dr. May is a consultant for Exact Sciences and Geneoscopy, both of which are developing stool tests, and for Freenome, which is developing stool and blood tests.
A version of this article originally appeared on Medscape.com.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
No link between PPIs and dementia in new study
TOPLINE:
A new study provides reassurance about the long-term safety of proton pump inhibitors (PPIs) and histamine-2 receptor antagonist (H2RA) use in older adults, finding no increased risk for dementia or cognitive changes.
METHODOLOGY:
- Post hoc observational study within the Aspirin in Reducing Events in the Elderly (ASPREE) clinical trial.
- 18,934 adults aged 65+ from the United States and Australia without dementia at baseline.
- 4,667 (25%) PPI users and 368 (2%) H2RA users at baseline.
- PPI and H2RA use, dementia incidence, and cognitive changes were tracked.
TAKEAWAY:
- In multivariable analysis, baseline PPI use was not associated with incident dementia (hazard ratio, 0.88) or cognitive impairment (HR, 1.00).
- PPI use was not linked to changes in overall cognitive test scores over time (beta –0.002).
- No associations were found between H2RA use and cognitive endpoints.
IN PRACTICE:
“Long-term use of PPIs in older adults is unlikely to have negative effects on cognition,” the study team concludes.
STUDY DETAILS:
The study was led by Raaj Mehta, MD, PhD, with Massachusetts General Hospital and Harvard Medical School in Boston. The study was published online in Gastroenterology. Funding was provided by grants from the National Institute on Aging, the National Cancer Institute, and other institutions.
LIMITATIONS:
Potential for residual confounding and underestimation of PPI and H2RA use, lack of data on medication dose and duration, and the absence of ApoE4 allele status.
DISCLOSURES:
Dr. Mehta has disclosed no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
TOPLINE:
A new study provides reassurance about the long-term safety of proton pump inhibitors (PPIs) and histamine-2 receptor antagonist (H2RA) use in older adults, finding no increased risk for dementia or cognitive changes.
METHODOLOGY:
- Post hoc observational study within the Aspirin in Reducing Events in the Elderly (ASPREE) clinical trial.
- 18,934 adults aged 65+ from the United States and Australia without dementia at baseline.
- 4,667 (25%) PPI users and 368 (2%) H2RA users at baseline.
- PPI and H2RA use, dementia incidence, and cognitive changes were tracked.
TAKEAWAY:
- In multivariable analysis, baseline PPI use was not associated with incident dementia (hazard ratio, 0.88) or cognitive impairment (HR, 1.00).
- PPI use was not linked to changes in overall cognitive test scores over time (beta –0.002).
- No associations were found between H2RA use and cognitive endpoints.
IN PRACTICE:
“Long-term use of PPIs in older adults is unlikely to have negative effects on cognition,” the study team concludes.
STUDY DETAILS:
The study was led by Raaj Mehta, MD, PhD, with Massachusetts General Hospital and Harvard Medical School in Boston. The study was published online in Gastroenterology. Funding was provided by grants from the National Institute on Aging, the National Cancer Institute, and other institutions.
LIMITATIONS:
Potential for residual confounding and underestimation of PPI and H2RA use, lack of data on medication dose and duration, and the absence of ApoE4 allele status.
DISCLOSURES:
Dr. Mehta has disclosed no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
TOPLINE:
A new study provides reassurance about the long-term safety of proton pump inhibitors (PPIs) and histamine-2 receptor antagonist (H2RA) use in older adults, finding no increased risk for dementia or cognitive changes.
METHODOLOGY:
- Post hoc observational study within the Aspirin in Reducing Events in the Elderly (ASPREE) clinical trial.
- 18,934 adults aged 65+ from the United States and Australia without dementia at baseline.
- 4,667 (25%) PPI users and 368 (2%) H2RA users at baseline.
- PPI and H2RA use, dementia incidence, and cognitive changes were tracked.
TAKEAWAY:
- In multivariable analysis, baseline PPI use was not associated with incident dementia (hazard ratio, 0.88) or cognitive impairment (HR, 1.00).
- PPI use was not linked to changes in overall cognitive test scores over time (beta –0.002).
- No associations were found between H2RA use and cognitive endpoints.
IN PRACTICE:
“Long-term use of PPIs in older adults is unlikely to have negative effects on cognition,” the study team concludes.
STUDY DETAILS:
The study was led by Raaj Mehta, MD, PhD, with Massachusetts General Hospital and Harvard Medical School in Boston. The study was published online in Gastroenterology. Funding was provided by grants from the National Institute on Aging, the National Cancer Institute, and other institutions.
LIMITATIONS:
Potential for residual confounding and underestimation of PPI and H2RA use, lack of data on medication dose and duration, and the absence of ApoE4 allele status.
DISCLOSURES:
Dr. Mehta has disclosed no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
IBD study characterizes biologic adherence, confirms nonadherence risk factors
, based on a retrospective study.
