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

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Changed
Mon, 09/23/2024 - 18:59

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

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

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

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

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

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

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

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

The interview responses have been condensed and edited for clarity.
 

What does this FDA approval mean for CRC screening?

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

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

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

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

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

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

 

 

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

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

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

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

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

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

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

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

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

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

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

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

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

 

 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The interview responses have been condensed and edited for clarity.
 

What does this FDA approval mean for CRC screening?

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

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

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

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

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

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

 

 

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

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

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

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

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

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

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

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

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

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

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

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

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

 

 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The interview responses have been condensed and edited for clarity.
 

What does this FDA approval mean for CRC screening?

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

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

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

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

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

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

 

 

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

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

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

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

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

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

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

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

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

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

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

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

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

 

 

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

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

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

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

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

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

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

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

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

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

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

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Five Steps to Improved Colonoscopy Performance

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Changed
Fri, 09/20/2024 - 11:12

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

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

Addressing Poor Prep

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

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

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

Dr. Brian Jacobson, Harvard Medical School, Boston, and Massachusetts General Hospital in Boston
Massachusetts General Hospital
Dr. Brian Jacobson


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

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

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

Improving Polyp Detection

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

 

 

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

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

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


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

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

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

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

Following Polyp Surveillance Intervals

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

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

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

Rajesh N. Keswani, MD, associate professor of medicine in gastroenterology and hepatology at Northwestern University in Chicago
Dr. Rajesh N. Keswani


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

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

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

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

 

 

Reducing Environmental Effects

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

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

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

Heiko Pohl, MD, MPH, is a professor of medicine at the Geisel School of Medicine at Dartmouth
Dr. Heiko Pohl


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

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

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

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

AI for Quality And Efficiency

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

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

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

Dr. Jason B. Samarasena
Dr. Jason B. Samarasena


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

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

“This should be an adjunct or an additional tool, not a replacement tool,” she added. “This doesn’t mean to stop doing astute observation.”
Aasma Shaukat, MD, MPH, AGAF, is Robert M. and Mary H. Glickman Professor of Medicine and Population Health and director of GI Outcomes Research at New York University.
New York University
Dr. Aasma Shaukat


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

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

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

 

 

A version of this article appeared on Medscape.com.

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

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

Addressing Poor Prep

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

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

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

Dr. Brian Jacobson, Harvard Medical School, Boston, and Massachusetts General Hospital in Boston
Massachusetts General Hospital
Dr. Brian Jacobson


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

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

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

Improving Polyp Detection

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

 

 

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

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

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


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

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

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

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

Following Polyp Surveillance Intervals

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

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

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

Rajesh N. Keswani, MD, associate professor of medicine in gastroenterology and hepatology at Northwestern University in Chicago
Dr. Rajesh N. Keswani


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

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

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

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

 

 

Reducing Environmental Effects

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

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

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

Heiko Pohl, MD, MPH, is a professor of medicine at the Geisel School of Medicine at Dartmouth
Dr. Heiko Pohl


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

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

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

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

AI for Quality And Efficiency

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

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

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

Dr. Jason B. Samarasena
Dr. Jason B. Samarasena


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

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

“This should be an adjunct or an additional tool, not a replacement tool,” she added. “This doesn’t mean to stop doing astute observation.”
Aasma Shaukat, MD, MPH, AGAF, is Robert M. and Mary H. Glickman Professor of Medicine and Population Health and director of GI Outcomes Research at New York University.
New York University
Dr. Aasma Shaukat


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

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

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

 

 

A version of this article appeared on Medscape.com.

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

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

Addressing Poor Prep

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

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

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

Dr. Brian Jacobson, Harvard Medical School, Boston, and Massachusetts General Hospital in Boston
Massachusetts General Hospital
Dr. Brian Jacobson


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

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

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

Improving Polyp Detection

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

 

 

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

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

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


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

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

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

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

Following Polyp Surveillance Intervals

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

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

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

Rajesh N. Keswani, MD, associate professor of medicine in gastroenterology and hepatology at Northwestern University in Chicago
Dr. Rajesh N. Keswani


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

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

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

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

 

 

Reducing Environmental Effects

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

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

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

Heiko Pohl, MD, MPH, is a professor of medicine at the Geisel School of Medicine at Dartmouth
Dr. Heiko Pohl


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

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

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

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

AI for Quality And Efficiency

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

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

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

Dr. Jason B. Samarasena
Dr. Jason B. Samarasena


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

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

“This should be an adjunct or an additional tool, not a replacement tool,” she added. “This doesn’t mean to stop doing astute observation.”
Aasma Shaukat, MD, MPH, AGAF, is Robert M. and Mary H. Glickman Professor of Medicine and Population Health and director of GI Outcomes Research at New York University.
New York University
Dr. Aasma Shaukat


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

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

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

 

 

A version of this article appeared on Medscape.com.

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

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

 

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

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

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

Dr. Emmanuel Tsochatzis, professor of hepatology at the University College London Institute for Liver and Digestive Health and Royal Free Hospital in London
Andrew McConnell/EASL
Dr. Emmanuel Tsochatzis

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

The study was published online in Clinical Gastroenterology and Hepatology.
 

Baveno VI Criteria Analysis

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

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

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

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

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

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

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

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

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

 

 

Baveno VI Considerations

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

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

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

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

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

Dr. Wayne Bai, gastroenterologist at Waikato Hospital and the University of Auckland in New Zealand.
Waikato Hospital
Dr. Wayne Bai


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

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

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

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

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

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

Dr. Emmanuel Tsochatzis, professor of hepatology at the University College London Institute for Liver and Digestive Health and Royal Free Hospital in London
Andrew McConnell/EASL
Dr. Emmanuel Tsochatzis

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

The study was published online in Clinical Gastroenterology and Hepatology.
 

Baveno VI Criteria Analysis

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

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

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

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

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

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

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

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

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

 

 

Baveno VI Considerations

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

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

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

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

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

Dr. Wayne Bai, gastroenterologist at Waikato Hospital and the University of Auckland in New Zealand.
Waikato Hospital
Dr. Wayne Bai


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

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

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

 

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

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

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

Dr. Emmanuel Tsochatzis, professor of hepatology at the University College London Institute for Liver and Digestive Health and Royal Free Hospital in London
Andrew McConnell/EASL
Dr. Emmanuel Tsochatzis

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

The study was published online in Clinical Gastroenterology and Hepatology.
 

Baveno VI Criteria Analysis

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

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

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

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

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

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

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

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

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

 

 

Baveno VI Considerations

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

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

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

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

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

Dr. Wayne Bai, gastroenterologist at Waikato Hospital and the University of Auckland in New Zealand.
Waikato Hospital
Dr. Wayne Bai


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

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

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

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Parents’ Technology Use May Shape Adolescents’ Mental Health

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Wed, 09/04/2024 - 10:38

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

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

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

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

The study was published online in JAMA Network Open.
 

Analyzing Parental Technoference

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

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

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

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

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

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

Considering Healthy Changes

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The study was published online in JAMA Network Open.
 

Analyzing Parental Technoference

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

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

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

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

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

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

Considering Healthy Changes

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The study was published online in JAMA Network Open.
 

Analyzing Parental Technoference

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

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

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

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

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

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

Considering Healthy Changes

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

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

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

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

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

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

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

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

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

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

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

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

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New Associations Identified Between IBD and Extraintestinal Manifestations

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Thu, 08/29/2024 - 13:07

Certain extraintestinal manifestations (EIMs) in inflammatory bowel disease (IBD) have distinct clinical, serologic, and genetic associations that reveal underlying mechanisms and indicate targets for new or existing drugs, according to a recent study.

For instance, antinuclear cytoplastic antibody is associated with primary sclerosing cholangitis (PSC) in Crohn’s disease, and CPEB4 genetic variation is associated with skin manifestations.

“Up to 40% of people with IBD suffer with symptoms from inflammation that occurs outside the gut, particularly affecting the liver, skin, and joints. These symptoms can often have a bigger impact on quality of life than the gut inflammation itself and can actually be life-threatening,” said senior author Dermot McGovern, MD, PhD, AGAF, director of translational medicine at the F. Widjaja Foundation Inflammatory Bowel Disease and Immunobiology Research Institute at Cedars-Sinai Medical Center, Los Angeles.

Dr. Dermot McGovern, director of translational medicine at the F. Widjaja Foundation Inflammatory Bowel Disease and Immunobiology Research Institute at Cedars-Sinai Medical Center, Los Angeles
Cedars-Sinai Medical Center
Dr. Dermot McGovern

“With the advances in therapies for IBD, including availability of gut-selective agents, treatment choices often incorporate whether a patient has one of these manifestations or not,” he said. “We need to understand who is at increased risk of these and why.”

The study was published in Gastroenterology .
 

Analyzing Associations

Dr. McGovern and colleagues analyzed data for 12,083 unrelated European ancestry IBD cases with presence or absence of EIMs across four cohorts in the Cedars-Sinai Medical Center IBD Research Repository, National Institute for Diabetes and Digestive and Kidney Diseases IBD Genetics Consortium, Sinai Helmsley Alliance for Research Excellence Consortium, and Risk Stratification and Identification of Immunogenetic and Microbial Markers of Rapid Disease Progression in Children with Crohn’s Disease.

In particular, the researchers looked at EIM phenotypes such as ankylosing spondylitis and sacroiliitis, PSC, peripheral arthritis, and skin and ocular manifestations. They analyzed clinical and serologic parameters through regression analyses using a mixed-effects model, as well as within-case logistic regression for genetic associations.

Overall, 14% of patients had at least one EIM. Contrary to previous reports, only 2% had multiple EIMs, and most co-occurrences were negatively correlated. Nearly all EIMs were more common in Crohn’s disease, except for PSC, which was more common in ulcerative colitis.

In general, EIMs occurred more often in women, particularly with Crohn’s disease and colonic disease location, and in patients who required surgery. Jewish ancestry was associated with psoriasis and overall skin manifestations.

Smoking increased the risk for multiple EIMs, except for PSC, where there appeared to be a “protective” effect. Older age at diagnosis and a family history of IBD were associated with increased risk for certain EIMs as well.

In addition, the research team noted multiple serologic associations, such as immunoglobulin (Ig) G and IgA, perinuclear antinuclear cytoplastic antibodies, and anti–Pseudomonas fluorescens–associated sequences with any EIM, as well as particular associations with PSC, such as anti-Saccharomyces cerevisiae antibodies and anti-flagellin.

There were also genome-wide significant associations within the major histocompatibility complex and CPEB4. Genetic associations implicated tumor necrosis factor, Janus kinase-signal transducer and activator of transcription, and interleukin 6 as potential targets for EIMs.

“We are working with colleagues across the world to increase the sample size, as we believe there is more to find,” Dr. McGovern said. “Importantly, this includes non-European ancestry subjects, as there is an urgent need to increase the diversity of populations we study so advances in clinical care are available to all communities.”
 

 

 

Considering Target Therapies

As medicine becomes more specialized, physicians should remember to consider the whole patient while choosing treatment strategies.

“Sometimes doctors wear blinders to the whole person, and it’s important to be aware of a holistic approach, where a gastroenterologist also asks about potential joint inflammation or a rheumatologist asks about bowel inflammation,” said David Rubin, MD, AGAF, chief of the Section of Gastroenterology, Hepatology and Nutrition at the University of Chicago Medicine, Chicago.

Dr. Rubin, who wasn’t involved with this study, has researched and published on EIMs in IBD. He and colleagues analyzed the prevalence, pathophysiology, and clinical presentation of EIMs to better understand possibilities for disease management.

Dr. David T. Rubin, University of Chicago
Dr. David T. Rubin


“As we’ve gotten a better understanding of the immune system, we’ve learned that an EIM can sometimes provide a clue to the treatment we might use,” he said. “Given a similar amount of bowel inflammation, if one patient also has joint pain and another doesn’t, we might choose different treatments based on the immune pathway that might be involved.”

In future studies, researchers may consider whether these genetic or serologic markers could predict EIM manifestation before it occurs clinically, Dr. Rubin said. He and colleagues are also studying the links between IBD and mental health associations.

“So far, we don’t have a blood test or biopsy test that tells you which treatment is more or less likely to work, so we need to think carefully as clinicians and look to other organ systems for clues,” he said. “It’s not only more efficient to pick a single therapy to treat both the skin and bowel, but it may actually be more effective if both have a particular dominant pathway.”

The study was supported by internal funds from the F. Widjaja Foundation Inflammatory Bowel and Immunobiology Research Institute. Several authors reported consultant roles or other associations with pharmaceutical companies. Dr. Rubin reported no relevant disclosures.

A version of this article appeared on Medscape.com.

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Certain extraintestinal manifestations (EIMs) in inflammatory bowel disease (IBD) have distinct clinical, serologic, and genetic associations that reveal underlying mechanisms and indicate targets for new or existing drugs, according to a recent study.

For instance, antinuclear cytoplastic antibody is associated with primary sclerosing cholangitis (PSC) in Crohn’s disease, and CPEB4 genetic variation is associated with skin manifestations.

“Up to 40% of people with IBD suffer with symptoms from inflammation that occurs outside the gut, particularly affecting the liver, skin, and joints. These symptoms can often have a bigger impact on quality of life than the gut inflammation itself and can actually be life-threatening,” said senior author Dermot McGovern, MD, PhD, AGAF, director of translational medicine at the F. Widjaja Foundation Inflammatory Bowel Disease and Immunobiology Research Institute at Cedars-Sinai Medical Center, Los Angeles.

Dr. Dermot McGovern, director of translational medicine at the F. Widjaja Foundation Inflammatory Bowel Disease and Immunobiology Research Institute at Cedars-Sinai Medical Center, Los Angeles
Cedars-Sinai Medical Center
Dr. Dermot McGovern

“With the advances in therapies for IBD, including availability of gut-selective agents, treatment choices often incorporate whether a patient has one of these manifestations or not,” he said. “We need to understand who is at increased risk of these and why.”

The study was published in Gastroenterology .
 

Analyzing Associations

Dr. McGovern and colleagues analyzed data for 12,083 unrelated European ancestry IBD cases with presence or absence of EIMs across four cohorts in the Cedars-Sinai Medical Center IBD Research Repository, National Institute for Diabetes and Digestive and Kidney Diseases IBD Genetics Consortium, Sinai Helmsley Alliance for Research Excellence Consortium, and Risk Stratification and Identification of Immunogenetic and Microbial Markers of Rapid Disease Progression in Children with Crohn’s Disease.

In particular, the researchers looked at EIM phenotypes such as ankylosing spondylitis and sacroiliitis, PSC, peripheral arthritis, and skin and ocular manifestations. They analyzed clinical and serologic parameters through regression analyses using a mixed-effects model, as well as within-case logistic regression for genetic associations.

Overall, 14% of patients had at least one EIM. Contrary to previous reports, only 2% had multiple EIMs, and most co-occurrences were negatively correlated. Nearly all EIMs were more common in Crohn’s disease, except for PSC, which was more common in ulcerative colitis.

In general, EIMs occurred more often in women, particularly with Crohn’s disease and colonic disease location, and in patients who required surgery. Jewish ancestry was associated with psoriasis and overall skin manifestations.

Smoking increased the risk for multiple EIMs, except for PSC, where there appeared to be a “protective” effect. Older age at diagnosis and a family history of IBD were associated with increased risk for certain EIMs as well.

In addition, the research team noted multiple serologic associations, such as immunoglobulin (Ig) G and IgA, perinuclear antinuclear cytoplastic antibodies, and anti–Pseudomonas fluorescens–associated sequences with any EIM, as well as particular associations with PSC, such as anti-Saccharomyces cerevisiae antibodies and anti-flagellin.

There were also genome-wide significant associations within the major histocompatibility complex and CPEB4. Genetic associations implicated tumor necrosis factor, Janus kinase-signal transducer and activator of transcription, and interleukin 6 as potential targets for EIMs.

“We are working with colleagues across the world to increase the sample size, as we believe there is more to find,” Dr. McGovern said. “Importantly, this includes non-European ancestry subjects, as there is an urgent need to increase the diversity of populations we study so advances in clinical care are available to all communities.”
 

