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The Appendix: Is It ’Useless,’ or a Safe House and Immune Training Ground?

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When doctors and patients consider the appendix, it’s often with urgency. In cases of appendicitis, the clock could be ticking down to a life-threatening burst. Thus, despite recent research suggesting antibiotics could be an alternative therapy, appendectomy remains standard for uncomplicated appendicitis.

But what if removing the appendix could raise the risk for gastrointestinal (GI) diseases like irritable bowel syndrome and colorectal cancer? That’s what some emerging science suggests. And though the research is early and mixed, it’s enough to give some health professionals pause.

“If there’s no reason to remove the appendix, then it’s better to have one,” said Heather Smith, PhD, a comparative anatomist at Midwestern University, Glendale, Arizona. Preemptive removal is not supported by the evidence, she said.

To be fair, we’ve come a long way since 1928, when American physician Miles Breuer, MD, suggested that people with infected appendixes should be left to perish, so as to remove their inferior DNA from the gene pool (he called such people “uncivilized” and “candidates for extinction”). Charles Darwin, while less radical, believed the appendix was at best useless — a mere vestige of our ancestors switching diets from leaves to fruits.

What we know now is that the appendix isn’t just a troublesome piece of worthless flesh. Instead, it may act as a safe house for friendly gut bacteria and a training camp for the immune system. It also appears to play a role in several medical conditions, from ulcerative colitis and colorectal cancer to Parkinson’s disease and lupus. The roughly 300,000 Americans who undergo appendectomy each year should be made aware of this, some experts say. But the frustrating truth is, scientists are still trying to figure out in which cases having an appendix is protective and in which we may be better off without it.
 

A ‘Worm’ as Intestinal Protection

The appendix is a blind pouch (meaning its ending is closed off) that extends from the large intestine. Not all mammals have one; it’s been found in several species of primates and rodents, as well as in rabbits, wombats, and Florida manatees, among others (dogs and cats don’t have it). While a human appendix “looks like a little worm,” Dr. Smith said, these anatomical structures come in various sizes and shapes. Some are thick, as in a beaver, while others are long and spiraling, like a rabbit’s.

Comparative anatomy studies reveal that the appendix has evolved independently at least 29 times throughout mammalian evolution. This suggests that “it has some kind of an adaptive function,” Dr. Smith said. When French scientists analyzed data from 258 species of mammals, they discovered that those that possess an appendix live longer than those without one. A possible explanation, the researchers wrote, may lie with the appendix’s role in preventing diarrhea.

Their 2023 study supported this hypothesis. Based on veterinary records of 45 different species of primates housed in a French zoo, the scientists established that primates with appendixes are far less likely to suffer severe diarrhea than those that don’t possess this organ. The appendix, it appears, might be our tiny weapon against bowel troubles.

For immunologist William Parker, PhD, a visiting scholar at the University of North Carolina at Chapel Hill, these data are “about as good as we could hope for” in support of the idea that the appendix might protect mammals from GI problems. An experiment on humans would be unethical, Dr. Parker said. But observational studies offer clues.

One study showed that compared with people with an intact appendix, young adults with a history of appendectomy have more than double the risk of developing a serious infection with non-typhoidal Salmonella of the kind that would require hospitalization.
 

 

 

A ‘Safe House’ for Bacteria

Such studies add weight to a theory that Dr. Parker and his colleagues developed back in 2007: That the appendix acts as a “safe house” for beneficial gut bacteria.

Think of the colon as a wide pipe, Dr. Parker said, that may become contaminated with a pathogen such as Salmonella. Diarrhea follows, and the pipe gets repeatedly flushed, wiping everything clean, including your friendly gut microbiome. Luckily, “you’ve got this little offshoot of that pipe,” where the flow can’t really get in “because it’s so constricted,” Dr. Parker said. The friendly gut microbes can survive inside the appendix and repopulate the colon once diarrhea is over. Dr. Parker and his colleagues found that the human appendix contains a thick layer of beneficial bacteria. “They were right where we predicted they would be,” he said.

This safe house hypothesis could explain why the gut microbiome may be different in people who no longer have an appendix. In one small study, people who’d had an appendectomy had a less diverse microbiome, with a lower abundance of beneficial strains such as Butyricicoccus and Barnesiella, than did those with intact appendixes.

The appendix likely has a second function, too, Dr. Smith said: It may serve as a training camp for the immune system. “When there is an invading pathogen in the gut, it helps the GI system to mount the immune response,” she said. The human appendix is rich in special cells known as M cells. These act as scouts, detecting and capturing invasive bacteria and viruses and presenting them to the body’s defense team, such as the T lymphocytes.

If the appendix shelters beneficial bacteria and boosts immune response, that may explain its links to various diseases. According to an epidemiological study from Taiwan,patients who underwent an appendectomy have a 46% higher risk of developing irritable bowel syndrome (IBS) — a disease associated with a low abundance of Butyricicoccus bacteria. This is why, the study authors wrote, doctors should pay careful attention to people who’ve had their appendixes removed, monitoring them for potential symptoms of IBS.

The same database helped uncover other connections between appendectomy and disease. For one, there was type 2 diabetes: Within 3 years of the surgery, patients under 30 had double the risk of developing this disorder. Then there was lupus: While those who underwent appendectomy generally had higher risk for this autoimmune disease, women were particularly affected.
 

The Contentious Connections

The most heated scientific discussion surrounds the links between the appendix and conditions such as Parkinson’s disease, ulcerative colitis, and colorectal cancer. A small 2019 study showed, for example, that appendectomy may improve symptoms of certain forms of ulcerative colitis that don’t respond to standard medical treatments. A third of patients improved after their appendix was removed, and 17% fully recovered.

Why? According to Dr. Parker, appendectomy may work for ulcerative colitis because it’s “a way of suppressing the immune system, especially in the lower intestinal areas.” A 2023 meta-analysis found that people who’d had their appendix removed before being diagnosed with ulcerative colitis were less likely to need their colon removed later on.

Such a procedure may have a serious side effect, however: Colorectal cancer. French scientists discovered that removing the appendix may reduce the numbers of certain immune cells called CD3+ and CD8+ T cells, causing a weakened immune surveillance. As a result, tumor cells might escape detection.

Yet the links between appendix removal and cancer are far from clear. A recent meta-analysis found that while people with appendectomies generally had a higher risk for colorectal cancer, for Europeans, these effects were insignificant. In fact, removal of the appendix actually protected European women from this particular form of cancer. For Parker, such mixed results may stem from the fact that treatments and populations vary widely. The issue “may depend on complex social and medical factors,” Dr. Parker said.

Things also appear complicated with Parkinson’s disease — another condition linked to the appendix. A large epidemiological study showed that appendectomy is associated with a lower risk for Parkinson’s disease and a delayed age of Parkinson’s onset. It also found that a normal appendix contains α-synuclein, a protein that may accumulate in the brain and contribute to the development of Parkinson’s. “Although α-synuclein is toxic when in the brain, it appears to be quite normal when present in the appendix,” said Luis Vitetta, PhD, MD, a clinical epidemiologist at the University of Sydney, Camperdown, Australia. Yet, not all studies find that removing the appendix lowers the risk for Parkinson’s. In fact, some show the opposite results.
 

 

 

How Should Doctors View the Appendix?

Even with these mysteries and contradictions, Dr. Vitetta said, a healthy appendix in a healthy body appears to be protective. This is why, he said, when someone is diagnosed with appendicitis, careful assessment is essential before surgery is performed.

“Perhaps an antibiotic can actually help fix it,” he said. A 2020 study published in The New England Journal of Medicine showed that antibiotics may indeed be a good alternative to surgery for the treatment of appendicitis. “We don’t want necessarily to remove an appendix that could be beneficial,” Dr. Smith said.

The many links between the appendix and various diseases mean that doctors should be more vigilant when treating patients who’ve had this organ removed, Dr. Parker said. “When a patient loses an appendix, depending on their environment, there may be effects on infection and cancer. So they might need more regular checkups,” he said. This could include monitoring for IBS and colorectal cancer.

What’s more, Dr. Parker believes that research on the appendix puts even more emphasis on the need to protect the gut microbiome — such as taking probiotics with antibiotics. And while we are still a long way from understanding how exactly this worm-like structure affects various diseases, one thing appears quite certain: The appendix is not useless. “If Darwin had the information that we have, he would not have drawn these conclusions,” Dr. Parker said.
 

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

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When doctors and patients consider the appendix, it’s often with urgency. In cases of appendicitis, the clock could be ticking down to a life-threatening burst. Thus, despite recent research suggesting antibiotics could be an alternative therapy, appendectomy remains standard for uncomplicated appendicitis.

But what if removing the appendix could raise the risk for gastrointestinal (GI) diseases like irritable bowel syndrome and colorectal cancer? That’s what some emerging science suggests. And though the research is early and mixed, it’s enough to give some health professionals pause.

“If there’s no reason to remove the appendix, then it’s better to have one,” said Heather Smith, PhD, a comparative anatomist at Midwestern University, Glendale, Arizona. Preemptive removal is not supported by the evidence, she said.

To be fair, we’ve come a long way since 1928, when American physician Miles Breuer, MD, suggested that people with infected appendixes should be left to perish, so as to remove their inferior DNA from the gene pool (he called such people “uncivilized” and “candidates for extinction”). Charles Darwin, while less radical, believed the appendix was at best useless — a mere vestige of our ancestors switching diets from leaves to fruits.

What we know now is that the appendix isn’t just a troublesome piece of worthless flesh. Instead, it may act as a safe house for friendly gut bacteria and a training camp for the immune system. It also appears to play a role in several medical conditions, from ulcerative colitis and colorectal cancer to Parkinson’s disease and lupus. The roughly 300,000 Americans who undergo appendectomy each year should be made aware of this, some experts say. But the frustrating truth is, scientists are still trying to figure out in which cases having an appendix is protective and in which we may be better off without it.
 

A ‘Worm’ as Intestinal Protection

The appendix is a blind pouch (meaning its ending is closed off) that extends from the large intestine. Not all mammals have one; it’s been found in several species of primates and rodents, as well as in rabbits, wombats, and Florida manatees, among others (dogs and cats don’t have it). While a human appendix “looks like a little worm,” Dr. Smith said, these anatomical structures come in various sizes and shapes. Some are thick, as in a beaver, while others are long and spiraling, like a rabbit’s.

Comparative anatomy studies reveal that the appendix has evolved independently at least 29 times throughout mammalian evolution. This suggests that “it has some kind of an adaptive function,” Dr. Smith said. When French scientists analyzed data from 258 species of mammals, they discovered that those that possess an appendix live longer than those without one. A possible explanation, the researchers wrote, may lie with the appendix’s role in preventing diarrhea.

Their 2023 study supported this hypothesis. Based on veterinary records of 45 different species of primates housed in a French zoo, the scientists established that primates with appendixes are far less likely to suffer severe diarrhea than those that don’t possess this organ. The appendix, it appears, might be our tiny weapon against bowel troubles.

For immunologist William Parker, PhD, a visiting scholar at the University of North Carolina at Chapel Hill, these data are “about as good as we could hope for” in support of the idea that the appendix might protect mammals from GI problems. An experiment on humans would be unethical, Dr. Parker said. But observational studies offer clues.

One study showed that compared with people with an intact appendix, young adults with a history of appendectomy have more than double the risk of developing a serious infection with non-typhoidal Salmonella of the kind that would require hospitalization.
 

 

 

A ‘Safe House’ for Bacteria

Such studies add weight to a theory that Dr. Parker and his colleagues developed back in 2007: That the appendix acts as a “safe house” for beneficial gut bacteria.

Think of the colon as a wide pipe, Dr. Parker said, that may become contaminated with a pathogen such as Salmonella. Diarrhea follows, and the pipe gets repeatedly flushed, wiping everything clean, including your friendly gut microbiome. Luckily, “you’ve got this little offshoot of that pipe,” where the flow can’t really get in “because it’s so constricted,” Dr. Parker said. The friendly gut microbes can survive inside the appendix and repopulate the colon once diarrhea is over. Dr. Parker and his colleagues found that the human appendix contains a thick layer of beneficial bacteria. “They were right where we predicted they would be,” he said.

This safe house hypothesis could explain why the gut microbiome may be different in people who no longer have an appendix. In one small study, people who’d had an appendectomy had a less diverse microbiome, with a lower abundance of beneficial strains such as Butyricicoccus and Barnesiella, than did those with intact appendixes.

The appendix likely has a second function, too, Dr. Smith said: It may serve as a training camp for the immune system. “When there is an invading pathogen in the gut, it helps the GI system to mount the immune response,” she said. The human appendix is rich in special cells known as M cells. These act as scouts, detecting and capturing invasive bacteria and viruses and presenting them to the body’s defense team, such as the T lymphocytes.

If the appendix shelters beneficial bacteria and boosts immune response, that may explain its links to various diseases. According to an epidemiological study from Taiwan,patients who underwent an appendectomy have a 46% higher risk of developing irritable bowel syndrome (IBS) — a disease associated with a low abundance of Butyricicoccus bacteria. This is why, the study authors wrote, doctors should pay careful attention to people who’ve had their appendixes removed, monitoring them for potential symptoms of IBS.

The same database helped uncover other connections between appendectomy and disease. For one, there was type 2 diabetes: Within 3 years of the surgery, patients under 30 had double the risk of developing this disorder. Then there was lupus: While those who underwent appendectomy generally had higher risk for this autoimmune disease, women were particularly affected.
 

The Contentious Connections

The most heated scientific discussion surrounds the links between the appendix and conditions such as Parkinson’s disease, ulcerative colitis, and colorectal cancer. A small 2019 study showed, for example, that appendectomy may improve symptoms of certain forms of ulcerative colitis that don’t respond to standard medical treatments. A third of patients improved after their appendix was removed, and 17% fully recovered.

Why? According to Dr. Parker, appendectomy may work for ulcerative colitis because it’s “a way of suppressing the immune system, especially in the lower intestinal areas.” A 2023 meta-analysis found that people who’d had their appendix removed before being diagnosed with ulcerative colitis were less likely to need their colon removed later on.

Such a procedure may have a serious side effect, however: Colorectal cancer. French scientists discovered that removing the appendix may reduce the numbers of certain immune cells called CD3+ and CD8+ T cells, causing a weakened immune surveillance. As a result, tumor cells might escape detection.

Yet the links between appendix removal and cancer are far from clear. A recent meta-analysis found that while people with appendectomies generally had a higher risk for colorectal cancer, for Europeans, these effects were insignificant. In fact, removal of the appendix actually protected European women from this particular form of cancer. For Parker, such mixed results may stem from the fact that treatments and populations vary widely. The issue “may depend on complex social and medical factors,” Dr. Parker said.

Things also appear complicated with Parkinson’s disease — another condition linked to the appendix. A large epidemiological study showed that appendectomy is associated with a lower risk for Parkinson’s disease and a delayed age of Parkinson’s onset. It also found that a normal appendix contains α-synuclein, a protein that may accumulate in the brain and contribute to the development of Parkinson’s. “Although α-synuclein is toxic when in the brain, it appears to be quite normal when present in the appendix,” said Luis Vitetta, PhD, MD, a clinical epidemiologist at the University of Sydney, Camperdown, Australia. Yet, not all studies find that removing the appendix lowers the risk for Parkinson’s. In fact, some show the opposite results.
 

 

 

How Should Doctors View the Appendix?

Even with these mysteries and contradictions, Dr. Vitetta said, a healthy appendix in a healthy body appears to be protective. This is why, he said, when someone is diagnosed with appendicitis, careful assessment is essential before surgery is performed.

“Perhaps an antibiotic can actually help fix it,” he said. A 2020 study published in The New England Journal of Medicine showed that antibiotics may indeed be a good alternative to surgery for the treatment of appendicitis. “We don’t want necessarily to remove an appendix that could be beneficial,” Dr. Smith said.

The many links between the appendix and various diseases mean that doctors should be more vigilant when treating patients who’ve had this organ removed, Dr. Parker said. “When a patient loses an appendix, depending on their environment, there may be effects on infection and cancer. So they might need more regular checkups,” he said. This could include monitoring for IBS and colorectal cancer.

What’s more, Dr. Parker believes that research on the appendix puts even more emphasis on the need to protect the gut microbiome — such as taking probiotics with antibiotics. And while we are still a long way from understanding how exactly this worm-like structure affects various diseases, one thing appears quite certain: The appendix is not useless. “If Darwin had the information that we have, he would not have drawn these conclusions,” Dr. Parker said.
 

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

When doctors and patients consider the appendix, it’s often with urgency. In cases of appendicitis, the clock could be ticking down to a life-threatening burst. Thus, despite recent research suggesting antibiotics could be an alternative therapy, appendectomy remains standard for uncomplicated appendicitis.

But what if removing the appendix could raise the risk for gastrointestinal (GI) diseases like irritable bowel syndrome and colorectal cancer? That’s what some emerging science suggests. And though the research is early and mixed, it’s enough to give some health professionals pause.

“If there’s no reason to remove the appendix, then it’s better to have one,” said Heather Smith, PhD, a comparative anatomist at Midwestern University, Glendale, Arizona. Preemptive removal is not supported by the evidence, she said.

To be fair, we’ve come a long way since 1928, when American physician Miles Breuer, MD, suggested that people with infected appendixes should be left to perish, so as to remove their inferior DNA from the gene pool (he called such people “uncivilized” and “candidates for extinction”). Charles Darwin, while less radical, believed the appendix was at best useless — a mere vestige of our ancestors switching diets from leaves to fruits.

What we know now is that the appendix isn’t just a troublesome piece of worthless flesh. Instead, it may act as a safe house for friendly gut bacteria and a training camp for the immune system. It also appears to play a role in several medical conditions, from ulcerative colitis and colorectal cancer to Parkinson’s disease and lupus. The roughly 300,000 Americans who undergo appendectomy each year should be made aware of this, some experts say. But the frustrating truth is, scientists are still trying to figure out in which cases having an appendix is protective and in which we may be better off without it.
 

A ‘Worm’ as Intestinal Protection

The appendix is a blind pouch (meaning its ending is closed off) that extends from the large intestine. Not all mammals have one; it’s been found in several species of primates and rodents, as well as in rabbits, wombats, and Florida manatees, among others (dogs and cats don’t have it). While a human appendix “looks like a little worm,” Dr. Smith said, these anatomical structures come in various sizes and shapes. Some are thick, as in a beaver, while others are long and spiraling, like a rabbit’s.

Comparative anatomy studies reveal that the appendix has evolved independently at least 29 times throughout mammalian evolution. This suggests that “it has some kind of an adaptive function,” Dr. Smith said. When French scientists analyzed data from 258 species of mammals, they discovered that those that possess an appendix live longer than those without one. A possible explanation, the researchers wrote, may lie with the appendix’s role in preventing diarrhea.

Their 2023 study supported this hypothesis. Based on veterinary records of 45 different species of primates housed in a French zoo, the scientists established that primates with appendixes are far less likely to suffer severe diarrhea than those that don’t possess this organ. The appendix, it appears, might be our tiny weapon against bowel troubles.

For immunologist William Parker, PhD, a visiting scholar at the University of North Carolina at Chapel Hill, these data are “about as good as we could hope for” in support of the idea that the appendix might protect mammals from GI problems. An experiment on humans would be unethical, Dr. Parker said. But observational studies offer clues.

One study showed that compared with people with an intact appendix, young adults with a history of appendectomy have more than double the risk of developing a serious infection with non-typhoidal Salmonella of the kind that would require hospitalization.
 

 

 

A ‘Safe House’ for Bacteria

Such studies add weight to a theory that Dr. Parker and his colleagues developed back in 2007: That the appendix acts as a “safe house” for beneficial gut bacteria.

Think of the colon as a wide pipe, Dr. Parker said, that may become contaminated with a pathogen such as Salmonella. Diarrhea follows, and the pipe gets repeatedly flushed, wiping everything clean, including your friendly gut microbiome. Luckily, “you’ve got this little offshoot of that pipe,” where the flow can’t really get in “because it’s so constricted,” Dr. Parker said. The friendly gut microbes can survive inside the appendix and repopulate the colon once diarrhea is over. Dr. Parker and his colleagues found that the human appendix contains a thick layer of beneficial bacteria. “They were right where we predicted they would be,” he said.

This safe house hypothesis could explain why the gut microbiome may be different in people who no longer have an appendix. In one small study, people who’d had an appendectomy had a less diverse microbiome, with a lower abundance of beneficial strains such as Butyricicoccus and Barnesiella, than did those with intact appendixes.

The appendix likely has a second function, too, Dr. Smith said: It may serve as a training camp for the immune system. “When there is an invading pathogen in the gut, it helps the GI system to mount the immune response,” she said. The human appendix is rich in special cells known as M cells. These act as scouts, detecting and capturing invasive bacteria and viruses and presenting them to the body’s defense team, such as the T lymphocytes.

If the appendix shelters beneficial bacteria and boosts immune response, that may explain its links to various diseases. According to an epidemiological study from Taiwan,patients who underwent an appendectomy have a 46% higher risk of developing irritable bowel syndrome (IBS) — a disease associated with a low abundance of Butyricicoccus bacteria. This is why, the study authors wrote, doctors should pay careful attention to people who’ve had their appendixes removed, monitoring them for potential symptoms of IBS.

The same database helped uncover other connections between appendectomy and disease. For one, there was type 2 diabetes: Within 3 years of the surgery, patients under 30 had double the risk of developing this disorder. Then there was lupus: While those who underwent appendectomy generally had higher risk for this autoimmune disease, women were particularly affected.
 

The Contentious Connections

The most heated scientific discussion surrounds the links between the appendix and conditions such as Parkinson’s disease, ulcerative colitis, and colorectal cancer. A small 2019 study showed, for example, that appendectomy may improve symptoms of certain forms of ulcerative colitis that don’t respond to standard medical treatments. A third of patients improved after their appendix was removed, and 17% fully recovered.

Why? According to Dr. Parker, appendectomy may work for ulcerative colitis because it’s “a way of suppressing the immune system, especially in the lower intestinal areas.” A 2023 meta-analysis found that people who’d had their appendix removed before being diagnosed with ulcerative colitis were less likely to need their colon removed later on.

Such a procedure may have a serious side effect, however: Colorectal cancer. French scientists discovered that removing the appendix may reduce the numbers of certain immune cells called CD3+ and CD8+ T cells, causing a weakened immune surveillance. As a result, tumor cells might escape detection.

Yet the links between appendix removal and cancer are far from clear. A recent meta-analysis found that while people with appendectomies generally had a higher risk for colorectal cancer, for Europeans, these effects were insignificant. In fact, removal of the appendix actually protected European women from this particular form of cancer. For Parker, such mixed results may stem from the fact that treatments and populations vary widely. The issue “may depend on complex social and medical factors,” Dr. Parker said.

Things also appear complicated with Parkinson’s disease — another condition linked to the appendix. A large epidemiological study showed that appendectomy is associated with a lower risk for Parkinson’s disease and a delayed age of Parkinson’s onset. It also found that a normal appendix contains α-synuclein, a protein that may accumulate in the brain and contribute to the development of Parkinson’s. “Although α-synuclein is toxic when in the brain, it appears to be quite normal when present in the appendix,” said Luis Vitetta, PhD, MD, a clinical epidemiologist at the University of Sydney, Camperdown, Australia. Yet, not all studies find that removing the appendix lowers the risk for Parkinson’s. In fact, some show the opposite results.
 

 

 

How Should Doctors View the Appendix?

Even with these mysteries and contradictions, Dr. Vitetta said, a healthy appendix in a healthy body appears to be protective. This is why, he said, when someone is diagnosed with appendicitis, careful assessment is essential before surgery is performed.

“Perhaps an antibiotic can actually help fix it,” he said. A 2020 study published in The New England Journal of Medicine showed that antibiotics may indeed be a good alternative to surgery for the treatment of appendicitis. “We don’t want necessarily to remove an appendix that could be beneficial,” Dr. Smith said.

The many links between the appendix and various diseases mean that doctors should be more vigilant when treating patients who’ve had this organ removed, Dr. Parker said. “When a patient loses an appendix, depending on their environment, there may be effects on infection and cancer. So they might need more regular checkups,” he said. This could include monitoring for IBS and colorectal cancer.

What’s more, Dr. Parker believes that research on the appendix puts even more emphasis on the need to protect the gut microbiome — such as taking probiotics with antibiotics. And while we are still a long way from understanding how exactly this worm-like structure affects various diseases, one thing appears quite certain: The appendix is not useless. “If Darwin had the information that we have, he would not have drawn these conclusions,” Dr. Parker said.
 