Nonadherence became increasingly common in the presence of four previously reported risk factors, including smoking status, narcotic use, psychiatric history, and prior biologic use, reported lead author Lauren A. George, MD, of the University of Maryland, Baltimore, and colleagues.
“Identifying patients at risk for nonadherence is important to develop strategies to improve adherence,” the investigators wrote in Gastro Hep Advances. “The aim of this analysis was to evaluate adherence across several academic centers with integrated specialty pharmacies, to assess if previously identified risk factors for nonadherence remained significant across several diverse IBD centers, and to evaluate outcomes associated with nonadherence.”
Three tertiary care IBD clinics provided data from 608 patients with IBD. Inclusion required at least three consecutive prescription claims. All biologics were self-injectable, including adalimumab, certolizumab, golimumab, and ustekinumab.
Primary outcomes were medication possession ratio (MPR) and adherence, with nonadherence defined by an MPR lower than 0.86. Secondary outcomes included ED visits and hospitalizations.
After a median follow-up period of 903 days, the overall MPR was 0.95, with adherence of 68%-70%, which is considered “high,” according to Dr. George and colleagues, as it exceeds previously reported national adherence rates.
“[Findings were] similar across all centers, geographic regions, and patient demographics,” the investigators noted.
The four previously described risk factors did in fact predict nonadherence, with likelihood of nonadherence significantly increasing with each additional risk factor present. Patients with all four risk factors had less than 50% adherence.
Nonadherence was also significantly associated with more ED visits and hospitalizations, highlighting “the impact of biologic adherence on direct patient outcomes and healthcare costs,” the investigators wrote.
“All healthcare industry stakeholders including healthcare systems, manufacturers, and third-party benefit providers need to understand the importance of improving patient adherence,” Dr. George and colleagues concluded. “Decreasing barriers to self-injectable medication acquisition, increasing direct patient interaction with integrated pharmacy teams, and comprehensive patient education are a start to improving patient adherence. In addition, we propose that enhanced care pathways for patients with risk factors for nonadherence would improve adherence and outcomes.”
No funding was reported. The investigators disclosed relationships with AbbVie, Janssen, UCB, and others.
This article was updated 7/13/23.
An important adage in medicine is that medications only work if patients take them. Inflammatory bowel disease is a chronic illness that, if inadequately treated, can lead to emergency department visits, hospitalizations, and surgery.
This study by George et al. showed that patients receiving care at academic medical centers with integrated pharmacies had high adherence to subcutaneous therapies. Unsurprisingly, patients with high adherence had fewer emergency room visits and hospitalizations.
An important contribution is the authors identified risk factors for nonadherence. Among others, opioid use, psychiatric illness, and Medicaid insurance were associated with lower adherence. Identifying patients with these risk factors may allow more intensive outreach to improve adherence. IBD centers with integrated pharmacies, such as those in this study, are likely best equipped to do this. Alternatively, these patients may be best served with infusions that are less frequent than injections and be regularly scheduled with an appointment.
While this study did not directly compare other practice models, adherence was much higher than in other studies. This suggests the addition of an integrated pharmacy improves adherence and lowers costs. Other factors such as highly trained IBD gastroenterologists and skilled support staff may have also helped improve adherence, but in any case the multidisciplinary care, especially integrated pharmacies, should be emulated by other IBD centers.
Martin H. Gregory, MD, MSCI, assistant professor of medicine, Washington University School of Medicine, St. Louis. Dr. Gregory disclosed serving on an advisory board for Bristol Myers Squibb.
An important adage in medicine is that medications only work if patients take them. Inflammatory bowel disease is a chronic illness that, if inadequately treated, can lead to emergency department visits, hospitalizations, and surgery.
This study by George et al. showed that patients receiving care at academic medical centers with integrated pharmacies had high adherence to subcutaneous therapies. Unsurprisingly, patients with high adherence had fewer emergency room visits and hospitalizations.
An important contribution is the authors identified risk factors for nonadherence. Among others, opioid use, psychiatric illness, and Medicaid insurance were associated with lower adherence. Identifying patients with these risk factors may allow more intensive outreach to improve adherence. IBD centers with integrated pharmacies, such as those in this study, are likely best equipped to do this. Alternatively, these patients may be best served with infusions that are less frequent than injections and be regularly scheduled with an appointment.
While this study did not directly compare other practice models, adherence was much higher than in other studies. This suggests the addition of an integrated pharmacy improves adherence and lowers costs. Other factors such as highly trained IBD gastroenterologists and skilled support staff may have also helped improve adherence, but in any case the multidisciplinary care, especially integrated pharmacies, should be emulated by other IBD centers.
Martin H. Gregory, MD, MSCI, assistant professor of medicine, Washington University School of Medicine, St. Louis. Dr. Gregory disclosed serving on an advisory board for Bristol Myers Squibb.