 

 

Considering Target Therapies

As medicine becomes more specialized, physicians should remember to consider the whole patient while choosing treatment strategies.

“Sometimes doctors wear blinders to the whole person, and it’s important to be aware of a holistic approach, where a gastroenterologist also asks about potential joint inflammation or a rheumatologist asks about bowel inflammation,” said David Rubin, MD, AGAF, chief of the Section of Gastroenterology, Hepatology and Nutrition at the University of Chicago Medicine, Chicago.

Dr. Rubin, who wasn’t involved with this study, has researched and published on EIMs in IBD. He and colleagues analyzed the prevalence, pathophysiology, and clinical presentation of EIMs to better understand possibilities for disease management.

Dr. David T. Rubin, University of Chicago
Dr. David T. Rubin


“As we’ve gotten a better understanding of the immune system, we’ve learned that an EIM can sometimes provide a clue to the treatment we might use,” he said. “Given a similar amount of bowel inflammation, if one patient also has joint pain and another doesn’t, we might choose different treatments based on the immune pathway that might be involved.”

In future studies, researchers may consider whether these genetic or serologic markers could predict EIM manifestation before it occurs clinically, Dr. Rubin said. He and colleagues are also studying the links between IBD and mental health associations.

“So far, we don’t have a blood test or biopsy test that tells you which treatment is more or less likely to work, so we need to think carefully as clinicians and look to other organ systems for clues,” he said. “It’s not only more efficient to pick a single therapy to treat both the skin and bowel, but it may actually be more effective if both have a particular dominant pathway.”

The study was supported by internal funds from the F. Widjaja Foundation Inflammatory Bowel and Immunobiology Research Institute. Several authors reported consultant roles or other associations with pharmaceutical companies. Dr. Rubin reported no relevant disclosures.

A version of this article appeared on Medscape.com.

Certain extraintestinal manifestations (EIMs) in inflammatory bowel disease (IBD) have distinct clinical, serologic, and genetic associations that reveal underlying mechanisms and indicate targets for new or existing drugs, according to a recent study.

For instance, antinuclear cytoplastic antibody is associated with primary sclerosing cholangitis (PSC) in Crohn’s disease, and CPEB4 genetic variation is associated with skin manifestations.

“Up to 40% of people with IBD suffer with symptoms from inflammation that occurs outside the gut, particularly affecting the liver, skin, and joints. These symptoms can often have a bigger impact on quality of life than the gut inflammation itself and can actually be life-threatening,” said senior author Dermot McGovern, MD, PhD, AGAF, director of translational medicine at the F. Widjaja Foundation Inflammatory Bowel Disease and Immunobiology Research Institute at Cedars-Sinai Medical Center, Los Angeles.

Dr. Dermot McGovern, director of translational medicine at the F. Widjaja Foundation Inflammatory Bowel Disease and Immunobiology Research Institute at Cedars-Sinai Medical Center, Los Angeles
Cedars-Sinai Medical Center
Dr. Dermot McGovern

“With the advances in therapies for IBD, including availability of gut-selective agents, treatment choices often incorporate whether a patient has one of these manifestations or not,” he said. “We need to understand who is at increased risk of these and why.”

The study was published in Gastroenterology .
 

Analyzing Associations

Dr. McGovern and colleagues analyzed data for 12,083 unrelated European ancestry IBD cases with presence or absence of EIMs across four cohorts in the Cedars-Sinai Medical Center IBD Research Repository, National Institute for Diabetes and Digestive and Kidney Diseases IBD Genetics Consortium, Sinai Helmsley Alliance for Research Excellence Consortium, and Risk Stratification and Identification of Immunogenetic and Microbial Markers of Rapid Disease Progression in Children with Crohn’s Disease.

In particular, the researchers looked at EIM phenotypes such as ankylosing spondylitis and sacroiliitis, PSC, peripheral arthritis, and skin and ocular manifestations. They analyzed clinical and serologic parameters through regression analyses using a mixed-effects model, as well as within-case logistic regression for genetic associations.

Overall, 14% of patients had at least one EIM. Contrary to previous reports, only 2% had multiple EIMs, and most co-occurrences were negatively correlated. Nearly all EIMs were more common in Crohn’s disease, except for PSC, which was more common in ulcerative colitis.

In general, EIMs occurred more often in women, particularly with Crohn’s disease and colonic disease location, and in patients who required surgery. Jewish ancestry was associated with psoriasis and overall skin manifestations.

Smoking increased the risk for multiple EIMs, except for PSC, where there appeared to be a “protective” effect. Older age at diagnosis and a family history of IBD were associated with increased risk for certain EIMs as well.

In addition, the research team noted multiple serologic associations, such as immunoglobulin (Ig) G and IgA, perinuclear antinuclear cytoplastic antibodies, and anti–Pseudomonas fluorescens–associated sequences with any EIM, as well as particular associations with PSC, such as anti-Saccharomyces cerevisiae antibodies and anti-flagellin.

There were also genome-wide significant associations within the major histocompatibility complex and CPEB4. Genetic associations implicated tumor necrosis factor, Janus kinase-signal transducer and activator of transcription, and interleukin 6 as potential targets for EIMs.

“We are working with colleagues across the world to increase the sample size, as we believe there is more to find,” Dr. McGovern said. “Importantly, this includes non-European ancestry subjects, as there is an urgent need to increase the diversity of populations we study so advances in clinical care are available to all communities.”
 

 

 

Considering Target Therapies

As medicine becomes more specialized, physicians should remember to consider the whole patient while choosing treatment strategies.

“Sometimes doctors wear blinders to the whole person, and it’s important to be aware of a holistic approach, where a gastroenterologist also asks about potential joint inflammation or a rheumatologist asks about bowel inflammation,” said David Rubin, MD, AGAF, chief of the Section of Gastroenterology, Hepatology and Nutrition at the University of Chicago Medicine, Chicago.

Dr. Rubin, who wasn’t involved with this study, has researched and published on EIMs in IBD. He and colleagues analyzed the prevalence, pathophysiology, and clinical presentation of EIMs to better understand possibilities for disease management.

Dr. David T. Rubin, University of Chicago
Dr. David T. Rubin


“As we’ve gotten a better understanding of the immune system, we’ve learned that an EIM can sometimes provide a clue to the treatment we might use,” he said. “Given a similar amount of bowel inflammation, if one patient also has joint pain and another doesn’t, we might choose different treatments based on the immune pathway that might be involved.”

In future studies, researchers may consider whether these genetic or serologic markers could predict EIM manifestation before it occurs clinically, Dr. Rubin said. He and colleagues are also studying the links between IBD and mental health associations.

“So far, we don’t have a blood test or biopsy test that tells you which treatment is more or less likely to work, so we need to think carefully as clinicians and look to other organ systems for clues,” he said. “It’s not only more efficient to pick a single therapy to treat both the skin and bowel, but it may actually be more effective if both have a particular dominant pathway.”

The study was supported by internal funds from the F. Widjaja Foundation Inflammatory Bowel and Immunobiology Research Institute. Several authors reported consultant roles or other associations with pharmaceutical companies. Dr. Rubin reported no relevant disclosures.

A version of this article appeared on Medscape.com.

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Is Your Patient Too Old for a Colonoscopy?

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Changed
Wed, 08/28/2024 - 02:47

 

Colonoscopy remains the gold standard method for detecting colorectal cancer (CRC) and removing precancerous polyps.

The recommended age for CRC screening in the United States spans 45-75 years, with the benefits of colonoscopy diminishing considerably after this point.

Older adults are much more likely to experience complications before, during, and after a colonoscopy. Bowel preps can cause dehydration or electrolyte problems in some, while bleeding and bowel perforation can occur perioperatively, and pulmonary or cardiovascular complications may arise postoperatively.

These risks often outweigh the benefits of catching a precancerous lesion or early-stage cancer, especially given the low rates of advanced neoplasia and CRC detected from screening and surveillance after age 75. Yet the research overall suggests that more than half of older individuals continue to receive screening and surveillance colonoscopies outside the recommended screening window.

So is there a point in time when a person is too old to receive a colonoscopy? The answer is not always clear-cut, but life expectancy should be a key consideration.

“Taking the most extreme example, if you have 6 months to live, finding early-stage cancer is not going to help you,” Michael B. Rothberg, MD, of Medical Institute and director of the Center for Value-Based Care Research, Cleveland Clinic, told this news organization.

For those with more time, the benefits of continued screening and surveillance may outweigh the risks, but when that balance shifts from helpful to not helpful remains inexact, Dr. Rothberg noted.
 

What’s Recommended?

In May 2021, the US Preventive Services Task Force (USPSTF) lowered the CRC screening threshold to age 45, recommending all adults aged between 45 and 75 years receive screening.

For those aged between 76 and 85 years, the USPSTF upheld its 2016 recommendation of selective screening, noting that the “net benefit of screening all persons in this age group is small” and should be determined on an individual basis. The USPSTF, however, did not provide recommendations on surveillance colonoscopies among those with previously identified polyps.

In November 2023, the American Gastroenterological Association (AGA) issued a clinical practice update that provided advice on risk stratification for CRC screening and post-polypectomy surveillance. For adults older than 75 years specifically, the AGA recommended that the decision to continue CRC screening or perform post-polypectomy surveillance be based on risks, benefits, comorbidities, and screening history and decided on a case-by-case basis.

For instance, previously unscreened patients without comorbidities could benefit from screening beyond age 75 — up to age 80 for men and 90 for women — while those who have had regular colonoscopies, per recommended guidelines, but severe comorbidities that may limit life expectancy could stop sooner, even by age 65.

Although an individualized approach leaves room for variation, it’s essential to consider life expectancy and the time it takes for a polyp to progress to CRC, as well as the risks associated with the procedure itself. Certain older adults are “less likely to live long enough to benefit from surveillance colonoscopy, due to competing, non-CRC mortality risks,” and clinicians should discuss these risks with their patients, the experts explained.
 

When to Stop Screening Colonoscopies

Research shows that screening colonoscopies continue well after the recommended stop age.

A 2023 JAMA Internal Medicine study found, for instance, that a large proportion of screening colonoscopies occurred among the 7067 patients who were 75 years and older with a life expectancy < 10 years. Overall, 30% of patients aged between 76 and 80 years with a limited life expectancy had a colonoscopy. That percentage increased to 71% for those aged 81-85 years and to 100% for those older than 85 years.

But the benefits of screening were minimal. Overall, colonoscopies detected advanced neoplasia in 5.4% of patients aged 76-80 years, 6.2% of those aged 81-85 years, and 9.5% of those older than 85 years. Only 15 patients (0.2%) had CRC detected via colonoscopy, five of whom underwent cancer treatment. Of those five, four had a life expectancy ≥ 10 years, and one had a life expectancy < 10 years.

At the same time, adverse events requiring hospitalization were common 10 days post-colonoscopy (13.58 per 1000), and the risk for hospitalization increased with age.

“For all kinds of screening, we’re not that comfortable in America with the idea that people are eventually going to die, but as you get older, the potential benefits for screening decrease,” study author Dr. Rothberg told this news organization.

In general, life expectancy provides a good predictor of whether people should continue screening or receive treatment following a CRC diagnosis.

Patients aged 76-80 years in good health, for instance, could benefit from screening and, potentially, treatment, Dr. Rothberg said. And “if doctors don’t feel comfortable or confident about predicting life expectancy, taking comorbid illnesses into account can be helpful, especially for that age range.”
 

Weighing Surveillance Benefits

Surveillance colonoscopy is often recommended post-polypectomy to reduce the risk for CRC. But even in this higher-risk population, those older than 75 years may not benefit.

Recent evidence indicates that those with a history of one or two adenomas less than 1 cm in size have only a slightly (1.3-fold) increased risk for incident CRC — and no significant increased risk for fatal CRC.

Another recent study found that detecting CRC at surveillance colonoscopy was rare among older adults. In surveillance colonoscopies performed among 9601 individuals aged 70-85 years with prior adenomas, 12% had advanced neoplasia detected, and only 0.3% had CRC detected.

Similar rates of advanced polyps (7.8%) or CRC (0.2%) were reported in another recent analysis of more than 9800 adults older than 65 years receiving surveillance colonoscopies.

Despite the low rates of polyp and CRC detection, nearly 90% of patients with recommendation information available received advice to return for a future colonoscopy. Even among patients with no polyps or small ones, almost 60% who had life expectancy of less than 5 years were told to return.

Although someone with prior adenomas has a higher risk for CRC, that doesn’t tell the whole story for an individual patient, Samir Gupta, MD, professor of gastroenterology at the University of California San Diego, and co-lead of the Cancer Control Program at Moores Cancer Center, told this news organization. For older adults, it’s vital to consider the competing risks and how much time it might take for CRC to develop.

At Digestive Disease Week in May, Dr. Gupta presented new research that looked at cumulative risk among patients aged 75 years and older with prior precancerous polyps vs prior normal colonoscopies. Although those with prior adenomas had a higher risk for CRC overall, their cumulative CRC risk was low — about 0.3% at 5 years and 0.8% at 10 years. Cumulative CRC deaths were even lower — 0.2% at 5 years and 0.7% at 10 years — while the risk of dying from something other than CRC was 20% at 5 years and 40% at 10 years.

“What this means to me is that patients who are 75 and older should think really carefully about whether they want to do surveillance,” said Dr. Gupta, who coauthored the AGA’s clinical practice update. “Someone who is very healthy and doesn’t have obvious medical problems can look at that risk for developing colon cancer and the risk of dying and make a decision about whether there’s enough concern to go ahead with surveillance.”

Those with competing health priorities, on other hand, should likely concentrate on those instead, he said, and feel reassured that even if they choose not to do surveillance, they’re probably not doing themselves any harm.

“The bottom line is that referring older adults or frail adults for surveillance colonoscopy shouldn’t be a rubber stamp or check-the-box action,” Dr. Gupta said. “We need to think about it carefully and give ourselves — as clinicians and patients — the room to decide that it may not need to take high priority.”
 

 

 

What to Tell Patients

Overall, older adults who have had prior colonoscopies, no or low-risk polyps, and low CRC risk will likely face greater risks from the procedure than benefits.

“The more invasive the screening the test, the more dangerous it could be,” Dr. Rothberg noted.

Many patients, however, are open to stopping and often trust their primary care provider in the decision-making process, said Audrey Calderwood, MD, director of the Comprehensive Gastroenterology Center at Dartmouth Hitchcock Medical Center. “But the systems we have in place don’t optimally support that decision-making at the time it matters most.”

For example, at a prior colonoscopy, a gastroenterologist may recommend surveillance again in 5-7 years. But in the interim, the patient could have new medications or develop comorbidities and other health issues. Rather than defer to the gastroenterologist’s recommendations from years ago, clinicians and patients can reassess the pros and cons of screening or surveillance based on current circumstances, Dr. Calderwood said.

“There should be lines of communication and systems of support to allow primary care providers to decide whether it is still needed,” she said.

While some may be ready to stop, other patients are going to continue to want and ask about CRC screening or surveillance, Dr. Rothberg said.

In these instances, communication style matters.

“You don’t want to tell a patient that they’re not going to be screened because they’re not going to live long enough to benefit,” Dr. Rothberg said.

However, steering people toward less invasive tests or telling them it’s important to give other health problems priority may be more sensitive ways to communicate that it’s time to ramp down or halt screening.

“Sometimes when you say you’re going to stop cancer screening, older adults misperceive that you’re giving up on them,” Dr. Gupta said. “We spend 30-40 years driving home the message that prevention and screening are important, and then it feels like we’re taking it away, so we need to find the best way to discuss it and make the choice that’s comfortable for them.”

Dr. Rothberg, Dr. Gupta, and Dr. Calderwood disclosed no relevant conflicts of interest.
 

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

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Colonoscopy remains the gold standard method for detecting colorectal cancer (CRC) and removing precancerous polyps.

The recommended age for CRC screening in the United States spans 45-75 years, with the benefits of colonoscopy diminishing considerably after this point.