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

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In cases of appendicitis, the clock could be ticking down to a life-threatening burst.</metaDescription> <articlePDF/> <teaserImage/> <teaser>It turns out the appendix, as easy to dismiss as it is to remove, may have a vital purpose after all, including protecting us from gastrointestinal and other diseases. </teaser> <title>The Appendix: Is It ’Useless,’ or a Safe House and Immune Training Ground?</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>rn</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>pn</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>oncr</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>nr</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> <journalTitle>Neurology Reviews</journalTitle> <journalFullTitle>Neurology Reviews</journalFullTitle> <copyrightStatement>2018 Frontline Medical Communications Inc.,</copyrightStatement> </publicationData> <publicationData> <publicationCode>mdsurg</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> <journalTitle/> <journalFullTitle/> <copyrightStatement>2018 Frontline Medical Communications Inc.,</copyrightStatement> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>GIHOLD</publicationCode> <pubIssueName>January 2014</pubIssueName> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> <journalTitle/> <journalFullTitle/> <copyrightStatement/> </publicationData> </publications_g> <publications> <term canonical="true">21</term> <term>26</term> <term>25</term> <term>31</term> <term>22</term> <term>52226</term> <term>15</term> </publications> <sections> <term canonical="true">27980</term> <term>39313</term> </sections> <topics> <term canonical="true">213</term> <term>234</term> <term>241</term> <term>269</term> <term>351</term> <term>337</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>The Appendix: Is It ’Useless,’ or a Safe House and Immune Training Ground?</title> <deck/> </itemMeta> <itemContent> <p>When doctors and patients consider the appendix, it’s often with urgency. In cases of appendicitis, the clock could be ticking down to a life-threatening burst. Thus, despite recent research suggesting antibiotics could be an alternative therapy, appendectomy remains standard for uncomplicated appendicitis.</p> <p>But what if removing the appendix could raise the risk for gastrointestinal (GI) diseases like irritable bowel syndrome and colorectal cancer? That’s what some emerging science suggests. And though the research is early and mixed, it’s enough to give some health professionals pause.<br/><br/>“If there’s no reason to remove the appendix, then it’s better to have one,” said Heather Smith, PhD, a comparative anatomist at Midwestern University, Glendale, Arizona. Preemptive removal is not supported by the evidence, she said.<br/><br/>To be fair, we’ve come a long way since 1928, when American physician Miles Breuer, MD, suggested that people with infected appendixes should be left to perish, so as to remove their inferior DNA from the gene pool (he called such people “uncivilized” and “candidates for extinction”). Charles Darwin, while less radical, believed the appendix was at best useless — a mere vestige of our ancestors switching diets from leaves to fruits.<br/><br/>What we know now is that the appendix isn’t just a troublesome piece of worthless flesh. Instead, it may act as a safe house for friendly gut bacteria and a training camp for the immune system. It also appears to play a role in several medical conditions, from ulcerative colitis and colorectal cancer to Parkinson’s disease and lupus. The roughly 300,000 Americans who undergo appendectomy each year should be made aware of this, some experts say. But the frustrating truth is, scientists are still trying to figure out in which cases having an appendix is protective and in which we may be better off without it.<br/><br/></p> <h2>A ‘Worm’ as Intestinal Protection</h2> <p>The appendix is a blind pouch (meaning its ending is closed off) that extends from the large intestine. Not all mammals have one; it’s been found in several species of primates and rodents, as well as in rabbits, wombats, and Florida manatees, among others (dogs and cats don’t have it). While a human appendix “looks like a little worm,” Dr. Smith said, these anatomical structures come in various sizes and shapes. Some are thick, as in a beaver, while others are long and spiraling, like a rabbit’s.</p> <p>Comparative anatomy studies reveal that the appendix has evolved independently at least 29 times throughout mammalian evolution. This suggests that “it has some kind of an adaptive function,” Dr. Smith said. When French scientists analyzed data from 258 species of mammals, they discovered that those that possess an appendix live longer than those without one. A possible explanation, the researchers wrote, may lie with the appendix’s role in preventing diarrhea.<br/><br/>Their 2023 study supported this hypothesis. Based on veterinary records of 45 different species of primates housed in a French zoo, the scientists established that primates with appendixes are far less likely to suffer severe diarrhea than those that don’t possess this organ. The appendix, it appears, might be our tiny weapon against bowel troubles.<br/><br/>For immunologist William Parker, PhD, a visiting scholar at the University of North Carolina at Chapel Hill, these data are “about as good as we could hope for” in support of the idea that the appendix might protect mammals from GI problems. An experiment on humans would be unethical, Dr. Parker said. But observational studies offer clues.<br/><br/>One study showed that compared with people with an intact appendix, young adults with a history of appendectomy have more than double the risk of developing a serious infection with non-typhoidal <em>Salmonella</em> of the kind that would require hospitalization.<br/><br/></p> <h2>A ‘Safe House’ for Bacteria</h2> <p>Such studies add weight to a theory that Dr. Parker and his colleagues developed back in 2007: That the appendix acts as a “safe house” for beneficial gut bacteria.</p> <p>Think of the colon as a wide pipe, Dr. Parker said, that may become contaminated with a pathogen such as <em>Salmonella</em>. Diarrhea follows, and the pipe gets repeatedly flushed, wiping everything clean, including your friendly gut microbiome. Luckily, “you’ve got this little offshoot of that pipe,” where the flow can’t really get in “because it’s so constricted,” Dr. Parker said. The friendly gut microbes can survive inside the appendix and repopulate the colon once diarrhea is over. Dr. Parker and his colleagues found that the human appendix contains a thick layer of beneficial bacteria. “They were right where we predicted they would be,” he said.<br/><br/>This safe house hypothesis could explain why the gut microbiome may be different in people who no longer have an appendix. In one small study, people who’d had an appendectomy had a less diverse microbiome, with a lower abundance of beneficial strains such as <em>Butyricicoccus</em> and <em>Barnesiella</em>, than did those with intact appendixes.<br/><br/>The appendix likely has a second function, too, Dr. Smith said: It may serve as a training camp for the immune system. “When there is an invading pathogen in the gut, it helps the GI system to mount the immune response,” she said. The human appendix is rich in special cells known as M cells. These act as scouts, detecting and capturing invasive bacteria and viruses and presenting them to the body’s defense team, such as the T lymphocytes.<br/><br/>If the appendix shelters beneficial bacteria and boosts immune response, that may explain its links to various diseases. According to an epidemiological study from Taiwan,patients who underwent an appendectomy have a 46% higher risk of developing irritable bowel syndrome (IBS) — a disease associated with a low abundance of Butyricicoccus bacteria. This is why, the study authors wrote, doctors should pay careful attention to people who’ve had their appendixes removed, monitoring them for potential symptoms of IBS.<br/><br/>The same database helped uncover other connections between appendectomy and disease. For one, there was type 2 diabetes: Within 3 years of the surgery, patients under 30 had double the risk of developing this disorder. Then there was lupus: While those who underwent appendectomy generally had higher risk for this autoimmune disease, women were particularly affected.<br/><br/></p> <h2>The Contentious Connections</h2> <p>The most heated scientific discussion surrounds the links between the appendix and conditions such as Parkinson’s disease, ulcerative colitis, and colorectal cancer. A small 2019 study showed, for example, that appendectomy may improve symptoms of certain forms of ulcerative colitis that don’t respond to standard medical treatments. A third of patients improved after their appendix was removed, and 17% fully recovered.</p> <p>Why? According to Dr. Parker, appendectomy may work for ulcerative colitis because it’s “a way of suppressing the immune system, especially in the lower intestinal areas.” A 2023 meta-analysis found that people who’d had their appendix removed before being diagnosed with ulcerative colitis were less likely to need their colon removed later on.<br/><br/>Such a procedure may have a serious side effect, however: Colorectal cancer. French scientists discovered that removing the appendix may reduce the numbers of certain immune cells called CD3+ and CD8+ T cells, causing a weakened immune surveillance. As a result, tumor cells might escape detection.<br/><br/>Yet the links between appendix removal and cancer are far from clear. A recent meta-analysis found that while people with appendectomies generally had a higher risk for colorectal cancer, for Europeans, these effects were insignificant. In fact, removal of the appendix actually protected European women from this particular form of cancer. For Parker, such mixed results may stem from the fact that treatments and populations vary widely. The issue “may depend on complex social and medical factors,” Dr. Parker said.<br/><br/>Things also appear complicated with Parkinson’s disease — another condition linked to the appendix. A large epidemiological study showed that appendectomy is associated with a lower risk for Parkinson’s disease and a delayed age of Parkinson’s onset. It also found that a normal appendix contains α-synuclein, a protein that may accumulate in the brain and contribute to the development of Parkinson’s. “Although α-synuclein is toxic when in the brain, it appears to be quite normal when present in the appendix,” said Luis Vitetta, PhD, MD, a clinical epidemiologist at the University of Sydney, Camperdown, Australia. Yet, not all studies find that removing the appendix lowers the risk for Parkinson’s. In fact, some show the opposite results.<br/><br/></p> <h2>How Should Doctors View the Appendix?</h2> <p>Even with these mysteries and contradictions, Dr. Vitetta said, a healthy appendix in a healthy body appears to be protective. This is why, he said, when someone is diagnosed with appendicitis, careful assessment is essential before surgery is performed.</p> <p>“Perhaps an antibiotic can actually help fix it,” he said. A 2020 study published in <em>The New England Journal of Medicine</em> showed that antibiotics may indeed be a good alternative to surgery for the treatment of appendicitis. “We don’t want necessarily to remove an appendix that could be beneficial,” Dr. Smith said.<br/><br/>The many links between the appendix and various diseases mean that doctors should be more vigilant when treating patients who’ve had this organ removed, Dr. Parker said. “When a patient loses an appendix, depending on their environment, there may be effects on infection and cancer. So they might need more regular checkups,” he said. This could include monitoring for IBS and colorectal cancer.<br/><br/>What’s more, Dr. Parker believes that research on the appendix puts even more emphasis on the need to protect the gut microbiome — such as taking probiotics with antibiotics. And while we are still a long way from understanding how exactly this worm-like structure affects various diseases, one thing appears quite certain: The appendix is not useless. “If Darwin had the information that we have, he would not have drawn these conclusions,” Dr. Parker said.<br/><br/></p> <p> <em>A version of this article first appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/useless-appendix-more-fascinating-than-we-thought-2024a1000au9">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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Young People’s Gut Bacteria May Drive Colorectal Cancer Risk

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CHICAGO — Genetics and diet have been among the top theories for what may be fueling the troubling rise of colorectal cancer in young adults. Now, an early look at genetic data from people with colorectal cancer further suggests that the cause is linked to what is happening in the gut.

The findings were presented at the annual meeting of the American Society for Clinical Oncology (ASCO) by researchers from Ohio State University. For the analysis, they analyzed genetic data on tumors.

The researchers found signs that a high-fat, low-fiber diet may increase inflammation in the gut that prevents it from naturally suppressing tumors. The cells of young people with colorectal cancer also appeared to have aged more quickly — by 15 years on average — than a person’s actual age. That’s unusual, because older people with colorectal cancer don’t have the same boost in cellular aging.

The rate of colorectal cancer among young people has been rising at an alarming rate, according to a 2023 report from the American Cancer Society. In 2019, one in five colorectal cancer cases were among people younger than 55. That’s up from 1 in 10 in 1995, which means the rate has doubled in less than 30 years.
 

Need Colon Cancer Screening?

Who needs a colorectal cancer screening? Ask colorectal cancer specialist Nancy Kemeny, MD.

2017 analysis estimated that a person’s risk of colorectal cancer increased 12% by eating 3.5 ounces of red or processed meat daily, which is the equivalent of the size of a deck of playing cards. The same study also linked colorectal cancer risk to alcohol intake, citing its ethanol content. Eating a diet high in fiber can reduce a person’s risk.

This latest study aligned with previous findings that link bacteria called Fusobacterium to colorectal cancer. It’s not unusual for Fusobacterium to be present in a person’s mouth, but it is more likely to be found in the intestines of colorectal cancer patients, compared with those of healthy people. One study even found that people with colorectal cancer were five times more likely to have Fusobacterium in their stool, compared with healthy people.

Colorectal cancer is more common among men than women, “likely reflecting differences in risk factor prevalence, such as excess body weight and processed meat consumption,” the authors of the 2023 American Cancer Society report explained.

People younger than 45 should alert their medical provider if they have constipation, rectal bleeding, or sudden changes in bowel movements, which can be symptoms of colorectal cancer. Screening for colorectal cancer should begin for most people at age 45.

A version of this article appeared on WebMD.com.

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CHICAGO — Genetics and diet have been among the top theories for what may be fueling the troubling rise of colorectal cancer in young adults. Now, an early look at genetic data from people with colorectal cancer further suggests that the cause is linked to what is happening in the gut.

The findings were presented at the annual meeting of the American Society for Clinical Oncology (ASCO) by researchers from Ohio State University. For the analysis, they analyzed genetic data on tumors.

The researchers found signs that a high-fat, low-fiber diet may increase inflammation in the gut that prevents it from naturally suppressing tumors. The cells of young people with colorectal cancer also appeared to have aged more quickly — by 15 years on average — than a person’s actual age. That’s unusual, because older people with colorectal cancer don’t have the same boost in cellular aging.

The rate of colorectal cancer among young people has been rising at an alarming rate, according to a 2023 report from the American Cancer Society. In 2019, one in five colorectal cancer cases were among people younger than 55. That’s up from 1 in 10 in 1995, which means the rate has doubled in less than 30 years.
 

Need Colon Cancer Screening?

Who needs a colorectal cancer screening? Ask colorectal cancer specialist Nancy Kemeny, MD.

2017 analysis estimated that a person’s risk of colorectal cancer increased 12% by eating 3.5 ounces of red or processed meat daily, which is the equivalent of the size of a deck of playing cards. The same study also linked colorectal cancer risk to alcohol intake, citing its ethanol content. Eating a diet high in fiber can reduce a person’s risk.

This latest study aligned with previous findings that link bacteria called Fusobacterium to colorectal cancer. It’s not unusual for Fusobacterium to be present in a person’s mouth, but it is more likely to be found in the intestines of colorectal cancer patients, compared with those of healthy people. One study even found that people with colorectal cancer were five times more likely to have Fusobacterium in their stool, compared with healthy people.

Colorectal cancer is more common among men than women, “likely reflecting differences in risk factor prevalence, such as excess body weight and processed meat consumption,” the authors of the 2023 American Cancer Society report explained.

People younger than 45 should alert their medical provider if they have constipation, rectal bleeding, or sudden changes in bowel movements, which can be symptoms of colorectal cancer. Screening for colorectal cancer should begin for most people at age 45.

A version of this article appeared on WebMD.com.

CHICAGO — Genetics and diet have been among the top theories for what may be fueling the troubling rise of colorectal cancer in young adults. Now, an early look at genetic data from people with colorectal cancer further suggests that the cause is linked to what is happening in the gut.

The findings were presented at the annual meeting of the American Society for Clinical Oncology (ASCO) by researchers from Ohio State University. For the analysis, they analyzed genetic data on tumors.

The researchers found signs that a high-fat, low-fiber diet may increase inflammation in the gut that prevents it from naturally suppressing tumors. The cells of young people with colorectal cancer also appeared to have aged more quickly — by 15 years on average — than a person’s actual age. That’s unusual, because older people with colorectal cancer don’t have the same boost in cellular aging.

The rate of colorectal cancer among young people has been rising at an alarming rate, according to a 2023 report from the American Cancer Society. In 2019, one in five colorectal cancer cases were among people younger than 55. That’s up from 1 in 10 in 1995, which means the rate has doubled in less than 30 years.
 

Need Colon Cancer Screening?

Who needs a colorectal cancer screening? Ask colorectal cancer specialist Nancy Kemeny, MD.

2017 analysis estimated that a person’s risk of colorectal cancer increased 12% by eating 3.5 ounces of red or processed meat daily, which is the equivalent of the size of a deck of playing cards. The same study also linked colorectal cancer risk to alcohol intake, citing its ethanol content. Eating a diet high in fiber can reduce a person’s risk.

This latest study aligned with previous findings that link bacteria called Fusobacterium to colorectal cancer. It’s not unusual for Fusobacterium to be present in a person’s mouth, but it is more likely to be found in the intestines of colorectal cancer patients, compared with those of healthy people. One study even found that people with colorectal cancer were five times more likely to have Fusobacterium in their stool, compared with healthy people.

Colorectal cancer is more common among men than women, “likely reflecting differences in risk factor prevalence, such as excess body weight and processed meat consumption,” the authors of the 2023 American Cancer Society report explained.

People younger than 45 should alert their medical provider if they have constipation, rectal bleeding, or sudden changes in bowel movements, which can be symptoms of colorectal cancer. Screening for colorectal cancer should begin for most people at age 45.

A version of this article appeared on WebMD.com.

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All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>an early look at genetic data from people with colorectal cancer further suggests that the cause is linked to what is happening in the gut.</metaDescription> <articlePDF/> <teaserImage/> <teaser>Researchers found signs that a high-fat, low-fiber diet may increase inflammation in the gut that prevents it from naturally suppressing tumors.</teaser> <title>Young People’s Gut Bacteria May Drive Colorectal Cancer Risk</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear>2024</pubPubdateYear> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>OP</publicationCode> <pubIssueName>March 2014</pubIssueName> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> <journalTitle>J Community Support Oncol</journalTitle> <journalFullTitle>The Journal of community and supportive oncology.</journalFullTitle> <copyrightStatement>Copyright Frontline Medical Communications Inc.</copyrightStatement> </publicationData> <publicationData> <publicationCode>PN</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> <journalTitle/> <journalFullTitle/> <copyrightStatement/> </publicationData> <publicationData> <publicationCode>oncr</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term>25</term> <term canonical="true">31</term> </publications> <sections> <term canonical="true">53</term> <term>39313</term> </sections> <topics> <term canonical="true">271</term> <term>263</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Young People’s Gut Bacteria May Drive Colorectal Cancer Risk</title> <deck/> </itemMeta> <itemContent> <p>CHICAGO — Genetics and diet have been among the top theories for what may be fueling the troubling rise of colorectal cancer in young adults. Now, <span class="tag metaDescription">an early look at genetic data from people with colorectal cancer further suggests that the cause is linked to what is happening in the gut.</span></p> <p>The findings were presented at the annual meeting of the American Society for Clinical Oncology (ASCO) by researchers from Ohio State University. For the analysis, they analyzed genetic data on tumors.<br/><br/>The researchers found signs that a high-fat, low-fiber diet may increase inflammation in the gut that prevents it from naturally suppressing tumors. The cells of young people with colorectal cancer also appeared to have aged more quickly — by 15 years on average — than a person’s actual age. That’s unusual, because older people with colorectal cancer don’t have the same boost in cellular aging.<br/><br/>The rate of colorectal cancer among young people has been rising at an alarming rate, according to a 2023 report from the <a href="https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/colorectal-cancer-facts-and-figures/colorectal-cancer-facts-and-figures-2023.pdf">American Cancer Society</a>. In 2019, one in five colorectal cancer cases were among people younger than 55. That’s up from 1 in 10 in 1995, which means the rate has doubled in less than 30 years.<br/><br/></p> <h2>Need Colon Cancer Screening?</h2> <p>Who needs a colorectal cancer screening? Ask colorectal cancer specialist Nancy Kemeny, MD.</p> <p>A <a href="https://www.annalsofoncology.org/article/S0923-7534(19)32133-7/fulltext">2017 analysis</a> estimated that a person’s risk of colorectal cancer increased 12% by eating 3.5 ounces of red or processed meat daily, which is the equivalent of the size of a deck of playing cards. The same study also linked colorectal cancer risk to alcohol intake, citing its ethanol content. Eating a diet high in fiber can reduce a person’s risk.<br/><br/>This latest study aligned with previous findings that link bacteria called <em>Fusobacterium</em> to colorectal cancer. It’s not unusual for <em>Fusobacterium</em> to be present in a person’s mouth, but it is more likely to be found in the intestines of colorectal cancer patients, compared with those of healthy people. One study even found that people with colorectal cancer were five times more likely to have <em>Fusobacterium</em> in their stool, compared with healthy people.<br/><br/>Colorectal cancer is more common among men than women, “likely reflecting differences in risk factor prevalence, such as excess body weight and processed meat consumption,” the authors of the 2023 American Cancer Society report explained.<br/><br/>People younger than 45 should alert their medical provider if they have constipation, rectal bleeding, or sudden changes in bowel movements, which can be <a href="https://www.yalemedicine.org/news/colorectal-cancer-in-young-people">symptoms of colorectal cancer</a>. Screening for colorectal cancer should begin for most people at age 45.<span class="end"/></p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/s/viewarticle/young-peoples-gut-bacteria-may-drive-colorectal-cancer-risk-2024a1000amd">WebMD.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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Red Flags for Early-Onset Colorectal Cancer Identified

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Mon, 06/10/2024 - 17:08

 

TOPLINE:

Patients with early-onset colorectal cancer (EOCRC) often present with hematochezia or abdominal pain, symptoms frequently overlooked in younger populations, leading to delays in diagnosis of 4-6 months, a new analysis showed.

METHODOLOGY:

  • As the number of cases of EOCRC, defined as colorectal cancer (CRC) diagnosed before age 50, continues to rise, early detection has become increasingly important. Improved recognition of presenting signs and symptoms associated with EOCRC could lead to a more timely diagnosis and better clinical outcomes.
  • In a systematic review and meta-analysis of 81 studies with 24.9 million EOCRC cases, researchers sought to determine the most common presenting signs and symptoms, their association with EOCRC risk, and the time from presentation to diagnosis.
  • Data extraction and quality assessment were performed independently in duplicate using PRISMA guidelines, and Joanna Briggs Institute critical appraisal tools were used to measure the risk of bias.

TAKEAWAY:

  • Hematochezia was the most common presenting sign/symptom, with a pooled prevalence of 45%, followed by abdominal pain, with a pooled prevalence of 40%.
  • Altered bowel habits, which included constipation, diarrhea, and alternating bowel habits, were the third most common presenting sign/symptom (pooled prevalence of 27%), followed by unexplained weight loss (pooled prevalence of 17%).
  • The likelihood of EOCRC was estimated to be fivefold to 54-fold higher with hematochezia and 1.3-fold to sixfold higher with abdominal pain.
  • The mean time from sign or symptom onset to EOCRC diagnosis was 6.4 months (range, 1.8-13.7 months).

IN PRACTICE:

“These findings and the increasing risk of CRC in individuals younger than 50 years highlight the urgent need to educate clinicians and patients about these signs and symptoms to ensure that diagnostic workup and resolution are not delayed. Adapting current clinical practice to identify and address these signs and symptoms through careful clinical triage and follow-up could help limit morbidity and mortality associated with EOCRC,” the authors wrote.

SOURCE:

The study, with Joshua Demb, PhD, MPH, division of gastroenterology, department of medicine, University of California, San Diego, was published online May 24 in JAMA Network Open.

LIMITATIONS:

Significant heterogeneity across studies affected the ability to meta-analyze some results. The cross-sectional data limited the ability to stratify by age, sex, race and ethnicity, or genetic ancestry. It was not possible to evaluate the impact of time to diagnosis on CRC outcomes due to a limited number of studies answering this question. Researchers were unable to examine the constellation of signs and symptoms because they lacked individual-level data from each study.

DISCLOSURES:

The authors disclosed no relevant conflicts of interest. No specific funding was disclosed.
 

A version of this article appeared on Medscape.com.

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TOPLINE:

Patients with early-onset colorectal cancer (EOCRC) often present with hematochezia or abdominal pain, symptoms frequently overlooked in younger populations, leading to delays in diagnosis of 4-6 months, a new analysis showed.

METHODOLOGY:

  • As the number of cases of EOCRC, defined as colorectal cancer (CRC) diagnosed before age 50, continues to rise, early detection has become increasingly important. Improved recognition of presenting signs and symptoms associated with EOCRC could lead to a more timely diagnosis and better clinical outcomes.
  • In a systematic review and meta-analysis of 81 studies with 24.9 million EOCRC cases, researchers sought to determine the most common presenting signs and symptoms, their association with EOCRC risk, and the time from presentation to diagnosis.
  • Data extraction and quality assessment were performed independently in duplicate using PRISMA guidelines, and Joanna Briggs Institute critical appraisal tools were used to measure the risk of bias.

TAKEAWAY:

  • Hematochezia was the most common presenting sign/symptom, with a pooled prevalence of 45%, followed by abdominal pain, with a pooled prevalence of 40%.
  • Altered bowel habits, which included constipation, diarrhea, and alternating bowel habits, were the third most common presenting sign/symptom (pooled prevalence of 27%), followed by unexplained weight loss (pooled prevalence of 17%).
  • The likelihood of EOCRC was estimated to be fivefold to 54-fold higher with hematochezia and 1.3-fold to sixfold higher with abdominal pain.
  • The mean time from sign or symptom onset to EOCRC diagnosis was 6.4 months (range, 1.8-13.7 months).

IN PRACTICE:

“These findings and the increasing risk of CRC in individuals younger than 50 years highlight the urgent need to educate clinicians and patients about these signs and symptoms to ensure that diagnostic workup and resolution are not delayed. Adapting current clinical practice to identify and address these signs and symptoms through careful clinical triage and follow-up could help limit morbidity and mortality associated with EOCRC,” the authors wrote.

SOURCE:

The study, with Joshua Demb, PhD, MPH, division of gastroenterology, department of medicine, University of California, San Diego, was published online May 24 in JAMA Network Open.

LIMITATIONS:

Significant heterogeneity across studies affected the ability to meta-analyze some results. The cross-sectional data limited the ability to stratify by age, sex, race and ethnicity, or genetic ancestry. It was not possible to evaluate the impact of time to diagnosis on CRC outcomes due to a limited number of studies answering this question. Researchers were unable to examine the constellation of signs and symptoms because they lacked individual-level data from each study.

DISCLOSURES:

The authors disclosed no relevant conflicts of interest. No specific funding was disclosed.
 

A version of this article appeared on Medscape.com.

 

TOPLINE:

Patients with early-onset colorectal cancer (EOCRC) often present with hematochezia or abdominal pain, symptoms frequently overlooked in younger populations, leading to delays in diagnosis of 4-6 months, a new analysis showed.

METHODOLOGY:

  • As the number of cases of EOCRC, defined as colorectal cancer (CRC) diagnosed before age 50, continues to rise, early detection has become increasingly important. Improved recognition of presenting signs and symptoms associated with EOCRC could lead to a more timely diagnosis and better clinical outcomes.
  • In a systematic review and meta-analysis of 81 studies with 24.9 million EOCRC cases, researchers sought to determine the most common presenting signs and symptoms, their association with EOCRC risk, and the time from presentation to diagnosis.
  • Data extraction and quality assessment were performed independently in duplicate using PRISMA guidelines, and Joanna Briggs Institute critical appraisal tools were used to measure the risk of bias.

TAKEAWAY:

  • Hematochezia was the most common presenting sign/symptom, with a pooled prevalence of 45%, followed by abdominal pain, with a pooled prevalence of 40%.
  • Altered bowel habits, which included constipation, diarrhea, and alternating bowel habits, were the third most common presenting sign/symptom (pooled prevalence of 27%), followed by unexplained weight loss (pooled prevalence of 17%).
  • The likelihood of EOCRC was estimated to be fivefold to 54-fold higher with hematochezia and 1.3-fold to sixfold higher with abdominal pain.
  • The mean time from sign or symptom onset to EOCRC diagnosis was 6.4 months (range, 1.8-13.7 months).

IN PRACTICE:

“These findings and the increasing risk of CRC in individuals younger than 50 years highlight the urgent need to educate clinicians and patients about these signs and symptoms to ensure that diagnostic workup and resolution are not delayed. Adapting current clinical practice to identify and address these signs and symptoms through careful clinical triage and follow-up could help limit morbidity and mortality associated with EOCRC,” the authors wrote.

SOURCE:

The study, with Joshua Demb, PhD, MPH, division of gastroenterology, department of medicine, University of California, San Diego, was published online May 24 in JAMA Network Open.

LIMITATIONS:

Significant heterogeneity across studies affected the ability to meta-analyze some results. The cross-sectional data limited the ability to stratify by age, sex, race and ethnicity, or genetic ancestry. It was not possible to evaluate the impact of time to diagnosis on CRC outcomes due to a limited number of studies answering this question. Researchers were unable to examine the constellation of signs and symptoms because they lacked individual-level data from each study.

DISCLOSURES:

The authors disclosed no relevant conflicts of interest. No specific funding was disclosed.
 

A version of this article appeared on Medscape.com.

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All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>Patients with early-onset colorectal cancer (EOCRC) often present with hematochezia or abdominal pain, symptoms frequently overlooked in younger populations, le</metaDescription> <articlePDF/> <teaserImage/> <teaser>Hematochezia was the most common presenting sign/symptom, followed by abdominal pain.</teaser> <title>Red Flags for Early-Onset Colorectal Cancer Identified</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>GIHOLD</publicationCode> <pubIssueName>January 2014</pubIssueName> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> <journalTitle/> <journalFullTitle/> <copyrightStatement/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>oncr</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term>15</term> <term canonical="true">21</term> <term>31</term> </publications> <sections> <term>27970</term> <term canonical="true">39313</term> </sections> <topics> <term>182</term> <term canonical="true">213</term> <term>263</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Red Flags for Early-Onset Colorectal Cancer Identified</title> <deck/> </itemMeta> <itemContent> <h2>TOPLINE:</h2> <p>Patients with early-onset colorectal cancer (EOCRC) often present with hematochezia or abdominal pain, symptoms frequently overlooked in younger populations, leading to delays in diagnosis of 4-6 months, a new analysis showed.</p> <h2>METHODOLOGY:</h2> <ul class="body"> <li>As the number of cases of EOCRC, defined as colorectal cancer (CRC) diagnosed before age 50, continues to rise, early detection has become increasingly important. Improved recognition of presenting signs and symptoms associated with EOCRC could lead to a more timely diagnosis and better clinical outcomes.</li> <li>In a systematic review and meta-analysis of 81 studies with 24.9 million EOCRC cases, researchers sought to determine the most common presenting signs and symptoms, their association with EOCRC risk, and the time from presentation to diagnosis.</li> <li>Data extraction and quality assessment were performed independently in duplicate using PRISMA guidelines, and Joanna Briggs Institute critical appraisal tools were used to measure the risk of bias.</li> </ul> <h2>TAKEAWAY:</h2> <ul class="body"> <li>Hematochezia was the most common presenting sign/symptom, with a pooled prevalence of 45%, followed by abdominal pain, with a pooled prevalence of 40%.</li> <li>Altered bowel habits, which included constipation, diarrhea, and alternating bowel habits, were the third most common presenting sign/symptom (pooled prevalence of 27%), followed by unexplained weight loss (pooled prevalence of 17%).</li> <li>The likelihood of EOCRC was estimated to be fivefold to 54-fold higher with hematochezia and 1.3-fold to sixfold higher with abdominal pain.</li> <li>The mean time from sign or symptom onset to EOCRC diagnosis was 6.4 months (range, 1.8-13.7 months).</li> </ul> <h2>IN PRACTICE:</h2> <p>“These findings and the increasing risk of CRC in individuals younger than 50 years highlight the urgent need to educate clinicians and patients about these signs and symptoms to ensure that diagnostic workup and resolution are not delayed. Adapting current clinical practice to identify and address these signs and symptoms through careful clinical triage and follow-up could help limit morbidity and mortality associated with EOCRC,” the authors wrote.</p> <h2>SOURCE:</h2> <p>The study, with Joshua Demb, PhD, MPH, division of gastroenterology, department of medicine, University of California, San Diego, was <span class="Hyperlink"><a href="https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2819248">published online</a></span> May 24 in <em>JAMA Network Open</em>.</p> <h2>LIMITATIONS:</h2> <p>Significant heterogeneity across studies affected the ability to meta-analyze some results. The cross-sectional data limited the ability to stratify by age, sex, race and ethnicity, or genetic ancestry. It was not possible to evaluate the impact of time to diagnosis on CRC outcomes due to a limited number of studies answering this question. Researchers were unable to examine the constellation of signs and symptoms because they lacked individual-level data from each study.</p> <h2>DISCLOSURES:</h2> <p>The authors disclosed no relevant conflicts of interest. No specific funding was disclosed.<br/><br/></p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/red-flags-early-onset-colorectal-cancer-identified-2024a1000afn">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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Late-Night Eaters May Have Increased Risk for Colorectal Cancer

Article Type
Changed
Mon, 06/10/2024 - 17:11

 

WASHINGTON — Eating within 3 hours of bedtime at least 4 days a week could increase chances for developing colorectal cancer, according to the results of research presented at the annual Digestive Disease Week® (DDW).