An important adage in medicine is that medications only work if patients take them. Inflammatory bowel disease is a chronic illness that, if inadequately treated, can lead to emergency department visits, hospitalizations, and surgery.
This study by George et al. showed that patients receiving care at academic medical centers with integrated pharmacies had high adherence to subcutaneous therapies. Unsurprisingly, patients with high adherence had fewer emergency room visits and hospitalizations.
An important contribution is the authors identified risk factors for nonadherence. Among others, opioid use, psychiatric illness, and Medicaid insurance were associated with lower adherence. Identifying patients with these risk factors may allow more intensive outreach to improve adherence. IBD centers with integrated pharmacies, such as those in this study, are likely best equipped to do this. Alternatively, these patients may be best served with infusions that are less frequent than injections and be regularly scheduled with an appointment.
While this study did not directly compare other practice models, adherence was much higher than in other studies. This suggests the addition of an integrated pharmacy improves adherence and lowers costs. Other factors such as highly trained IBD gastroenterologists and skilled support staff may have also helped improve adherence, but in any case the multidisciplinary care, especially integrated pharmacies, should be emulated by other IBD centers.
Martin H. Gregory, MD, MSCI, assistant professor of medicine, Washington University School of Medicine, St. Louis. Dr. Gregory disclosed serving on an advisory board for Bristol Myers Squibb.
, based on a retrospective study.
Nonadherence became increasingly common in the presence of four previously reported risk factors, including smoking status, narcotic use, psychiatric history, and prior biologic use, reported lead author Lauren A. George, MD, of the University of Maryland, Baltimore, and colleagues.
“Identifying patients at risk for nonadherence is important to develop strategies to improve adherence,” the investigators wrote in Gastro Hep Advances. “The aim of this analysis was to evaluate adherence across several academic centers with integrated specialty pharmacies, to assess if previously identified risk factors for nonadherence remained significant across several diverse IBD centers, and to evaluate outcomes associated with nonadherence.”
Three tertiary care IBD clinics provided data from 608 patients with IBD. Inclusion required at least three consecutive prescription claims. All biologics were self-injectable, including adalimumab, certolizumab, golimumab, and ustekinumab.
Primary outcomes were medication possession ratio (MPR) and adherence, with nonadherence defined by an MPR lower than 0.86. Secondary outcomes included ED visits and hospitalizations.
After a median follow-up period of 903 days, the overall MPR was 0.95, with adherence of 68%-70%, which is considered “high,” according to Dr. George and colleagues, as it exceeds previously reported national adherence rates.
“[Findings were] similar across all centers, geographic regions, and patient demographics,” the investigators noted.
The four previously described risk factors did in fact predict nonadherence, with likelihood of nonadherence significantly increasing with each additional risk factor present. Patients with all four risk factors had less than 50% adherence.
Nonadherence was also significantly associated with more ED visits and hospitalizations, highlighting “the impact of biologic adherence on direct patient outcomes and healthcare costs,” the investigators wrote.
“All healthcare industry stakeholders including healthcare systems, manufacturers, and third-party benefit providers need to understand the importance of improving patient adherence,” Dr. George and colleagues concluded. “Decreasing barriers to self-injectable medication acquisition, increasing direct patient interaction with integrated pharmacy teams, and comprehensive patient education are a start to improving patient adherence. In addition, we propose that enhanced care pathways for patients with risk factors for nonadherence would improve adherence and outcomes.”
No funding was reported. The investigators disclosed relationships with AbbVie, Janssen, UCB, and others.
This article was updated 7/13/23.
, based on a retrospective study.
Nonadherence became increasingly common in the presence of four previously reported risk factors, including smoking status, narcotic use, psychiatric history, and prior biologic use, reported lead author Lauren A. George, MD, of the University of Maryland, Baltimore, and colleagues.
“Identifying patients at risk for nonadherence is important to develop strategies to improve adherence,” the investigators wrote in Gastro Hep Advances. “The aim of this analysis was to evaluate adherence across several academic centers with integrated specialty pharmacies, to assess if previously identified risk factors for nonadherence remained significant across several diverse IBD centers, and to evaluate outcomes associated with nonadherence.”
Three tertiary care IBD clinics provided data from 608 patients with IBD. Inclusion required at least three consecutive prescription claims. All biologics were self-injectable, including adalimumab, certolizumab, golimumab, and ustekinumab.
Primary outcomes were medication possession ratio (MPR) and adherence, with nonadherence defined by an MPR lower than 0.86. Secondary outcomes included ED visits and hospitalizations.
After a median follow-up period of 903 days, the overall MPR was 0.95, with adherence of 68%-70%, which is considered “high,” according to Dr. George and colleagues, as it exceeds previously reported national adherence rates.
“[Findings were] similar across all centers, geographic regions, and patient demographics,” the investigators noted.
The four previously described risk factors did in fact predict nonadherence, with likelihood of nonadherence significantly increasing with each additional risk factor present. Patients with all four risk factors had less than 50% adherence.