Older adults are much more likely to experience complications before, during, and after a colonoscopy. Bowel preps can cause dehydration or electrolyte problems in some, while bleeding and bowel perforation can occur perioperatively, and pulmonary or cardiovascular complications may arise postoperatively.

These risks often outweigh the benefits of catching a precancerous lesion or early-stage cancer, especially given the low rates of advanced neoplasia and CRC detected from screening and surveillance after age 75. Yet the research overall suggests that more than half of older individuals continue to receive screening and surveillance colonoscopies outside the recommended screening window.

So is there a point in time when a person is too old to receive a colonoscopy? The answer is not always clear-cut, but life expectancy should be a key consideration.

“Taking the most extreme example, if you have 6 months to live, finding early-stage cancer is not going to help you,” Michael B. Rothberg, MD, of Medical Institute and director of the Center for Value-Based Care Research, Cleveland Clinic, told this news organization.

For those with more time, the benefits of continued screening and surveillance may outweigh the risks, but when that balance shifts from helpful to not helpful remains inexact, Dr. Rothberg noted.
 

What’s Recommended?

In May 2021, the US Preventive Services Task Force (USPSTF) lowered the CRC screening threshold to age 45, recommending all adults aged between 45 and 75 years receive screening.

For those aged between 76 and 85 years, the USPSTF upheld its 2016 recommendation of selective screening, noting that the “net benefit of screening all persons in this age group is small” and should be determined on an individual basis. The USPSTF, however, did not provide recommendations on surveillance colonoscopies among those with previously identified polyps.

In November 2023, the American Gastroenterological Association (AGA) issued a clinical practice update that provided advice on risk stratification for CRC screening and post-polypectomy surveillance. For adults older than 75 years specifically, the AGA recommended that the decision to continue CRC screening or perform post-polypectomy surveillance be based on risks, benefits, comorbidities, and screening history and decided on a case-by-case basis.

For instance, previously unscreened patients without comorbidities could benefit from screening beyond age 75 — up to age 80 for men and 90 for women — while those who have had regular colonoscopies, per recommended guidelines, but severe comorbidities that may limit life expectancy could stop sooner, even by age 65.

Although an individualized approach leaves room for variation, it’s essential to consider life expectancy and the time it takes for a polyp to progress to CRC, as well as the risks associated with the procedure itself. Certain older adults are “less likely to live long enough to benefit from surveillance colonoscopy, due to competing, non-CRC mortality risks,” and clinicians should discuss these risks with their patients, the experts explained.
 

When to Stop Screening Colonoscopies

Research shows that screening colonoscopies continue well after the recommended stop age.

A 2023 JAMA Internal Medicine study found, for instance, that a large proportion of screening colonoscopies occurred among the 7067 patients who were 75 years and older with a life expectancy < 10 years. Overall, 30% of patients aged between 76 and 80 years with a limited life expectancy had a colonoscopy. That percentage increased to 71% for those aged 81-85 years and to 100% for those older than 85 years.

But the benefits of screening were minimal. Overall, colonoscopies detected advanced neoplasia in 5.4% of patients aged 76-80 years, 6.2% of those aged 81-85 years, and 9.5% of those older than 85 years. Only 15 patients (0.2%) had CRC detected via colonoscopy, five of whom underwent cancer treatment. Of those five, four had a life expectancy ≥ 10 years, and one had a life expectancy < 10 years.

At the same time, adverse events requiring hospitalization were common 10 days post-colonoscopy (13.58 per 1000), and the risk for hospitalization increased with age.

“For all kinds of screening, we’re not that comfortable in America with the idea that people are eventually going to die, but as you get older, the potential benefits for screening decrease,” study author Dr. Rothberg told this news organization.

In general, life expectancy provides a good predictor of whether people should continue screening or receive treatment following a CRC diagnosis.

Patients aged 76-80 years in good health, for instance, could benefit from screening and, potentially, treatment, Dr. Rothberg said. And “if doctors don’t feel comfortable or confident about predicting life expectancy, taking comorbid illnesses into account can be helpful, especially for that age range.”
 

Weighing Surveillance Benefits

Surveillance colonoscopy is often recommended post-polypectomy to reduce the risk for CRC. But even in this higher-risk population, those older than 75 years may not benefit.

Recent evidence indicates that those with a history of one or two adenomas less than 1 cm in size have only a slightly (1.3-fold) increased risk for incident CRC — and no significant increased risk for fatal CRC.

Another recent study found that detecting CRC at surveillance colonoscopy was rare among older adults. In surveillance colonoscopies performed among 9601 individuals aged 70-85 years with prior adenomas, 12% had advanced neoplasia detected, and only 0.3% had CRC detected.

Similar rates of advanced polyps (7.8%) or CRC (0.2%) were reported in another recent analysis of more than 9800 adults older than 65 years receiving surveillance colonoscopies.

Despite the low rates of polyp and CRC detection, nearly 90% of patients with recommendation information available received advice to return for a future colonoscopy. Even among patients with no polyps or small ones, almost 60% who had life expectancy of less than 5 years were told to return.

Although someone with prior adenomas has a higher risk for CRC, that doesn’t tell the whole story for an individual patient, Samir Gupta, MD, professor of gastroenterology at the University of California San Diego, and co-lead of the Cancer Control Program at Moores Cancer Center, told this news organization. For older adults, it’s vital to consider the competing risks and how much time it might take for CRC to develop.

At Digestive Disease Week in May, Dr. Gupta presented new research that looked at cumulative risk among patients aged 75 years and older with prior precancerous polyps vs prior normal colonoscopies. Although those with prior adenomas had a higher risk for CRC overall, their cumulative CRC risk was low — about 0.3% at 5 years and 0.8% at 10 years. Cumulative CRC deaths were even lower — 0.2% at 5 years and 0.7% at 10 years — while the risk of dying from something other than CRC was 20% at 5 years and 40% at 10 years.

“What this means to me is that patients who are 75 and older should think really carefully about whether they want to do surveillance,” said Dr. Gupta, who coauthored the AGA’s clinical practice update. “Someone who is very healthy and doesn’t have obvious medical problems can look at that risk for developing colon cancer and the risk of dying and make a decision about whether there’s enough concern to go ahead with surveillance.”

Those with competing health priorities, on other hand, should likely concentrate on those instead, he said, and feel reassured that even if they choose not to do surveillance, they’re probably not doing themselves any harm.

“The bottom line is that referring older adults or frail adults for surveillance colonoscopy shouldn’t be a rubber stamp or check-the-box action,” Dr. Gupta said. “We need to think about it carefully and give ourselves — as clinicians and patients — the room to decide that it may not need to take high priority.”
 

 

 

What to Tell Patients

Overall, older adults who have had prior colonoscopies, no or low-risk polyps, and low CRC risk will likely face greater risks from the procedure than benefits.

“The more invasive the screening the test, the more dangerous it could be,” Dr. Rothberg noted.

Many patients, however, are open to stopping and often trust their primary care provider in the decision-making process, said Audrey Calderwood, MD, director of the Comprehensive Gastroenterology Center at Dartmouth Hitchcock Medical Center. “But the systems we have in place don’t optimally support that decision-making at the time it matters most.”

For example, at a prior colonoscopy, a gastroenterologist may recommend surveillance again in 5-7 years. But in the interim, the patient could have new medications or develop comorbidities and other health issues. Rather than defer to the gastroenterologist’s recommendations from years ago, clinicians and patients can reassess the pros and cons of screening or surveillance based on current circumstances, Dr. Calderwood said.

“There should be lines of communication and systems of support to allow primary care providers to decide whether it is still needed,” she said.

While some may be ready to stop, other patients are going to continue to want and ask about CRC screening or surveillance, Dr. Rothberg said.

In these instances, communication style matters.

“You don’t want to tell a patient that they’re not going to be screened because they’re not going to live long enough to benefit,” Dr. Rothberg said.

However, steering people toward less invasive tests or telling them it’s important to give other health problems priority may be more sensitive ways to communicate that it’s time to ramp down or halt screening.

“Sometimes when you say you’re going to stop cancer screening, older adults misperceive that you’re giving up on them,” Dr. Gupta said. “We spend 30-40 years driving home the message that prevention and screening are important, and then it feels like we’re taking it away, so we need to find the best way to discuss it and make the choice that’s comfortable for them.”

Dr. Rothberg, Dr. Gupta, and Dr. Calderwood disclosed no relevant conflicts of interest.
 

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

 

Colonoscopy remains the gold standard method for detecting colorectal cancer (CRC) and removing precancerous polyps.

The recommended age for CRC screening in the United States spans 45-75 years, with the benefits of colonoscopy diminishing considerably after this point.

Older adults are much more likely to experience complications before, during, and after a colonoscopy. Bowel preps can cause dehydration or electrolyte problems in some, while bleeding and bowel perforation can occur perioperatively, and pulmonary or cardiovascular complications may arise postoperatively.

These risks often outweigh the benefits of catching a precancerous lesion or early-stage cancer, especially given the low rates of advanced neoplasia and CRC detected from screening and surveillance after age 75. Yet the research overall suggests that more than half of older individuals continue to receive screening and surveillance colonoscopies outside the recommended screening window.

So is there a point in time when a person is too old to receive a colonoscopy? The answer is not always clear-cut, but life expectancy should be a key consideration.

“Taking the most extreme example, if you have 6 months to live, finding early-stage cancer is not going to help you,” Michael B. Rothberg, MD, of Medical Institute and director of the Center for Value-Based Care Research, Cleveland Clinic, told this news organization.

For those with more time, the benefits of continued screening and surveillance may outweigh the risks, but when that balance shifts from helpful to not helpful remains inexact, Dr. Rothberg noted.
 

What’s Recommended?

In May 2021, the US Preventive Services Task Force (USPSTF) lowered the CRC screening threshold to age 45, recommending all adults aged between 45 and 75 years receive screening.

For those aged between 76 and 85 years, the USPSTF upheld its 2016 recommendation of selective screening, noting that the “net benefit of screening all persons in this age group is small” and should be determined on an individual basis. The USPSTF, however, did not provide recommendations on surveillance colonoscopies among those with previously identified polyps.

In November 2023, the American Gastroenterological Association (AGA) issued a clinical practice update that provided advice on risk stratification for CRC screening and post-polypectomy surveillance. For adults older than 75 years specifically, the AGA recommended that the decision to continue CRC screening or perform post-polypectomy surveillance be based on risks, benefits, comorbidities, and screening history and decided on a case-by-case basis.

For instance, previously unscreened patients without comorbidities could benefit from screening beyond age 75 — up to age 80 for men and 90 for women — while those who have had regular colonoscopies, per recommended guidelines, but severe comorbidities that may limit life expectancy could stop sooner, even by age 65.

Although an individualized approach leaves room for variation, it’s essential to consider life expectancy and the time it takes for a polyp to progress to CRC, as well as the risks associated with the procedure itself. Certain older adults are “less likely to live long enough to benefit from surveillance colonoscopy, due to competing, non-CRC mortality risks,” and clinicians should discuss these risks with their patients, the experts explained.
 

When to Stop Screening Colonoscopies

Research shows that screening colonoscopies continue well after the recommended stop age.

A 2023 JAMA Internal Medicine study found, for instance, that a large proportion of screening colonoscopies occurred among the 7067 patients who were 75 years and older with a life expectancy < 10 years. Overall, 30% of patients aged between 76 and 80 years with a limited life expectancy had a colonoscopy. That percentage increased to 71% for those aged 81-85 years and to 100% for those older than 85 years.

But the benefits of screening were minimal. Overall, colonoscopies detected advanced neoplasia in 5.4% of patients aged 76-80 years, 6.2% of those aged 81-85 years, and 9.5% of those older than 85 years. Only 15 patients (0.2%) had CRC detected via colonoscopy, five of whom underwent cancer treatment. Of those five, four had a life expectancy ≥ 10 years, and one had a life expectancy < 10 years.

At the same time, adverse events requiring hospitalization were common 10 days post-colonoscopy (13.58 per 1000), and the risk for hospitalization increased with age.

“For all kinds of screening, we’re not that comfortable in America with the idea that people are eventually going to die, but as you get older, the potential benefits for screening decrease,” study author Dr. Rothberg told this news organization.

In general, life expectancy provides a good predictor of whether people should continue screening or receive treatment following a CRC diagnosis.

Patients aged 76-80 years in good health, for instance, could benefit from screening and, potentially, treatment, Dr. Rothberg said. And “if doctors don’t feel comfortable or confident about predicting life expectancy, taking comorbid illnesses into account can be helpful, especially for that age range.”
 

Weighing Surveillance Benefits

Surveillance colonoscopy is often recommended post-polypectomy to reduce the risk for CRC. But even in this higher-risk population, those older than 75 years may not benefit.

Recent evidence indicates that those with a history of one or two adenomas less than 1 cm in size have only a slightly (1.3-fold) increased risk for incident CRC — and no significant increased risk for fatal CRC.

Another recent study found that detecting CRC at surveillance colonoscopy was rare among older adults. In surveillance colonoscopies performed among 9601 individuals aged 70-85 years with prior adenomas, 12% had advanced neoplasia detected, and only 0.3% had CRC detected.

Similar rates of advanced polyps (7.8%) or CRC (0.2%) were reported in another recent analysis of more than 9800 adults older than 65 years receiving surveillance colonoscopies.

Despite the low rates of polyp and CRC detection, nearly 90% of patients with recommendation information available received advice to return for a future colonoscopy. Even among patients with no polyps or small ones, almost 60% who had life expectancy of less than 5 years were told to return.

Although someone with prior adenomas has a higher risk for CRC, that doesn’t tell the whole story for an individual patient, Samir Gupta, MD, professor of gastroenterology at the University of California San Diego, and co-lead of the Cancer Control Program at Moores Cancer Center, told this news organization. For older adults, it’s vital to consider the competing risks and how much time it might take for CRC to develop.

At Digestive Disease Week in May, Dr. Gupta presented new research that looked at cumulative risk among patients aged 75 years and older with prior precancerous polyps vs prior normal colonoscopies. Although those with prior adenomas had a higher risk for CRC overall, their cumulative CRC risk was low — about 0.3% at 5 years and 0.8% at 10 years. Cumulative CRC deaths were even lower — 0.2% at 5 years and 0.7% at 10 years — while the risk of dying from something other than CRC was 20% at 5 years and 40% at 10 years.

“What this means to me is that patients who are 75 and older should think really carefully about whether they want to do surveillance,” said Dr. Gupta, who coauthored the AGA’s clinical practice update. “Someone who is very healthy and doesn’t have obvious medical problems can look at that risk for developing colon cancer and the risk of dying and make a decision about whether there’s enough concern to go ahead with surveillance.”

Those with competing health priorities, on other hand, should likely concentrate on those instead, he said, and feel reassured that even if they choose not to do surveillance, they’re probably not doing themselves any harm.

“The bottom line is that referring older adults or frail adults for surveillance colonoscopy shouldn’t be a rubber stamp or check-the-box action,” Dr. Gupta said. “We need to think about it carefully and give ourselves — as clinicians and patients — the room to decide that it may not need to take high priority.”
 

 

 

What to Tell Patients

Overall, older adults who have had prior colonoscopies, no or low-risk polyps, and low CRC risk will likely face greater risks from the procedure than benefits.

“The more invasive the screening the test, the more dangerous it could be,” Dr. Rothberg noted.

Many patients, however, are open to stopping and often trust their primary care provider in the decision-making process, said Audrey Calderwood, MD, director of the Comprehensive Gastroenterology Center at Dartmouth Hitchcock Medical Center. “But the systems we have in place don’t optimally support that decision-making at the time it matters most.”

For example, at a prior colonoscopy, a gastroenterologist may recommend surveillance again in 5-7 years. But in the interim, the patient could have new medications or develop comorbidities and other health issues. Rather than defer to the gastroenterologist’s recommendations from years ago, clinicians and patients can reassess the pros and cons of screening or surveillance based on current circumstances, Dr. Calderwood said.

“There should be lines of communication and systems of support to allow primary care providers to decide whether it is still needed,” she said.

While some may be ready to stop, other patients are going to continue to want and ask about CRC screening or surveillance, Dr. Rothberg said.