Investigators in a new study questioned 664 people getting a colonoscopy to screen for cancer, and 42% said they were late eaters. This group was 46% more likely than non–late eaters to have an adenoma found during colonoscopy. An estimated 5% to 10% of them become cancerous over time.

“A lot of other studies are about what we eat but not when we eat,” said Edena Khoshaba, lead investigator and a medical student at Rush University Medical College in Chicago. “The common advice includes not eating red meat, eating more fruits and vegetables — which is great, of course — but we wanted to see if the timing affects us at all.”

Ms. Khoshaba and colleagues found it did. Late eaters were 5.5 times more likely to have three or more tubular adenomas compared to non–late eaters, even after adjusting for what people were eating. Tubular adenomas are the most common type of polyp found in the colon.

So, what’s the possible connection between late eating and the risk for colorectal cancer?
 

Resetting Your Internal Clock

Eating close to bedtime could be throwing off the body’s circadian rhythm. But in this case, it’s not the central circadian center located in the brain — the one that releases melatonin. Instead, late eating could disrupt the peripheral circadian rhythm, part of which is found in the GI tract. For example, if a person is eating late at night, the brain thinks it is nighttime while the gut thinks it is daytime, Ms. Khoshaba said in an interview.

This is an interesting study, said Amy Bragagnini, MS, RD, spokesperson for the Academy of Nutrition and Dietetics, when asked to comment on the research. “It is true that eating later at night can disrupt your circadian rhythm.”

“In addition, many of my patients have told me that when they do eat later at night, they don’t always make the healthiest food choices,” Ms. Bragagnini said. “Their late-night food choices are generally higher in added sugar and fat. This may cause them to consume far more calories than their body needs.” So, eating late at night can also lead to unwanted weight gain.

An unanswered question is if late eating is connected in any way at all to increasing rates of colorectal cancer seen in younger patients.

This was an observational study, and another possible limitation, Ms. Khoshaba said, is that people were asked to recall their diets over 24 hours, which may not always be accurate.

Some of the organisms in the gut have their own internal clocks that follow a daily rhythm, and what someone eat determines how many different kinds of these organisms are active, Ms. Bragagnini said.

“So, if your late-night eating consists of foods high in sugar and fat, you may be negatively impacting your microbiome.” she said.

The next step for Ms. Khoshaba and colleagues is a study examining the peripheral circadian rhythm, changes in the gut microbiome, and the risk for developing metabolic syndrome. Ms. Khoshaba and Ms. Bragagnini had no relevant disclosures.

A version of this article appeared on Medscape.com.

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WASHINGTON — Eating within 3 hours of bedtime at least 4 days a week could increase chances for developing colorectal cancer, according to the results of research presented at the annual Digestive Disease Week® (DDW).

Investigators in a new study questioned 664 people getting a colonoscopy to screen for cancer, and 42% said they were late eaters. This group was 46% more likely than non–late eaters to have an adenoma found during colonoscopy. An estimated 5% to 10% of them become cancerous over time.

“A lot of other studies are about what we eat but not when we eat,” said Edena Khoshaba, lead investigator and a medical student at Rush University Medical College in Chicago. “The common advice includes not eating red meat, eating more fruits and vegetables — which is great, of course — but we wanted to see if the timing affects us at all.”

Ms. Khoshaba and colleagues found it did. Late eaters were 5.5 times more likely to have three or more tubular adenomas compared to non–late eaters, even after adjusting for what people were eating. Tubular adenomas are the most common type of polyp found in the colon.

So, what’s the possible connection between late eating and the risk for colorectal cancer?
 

Resetting Your Internal Clock

Eating close to bedtime could be throwing off the body’s circadian rhythm. But in this case, it’s not the central circadian center located in the brain — the one that releases melatonin. Instead, late eating could disrupt the peripheral circadian rhythm, part of which is found in the GI tract. For example, if a person is eating late at night, the brain thinks it is nighttime while the gut thinks it is daytime, Ms. Khoshaba said in an interview.

This is an interesting study, said Amy Bragagnini, MS, RD, spokesperson for the Academy of Nutrition and Dietetics, when asked to comment on the research. “It is true that eating later at night can disrupt your circadian rhythm.”

“In addition, many of my patients have told me that when they do eat later at night, they don’t always make the healthiest food choices,” Ms. Bragagnini said. “Their late-night food choices are generally higher in added sugar and fat. This may cause them to consume far more calories than their body needs.” So, eating late at night can also lead to unwanted weight gain.

An unanswered question is if late eating is connected in any way at all to increasing rates of colorectal cancer seen in younger patients.

This was an observational study, and another possible limitation, Ms. Khoshaba said, is that people were asked to recall their diets over 24 hours, which may not always be accurate.

Some of the organisms in the gut have their own internal clocks that follow a daily rhythm, and what someone eat determines how many different kinds of these organisms are active, Ms. Bragagnini said.

“So, if your late-night eating consists of foods high in sugar and fat, you may be negatively impacting your microbiome.” she said.

The next step for Ms. Khoshaba and colleagues is a study examining the peripheral circadian rhythm, changes in the gut microbiome, and the risk for developing metabolic syndrome. Ms. Khoshaba and Ms. Bragagnini had no relevant disclosures.

A version of this article appeared on Medscape.com.

 

WASHINGTON — Eating within 3 hours of bedtime at least 4 days a week could increase chances for developing colorectal cancer, according to the results of research presented at the annual Digestive Disease Week® (DDW).

Investigators in a new study questioned 664 people getting a colonoscopy to screen for cancer, and 42% said they were late eaters. This group was 46% more likely than non–late eaters to have an adenoma found during colonoscopy. An estimated 5% to 10% of them become cancerous over time.

“A lot of other studies are about what we eat but not when we eat,” said Edena Khoshaba, lead investigator and a medical student at Rush University Medical College in Chicago. “The common advice includes not eating red meat, eating more fruits and vegetables — which is great, of course — but we wanted to see if the timing affects us at all.”

Ms. Khoshaba and colleagues found it did. Late eaters were 5.5 times more likely to have three or more tubular adenomas compared to non–late eaters, even after adjusting for what people were eating. Tubular adenomas are the most common type of polyp found in the colon.

So, what’s the possible connection between late eating and the risk for colorectal cancer?
 

Resetting Your Internal Clock

Eating close to bedtime could be throwing off the body’s circadian rhythm. But in this case, it’s not the central circadian center located in the brain — the one that releases melatonin. Instead, late eating could disrupt the peripheral circadian rhythm, part of which is found in the GI tract. For example, if a person is eating late at night, the brain thinks it is nighttime while the gut thinks it is daytime, Ms. Khoshaba said in an interview.

This is an interesting study, said Amy Bragagnini, MS, RD, spokesperson for the Academy of Nutrition and Dietetics, when asked to comment on the research. “It is true that eating later at night can disrupt your circadian rhythm.”

“In addition, many of my patients have told me that when they do eat later at night, they don’t always make the healthiest food choices,” Ms. Bragagnini said. “Their late-night food choices are generally higher in added sugar and fat. This may cause them to consume far more calories than their body needs.” So, eating late at night can also lead to unwanted weight gain.

An unanswered question is if late eating is connected in any way at all to increasing rates of colorectal cancer seen in younger patients.

This was an observational study, and another possible limitation, Ms. Khoshaba said, is that people were asked to recall their diets over 24 hours, which may not always be accurate.

Some of the organisms in the gut have their own internal clocks that follow a daily rhythm, and what someone eat determines how many different kinds of these organisms are active, Ms. Bragagnini said.

“So, if your late-night eating consists of foods high in sugar and fat, you may be negatively impacting your microbiome.” she said.

The next step for Ms. Khoshaba and colleagues is a study examining the peripheral circadian rhythm, changes in the gut microbiome, and the risk for developing metabolic syndrome. Ms. Khoshaba and Ms. Bragagnini had no relevant disclosures.

A version of this article appeared on Medscape.com.

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All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>Eating within 3 hours of bedtime at least 4 days a week could increase chances for developing colorectal cancer</metaDescription> <articlePDF/> <teaserImage/> <teaser>Late eating could disrupt the peripheral circadian rhythm, part of which is found in the GI tract.</teaser> <title>Late-Night Eaters May Have Increased Risk for Colorectal Cancer</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>oncr</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>GIHOLD</publicationCode> <pubIssueName>January 2014</pubIssueName> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> <journalTitle/> <journalFullTitle/> <copyrightStatement/> </publicationData> </publications_g> <publications> <term canonical="true">21</term> <term>15</term> <term>31</term> </publications> <sections> <term canonical="true">53</term> <term>39313</term> </sections> <topics> <term>263</term> <term canonical="true">213</term> <term>49620</term> <term>67020</term> <term>280</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Late-Night Eaters May Have Increased Risk for Colorectal Cancer</title> <deck/> </itemMeta> <itemContent> <p>WASHINGTON — <span class="tag metaDescription">Eating within 3 hours of bedtime at least 4 days a week could increase chances for developing colorectal cancer</span>, according to the results of research presented at the annual Digestive Disease Week<sup>®</sup> (DDW).</p> <p>Investigators in a new study questioned 664 people getting a colonoscopy to screen for cancer, and 42% said they were late eaters. This group was 46% more likely than non–late eaters to have an adenoma found during colonoscopy. An estimated 5% to 10% of them become cancerous over time.<br/><br/>“A lot of other studies are about what we eat but not when we eat,” said Edena Khoshaba, lead investigator and a medical student at Rush University Medical College in Chicago. “The common advice includes not eating red meat, eating more fruits and vegetables — which is great, of course — but we wanted to see if the timing affects us at all.”<br/><br/>Ms. Khoshaba and colleagues found it did. Late eaters were 5.5 times more likely to have three or more <span class="Hyperlink"><a href="https://www.webmd.com/colorectal-cancer/colorectal-tubular-adenoma">tubular adenomas</a></span> compared to non–late eaters, even after adjusting for what people were eating. Tubular adenomas are the most common type of polyp found in the colon.<br/><br/>So, what’s the possible connection between late eating and the risk for colorectal cancer?<br/><br/></p> <h2>Resetting Your Internal Clock</h2> <p>Eating close to bedtime could be throwing off the body’s circadian rhythm. But in this case, it’s not the central circadian center located in the brain — the one that releases melatonin. Instead, late eating could disrupt the peripheral circadian rhythm, part of which is found in the GI tract. For example, if a person is eating late at night, the brain thinks it is nighttime while the gut thinks it is daytime, Ms. Khoshaba said in an interview.</p> <p>This is an interesting study, said Amy Bragagnini, MS, RD, spokesperson for the Academy of Nutrition and Dietetics, when asked to comment on the research. “It is true that eating later at night can disrupt your circadian rhythm.”<br/><br/>“In addition, many of my patients have told me that when they do eat later at night, they don’t always make the healthiest food choices,” Ms. Bragagnini said. “Their late-night food choices are generally higher in added sugar and fat. This may cause them to consume far more calories than their body needs.” So, eating late at night can also lead to unwanted weight gain.<br/><br/>An unanswered question is if late eating is connected in any way at all to increasing rates of colorectal cancer <span class="Hyperlink"><a href="https://www.webmd.com/colorectal-cancer/news/20240515/behind-the-spike-in-colorectal-cancer-cases">seen in younger patients</a></span>.<br/><br/>This was an observational study, and another possible limitation, Ms. Khoshaba said, is that people were asked to recall their diets over 24 hours, which may not always be accurate.<br/><br/>Some of the organisms in the gut have their own internal clocks that follow a daily rhythm, and what someone eat determines how many different kinds of these organisms are active, Ms. Bragagnini said.<br/><br/>“So, if your late-night eating consists of foods high in sugar and fat, you may be negatively impacting your microbiome.” she said.<br/><br/>The next step for Ms. Khoshaba and colleagues is a study examining the peripheral circadian rhythm, changes in the gut microbiome, and the risk for developing metabolic syndrome. Ms. Khoshaba and Ms. Bragagnini had no relevant disclosures.<span class="end"/></p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/s/viewarticle/late-night-eaters-may-have-increased-risk-colorectal-cancer-2024a10009u0">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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Negative Colonoscopy? 15-Year Screening Interval May Be Safe

Article Type
Changed
Mon, 05/13/2024 - 12:14

 

TOPLINE:

The recommended 10-year interval between screening colonoscopies may be safely extended to 15 years in adults with no family history of colorectal cancer (CRC) whose first colonoscopy is negative for CRC, a population-based study suggests.

METHODOLOGY:

  • Using Swedish nationwide registry data, researchers compared 110,074 individuals who had a first colonoscopy with negative findings for CRC at age 45-69 years (exposed group) with more than 1.9 million matched controls who either did not have a colonoscopy during the study period or underwent colonoscopy that led to a CRC diagnosis.
  • They calculated 10-year standardized incidence ratio (SIR) and standardized mortality ratio (SMR) to compare risks for CRC and CRC-specific death in the exposed and control groups based on different follow-up screening intervals.

TAKEAWAY:

  • During up to 29 years of follow-up, 484 incident CRCs and 112 CRC deaths occurred in the group with a negative initial colonoscopy.
  • Up to 15 years after negative colonoscopy, the 10-year cumulative risk for CRC and CRC mortality was lower than in the control group, with an SIR of 0.72 and SMR of 0.55, respectively.
  • Extending the screening interval from 10 to 15 years would miss early detection of only two CRC cases and prevention of only one CRC death per 1000 individuals, while potentially avoiding 1000 colonoscopies.

IN PRACTICE:

“This study provides evidence for recommending a longer colonoscopy screening interval than what is currently recommended in most guidelines for populations with no familial risk of CRC,” the authors wrote. “A longer interval between colonoscopy screenings could be beneficial in avoiding unnecessary invasive examinations.”

SOURCE:

The study, with first author Qunfeng Liang, MSc, with the German Cancer Research Center, Heidelberg, Germany, was published online on May 2 in JAMA Oncology.

LIMITATIONS:

The study population primarily included White individuals, particularly ethnic Swedish individuals, so external validation would be necessary to generalize the recommendation to other populations. The researchers lacked data on non-endoscopic tests, such as fecal occult blood tests, which could have been performed as a substitution for colonoscopy during the interval between colonoscopy screenings.

DISCLOSURES:

The study had no specific funding. The authors had no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

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TOPLINE:

The recommended 10-year interval between screening colonoscopies may be safely extended to 15 years in adults with no family history of colorectal cancer (CRC) whose first colonoscopy is negative for CRC, a population-based study suggests.

METHODOLOGY:

  • Using Swedish nationwide registry data, researchers compared 110,074 individuals who had a first colonoscopy with negative findings for CRC at age 45-69 years (exposed group) with more than 1.9 million matched controls who either did not have a colonoscopy during the study period or underwent colonoscopy that led to a CRC diagnosis.
  • They calculated 10-year standardized incidence ratio (SIR) and standardized mortality ratio (SMR) to compare risks for CRC and CRC-specific death in the exposed and control groups based on different follow-up screening intervals.

TAKEAWAY:

  • During up to 29 years of follow-up, 484 incident CRCs and 112 CRC deaths occurred in the group with a negative initial colonoscopy.
  • Up to 15 years after negative colonoscopy, the 10-year cumulative risk for CRC and CRC mortality was lower than in the control group, with an SIR of 0.72 and SMR of 0.55, respectively.
  • Extending the screening interval from 10 to 15 years would miss early detection of only two CRC cases and prevention of only one CRC death per 1000 individuals, while potentially avoiding 1000 colonoscopies.

IN PRACTICE:

“This study provides evidence for recommending a longer colonoscopy screening interval than what is currently recommended in most guidelines for populations with no familial risk of CRC,” the authors wrote. “A longer interval between colonoscopy screenings could be beneficial in avoiding unnecessary invasive examinations.”

SOURCE:

The study, with first author Qunfeng Liang, MSc, with the German Cancer Research Center, Heidelberg, Germany, was published online on May 2 in JAMA Oncology.

LIMITATIONS:

The study population primarily included White individuals, particularly ethnic Swedish individuals, so external validation would be necessary to generalize the recommendation to other populations. The researchers lacked data on non-endoscopic tests, such as fecal occult blood tests, which could have been performed as a substitution for colonoscopy during the interval between colonoscopy screenings.

DISCLOSURES:

The study had no specific funding. The authors had no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

 

TOPLINE:

The recommended 10-year interval between screening colonoscopies may be safely extended to 15 years in adults with no family history of colorectal cancer (CRC) whose first colonoscopy is negative for CRC, a population-based study suggests.

METHODOLOGY:

  • Using Swedish nationwide registry data, researchers compared 110,074 individuals who had a first colonoscopy with negative findings for CRC at age 45-69 years (exposed group) with more than 1.9 million matched controls who either did not have a colonoscopy during the study period or underwent colonoscopy that led to a CRC diagnosis.
  • They calculated 10-year standardized incidence ratio (SIR) and standardized mortality ratio (SMR) to compare risks for CRC and CRC-specific death in the exposed and control groups based on different follow-up screening intervals.

TAKEAWAY:

  • During up to 29 years of follow-up, 484 incident CRCs and 112 CRC deaths occurred in the group with a negative initial colonoscopy.
  • Up to 15 years after negative colonoscopy, the 10-year cumulative risk for CRC and CRC mortality was lower than in the control group, with an SIR of 0.72 and SMR of 0.55, respectively.
  • Extending the screening interval from 10 to 15 years would miss early detection of only two CRC cases and prevention of only one CRC death per 1000 individuals, while potentially avoiding 1000 colonoscopies.

IN PRACTICE:

“This study provides evidence for recommending a longer colonoscopy screening interval than what is currently recommended in most guidelines for populations with no familial risk of CRC,” the authors wrote. “A longer interval between colonoscopy screenings could be beneficial in avoiding unnecessary invasive examinations.”

SOURCE:

The study, with first author Qunfeng Liang, MSc, with the German Cancer Research Center, Heidelberg, Germany, was published online on May 2 in JAMA Oncology.

LIMITATIONS:

The study population primarily included White individuals, particularly ethnic Swedish individuals, so external validation would be necessary to generalize the recommendation to other populations. The researchers lacked data on non-endoscopic tests, such as fecal occult blood tests, which could have been performed as a substitution for colonoscopy during the interval between colonoscopy screenings.

DISCLOSURES:

The study had no specific funding. The authors had no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

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All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>The recommended 10-year interval between screening colonoscopies may be safely extended to 15 years in adults with no family history of colorectal cancer (CRC) </metaDescription> <articlePDF/> <teaserImage/> <teaser>Researchers compare patients who had a first colonoscopy with negative findings for CRC with matched controls who either did not have a colonoscopy or underwent colonoscopy that led to a CRC diagnosis.</teaser> <title>Negative Colonoscopy? 15-Year Screening Interval May Be Safe</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>oncr</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>GIHOLD</publicationCode> <pubIssueName>January 2014</pubIssueName> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> <journalTitle/> <journalFullTitle/> <copyrightStatement/> </publicationData> </publications_g> <publications> <term>15</term> <term>21</term> <term canonical="true">31</term> </publications> <sections> <term canonical="true">27970</term> <term>39313</term> </sections> <topics> <term>213</term> <term>263</term> <term>280</term> <term canonical="true">67020</term> <term>270</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Negative Colonoscopy? 15-Year Screening Interval May Be Safe</title> <deck/> </itemMeta> <itemContent> <h2>TOPLINE:</h2> <p><span class="tag metaDescription">The recommended 10-year interval between screening colonoscopies may be safely extended to 15 years in adults with no family history of colorectal cancer (CRC) whose first colonoscopy is negative for CRC,</span> a population-based study suggests.</p> <h2>METHODOLOGY:</h2> <ul class="body"> <li>Using Swedish nationwide registry data, researchers compared 110,074 individuals who had a first colonoscopy with negative findings for CRC at age 45-69 years (exposed group) with more than 1.9 million matched controls who either did not have a colonoscopy during the study period or underwent colonoscopy that led to a CRC diagnosis.</li> <li>They calculated 10-year standardized incidence ratio (SIR) and standardized mortality ratio (SMR) to compare risks for CRC and CRC-specific death in the exposed and control groups based on different follow-up screening intervals.</li> </ul> <h2>TAKEAWAY:</h2> <ul class="body"> <li>During up to 29 years of follow-up, 484 incident CRCs and 112 CRC deaths occurred in the group with a negative initial colonoscopy.</li> <li>Up to 15 years after negative colonoscopy, the 10-year cumulative risk for CRC and CRC mortality was lower than in the control group, with an SIR of 0.72 and SMR of 0.55, respectively.</li> <li>Extending the screening interval from 10 to 15 years would miss early detection of only two CRC cases and prevention of only one CRC death per 1000 individuals, while potentially avoiding 1000 colonoscopies.</li> </ul> <h2>IN PRACTICE:</h2> <p>“This study provides evidence for recommending a longer colonoscopy screening interval than what is currently recommended in most guidelines for populations with no familial risk of CRC,” the authors wrote. “A longer interval between colonoscopy screenings could be beneficial in avoiding unnecessary invasive examinations.”</p> <h2>SOURCE:</h2> <p>The study, with first author Qunfeng Liang, MSc, with the German Cancer Research Center, Heidelberg, Germany, was <a href="https://jamanetwork.com/journals/jamaoncology/article-abstract/2818448">published online</a> on May 2 in JAMA Oncology.</p> <h2>LIMITATIONS:</h2> <p>The study population primarily included White individuals, particularly ethnic Swedish individuals, so external validation would be necessary to generalize the recommendation to other populations. The researchers lacked data on non-endoscopic tests, such as fecal occult blood tests, which could have been performed as a substitution for colonoscopy during the interval between colonoscopy screenings.</p> <h2>DISCLOSURES:</h2> <p>The study had no specific funding. The authors had no relevant conflicts of interest.</p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/negative-colonoscopy-15-year-screening-interval-may-be-safe-2024a10008wn">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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The Long, Controversial Search for a ‘Cancer Microbiome’

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Mon, 05/13/2024 - 12:15

A contentious scientific debate is clouding prospects for a deeper understanding of the microbiome’s role in cancer, a relatively young field of research that some believe could lead to breakthroughs in the diagnosis and treatment of the second-leading cause of death in the United States. 

Last year, the controversy heightened when experts questioned a high-profile study — a 2020 analysis claiming that the tumors of 33 different cancers had their own unique microbiomes — on whether the “signature” of these bacterial compositions could help diagnose cancer.

The incident renewed the spotlight on “tumor microbiomes” because of the bold claims of the original paper and the strongly worded refutations of those claims. The broader field has focused primarily on ways the body’s microbiome interacts with cancers and cancer treatment.

This controversy has highlighted the challenges of making headway in a field where researchers may not even have the tools yet to puzzle-out the wide-ranging implications the microbiome holds for cancer diagnosis and treatment.

But it is also part of a provocative question within that larger field: whether tumors in the body, far from the natural microbiome in the gut, have their own thriving communities of bacteria, viruses, and fungi. And, if they do, how do those tumor microbiomes affect the development and progression of the cancer and the effectiveness of cancer therapies? 
 

Cancer Controversy

The evidence is undeniable that some microbes can directly cause certain cancers and that the human gut microbiome can influence the effectiveness of certain therapies. Beyond that established science, however, the research has raised as many questions as answers about what we do and don’t know about microbiota and cancer.

The only confirmed microbiomes are on the skin and in the gut, mouth, and vagina, which are all areas with an easy direct route for bacteria to enter and grow in or on the body. A series of papers in recent years have suggested that other internal organs, and tumors within them, may have their own microbiomes. 

“Whether microbes exist in tumors of internal organs beyond body surfaces exposed to the environment is a different matter,” said Ivan Vujkovic-Cvijin, PhD, an assistant professor of biomedical sciences and gastroenterology at Cedars-Sinai Medical Center in Los Angeles, whose lab studies how human gut microbes affect inflammatory diseases. “We’ve only recently had the tools to study that question on a molecular level, and the reported results have been conflicting.” 

For example, research allegedly identified microbiota in the human placenta nearly one decade ago. But subsequent research contradicted those claims and showed that the source of the “placental microbiome” was actually contamination. Subsequent similar studies for other parts of the body faced the same scrutiny and, often, eventual debunking.

“Most likely, our immune system has undergone selective pressure to eliminate everything that crosses the gut barrier because there’s not much benefit to the body to have bacteria run amok in our internal organs,” Dr. Vujkovic-Cvijin said. “That can only disrupt the functioning of our tissues, to have an external organism living inside them.” 

The controversy that erupted last summer, surrounding research from the lab of Rob Knight, PhD, at the University of California, San Diego, centered on a slightly different but related question: Could tumors harbor their own microbiomes?

This news organization spoke with two of the authors who published a paper contesting Dr. Knight’s findings: Steven Salzberg, PhD, a professor of biomedical engineering at John Hopkins Medicine, Baltimore, Maryland, and Abraham Gihawi, PhD, a research fellow at Norwich Medical School at the University of East Anglia in the United Kingdom. 

Dr. Salzberg described two major problems with Dr. Knight’s study. 

“What they found were false positives because of contamination in the database and flaws in their methods,” Dr. Salzberg said. “I can’t prove there’s no cancer microbiome, but I can say the cancer microbiomes that they reported don’t exist because the species they were finding aren’t there.”

Dr. Knight disagrees with Dr. Salzberg’s findings, noting that Dr. Salzberg and his co-authors did not examine the publicly available databases used in his study. In a written response, he said that his team’s examination of the database revealed that less than 1% of the microbial genomes overlapped with human ones and that removing them did not change their findings.

Dr. Knight also noted that his team could still “distinguish cancer types by their microbiome” even after running their analysis without the technique that Dr. Salzberg found fault with.

Dr. Salzberg said that the database linked above is not the one Dr. Knight’s study used, however. “The primary database in their study was never made public (it’s too large, they said), and it has/had about 69,000 genomes,” Dr. Salzberg said by email. “But even if we did, this is irrelevant. He’s trying to distract from the primary errors in their study,” which Dr. Salzberg said Dr. Knight’s team has not addressed. 

The critiques Dr. Salzberg raised have been leveled at other studies investigating microbiomes specifically within tumors and independent of the body’s microbiome.

For example, a 2019 study in Nature described a fungal microbiome in pancreatic cancer that a Nature paper 4 years later directly contradicted, citing flaws that invalidated the original findings. A different 2019 study in Cell examined pancreatic tumor microbiota and patient outcomes, but it’s unclear whether the microorganisms moved from the gut to the pancreas or “constitute a durably colonized community that lives inside the tumor,” which remains a matter of debate, Dr. Vujkovic-Cvijin said.

2020 study in Science suggested diverse microbial communities in seven tumor types, but those findings were similarly called into question. That study stated that “bacteria were first detected in human tumors more than 100 years ago” and that “bacteria are well-known residents in human tumors,” but Dr. Salzberg considers those statements misleading. 

It’s true that bacteria and viruses have been detected in tumors because “there’s very good evidence that an acute infection caused by a very small number of viruses and bacteria can cause a tumor,” Dr. Salzberg said. Human papillomavirus, for example, can cause six different types of cancer. Inflammation and ulcers caused by Helicobacter pylori may progress to stomach cancer, and Fusobacterium nucleatum and Enterococcus faecalis have been shown to contribute to colorectal cancer. Those examples differ from a microbiome; this “a community of bacteria and possibly other microscopic bugs, like fungi, that are happily living in the tumor” the same way microbes reside in our guts, he said.

Dr. Knight said that many bacteria his team identified “have been confirmed independently in subsequent work.” He acknowledged, however, that more research is needed. 

Several of the contested studies above were among a lengthy list that Dr. Knight provided, noting that most of the disagreements “have two sides to them, and critiques from one particular group does not immediately invalidate a reported finding.” 

Yet, many of the papers Dr. Knight listed are precisely the types that skeptics like Dr. Salzberg believe are too flawed to draw reliable conclusions. 

“I think many agree that microbes may exist within tumors that are exposed to the environment, like tumors of the skin, gut, and mouth,” Dr. Vujkovic-Cvijin said. It’s less clear, however, whether tumors further from the body’s microbiome harbor any microbes or where they came from if they do. Microbial signals in organs elsewhere in the body become faint quickly, he said.
 