Nonadherence was also significantly associated with more ED visits and hospitalizations, highlighting “the impact of biologic adherence on direct patient outcomes and healthcare costs,” the investigators wrote.
“All healthcare industry stakeholders including healthcare systems, manufacturers, and third-party benefit providers need to understand the importance of improving patient adherence,” Dr. George and colleagues concluded. “Decreasing barriers to self-injectable medication acquisition, increasing direct patient interaction with integrated pharmacy teams, and comprehensive patient education are a start to improving patient adherence. In addition, we propose that enhanced care pathways for patients with risk factors for nonadherence would improve adherence and outcomes.”
No funding was reported. The investigators disclosed relationships with AbbVie, Janssen, UCB, and others.
This article was updated 7/13/23.
FROM GASTRO HEP ADVANCES
New AGA CPU focuses on gastric peroral endoscopic myotomy for gastroparesis
Authored by Mouen A. Khashab, MD, director of therapeutic endoscopy at Johns Hopkins Medicine, Baltimore; Andrew Y. Wang, MD, AGAF, chief of interventional endoscopy, University of Virginia, Charlottesville; and, Qiang Cai, MD, PhD, chief of gastroenterology, Ochsner LSU Health Shreveport (La.), the update covers patient selection, procedural considerations, adverse events (AEs), and other topics.
“G-POEM is being performed worldwide to treat patients with refractory gastroparesis,” the investigators wrote in Gastroenterology). “G-POEM is an overall safe procedure with high technical success rates, particularly when performed by an endoscopist experienced in third-space endoscopy. Even if the durable clinical success of G-POEM is in the 50% to 60% range, this represents a huge clinical benefit to patients with refractory gastroparesis, which is a disease associated with substantial morbidity, poor quality of life, and a paucity of safe and effective treatments.”
The authors listed treatment alternatives, noting how associated clinical data have fallen short.
“Although endoscopic pyloric balloon dilation, intrapyloric botulinum toxin injection, gastric electrical stimulation, and transpyloric stenting have been used in patients [with gastroparesis] who have not responded to medical therapy, published studies concerning these therapies have been inconsistent, shown no benefit, or lacked methodologic rigor,” they wrote.
Patient selection
G-POEM should be considered in patients with medically refractory gastroparesis due to diabetes, prior surgery, or idiopathic causes. Candidates should undergo endoscopy to confirm no mechanical obstruction, as well as a solid-phase gastric emptying scan to confirm delayed emptying, with ideal candidates showing at least 20% retention at 4 hours, as this threshold has been linked with better clinical outcomes.
G-POEM is most beneficial when moderate to severe symptoms are present, the investigators wrote, particularly vomiting and nausea. The Gastroparesis Cardinal Symptom Index (GCSI) can be used to determine severity, with a score greater than 2 indicating moderate to severe presentation.
Procedural considerations
The CPU offers detailed procedural considerations, including preparation and equipment, technical guidance, and postprocedural strategy.
“G-POEM should only be performed by interventional endoscopists with expertise or training in third-space endoscopy,” Dr. Khashab and colleagues wrote. “Although experience in endoscopic submucosal dissection (ESD) is not mandatory before performing G-POEM, it likely shortens the learning curve.”
Equipment minimums are also described, including “a high-definition gastroscope, with a waterjet, affixed with a clear distal cap” and “a modern electrosurgical generator capable of modulating power based on tissue resistance and circuit impedance.”
While G-POEM is typically performed via a greater-curvature approach, similar outcomes have been documented for a lesser-curvature approach, Dr. Khashab and colleagues wrote. This alternative technique may increase difficulty of pyloromyotomy, they added.
Postprocedural care may involve an overnight stay, according to the update, with an upper GI study on the subsequent day to ensure no contrast leakage, though this is not mandatory.
Adverse events
“G-POEM is generally safe when performed by trained and/or experienced endoscopists, and AEs are uncommon,” the investigators wrote. “However, serious AEs can occur and have been reported.”
Reported AEs include capnoperitoneum, inadvertent mucosotomy, thermal-mucosal injury, abdominal pain, bleeding, gastric ulceration, and dumping syndrome.
Insurance companies called to action
After reviewing emerging data, the authors suggested the time has come to consider G-POEM as a routine, evidence-based procedure that deserves appropriate reimbursement by financial stakeholders.
“Many insurers still consider G-POEM investigational and refuse to cover this procedure for patients with medically refractory gastroparesis,” they wrote. “As the safety and clinical effectiveness of G-POEM is now well supported, insurance companies and payors should cover G-POEM for patients with significant gastroparesis.”
The clinical practice update was commissioned and approved by the American Gastroenterological Association. The investigators disclosed relationships with Boston Scientific, Medtronic, and Olympus, among others.