In these instances, communication style matters.

“You don’t want to tell a patient that they’re not going to be screened because they’re not going to live long enough to benefit,” Dr. Rothberg said.

However, steering people toward less invasive tests or telling them it’s important to give other health problems priority may be more sensitive ways to communicate that it’s time to ramp down or halt screening.

“Sometimes when you say you’re going to stop cancer screening, older adults misperceive that you’re giving up on them,” Dr. Gupta said. “We spend 30-40 years driving home the message that prevention and screening are important, and then it feels like we’re taking it away, so we need to find the best way to discuss it and make the choice that’s comfortable for them.”

Dr. Rothberg, Dr. Gupta, and Dr. Calderwood disclosed no relevant conflicts of interest.
 

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

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Top-Down Treatment Appears Better for Patients With Crohn’s Disease

Article Type
Changed
Wed, 08/14/2024 - 11:56

Top-down treatment with a combination of infliximab and an immunomodulator should be adopted as the standard of care for most patients with newly diagnosed active Crohn’s disease, according to a recent study.

Top-down treatment achieved substantially better outcomes at one year after diagnosis than step-up treatment, with nearly 80% of those receiving top-down therapy having both symptoms and inflammatory markers controlled, as compared with only 15% of those receiving accelerated step-up therapy.

professor of translational gastroenterology at the University of Cambridge (UK) and director of the National Institute for Health and Care Research (NIHR) Cambridge Biomedical Research Centre
NIHR Cambridge
Dr. Miles Parkes

“Up until now, the view has been: ‘Why would you use a more expensive treatment strategy and potentially overtreat people if there’s a chance they might do fine anyway?’ ” asked senior author Miles Parkes, MBBS, professor of translational gastroenterology at the University of Cambridge in England and director of the National Institute for Health and Care Research (NIHR) Cambridge Biomedical Research Centre.

“As we’ve shown, and as previous studies have demonstrated, there’s actually a pretty high risk that an individual with Crohn’s disease will experience disease flares and complications even in the first year after diagnosis,” he said. “We now know we can prevent the majority of adverse outcomes, including need for urgent surgery, by providing a treatment strategy that is safe and becoming increasingly affordable.”

The study was published in The Lancet Gastroenterology & Hepatology.
 

Comparing Treatments

Dr. Parkes and colleagues conducted a multicenter, open-label, biomarker-stratified randomized controlled trial among adults with newly diagnosed active Crohn’s disease. Participants were tested for a prognostic biomarker derived from T-cell transcriptional signatures and randomly assigned to a top-down or accelerated step-up treatment based on biomarker subgroup, endoscopic inflammation (mild, moderate, or severe), and extent (colonic or other).

The primary endpoint was sustained steroid-free and surgery-free remission after completing a steroid induction (maximum 8-week course) to week 48. Remission was defined by a composite of symptoms and inflammatory markers at all visits, with a Harvey-Bradshaw Index (HBI) score of less than 5 or resolved inflammatory markers or both, while a flare was defined as active symptoms (HBI ≥ 5) and raised inflammatory markers.

Across 40 UK hospitals, 386 patients (mean age, 33.6 years; 54% male) were randomized, with 193 receiving a top-down therapy of combination intravenous infliximab plus immunomodulator (azathioprine, low-dose mercaptopurine with allopurinol, or methotrexate) and 193 receiving an accelerated step-up therapy of an immunomodulator and then infliximab if further flares occurred after the steroid course. In the step-up group, 85% required escalation to an immunomodulator, and 41% required infliximab by week 48.

Overall, sustained steroid-free and surgery-free remission was significantly more frequent in the top-down group than in the accelerated step-up group (among 149 of 189 patients vs 29 of 190 patients), at 79% vs 15%, marking an absolute difference of 64 percentage points.

Top-down treatment also showed greater efficacy in achieving endoscopic remission (67% vs 44%), improved quality of life, lower need for steroids, and reduced number of flares requiring treatment escalation.

In addition, there were fewer adverse events (168 vs 315) and fewer serious adverse events (15 vs 42) in the top-down group than in the step-up group. There were also fewer complications that required urgent abdominal surgery, with one in the top-down group for gallstone ileus and nine in the step-up group requiring intestinal resection for structuring or fistulating complications.

However, the biomarker showed no clinical utility, and none of the baseline measurements predicted which patients were at risk of adverse outcomes with the step-up approach, Dr. Parkes said.

“The key message is that Crohn’s is unpredictable, hence you are better off treating everyone who has significant disease at diagnosis with combo therapy (anti-TNF [tumor necrosis factor] plus immunomodulator) rather than ‘wait and see,’ as bad things happen to people with uncontrolled inflammation during that ‘wait and see’ stage,” he said.
 

 

 

Additional Considerations

In the PROFILE trial, the need for a prognostic biomarker was based on the lack of an effective, safe, and affordable treatment strategy for newly diagnosed patients, the study authors wrote, but effective top-down management could reduce the need for a biomarker.

McMaster University, Ontario, Canada and staff gastroenterologist at Hamilton Health Sciences
McMaster University
Dr. Neeraj Narula

“In one sense, this is a negative study as the blood-based CD8+ T-cell transcriptomic biomarker that was being studied was not predictive of outcomes at all. But PROFILE makes it very clear that early effective therapy leads to better outcomes than accelerated step-up therapy,” said Neeraj Narula, MD, associate professor of medicine at McMaster University, Hamilton, Ontario, Canada, and staff gastroenterologist focused on inflammatory bowel disease at Hamilton Health Sciences.

Dr. Narula, who wasn’t involved with this study, has researched the comparative effectiveness of biologics for endoscopic healing of the ileum and colon in Crohn’s disease. He and colleagues found that anti-TNF biologics were effective in achieving 1-year endoscopic healing in moderate to severe Crohn’s disease.

“These findings likely aren’t specific to infliximab/azathioprine, and I suspect similar outcomes would be shown for other advanced therapies used early in the course of disease,” he said. “There does remain a concern that using this strategy for all patients may lead to overtreatment of some, but perhaps any harm done by overtreatment of a minority may be offset by the harm resulting from undertreatment of the majority. It’s hard to say for sure, but it certainly gives us some food for thought.”

The study was funded by Wellcome and PredictImmune and jointly sponsored by the University of Cambridge and Cambridge University Hospitals NHS Foundation Trust. Dr. Parkes and several authors declared fees and grants from numerous companies outside of this study. Dr. Narula reported no relevant disclosures.

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Top-down treatment with a combination of infliximab and an immunomodulator should be adopted as the standard of care for most patients with newly diagnosed active Crohn’s disease, according to a recent study.

Top-down treatment achieved substantially better outcomes at one year after diagnosis than step-up treatment, with nearly 80% of those receiving top-down therapy having both symptoms and inflammatory markers controlled, as compared with only 15% of those receiving accelerated step-up therapy.

professor of translational gastroenterology at the University of Cambridge (UK) and director of the National Institute for Health and Care Research (NIHR) Cambridge Biomedical Research Centre
NIHR Cambridge
Dr. Miles Parkes

“Up until now, the view has been: ‘Why would you use a more expensive treatment strategy and potentially overtreat people if there’s a chance they might do fine anyway?’ ” asked senior author Miles Parkes, MBBS, professor of translational gastroenterology at the University of Cambridge in England and director of the National Institute for Health and Care Research (NIHR) Cambridge Biomedical Research Centre.

“As we’ve shown, and as previous studies have demonstrated, there’s actually a pretty high risk that an individual with Crohn’s disease will experience disease flares and complications even in the first year after diagnosis,” he said. “We now know we can prevent the majority of adverse outcomes, including need for urgent surgery, by providing a treatment strategy that is safe and becoming increasingly affordable.”

The study was published in The Lancet Gastroenterology & Hepatology.
 

Comparing Treatments

Dr. Parkes and colleagues conducted a multicenter, open-label, biomarker-stratified randomized controlled trial among adults with newly diagnosed active Crohn’s disease. Participants were tested for a prognostic biomarker derived from T-cell transcriptional signatures and randomly assigned to a top-down or accelerated step-up treatment based on biomarker subgroup, endoscopic inflammation (mild, moderate, or severe), and extent (colonic or other).

The primary endpoint was sustained steroid-free and surgery-free remission after completing a steroid induction (maximum 8-week course) to week 48. Remission was defined by a composite of symptoms and inflammatory markers at all visits, with a Harvey-Bradshaw Index (HBI) score of less than 5 or resolved inflammatory markers or both, while a flare was defined as active symptoms (HBI ≥ 5) and raised inflammatory markers.

Across 40 UK hospitals, 386 patients (mean age, 33.6 years; 54% male) were randomized, with 193 receiving a top-down therapy of combination intravenous infliximab plus immunomodulator (azathioprine, low-dose mercaptopurine with allopurinol, or methotrexate) and 193 receiving an accelerated step-up therapy of an immunomodulator and then infliximab if further flares occurred after the steroid course. In the step-up group, 85% required escalation to an immunomodulator, and 41% required infliximab by week 48.

Overall, sustained steroid-free and surgery-free remission was significantly more frequent in the top-down group than in the accelerated step-up group (among 149 of 189 patients vs 29 of 190 patients), at 79% vs 15%, marking an absolute difference of 64 percentage points.

Top-down treatment also showed greater efficacy in achieving endoscopic remission (67% vs 44%), improved quality of life, lower need for steroids, and reduced number of flares requiring treatment escalation.

In addition, there were fewer adverse events (168 vs 315) and fewer serious adverse events (15 vs 42) in the top-down group than in the step-up group. There were also fewer complications that required urgent abdominal surgery, with one in the top-down group for gallstone ileus and nine in the step-up group requiring intestinal resection for structuring or fistulating complications.

However, the biomarker showed no clinical utility, and none of the baseline measurements predicted which patients were at risk of adverse outcomes with the step-up approach, Dr. Parkes said.

“The key message is that Crohn’s is unpredictable, hence you are better off treating everyone who has significant disease at diagnosis with combo therapy (anti-TNF [tumor necrosis factor] plus immunomodulator) rather than ‘wait and see,’ as bad things happen to people with uncontrolled inflammation during that ‘wait and see’ stage,” he said.
 

 

 

Additional Considerations

In the PROFILE trial, the need for a prognostic biomarker was based on the lack of an effective, safe, and affordable treatment strategy for newly diagnosed patients, the study authors wrote, but effective top-down management could reduce the need for a biomarker.

McMaster University, Ontario, Canada and staff gastroenterologist at Hamilton Health Sciences
McMaster University
Dr. Neeraj Narula

“In one sense, this is a negative study as the blood-based CD8+ T-cell transcriptomic biomarker that was being studied was not predictive of outcomes at all. But PROFILE makes it very clear that early effective therapy leads to better outcomes than accelerated step-up therapy,” said Neeraj Narula, MD, associate professor of medicine at McMaster University, Hamilton, Ontario, Canada, and staff gastroenterologist focused on inflammatory bowel disease at Hamilton Health Sciences.

Dr. Narula, who wasn’t involved with this study, has researched the comparative effectiveness of biologics for endoscopic healing of the ileum and colon in Crohn’s disease. He and colleagues found that anti-TNF biologics were effective in achieving 1-year endoscopic healing in moderate to severe Crohn’s disease.

“These findings likely aren’t specific to infliximab/azathioprine, and I suspect similar outcomes would be shown for other advanced therapies used early in the course of disease,” he said. “There does remain a concern that using this strategy for all patients may lead to overtreatment of some, but perhaps any harm done by overtreatment of a minority may be offset by the harm resulting from undertreatment of the majority. It’s hard to say for sure, but it certainly gives us some food for thought.”

The study was funded by Wellcome and PredictImmune and jointly sponsored by the University of Cambridge and Cambridge University Hospitals NHS Foundation Trust. Dr. Parkes and several authors declared fees and grants from numerous companies outside of this study. Dr. Narula reported no relevant disclosures.

Top-down treatment with a combination of infliximab and an immunomodulator should be adopted as the standard of care for most patients with newly diagnosed active Crohn’s disease, according to a recent study.

Top-down treatment achieved substantially better outcomes at one year after diagnosis than step-up treatment, with nearly 80% of those receiving top-down therapy having both symptoms and inflammatory markers controlled, as compared with only 15% of those receiving accelerated step-up therapy.

professor of translational gastroenterology at the University of Cambridge (UK) and director of the National Institute for Health and Care Research (NIHR) Cambridge Biomedical Research Centre
NIHR Cambridge
Dr. Miles Parkes

“Up until now, the view has been: ‘Why would you use a more expensive treatment strategy and potentially overtreat people if there’s a chance they might do fine anyway?’ ” asked senior author Miles Parkes, MBBS, professor of translational gastroenterology at the University of Cambridge in England and director of the National Institute for Health and Care Research (NIHR) Cambridge Biomedical Research Centre.

“As we’ve shown, and as previous studies have demonstrated, there’s actually a pretty high risk that an individual with Crohn’s disease will experience disease flares and complications even in the first year after diagnosis,” he said. “We now know we can prevent the majority of adverse outcomes, including need for urgent surgery, by providing a treatment strategy that is safe and becoming increasingly affordable.”

The study was published in The Lancet Gastroenterology & Hepatology.
 

Comparing Treatments

Dr. Parkes and colleagues conducted a multicenter, open-label, biomarker-stratified randomized controlled trial among adults with newly diagnosed active Crohn’s disease. Participants were tested for a prognostic biomarker derived from T-cell transcriptional signatures and randomly assigned to a top-down or accelerated step-up treatment based on biomarker subgroup, endoscopic inflammation (mild, moderate, or severe), and extent (colonic or other).

The primary endpoint was sustained steroid-free and surgery-free remission after completing a steroid induction (maximum 8-week course) to week 48. Remission was defined by a composite of symptoms and inflammatory markers at all visits, with a Harvey-Bradshaw Index (HBI) score of less than 5 or resolved inflammatory markers or both, while a flare was defined as active symptoms (HBI ≥ 5) and raised inflammatory markers.

Across 40 UK hospitals, 386 patients (mean age, 33.6 years; 54% male) were randomized, with 193 receiving a top-down therapy of combination intravenous infliximab plus immunomodulator (azathioprine, low-dose mercaptopurine with allopurinol, or methotrexate) and 193 receiving an accelerated step-up therapy of an immunomodulator and then infliximab if further flares occurred after the steroid course. In the step-up group, 85% required escalation to an immunomodulator, and 41% required infliximab by week 48.

Overall, sustained steroid-free and surgery-free remission was significantly more frequent in the top-down group than in the accelerated step-up group (among 149 of 189 patients vs 29 of 190 patients), at 79% vs 15%, marking an absolute difference of 64 percentage points.

Top-down treatment also showed greater efficacy in achieving endoscopic remission (67% vs 44%), improved quality of life, lower need for steroids, and reduced number of flares requiring treatment escalation.

In addition, there were fewer adverse events (168 vs 315) and fewer serious adverse events (15 vs 42) in the top-down group than in the step-up group. There were also fewer complications that required urgent abdominal surgery, with one in the top-down group for gallstone ileus and nine in the step-up group requiring intestinal resection for structuring or fistulating complications.

However, the biomarker showed no clinical utility, and none of the baseline measurements predicted which patients were at risk of adverse outcomes with the step-up approach, Dr. Parkes said.

“The key message is that Crohn’s is unpredictable, hence you are better off treating everyone who has significant disease at diagnosis with combo therapy (anti-TNF [tumor necrosis factor] plus immunomodulator) rather than ‘wait and see,’ as bad things happen to people with uncontrolled inflammation during that ‘wait and see’ stage,” he said.
 

 

 

Additional Considerations

In the PROFILE trial, the need for a prognostic biomarker was based on the lack of an effective, safe, and affordable treatment strategy for newly diagnosed patients, the study authors wrote, but effective top-down management could reduce the need for a biomarker.