 

 

Underdeveloped Technology 

Though Dr. Salzberg said that the concept of a tumor microbiome is “implausible” because there’s no easy route for bacteria to reach internal organs, it’s unclear whether scientists have the technology yet to adequately answer this question. 

For one thing, samples in these types of studies are typically “ultra-low biomass samples, where the signal — the amount of microbes in the sample — is so low that it’s comparable to how much would be expected to be found in reagents and environmental contamination through processing,” Dr. Vujkovic-Cvijin explained. Many polymerases used to amplify a DNA signal, for example, are made in bacteria and may retain trace amounts identified in these studies. 

Dr. Knight agreed that low biomass is a challenge in this field but is not an unsurmountable one. 

Another challenge is that study samples, as with Dr. Knight’s work, were collected during routine surgeries without the intent to find a microbial signal. Simply using a scalpel to cut through the skin means cutting through a layer of bacteria, and surgery rooms are not designed to eliminate all bacteria. Some work has even shown there is a “hospital microbiome,” so “you can easily have that creep into your signal and mistake it for tumor-resident bacteria,” Dr. Vujkovic-Cvijin said. 

Dr. Knight asserted that the samples are taken under sterile conditions, but other researchers do not think the level of sterility necessary for completely clean samples is possible. 

“Just because it’s in your sample doesn’t mean it was in your tumor,” Dr. Gihawi said.

Even if scientists can retrieve a reliable sample without contamination, analyzing it requires comparing the genetic material to existing databases of microbial genomes. Yet, contamination and misclassification of genetic sequences can be problems in those reference genomes too, Dr. Gihawi explained.

Machine learning algorithms have a role in interpreting data, but “we need to be careful of what we use them for,” he added.

“These techniques are in their infancy, and we’re starting to chase them down, which is why we need to move microbiome research in a way that can be used clinically,” Dr. Gihawi said. 
 

Influence on Cancer Treatment Outcomes

Again, however, the question of whether microbiomes exist within tumors is only one slice of the much larger field looking at microbiomes and cancer, including its influence on cancer treatment outcomes. Although much remains to be learned, less controversy exists over the thousands of studies in the past two decades that have gradually revealed how the body’s microbiome can affect both the course of a cancer and the effectiveness of different treatments.

The growing research showing the importance of the gut microbiome in cancer treatments is not surprising given its role in immunity more broadly. Because the human immune system must recognize and defend against microbes, the microbiome helps train it, Dr. Vujkovic-Cvijin said. 

Some bacteria can escape the gut — a phenomenon called bacterial translocation — and may aid in fighting tumors. To grow large enough to be seen on imaging, tumors need to evolve several abilities, such as growing enough vascularization to receive blood flow and shutting down local immune responses.

“Any added boost, like immunotherapy, has a chance of breaking through that immune forcefield and killing the tumor cells,” Dr. Vujkovic-Cvijin said. Escaped gut bacteria may provide that boost. 

“There’s a lot of evidence that depletion of the gut microbiome impairs immunotherapy and chemotherapy. The thinking behind some of those studies is that gut microbes can cross the gut barrier and when they do, they activate the immune system,” he said. 

In mice engineered to have sterile guts, for example, the lack of bacteria results in less effective immune systems, Dr. Vujkovic-Cvijin pointed out. A host of research has shown that antibiotic exposure during and even 6 months before immunotherapy dramatically reduces survival rates. “That’s pretty convincing to me that gut microbes are important,” he said. 

Dr. Vujkovic-Cvijin cautioned that there continues to be controversy on understanding which bacteria are important for response to immunotherapy. “The field is still in its infancy in terms of understanding which bacteria are most important for these effects,” he said.

Dr. Knight suggested that escaped bacteria may be the genesis of the ones that he and other researchers believe exist in tumors. “Because tumor microbes must come from somewhere, it is to be expected that some of those microbes will be co-opted from body-site specific commensals.”

It’s also possible that metabolites released from gut bacteria escape the gut and could theoretically affect distant tumor growth, Dr. Gihawi said. The most promising avenue of research in this area is metabolites being used as biomarkers, added Dr. Gihawi, whose lab published research on a link between bacteria detected in men’s urine and a more aggressive subset of prostate cancers. But that research is not far enough along to develop lab tests for clinical use, he noted. 
 

 

 

No Consensus Yet

Even before the controversy erupted around Dr. Knight’s research, he co-founded the company Micronoma to develop cancer tests based on his microbe findings. The company has raised $17.5 million from private investors as of August 2023 and received the US Food and Drug Administration’s Breakthrough Device designation, allowing the firm to fast-track clinical trials testing the technology. The recent critiques have not changed the company’s plans. 

It’s safe to say that scientists will continue to research and debate the possibility of tumor microbiomes until a consensus emerges. 

“The field is evolving and studies testing the reproducibility of tumor-resident microbial signals are essential for developing our understanding in this area,” Dr. Vujkovic-Cvijin said.

Even if that path ultimately leads nowhere, as Dr. Salzberg expects, research into microbiomes and cancer has plenty of other directions to go.

“I’m actually quite an optimist,” Dr. Gihawi said. “I think there’s a lot of scope for some really good research here, especially in the sites where we know there is a strong microbiome, such as the gastrointestinal tract.”

A version of this article appeared on Medscape.com.

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A contentious scientific debate is clouding prospects for a deeper understanding of the microbiome’s role in cancer, a relatively young field of research that some believe could lead to breakthroughs in the diagnosis and treatment of the second-leading cause of death in the United States. 

Last year, the controversy heightened when experts questioned a high-profile study — a 2020 analysis claiming that the tumors of 33 different cancers had their own unique microbiomes — on whether the “signature” of these bacterial compositions could help diagnose cancer.

The incident renewed the spotlight on “tumor microbiomes” because of the bold claims of the original paper and the strongly worded refutations of those claims. The broader field has focused primarily on ways the body’s microbiome interacts with cancers and cancer treatment.

This controversy has highlighted the challenges of making headway in a field where researchers may not even have the tools yet to puzzle-out the wide-ranging implications the microbiome holds for cancer diagnosis and treatment.

But it is also part of a provocative question within that larger field: whether tumors in the body, far from the natural microbiome in the gut, have their own thriving communities of bacteria, viruses, and fungi. And, if they do, how do those tumor microbiomes affect the development and progression of the cancer and the effectiveness of cancer therapies? 
 

Cancer Controversy

The evidence is undeniable that some microbes can directly cause certain cancers and that the human gut microbiome can influence the effectiveness of certain therapies. Beyond that established science, however, the research has raised as many questions as answers about what we do and don’t know about microbiota and cancer.

The only confirmed microbiomes are on the skin and in the gut, mouth, and vagina, which are all areas with an easy direct route for bacteria to enter and grow in or on the body. A series of papers in recent years have suggested that other internal organs, and tumors within them, may have their own microbiomes. 

“Whether microbes exist in tumors of internal organs beyond body surfaces exposed to the environment is a different matter,” said Ivan Vujkovic-Cvijin, PhD, an assistant professor of biomedical sciences and gastroenterology at Cedars-Sinai Medical Center in Los Angeles, whose lab studies how human gut microbes affect inflammatory diseases. “We’ve only recently had the tools to study that question on a molecular level, and the reported results have been conflicting.” 

For example, research allegedly identified microbiota in the human placenta nearly one decade ago. But subsequent research contradicted those claims and showed that the source of the “placental microbiome” was actually contamination. Subsequent similar studies for other parts of the body faced the same scrutiny and, often, eventual debunking.

“Most likely, our immune system has undergone selective pressure to eliminate everything that crosses the gut barrier because there’s not much benefit to the body to have bacteria run amok in our internal organs,” Dr. Vujkovic-Cvijin said. “That can only disrupt the functioning of our tissues, to have an external organism living inside them.” 

The controversy that erupted last summer, surrounding research from the lab of Rob Knight, PhD, at the University of California, San Diego, centered on a slightly different but related question: Could tumors harbor their own microbiomes?

This news organization spoke with two of the authors who published a paper contesting Dr. Knight’s findings: Steven Salzberg, PhD, a professor of biomedical engineering at John Hopkins Medicine, Baltimore, Maryland, and Abraham Gihawi, PhD, a research fellow at Norwich Medical School at the University of East Anglia in the United Kingdom. 

Dr. Salzberg described two major problems with Dr. Knight’s study. 

“What they found were false positives because of contamination in the database and flaws in their methods,” Dr. Salzberg said. “I can’t prove there’s no cancer microbiome, but I can say the cancer microbiomes that they reported don’t exist because the species they were finding aren’t there.”

Dr. Knight disagrees with Dr. Salzberg’s findings, noting that Dr. Salzberg and his co-authors did not examine the publicly available databases used in his study. In a written response, he said that his team’s examination of the database revealed that less than 1% of the microbial genomes overlapped with human ones and that removing them did not change their findings.

Dr. Knight also noted that his team could still “distinguish cancer types by their microbiome” even after running their analysis without the technique that Dr. Salzberg found fault with.

Dr. Salzberg said that the database linked above is not the one Dr. Knight’s study used, however. “The primary database in their study was never made public (it’s too large, they said), and it has/had about 69,000 genomes,” Dr. Salzberg said by email. “But even if we did, this is irrelevant. He’s trying to distract from the primary errors in their study,” which Dr. Salzberg said Dr. Knight’s team has not addressed. 

The critiques Dr. Salzberg raised have been leveled at other studies investigating microbiomes specifically within tumors and independent of the body’s microbiome.

For example, a 2019 study in Nature described a fungal microbiome in pancreatic cancer that a Nature paper 4 years later directly contradicted, citing flaws that invalidated the original findings. A different 2019 study in Cell examined pancreatic tumor microbiota and patient outcomes, but it’s unclear whether the microorganisms moved from the gut to the pancreas or “constitute a durably colonized community that lives inside the tumor,” which remains a matter of debate, Dr. Vujkovic-Cvijin said.

2020 study in Science suggested diverse microbial communities in seven tumor types, but those findings were similarly called into question. That study stated that “bacteria were first detected in human tumors more than 100 years ago” and that “bacteria are well-known residents in human tumors,” but Dr. Salzberg considers those statements misleading. 

It’s true that bacteria and viruses have been detected in tumors because “there’s very good evidence that an acute infection caused by a very small number of viruses and bacteria can cause a tumor,” Dr. Salzberg said. Human papillomavirus, for example, can cause six different types of cancer. Inflammation and ulcers caused by Helicobacter pylori may progress to stomach cancer, and Fusobacterium nucleatum and Enterococcus faecalis have been shown to contribute to colorectal cancer. Those examples differ from a microbiome; this “a community of bacteria and possibly other microscopic bugs, like fungi, that are happily living in the tumor” the same way microbes reside in our guts, he said.

Dr. Knight said that many bacteria his team identified “have been confirmed independently in subsequent work.” He acknowledged, however, that more research is needed. 

Several of the contested studies above were among a lengthy list that Dr. Knight provided, noting that most of the disagreements “have two sides to them, and critiques from one particular group does not immediately invalidate a reported finding.” 

Yet, many of the papers Dr. Knight listed are precisely the types that skeptics like Dr. Salzberg believe are too flawed to draw reliable conclusions. 

“I think many agree that microbes may exist within tumors that are exposed to the environment, like tumors of the skin, gut, and mouth,” Dr. Vujkovic-Cvijin said. It’s less clear, however, whether tumors further from the body’s microbiome harbor any microbes or where they came from if they do. Microbial signals in organs elsewhere in the body become faint quickly, he said.
 

 

 

Underdeveloped Technology 

Though Dr. Salzberg said that the concept of a tumor microbiome is “implausible” because there’s no easy route for bacteria to reach internal organs, it’s unclear whether scientists have the technology yet to adequately answer this question. 

For one thing, samples in these types of studies are typically “ultra-low biomass samples, where the signal — the amount of microbes in the sample — is so low that it’s comparable to how much would be expected to be found in reagents and environmental contamination through processing,” Dr. Vujkovic-Cvijin explained. Many polymerases used to amplify a DNA signal, for example, are made in bacteria and may retain trace amounts identified in these studies. 

Dr. Knight agreed that low biomass is a challenge in this field but is not an unsurmountable one. 

Another challenge is that study samples, as with Dr. Knight’s work, were collected during routine surgeries without the intent to find a microbial signal. Simply using a scalpel to cut through the skin means cutting through a layer of bacteria, and surgery rooms are not designed to eliminate all bacteria. Some work has even shown there is a “hospital microbiome,” so “you can easily have that creep into your signal and mistake it for tumor-resident bacteria,” Dr. Vujkovic-Cvijin said. 

Dr. Knight asserted that the samples are taken under sterile conditions, but other researchers do not think the level of sterility necessary for completely clean samples is possible. 

“Just because it’s in your sample doesn’t mean it was in your tumor,” Dr. Gihawi said.

Even if scientists can retrieve a reliable sample without contamination, analyzing it requires comparing the genetic material to existing databases of microbial genomes. Yet, contamination and misclassification of genetic sequences can be problems in those reference genomes too, Dr. Gihawi explained.

Machine learning algorithms have a role in interpreting data, but “we need to be careful of what we use them for,” he added.

“These techniques are in their infancy, and we’re starting to chase them down, which is why we need to move microbiome research in a way that can be used clinically,” Dr. Gihawi said. 
 

Influence on Cancer Treatment Outcomes

Again, however, the question of whether microbiomes exist within tumors is only one slice of the much larger field looking at microbiomes and cancer, including its influence on cancer treatment outcomes. Although much remains to be learned, less controversy exists over the thousands of studies in the past two decades that have gradually revealed how the body’s microbiome can affect both the course of a cancer and the effectiveness of different treatments.

The growing research showing the importance of the gut microbiome in cancer treatments is not surprising given its role in immunity more broadly. Because the human immune system must recognize and defend against microbes, the microbiome helps train it, Dr. Vujkovic-Cvijin said. 

Some bacteria can escape the gut — a phenomenon called bacterial translocation — and may aid in fighting tumors. To grow large enough to be seen on imaging, tumors need to evolve several abilities, such as growing enough vascularization to receive blood flow and shutting down local immune responses.

“Any added boost, like immunotherapy, has a chance of breaking through that immune forcefield and killing the tumor cells,” Dr. Vujkovic-Cvijin said. Escaped gut bacteria may provide that boost. 

“There’s a lot of evidence that depletion of the gut microbiome impairs immunotherapy and chemotherapy. The thinking behind some of those studies is that gut microbes can cross the gut barrier and when they do, they activate the immune system,” he said. 

In mice engineered to have sterile guts, for example, the lack of bacteria results in less effective immune systems, Dr. Vujkovic-Cvijin pointed out. A host of research has shown that antibiotic exposure during and even 6 months before immunotherapy dramatically reduces survival rates. “That’s pretty convincing to me that gut microbes are important,” he said. 

Dr. Vujkovic-Cvijin cautioned that there continues to be controversy on understanding which bacteria are important for response to immunotherapy. “The field is still in its infancy in terms of understanding which bacteria are most important for these effects,” he said.

Dr. Knight suggested that escaped bacteria may be the genesis of the ones that he and other researchers believe exist in tumors. “Because tumor microbes must come from somewhere, it is to be expected that some of those microbes will be co-opted from body-site specific commensals.”

It’s also possible that metabolites released from gut bacteria escape the gut and could theoretically affect distant tumor growth, Dr. Gihawi said. The most promising avenue of research in this area is metabolites being used as biomarkers, added Dr. Gihawi, whose lab published research on a link between bacteria detected in men’s urine and a more aggressive subset of prostate cancers. But that research is not far enough along to develop lab tests for clinical use, he noted. 
 

 

 

No Consensus Yet

Even before the controversy erupted around Dr. Knight’s research, he co-founded the company Micronoma to develop cancer tests based on his microbe findings. The company has raised $17.5 million from private investors as of August 2023 and received the US Food and Drug Administration’s Breakthrough Device designation, allowing the firm to fast-track clinical trials testing the technology. The recent critiques have not changed the company’s plans. 

It’s safe to say that scientists will continue to research and debate the possibility of tumor microbiomes until a consensus emerges. 

“The field is evolving and studies testing the reproducibility of tumor-resident microbial signals are essential for developing our understanding in this area,” Dr. Vujkovic-Cvijin said.

Even if that path ultimately leads nowhere, as Dr. Salzberg expects, research into microbiomes and cancer has plenty of other directions to go.

“I’m actually quite an optimist,” Dr. Gihawi said. “I think there’s a lot of scope for some really good research here, especially in the sites where we know there is a strong microbiome, such as the gastrointestinal tract.”

A version of this article appeared on Medscape.com.

A contentious scientific debate is clouding prospects for a deeper understanding of the microbiome’s role in cancer, a relatively young field of research that some believe could lead to breakthroughs in the diagnosis and treatment of the second-leading cause of death in the United States. 

Last year, the controversy heightened when experts questioned a high-profile study — a 2020 analysis claiming that the tumors of 33 different cancers had their own unique microbiomes — on whether the “signature” of these bacterial compositions could help diagnose cancer.

The incident renewed the spotlight on “tumor microbiomes” because of the bold claims of the original paper and the strongly worded refutations of those claims. The broader field has focused primarily on ways the body’s microbiome interacts with cancers and cancer treatment.

This controversy has highlighted the challenges of making headway in a field where researchers may not even have the tools yet to puzzle-out the wide-ranging implications the microbiome holds for cancer diagnosis and treatment.

But it is also part of a provocative question within that larger field: whether tumors in the body, far from the natural microbiome in the gut, have their own thriving communities of bacteria, viruses, and fungi. And, if they do, how do those tumor microbiomes affect the development and progression of the cancer and the effectiveness of cancer therapies? 
 

Cancer Controversy

The evidence is undeniable that some microbes can directly cause certain cancers and that the human gut microbiome can influence the effectiveness of certain therapies. Beyond that established science, however, the research has raised as many questions as answers about what we do and don’t know about microbiota and cancer.

The only confirmed microbiomes are on the skin and in the gut, mouth, and vagina, which are all areas with an easy direct route for bacteria to enter and grow in or on the body. A series of papers in recent years have suggested that other internal organs, and tumors within them, may have their own microbiomes. 

“Whether microbes exist in tumors of internal organs beyond body surfaces exposed to the environment is a different matter,” said Ivan Vujkovic-Cvijin, PhD, an assistant professor of biomedical sciences and gastroenterology at Cedars-Sinai Medical Center in Los Angeles, whose lab studies how human gut microbes affect inflammatory diseases. “We’ve only recently had the tools to study that question on a molecular level, and the reported results have been conflicting.” 

For example, research allegedly identified microbiota in the human placenta nearly one decade ago. But subsequent research contradicted those claims and showed that the source of the “placental microbiome” was actually contamination. Subsequent similar studies for other parts of the body faced the same scrutiny and, often, eventual debunking.

“Most likely, our immune system has undergone selective pressure to eliminate everything that crosses the gut barrier because there’s not much benefit to the body to have bacteria run amok in our internal organs,” Dr. Vujkovic-Cvijin said. “That can only disrupt the functioning of our tissues, to have an external organism living inside them.” 

The controversy that erupted last summer, surrounding research from the lab of Rob Knight, PhD, at the University of California, San Diego, centered on a slightly different but related question: Could tumors harbor their own microbiomes?

This news organization spoke with two of the authors who published a paper contesting Dr. Knight’s findings: Steven Salzberg, PhD, a professor of biomedical engineering at John Hopkins Medicine, Baltimore, Maryland, and Abraham Gihawi, PhD, a research fellow at Norwich Medical School at the University of East Anglia in the United Kingdom. 

Dr. Salzberg described two major problems with Dr. Knight’s study. 

“What they found were false positives because of contamination in the database and flaws in their methods,” Dr. Salzberg said. “I can’t prove there’s no cancer microbiome, but I can say the cancer microbiomes that they reported don’t exist because the species they were finding aren’t there.”

Dr. Knight disagrees with Dr. Salzberg’s findings, noting that Dr. Salzberg and his co-authors did not examine the publicly available databases used in his study. In a written response, he said that his team’s examination of the database revealed that less than 1% of the microbial genomes overlapped with human ones and that removing them did not change their findings.

Dr. Knight also noted that his team could still “distinguish cancer types by their microbiome” even after running their analysis without the technique that Dr. Salzberg found fault with.

Dr. Salzberg said that the database linked above is not the one Dr. Knight’s study used, however. “The primary database in their study was never made public (it’s too large, they said), and it has/had about 69,000 genomes,” Dr. Salzberg said by email. “But even if we did, this is irrelevant. He’s trying to distract from the primary errors in their study,” which Dr. Salzberg said Dr. Knight’s team has not addressed. 

The critiques Dr. Salzberg raised have been leveled at other studies investigating microbiomes specifically within tumors and independent of the body’s microbiome.

For example, a 2019 study in Nature described a fungal microbiome in pancreatic cancer that a Nature paper 4 years later directly contradicted, citing flaws that invalidated the original findings. A different 2019 study in Cell examined pancreatic tumor microbiota and patient outcomes, but it’s unclear whether the microorganisms moved from the gut to the pancreas or “constitute a durably colonized community that lives inside the tumor,” which remains a matter of debate, Dr. Vujkovic-Cvijin said.

2020 study in Science suggested diverse microbial communities in seven tumor types, but those findings were similarly called into question. That study stated that “bacteria were first detected in human tumors more than 100 years ago” and that “bacteria are well-known residents in human tumors,” but Dr. Salzberg considers those statements misleading. 

It’s true that bacteria and viruses have been detected in tumors because “there’s very good evidence that an acute infection caused by a very small number of viruses and bacteria can cause a tumor,” Dr. Salzberg said. Human papillomavirus, for example, can cause six different types of cancer. Inflammation and ulcers caused by Helicobacter pylori may progress to stomach cancer, and Fusobacterium nucleatum and Enterococcus faecalis have been shown to contribute to colorectal cancer. Those examples differ from a microbiome; this “a community of bacteria and possibly other microscopic bugs, like fungi, that are happily living in the tumor” the same way microbes reside in our guts, he said.

Dr. Knight said that many bacteria his team identified “have been confirmed independently in subsequent work.” He acknowledged, however, that more research is needed. 

Several of the contested studies above were among a lengthy list that Dr. Knight provided, noting that most of the disagreements “have two sides to them, and critiques from one particular group does not immediately invalidate a reported finding.” 

Yet, many of the papers Dr. Knight listed are precisely the types that skeptics like Dr. Salzberg believe are too flawed to draw reliable conclusions. 

“I think many agree that microbes may exist within tumors that are exposed to the environment, like tumors of the skin, gut, and mouth,” Dr. Vujkovic-Cvijin said. It’s less clear, however, whether tumors further from the body’s microbiome harbor any microbes or where they came from if they do. Microbial signals in organs elsewhere in the body become faint quickly, he said.
 

 

 

Underdeveloped Technology 

Though Dr. Salzberg said that the concept of a tumor microbiome is “implausible” because there’s no easy route for bacteria to reach internal organs, it’s unclear whether scientists have the technology yet to adequately answer this question. 

For one thing, samples in these types of studies are typically “ultra-low biomass samples, where the signal — the amount of microbes in the sample — is so low that it’s comparable to how much would be expected to be found in reagents and environmental contamination through processing,” Dr. Vujkovic-Cvijin explained. Many polymerases used to amplify a DNA signal, for example, are made in bacteria and may retain trace amounts identified in these studies. 

Dr. Knight agreed that low biomass is a challenge in this field but is not an unsurmountable one. 

Another challenge is that study samples, as with Dr. Knight’s work, were collected during routine surgeries without the intent to find a microbial signal. Simply using a scalpel to cut through the skin means cutting through a layer of bacteria, and surgery rooms are not designed to eliminate all bacteria. Some work has even shown there is a “hospital microbiome,” so “you can easily have that creep into your signal and mistake it for tumor-resident bacteria,” Dr. Vujkovic-Cvijin said. 

Dr. Knight asserted that the samples are taken under sterile conditions, but other researchers do not think the level of sterility necessary for completely clean samples is possible. 

“Just because it’s in your sample doesn’t mean it was in your tumor,” Dr. Gihawi said.

Even if scientists can retrieve a reliable sample without contamination, analyzing it requires comparing the genetic material to existing databases of microbial genomes. Yet, contamination and misclassification of genetic sequences can be problems in those reference genomes too, Dr. Gihawi explained.

Machine learning algorithms have a role in interpreting data, but “we need to be careful of what we use them for,” he added.

“These techniques are in their infancy, and we’re starting to chase them down, which is why we need to move microbiome research in a way that can be used clinically,” Dr. Gihawi said. 
 

Influence on Cancer Treatment Outcomes

Again, however, the question of whether microbiomes exist within tumors is only one slice of the much larger field looking at microbiomes and cancer, including its influence on cancer treatment outcomes. Although much remains to be learned, less controversy exists over the thousands of studies in the past two decades that have gradually revealed how the body’s microbiome can affect both the course of a cancer and the effectiveness of different treatments.

The growing research showing the importance of the gut microbiome in cancer treatments is not surprising given its role in immunity more broadly. Because the human immune system must recognize and defend against microbes, the microbiome helps train it, Dr. Vujkovic-Cvijin said. 

Some bacteria can escape the gut — a phenomenon called bacterial translocation — and may aid in fighting tumors. To grow large enough to be seen on imaging, tumors need to evolve several abilities, such as growing enough vascularization to receive blood flow and shutting down local immune responses.

“Any added boost, like immunotherapy, has a chance of breaking through that immune forcefield and killing the tumor cells,” Dr. Vujkovic-Cvijin said. Escaped gut bacteria may provide that boost. 

“There’s a lot of evidence that depletion of the gut microbiome impairs immunotherapy and chemotherapy. The thinking behind some of those studies is that gut microbes can cross the gut barrier and when they do, they activate the immune system,” he said. 

In mice engineered to have sterile guts, for example, the lack of bacteria results in less effective immune systems, Dr. Vujkovic-Cvijin pointed out. A host of research has shown that antibiotic exposure during and even 6 months before immunotherapy dramatically reduces survival rates. “That’s pretty convincing to me that gut microbes are important,” he said. 

Dr. Vujkovic-Cvijin cautioned that there continues to be controversy on understanding which bacteria are important for response to immunotherapy. “The field is still in its infancy in terms of understanding which bacteria are most important for these effects,” he said.

Dr. Knight suggested that escaped bacteria may be the genesis of the ones that he and other researchers believe exist in tumors. “Because tumor microbes must come from somewhere, it is to be expected that some of those microbes will be co-opted from body-site specific commensals.”

It’s also possible that metabolites released from gut bacteria escape the gut and could theoretically affect distant tumor growth, Dr. Gihawi said. The most promising avenue of research in this area is metabolites being used as biomarkers, added Dr. Gihawi, whose lab published research on a link between bacteria detected in men’s urine and a more aggressive subset of prostate cancers. But that research is not far enough along to develop lab tests for clinical use, he noted. 
 

 

 

No Consensus Yet

Even before the controversy erupted around Dr. Knight’s research, he co-founded the company Micronoma to develop cancer tests based on his microbe findings. The company has raised $17.5 million from private investors as of August 2023 and received the US Food and Drug Administration’s Breakthrough Device designation, allowing the firm to fast-track clinical trials testing the technology. The recent critiques have not changed the company’s plans. 

It’s safe to say that scientists will continue to research and debate the possibility of tumor microbiomes until a consensus emerges. 

“The field is evolving and studies testing the reproducibility of tumor-resident microbial signals are essential for developing our understanding in this area,” Dr. Vujkovic-Cvijin said.

Even if that path ultimately leads nowhere, as Dr. Salzberg expects, research into microbiomes and cancer has plenty of other directions to go.

“I’m actually quite an optimist,” Dr. Gihawi said. “I think there’s a lot of scope for some really good research here, especially in the sites where we know there is a strong microbiome, such as the gastrointestinal tract.”

A version of this article appeared on Medscape.com.