Authored by Mouen A. Khashab, MD, director of therapeutic endoscopy at Johns Hopkins Medicine, Baltimore; Andrew Y. Wang, MD, AGAF, chief of interventional endoscopy, University of Virginia, Charlottesville; and, Qiang Cai, MD, PhD, chief of gastroenterology, Ochsner LSU Health Shreveport (La.), the update covers patient selection, procedural considerations, adverse events (AEs), and other topics.
“G-POEM is being performed worldwide to treat patients with refractory gastroparesis,” the investigators wrote in Gastroenterology). “G-POEM is an overall safe procedure with high technical success rates, particularly when performed by an endoscopist experienced in third-space endoscopy. Even if the durable clinical success of G-POEM is in the 50% to 60% range, this represents a huge clinical benefit to patients with refractory gastroparesis, which is a disease associated with substantial morbidity, poor quality of life, and a paucity of safe and effective treatments.”
The authors listed treatment alternatives, noting how associated clinical data have fallen short.
“Although endoscopic pyloric balloon dilation, intrapyloric botulinum toxin injection, gastric electrical stimulation, and transpyloric stenting have been used in patients [with gastroparesis] who have not responded to medical therapy, published studies concerning these therapies have been inconsistent, shown no benefit, or lacked methodologic rigor,” they wrote.
Patient selection
G-POEM should be considered in patients with medically refractory gastroparesis due to diabetes, prior surgery, or idiopathic causes. Candidates should undergo endoscopy to confirm no mechanical obstruction, as well as a solid-phase gastric emptying scan to confirm delayed emptying, with ideal candidates showing at least 20% retention at 4 hours, as this threshold has been linked with better clinical outcomes.
G-POEM is most beneficial when moderate to severe symptoms are present, the investigators wrote, particularly vomiting and nausea. The Gastroparesis Cardinal Symptom Index (GCSI) can be used to determine severity, with a score greater than 2 indicating moderate to severe presentation.
Procedural considerations
The CPU offers detailed procedural considerations, including preparation and equipment, technical guidance, and postprocedural strategy.
“G-POEM should only be performed by interventional endoscopists with expertise or training in third-space endoscopy,” Dr. Khashab and colleagues wrote. “Although experience in endoscopic submucosal dissection (ESD) is not mandatory before performing G-POEM, it likely shortens the learning curve.”
Equipment minimums are also described, including “a high-definition gastroscope, with a waterjet, affixed with a clear distal cap” and “a modern electrosurgical generator capable of modulating power based on tissue resistance and circuit impedance.”
While G-POEM is typically performed via a greater-curvature approach, similar outcomes have been documented for a lesser-curvature approach, Dr. Khashab and colleagues wrote. This alternative technique may increase difficulty of pyloromyotomy, they added.
Postprocedural care may involve an overnight stay, according to the update, with an upper GI study on the subsequent day to ensure no contrast leakage, though this is not mandatory.
Adverse events
“G-POEM is generally safe when performed by trained and/or experienced endoscopists, and AEs are uncommon,” the investigators wrote. “However, serious AEs can occur and have been reported.”
Reported AEs include capnoperitoneum, inadvertent mucosotomy, thermal-mucosal injury, abdominal pain, bleeding, gastric ulceration, and dumping syndrome.
Insurance companies called to action
After reviewing emerging data, the authors suggested the time has come to consider G-POEM as a routine, evidence-based procedure that deserves appropriate reimbursement by financial stakeholders.
“Many insurers still consider G-POEM investigational and refuse to cover this procedure for patients with medically refractory gastroparesis,” they wrote. “As the safety and clinical effectiveness of G-POEM is now well supported, insurance companies and payors should cover G-POEM for patients with significant gastroparesis.”
The clinical practice update was commissioned and approved by the American Gastroenterological Association. The investigators disclosed relationships with Boston Scientific, Medtronic, and Olympus, among others.
Authored by Mouen A. Khashab, MD, director of therapeutic endoscopy at Johns Hopkins Medicine, Baltimore; Andrew Y. Wang, MD, AGAF, chief of interventional endoscopy, University of Virginia, Charlottesville; and, Qiang Cai, MD, PhD, chief of gastroenterology, Ochsner LSU Health Shreveport (La.), the update covers patient selection, procedural considerations, adverse events (AEs), and other topics.
“G-POEM is being performed worldwide to treat patients with refractory gastroparesis,” the investigators wrote in Gastroenterology). “G-POEM is an overall safe procedure with high technical success rates, particularly when performed by an endoscopist experienced in third-space endoscopy. Even if the durable clinical success of G-POEM is in the 50% to 60% range, this represents a huge clinical benefit to patients with refractory gastroparesis, which is a disease associated with substantial morbidity, poor quality of life, and a paucity of safe and effective treatments.”
The authors listed treatment alternatives, noting how associated clinical data have fallen short.
“Although endoscopic pyloric balloon dilation, intrapyloric botulinum toxin injection, gastric electrical stimulation, and transpyloric stenting have been used in patients [with gastroparesis] who have not responded to medical therapy, published studies concerning these therapies have been inconsistent, shown no benefit, or lacked methodologic rigor,” they wrote.