McMaster University, Ontario, Canada and staff gastroenterologist at Hamilton Health Sciences
McMaster University
Dr. Neeraj Narula

“In one sense, this is a negative study as the blood-based CD8+ T-cell transcriptomic biomarker that was being studied was not predictive of outcomes at all. But PROFILE makes it very clear that early effective therapy leads to better outcomes than accelerated step-up therapy,” said Neeraj Narula, MD, associate professor of medicine at McMaster University, Hamilton, Ontario, Canada, and staff gastroenterologist focused on inflammatory bowel disease at Hamilton Health Sciences.

Dr. Narula, who wasn’t involved with this study, has researched the comparative effectiveness of biologics for endoscopic healing of the ileum and colon in Crohn’s disease. He and colleagues found that anti-TNF biologics were effective in achieving 1-year endoscopic healing in moderate to severe Crohn’s disease.

“These findings likely aren’t specific to infliximab/azathioprine, and I suspect similar outcomes would be shown for other advanced therapies used early in the course of disease,” he said. “There does remain a concern that using this strategy for all patients may lead to overtreatment of some, but perhaps any harm done by overtreatment of a minority may be offset by the harm resulting from undertreatment of the majority. It’s hard to say for sure, but it certainly gives us some food for thought.”

The study was funded by Wellcome and PredictImmune and jointly sponsored by the University of Cambridge and Cambridge University Hospitals NHS Foundation Trust. Dr. Parkes and several authors declared fees and grants from numerous companies outside of this study. Dr. Narula reported no relevant disclosures.

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Snare Tip Soft Coagulation Leaves Clean Margins After Resection

Article Type
Changed
Mon, 08/12/2024 - 11:33

After endoscopic mucosal resection (EMR), both snare tip soft coagulation (STSC) and argon plasma coagulation (APC) appear superior to no thermal margin treatment, according to a recent study.

Since STSC was faster to apply than APC and results in lower cost and plastic waste (because of APC requiring an additional catheter), STSC was the preferred option.

“The reduction in recurrence rate with thermal margin treatment is arguably the most important development in endoscopic mucosal resection in the past 2 decades,” said lead author Douglas Rex, MD, AGAF, a distinguished professor emeritus at the Indiana University School of Medicine and director of endoscopy at Indiana University Hospitals, both in Indianapolis.

Dr. Douglas K. Rex, emeritus professor of medicine, Indiana University School of Medicine, Indianapolis
Dr. Douglas K. Rex

“Margin thermal therapy with STSC should now be standard treatment after piecemeal EMR in the colorectum,” he said. “Before applying STSC, the endoscopist must ensure that the entire lesion is resected down to the submucosa. Then STSC should be aggressively applied to 100% of the margin.”

The study was published in Clinical Gastroenterology and Hepatology .
 

Comparing Treatments

Dr. Rex and colleagues performed a randomized three-arm trial in nine U.S. centers, comparing STSC with APC and no margin treatment in patients undergoing colorectal EMR of nonpedunculated lesions of 15 mm or greater.

All lesions underwent conventional injection and snare resection EMR using electrocautery, but the endoscopist chose the injection fluid and snare type and size. Areas with residual polyp that weren’t removable by snare resection because of flat shape or fibrosis were removed by hot or cold avulsion. After that, patients were randomized to one of the three arms.

Patients were scheduled for a follow-up appointment six months after the initial EMR. Any visible recurrence was resected using methods at the discretion of the endoscopist, and if no visible recurrence was present, EMR site biopsies were recommended.

Among 384 patients with 414 lesions, 308 patients with 328 lesions completed at least one follow-up appointment. The median interval to the first follow-up was 6.4 months, ranging from 2 to 37 months. The primary endpoint was the presence of recurrent or residual polyp at first follow-up.

The median polyp size was 25 mm, and 65 of the 414 polyps (15.7%) were 15-19 mm in size. Overall, 14.8% of lesions were resected en bloc, with no difference between the study arms.

The proportion of lesions with residual polyp at first follow-up was 4.6% with STSC, 9.3% with APC, and 21.4% among control subjects with no margin treatment.

The odds of having a residual polyp at first follow-up were lower for STSC and APC when compared with control subjects (odds ratio [OR] of 0.182 and 0.341, or P = .001 and P = .01, respectively). There wasn’t a significant difference in the odds of recurrence between STSC and APC (OR, 1.874).

In 259 lesions in 248 patients that were 20 mm or greater, the recurrence rates at first follow-up were 5.9% for STSC, 10.1% for APC, and 25.9% for the control group. In these lesions, STSC and APC remained associated with a lower risk of recurrence versus the control (OR, 0.18 and 0.323, respectively). The difference in recurrence rates between STSC and APC wasn’t significant.

Even still, STSC took less time to apply than APC, with a median time of 3.35 minutes vs 4.08 minutes.

The rates of adverse events were low, with no difference between the three arms. There were no immediate or delayed perforations in any arm, and the overall occurrence of delayed bleeding was low at 3.6%.

“I think STSC won the trial because it was numerically (though not statistically) superior to APC, was faster to apply, and using STSC results in lower cost and less plastic compared to APC,” Dr. Rex said.
 

 

 

Additional Considerations

Based on charges at the nine U.S. centers and a survey of two manufacturers, APC catheters typically cost $175-$275 each, the study authors wrote, noting that APC results in increased cost, plastic waste because of the catheter, and carbon emissions associated with its manufacture.

Dr. Michael B. Wallace
Dr. Michael B. Wallace

“What we’re seeing — now over several trials — is STSC appears to be the most effective method of treating the edges, and it’s inexpensive because it uses the same device used for snare resection, so there’s no incremental cost for the device,” said Michael Wallace, MD, professor of medicine and director of the digestive diseases research program at Mayo Clinic, Jacksonville, Florida.

Dr. Wallace, who wasn’t involved with this study, has researched thermal ablation after EMR, including both the margins and the base.

“The single most important message now is that patients shouldn’t be getting surgical resections for endoscopically treatable polyps,” he said. “We see many patients who are told they need to get surgery, but overwhelmingly, the data shows we can remove polyps without surgery.”

Dr. Rex and several authors declared fees and grants from numerous companies outside of this study. Dr. Wallace reported no relevant disclosures.

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After endoscopic mucosal resection (EMR), both snare tip soft coagulation (STSC) and argon plasma coagulation (APC) appear superior to no thermal margin treatment, according to a recent study.

Since STSC was faster to apply than APC and results in lower cost and plastic waste (because of APC requiring an additional catheter), STSC was the preferred option.

“The reduction in recurrence rate with thermal margin treatment is arguably the most important development in endoscopic mucosal resection in the past 2 decades,” said lead author Douglas Rex, MD, AGAF, a distinguished professor emeritus at the Indiana University School of Medicine and director of endoscopy at Indiana University Hospitals, both in Indianapolis.

Dr. Douglas K. Rex, emeritus professor of medicine, Indiana University School of Medicine, Indianapolis
Dr. Douglas K. Rex

“Margin thermal therapy with STSC should now be standard treatment after piecemeal EMR in the colorectum,” he said. “Before applying STSC, the endoscopist must ensure that the entire lesion is resected down to the submucosa. Then STSC should be aggressively applied to 100% of the margin.”

The study was published in Clinical Gastroenterology and Hepatology .
 

Comparing Treatments

Dr. Rex and colleagues performed a randomized three-arm trial in nine U.S. centers, comparing STSC with APC and no margin treatment in patients undergoing colorectal EMR of nonpedunculated lesions of 15 mm or greater.

All lesions underwent conventional injection and snare resection EMR using electrocautery, but the endoscopist chose the injection fluid and snare type and size. Areas with residual polyp that weren’t removable by snare resection because of flat shape or fibrosis were removed by hot or cold avulsion. After that, patients were randomized to one of the three arms.

Patients were scheduled for a follow-up appointment six months after the initial EMR. Any visible recurrence was resected using methods at the discretion of the endoscopist, and if no visible recurrence was present, EMR site biopsies were recommended.

Among 384 patients with 414 lesions, 308 patients with 328 lesions completed at least one follow-up appointment. The median interval to the first follow-up was 6.4 months, ranging from 2 to 37 months. The primary endpoint was the presence of recurrent or residual polyp at first follow-up.

The median polyp size was 25 mm, and 65 of the 414 polyps (15.7%) were 15-19 mm in size. Overall, 14.8% of lesions were resected en bloc, with no difference between the study arms.

The proportion of lesions with residual polyp at first follow-up was 4.6% with STSC, 9.3% with APC, and 21.4% among control subjects with no margin treatment.

The odds of having a residual polyp at first follow-up were lower for STSC and APC when compared with control subjects (odds ratio [OR] of 0.182 and 0.341, or P = .001 and P = .01, respectively). There wasn’t a significant difference in the odds of recurrence between STSC and APC (OR, 1.874).

In 259 lesions in 248 patients that were 20 mm or greater, the recurrence rates at first follow-up were 5.9% for STSC, 10.1% for APC, and 25.9% for the control group. In these lesions, STSC and APC remained associated with a lower risk of recurrence versus the control (OR, 0.18 and 0.323, respectively). The difference in recurrence rates between STSC and APC wasn’t significant.

Even still, STSC took less time to apply than APC, with a median time of 3.35 minutes vs 4.08 minutes.

The rates of adverse events were low, with no difference between the three arms. There were no immediate or delayed perforations in any arm, and the overall occurrence of delayed bleeding was low at 3.6%.

“I think STSC won the trial because it was numerically (though not statistically) superior to APC, was faster to apply, and using STSC results in lower cost and less plastic compared to APC,” Dr. Rex said.
 

 

 

Additional Considerations

Based on charges at the nine U.S. centers and a survey of two manufacturers, APC catheters typically cost $175-$275 each, the study authors wrote, noting that APC results in increased cost, plastic waste because of the catheter, and carbon emissions associated with its manufacture.

Dr. Michael B. Wallace
Dr. Michael B. Wallace

“What we’re seeing — now over several trials — is STSC appears to be the most effective method of treating the edges, and it’s inexpensive because it uses the same device used for snare resection, so there’s no incremental cost for the device,” said Michael Wallace, MD, professor of medicine and director of the digestive diseases research program at Mayo Clinic, Jacksonville, Florida.

Dr. Wallace, who wasn’t involved with this study, has researched thermal ablation after EMR, including both the margins and the base.

“The single most important message now is that patients shouldn’t be getting surgical resections for endoscopically treatable polyps,” he said. “We see many patients who are told they need to get surgery, but overwhelmingly, the data shows we can remove polyps without surgery.”

Dr. Rex and several authors declared fees and grants from numerous companies outside of this study. Dr. Wallace reported no relevant disclosures.

After endoscopic mucosal resection (EMR), both snare tip soft coagulation (STSC) and argon plasma coagulation (APC) appear superior to no thermal margin treatment, according to a recent study.

Since STSC was faster to apply than APC and results in lower cost and plastic waste (because of APC requiring an additional catheter), STSC was the preferred option.

“The reduction in recurrence rate with thermal margin treatment is arguably the most important development in endoscopic mucosal resection in the past 2 decades,” said lead author Douglas Rex, MD, AGAF, a distinguished professor emeritus at the Indiana University School of Medicine and director of endoscopy at Indiana University Hospitals, both in Indianapolis.

Dr. Douglas K. Rex, emeritus professor of medicine, Indiana University School of Medicine, Indianapolis
Dr. Douglas K. Rex

“Margin thermal therapy with STSC should now be standard treatment after piecemeal EMR in the colorectum,” he said. “Before applying STSC, the endoscopist must ensure that the entire lesion is resected down to the submucosa. Then STSC should be aggressively applied to 100% of the margin.”

The study was published in Clinical Gastroenterology and Hepatology .
 

Comparing Treatments

Dr. Rex and colleagues performed a randomized three-arm trial in nine U.S. centers, comparing STSC with APC and no margin treatment in patients undergoing colorectal EMR of nonpedunculated lesions of 15 mm or greater.

All lesions underwent conventional injection and snare resection EMR using electrocautery, but the endoscopist chose the injection fluid and snare type and size. Areas with residual polyp that weren’t removable by snare resection because of flat shape or fibrosis were removed by hot or cold avulsion. After that, patients were randomized to one of the three arms.

Patients were scheduled for a follow-up appointment six months after the initial EMR. Any visible recurrence was resected using methods at the discretion of the endoscopist, and if no visible recurrence was present, EMR site biopsies were recommended.

Among 384 patients with 414 lesions, 308 patients with 328 lesions completed at least one follow-up appointment. The median interval to the first follow-up was 6.4 months, ranging from 2 to 37 months. The primary endpoint was the presence of recurrent or residual polyp at first follow-up.

The median polyp size was 25 mm, and 65 of the 414 polyps (15.7%) were 15-19 mm in size. Overall, 14.8% of lesions were resected en bloc, with no difference between the study arms.

The proportion of lesions with residual polyp at first follow-up was 4.6% with STSC, 9.3% with APC, and 21.4% among control subjects with no margin treatment.

The odds of having a residual polyp at first follow-up were lower for STSC and APC when compared with control subjects (odds ratio [OR] of 0.182 and 0.341, or P = .001 and P = .01, respectively). There wasn’t a significant difference in the odds of recurrence between STSC and APC (OR, 1.874).

In 259 lesions in 248 patients that were 20 mm or greater, the recurrence rates at first follow-up were 5.9% for STSC, 10.1% for APC, and 25.9% for the control group. In these lesions, STSC and APC remained associated with a lower risk of recurrence versus the control (OR, 0.18 and 0.323, respectively). The difference in recurrence rates between STSC and APC wasn’t significant.

Even still, STSC took less time to apply than APC, with a median time of 3.35 minutes vs 4.08 minutes.

The rates of adverse events were low, with no difference between the three arms. There were no immediate or delayed perforations in any arm, and the overall occurrence of delayed bleeding was low at 3.6%.

“I think STSC won the trial because it was numerically (though not statistically) superior to APC, was faster to apply, and using STSC results in lower cost and less plastic compared to APC,” Dr. Rex said.
 

 

 

Additional Considerations

Based on charges at the nine U.S. centers and a survey of two manufacturers, APC catheters typically cost $175-$275 each, the study authors wrote, noting that APC results in increased cost, plastic waste because of the catheter, and carbon emissions associated with its manufacture.

Dr. Michael B. Wallace
Dr. Michael B. Wallace

“What we’re seeing — now over several trials — is STSC appears to be the most effective method of treating the edges, and it’s inexpensive because it uses the same device used for snare resection, so there’s no incremental cost for the device,” said Michael Wallace, MD, professor of medicine and director of the digestive diseases research program at Mayo Clinic, Jacksonville, Florida.

Dr. Wallace, who wasn’t involved with this study, has researched thermal ablation after EMR, including both the margins and the base.

“The single most important message now is that patients shouldn’t be getting surgical resections for endoscopically treatable polyps,” he said. “We see many patients who are told they need to get surgery, but overwhelmingly, the data shows we can remove polyps without surgery.”

Dr. Rex and several authors declared fees and grants from numerous companies outside of this study. Dr. Wallace reported no relevant disclosures.

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Gastroenterologists Can Play a Critical Role in Obesity Management

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Mon, 08/12/2024 - 10:15

As the prevalence of obesity grows in the United States and worldwide, more solutions are needed at more levels of care to help patients, according to a series of presentations during the American Gastroenterological Association (AGA) Postgraduate Course held at Digestive Disease Week® (DDW) in May.

Gastroenterologists can step up as part of a multidisciplinary response to provide treatment — with a range of lifestyle interventions, pharmacological options, and bariatric endoscopic possibilities — based on a patient’s needs and preferences.

Dr. Andres J. Acosta of the Mayo Clinic
Dr. Andres J. Acosta

“Obesity is in our clinics. We’re usually the first line of obesity, and that’s why we need to know it, learn how to manage it, and understand the complications,” said Andres Acosta, MD, an associate professor of medicine and gastroenterologist at Mayo Clinic, Rochester, Minnesota, and principal investigator of Mayo’s Precision Medicine for Obesity Laboratory.

Obesity tops the charts as the most significant chronic disease in the world, affecting 130 million patients in the United States and 1 billion globally, he said, and those numbers will only climb higher in coming years. By 2030, the United States is projected to have an obesity prevalence of 50% and overweight prevalence of 80%, with every state having a prevalence greater than 35%.