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The broader field has focused primarily on ways the body’s microbiome interacts with cancers and cancer treatment.<br/><br/>This controversy has highlighted the challenges of making headway in a field where researchers may not even have the tools yet to puzzle-out the wide-ranging implications the microbiome holds for cancer diagnosis and treatment.<br/><br/>But it is also part of a provocative question within that larger field: whether tumors in the body, far from the natural microbiome in the gut, have their own thriving communities of bacteria, viruses, and fungi. And, if they do, how do those tumor microbiomes affect the development and progression of the cancer and the effectiveness of cancer therapies? <br/><br/></p> <h2>Cancer Controversy</h2> <p>The evidence is undeniable that <span class="Hyperlink"><a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7247677/">some microbes can directly cause</a></span> certain cancers and that the human gut <span class="Hyperlink"><a href="https://www.nature.com/articles/s41392-023-01406-7">microbiome can influence</a></span> the effectiveness of certain therapies. Beyond that established science, however, the research has raised as many questions as answers about what we do and don’t know about microbiota and cancer.<br/><br/>The only confirmed microbiomes are on the skin and in the gut, mouth, and vagina, which are all areas with an easy direct route for bacteria to enter and grow in or on the body. A series of papers in recent years have suggested that other internal organs, and tumors within them, may have their own microbiomes. <br/><br/>“Whether microbes exist in tumors of internal organs beyond body surfaces exposed to the environment is a different matter,” said <span class="Hyperlink"><a href="https://researchers.cedars-sinai.edu/Ivan.Vujkovic-Cvijin">Ivan Vujkovic-Cvijin</a></span>, PhD, an assistant professor of biomedical sciences and gastroenterology at Cedars-Sinai Medical Center in Los Angeles, whose <span class="Hyperlink"><a href="https://www.cedars-sinai.edu/research/labs/vujkovic-cvijin.html">lab studies</a></span> how human gut microbes affect inflammatory diseases. “We’ve only recently had the tools to study that question on a molecular level, and the reported results have been conflicting.” <br/><br/>For example, <span class="Hyperlink"><a href="https://www.science.org/content/article/placenta-harbors-bacteria-may-impact-fetal-health">research</a></span> allegedly identified microbiota in the human placenta nearly one decade ago. But subsequent <span class="Hyperlink"><a href="https://bmcmicrobiol.biomedcentral.com/articles/10.1186/s12866-023-02764-6">research</a></span> <span class="Hyperlink"><a href="https://www.science.org/content/article/bacteria-free-placentas-suggest-babies-pick-microbiome-birth">contradicted</a></span> those claims and showed that the source of the “placental microbiome” was actually <span class="Hyperlink"><a href="https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0237232">contamination</a></span>. Subsequent similar studies for other parts of the body faced the same scrutiny and, often, eventual debunking.<br/><br/>“Most likely, our immune system has undergone selective pressure to eliminate everything that crosses the gut barrier because there’s not much benefit to the body to have bacteria run amok in our internal organs,” Dr. Vujkovic-Cvijin said. “That can only disrupt the functioning of our tissues, to have an external organism living inside them.” <br/><br/>The controversy that erupted last summer, surrounding research from the <span class="Hyperlink"><a href="https://knightlab.ucsd.edu/">lab</a></span> of <span class="Hyperlink"><a href="https://knightlab.ucsd.edu/wordpress/?page_id=47">Rob Knight</a></span>, PhD, at the University of California, San Diego, centered on a slightly different but related question: Could tumors harbor their own microbiomes?<br/><br/>This news organization spoke with two of the authors who published <span class="Hyperlink"><a href="https://journals.asm.org/doi/10.1128/mbio.01607-23">a paper</a></span> contesting Dr. Knight’s findings: <span class="Hyperlink"><a href="https://www.hopkinsmedicine.org/profiles/details/steven-salzberg">Steven Salzberg</a></span>, PhD, a professor of biomedical engineering at John Hopkins Medicine, Baltimore, Maryland, and <span class="Hyperlink"><a href="https://research-portal.uea.ac.uk/en/persons/abraham-gihawi">Abraham Gihawi</a></span>, PhD, a research fellow at Norwich Medical School at the University of East Anglia in the United Kingdom. <br/><br/>Dr. Salzberg described two major problems with Dr. Knight’s study. <br/><br/>“What they found were false positives because of contamination in the database and flaws in their methods,” Dr. Salzberg said. “I can’t prove there’s no cancer microbiome, but I can say the cancer microbiomes that they reported don’t exist because the species they were finding aren’t there.”<br/><br/>Dr. Knight disagrees with Dr. Salzberg’s findings, noting that Dr. Salzberg and his co-authors did not examine the publicly available <span class="Hyperlink"><a href="https://ftp.microbio.me/pub/wol-20April2021/">databases</a></span> used in his study. In a written response, he said that his team’s examination of the database revealed that less than 1% of the microbial genomes overlapped with human ones and that removing them did not change their findings.<br/><br/>Dr. Knight also noted that his team could still “distinguish cancer types by their microbiome” even after running their analysis without the technique that Dr. Salzberg found fault with.<br/><br/>Dr. Salzberg said that the database linked above is not the one Dr. Knight’s study used, however. “The primary database in their study was never made public (it’s too large, they said), and it has/had about 69,000 genomes,” Dr. Salzberg said by email. “But even if we did, this is irrelevant. He’s trying to distract from the primary errors in their study,” which Dr. Salzberg said Dr. Knight’s team has not addressed. <br/><br/>The critiques Dr. Salzberg raised have been leveled at other studies investigating microbiomes specifically within tumors and independent of the body’s microbiome.<br/><br/>For example, a <a href="https://www.nature.com/articles/s41586-019-1608-2"><span class="Hyperlink">2019 study in </span><em>Nature</em></a> described a fungal microbiome in <span class="Hyperlink"><a href="https://emedicine.medscape.com/article/280605-overview">pancreatic cancer</a></span> that a <a href="https://www.nature.com/articles/s41586-023-06292-1"><em>Nature</em><span class="Hyperlink"> paper</span></a> 4 years later directly contradicted, citing flaws that invalidated the original findings. A different <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7288240/"><span class="Hyperlink">2019 study in </span><em>Cell</em></a> examined pancreatic tumor microbiota and patient outcomes, but it’s unclear whether the microorganisms moved from the gut to the pancreas or “constitute a durably colonized community that lives inside the tumor,” which remains a matter of debate, Dr. Vujkovic-Cvijin said.<br/><br/>A <span class="Hyperlink"><a href="https://www.science.org/doi/10.1126/science.aay9189">2020 study</a></span> in <em>Science</em> suggested diverse microbial communities in seven tumor types, but those findings were similarly <span class="Hyperlink">called into question</span>. That study stated that “bacteria were first detected in human tumors more than 100 years ago” and that “bacteria are well-known residents in human tumors,” but Dr. Salzberg considers those statements misleading. <br/><br/>It’s true that bacteria and viruses have been detected in tumors because “there’s very good evidence that an acute infection caused by a very small number of viruses and bacteria can cause a tumor,” Dr. Salzberg said. <span class="Hyperlink"><a href="https://emedicine.medscape.com/article/219110-overview">Human papillomavirus</a></span>, for example, can cause six different types of cancer. Inflammation and ulcers caused by <em>Helicobacter pylori</em> may <span class="Hyperlink"><a href="https://www.cancer.gov/about-cancer/causes-prevention/risk/infectious-agents/h-pylori-fact-sheet">progress</a></span> to <span class="Hyperlink"><a href="https://emedicine.medscape.com/article/278744-overview">stomach cancer</a></span>, and <em>Fusobacterium nucleatum</em> and <em>Enterococcus faecalis</em> have been <span class="Hyperlink"><a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5852398/">shown to contribute</a></span> to <span class="Hyperlink"><a href="https://emedicine.medscape.com/article/2500006-overview">colorectal cancer</a></span>. Those examples differ from a microbiome; this “a community of bacteria and possibly other microscopic bugs, like fungi, that are happily living in the tumor” the same way microbes reside in our guts, he said.<br/><br/>Dr. Knight said that many bacteria his team identified “have been confirmed independently in subsequent work.” He acknowledged, however, that more research is needed. <br/><br/>Several of the contested studies above were <span class="Hyperlink"><a href="https://linkinghub.elsevier.com/retrieve/pii/S0092-8674(22)01173-4">among</a></span> <span class="Hyperlink"><a href="https://www.nature.com/articles/s41586-021-03368-8">a</a></span> <span class="Hyperlink"><a href="https://www.cell.com/cell/fulltext/S0092-8674(24)00312-X">lengthy</a></span> <span class="Hyperlink"><a href="https://www.cell.com/cell/pdf/S0092-8674(18)31654-4.pdf">list</a></span> <span class="Hyperlink"><a href="https://www.cell.com/cell/pdf/S0092-8674(22)00260-4.pdf">that</a></span> <span class="Hyperlink"><a href="https://www.nature.com/articles/s41586-023-06081-w">Dr. Knight</a></span> <span class="Hyperlink"><a href="https://www.cell.com/cancer-cell/pdf/S1535-6108(23)00328-8.pdf">provided</a></span>, noting that most of the disagreements “have two sides to them, and critiques from one particular group does not immediately invalidate a reported finding.” <br/><br/>Yet, <span class="Hyperlink"><a href="https://aacrjournals.org/cancerdiscovery/article/11/2/293/2699/Lower-Airway-Dysbiosis-Affects-Lung-Cancer">many</a></span> <span class="Hyperlink"><a href="https://www.cell.com/cell-reports-medicine/pdfExtended/S2666-3791(24)00167-8">of</a></span> <span class="Hyperlink"><a href="https://www.science.org/doi/10.1126/science.aah5043">the</a></span> <span class="Hyperlink"><a href="https://www.sciencedirect.com/science/article/abs/pii/S0092867423002714">papers</a></span> Dr. Knight <span class="Hyperlink"><a href="https://www.nature.com/articles/s41467-023-40987-3">listed</a></span> <span class="Hyperlink"><a href="https://www.science.org/doi/10.1126/science.aal5240">are</a></span> <span class="Hyperlink"><a href="https://jitc.bmj.com/content/10/7/e004698">precisely</a></span> <span class="Hyperlink"><a href="https://www.cell.com/cancer-cell/abstract/S1535-6108(23)00288-X">the</a></span> <span class="Hyperlink"><a href="https://www.nature.com/articles/s41389-024-00513-6">types</a></span> that skeptics like Dr. Salzberg believe are too flawed to draw reliable conclusions. <br/><br/>“I think many agree that microbes may exist within tumors that are exposed to the environment, like tumors of the skin, gut, and mouth,” Dr. Vujkovic-Cvijin said. It’s less clear, however, whether tumors further from the body’s microbiome harbor any microbes or where they came from if they do. Microbial signals in organs elsewhere in the body become faint quickly, he said.<br/><br/></p> <h2>Underdeveloped Technology </h2> <p>Though Dr. Salzberg said that the concept of a tumor microbiome is “implausible” because there’s no easy route for bacteria to reach internal organs, it’s unclear whether scientists have the technology yet to adequately answer this question. <br/><br/>For one thing, samples in these types of studies are typically “ultra-low biomass samples, where the signal — the amount of microbes in the sample — is so low that it’s comparable to how much would be expected to be found in reagents and environmental contamination through processing,” Dr. Vujkovic-Cvijin explained. Many polymerases used to amplify a DNA signal, for example, are made in bacteria and may retain trace amounts identified in these studies. <br/><br/>Dr. Knight agreed that low biomass is a challenge in this field but is not an unsurmountable one. <br/><br/>Another challenge is that study samples, as with Dr. Knight’s work, were collected during routine surgeries without the intent to find a microbial signal. Simply using a scalpel to cut through the skin means cutting through a layer of bacteria, and surgery rooms are not designed to eliminate all bacteria. Some work has even shown there is a “hospital microbiome,” so “you can easily have that creep into your signal and mistake it for tumor-resident bacteria,” Dr. Vujkovic-Cvijin said. <br/><br/>Dr. Knight asserted that the samples are taken under sterile conditions, but other researchers do not think the level of sterility necessary for completely clean samples is possible. <br/><br/>“Just because it’s in your sample doesn’t mean it was in your tumor,” Dr. Gihawi said.<br/><br/>Even if scientists can retrieve a reliable sample without contamination, analyzing it requires comparing the genetic material to existing databases of microbial genomes. Yet, contamination and misclassification of genetic sequences can be problems in those reference genomes too, Dr. Gihawi explained.<br/><br/>Machine learning algorithms have a role in interpreting data, but “we need to be careful of what we use them for,” he added.<br/><br/>“These techniques are in their infancy, and we’re starting to chase them down, which is why we need to move microbiome research in a way that can be used clinically,” Dr. Gihawi said. <br/><br/></p> <h2>Influence on Cancer Treatment Outcomes</h2> <p>Again, however, the question of whether microbiomes exist within tumors is only one slice of the much larger field looking at microbiomes and cancer, including its influence on cancer treatment outcomes. Although much remains to be learned, less controversy exists over the thousands of studies in the past two decades that have gradually revealed how the body’s microbiome can affect both the course of a cancer and the effectiveness of different treatments.<br/><br/>The growing research showing the importance of the gut microbiome in cancer treatments is not surprising given its role in immunity more broadly. Because the human immune system must recognize and defend against microbes, the microbiome helps train it, Dr. Vujkovic-Cvijin said. <br/><br/>Some bacteria can escape the gut — a phenomenon called <span class="Hyperlink">bacterial translocation</span> — and may aid in fighting tumors. To grow large enough to be seen on imaging, tumors need to evolve several abilities, such as growing enough vascularization to receive blood flow and shutting down local immune responses.<br/><br/>“Any added boost, like immunotherapy, has a chance of breaking through that immune forcefield and killing the tumor cells,” Dr. Vujkovic-Cvijin said. Escaped gut bacteria may provide that boost. <br/><br/>“There’s a lot of evidence that depletion of the gut microbiome impairs immunotherapy and chemotherapy. The thinking behind some of those studies is that gut microbes can cross the gut barrier and when they do, they activate the immune system,” he said. <br/><br/>In mice engineered to have sterile guts, for example, the lack of bacteria results in less effective immune systems, Dr. Vujkovic-Cvijin pointed out. A <span class="Hyperlink"><a href="https://pubmed.ncbi.nlm.nih.gov/34593446/">host</a></span> of <span class="Hyperlink"><a href="https://jamanetwork.com/journals/jamaoncology/fullarticle/2749683">research</a></span> has shown that antibiotic exposure <span class="Hyperlink"><a href="https://karger.com/lic/article/10/6/606/828600/Use-of-Antibiotics-during-Immune-Checkpoint">during</a></span> and even <span class="Hyperlink"><a href="https://www.sciencedirect.com/science/article/pii/S0895435622000865">6 months before</a></span> immunotherapy dramatically <span class="Hyperlink"><a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10136869/">reduces</a></span> survival rates. “That’s pretty convincing to me that gut microbes are important,” he said. <br/><br/>Dr. Vujkovic-Cvijin cautioned that there continues to be controversy on understanding which bacteria are important for response to immunotherapy. “The field is still in its infancy in terms of understanding which bacteria are most important for these effects,” he said.<br/><br/>Dr. Knight suggested that escaped bacteria may be the genesis of the ones that he and other researchers believe exist in tumors. “Because tumor microbes must come from somewhere, it is to be expected that some of those microbes will be co-opted from body-site specific commensals.”<br/><br/>It’s also possible that metabolites released from gut bacteria escape the gut and could theoretically affect distant tumor growth, Dr. Gihawi said. The most promising avenue of research in this area is metabolites being used as biomarkers, added Dr. Gihawi, whose lab published research on a link between bacteria detected in men’s urine and a more aggressive subset of prostate cancers. But that research is not far enough along to develop lab tests for clinical use, he noted. <br/><br/></p> <h2>No Consensus Yet</h2> <p>Even before the controversy erupted around Dr. Knight’s research, he co-founded the company Micronoma to develop cancer tests based on his microbe findings. The company has raised $17.5 million from private investors <span class="Hyperlink"><a href="https://www.nytimes.com/2023/08/25/health/cancer-microbes-debate.html">as of August 2023</a></span> and received the US Food and Drug Administration’s <span class="Hyperlink"><a href="https://micronoma.com/micronoma-receives-fda-breakthrough-device-designation-for-oncobiotalung-a-novel-liquid-biopsy-assay-for-lung-carcinoma-detection/">Breakthrough Device</a></span> designation, allowing the firm to fast-track clinical trials testing the technology. The recent critiques have not changed the company’s plans. <br/><br/>It’s safe to say that scientists will continue to research and debate the possibility of tumor microbiomes until a consensus emerges. <br/><br/>“The field is evolving and studies testing the reproducibility of tumor-resident microbial signals are essential for developing our understanding in this area,” Dr. Vujkovic-Cvijin said.<br/><br/>Even if that path ultimately leads nowhere, as Dr. Salzberg expects, research into microbiomes and cancer has plenty of other directions to go.<br/><br/>“I’m actually quite an optimist,” Dr. Gihawi said. “I think there’s a lot of scope for some really good research here, especially in the sites where we know there is a strong microbiome, such as the gastrointestinal tract.”<span class="end"/></p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/long-controversial-search-cancer-microbiome-2024a10008fw">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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Late-Stage Incidence Rates Support CRC Screening From Age 45

Article Type
Changed
Mon, 04/29/2024 - 10:34

In the setting of conflicting national screening guidelines, the incidence of distant- and regional-stage colorectal adenocarcinoma (CRC) has been increasing in individuals aged 46-49 years, a cross-sectional study of stage-stratified CRC found.

It is well known that CRC is becoming more prevalent generally in the under 50-year population, but stage-related analyses have not been done.

Staging analysis in this age group is important, however, as an increasing burden of advance-staged disease would provide further evidence for earlier screening initiation, wrote Eric M. Montminy, MD, a gastroenterologist at John H. Stroger Hospital of County Cook, Chicago, Illinois, and colleagues in JAMA Network Open.

Montminy_Eric_IL_web.jpg
%3Cp%3EDr.%20Eric%20M.%20Montminy%3C%2Fp%3E


The United States Preventive Services Task Force (USPSTF) has recommended that average-risk screening begin at 45 years of age, as do the American Gastroenterological Association and other GI societies, although the American College of Physicians last year published clinical guidance recommending 50 years as the age to start screening for CRC for patients with average risk.

“Patients aged 46-49 may become confused on which guideline to follow, similar to confusion occurring with prior breast cancer screening changes,” Dr. Montminy said in an interview. “We wanted to demonstrate incidence rates with stage stratification to help clarify the incidence trends in this age group. Stage stratification is a key because it provides insight into the relationship between time and cancer incidence, ie, is screening finding early cancer or not?”

A 2020 study in JAMA Network Open demonstrated a 46.1% increase in CRC incidence rates (IRs) in persons aged 49-50 years. This steep increase is consistent with the presence of a large preexisting and undetected case burden.

“Our results demonstrate that adults aged 46-49 years, who are between now-conflicting guidelines on whether to start screening at age 45 or 50 years, have an increasing burden of more advanced-stage CRC and thus may be at an increased risk if screening is not initiated at age 45 years,” Dr. Montminy’s group wrote.

Using incidence data per 100,000 population from the National Cancer Institute’s Surveillance, Epidemiology, and End Results registry, the investigators observed the following IRs for early-onset CRC in the age group of 46-49 years:

  • Distant adenocarcinoma IRs increased faster than other stages: annual percentage change (APC), 2.2 (95% CI, 1.8-2.6).
  • Regional IRs also significantly increased: APC, 1.3 (95% CI, 0.8-1.7).
  • Absolute regional IRs of CRC in the age bracket of 46-49 years are similar to total pancreatic cancer IRs in all ages and all stages combined (13.2 of 100,000) over similar years. When distant IRs for CRC are included with regional IRs, those for IRs for CRC are double those for pancreatic cancer of all stages combined.
  • The only decrease was seen in localized IRs: APC, -0.6 (95% CI, -1 to -0.2).

“My best advice for clinicians is to provide the facts from the data to patients so they can make an informed health decision,” Dr. Montminy said. “This includes taking an appropriate personal and family history and having the patient factor this aspect into their decision on when and how they want to perform colon cancer screening.”

His institution adheres to the USPSTF recommendation of initiation of CRC screening at age 45 years.
 

 

 

Findings From 2000 to 2020

During 2000-2020 period, 26,887 CRCs were diagnosed in adults aged 46-49 years (54.5% in men).

As of 2020, the localized adenocarcinoma IR decreased to 7.7 of 100,000, but regional adenocarcinoma IR increased to 13.4 of 100,000 and distant adenocarcinoma IR increased to 9.0 of 100,000.

Regional adenocarcinoma IR remained the highest of all stages in 2000-2020. From 2014 to 2020, distant IRs became similar to localized IRs, except in 2017 when distant IRs were significantly higher than localized.
 

Why the CRC Uptick?

“It remains an enigma at this time as to why we’re seeing this shift,” Dr. Montminy said, noting that etiologies from the colonic microbiome to cellphones have been postulated. “To date, no theory has substantially provided causality. But whatever the source is, it is affecting Western countries in unison with data demonstrating a birth cohort effect as well,” he added. “We additionally know, based on the current epidemiologic data, that current screening practices are failing, and a unified discussion must occur in order to prevent young patients from developing advanced colon cancer.”

Meyer_Joshua_PA_web.jpg
%3Cp%3EDr.%20Joshua%20Meyer%3C%2Fp%3E

Offering his perspective on the findings, Joshua Meyer, MD, vice chair of translational research in the Department of Radiation Oncology at Fox Chase Cancer Center in Philadelphia, said the findings reinforce the practice of offering screening to average-risk individuals starting at age 45 years, the threshold at his institution. “There are previously published data demonstrating an increase in advanced stage at the time of screening initiation, and these data support that,” said Dr. Meyer, who was not involved in the present analysis.

More research needs to be done, he continued, not just on optimal age but also on the effect of multiple other factors impacting risk. “These may include family history and genetic risk as well as the role of blood- and stool-based screening assays in an integrated strategy to screen for colorectal cancer.”

There are multiple screening tests, and while colonoscopy, the gold standard, is very safe, it is not completely without risks, Dr. Meyer added. “And the question of the appropriate allocation of limited societal resources continues to be discussed on a broader level and largely explains the difference between the two guidelines.”

This study received no specific funding. Co-author Jordan J. Karlitz, MD, reported personal fees from GRAIL (senior medical director) and an equity position from Gastro Girl/GI On Demand outside f the submitted work. Dr. Meyer disclosed no conflicts of interest relevant to his comments.

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In the setting of conflicting national screening guidelines, the incidence of distant- and regional-stage colorectal adenocarcinoma (CRC) has been increasing in individuals aged 46-49 years, a cross-sectional study of stage-stratified CRC found.

It is well known that CRC is becoming more prevalent generally in the under 50-year population, but stage-related analyses have not been done.

Staging analysis in this age group is important, however, as an increasing burden of advance-staged disease would provide further evidence for earlier screening initiation, wrote Eric M. Montminy, MD, a gastroenterologist at John H. Stroger Hospital of County Cook, Chicago, Illinois, and colleagues in JAMA Network Open.

Montminy_Eric_IL_web.jpg
%3Cp%3EDr.%20Eric%20M.%20Montminy%3C%2Fp%3E


The United States Preventive Services Task Force (USPSTF) has recommended that average-risk screening begin at 45 years of age, as do the American Gastroenterological Association and other GI societies, although the American College of Physicians last year published clinical guidance recommending 50 years as the age to start screening for CRC for patients with average risk.

“Patients aged 46-49 may become confused on which guideline to follow, similar to confusion occurring with prior breast cancer screening changes,” Dr. Montminy said in an interview. “We wanted to demonstrate incidence rates with stage stratification to help clarify the incidence trends in this age group. Stage stratification is a key because it provides insight into the relationship between time and cancer incidence, ie, is screening finding early cancer or not?”

A 2020 study in JAMA Network Open demonstrated a 46.1% increase in CRC incidence rates (IRs) in persons aged 49-50 years. This steep increase is consistent with the presence of a large preexisting and undetected case burden.

“Our results demonstrate that adults aged 46-49 years, who are between now-conflicting guidelines on whether to start screening at age 45 or 50 years, have an increasing burden of more advanced-stage CRC and thus may be at an increased risk if screening is not initiated at age 45 years,” Dr. Montminy’s group wrote.

Using incidence data per 100,000 population from the National Cancer Institute’s Surveillance, Epidemiology, and End Results registry, the investigators observed the following IRs for early-onset CRC in the age group of 46-49 years:

  • Distant adenocarcinoma IRs increased faster than other stages: annual percentage change (APC), 2.2 (95% CI, 1.8-2.6).
  • Regional IRs also significantly increased: APC, 1.3 (95% CI, 0.8-1.7).
  • Absolute regional IRs of CRC in the age bracket of 46-49 years are similar to total pancreatic cancer IRs in all ages and all stages combined (13.2 of 100,000) over similar years. When distant IRs for CRC are included with regional IRs, those for IRs for CRC are double those for pancreatic cancer of all stages combined.
  • The only decrease was seen in localized IRs: APC, -0.6 (95% CI, -1 to -0.2).

“My best advice for clinicians is to provide the facts from the data to patients so they can make an informed health decision,” Dr. Montminy said. “This includes taking an appropriate personal and family history and having the patient factor this aspect into their decision on when and how they want to perform colon cancer screening.”

His institution adheres to the USPSTF recommendation of initiation of CRC screening at age 45 years.
 

 

 

Findings From 2000 to 2020

During 2000-2020 period, 26,887 CRCs were diagnosed in adults aged 46-49 years (54.5% in men).

As of 2020, the localized adenocarcinoma IR decreased to 7.7 of 100,000, but regional adenocarcinoma IR increased to 13.4 of 100,000 and distant adenocarcinoma IR increased to 9.0 of 100,000.

Regional adenocarcinoma IR remained the highest of all stages in 2000-2020. From 2014 to 2020, distant IRs became similar to localized IRs, except in 2017 when distant IRs were significantly higher than localized.
 

Why the CRC Uptick?

“It remains an enigma at this time as to why we’re seeing this shift,” Dr. Montminy said, noting that etiologies from the colonic microbiome to cellphones have been postulated. “To date, no theory has substantially provided causality. But whatever the source is, it is affecting Western countries in unison with data demonstrating a birth cohort effect as well,” he added. “We additionally know, based on the current epidemiologic data, that current screening practices are failing, and a unified discussion must occur in order to prevent young patients from developing advanced colon cancer.”

Meyer_Joshua_PA_web.jpg
%3Cp%3EDr.%20Joshua%20Meyer%3C%2Fp%3E

Offering his perspective on the findings, Joshua Meyer, MD, vice chair of translational research in the Department of Radiation Oncology at Fox Chase Cancer Center in Philadelphia, said the findings reinforce the practice of offering screening to average-risk individuals starting at age 45 years, the threshold at his institution. “There are previously published data demonstrating an increase in advanced stage at the time of screening initiation, and these data support that,” said Dr. Meyer, who was not involved in the present analysis.

More research needs to be done, he continued, not just on optimal age but also on the effect of multiple other factors impacting risk. “These may include family history and genetic risk as well as the role of blood- and stool-based screening assays in an integrated strategy to screen for colorectal cancer.”

There are multiple screening tests, and while colonoscopy, the gold standard, is very safe, it is not completely without risks, Dr. Meyer added. “And the question of the appropriate allocation of limited societal resources continues to be discussed on a broader level and largely explains the difference between the two guidelines.”

This study received no specific funding. Co-author Jordan J. Karlitz, MD, reported personal fees from GRAIL (senior medical director) and an equity position from Gastro Girl/GI On Demand outside f the submitted work. Dr. Meyer disclosed no conflicts of interest relevant to his comments.

In the setting of conflicting national screening guidelines, the incidence of distant- and regional-stage colorectal adenocarcinoma (CRC) has been increasing in individuals aged 46-49 years, a cross-sectional study of stage-stratified CRC found.

It is well known that CRC is becoming more prevalent generally in the under 50-year population, but stage-related analyses have not been done.

Staging analysis in this age group is important, however, as an increasing burden of advance-staged disease would provide further evidence for earlier screening initiation, wrote Eric M. Montminy, MD, a gastroenterologist at John H. Stroger Hospital of County Cook, Chicago, Illinois, and colleagues in JAMA Network Open.

Montminy_Eric_IL_web.jpg
%3Cp%3EDr.%20Eric%20M.%20Montminy%3C%2Fp%3E


The United States Preventive Services Task Force (USPSTF) has recommended that average-risk screening begin at 45 years of age, as do the American Gastroenterological Association and other GI societies, although the American College of Physicians last year published clinical guidance recommending 50 years as the age to start screening for CRC for patients with average risk.

“Patients aged 46-49 may become confused on which guideline to follow, similar to confusion occurring with prior breast cancer screening changes,” Dr. Montminy said in an interview. “We wanted to demonstrate incidence rates with stage stratification to help clarify the incidence trends in this age group. Stage stratification is a key because it provides insight into the relationship between time and cancer incidence, ie, is screening finding early cancer or not?”