Patient selection
G-POEM should be considered in patients with medically refractory gastroparesis due to diabetes, prior surgery, or idiopathic causes. Candidates should undergo endoscopy to confirm no mechanical obstruction, as well as a solid-phase gastric emptying scan to confirm delayed emptying, with ideal candidates showing at least 20% retention at 4 hours, as this threshold has been linked with better clinical outcomes.
G-POEM is most beneficial when moderate to severe symptoms are present, the investigators wrote, particularly vomiting and nausea. The Gastroparesis Cardinal Symptom Index (GCSI) can be used to determine severity, with a score greater than 2 indicating moderate to severe presentation.
Procedural considerations
The CPU offers detailed procedural considerations, including preparation and equipment, technical guidance, and postprocedural strategy.
“G-POEM should only be performed by interventional endoscopists with expertise or training in third-space endoscopy,” Dr. Khashab and colleagues wrote. “Although experience in endoscopic submucosal dissection (ESD) is not mandatory before performing G-POEM, it likely shortens the learning curve.”
Equipment minimums are also described, including “a high-definition gastroscope, with a waterjet, affixed with a clear distal cap” and “a modern electrosurgical generator capable of modulating power based on tissue resistance and circuit impedance.”
While G-POEM is typically performed via a greater-curvature approach, similar outcomes have been documented for a lesser-curvature approach, Dr. Khashab and colleagues wrote. This alternative technique may increase difficulty of pyloromyotomy, they added.
Postprocedural care may involve an overnight stay, according to the update, with an upper GI study on the subsequent day to ensure no contrast leakage, though this is not mandatory.
Adverse events
“G-POEM is generally safe when performed by trained and/or experienced endoscopists, and AEs are uncommon,” the investigators wrote. “However, serious AEs can occur and have been reported.”
Reported AEs include capnoperitoneum, inadvertent mucosotomy, thermal-mucosal injury, abdominal pain, bleeding, gastric ulceration, and dumping syndrome.
Insurance companies called to action
After reviewing emerging data, the authors suggested the time has come to consider G-POEM as a routine, evidence-based procedure that deserves appropriate reimbursement by financial stakeholders.
“Many insurers still consider G-POEM investigational and refuse to cover this procedure for patients with medically refractory gastroparesis,” they wrote. “As the safety and clinical effectiveness of G-POEM is now well supported, insurance companies and payors should cover G-POEM for patients with significant gastroparesis.”
The clinical practice update was commissioned and approved by the American Gastroenterological Association. The investigators disclosed relationships with Boston Scientific, Medtronic, and Olympus, among others.
FROM GASTROENTEROLOGY
Mucosal exposure device boosts AI-assisted detection of adenomas
based on results of a randomized trial.
Using the mucosal exposure device increased adenoma detection rate by 12% without impacting safety or withdrawal time, suggesting that the two approaches have a synergistic effect, reported lead author Marco Spadaccini, MD, of Humanitas University, Pieve Emanuele, Italy, and colleagues.
“Recent advances in AI, deep learning, and computer vision led to implementation of computer-aided detection [CADe] of colorectal polyps,” the investigators wrote in Gastroenterology. “CADe-assisted colonoscopy already proved its efficacy by increasing adenoma detection in randomized parallel and crossover trials. However, such benefit is mostly related to the higher accuracy in spotting lesions already within the visual field, not affecting the amount of mucosa exposed by the endoscopist during the scope withdrawal. Increasing the mucosa exposure represents a complementary strategy to CADe in order to further improve detection of colorectal neoplasia.”
To test their hypothesis, the investigators conducted a randomized trial involving 1,316 subjects undergoing routine colonoscopy at six centers in Italy and Switzerland. Participants were randomized in a 1:1 ratio to undergo colonoscopy with CADe (GI Genius, Medtronic) or CADe plus a mucosal exposure device (Endocuff Vision, Olympus).
The combination approach yielded a 49.6% adenoma detection rate, compared with a 44.0% detection rate for CADe alone (relative risk, 1.12; 95% confidence interval, 1.00-1.26; P = .04). Adding the mucosal exposure device was also associated with a higher number of adenomas detected per colonoscopy. Withdrawal time and rate of unnecessary polypectomies did not differ between groups.
“The benefit of adding [the mucosal exposure device] to AI was expected due to the complementary nature of the interventions,” Dr. Spadaccini and colleagues wrote. “The benefit of [the mucosal exposure device] is limited to increase the quantity of mucosa exposed to the lens by flatting the folds and strengthening the angulations, and the benefit of AI is only in spotting a lesion that is already displayed within the field of view. Thus, we may speculate that the additional mucosal exposure was synergistic to the AI-assisted polyp recognition by AI.”