The alarming prevalence rates matter not because of aesthetics or personal preference, he noted, but because of the major associations with premature death, cardiovascular disease, stroke, type 2 diabetes, numerous cancers, and 280 other diseases.

“Choose the organ you like, and obesity is a major contributor to its most important disease,” Dr. Acosta said. “Obesity affects every single disease and every single organ in the gastrointestinal system, so it’s essential that we actually manage this.”

Based on current recommendations focused on body mass index (BMI), diet, exercise, and behavioral therapy are suggested for a BMI of 25 or higher, followed by pharmacotherapy for a BMI greater than 27 with comorbidities, endoscopic procedures for a BMI greater than 30, and surgical options for a BMI greater than 40 or BMI greater than 30 with comorbidities. At each step, clinicians can start shared decision-making conversations with patients about the best options for them.

“We’re moving from a pyramid approach where we tell patients to choose one intervention toward multidisciplinary programs where we offer interventions in combination,” Dr. Acosta said, recommending AGA’s POWER - Practice Guide on Obesity and Weight Management Education and Resources . Other AGA resources for physicians treating patients with obesity include the AGA Clinical Practice Guideline on Pharmacological Interventions for Adults With Obesity , and the Obesity Resource Center on the AGA website .
 

Progress in Pharmacotherapy

In recent years, developments focused on glucagon-like peptide 1 (GLP-1) receptor agonists, such as semaglutide and tirzepatide, have “changed the conversation about obesity,” Dr. Acosta said. For the first time, medications not only reduce weight but also cardiovascular disease risks, which were previously only observed with bariatric surgery.

Additional GLP-1 options are in research pipelines. During the next 3 years, for instance, more medications will focus on how the gut signals to the brain through intestinal hormones, targeting GLP-1, glucose-dependent insulinotropic polypeptide, and other receptors. Leading the pipeline, Eli Lilly’s retatrutide shows promise, with weight loss and comorbidity improvement reported similar to or better than tirzepatide. Additional data from phase 3 trials are forthcoming.

In clinical practice, major conversations remain about gastrointestinal side effects, particularly gastroparesis, that may pose a risk for aspiration in upper endoscopy. Gastroenterologists should feel comfortable about managing these types of side effects when starting patients on these medications, Dr. Acosta said, but also continue to ask questions about side effects and the latest research developments.

Of course, major obstacles remain regarding patient access, insurance coverage, cost-effective options, and heterogeneous patient responses. At the Mayo Clinic, Dr. Acosta and colleagues are researching and targeting obesity phenotypes — such as the “hungry gut” or “hungry brain” — to improve weight loss outcomes and patient adherence.

Ultimately, he said, the most important obstacle is our healthcare system. “We cannot afford to manage obesity with expensive procedures or expensive medications.”
 

 

 

Efficacy of Endobariatrics

For patients with a BMI of 30 or higher, minimally invasive bariatric endoscopic procedures can lead to weight loss, improvement in metabolic outcomes, and fewer adverse events compared to bariatric surgery, said Violeta Popov, MD, director of bariatric endoscopy at the New York Veterans Affairs Harbor Healthcare System in New York City.

Dr. Violeta Popov, VA New York Harbor Healthcare System, and assistant professor of medicine at New York University
Dr. Violeta Popov

For example, intragastric balloons — marketed under the names Orbera and Spatz — work by altering the rate of gastric emptying. They’re placed temporarily and removed after several months, and Spatz can be adjusted while in place, either by removing or adding volume if needed. Data show that associated weight loss can lead to improvements in insulin resistance, visceral obesity, dyslipidemia, high blood pressure, liver enzymes, metabolic dysfunction–associated steatotic liver disease (MASLD), and metabolic dysfunction–associated steatohepatitis (MASH).

Although the majority of patients undergoing minimally invasive procedures do experience adverse events such as nausea and vomiting, symptoms tend to subside in the first few weeks, Dr. Popov said. At the same time, gastroesophageal reflux disease (GERD) can worsen in patients who have experienced it, so proton pump inhibitors are recommended for as long as the balloon is inserted.

Endoscopic sleeve gastroplasty has become the most prevalent endobariatric method in Dr. Popov’s practice during the past few years. The procedure uses full thickness sutures placed with an endoscopic suturing device called OverStitch, to decrease the size of the opening into the stomach. In previous trials, patients lost up to 40 pounds, and more than 80% maintained the lost weight up to 5 years. The procedure, which showed no worsening of GERD, works by preserving gastric contractility while delaying gastric emptying.

Dr. Popov noted one of the main challenges is training and credentialing, with many patients not having access to those who can perform these procedures. As a diplomate of the American Board of Obesity Medicine, Dr. Popov highlighted the need for bariatric endoscopy fellowships or training during GI fellowships, post-fellowship hands-on courses, and competency training with simulators.

“It’s not just technical competency in performing a procedure — it’s also the administrative work of setting up a multidisciplinary program,” she said. “It’s very important to understand obesity as a disease and learn how to manage it.”
 

Monitoring MASLD

Linked strongly to insulin resistance, MASLD prevalence is increasing worldwide as obesity increases, reaching 30% in the United States and even higher among certain patient populations, said Sonali Paul, MD, an assistant professor of medicine and hepatologist at the Center for Liver Diseases at the University of Chicago Medicine in Illinois.

Sonali Paul, MD, transplant hepatologist with the University of Chicago Medicine
University of Chicago
Dr. Sonali Paul

The good news is that the associations between MASLD and obesity also move the other way — if patients lose weight and improve cardiovascular risk factors, MASLD can improve as well. Notably, steatosis can disappear at 3% weight loss, inflammation decreases at 5% weight loss, MASH resolution occurs at 7% weight loss, and fibrosis improves at 10% weight loss.

Primarily, Dr. Paul and colleagues have focused on lifestyle interventions, especially diet, by working carefully with dietitians. A modified Mediterranean diet with olive oil and monounsaturated fats can decrease steatosis on MRI, as compared with a high-fat/low-carb diet, and it also appears to decrease mortality, cardiovascular disease, and obesity. As part of the modified diet, carbohydrates are limited to 30 grams per meal per day.

“We really want to tailor the diet to cultural and personal preferences,” she said. “I’m South Asian, and when I tell my South Asian patients not to eat rice, they don’t love that, so we work with them to meet them where they are.”

Dr. Paul recommends physical activity interventions, proper sleep hygiene, treatment of obstructive sleep apnea, pharmacological options, and bariatric solutions to reduce weight, improve insulin resistance, and target MASLD risk factors. For instance, recent phase 2b studies indicate semaglutide can lead to MASH resolution, with phase 3 trial data expected by the end of 2024.

In addition, resmetirom, a liver-directed thyroid hormone receptor beta selective agonist — the first Food and Drug Administration–approved drug for MASH — achieved both primary endpoints of MASH resolution and fibrosis improvement. American Association for the Study of Liver Diseases guidelines are forthcoming about who should use the drug, Dr. Paul said.

“In terms of the paradigm that I think about with MASLD, we want to target other causes and diagnose advanced fibrosis, treat risk factors, and target MASH through treatment,” she said.
 

 

 

Considering the Community Perspective

Community-based clinicians face a unique set of challenges when addressing obesity through a multidisciplinary approach and longitudinal care, but it remains vital as more practices see increased patient loads with obesity-related GI comorbidities, said Pooja Singhal, MD, assistant professor of medicine at the University of Oklahoma Health Sciences Center, Oklahoma City, and founder/president of Oklahoma Gastro Health and Wellness.

University of Oklahoma Health Sciences Center and Oklahoma Gastro Health and Wellness, Oklahoma City
Oklahoma Gastro Health and Wellness
Dr. Pooja Singhal

Dr. Singhal noted obesity-related associations with earlier presentations of GERD, elevated liver enzymes, MASLD, MASH, IBS, IBD, gallbladder disease, colon polyps, and GI cancers.

“Gastroenterologists, as most of us are board-certified internists, are in a unique position to offer both pharmacotherapy and endoscopic treatment,” she said. “The GI comorbidities provide an opportunity for early intervention, and we’re seeing a lot of side effects of antiobesity medications, so whether we like it or not, we are involved.”

The best practices at the community level start with a patient-centric approach, Dr. Singhal said. Although clinicians are already time constrained and focused on addressing GI-related comorbidities, using the 5A’s framework can help:

  • Asking if the patient is ready to talk
  • Assessing for factors contributing to obesity
  • Advising them of treatment options
  • Agreeing on goals based on shared decision-making
  • Assisting or Arranging the agreed-on plan.

During the assessment phase, Dr. Singhal suggested not only looking at medical and physical values but also secondary causes of weight gain, including the patient’s relationship with food, micronutrient deficiencies, psychosocial concerns, body image disorders, and triggers for eating.

During the advising phase, clinicians should consider multiple targets — such as diet, physical activity, and behavior — with a supervised and structured approach. Dr. Singhal and colleagues include a meal plan, aerobic activity, resistance training, behavior modification of eating habits, sleep hygiene, and patient self-monitoring through smartphone apps and wearables. Pharmacotherapy may be relevant and effective for some patients but less accessible for many, she noted.

Above all, Dr. Singhal recommended training through the American Board of Obesity Medicine, major GI society guidelines and conferences, American Society for Gastrointestinal Endoscopy STAR courses, and connecting with a multidisciplinary team of dietitians, coaches, physical therapists, and other GI specialists when possible.

“Most importantly, we’re dealing with decades of stigma and bias around this disease, where ‘you are what you eat,’ ” she said. “This mentality of ‘I can lose weight without help’ is a real challenge.”

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As the prevalence of obesity grows in the United States and worldwide, more solutions are needed at more levels of care to help patients, according to a series of presentations during the American Gastroenterological Association (AGA) Postgraduate Course held at Digestive Disease Week® (DDW) in May.

Gastroenterologists can step up as part of a multidisciplinary response to provide treatment — with a range of lifestyle interventions, pharmacological options, and bariatric endoscopic possibilities — based on a patient’s needs and preferences.

Dr. Andres J. Acosta of the Mayo Clinic
Dr. Andres J. Acosta

“Obesity is in our clinics. We’re usually the first line of obesity, and that’s why we need to know it, learn how to manage it, and understand the complications,” said Andres Acosta, MD, an associate professor of medicine and gastroenterologist at Mayo Clinic, Rochester, Minnesota, and principal investigator of Mayo’s Precision Medicine for Obesity Laboratory.

Obesity tops the charts as the most significant chronic disease in the world, affecting 130 million patients in the United States and 1 billion globally, he said, and those numbers will only climb higher in coming years. By 2030, the United States is projected to have an obesity prevalence of 50% and overweight prevalence of 80%, with every state having a prevalence greater than 35%.

The alarming prevalence rates matter not because of aesthetics or personal preference, he noted, but because of the major associations with premature death, cardiovascular disease, stroke, type 2 diabetes, numerous cancers, and 280 other diseases.

“Choose the organ you like, and obesity is a major contributor to its most important disease,” Dr. Acosta said. “Obesity affects every single disease and every single organ in the gastrointestinal system, so it’s essential that we actually manage this.”

Based on current recommendations focused on body mass index (BMI), diet, exercise, and behavioral therapy are suggested for a BMI of 25 or higher, followed by pharmacotherapy for a BMI greater than 27 with comorbidities, endoscopic procedures for a BMI greater than 30, and surgical options for a BMI greater than 40 or BMI greater than 30 with comorbidities. At each step, clinicians can start shared decision-making conversations with patients about the best options for them.

“We’re moving from a pyramid approach where we tell patients to choose one intervention toward multidisciplinary programs where we offer interventions in combination,” Dr. Acosta said, recommending AGA’s POWER - Practice Guide on Obesity and Weight Management Education and Resources . Other AGA resources for physicians treating patients with obesity include the AGA Clinical Practice Guideline on Pharmacological Interventions for Adults With Obesity , and the Obesity Resource Center on the AGA website .
 

Progress in Pharmacotherapy

In recent years, developments focused on glucagon-like peptide 1 (GLP-1) receptor agonists, such as semaglutide and tirzepatide, have “changed the conversation about obesity,” Dr. Acosta said. For the first time, medications not only reduce weight but also cardiovascular disease risks, which were previously only observed with bariatric surgery.

Additional GLP-1 options are in research pipelines. During the next 3 years, for instance, more medications will focus on how the gut signals to the brain through intestinal hormones, targeting GLP-1, glucose-dependent insulinotropic polypeptide, and other receptors. Leading the pipeline, Eli Lilly’s retatrutide shows promise, with weight loss and comorbidity improvement reported similar to or better than tirzepatide. Additional data from phase 3 trials are forthcoming.

In clinical practice, major conversations remain about gastrointestinal side effects, particularly gastroparesis, that may pose a risk for aspiration in upper endoscopy. Gastroenterologists should feel comfortable about managing these types of side effects when starting patients on these medications, Dr. Acosta said, but also continue to ask questions about side effects and the latest research developments.

Of course, major obstacles remain regarding patient access, insurance coverage, cost-effective options, and heterogeneous patient responses. At the Mayo Clinic, Dr. Acosta and colleagues are researching and targeting obesity phenotypes — such as the “hungry gut” or “hungry brain” — to improve weight loss outcomes and patient adherence.

Ultimately, he said, the most important obstacle is our healthcare system. “We cannot afford to manage obesity with expensive procedures or expensive medications.”
 

 

 

Efficacy of Endobariatrics

For patients with a BMI of 30 or higher, minimally invasive bariatric endoscopic procedures can lead to weight loss, improvement in metabolic outcomes, and fewer adverse events compared to bariatric surgery, said Violeta Popov, MD, director of bariatric endoscopy at the New York Veterans Affairs Harbor Healthcare System in New York City.

Dr. Violeta Popov, VA New York Harbor Healthcare System, and assistant professor of medicine at New York University
Dr. Violeta Popov

For example, intragastric balloons — marketed under the names Orbera and Spatz — work by altering the rate of gastric emptying. They’re placed temporarily and removed after several months, and Spatz can be adjusted while in place, either by removing or adding volume if needed. Data show that associated weight loss can lead to improvements in insulin resistance, visceral obesity, dyslipidemia, high blood pressure, liver enzymes, metabolic dysfunction–associated steatotic liver disease (MASLD), and metabolic dysfunction–associated steatohepatitis (MASH).

Although the majority of patients undergoing minimally invasive procedures do experience adverse events such as nausea and vomiting, symptoms tend to subside in the first few weeks, Dr. Popov said. At the same time, gastroesophageal reflux disease (GERD) can worsen in patients who have experienced it, so proton pump inhibitors are recommended for as long as the balloon is inserted.

Endoscopic sleeve gastroplasty has become the most prevalent endobariatric method in Dr. Popov’s practice during the past few years. The procedure uses full thickness sutures placed with an endoscopic suturing device called OverStitch, to decrease the size of the opening into the stomach. In previous trials, patients lost up to 40 pounds, and more than 80% maintained the lost weight up to 5 years. The procedure, which showed no worsening of GERD, works by preserving gastric contractility while delaying gastric emptying.

Dr. Popov noted one of the main challenges is training and credentialing, with many patients not having access to those who can perform these procedures. As a diplomate of the American Board of Obesity Medicine, Dr. Popov highlighted the need for bariatric endoscopy fellowships or training during GI fellowships, post-fellowship hands-on courses, and competency training with simulators.

“It’s not just technical competency in performing a procedure — it’s also the administrative work of setting up a multidisciplinary program,” she said. “It’s very important to understand obesity as a disease and learn how to manage it.”
 

Monitoring MASLD

Linked strongly to insulin resistance, MASLD prevalence is increasing worldwide as obesity increases, reaching 30% in the United States and even higher among certain patient populations, said Sonali Paul, MD, an assistant professor of medicine and hepatologist at the Center for Liver Diseases at the University of Chicago Medicine in Illinois.

Sonali Paul, MD, transplant hepatologist with the University of Chicago Medicine
University of Chicago
Dr. Sonali Paul

The good news is that the associations between MASLD and obesity also move the other way — if patients lose weight and improve cardiovascular risk factors, MASLD can improve as well. Notably, steatosis can disappear at 3% weight loss, inflammation decreases at 5% weight loss, MASH resolution occurs at 7% weight loss, and fibrosis improves at 10% weight loss.