A 2020 study in JAMA Network Open demonstrated a 46.1% increase in CRC incidence rates (IRs) in persons aged 49-50 years. This steep increase is consistent with the presence of a large preexisting and undetected case burden.

“Our results demonstrate that adults aged 46-49 years, who are between now-conflicting guidelines on whether to start screening at age 45 or 50 years, have an increasing burden of more advanced-stage CRC and thus may be at an increased risk if screening is not initiated at age 45 years,” Dr. Montminy’s group wrote.

Using incidence data per 100,000 population from the National Cancer Institute’s Surveillance, Epidemiology, and End Results registry, the investigators observed the following IRs for early-onset CRC in the age group of 46-49 years:

  • Distant adenocarcinoma IRs increased faster than other stages: annual percentage change (APC), 2.2 (95% CI, 1.8-2.6).
  • Regional IRs also significantly increased: APC, 1.3 (95% CI, 0.8-1.7).
  • Absolute regional IRs of CRC in the age bracket of 46-49 years are similar to total pancreatic cancer IRs in all ages and all stages combined (13.2 of 100,000) over similar years. When distant IRs for CRC are included with regional IRs, those for IRs for CRC are double those for pancreatic cancer of all stages combined.
  • The only decrease was seen in localized IRs: APC, -0.6 (95% CI, -1 to -0.2).

“My best advice for clinicians is to provide the facts from the data to patients so they can make an informed health decision,” Dr. Montminy said. “This includes taking an appropriate personal and family history and having the patient factor this aspect into their decision on when and how they want to perform colon cancer screening.”

His institution adheres to the USPSTF recommendation of initiation of CRC screening at age 45 years.
 

 

 

Findings From 2000 to 2020

During 2000-2020 period, 26,887 CRCs were diagnosed in adults aged 46-49 years (54.5% in men).

As of 2020, the localized adenocarcinoma IR decreased to 7.7 of 100,000, but regional adenocarcinoma IR increased to 13.4 of 100,000 and distant adenocarcinoma IR increased to 9.0 of 100,000.

Regional adenocarcinoma IR remained the highest of all stages in 2000-2020. From 2014 to 2020, distant IRs became similar to localized IRs, except in 2017 when distant IRs were significantly higher than localized.
 

Why the CRC Uptick?

“It remains an enigma at this time as to why we’re seeing this shift,” Dr. Montminy said, noting that etiologies from the colonic microbiome to cellphones have been postulated. “To date, no theory has substantially provided causality. But whatever the source is, it is affecting Western countries in unison with data demonstrating a birth cohort effect as well,” he added. “We additionally know, based on the current epidemiologic data, that current screening practices are failing, and a unified discussion must occur in order to prevent young patients from developing advanced colon cancer.”

Meyer_Joshua_PA_web.jpg
%3Cp%3EDr.%20Joshua%20Meyer%3C%2Fp%3E

Offering his perspective on the findings, Joshua Meyer, MD, vice chair of translational research in the Department of Radiation Oncology at Fox Chase Cancer Center in Philadelphia, said the findings reinforce the practice of offering screening to average-risk individuals starting at age 45 years, the threshold at his institution. “There are previously published data demonstrating an increase in advanced stage at the time of screening initiation, and these data support that,” said Dr. Meyer, who was not involved in the present analysis.

More research needs to be done, he continued, not just on optimal age but also on the effect of multiple other factors impacting risk. “These may include family history and genetic risk as well as the role of blood- and stool-based screening assays in an integrated strategy to screen for colorectal cancer.”

There are multiple screening tests, and while colonoscopy, the gold standard, is very safe, it is not completely without risks, Dr. Meyer added. “And the question of the appropriate allocation of limited societal resources continues to be discussed on a broader level and largely explains the difference between the two guidelines.”

This study received no specific funding. Co-author Jordan J. Karlitz, MD, reported personal fees from GRAIL (senior medical director) and an equity position from Gastro Girl/GI On Demand outside f the submitted work. Dr. Meyer disclosed no conflicts of interest relevant to his comments.

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Montminy, MD, a gastroenterologist at John H. Stroger Hospital of County Cook, Chicago, Illinois, and colleagues <a href="https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2816222"><span class="Hyperlink">in</span><em> JAMA Network Open</em></a>.<br/><br/>The United States Preventive Services Task Force (USPSTF) has recommended that average-risk screening begin at 45 years of age, as do the American Gastroenterological Association and other GI societies, although the American College of Physicians last year published clinical guidance recommending 50 years as the age to start screening for CRC for patients with average risk.<br/><br/>“Patients aged 46-49 may become confused on which guideline to follow, similar to confusion occurring with prior breast cancer screening changes,” Dr. Montminy said in an interview. “We wanted to demonstrate incidence rates with stage stratification to help clarify the incidence trends in this age group. Stage stratification is a key because it provides insight into the relationship between time and cancer incidence, ie, is screening finding early cancer or not?”<br/><br/>A 2020 study <a href="https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2759846"><span class="Hyperlink">in </span><em>JAMA Network Open</em></a> demonstrated a 46.1% increase in CRC incidence rates (IRs) in persons aged 49-50 years. This steep increase is consistent with the presence of a large preexisting and undetected case burden.<br/><br/>“Our results demonstrate that adults aged 46-49 years, who are between now-conflicting guidelines on whether to start screening at age 45 or 50 years, have an increasing burden of more advanced-stage CRC and thus may be at an increased risk if screening is not initiated at age 45 years,” Dr. Montminy’s group wrote.<br/><br/>Using incidence data per 100,000 population from the National Cancer Institute’s Surveillance, Epidemiology, and End Results registry, the investigators observed the following IRs for early-onset CRC in the age group of 46-49 years:</p> <ul class="body"> <li>Distant adenocarcinoma IRs increased faster than other stages: annual percentage change (APC), 2.2 (95% CI, 1.8-2.6). </li> <li>Regional IRs also significantly increased: APC, 1.3 (95% CI, 0.8-1.7).</li> <li>Absolute regional IRs of CRC in the age bracket of 46-49 years are similar to total pancreatic cancer IRs in all ages and all stages combined (13.2 of 100,000) over similar years. When distant IRs for CRC are included with regional IRs, those for IRs for CRC are <span class="Hyperlink">double those for pancreatic cancer</span> of all stages combined.</li> <li>The only decrease was seen in localized IRs: APC, -0.6 (95% CI, -1 to -0.2).</li> </ul> <p>“My best advice for clinicians is to provide the facts from the data to patients so they can make an informed health decision,” Dr. Montminy said. “This includes taking an appropriate personal and family history and having the patient factor this aspect into their decision on when and how they want to perform colon cancer screening.”<br/><br/>His institution adheres to the USPSTF recommendation of initiation of CRC screening at age 45 years.<br/><br/></p> <h2>Findings From 2000 to 2020</h2> <p>During 2000-2020 period, 26,887 CRCs were diagnosed in adults aged 46-49 years (54.5% in men).</p> <p>As of 2020, the localized adenocarcinoma IR decreased to 7.7 of 100,000, but regional adenocarcinoma IR increased to 13.4 of 100,000 and distant adenocarcinoma IR increased to 9.0 of 100,000.<br/><br/>Regional adenocarcinoma IR remained the highest of all stages in 2000-2020. From 2014 to 2020, distant IRs became similar to localized IRs, except in 2017 when distant IRs were significantly higher than localized.<br/><br/></p> <h2>Why the CRC Uptick?</h2> <p>“It remains an enigma at this time as to why we’re seeing this shift,” Dr. Montminy said, noting that etiologies from the colonic microbiome to cellphones have been postulated. “To date, no theory has substantially provided causality. But whatever the source is, it is affecting Western countries in unison with data demonstrating a birth cohort effect as well,” he added. “We additionally know, based on the current epidemiologic data, that current screening practices are failing, and a unified discussion must occur in order to prevent young patients from developing advanced colon cancer.”</p> <p>Offering his perspective on the findings, Joshua Meyer, MD, vice chair of translational research in the Department of Radiation Oncology at Fox Chase Cancer Center in Philadelphia, said the findings reinforce the practice of offering screening to average-risk individuals starting at age 45 years, the threshold at his institution. “There are previously published data demonstrating an increase in advanced stage at the time of screening initiation, and these data support that,” said Dr. Meyer, who was not involved in the present analysis.<br/><br/>More research needs to be done, he continued, not just on optimal age but also on the effect of multiple other factors impacting risk. “These may include family history and genetic risk as well as the role of blood- and stool-based screening assays in an integrated strategy to screen for colorectal cancer.”<br/><br/>There are multiple screening tests, and while colonoscopy, the gold standard, is very safe, it is not completely without risks, Dr. Meyer added. “And the question of the appropriate allocation of limited societal resources continues to be discussed on a broader level and largely explains the difference between the two guidelines.”<br/><br/>This study received no specific funding. Co-author Jordan J. Karlitz, MD, reported personal fees from GRAIL (senior medical director) and an equity position from Gastro Girl/GI On Demand outside f the submitted work. Dr. Meyer disclosed no conflicts of interest relevant to his comments.<span class="end"/></p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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Improving Fecal Immunochemical Test Collection for Colorectal Cancer Screening During the COVID-19 Pandemic

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Colorectal cancer (CRC) is the third-most common cancer worldwide and accounts for almost 11% of all cancer diagnoses, with > 1.9 million cases reported globally.1,2 CRC is the second-most deadly cancer, responsible for about 935,000 deaths.1 Over the past several decades, a steady decline in CRC incidence and mortality has been reported in developed countries, including the US.3,4 From 2008 through 2017, an annual reduction of 3% in CRC death rates was reported in individuals aged ≥ 65 years.5 This decline can mainly be attributed to improvements made in health systems and advancements in CRC screening programs.3,5

US Preventive Services Task Force (USPSTF) recommends CRC screening in individuals aged 45 to 75 years. USPSTF recommends direct visualization tests, such as colonoscopy and flexible sigmoidoscopy for CRC screening.6 Although colonoscopy is commonly used for CRC screening, it is an invasive procedure that requires bowel preparation and sedation, and has the potential risk of colonic perforation, bleeding, and infection. Additionally, social determinants—such as health care costs, missed work, and geographic location (eg, rural communities)—may limit colonoscopy utilization.7 As a result, other cost-effective, noninvasive tests such as high-sensitivity guaiac-based fecal occult blood test (gFOBT) and fecal immunochemical test (FIT) are also used for CRC screening. These tests detect occult blood in the stool of individuals who may be at risk for CRC, helping direct them to colonoscopy if they screen positive.8

The gFOBT relies on simple oxidation and requires a stool sample to detect the presence of the heme component of blood.9 If heme is present in the stool sample, it will enable the oxidation of guaiac to form a blue-colored dye when added to hydrogen peroxide. It is important to note that the oxidation component of this test may lead to false-positive results, as it may detect dietary hemoglobin present in red meat. Medications or foods that have peroxidase properties may also result in a false-positive gFOBT result. Additionally, false-negative results may be caused by antioxidants, which may interfere with the oxidation of guaiac.

FIT uses antibodies, which bind to the intact globin component of human hemoglobin.9 The quantity of bound antibody-hemoglobin complex is detected and measured by a variety of automated quantitative techniques. This testing strategy eliminates the need for food or medication restrictions and the subjective visual assessment of change in color, as required for the gFOBT.9 A 2016 meta-analysis found that FIT performed better compared with gFOBT in terms of specificity, positivity rate, number needed to scope, and number needed to screen.8 The FIT screening method has also been found to have greater adherence rates, which is likely due to fewer stool sampling requirements and the lack of medication or dietary restrictions, compared with gFOBT.7,8

The COVID-19 pandemic had a drastic impact on CRC preventive care services. In March 2020, elective colonoscopies were temporarily ceased across the country and the US Department of Veterans Affairs (VA) deferred all elective surgeries and medical procedures, including screening and surveillance colonoscopies. In line with these recommendations, elective colonoscopies were temporarily ceased across the country.10 The National Cancer Institute’s Population-Based Research to Optimize the Screening Process consortium reported that CRC screening rates decreased by 82% across the US in 2020.11 Public health measures are likely the main reason for this decline, but other factors may include a lack of resource availability in outpatient settings and public fear of the pandemic.10

figure_1.png

The James A. Haley Veterans Affairs Hospital (JAHVAH) in Tampa, Florida, encouraged the use of FIT in place of colonoscopies to avoid delaying preventive services. The initiative to continue CRC screening methods via FIT was scrutinized when laboratory personnel reported that in fiscal year (FY) 2020, 62% of the FIT kits that patients returned to the laboratory were missing information or had other errors (Figure 1). These improperly returned FIT kits led to delayed processing, canceled orders, increased staff workload, and more costs for FIT repetition.

Research shows many patients often fail to adhere to the instructions for proper FIT sample collection and return. Wang and colleagues reported that of 4916 FIT samples returned to the laboratory, 971 (20%) had collection errors, and 910 (94%) of those samples were missing a sample collection date.12 The sample collection date is important because hemoglobin degradation occurs over time, which may create false-negative FIT results. Although studies have found that sample return times of ≤ 10 days are not associated with a decrease in FIT positive rates, it is recommended to mail completed FITs within 24 hours of sample collection.13

Because remote screening methods like FIT were preferred during the COVID-19 pandemic, we conducted a quality improvement (QI) project to address FIT inefficiency. The aim of this initiative was to determine the root cause behind incorrectly returned FIT kits and to increase correctly collected and testable FIT kits upon initial laboratory arrival by at least 20% by the second quarter of FY 2021.

 

 

Quality Improvement Project

This QI project was conducted from July 2020 to June 2021 at the JAHVAH, which provides primary care and specialty health services to veterans in central and south Florida. The QI was designed based on the Plan-Do-Study-Act (PDSA) model of health care improvement. The QI team consisted of physicians, nurses, administrative staff, and laboratory personnel. A SIPOC (Suppliers, Input, Process, Output, Customers) map was initially designed to help clarify the different groups involved in the process of FIT kit distribution and return. This map helped the team decide who should be involved in the solution process.

The QI team performed a root cause analysis using a fishbone diagram and identified the reasons FIT kits were returned to the laboratory with errors that prevented processing. The team brainstormed potential change ideas and created an impact vs effort chart to increase the number of correctly returned and testable FIT kits upon initial arrival at the laboratory by at least 20% by the second quarter of FY 2021. We identified strengths and prioritized change ideas to improve the number of testable and correctly returned FIT kits to the hospital laboratory. These ideas included centralizing FIT kit dispersal to a new administrative group, building redundant patient reminders on kit completion and giving patients more accessible places for kit return.

Patients included in the study were adults aged 50 to 75 years seen at the JAHVAH outpatient clinic who were asked to undergo FIT CRC screening. FIT orders for other facilities were excluded. The primary endpoint of this project was to improve the number of correctly returned FITs. The number of correct and incorrect returned FITs were measured from July 2020 to June 2021. FITs returned with errors were categorized by the type of error, including: no order on file in the electronic health record (EHR), canceled test, expired test, unable to identify test, missing information, and missing collection date.

We attempted to calculate costs of FITs that were returned to the laboratory but could not be analyzed and were discarded. In FY 2020, 1568 FITs were discarded. Each FIT cost about $7.80 to process for an annualized expense of $12,230 for discarded FITs.

Root Cause Analysis

Root causes were obtained by making a fishbone diagram. From this diagram, an impact vs effort chart was created to form and prioritize ideas for our PDSA cycles. Data about correctly and incorrectly returned kits were collected monthly from laboratory personnel, then analyzed by the QI team using run charts to look for change in frequency and patterns.

To improve this process, a swim lane chart for FIT processing was assembled and later used to make a comprehensive fishbone diagram to establish the 6 main root cause errors: missing FIT EHR order, cancelled FIT EHR order, expired stool specimen, partial patient identifiers, no patient identifiers, and no stool collection date. Pareto and run charts were superimposed with the laboratory data. The most common cause of incorrectly returned FITs was no collection date.

PDSA Cycles

figure_2.png

Beginning in January 2021, PDSA cycles from the ideas in the impact vs effort chart were used. Organization and implementation of the project occurred from July 2020 to April 2021. The team reassessed the data in April 2021 to evaluate progress after PDSA initiation. The mean rate of missing collection date dropped from 24% in FY 2020 prior to PDSA cycles to 14% in April 2021; however, the number of incorrectly returned kits was similar to the baseline level. When reviewing this discrepancy, the QI team found that although the missing collection date rate had improved, the rate of FITs with not enough information had increased from 5% in FY 2020 to 67% in April 2021 (Figure 2). After discussing with laboratory personnel, it was determined that the EHR order was missing when the process pathway changed. Our PDSA initiative changed the process pathway and different individuals were responsible for FIT dispersal. The error was quickly addressed with the help of clinical and administrative staff; a 30-day follow-up on June 21, 2021, revealed that only 9% of the patients had sent back kits with not enough information.

After troubleshooting, the team achieved a sustainable increase in the number of correctly returned FIT kits from an average of 38% before the project to 72% after 30-day follow-up.

 

 

Discussion

Proper collection and return of FIT samples are vital for process efficiency for both physicians and patients. This initiative aimed to improve the rate of correctly returned FIT kits by 20%, but its final numbers showed an improvement of 33.6%. Operational benefits from this project included early detection of CRC, improved laboratory workflow, decreased FIT kit waste, and increased patient satisfaction.

The multipronged PDSA cycle attempted to increase the rate of correctly returned FIT kits. We improved kit comprehension and laboratory accessibility, and instituted redundant return reminders for patients. We also centralized a new process pathway for FIT distribution and educated physicians and support staff. Sampling and FIT return may seem like a simple procedure, but the FIT can be cumbersome for patients and directions can be confusing. Therefore, to maximize screening participation, it is essential to minimize confusion in the collection and return of a FIT sample.14,15

This QI initiative was presented at Grand Rounds at the University of South Florida in June 2021 and has since been shared with other VA hospitals. It was also presented at the American College of Gastroenterology Conference in 2021.

 

Limitations

This study was a single-center QI project and focused mostly on FIT kit return rates. To fully address CRC screening, it is important to ensure that individuals with a positive screen are appropriately followed up with a colonoscopy. Although follow-up was not in the scope of this project, it is key to CRC screening in general and should be the subject of future research.

Conclusions

FIT is a useful method for CRC screening that can be particularly helpful when in-person visits are limited, as seen during the COVID-19 pandemic. This increase in demand for FITs during the pandemic revealed process deficiencies and gave JAHVAH an opportunity to improve workflow. Through the aid of a multidisciplinary team, the process to complete and return FITs improved and surpassed the goal of 20% improvement. Our goal is to continue to fine-tune the workflow and troubleshoot the system as needed.

References

1. Sawicki T, Ruszkowska M, Danielewicz A, Niedz′wiedzka E, Arłukowicz T, Przybyłowicz KE. A review of colorectal cancer in terms of epidemiology, risk factors, development, symptoms and diagnosis. Cancers (Basel). 2021;13(9):2025. Published 2021 Apr 22. doi:10.3390/cancers13092025

2. Rawla P, Sunkara T, Barsouk A. Epidemiology of colorectal cancer: incidence, mortality, survival, and risk factors. Prz Gastroenterol. 2019;14(2):89-103. doi:10.5114/pg.2018.81072

3. Yang DX, Gross CP, Soulos PR, Yu JB. Estimating the magnitude of colorectal cancers prevented during the era of screening: 1976 to 2009. Cancer. 2014;120(18):2893-2901. doi:10.1002/cncr.28794

4. Naishadham D, Lansdorp-Vogelaar I, Siegel R, Cokkinides V, Jemal A. State disparities in colorectal cancer mortality patterns in the United States. Cancer Epidemiol Biomarkers Prev. 2011;20(7):1296-1302. doi:10.1158/1055-9965.EPI-11-0250

5. Siegel RL, Miller KD, Goding Sauer A, et al. Colorectal cancer statistics, 2020. CA Cancer J Clin. 2020;70(3):145-164. doi:10.3322/caac.21601

6. US Preventive Services Task Force, Davidson KW, Barry MJ, et al. Screening for colorectal cancer: US Preventive

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Shruthi Narasimha, MDa; Sukhjinder Chauhan, MDb; Roger Nehaul, MDa; Jeffrey Cummings, MDa; Susan Wrighta; Alexis Pattersona; Raymond Mullinsa; William Messina, DNPa; Brian Zilka, MDa; Ana Kraus, MDa

Correspondence: Sukhjinder Chauhan (sukhjindermd@gmail.com)

aJames A. Haley Veterans Affairs Medical Center, Tampa, Florida

bHCA Sunrise Health Graduate Medical EducationConsortium, Las Vegas, Nevada

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

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Shruthi Narasimha, MDa; Sukhjinder Chauhan, MDb; Roger Nehaul, MDa; Jeffrey Cummings, MDa; Susan Wrighta; Alexis Pattersona; Raymond Mullinsa; William Messina, DNPa; Brian Zilka, MDa; Ana Kraus, MDa

Correspondence: Sukhjinder Chauhan (sukhjindermd@gmail.com)

aJames A. Haley Veterans Affairs Medical Center, Tampa, Florida

bHCA Sunrise Health Graduate Medical EducationConsortium, Las Vegas, Nevada

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

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The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

This project did not require institutional review board approval.

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Shruthi Narasimha, MDa; Sukhjinder Chauhan, MDb; Roger Nehaul, MDa; Jeffrey Cummings, MDa; Susan Wrighta; Alexis Pattersona; Raymond Mullinsa; William Messina, DNPa; Brian Zilka, MDa; Ana Kraus, MDa

Correspondence: Sukhjinder Chauhan (sukhjindermd@gmail.com)

aJames A. Haley Veterans Affairs Medical Center, Tampa, Florida

bHCA Sunrise Health Graduate Medical EducationConsortium, Las Vegas, Nevada

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

This project did not require institutional review board approval.

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Colorectal cancer (CRC) is the third-most common cancer worldwide and accounts for almost 11% of all cancer diagnoses, with > 1.9 million cases reported globally.1,2 CRC is the second-most deadly cancer, responsible for about 935,000 deaths.1 Over the past several decades, a steady decline in CRC incidence and mortality has been reported in developed countries, including the US.3,4 From 2008 through 2017, an annual reduction of 3% in CRC death rates was reported in individuals aged ≥ 65 years.5 This decline can mainly be attributed to improvements made in health systems and advancements in CRC screening programs.3,5

US Preventive Services Task Force (USPSTF) recommends CRC screening in individuals aged 45 to 75 years. USPSTF recommends direct visualization tests, such as colonoscopy and flexible sigmoidoscopy for CRC screening.6 Although colonoscopy is commonly used for CRC screening, it is an invasive procedure that requires bowel preparation and sedation, and has the potential risk of colonic perforation, bleeding, and infection. Additionally, social determinants—such as health care costs, missed work, and geographic location (eg, rural communities)—may limit colonoscopy utilization.7 As a result, other cost-effective, noninvasive tests such as high-sensitivity guaiac-based fecal occult blood test (gFOBT) and fecal immunochemical test (FIT) are also used for CRC screening. These tests detect occult blood in the stool of individuals who may be at risk for CRC, helping direct them to colonoscopy if they screen positive.8

The gFOBT relies on simple oxidation and requires a stool sample to detect the presence of the heme component of blood.9 If heme is present in the stool sample, it will enable the oxidation of guaiac to form a blue-colored dye when added to hydrogen peroxide. It is important to note that the oxidation component of this test may lead to false-positive results, as it may detect dietary hemoglobin present in red meat. Medications or foods that have peroxidase properties may also result in a false-positive gFOBT result. Additionally, false-negative results may be caused by antioxidants, which may interfere with the oxidation of guaiac.

FIT uses antibodies, which bind to the intact globin component of human hemoglobin.9 The quantity of bound antibody-hemoglobin complex is detected and measured by a variety of automated quantitative techniques. This testing strategy eliminates the need for food or medication restrictions and the subjective visual assessment of change in color, as required for the gFOBT.9 A 2016 meta-analysis found that FIT performed better compared with gFOBT in terms of specificity, positivity rate, number needed to scope, and number needed to screen.8 The FIT screening method has also been found to have greater adherence rates, which is likely due to fewer stool sampling requirements and the lack of medication or dietary restrictions, compared with gFOBT.7,8

The COVID-19 pandemic had a drastic impact on CRC preventive care services. In March 2020, elective colonoscopies were temporarily ceased across the country and the US Department of Veterans Affairs (VA) deferred all elective surgeries and medical procedures, including screening and surveillance colonoscopies. In line with these recommendations, elective colonoscopies were temporarily ceased across the country.10 The National Cancer Institute’s Population-Based Research to Optimize the Screening Process consortium reported that CRC screening rates decreased by 82% across the US in 2020.11 Public health measures are likely the main reason for this decline, but other factors may include a lack of resource availability in outpatient settings and public fear of the pandemic.10

figure_1.png

The James A. Haley Veterans Affairs Hospital (JAHVAH) in Tampa, Florida, encouraged the use of FIT in place of colonoscopies to avoid delaying preventive services. The initiative to continue CRC screening methods via FIT was scrutinized when laboratory personnel reported that in fiscal year (FY) 2020, 62% of the FIT kits that patients returned to the laboratory were missing information or had other errors (Figure 1). These improperly returned FIT kits led to delayed processing, canceled orders, increased staff workload, and more costs for FIT repetition.

Research shows many patients often fail to adhere to the instructions for proper FIT sample collection and return. Wang and colleagues reported that of 4916 FIT samples returned to the laboratory, 971 (20%) had collection errors, and 910 (94%) of those samples were missing a sample collection date.12 The sample collection date is important because hemoglobin degradation occurs over time, which may create false-negative FIT results. Although studies have found that sample return times of ≤ 10 days are not associated with a decrease in FIT positive rates, it is recommended to mail completed FITs within 24 hours of sample collection.13

Because remote screening methods like FIT were preferred during the COVID-19 pandemic, we conducted a quality improvement (QI) project to address FIT inefficiency. The aim of this initiative was to determine the root cause behind incorrectly returned FIT kits and to increase correctly collected and testable FIT kits upon initial laboratory arrival by at least 20% by the second quarter of FY 2021.

 

 

Quality Improvement Project

This QI project was conducted from July 2020 to June 2021 at the JAHVAH, which provides primary care and specialty health services to veterans in central and south Florida. The QI was designed based on the Plan-Do-Study-Act (PDSA) model of health care improvement. The QI team consisted of physicians, nurses, administrative staff, and laboratory personnel. A SIPOC (Suppliers, Input, Process, Output, Customers) map was initially designed to help clarify the different groups involved in the process of FIT kit distribution and return. This map helped the team decide who should be involved in the solution process.

The QI team performed a root cause analysis using a fishbone diagram and identified the reasons FIT kits were returned to the laboratory with errors that prevented processing. The team brainstormed potential change ideas and created an impact vs effort chart to increase the number of correctly returned and testable FIT kits upon initial arrival at the laboratory by at least 20% by the second quarter of FY 2021. We identified strengths and prioritized change ideas to improve the number of testable and correctly returned FIT kits to the hospital laboratory. These ideas included centralizing FIT kit dispersal to a new administrative group, building redundant patient reminders on kit completion and giving patients more accessible places for kit return.

Patients included in the study were adults aged 50 to 75 years seen at the JAHVAH outpatient clinic who were asked to undergo FIT CRC screening. FIT orders for other facilities were excluded. The primary endpoint of this project was to improve the number of correctly returned FITs. The number of correct and incorrect returned FITs were measured from July 2020 to June 2021. FITs returned with errors were categorized by the type of error, including: no order on file in the electronic health record (EHR), canceled test, expired test, unable to identify test, missing information, and missing collection date.

We attempted to calculate costs of FITs that were returned to the laboratory but could not be analyzed and were discarded. In FY 2020, 1568 FITs were discarded. Each FIT cost about $7.80 to process for an annualized expense of $12,230 for discarded FITs.

Root Cause Analysis

Root causes were obtained by making a fishbone diagram. From this diagram, an impact vs effort chart was created to form and prioritize ideas for our PDSA cycles. Data about correctly and incorrectly returned kits were collected monthly from laboratory personnel, then analyzed by the QI team using run charts to look for change in frequency and patterns.

To improve this process, a swim lane chart for FIT processing was assembled and later used to make a comprehensive fishbone diagram to establish the 6 main root cause errors: missing FIT EHR order, cancelled FIT EHR order, expired stool specimen, partial patient identifiers, no patient identifiers, and no stool collection date. Pareto and run charts were superimposed with the laboratory data. The most common cause of incorrectly returned FITs was no collection date.