The benefits of a combination approach were not universal, however, as the mucosal exposure device did not improve detection of either serrated lesions or advanced adenomas. This result was anticipated, the investigators noted, since the miss rate for diminutive or proximal adenomas is higher than it is for larger or distal lesions, and previous research has suggested that AI-assisted and mucosal exposure techniques, when used alone, are most effective for detecting smaller, proximal lesions.
The study was funded by a European Society of Gastrointestinal Endoscopy Artificial Intelligence Award. The investigators disclosed additional relationships with Fujifilm, Medtronic, Olympus, and others.
The paradigm of adenoma detection is rapidly shifting within the context of screening-related colonoscopy. If one considers the various interventions available to improve one’s adenoma detection rate (ADR), the landscape is vastly different than it was 5-10 years ago. Two established interventions with robust supporting data from randomized controlled trials (RCTs) are computer-aided detection (CADe) platforms such as GI Genius (Medtronic) and distal attachment devices such as Endocuff Vision (Olympus). This RCT by Spadaccini and colleagues tested the intuitive hypothesis that these interventions applied together boost ADR, compared with CADe alone.
Real-world studies of CADe’s effectiveness on ADR are less impressive than efficacy data from trials. Whereas CADe platforms require a significant one-time investment, distal attachment devices represent a small fraction of single procedural costs which then incrementally add up when used over large volumes. More head-to-head studies, cost-effectiveness analyses, and real-world studies are needed to elucidate the best single and/or combination strategies for optimizing ADR. In the meantime, endoscopists should be aware of all evidence-based techniques for ADR improvement, including those that can be incorporated at little to no cost.
Nauzer Forbes, MD, MSc, FASGE, is an associate professor at the University of Calgary (Alta.), where he is the training program director for advanced/therapeutic endoscopy. He is a consultant for and has received speaker’s fees from Pentax Medical and Boston Scientific, is a consultant for AstraZeneca, and has received research funding from Pentax Medical.
The paradigm of adenoma detection is rapidly shifting within the context of screening-related colonoscopy. If one considers the various interventions available to improve one’s adenoma detection rate (ADR), the landscape is vastly different than it was 5-10 years ago. Two established interventions with robust supporting data from randomized controlled trials (RCTs) are computer-aided detection (CADe) platforms such as GI Genius (Medtronic) and distal attachment devices such as Endocuff Vision (Olympus). This RCT by Spadaccini and colleagues tested the intuitive hypothesis that these interventions applied together boost ADR, compared with CADe alone.
Real-world studies of CADe’s effectiveness on ADR are less impressive than efficacy data from trials. Whereas CADe platforms require a significant one-time investment, distal attachment devices represent a small fraction of single procedural costs which then incrementally add up when used over large volumes. More head-to-head studies, cost-effectiveness analyses, and real-world studies are needed to elucidate the best single and/or combination strategies for optimizing ADR. In the meantime, endoscopists should be aware of all evidence-based techniques for ADR improvement, including those that can be incorporated at little to no cost.
Nauzer Forbes, MD, MSc, FASGE, is an associate professor at the University of Calgary (Alta.), where he is the training program director for advanced/therapeutic endoscopy. He is a consultant for and has received speaker’s fees from Pentax Medical and Boston Scientific, is a consultant for AstraZeneca, and has received research funding from Pentax Medical.
The paradigm of adenoma detection is rapidly shifting within the context of screening-related colonoscopy. If one considers the various interventions available to improve one’s adenoma detection rate (ADR), the landscape is vastly different than it was 5-10 years ago. Two established interventions with robust supporting data from randomized controlled trials (RCTs) are computer-aided detection (CADe) platforms such as GI Genius (Medtronic) and distal attachment devices such as Endocuff Vision (Olympus). This RCT by Spadaccini and colleagues tested the intuitive hypothesis that these interventions applied together boost ADR, compared with CADe alone.
Real-world studies of CADe’s effectiveness on ADR are less impressive than efficacy data from trials. Whereas CADe platforms require a significant one-time investment, distal attachment devices represent a small fraction of single procedural costs which then incrementally add up when used over large volumes. More head-to-head studies, cost-effectiveness analyses, and real-world studies are needed to elucidate the best single and/or combination strategies for optimizing ADR. In the meantime, endoscopists should be aware of all evidence-based techniques for ADR improvement, including those that can be incorporated at little to no cost.
Nauzer Forbes, MD, MSc, FASGE, is an associate professor at the University of Calgary (Alta.), where he is the training program director for advanced/therapeutic endoscopy. He is a consultant for and has received speaker’s fees from Pentax Medical and Boston Scientific, is a consultant for AstraZeneca, and has received research funding from Pentax Medical.
based on results of a randomized trial.
Using the mucosal exposure device increased adenoma detection rate by 12% without impacting safety or withdrawal time, suggesting that the two approaches have a synergistic effect, reported lead author Marco Spadaccini, MD, of Humanitas University, Pieve Emanuele, Italy, and colleagues.