Primarily, Dr. Paul and colleagues have focused on lifestyle interventions, especially diet, by working carefully with dietitians. A modified Mediterranean diet with olive oil and monounsaturated fats can decrease steatosis on MRI, as compared with a high-fat/low-carb diet, and it also appears to decrease mortality, cardiovascular disease, and obesity. As part of the modified diet, carbohydrates are limited to 30 grams per meal per day.

“We really want to tailor the diet to cultural and personal preferences,” she said. “I’m South Asian, and when I tell my South Asian patients not to eat rice, they don’t love that, so we work with them to meet them where they are.”

Dr. Paul recommends physical activity interventions, proper sleep hygiene, treatment of obstructive sleep apnea, pharmacological options, and bariatric solutions to reduce weight, improve insulin resistance, and target MASLD risk factors. For instance, recent phase 2b studies indicate semaglutide can lead to MASH resolution, with phase 3 trial data expected by the end of 2024.

In addition, resmetirom, a liver-directed thyroid hormone receptor beta selective agonist — the first Food and Drug Administration–approved drug for MASH — achieved both primary endpoints of MASH resolution and fibrosis improvement. American Association for the Study of Liver Diseases guidelines are forthcoming about who should use the drug, Dr. Paul said.

“In terms of the paradigm that I think about with MASLD, we want to target other causes and diagnose advanced fibrosis, treat risk factors, and target MASH through treatment,” she said.
 

 

 

Considering the Community Perspective

Community-based clinicians face a unique set of challenges when addressing obesity through a multidisciplinary approach and longitudinal care, but it remains vital as more practices see increased patient loads with obesity-related GI comorbidities, said Pooja Singhal, MD, assistant professor of medicine at the University of Oklahoma Health Sciences Center, Oklahoma City, and founder/president of Oklahoma Gastro Health and Wellness.

University of Oklahoma Health Sciences Center and Oklahoma Gastro Health and Wellness, Oklahoma City
Oklahoma Gastro Health and Wellness
Dr. Pooja Singhal

Dr. Singhal noted obesity-related associations with earlier presentations of GERD, elevated liver enzymes, MASLD, MASH, IBS, IBD, gallbladder disease, colon polyps, and GI cancers.

“Gastroenterologists, as most of us are board-certified internists, are in a unique position to offer both pharmacotherapy and endoscopic treatment,” she said. “The GI comorbidities provide an opportunity for early intervention, and we’re seeing a lot of side effects of antiobesity medications, so whether we like it or not, we are involved.”

The best practices at the community level start with a patient-centric approach, Dr. Singhal said. Although clinicians are already time constrained and focused on addressing GI-related comorbidities, using the 5A’s framework can help:

  • Asking if the patient is ready to talk
  • Assessing for factors contributing to obesity
  • Advising them of treatment options
  • Agreeing on goals based on shared decision-making
  • Assisting or Arranging the agreed-on plan.

During the assessment phase, Dr. Singhal suggested not only looking at medical and physical values but also secondary causes of weight gain, including the patient’s relationship with food, micronutrient deficiencies, psychosocial concerns, body image disorders, and triggers for eating.

During the advising phase, clinicians should consider multiple targets — such as diet, physical activity, and behavior — with a supervised and structured approach. Dr. Singhal and colleagues include a meal plan, aerobic activity, resistance training, behavior modification of eating habits, sleep hygiene, and patient self-monitoring through smartphone apps and wearables. Pharmacotherapy may be relevant and effective for some patients but less accessible for many, she noted.

Above all, Dr. Singhal recommended training through the American Board of Obesity Medicine, major GI society guidelines and conferences, American Society for Gastrointestinal Endoscopy STAR courses, and connecting with a multidisciplinary team of dietitians, coaches, physical therapists, and other GI specialists when possible.

“Most importantly, we’re dealing with decades of stigma and bias around this disease, where ‘you are what you eat,’ ” she said. “This mentality of ‘I can lose weight without help’ is a real challenge.”

As the prevalence of obesity grows in the United States and worldwide, more solutions are needed at more levels of care to help patients, according to a series of presentations during the American Gastroenterological Association (AGA) Postgraduate Course held at Digestive Disease Week® (DDW) in May.

Gastroenterologists can step up as part of a multidisciplinary response to provide treatment — with a range of lifestyle interventions, pharmacological options, and bariatric endoscopic possibilities — based on a patient’s needs and preferences.

Dr. Andres J. Acosta of the Mayo Clinic
Dr. Andres J. Acosta

“Obesity is in our clinics. We’re usually the first line of obesity, and that’s why we need to know it, learn how to manage it, and understand the complications,” said Andres Acosta, MD, an associate professor of medicine and gastroenterologist at Mayo Clinic, Rochester, Minnesota, and principal investigator of Mayo’s Precision Medicine for Obesity Laboratory.

Obesity tops the charts as the most significant chronic disease in the world, affecting 130 million patients in the United States and 1 billion globally, he said, and those numbers will only climb higher in coming years. By 2030, the United States is projected to have an obesity prevalence of 50% and overweight prevalence of 80%, with every state having a prevalence greater than 35%.

The alarming prevalence rates matter not because of aesthetics or personal preference, he noted, but because of the major associations with premature death, cardiovascular disease, stroke, type 2 diabetes, numerous cancers, and 280 other diseases.

“Choose the organ you like, and obesity is a major contributor to its most important disease,” Dr. Acosta said. “Obesity affects every single disease and every single organ in the gastrointestinal system, so it’s essential that we actually manage this.”

Based on current recommendations focused on body mass index (BMI), diet, exercise, and behavioral therapy are suggested for a BMI of 25 or higher, followed by pharmacotherapy for a BMI greater than 27 with comorbidities, endoscopic procedures for a BMI greater than 30, and surgical options for a BMI greater than 40 or BMI greater than 30 with comorbidities. At each step, clinicians can start shared decision-making conversations with patients about the best options for them.

“We’re moving from a pyramid approach where we tell patients to choose one intervention toward multidisciplinary programs where we offer interventions in combination,” Dr. Acosta said, recommending AGA’s POWER - Practice Guide on Obesity and Weight Management Education and Resources . Other AGA resources for physicians treating patients with obesity include the AGA Clinical Practice Guideline on Pharmacological Interventions for Adults With Obesity , and the Obesity Resource Center on the AGA website .
 

Progress in Pharmacotherapy

In recent years, developments focused on glucagon-like peptide 1 (GLP-1) receptor agonists, such as semaglutide and tirzepatide, have “changed the conversation about obesity,” Dr. Acosta said. For the first time, medications not only reduce weight but also cardiovascular disease risks, which were previously only observed with bariatric surgery.

Additional GLP-1 options are in research pipelines. During the next 3 years, for instance, more medications will focus on how the gut signals to the brain through intestinal hormones, targeting GLP-1, glucose-dependent insulinotropic polypeptide, and other receptors. Leading the pipeline, Eli Lilly’s retatrutide shows promise, with weight loss and comorbidity improvement reported similar to or better than tirzepatide. Additional data from phase 3 trials are forthcoming.

In clinical practice, major conversations remain about gastrointestinal side effects, particularly gastroparesis, that may pose a risk for aspiration in upper endoscopy. Gastroenterologists should feel comfortable about managing these types of side effects when starting patients on these medications, Dr. Acosta said, but also continue to ask questions about side effects and the latest research developments.

Of course, major obstacles remain regarding patient access, insurance coverage, cost-effective options, and heterogeneous patient responses. At the Mayo Clinic, Dr. Acosta and colleagues are researching and targeting obesity phenotypes — such as the “hungry gut” or “hungry brain” — to improve weight loss outcomes and patient adherence.

Ultimately, he said, the most important obstacle is our healthcare system. “We cannot afford to manage obesity with expensive procedures or expensive medications.”
 

 

 

Efficacy of Endobariatrics

For patients with a BMI of 30 or higher, minimally invasive bariatric endoscopic procedures can lead to weight loss, improvement in metabolic outcomes, and fewer adverse events compared to bariatric surgery, said Violeta Popov, MD, director of bariatric endoscopy at the New York Veterans Affairs Harbor Healthcare System in New York City.

Dr. Violeta Popov, VA New York Harbor Healthcare System, and assistant professor of medicine at New York University
Dr. Violeta Popov

For example, intragastric balloons — marketed under the names Orbera and Spatz — work by altering the rate of gastric emptying. They’re placed temporarily and removed after several months, and Spatz can be adjusted while in place, either by removing or adding volume if needed. Data show that associated weight loss can lead to improvements in insulin resistance, visceral obesity, dyslipidemia, high blood pressure, liver enzymes, metabolic dysfunction–associated steatotic liver disease (MASLD), and metabolic dysfunction–associated steatohepatitis (MASH).

Although the majority of patients undergoing minimally invasive procedures do experience adverse events such as nausea and vomiting, symptoms tend to subside in the first few weeks, Dr. Popov said. At the same time, gastroesophageal reflux disease (GERD) can worsen in patients who have experienced it, so proton pump inhibitors are recommended for as long as the balloon is inserted.

Endoscopic sleeve gastroplasty has become the most prevalent endobariatric method in Dr. Popov’s practice during the past few years. The procedure uses full thickness sutures placed with an endoscopic suturing device called OverStitch, to decrease the size of the opening into the stomach. In previous trials, patients lost up to 40 pounds, and more than 80% maintained the lost weight up to 5 years. The procedure, which showed no worsening of GERD, works by preserving gastric contractility while delaying gastric emptying.

Dr. Popov noted one of the main challenges is training and credentialing, with many patients not having access to those who can perform these procedures. As a diplomate of the American Board of Obesity Medicine, Dr. Popov highlighted the need for bariatric endoscopy fellowships or training during GI fellowships, post-fellowship hands-on courses, and competency training with simulators.

“It’s not just technical competency in performing a procedure — it’s also the administrative work of setting up a multidisciplinary program,” she said. “It’s very important to understand obesity as a disease and learn how to manage it.”
 

Monitoring MASLD

Linked strongly to insulin resistance, MASLD prevalence is increasing worldwide as obesity increases, reaching 30% in the United States and even higher among certain patient populations, said Sonali Paul, MD, an assistant professor of medicine and hepatologist at the Center for Liver Diseases at the University of Chicago Medicine in Illinois.

Sonali Paul, MD, transplant hepatologist with the University of Chicago Medicine
University of Chicago
Dr. Sonali Paul

The good news is that the associations between MASLD and obesity also move the other way — if patients lose weight and improve cardiovascular risk factors, MASLD can improve as well. Notably, steatosis can disappear at 3% weight loss, inflammation decreases at 5% weight loss, MASH resolution occurs at 7% weight loss, and fibrosis improves at 10% weight loss.

Primarily, Dr. Paul and colleagues have focused on lifestyle interventions, especially diet, by working carefully with dietitians. A modified Mediterranean diet with olive oil and monounsaturated fats can decrease steatosis on MRI, as compared with a high-fat/low-carb diet, and it also appears to decrease mortality, cardiovascular disease, and obesity. As part of the modified diet, carbohydrates are limited to 30 grams per meal per day.

“We really want to tailor the diet to cultural and personal preferences,” she said. “I’m South Asian, and when I tell my South Asian patients not to eat rice, they don’t love that, so we work with them to meet them where they are.”

Dr. Paul recommends physical activity interventions, proper sleep hygiene, treatment of obstructive sleep apnea, pharmacological options, and bariatric solutions to reduce weight, improve insulin resistance, and target MASLD risk factors. For instance, recent phase 2b studies indicate semaglutide can lead to MASH resolution, with phase 3 trial data expected by the end of 2024.

In addition, resmetirom, a liver-directed thyroid hormone receptor beta selective agonist — the first Food and Drug Administration–approved drug for MASH — achieved both primary endpoints of MASH resolution and fibrosis improvement. American Association for the Study of Liver Diseases guidelines are forthcoming about who should use the drug, Dr. Paul said.

“In terms of the paradigm that I think about with MASLD, we want to target other causes and diagnose advanced fibrosis, treat risk factors, and target MASH through treatment,” she said.
 

 

 

Considering the Community Perspective

Community-based clinicians face a unique set of challenges when addressing obesity through a multidisciplinary approach and longitudinal care, but it remains vital as more practices see increased patient loads with obesity-related GI comorbidities, said Pooja Singhal, MD, assistant professor of medicine at the University of Oklahoma Health Sciences Center, Oklahoma City, and founder/president of Oklahoma Gastro Health and Wellness.

University of Oklahoma Health Sciences Center and Oklahoma Gastro Health and Wellness, Oklahoma City
Oklahoma Gastro Health and Wellness
Dr. Pooja Singhal

Dr. Singhal noted obesity-related associations with earlier presentations of GERD, elevated liver enzymes, MASLD, MASH, IBS, IBD, gallbladder disease, colon polyps, and GI cancers.

“Gastroenterologists, as most of us are board-certified internists, are in a unique position to offer both pharmacotherapy and endoscopic treatment,” she said. “The GI comorbidities provide an opportunity for early intervention, and we’re seeing a lot of side effects of antiobesity medications, so whether we like it or not, we are involved.”

The best practices at the community level start with a patient-centric approach, Dr. Singhal said. Although clinicians are already time constrained and focused on addressing GI-related comorbidities, using the 5A’s framework can help:

  • Asking if the patient is ready to talk
  • Assessing for factors contributing to obesity
  • Advising them of treatment options
  • Agreeing on goals based on shared decision-making
  • Assisting or Arranging the agreed-on plan.

During the assessment phase, Dr. Singhal suggested not only looking at medical and physical values but also secondary causes of weight gain, including the patient’s relationship with food, micronutrient deficiencies, psychosocial concerns, body image disorders, and triggers for eating.

During the advising phase, clinicians should consider multiple targets — such as diet, physical activity, and behavior — with a supervised and structured approach. Dr. Singhal and colleagues include a meal plan, aerobic activity, resistance training, behavior modification of eating habits, sleep hygiene, and patient self-monitoring through smartphone apps and wearables. Pharmacotherapy may be relevant and effective for some patients but less accessible for many, she noted.

Above all, Dr. Singhal recommended training through the American Board of Obesity Medicine, major GI society guidelines and conferences, American Society for Gastrointestinal Endoscopy STAR courses, and connecting with a multidisciplinary team of dietitians, coaches, physical therapists, and other GI specialists when possible.

“Most importantly, we’re dealing with decades of stigma and bias around this disease, where ‘you are what you eat,’ ” she said. “This mentality of ‘I can lose weight without help’ is a real challenge.”

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AGA Issues Guidance on Identifying, Treating Cyclic Vomiting Syndrome

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Wed, 08/21/2024 - 11:45

Clinicians and patients should become familiar with the signs and symptoms of cyclic vomiting syndrome (CVS), including sudden episodes of intense nausea, vomiting, and retching amid episode-free periods, according to a new clinical practice update from the American Gastroenterological Association.

CVS affects up to 2% of U.S. adults and is more common in women, young adults, and those with a personal or family history of migraine headaches. However, most patients don’t receive a diagnosis or often experience years of delay in receiving effective treatment.

“A diagnosis is a powerful tool. Not only does it help patients make sense of debilitating symptoms, but it allows healthcare providers to create an effective treatment plan,” said author David J. Levinthal, MD, AGAF, director of the Neurogastroenterology and Motility Center at the University of Pittsburgh Medical Center.

Dr. David J. Levinthal, director of the Neurogastroenterology and Motility Center at the University of Pittsburgh Medical Center
University of Pittsburgh Medical Center
Dr. David J. Levinthal
“Our goal with this clinical practice update is to increase awareness of cyclic vomiting syndrome to reduce the diagnostic delay and increase patients’ access to treatment,” he said. “We hope to reach primary care, ER, and urgent care providers who are on the frontlines interacting with CVS patients seeking care, especially during an attack.”


The update was published online in Gastroenterology.