PDSA Cycles

figure_2.png

Beginning in January 2021, PDSA cycles from the ideas in the impact vs effort chart were used. Organization and implementation of the project occurred from July 2020 to April 2021. The team reassessed the data in April 2021 to evaluate progress after PDSA initiation. The mean rate of missing collection date dropped from 24% in FY 2020 prior to PDSA cycles to 14% in April 2021; however, the number of incorrectly returned kits was similar to the baseline level. When reviewing this discrepancy, the QI team found that although the missing collection date rate had improved, the rate of FITs with not enough information had increased from 5% in FY 2020 to 67% in April 2021 (Figure 2). After discussing with laboratory personnel, it was determined that the EHR order was missing when the process pathway changed. Our PDSA initiative changed the process pathway and different individuals were responsible for FIT dispersal. The error was quickly addressed with the help of clinical and administrative staff; a 30-day follow-up on June 21, 2021, revealed that only 9% of the patients had sent back kits with not enough information.

After troubleshooting, the team achieved a sustainable increase in the number of correctly returned FIT kits from an average of 38% before the project to 72% after 30-day follow-up.

 

 

Discussion

Proper collection and return of FIT samples are vital for process efficiency for both physicians and patients. This initiative aimed to improve the rate of correctly returned FIT kits by 20%, but its final numbers showed an improvement of 33.6%. Operational benefits from this project included early detection of CRC, improved laboratory workflow, decreased FIT kit waste, and increased patient satisfaction.

The multipronged PDSA cycle attempted to increase the rate of correctly returned FIT kits. We improved kit comprehension and laboratory accessibility, and instituted redundant return reminders for patients. We also centralized a new process pathway for FIT distribution and educated physicians and support staff. Sampling and FIT return may seem like a simple procedure, but the FIT can be cumbersome for patients and directions can be confusing. Therefore, to maximize screening participation, it is essential to minimize confusion in the collection and return of a FIT sample.14,15

This QI initiative was presented at Grand Rounds at the University of South Florida in June 2021 and has since been shared with other VA hospitals. It was also presented at the American College of Gastroenterology Conference in 2021.

 

Limitations

This study was a single-center QI project and focused mostly on FIT kit return rates. To fully address CRC screening, it is important to ensure that individuals with a positive screen are appropriately followed up with a colonoscopy. Although follow-up was not in the scope of this project, it is key to CRC screening in general and should be the subject of future research.

Conclusions

FIT is a useful method for CRC screening that can be particularly helpful when in-person visits are limited, as seen during the COVID-19 pandemic. This increase in demand for FITs during the pandemic revealed process deficiencies and gave JAHVAH an opportunity to improve workflow. Through the aid of a multidisciplinary team, the process to complete and return FITs improved and surpassed the goal of 20% improvement. Our goal is to continue to fine-tune the workflow and troubleshoot the system as needed.

Colorectal cancer (CRC) is the third-most common cancer worldwide and accounts for almost 11% of all cancer diagnoses, with > 1.9 million cases reported globally.1,2 CRC is the second-most deadly cancer, responsible for about 935,000 deaths.1 Over the past several decades, a steady decline in CRC incidence and mortality has been reported in developed countries, including the US.3,4 From 2008 through 2017, an annual reduction of 3% in CRC death rates was reported in individuals aged ≥ 65 years.5 This decline can mainly be attributed to improvements made in health systems and advancements in CRC screening programs.3,5

US Preventive Services Task Force (USPSTF) recommends CRC screening in individuals aged 45 to 75 years. USPSTF recommends direct visualization tests, such as colonoscopy and flexible sigmoidoscopy for CRC screening.6 Although colonoscopy is commonly used for CRC screening, it is an invasive procedure that requires bowel preparation and sedation, and has the potential risk of colonic perforation, bleeding, and infection. Additionally, social determinants—such as health care costs, missed work, and geographic location (eg, rural communities)—may limit colonoscopy utilization.7 As a result, other cost-effective, noninvasive tests such as high-sensitivity guaiac-based fecal occult blood test (gFOBT) and fecal immunochemical test (FIT) are also used for CRC screening. These tests detect occult blood in the stool of individuals who may be at risk for CRC, helping direct them to colonoscopy if they screen positive.8

The gFOBT relies on simple oxidation and requires a stool sample to detect the presence of the heme component of blood.9 If heme is present in the stool sample, it will enable the oxidation of guaiac to form a blue-colored dye when added to hydrogen peroxide. It is important to note that the oxidation component of this test may lead to false-positive results, as it may detect dietary hemoglobin present in red meat. Medications or foods that have peroxidase properties may also result in a false-positive gFOBT result. Additionally, false-negative results may be caused by antioxidants, which may interfere with the oxidation of guaiac.

FIT uses antibodies, which bind to the intact globin component of human hemoglobin.9 The quantity of bound antibody-hemoglobin complex is detected and measured by a variety of automated quantitative techniques. This testing strategy eliminates the need for food or medication restrictions and the subjective visual assessment of change in color, as required for the gFOBT.9 A 2016 meta-analysis found that FIT performed better compared with gFOBT in terms of specificity, positivity rate, number needed to scope, and number needed to screen.8 The FIT screening method has also been found to have greater adherence rates, which is likely due to fewer stool sampling requirements and the lack of medication or dietary restrictions, compared with gFOBT.7,8

The COVID-19 pandemic had a drastic impact on CRC preventive care services. In March 2020, elective colonoscopies were temporarily ceased across the country and the US Department of Veterans Affairs (VA) deferred all elective surgeries and medical procedures, including screening and surveillance colonoscopies. In line with these recommendations, elective colonoscopies were temporarily ceased across the country.10 The National Cancer Institute’s Population-Based Research to Optimize the Screening Process consortium reported that CRC screening rates decreased by 82% across the US in 2020.11 Public health measures are likely the main reason for this decline, but other factors may include a lack of resource availability in outpatient settings and public fear of the pandemic.10

figure_1.png

The James A. Haley Veterans Affairs Hospital (JAHVAH) in Tampa, Florida, encouraged the use of FIT in place of colonoscopies to avoid delaying preventive services. The initiative to continue CRC screening methods via FIT was scrutinized when laboratory personnel reported that in fiscal year (FY) 2020, 62% of the FIT kits that patients returned to the laboratory were missing information or had other errors (Figure 1). These improperly returned FIT kits led to delayed processing, canceled orders, increased staff workload, and more costs for FIT repetition.

Research shows many patients often fail to adhere to the instructions for proper FIT sample collection and return. Wang and colleagues reported that of 4916 FIT samples returned to the laboratory, 971 (20%) had collection errors, and 910 (94%) of those samples were missing a sample collection date.12 The sample collection date is important because hemoglobin degradation occurs over time, which may create false-negative FIT results. Although studies have found that sample return times of ≤ 10 days are not associated with a decrease in FIT positive rates, it is recommended to mail completed FITs within 24 hours of sample collection.13

Because remote screening methods like FIT were preferred during the COVID-19 pandemic, we conducted a quality improvement (QI) project to address FIT inefficiency. The aim of this initiative was to determine the root cause behind incorrectly returned FIT kits and to increase correctly collected and testable FIT kits upon initial laboratory arrival by at least 20% by the second quarter of FY 2021.

 

 

Quality Improvement Project

This QI project was conducted from July 2020 to June 2021 at the JAHVAH, which provides primary care and specialty health services to veterans in central and south Florida. The QI was designed based on the Plan-Do-Study-Act (PDSA) model of health care improvement. The QI team consisted of physicians, nurses, administrative staff, and laboratory personnel. A SIPOC (Suppliers, Input, Process, Output, Customers) map was initially designed to help clarify the different groups involved in the process of FIT kit distribution and return. This map helped the team decide who should be involved in the solution process.

The QI team performed a root cause analysis using a fishbone diagram and identified the reasons FIT kits were returned to the laboratory with errors that prevented processing. The team brainstormed potential change ideas and created an impact vs effort chart to increase the number of correctly returned and testable FIT kits upon initial arrival at the laboratory by at least 20% by the second quarter of FY 2021. We identified strengths and prioritized change ideas to improve the number of testable and correctly returned FIT kits to the hospital laboratory. These ideas included centralizing FIT kit dispersal to a new administrative group, building redundant patient reminders on kit completion and giving patients more accessible places for kit return.

Patients included in the study were adults aged 50 to 75 years seen at the JAHVAH outpatient clinic who were asked to undergo FIT CRC screening. FIT orders for other facilities were excluded. The primary endpoint of this project was to improve the number of correctly returned FITs. The number of correct and incorrect returned FITs were measured from July 2020 to June 2021. FITs returned with errors were categorized by the type of error, including: no order on file in the electronic health record (EHR), canceled test, expired test, unable to identify test, missing information, and missing collection date.

We attempted to calculate costs of FITs that were returned to the laboratory but could not be analyzed and were discarded. In FY 2020, 1568 FITs were discarded. Each FIT cost about $7.80 to process for an annualized expense of $12,230 for discarded FITs.

Root Cause Analysis

Root causes were obtained by making a fishbone diagram. From this diagram, an impact vs effort chart was created to form and prioritize ideas for our PDSA cycles. Data about correctly and incorrectly returned kits were collected monthly from laboratory personnel, then analyzed by the QI team using run charts to look for change in frequency and patterns.

To improve this process, a swim lane chart for FIT processing was assembled and later used to make a comprehensive fishbone diagram to establish the 6 main root cause errors: missing FIT EHR order, cancelled FIT EHR order, expired stool specimen, partial patient identifiers, no patient identifiers, and no stool collection date. Pareto and run charts were superimposed with the laboratory data. The most common cause of incorrectly returned FITs was no collection date.

PDSA Cycles

figure_2.png

Beginning in January 2021, PDSA cycles from the ideas in the impact vs effort chart were used. Organization and implementation of the project occurred from July 2020 to April 2021. The team reassessed the data in April 2021 to evaluate progress after PDSA initiation. The mean rate of missing collection date dropped from 24% in FY 2020 prior to PDSA cycles to 14% in April 2021; however, the number of incorrectly returned kits was similar to the baseline level. When reviewing this discrepancy, the QI team found that although the missing collection date rate had improved, the rate of FITs with not enough information had increased from 5% in FY 2020 to 67% in April 2021 (Figure 2). After discussing with laboratory personnel, it was determined that the EHR order was missing when the process pathway changed. Our PDSA initiative changed the process pathway and different individuals were responsible for FIT dispersal. The error was quickly addressed with the help of clinical and administrative staff; a 30-day follow-up on June 21, 2021, revealed that only 9% of the patients had sent back kits with not enough information.

After troubleshooting, the team achieved a sustainable increase in the number of correctly returned FIT kits from an average of 38% before the project to 72% after 30-day follow-up.

 

 

Discussion

Proper collection and return of FIT samples are vital for process efficiency for both physicians and patients. This initiative aimed to improve the rate of correctly returned FIT kits by 20%, but its final numbers showed an improvement of 33.6%. Operational benefits from this project included early detection of CRC, improved laboratory workflow, decreased FIT kit waste, and increased patient satisfaction.

The multipronged PDSA cycle attempted to increase the rate of correctly returned FIT kits. We improved kit comprehension and laboratory accessibility, and instituted redundant return reminders for patients. We also centralized a new process pathway for FIT distribution and educated physicians and support staff. Sampling and FIT return may seem like a simple procedure, but the FIT can be cumbersome for patients and directions can be confusing. Therefore, to maximize screening participation, it is essential to minimize confusion in the collection and return of a FIT sample.14,15

This QI initiative was presented at Grand Rounds at the University of South Florida in June 2021 and has since been shared with other VA hospitals. It was also presented at the American College of Gastroenterology Conference in 2021.

 

Limitations

This study was a single-center QI project and focused mostly on FIT kit return rates. To fully address CRC screening, it is important to ensure that individuals with a positive screen are appropriately followed up with a colonoscopy. Although follow-up was not in the scope of this project, it is key to CRC screening in general and should be the subject of future research.

Conclusions

FIT is a useful method for CRC screening that can be particularly helpful when in-person visits are limited, as seen during the COVID-19 pandemic. This increase in demand for FITs during the pandemic revealed process deficiencies and gave JAHVAH an opportunity to improve workflow. Through the aid of a multidisciplinary team, the process to complete and return FITs improved and surpassed the goal of 20% improvement. Our goal is to continue to fine-tune the workflow and troubleshoot the system as needed.

References

1. Sawicki T, Ruszkowska M, Danielewicz A, Niedz′wiedzka E, Arłukowicz T, Przybyłowicz KE. A review of colorectal cancer in terms of epidemiology, risk factors, development, symptoms and diagnosis. Cancers (Basel). 2021;13(9):2025. Published 2021 Apr 22. doi:10.3390/cancers13092025

2. Rawla P, Sunkara T, Barsouk A. Epidemiology of colorectal cancer: incidence, mortality, survival, and risk factors. Prz Gastroenterol. 2019;14(2):89-103. doi:10.5114/pg.2018.81072

3. Yang DX, Gross CP, Soulos PR, Yu JB. Estimating the magnitude of colorectal cancers prevented during the era of screening: 1976 to 2009. Cancer. 2014;120(18):2893-2901. doi:10.1002/cncr.28794

4. Naishadham D, Lansdorp-Vogelaar I, Siegel R, Cokkinides V, Jemal A. State disparities in colorectal cancer mortality patterns in the United States. Cancer Epidemiol Biomarkers Prev. 2011;20(7):1296-1302. doi:10.1158/1055-9965.EPI-11-0250

5. Siegel RL, Miller KD, Goding Sauer A, et al. Colorectal cancer statistics, 2020. CA Cancer J Clin. 2020;70(3):145-164. doi:10.3322/caac.21601

6. US Preventive Services Task Force, Davidson KW, Barry MJ, et al. Screening for colorectal cancer: US Preventive

References

1. Sawicki T, Ruszkowska M, Danielewicz A, Niedz′wiedzka E, Arłukowicz T, Przybyłowicz KE. A review of colorectal cancer in terms of epidemiology, risk factors, development, symptoms and diagnosis. Cancers (Basel). 2021;13(9):2025. Published 2021 Apr 22. doi:10.3390/cancers13092025

2. Rawla P, Sunkara T, Barsouk A. Epidemiology of colorectal cancer: incidence, mortality, survival, and risk factors. Prz Gastroenterol. 2019;14(2):89-103. doi:10.5114/pg.2018.81072

3. Yang DX, Gross CP, Soulos PR, Yu JB. Estimating the magnitude of colorectal cancers prevented during the era of screening: 1976 to 2009. Cancer. 2014;120(18):2893-2901. doi:10.1002/cncr.28794

4. Naishadham D, Lansdorp-Vogelaar I, Siegel R, Cokkinides V, Jemal A. State disparities in colorectal cancer mortality patterns in the United States. Cancer Epidemiol Biomarkers Prev. 2011;20(7):1296-1302. doi:10.1158/1055-9965.EPI-11-0250

5. Siegel RL, Miller KD, Goding Sauer A, et al. Colorectal cancer statistics, 2020. CA Cancer J Clin. 2020;70(3):145-164. doi:10.3322/caac.21601

6. US Preventive Services Task Force, Davidson KW, Barry MJ, et al. Screening for colorectal cancer: US Preventive

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<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>0524 FED AVAHO FIT</fileName> <TBEID>0C02F569.SIG</TBEID> <TBUniqueIdentifier>NJ_0C02F569</TBUniqueIdentifier> <newsOrJournal>Journal</newsOrJournal> <publisherName>Frontline Medical Communications Inc.</publisherName> <storyname/> <articleType>1</articleType> <TBLocation>Copyfitting-FED</TBLocation> <QCDate/> <firstPublished>20240428T215119</firstPublished> <LastPublished>20240428T215119</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240428T215118</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline/> <bylineText>Shruthi Narasimha, MDa; Sukhjinder Chauhan, MDb; Roger Nehaul, MDa; Jeffrey Cummings, MDa; Susan Wrighta;Alexis Pattersona; Raymond Mullinsa; William Messina, DNPa; Brian Zilka, MDa; Ana Kraus, MDa</bylineText> <bylineFull/> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType/> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:"> <name/> <rightsInfo> <copyrightHolder> <name/> </copyrightHolder> <copyrightNotice/> </rightsInfo> </provider> <abstract/> <metaDescription>Colorectal cancer (CRC) is the third-most common cancer worldwide and accounts for almost 11% of all cancer diagnoses, with &gt; 1.9 million cases reported globall</metaDescription> <articlePDF/> <teaserImage/> <title>Improving Fecal Immunochemical Test Collection for Colorectal Cancer Screening During the COVID-19 Pandemic</title> <deck/> <eyebrow>program profile</eyebrow> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear>2024</pubPubdateYear> <pubPubdateMonth>May</pubPubdateMonth> <pubPubdateDay/> <pubVolume>41</pubVolume> <pubNumber>5</pubNumber> <wireChannels/> <primaryCMSID/> <CMSIDs> <CMSID>4473</CMSID> <CMSID>3639</CMSID> </CMSIDs> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>FED</publicationCode> <pubIssueName>May 2024</pubIssueName> <pubArticleType>Feature Articles | 3639</pubArticleType> <pubTopics/> <pubCategories/> <pubSections> <pubSection>Program Profile | 4473<pubSubsection/></pubSection> </pubSections> <journalTitle>Fed Pract</journalTitle> <journalFullTitle>Federal Practitioner</journalFullTitle> <copyrightStatement>Copyright 2017 Frontline Medical Communications Inc., Parsippany, NJ, USA. All rights reserved.</copyrightStatement> </publicationData> </publications_g> <publications> <term canonical="true">16</term> </publications> <sections> <term canonical="true">61535</term> </sections> <topics> <term canonical="true">337</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Improving Fecal Immunochemical Test Collection for Colorectal Cancer Screening During the COVID-19 Pandemic</title> <deck/> </itemMeta> <itemContent> <p class="abstract"><b/><b>Background:</b> Colonoscopy is a first-line method for colorectal cancer (CRC) screening. However, cost-effective noninvasive tests, such as high-sensitivity guaiac-based fecal occult blood test (gFOBT) and fecal immunochemical test (FIT), are also used. The COVID-19 pandemic had a substantial negative impact on CRC screening rates. The James A. Haley Veterans Affairs Hospital (JAHVAH) continued socially distant CRC screening using FITs, but encountered inefficiencies due to high rates of incorrectly collected FIT samples. A quality improvement (QI) project was conducted to increase correctly collected and testable FIT kits upon initial laboratory submission.<br/><br/><b>Observations</b>: The ambulatory QI project sought out root causes for incorrectly returned FITs and proposed Plan-Do-Study-Act (PDSA) cycles based on a series of approved action plans. A multidisciplinary team of laboratory, nursing, administrative, and primary care staff worked together to discover 6 major root causes. Our multipronged PDSA cycle attempted to set up redundant patient reminders, centralize the FIT dispersal process, and make the patient-FIT interface more user-friendly. All PDSA solutions were implemented over 4 months. Lack of collection date was the most common reason for incorrectly returned FIT kits and the focus of PDSA improvements. The rate of FITs with missing collection dates dropped from 24% prior to PDSA to 14% in April 2021. The rate of correctly returned FIT kits rose from 38% before the project to 72% afterwards, surpassing the 20% improvement goal.<b>Conclusions</b>: FIT is a useful method for CRC screening that can be particularly helpful when in-person visits are limited, as seen during the COVID-19 pandemic. The increase in demand for FITs during the pandemic revealed process deficiencies and gave JAHVAH an opportunity to improve workflow.</p> <p>Colorectal cancer (CRC) is the third-most common cancer worldwide and accounts for almost 11% of all cancer diagnoses, with &gt; 1.9 million cases reported globally.<sup>1,2</sup> CRC is the second-most deadly cancer, responsible for about 935,000 deaths.<sup>1</sup> Over the past several decades, a steady decline in CRC incidence and mortality has been reported in developed countries, including the US.<sup>3,4</sup> From 2008 through 2017, an annual reduction of 3% in CRC death rates was reported in individuals aged ≥ 65 years.<sup>5</sup> This decline can mainly be attributed to improvements made in health systems and advancements in CRC screening programs.<sup>3,5</sup></p> <p>US Preventive Services Task Force (USPSTF) recommends CRC screening in individuals aged 45 to 75 years. USPSTF recommends direct visualization tests, such as colonoscopy and flexible sigmoidoscopy for CRC screening.<sup>6</sup> Although colonoscopy is commonly used for CRC screening, it is an invasive procedure that requires bowel preparation and sedation, and has the potential risk of colonic perforation, bleeding, and infection. Additionally, social determinants—such as health care costs, missed work, and geographic location (eg, rural communities)—may limit colonoscopy utilization.<sup>7</sup> As a result, other cost-effective, noninvasive tests such as high-sensitivity guaiac-based fecal occult blood test (gFOBT) and fecal immunochemical test (FIT) are also used for CRC screening. These tests detect occult blood in the stool of individuals who may be at risk for CRC, helping direct them to colonoscopy if they screen positive.<sup>8<br/><br/></sup>The gFOBT relies on simple oxidation and requires a stool sample to detect the presence of the heme component of blood.<sup>9</sup> If heme is present in the stool sample, it will enable the oxidation of guaiac to form a blue-colored dye when added to hydrogen peroxide. It is important to note that the oxidation component of this test may lead to false-positive results, as it may detect dietary hemoglobin present in red meat. Medications or foods that have peroxidase properties may also result in a false-positive gFOBT result. Additionally, false-negative results may be caused by antioxidants, which may interfere with the oxidation of guaiac. <br/><br/>FIT uses antibodies, which bind to the intact globin component of human hemoglobin.<sup>9</sup> The quantity of bound antibody-hemoglobin complex is detected and measured by a variety of automated quantitative techniques. This testing strategy eliminates the need for food or medication restrictions and the subjective visual assessment of change in color, as required for the gFOBT.<sup>9</sup> A 2016 meta-analysis found that FIT performed better compared with gFOBT in terms of specificity, positivity rate, number needed to scope, and number needed to screen.<sup>8</sup> The FIT screening method has also been found to have greater adherence rates, which is likely due to fewer stool sampling requirements and the lack of medication or dietary restrictions, compared with gFOBT.<sup>7,8<br/><br/></sup>The COVID-19 pandemic had a drastic impact on CRC preventive care services. In March 2020, elective colonoscopies were temporarily ceased across the country and the US Department of Veterans Affairs (VA) deferred all elective surgeries and medical procedures, including screening and surveillance colonoscopies. In line with these recommendations, elective colonoscopies were temporarily ceased across the country.<sup>10</sup> The National Cancer Institute’s Population-Based Research to Optimize the Screening Process consortium reported that CRC screening rates decreased by 82% across the US in 2020.<sup>11</sup> Public health measures are likely the main reason for this decline, but other factors may include a lack of resource availability in outpatient settings and public fear of the pandemic.<sup>10<br/><br/></sup>The James A. Haley Veterans Affairs Hospital (JAHVAH) in Tampa, Florida, encouraged the use of FIT in place of colonoscopies to avoid delaying preventive services. The initiative to continue CRC screening methods via FIT was scrutinized when laboratory personnel reported that in fiscal year (FY) 2020, 62% of the FIT kits that patients returned to the laboratory were missing information or had other errors (Figure 1). These improperly returned FIT kits led to delayed processing, canceled orders, increased staff workload, and more costs for FIT repetition.Research shows many patients often fail to adhere to the instructions for proper FIT sample collection and return. Wang and colleagues reported that of 4916 FIT samples returned to the laboratory, 971 (20%) had collection errors, and 910 (94%) of those samples were missing a sample collection date.<sup>12</sup> The sample collection date is important because hemoglobin degradation occurs over time, which may create false-negative FIT results. Although studies have found that sample return times of ≤ 10 days are not associated with a decrease in FIT positive rates, it is recommended to mail completed FITs within 24 hours of sample collection.<sup>13<br/><br/></sup>Because remote screening methods like FIT were preferred during the COVID-19 pandemic, we conducted a quality improvement (QI) project to address FIT inefficiency. The aim of this initiative was to determine the root cause behind incorrectly returned FIT kits and to increase correctly collected and testable FIT kits upon initial laboratory arrival by at least 20% by the second quarter of FY 2021.</p> <h2>Quality Improvement Project</h2> <p>This QI project was conducted from July 2020 to June 2021 at the JAHVAH, which provides primary care and specialty health services to veterans in central and south Florida. The QI was designed based on the Plan-Do-Study-Act (PDSA) model of health care improvement. The QI team consisted of physicians, nurses, administrative staff, and laboratory personnel. A SIPOC (Suppliers, Input, Process, Output, Customers) map was initially designed to help clarify the different groups involved in the process of FIT kit distribution and return. This map helped the team decide who should be involved in the solution process.</p> <p>The QI team performed a root cause analysis using a fishbone diagram and identified the reasons FIT kits were returned to the laboratory with errors that prevented processing. The team brainstormed potential change ideas and created an impact vs effort chart to increase the number of correctly returned and testable FIT kits upon initial arrival at the laboratory by at least 20% by the second quarter of FY 2021. We identified strengths and prioritized change ideas to improve the number of testable and correctly returned FIT kits to the hospital laboratory. These ideas included centralizing FIT kit dispersal to a new administrative group, building redundant patient reminders on kit completion and giving patients more accessible places for kit return. <br/><br/>Patients included in the study were adults aged 50 to 75 years seen at the JAHVAH outpatient clinic who were asked to undergo FIT CRC screening. FIT orders for other facilities were excluded. The primary endpoint of this project was to improve the number of correctly returned FITs. The number of correct and incorrect returned FITs were measured from July 2020 to June 2021. FITs returned with errors were categorized by the type of error, including: no order on file in the electronic health record (EHR), canceled test, expired test, unable to identify test, missing information, and missing collection date.<br/><br/>We attempted to calculate costs of FITs that were returned to the laboratory but could not be analyzed and were discarded. In FY 2020, 1568 FITs were discarded. Each FIT cost about $7.80 to process for an annualized expense of $12,230 for discarded FITs.</p> <h3>Root Cause Analysis</h3> <p>Root causes were obtained by making a fishbone diagram. From this diagram, an impact vs effort chart was created to form and prioritize ideas for our PDSA cycles. Data about correctly and incorrectly returned kits were collected monthly from laboratory personnel, then analyzed by the QI team using run charts to look for change in frequency and patterns.</p> <p>To improve this process, a swim lane chart for FIT processing was assembled and later used to make a comprehensive fishbone diagram to establish the 6 main root cause errors: missing FIT EHR order, cancelled FIT EHR order, expired stool specimen, partial patient identifiers, no patient identifiers, and no stool collection date. Pareto and run charts were superimposed with the laboratory data. The most common cause of incorrectly returned FITs was no collection date.</p> <h3>PDSA Cycles</h3> <p>Beginning in January 2021, PDSA cycles from the ideas in the impact vs effort chart were used. Organization and implementation of the project occurred from July 2020 to April 2021. The team reassessed the data in April 2021 to evaluate progress after PDSA initiation. The mean rate of missing collection date dropped from 24% in FY 2020 prior to PDSA cycles to 14% in April 2021; however, the number of incorrectly returned kits was similar to the baseline level. When reviewing this discrepancy, the QI team found that although the missing collection date rate had improved, the rate of FITs with not enough information had increased from 5% in FY 2020<b> </b>to 67% in April 2021 (Figure 2). After discussing with laboratory personnel, it was determined that the EHR order was missing when the process pathway changed. Our PDSA initiative changed the process pathway and different individuals were responsible for FIT dispersal. The error was quickly addressed with the help of clinical and administrative staff; a 30-day follow-up on June 21, 2021, revealed that only 9% of the patients had sent back kits with not enough information.</p> <p>After troubleshooting, the team achieved a sustainable increase in the number of correctly returned FIT kits from an average of 38% before the project to 72% after 30-day follow-up.</p> <h2>Discussion</h2> <p>Proper collection and return of FIT samples are vital for process efficiency for both physicians and patients. This initiative aimed to improve the rate of correctly returned FIT kits by 20%, but its final numbers showed an improvement of 33.6%. Operational benefits from this project included early detection of CRC, improved laboratory workflow, decreased FIT kit waste, and increased patient satisfaction.</p> <p>The multipronged PDSA cycle attempted to increase the rate of correctly returned FIT kits. We improved kit comprehension and laboratory accessibility, and instituted redundant return reminders for patients. We also centralized a new process pathway for FIT distribution and educated physicians and support staff. Sampling and FIT return may seem like a simple procedure, but the FIT can be cumbersome for patients and directions can be confusing. Therefore, to maximize screening participation, it is essential to minimize confusion in the collection and return of a FIT sample.<sup>14,15<br/><br/></sup>This QI initiative was presented at Grand Rounds at the University of South Florida in June 2021 and has since been shared with other VA hospitals. It was also presented at the American College of Gastroenterology Conference in 2021.</p> <h3>Limitations</h3> <p>This study was a single-center QI project and focused mostly on FIT kit return rates. To fully address CRC screening, it is important to ensure that individuals with a positive screen are appropriately followed up with a colonoscopy. Although follow-up was not in the scope of this project, it is key to CRC screening in general and should be the subject of future research.</p> <h2>Conclusions</h2> <p>FIT is a useful method for CRC screening that can be particularly helpful when in-person visits are limited, as seen during the COVID-19 pandemic. This increase in demand for FITs during the pandemic revealed process deficiencies and gave JAHVAH an opportunity to improve workflow. Through the aid of a multidisciplinary team, the process to complete and return FITs improved and surpassed the goal of 20% improvement. Our goal is to continue to fine-tune the workflow and troubleshoot the system as needed.</p> <p class="isub">Author affiliations</p> <p> <em><sup>a</sup>James A. Haley Veterans Affairs Medical Center, Tampa, Florida<br/><br/><sup>b</sup>HCA Sunrise Health Graduate Medical EducationConsortium, Las Vegas, Nevada</em> </p> <p class="isub">Author disclosures</p> <p> <em>The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.</em> </p> <p class="isub">Disclaimer</p> <p> <em>The opinions expressed herein are those of the authors and do not necessarily reflect those of <i>Federal Practitioner</i>, Frontline Medical Communications Inc., the US Government, or any of its agencies.</em> </p> <p class="isub">Ethics and consent</p> <p> <em>This project did not require institutional review board approval.</em> </p> <h2>References</h2> <p class="reference"> 1. Sawicki T, Ruszkowska M, Danielewicz A, Niedz′wiedzka E, Arłukowicz T, Przybyłowicz KE. A review of colorectal cancer in terms of epidemiology, risk factors, development, symptoms and diagnosis. <i>Cancers (Basel)</i>. 2021;13(9):2025. Published 2021 Apr 22. doi:10.3390/cancers13092025<br/><br/> 2. Rawla P, Sunkara T, Barsouk A. Epidemiology of colorectal cancer: incidence, mortality, survival, and risk factors. <i>Prz Gastroenterol</i>. 2019;14(2):89-103. doi:10.5114/pg.2018.81072<br/><br/> 3. Yang DX, Gross CP, Soulos PR, Yu JB. Estimating the magnitude of colorectal cancers prevented during the era of screening: 1976 to 2009. <i>Cancer</i>. 2014;120(18):2893-2901. doi:10.1002/cncr.28794<br/><br/> 4. Naishadham D, Lansdorp-Vogelaar I, Siegel R, Cokkinides V, Jemal A. State disparities in colorectal cancer mortality patterns in the United States. <i>Cancer Epidemiol Biomarkers Prev</i>. 2011;20(7):1296-1302. doi:10.1158/1055-9965.EPI-11-0250<br/><br/> 5. Siegel RL, Miller KD, Goding Sauer A, et al. Colorectal cancer statistics, 2020. <i>CA Cancer J Clin</i>. 2020;70(3):145-164. doi:10.3322/caac.21601</p> <p class="reference"> 6. US Preventive Services Task Force, Davidson KW, Barry MJ, et al. Screening for colorectal cancer: US Preventive</p> </itemContent> </newsItem> </itemSet></root>
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Potential Impact of USPS Mail Delivery Delays on Colorectal Cancer Screening Programs