“Recent advances in AI, deep learning, and computer vision led to implementation of computer-aided detection [CADe] of colorectal polyps,” the investigators wrote in Gastroenterology. “CADe-assisted colonoscopy already proved its efficacy by increasing adenoma detection in randomized parallel and crossover trials. However, such benefit is mostly related to the higher accuracy in spotting lesions already within the visual field, not affecting the amount of mucosa exposed by the endoscopist during the scope withdrawal. Increasing the mucosa exposure represents a complementary strategy to CADe in order to further improve detection of colorectal neoplasia.”
To test their hypothesis, the investigators conducted a randomized trial involving 1,316 subjects undergoing routine colonoscopy at six centers in Italy and Switzerland. Participants were randomized in a 1:1 ratio to undergo colonoscopy with CADe (GI Genius, Medtronic) or CADe plus a mucosal exposure device (Endocuff Vision, Olympus).
The combination approach yielded a 49.6% adenoma detection rate, compared with a 44.0% detection rate for CADe alone (relative risk, 1.12; 95% confidence interval, 1.00-1.26; P = .04). Adding the mucosal exposure device was also associated with a higher number of adenomas detected per colonoscopy. Withdrawal time and rate of unnecessary polypectomies did not differ between groups.
“The benefit of adding [the mucosal exposure device] to AI was expected due to the complementary nature of the interventions,” Dr. Spadaccini and colleagues wrote. “The benefit of [the mucosal exposure device] is limited to increase the quantity of mucosa exposed to the lens by flatting the folds and strengthening the angulations, and the benefit of AI is only in spotting a lesion that is already displayed within the field of view. Thus, we may speculate that the additional mucosal exposure was synergistic to the AI-assisted polyp recognition by AI.”
The benefits of a combination approach were not universal, however, as the mucosal exposure device did not improve detection of either serrated lesions or advanced adenomas. This result was anticipated, the investigators noted, since the miss rate for diminutive or proximal adenomas is higher than it is for larger or distal lesions, and previous research has suggested that AI-assisted and mucosal exposure techniques, when used alone, are most effective for detecting smaller, proximal lesions.
The study was funded by a European Society of Gastrointestinal Endoscopy Artificial Intelligence Award. The investigators disclosed additional relationships with Fujifilm, Medtronic, Olympus, and others.
based on results of a randomized trial.
Using the mucosal exposure device increased adenoma detection rate by 12% without impacting safety or withdrawal time, suggesting that the two approaches have a synergistic effect, reported lead author Marco Spadaccini, MD, of Humanitas University, Pieve Emanuele, Italy, and colleagues.
“Recent advances in AI, deep learning, and computer vision led to implementation of computer-aided detection [CADe] of colorectal polyps,” the investigators wrote in Gastroenterology. “CADe-assisted colonoscopy already proved its efficacy by increasing adenoma detection in randomized parallel and crossover trials. However, such benefit is mostly related to the higher accuracy in spotting lesions already within the visual field, not affecting the amount of mucosa exposed by the endoscopist during the scope withdrawal. Increasing the mucosa exposure represents a complementary strategy to CADe in order to further improve detection of colorectal neoplasia.”
To test their hypothesis, the investigators conducted a randomized trial involving 1,316 subjects undergoing routine colonoscopy at six centers in Italy and Switzerland. Participants were randomized in a 1:1 ratio to undergo colonoscopy with CADe (GI Genius, Medtronic) or CADe plus a mucosal exposure device (Endocuff Vision, Olympus).
The combination approach yielded a 49.6% adenoma detection rate, compared with a 44.0% detection rate for CADe alone (relative risk, 1.12; 95% confidence interval, 1.00-1.26; P = .04). Adding the mucosal exposure device was also associated with a higher number of adenomas detected per colonoscopy. Withdrawal time and rate of unnecessary polypectomies did not differ between groups.
“The benefit of adding [the mucosal exposure device] to AI was expected due to the complementary nature of the interventions,” Dr. Spadaccini and colleagues wrote. “The benefit of [the mucosal exposure device] is limited to increase the quantity of mucosa exposed to the lens by flatting the folds and strengthening the angulations, and the benefit of AI is only in spotting a lesion that is already displayed within the field of view. Thus, we may speculate that the additional mucosal exposure was synergistic to the AI-assisted polyp recognition by AI.”
The benefits of a combination approach were not universal, however, as the mucosal exposure device did not improve detection of either serrated lesions or advanced adenomas. This result was anticipated, the investigators noted, since the miss rate for diminutive or proximal adenomas is higher than it is for larger or distal lesions, and previous research has suggested that AI-assisted and mucosal exposure techniques, when used alone, are most effective for detecting smaller, proximal lesions.
The study was funded by a European Society of Gastrointestinal Endoscopy Artificial Intelligence Award. The investigators disclosed additional relationships with Fujifilm, Medtronic, Olympus, and others.
FROM GASTROENTEROLOGY