Understanding Cyclic Vomiting Syndrome

CVS is a chronic disorder of gut-brain interaction (DGBI), which is characterized by acute episodes of nausea and vomiting, separated by time without symptoms. Patients can usually identify a pattern of symptoms that show up during and between episodes.

CVS can vary, ranging from mild — with less than four episodes per year and lasting less than 2 days — to moderate-severe — with more than four episodes per year, lasting more than 2 days, and requiring at least one emergency department visit or hospitalization.

The disorder has four distinct phases — inter-episodic, prodromal, emetic, and recovery — that align with distinct treatment and management strategies. Between episodes, patients typically don’t experience repetitive vomiting but may experience symptoms such as mild nausea, indigestion, and occasional vomiting. Although CVS episodes can happen at any time, most tend to occur in the early morning.

For diagnosis, clinicians should consider CVS in adults presenting with episodic bouts of repetitive vomiting, following criteria established by the Rome Foundation. Rome IV criteria include acute-onset vomiting lasting less than 7 days, at least three discrete episodes in a year with two in the previous 6 months, and an absence of vomiting between episodes separated by at least 1 week of baseline health.


About 65% of patients with CVS experience prodromal symptoms, which last for about an hour before the onset of vomiting and may include panic, a sense of doom, and an inability to communicate effectively. During prodromal or emetic phases, patients have also reported fatigue, brain fog, restlessness, anxiety, headache, bowel urgency, abdominal pain, flushing, or shakiness.

As with migraines, CVS episodes may often be triggered by psychological and physiological factors, particularly stress. Episodes can stem from both negative stress, such as a death or relationship conflicts, as well as positive stress, such as birthdays and vacations. Other triggers include sleep deprivation, hormonal fluctuations linked to the menstrual cycle, travel, motion sickness, or acute infections.

Adult CVS is associated with several conditions, particularly mood disorders, including anxiety, depression, and panic disorder. Patients may also experience migraines, seizure disorders, or autonomic imbalances, such as postural orthostatic tachycardia syndrome, which may indicate pathophysiological mechanisms and routes for management.

The American Neurogastroenterology and Motility Society recommends testing to rule out similar or overlapping conditions, such as Addison’s disease, hypothyroidism, and hepatic porphyria. Diagnostic workup should include blood work, urinalysis, and one-time esophagogastroduodenoscopy or upper gastrointestinal imaging. Repeated imaging and gastric emptying scans should be avoided.
 

 

 

Providing Treatment and Prevention

For treatment, knowing the CVS phase is “essential,” the authors wrote. For instance, during the prodromal phase, abortive therapies can halt the transition to the emetic phase, and earlier intervention is associated with a higher probability of stopping an episode. The authors recommend intranasal sumatriptan, ondansetron, antihistamines, and sedatives.

During the emetic phase, supportive therapy can help terminate the episode. This may include continuing the abortive regimen and going to the emergency department for hydration and antiemetic medications. Patients may also find relief in a quiet, darker room in the emergency department, along with IV benzodiazepines, with the goal of inducing sedation.

During the recovery phase, patients should rest and focus on rehydration and nutrition to return to the well phase.

During the well or inter-episodic phase, patients can follow lifestyle measures to identify and avoid triggers, such as taking prophylactic medication (tricyclic antidepressants, anticonvulsants, and neurokinin-1 receptor antagonists such as aprepitant), reducing stress, and implementing a good sleep routine.

As part of patient education, clinicians can discuss the four phases and rehearse the actions to take to prevent or stop an episode.

“CVS has a significant impact on patients, families, and the healthcare system. The unpredictable and disruptive nature of episodes can result in reduced health-related quality of life, job loss precipitated by work absenteeism, and even divorce,” said Rosita Frazier, MD, a gastroenterologist at Mayo Clinic Arizona in Scottsdale who specializes in DGBI and CVS. Dr. Frazier, who wasn’t involved with the clinical practice update, has previously written about CVS diagnosis and management.

Dr. Rosita Frazier, gastroenterologist at Mayo Clinic Arizona in Scottsdale
Mayo Clinic Arizona
Dr. Rosita Frazier
Patients with CVS often report negative interactions with physicians, particularly in the emergency department, where they may request specific treatments based on past experiences but are labeled as “drug seeking” and denied standard medical treatment, she said.

“Providing an individualized care plan for all patients could potentially address this problem and improve the physician-patient interaction,” she said. “Educational efforts to raise awareness among the medical community and increase both patient and provider engagement can optimize outcomes and are needed to address this critical problem.”

The authors received no specific funding for this update. Dr. Levinthal is a consultant for Takeda Pharmaceuticals and Mahana. Dr. Frazier reported no relevant financial disclosures.

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Clinicians and patients should become familiar with the signs and symptoms of cyclic vomiting syndrome (CVS), including sudden episodes of intense nausea, vomiting, and retching amid episode-free periods, according to a new clinical practice update from the American Gastroenterological Association.

CVS affects up to 2% of U.S. adults and is more common in women, young adults, and those with a personal or family history of migraine headaches. However, most patients don’t receive a diagnosis or often experience years of delay in receiving effective treatment.

“A diagnosis is a powerful tool. Not only does it help patients make sense of debilitating symptoms, but it allows healthcare providers to create an effective treatment plan,” said author David J. Levinthal, MD, AGAF, director of the Neurogastroenterology and Motility Center at the University of Pittsburgh Medical Center.

Dr. David J. Levinthal, director of the Neurogastroenterology and Motility Center at the University of Pittsburgh Medical Center
University of Pittsburgh Medical Center
Dr. David J. Levinthal
“Our goal with this clinical practice update is to increase awareness of cyclic vomiting syndrome to reduce the diagnostic delay and increase patients’ access to treatment,” he said. “We hope to reach primary care, ER, and urgent care providers who are on the frontlines interacting with CVS patients seeking care, especially during an attack.”


The update was published online in Gastroenterology.

Understanding Cyclic Vomiting Syndrome

CVS is a chronic disorder of gut-brain interaction (DGBI), which is characterized by acute episodes of nausea and vomiting, separated by time without symptoms. Patients can usually identify a pattern of symptoms that show up during and between episodes.

CVS can vary, ranging from mild — with less than four episodes per year and lasting less than 2 days — to moderate-severe — with more than four episodes per year, lasting more than 2 days, and requiring at least one emergency department visit or hospitalization.

The disorder has four distinct phases — inter-episodic, prodromal, emetic, and recovery — that align with distinct treatment and management strategies. Between episodes, patients typically don’t experience repetitive vomiting but may experience symptoms such as mild nausea, indigestion, and occasional vomiting. Although CVS episodes can happen at any time, most tend to occur in the early morning.

For diagnosis, clinicians should consider CVS in adults presenting with episodic bouts of repetitive vomiting, following criteria established by the Rome Foundation. Rome IV criteria include acute-onset vomiting lasting less than 7 days, at least three discrete episodes in a year with two in the previous 6 months, and an absence of vomiting between episodes separated by at least 1 week of baseline health.


About 65% of patients with CVS experience prodromal symptoms, which last for about an hour before the onset of vomiting and may include panic, a sense of doom, and an inability to communicate effectively. During prodromal or emetic phases, patients have also reported fatigue, brain fog, restlessness, anxiety, headache, bowel urgency, abdominal pain, flushing, or shakiness.

As with migraines, CVS episodes may often be triggered by psychological and physiological factors, particularly stress. Episodes can stem from both negative stress, such as a death or relationship conflicts, as well as positive stress, such as birthdays and vacations. Other triggers include sleep deprivation, hormonal fluctuations linked to the menstrual cycle, travel, motion sickness, or acute infections.

Adult CVS is associated with several conditions, particularly mood disorders, including anxiety, depression, and panic disorder. Patients may also experience migraines, seizure disorders, or autonomic imbalances, such as postural orthostatic tachycardia syndrome, which may indicate pathophysiological mechanisms and routes for management.

The American Neurogastroenterology and Motility Society recommends testing to rule out similar or overlapping conditions, such as Addison’s disease, hypothyroidism, and hepatic porphyria. Diagnostic workup should include blood work, urinalysis, and one-time esophagogastroduodenoscopy or upper gastrointestinal imaging. Repeated imaging and gastric emptying scans should be avoided.
 

 

 

Providing Treatment and Prevention

For treatment, knowing the CVS phase is “essential,” the authors wrote. For instance, during the prodromal phase, abortive therapies can halt the transition to the emetic phase, and earlier intervention is associated with a higher probability of stopping an episode. The authors recommend intranasal sumatriptan, ondansetron, antihistamines, and sedatives.

During the emetic phase, supportive therapy can help terminate the episode. This may include continuing the abortive regimen and going to the emergency department for hydration and antiemetic medications. Patients may also find relief in a quiet, darker room in the emergency department, along with IV benzodiazepines, with the goal of inducing sedation.

During the recovery phase, patients should rest and focus on rehydration and nutrition to return to the well phase.

During the well or inter-episodic phase, patients can follow lifestyle measures to identify and avoid triggers, such as taking prophylactic medication (tricyclic antidepressants, anticonvulsants, and neurokinin-1 receptor antagonists such as aprepitant), reducing stress, and implementing a good sleep routine.

As part of patient education, clinicians can discuss the four phases and rehearse the actions to take to prevent or stop an episode.

“CVS has a significant impact on patients, families, and the healthcare system. The unpredictable and disruptive nature of episodes can result in reduced health-related quality of life, job loss precipitated by work absenteeism, and even divorce,” said Rosita Frazier, MD, a gastroenterologist at Mayo Clinic Arizona in Scottsdale who specializes in DGBI and CVS. Dr. Frazier, who wasn’t involved with the clinical practice update, has previously written about CVS diagnosis and management.

Dr. Rosita Frazier, gastroenterologist at Mayo Clinic Arizona in Scottsdale
Mayo Clinic Arizona
Dr. Rosita Frazier
Patients with CVS often report negative interactions with physicians, particularly in the emergency department, where they may request specific treatments based on past experiences but are labeled as “drug seeking” and denied standard medical treatment, she said.

“Providing an individualized care plan for all patients could potentially address this problem and improve the physician-patient interaction,” she said. “Educational efforts to raise awareness among the medical community and increase both patient and provider engagement can optimize outcomes and are needed to address this critical problem.”

The authors received no specific funding for this update. Dr. Levinthal is a consultant for Takeda Pharmaceuticals and Mahana. Dr. Frazier reported no relevant financial disclosures.

Clinicians and patients should become familiar with the signs and symptoms of cyclic vomiting syndrome (CVS), including sudden episodes of intense nausea, vomiting, and retching amid episode-free periods, according to a new clinical practice update from the American Gastroenterological Association.

CVS affects up to 2% of U.S. adults and is more common in women, young adults, and those with a personal or family history of migraine headaches. However, most patients don’t receive a diagnosis or often experience years of delay in receiving effective treatment.

“A diagnosis is a powerful tool. Not only does it help patients make sense of debilitating symptoms, but it allows healthcare providers to create an effective treatment plan,” said author David J. Levinthal, MD, AGAF, director of the Neurogastroenterology and Motility Center at the University of Pittsburgh Medical Center.

Dr. David J. Levinthal, director of the Neurogastroenterology and Motility Center at the University of Pittsburgh Medical Center
University of Pittsburgh Medical Center
Dr. David J. Levinthal
“Our goal with this clinical practice update is to increase awareness of cyclic vomiting syndrome to reduce the diagnostic delay and increase patients’ access to treatment,” he said. “We hope to reach primary care, ER, and urgent care providers who are on the frontlines interacting with CVS patients seeking care, especially during an attack.”


The update was published online in Gastroenterology.

Understanding Cyclic Vomiting Syndrome

CVS is a chronic disorder of gut-brain interaction (DGBI), which is characterized by acute episodes of nausea and vomiting, separated by time without symptoms. Patients can usually identify a pattern of symptoms that show up during and between episodes.

CVS can vary, ranging from mild — with less than four episodes per year and lasting less than 2 days — to moderate-severe — with more than four episodes per year, lasting more than 2 days, and requiring at least one emergency department visit or hospitalization.

The disorder has four distinct phases — inter-episodic, prodromal, emetic, and recovery — that align with distinct treatment and management strategies. Between episodes, patients typically don’t experience repetitive vomiting but may experience symptoms such as mild nausea, indigestion, and occasional vomiting. Although CVS episodes can happen at any time, most tend to occur in the early morning.

For diagnosis, clinicians should consider CVS in adults presenting with episodic bouts of repetitive vomiting, following criteria established by the Rome Foundation. Rome IV criteria include acute-onset vomiting lasting less than 7 days, at least three discrete episodes in a year with two in the previous 6 months, and an absence of vomiting between episodes separated by at least 1 week of baseline health.


About 65% of patients with CVS experience prodromal symptoms, which last for about an hour before the onset of vomiting and may include panic, a sense of doom, and an inability to communicate effectively. During prodromal or emetic phases, patients have also reported fatigue, brain fog, restlessness, anxiety, headache, bowel urgency, abdominal pain, flushing, or shakiness.

As with migraines, CVS episodes may often be triggered by psychological and physiological factors, particularly stress. Episodes can stem from both negative stress, such as a death or relationship conflicts, as well as positive stress, such as birthdays and vacations. Other triggers include sleep deprivation, hormonal fluctuations linked to the menstrual cycle, travel, motion sickness, or acute infections.

Adult CVS is associated with several conditions, particularly mood disorders, including anxiety, depression, and panic disorder. Patients may also experience migraines, seizure disorders, or autonomic imbalances, such as postural orthostatic tachycardia syndrome, which may indicate pathophysiological mechanisms and routes for management.

The American Neurogastroenterology and Motility Society recommends testing to rule out similar or overlapping conditions, such as Addison’s disease, hypothyroidism, and hepatic porphyria. Diagnostic workup should include blood work, urinalysis, and one-time esophagogastroduodenoscopy or upper gastrointestinal imaging. Repeated imaging and gastric emptying scans should be avoided.
 

 

 

Providing Treatment and Prevention

For treatment, knowing the CVS phase is “essential,” the authors wrote. For instance, during the prodromal phase, abortive therapies can halt the transition to the emetic phase, and earlier intervention is associated with a higher probability of stopping an episode. The authors recommend intranasal sumatriptan, ondansetron, antihistamines, and sedatives.

During the emetic phase, supportive therapy can help terminate the episode. This may include continuing the abortive regimen and going to the emergency department for hydration and antiemetic medications. Patients may also find relief in a quiet, darker room in the emergency department, along with IV benzodiazepines, with the goal of inducing sedation.

During the recovery phase, patients should rest and focus on rehydration and nutrition to return to the well phase.

During the well or inter-episodic phase, patients can follow lifestyle measures to identify and avoid triggers, such as taking prophylactic medication (tricyclic antidepressants, anticonvulsants, and neurokinin-1 receptor antagonists such as aprepitant), reducing stress, and implementing a good sleep routine.

As part of patient education, clinicians can discuss the four phases and rehearse the actions to take to prevent or stop an episode.

“CVS has a significant impact on patients, families, and the healthcare system. The unpredictable and disruptive nature of episodes can result in reduced health-related quality of life, job loss precipitated by work absenteeism, and even divorce,” said Rosita Frazier, MD, a gastroenterologist at Mayo Clinic Arizona in Scottsdale who specializes in DGBI and CVS. Dr. Frazier, who wasn’t involved with the clinical practice update, has previously written about CVS diagnosis and management.

Dr. Rosita Frazier, gastroenterologist at Mayo Clinic Arizona in Scottsdale
Mayo Clinic Arizona
Dr. Rosita Frazier
Patients with CVS often report negative interactions with physicians, particularly in the emergency department, where they may request specific treatments based on past experiences but are labeled as “drug seeking” and denied standard medical treatment, she said.

“Providing an individualized care plan for all patients could potentially address this problem and improve the physician-patient interaction,” she said. “Educational efforts to raise awareness among the medical community and increase both patient and provider engagement can optimize outcomes and are needed to address this critical problem.”

The authors received no specific funding for this update. Dr. Levinthal is a consultant for Takeda Pharmaceuticals and Mahana. Dr. Frazier reported no relevant financial disclosures.

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