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Colorectal cancer (CRC) is the second leading cause of cancer deaths in the United States.1 In 2022, there were an estimated 151,030 new CRC cases and 52,580 deaths.1 Options for CRC screening of patients at average risk include stool tests (annual fecal immunochemical test [FIT], annual guaiac-based fecal occult blood test, or stool FIT-DNA test every 1 to 3 years), colonoscopies every 10 years, flexible sigmoidoscopies every 5 years (or every 10 years with annual FIT), and computed tomography (CT) colonography every 5 years.2 Many health care systems use annual FIT for patients at average risk. Compared with guaiac-based fecal occult blood testing, FIT does not require dietary or medication modifications and yields greater sensitivity and patient participation.3

The COVID-19 pandemic and staffing issues have caused a scheduling backlog for screening, diagnostic, and surveillance endoscopies at some medical centers. As a result, FIT has become the primary means of CRC screening at these institutions. FIT kits for home use are typically distributed to eligible patients at an office visit or by mail, and patients are then instructed to mail the kits back to the laboratory. For the test to be as sensitive as possible, FIT kit manufacturers advise laboratory analysis within 14 to 15 days of collection, if stored at ambient temperature, and to reject the sample if it does not meet testing criteria for stability. Delayed FIT sample analysis has been associated with higher false-negative rates because of hemoglobin degradation.4 FIT sample exposure to high ambient temperatures also has been linked to decreased sensitivity for detecting CRC.5

US Postal Service (USPS) mail delivery delays have plagued many areas of the country. A variety of factors, including the COVID-19 pandemic, understaffing, changes in USPS policies, closure of post offices, and changes in mail delivery standards, may also be contributory causes. According to the USPS website, delivery standard for first-class mail is 1 to 5 days, but this is not guaranteed.6

The Jesse Brown Veterans Affairs Medical Center (JBVAMC) laboratory in Chicago has reported receiving FIT kit envelopes in batches by the USPS, with some prepaid first-class business reply envelopes delivered up to 60 days after the time of sample collection. Polymedco, a company that assists US Department of Veterans Affairs (VA) medical centers with logistics of FIT programs for CRC screening, reports that USPS batching of FIT kits leading to delayed delivery has been a periodic problem for medical centers around the country. Polymedco staff remind USPS staff about 4 points when they encounter this issue: Mailers are first-class mail; mailers contain a human biologic specimen that has limited viability; the biological sample used for detecting cancer is time sensitive; and delays in delivery by holding/batching kits could impact morbidity and mortality. Reviewing these key points with local USPS staff usually helps, however, batching and delayed delivery of the FIT kits can sometimes recur with USPS staffing turnover.

Tracking and identifying when a patient receives the FIT kit is difficult. Patients are instructed to write the date of collection on the kit, so the receiving laboratory knows whether the sample can be reliably analyzed. When patients are notified about delayed delivery of their sample, a staff member asks if they postponed dropping the kit in the mail. Most patients report mailing the sample within 1 to 2 days of collection. Tracking and dating each step of FIT kit events is not feasible with a mass mailing campaign. In our experience, most patients write the date of collection on the kit. If a collection date is not provided, the laboratory will call the patient to confirm a date. Cheng and colleagues reviewed the causes for FIT specimen rejection in a laboratory analyzing specimens for VA patients and found that 14% of submitted samples were rejected because the specimen was received > 14 days after collection, and 6% because the patient did not record the collection date. With a series of interventions aimed at reminding patients and improving laboratory procedures, rates of rejection for these 2 causes were reduced to < 4%.7 USPS delays were not identified as a factor or tracked in this study.

It is unclear why the USPS sometimes holds FIT kits at their facilities and then delivers large bins of them at the same time. Because FIT kits should be analyzed within 14 to 15 days of sample collection to assure reliable results, mail delivery delays can result in increased sample rejection. Based on the JBVAMC experience, up to 30% of submitted samples might need to be discarded when batched delivery takes place. In these cases, patients need to be contacted, informed of the problem, and asked to submit new kits. Understandably, patients are reluctant to repeat this type of testing, and we are concerned this could lead to reduced rates of CRC screening in affected communities.

As an alternative to discarding delayed samples, laboratories could report the results of delayed FIT kits with an added comment that “negative test results may be less reliable due to delayed processing,” but this approach would raise quality and medicolegal concerns. Clinicians have reached out to local USPS supervisory personnel with mixed results. Sometimes batching and delayed deliveries stop for a few months, only to resume without warning. Dropping off the sample directly at the laboratory is not a realistic option for most patients. Some patients can be convinced to submit another sample, some elect to switch to other CRC screening strategies, while others, unfortunately, decline further screening efforts.

 

 

Laboratory staff can be overwhelmed with having to process hundreds of samples in a short time frame, especially because there is no way of knowing when USPS will make a batched delivery. Laboratory capacities can limit staff at some facilities to performing analysis of only 10 tests at a time. The FIT kits should be delivered on a rolling basis and without delay so that the samples can be reliably analyzed with a predictable workload for the laboratory personnel and without unexpected surges.

When health care facilities identify delayed mail delivery of FIT kits via USPS, laboratories should first ensure that the correct postage rates are used on the prepaid envelopes and that their USPS accounts are properly funded, so that insufficient funds are not contributing to delayed deliveries. Stakeholders should then reach out to local USPS supervisory staff and request that the practice of batching the delivery of FIT kits be stopped. Educating USPS supervisory staff about concerns related to decreased test reliability associated with delayed mail delivery can be a persuasive argument. Adding additional language to the preprinted envelopes, such as “time sensitive,” may also be helpful. Unfortunately, the JBVAMC experience has been that the problem initially gets better after contacting the USPS, only to unexpectedly resurface months later. This cycle has been repeated several times in the past 2 years at JBVAMC.

All clinicians involved in CRC screening and treatment at institutions that use FIT kits need to be aware of the impact that local USPS delays can have on the reliability of these results. Health care systems should be prepared to implement mitigation strategies if they encounter significant delays with mail delivery. If delays cannot be reliably resolved by working with the local USPS staff, consider involving national USPS oversight bodies. And if the problems persist despite an attempt to work with the USPS, some institutions might find it feasible to offer drop boxes at their clinics and instruct patients to drop off FIT kits immediately following collection, in lieu of mailing them. Switching to private carriers is not a cost-effective alternative for most health care systems, and some may exclude rural areas. Depending on the local availability and capacity of endoscopists, some clinicians might prioritize referring patients for screening colonoscopies or screening flexible sigmoidoscopies, and might deemphasize FIT kits as a preferred option for CRC screening. CT colonography is an alternative screening method that is not as widely offered, nor as widely accepted at this time.

Conclusions

CRC screening is an essential part of preventive medicine, and the percentage of eligible patients screened is a well-established quality metric in primary care settings. Health care systems, clinicians, and laboratories must be vigilant to ensure that USPS delays in delivering FIT kits do not negatively impact their CRC screening programs. Facilities should actively monitor for delays in the return of FIT kits.

Despite the widespread use of mail-order pharmacies and the use of mail to communicate notifications about test results and follow-up appointments, unreliable or delayed mail delivery traditionally has not been considered a social determinant of health.8 This article highlights the impact delayed mail delivery can have on health outcomes. Disadvantaged communities in inner cities and rural areas have been disproportionately affected by the worsening performance of the USPS over the past few years.9 This represents an underappreciated public health concern in need of a sustainable solution.

References

1. Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022;72(1):7-33. doi:10.3322/caac.21708

2. Centers for Disease Control and Prevention. Colorectal cancer screening tests. Updated February 23, 2023. Accessed March 14, 2024. https://www.cdc.gov/cancer/colorectal/basic_info/screening/tests.htm

3. van Rossum LG, van Rijn AF, Laheij RJ, et al. Random comparison of guaiac and immunochemical fecal occult blood tests for colorectal cancer in a screening population. Gastroenterology. 2008;135(1):82-90. doi:10.1053/j.gastro.2008.03.040

4. van Rossum LG, van Rijn AF, van Oijen MG, et al. False negative fecal occult blood tests due to delayed sample return in colorectal cancer screening. Int J Cancer. 2009;125(4):746-750. doi:10.1002/ijc.24458

5. Doubeni CA, Jensen CD, Fedewa SA, et al. Fecal immunochemical test (FIT) for colon cancer screening: variable performance with ambient temperature. J Am Board Fam Med. 2016;29(6):672-681. doi:10.3122/jabfm.2016.06.160060

6. United States Postal Service. Shipping and mailing with USPS. Accessed March 14, 2024. https://www.usps.com/ship

7. Cheng C, Ganz DA, Chang ET, Huynh A, De Peralta S. Reducing rejected fecal immunochemical tests received in the laboratory for colorectal cancer screening. J Healthc Qual. 2019;41(2):75-82.doi:10.1097/JHQ.0000000000000181

8. Hussaini SMQ, Alexander GC. The United States Postal Service: an essential public health agency? J Gen Intern Med. 2020;35(12):3699-3701. doi:10.1007/s11606-020-06275-2

9. Hampton DJ. Colorado mountain towns are plagued by post office delays as residents wait weeks for medication and retirement checks. NBC News. February 25, 2023. Accessed March 14, 2024. https://www.nbcnews.com/news/us-news/colo-mountain-towns-are-plagued-post-office-delays-residents-wait-week-rcna72085

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aDepartment of Medicine, Division of Academic Internal Medicine, University of Illinois College of Medicine, Chicago

bJesse Brown Veterans Affairs Medical Center, Chicago, Illinois

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The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

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aDepartment of Medicine, Division of Academic Internal Medicine, University of Illinois College of Medicine, Chicago

bJesse Brown Veterans Affairs Medical Center, Chicago, Illinois

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The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

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Patrick O. Godwin, MD, MBAa,b; Hobart Z. Zhu, MDa,b; Bradley Recht, MDa,b

Correspondence:  Patrick Godwin  (patrick.godwin@va.gov)

aDepartment of Medicine, Division of Academic Internal Medicine, University of Illinois College of Medicine, Chicago

bJesse Brown Veterans Affairs Medical Center, Chicago, Illinois

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The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

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The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

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Colorectal cancer (CRC) is the second leading cause of cancer deaths in the United States.1 In 2022, there were an estimated 151,030 new CRC cases and 52,580 deaths.1 Options for CRC screening of patients at average risk include stool tests (annual fecal immunochemical test [FIT], annual guaiac-based fecal occult blood test, or stool FIT-DNA test every 1 to 3 years), colonoscopies every 10 years, flexible sigmoidoscopies every 5 years (or every 10 years with annual FIT), and computed tomography (CT) colonography every 5 years.2 Many health care systems use annual FIT for patients at average risk. Compared with guaiac-based fecal occult blood testing, FIT does not require dietary or medication modifications and yields greater sensitivity and patient participation.3

The COVID-19 pandemic and staffing issues have caused a scheduling backlog for screening, diagnostic, and surveillance endoscopies at some medical centers. As a result, FIT has become the primary means of CRC screening at these institutions. FIT kits for home use are typically distributed to eligible patients at an office visit or by mail, and patients are then instructed to mail the kits back to the laboratory. For the test to be as sensitive as possible, FIT kit manufacturers advise laboratory analysis within 14 to 15 days of collection, if stored at ambient temperature, and to reject the sample if it does not meet testing criteria for stability. Delayed FIT sample analysis has been associated with higher false-negative rates because of hemoglobin degradation.4 FIT sample exposure to high ambient temperatures also has been linked to decreased sensitivity for detecting CRC.5

US Postal Service (USPS) mail delivery delays have plagued many areas of the country. A variety of factors, including the COVID-19 pandemic, understaffing, changes in USPS policies, closure of post offices, and changes in mail delivery standards, may also be contributory causes. According to the USPS website, delivery standard for first-class mail is 1 to 5 days, but this is not guaranteed.6

The Jesse Brown Veterans Affairs Medical Center (JBVAMC) laboratory in Chicago has reported receiving FIT kit envelopes in batches by the USPS, with some prepaid first-class business reply envelopes delivered up to 60 days after the time of sample collection. Polymedco, a company that assists US Department of Veterans Affairs (VA) medical centers with logistics of FIT programs for CRC screening, reports that USPS batching of FIT kits leading to delayed delivery has been a periodic problem for medical centers around the country. Polymedco staff remind USPS staff about 4 points when they encounter this issue: Mailers are first-class mail; mailers contain a human biologic specimen that has limited viability; the biological sample used for detecting cancer is time sensitive; and delays in delivery by holding/batching kits could impact morbidity and mortality. Reviewing these key points with local USPS staff usually helps, however, batching and delayed delivery of the FIT kits can sometimes recur with USPS staffing turnover.

Tracking and identifying when a patient receives the FIT kit is difficult. Patients are instructed to write the date of collection on the kit, so the receiving laboratory knows whether the sample can be reliably analyzed. When patients are notified about delayed delivery of their sample, a staff member asks if they postponed dropping the kit in the mail. Most patients report mailing the sample within 1 to 2 days of collection. Tracking and dating each step of FIT kit events is not feasible with a mass mailing campaign. In our experience, most patients write the date of collection on the kit. If a collection date is not provided, the laboratory will call the patient to confirm a date. Cheng and colleagues reviewed the causes for FIT specimen rejection in a laboratory analyzing specimens for VA patients and found that 14% of submitted samples were rejected because the specimen was received > 14 days after collection, and 6% because the patient did not record the collection date. With a series of interventions aimed at reminding patients and improving laboratory procedures, rates of rejection for these 2 causes were reduced to < 4%.7 USPS delays were not identified as a factor or tracked in this study.

It is unclear why the USPS sometimes holds FIT kits at their facilities and then delivers large bins of them at the same time. Because FIT kits should be analyzed within 14 to 15 days of sample collection to assure reliable results, mail delivery delays can result in increased sample rejection. Based on the JBVAMC experience, up to 30% of submitted samples might need to be discarded when batched delivery takes place. In these cases, patients need to be contacted, informed of the problem, and asked to submit new kits. Understandably, patients are reluctant to repeat this type of testing, and we are concerned this could lead to reduced rates of CRC screening in affected communities.

As an alternative to discarding delayed samples, laboratories could report the results of delayed FIT kits with an added comment that “negative test results may be less reliable due to delayed processing,” but this approach would raise quality and medicolegal concerns. Clinicians have reached out to local USPS supervisory personnel with mixed results. Sometimes batching and delayed deliveries stop for a few months, only to resume without warning. Dropping off the sample directly at the laboratory is not a realistic option for most patients. Some patients can be convinced to submit another sample, some elect to switch to other CRC screening strategies, while others, unfortunately, decline further screening efforts.

 

 

Laboratory staff can be overwhelmed with having to process hundreds of samples in a short time frame, especially because there is no way of knowing when USPS will make a batched delivery. Laboratory capacities can limit staff at some facilities to performing analysis of only 10 tests at a time. The FIT kits should be delivered on a rolling basis and without delay so that the samples can be reliably analyzed with a predictable workload for the laboratory personnel and without unexpected surges.

When health care facilities identify delayed mail delivery of FIT kits via USPS, laboratories should first ensure that the correct postage rates are used on the prepaid envelopes and that their USPS accounts are properly funded, so that insufficient funds are not contributing to delayed deliveries. Stakeholders should then reach out to local USPS supervisory staff and request that the practice of batching the delivery of FIT kits be stopped. Educating USPS supervisory staff about concerns related to decreased test reliability associated with delayed mail delivery can be a persuasive argument. Adding additional language to the preprinted envelopes, such as “time sensitive,” may also be helpful. Unfortunately, the JBVAMC experience has been that the problem initially gets better after contacting the USPS, only to unexpectedly resurface months later. This cycle has been repeated several times in the past 2 years at JBVAMC.

All clinicians involved in CRC screening and treatment at institutions that use FIT kits need to be aware of the impact that local USPS delays can have on the reliability of these results. Health care systems should be prepared to implement mitigation strategies if they encounter significant delays with mail delivery. If delays cannot be reliably resolved by working with the local USPS staff, consider involving national USPS oversight bodies. And if the problems persist despite an attempt to work with the USPS, some institutions might find it feasible to offer drop boxes at their clinics and instruct patients to drop off FIT kits immediately following collection, in lieu of mailing them. Switching to private carriers is not a cost-effective alternative for most health care systems, and some may exclude rural areas. Depending on the local availability and capacity of endoscopists, some clinicians might prioritize referring patients for screening colonoscopies or screening flexible sigmoidoscopies, and might deemphasize FIT kits as a preferred option for CRC screening. CT colonography is an alternative screening method that is not as widely offered, nor as widely accepted at this time.

Conclusions

CRC screening is an essential part of preventive medicine, and the percentage of eligible patients screened is a well-established quality metric in primary care settings. Health care systems, clinicians, and laboratories must be vigilant to ensure that USPS delays in delivering FIT kits do not negatively impact their CRC screening programs. Facilities should actively monitor for delays in the return of FIT kits.

Despite the widespread use of mail-order pharmacies and the use of mail to communicate notifications about test results and follow-up appointments, unreliable or delayed mail delivery traditionally has not been considered a social determinant of health.8 This article highlights the impact delayed mail delivery can have on health outcomes. Disadvantaged communities in inner cities and rural areas have been disproportionately affected by the worsening performance of the USPS over the past few years.9 This represents an underappreciated public health concern in need of a sustainable solution.

Colorectal cancer (CRC) is the second leading cause of cancer deaths in the United States.1 In 2022, there were an estimated 151,030 new CRC cases and 52,580 deaths.1 Options for CRC screening of patients at average risk include stool tests (annual fecal immunochemical test [FIT], annual guaiac-based fecal occult blood test, or stool FIT-DNA test every 1 to 3 years), colonoscopies every 10 years, flexible sigmoidoscopies every 5 years (or every 10 years with annual FIT), and computed tomography (CT) colonography every 5 years.2 Many health care systems use annual FIT for patients at average risk. Compared with guaiac-based fecal occult blood testing, FIT does not require dietary or medication modifications and yields greater sensitivity and patient participation.3

The COVID-19 pandemic and staffing issues have caused a scheduling backlog for screening, diagnostic, and surveillance endoscopies at some medical centers. As a result, FIT has become the primary means of CRC screening at these institutions. FIT kits for home use are typically distributed to eligible patients at an office visit or by mail, and patients are then instructed to mail the kits back to the laboratory. For the test to be as sensitive as possible, FIT kit manufacturers advise laboratory analysis within 14 to 15 days of collection, if stored at ambient temperature, and to reject the sample if it does not meet testing criteria for stability. Delayed FIT sample analysis has been associated with higher false-negative rates because of hemoglobin degradation.4 FIT sample exposure to high ambient temperatures also has been linked to decreased sensitivity for detecting CRC.5

US Postal Service (USPS) mail delivery delays have plagued many areas of the country. A variety of factors, including the COVID-19 pandemic, understaffing, changes in USPS policies, closure of post offices, and changes in mail delivery standards, may also be contributory causes. According to the USPS website, delivery standard for first-class mail is 1 to 5 days, but this is not guaranteed.6

The Jesse Brown Veterans Affairs Medical Center (JBVAMC) laboratory in Chicago has reported receiving FIT kit envelopes in batches by the USPS, with some prepaid first-class business reply envelopes delivered up to 60 days after the time of sample collection. Polymedco, a company that assists US Department of Veterans Affairs (VA) medical centers with logistics of FIT programs for CRC screening, reports that USPS batching of FIT kits leading to delayed delivery has been a periodic problem for medical centers around the country. Polymedco staff remind USPS staff about 4 points when they encounter this issue: Mailers are first-class mail; mailers contain a human biologic specimen that has limited viability; the biological sample used for detecting cancer is time sensitive; and delays in delivery by holding/batching kits could impact morbidity and mortality. Reviewing these key points with local USPS staff usually helps, however, batching and delayed delivery of the FIT kits can sometimes recur with USPS staffing turnover.

Tracking and identifying when a patient receives the FIT kit is difficult. Patients are instructed to write the date of collection on the kit, so the receiving laboratory knows whether the sample can be reliably analyzed. When patients are notified about delayed delivery of their sample, a staff member asks if they postponed dropping the kit in the mail. Most patients report mailing the sample within 1 to 2 days of collection. Tracking and dating each step of FIT kit events is not feasible with a mass mailing campaign. In our experience, most patients write the date of collection on the kit. If a collection date is not provided, the laboratory will call the patient to confirm a date. Cheng and colleagues reviewed the causes for FIT specimen rejection in a laboratory analyzing specimens for VA patients and found that 14% of submitted samples were rejected because the specimen was received > 14 days after collection, and 6% because the patient did not record the collection date. With a series of interventions aimed at reminding patients and improving laboratory procedures, rates of rejection for these 2 causes were reduced to < 4%.7 USPS delays were not identified as a factor or tracked in this study.

It is unclear why the USPS sometimes holds FIT kits at their facilities and then delivers large bins of them at the same time. Because FIT kits should be analyzed within 14 to 15 days of sample collection to assure reliable results, mail delivery delays can result in increased sample rejection. Based on the JBVAMC experience, up to 30% of submitted samples might need to be discarded when batched delivery takes place. In these cases, patients need to be contacted, informed of the problem, and asked to submit new kits. Understandably, patients are reluctant to repeat this type of testing, and we are concerned this could lead to reduced rates of CRC screening in affected communities.

As an alternative to discarding delayed samples, laboratories could report the results of delayed FIT kits with an added comment that “negative test results may be less reliable due to delayed processing,” but this approach would raise quality and medicolegal concerns. Clinicians have reached out to local USPS supervisory personnel with mixed results. Sometimes batching and delayed deliveries stop for a few months, only to resume without warning. Dropping off the sample directly at the laboratory is not a realistic option for most patients. Some patients can be convinced to submit another sample, some elect to switch to other CRC screening strategies, while others, unfortunately, decline further screening efforts.

 

 

Laboratory staff can be overwhelmed with having to process hundreds of samples in a short time frame, especially because there is no way of knowing when USPS will make a batched delivery. Laboratory capacities can limit staff at some facilities to performing analysis of only 10 tests at a time. The FIT kits should be delivered on a rolling basis and without delay so that the samples can be reliably analyzed with a predictable workload for the laboratory personnel and without unexpected surges.

When health care facilities identify delayed mail delivery of FIT kits via USPS, laboratories should first ensure that the correct postage rates are used on the prepaid envelopes and that their USPS accounts are properly funded, so that insufficient funds are not contributing to delayed deliveries. Stakeholders should then reach out to local USPS supervisory staff and request that the practice of batching the delivery of FIT kits be stopped. Educating USPS supervisory staff about concerns related to decreased test reliability associated with delayed mail delivery can be a persuasive argument. Adding additional language to the preprinted envelopes, such as “time sensitive,” may also be helpful. Unfortunately, the JBVAMC experience has been that the problem initially gets better after contacting the USPS, only to unexpectedly resurface months later. This cycle has been repeated several times in the past 2 years at JBVAMC.

All clinicians involved in CRC screening and treatment at institutions that use FIT kits need to be aware of the impact that local USPS delays can have on the reliability of these results. Health care systems should be prepared to implement mitigation strategies if they encounter significant delays with mail delivery. If delays cannot be reliably resolved by working with the local USPS staff, consider involving national USPS oversight bodies. And if the problems persist despite an attempt to work with the USPS, some institutions might find it feasible to offer drop boxes at their clinics and instruct patients to drop off FIT kits immediately following collection, in lieu of mailing them. Switching to private carriers is not a cost-effective alternative for most health care systems, and some may exclude rural areas. Depending on the local availability and capacity of endoscopists, some clinicians might prioritize referring patients for screening colonoscopies or screening flexible sigmoidoscopies, and might deemphasize FIT kits as a preferred option for CRC screening. CT colonography is an alternative screening method that is not as widely offered, nor as widely accepted at this time.

Conclusions

CRC screening is an essential part of preventive medicine, and the percentage of eligible patients screened is a well-established quality metric in primary care settings. Health care systems, clinicians, and laboratories must be vigilant to ensure that USPS delays in delivering FIT kits do not negatively impact their CRC screening programs. Facilities should actively monitor for delays in the return of FIT kits.

Despite the widespread use of mail-order pharmacies and the use of mail to communicate notifications about test results and follow-up appointments, unreliable or delayed mail delivery traditionally has not been considered a social determinant of health.8 This article highlights the impact delayed mail delivery can have on health outcomes. Disadvantaged communities in inner cities and rural areas have been disproportionately affected by the worsening performance of the USPS over the past few years.9 This represents an underappreciated public health concern in need of a sustainable solution.

References

1. Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022;72(1):7-33. doi:10.3322/caac.21708

2. Centers for Disease Control and Prevention. Colorectal cancer screening tests. Updated February 23, 2023. Accessed March 14, 2024. https://www.cdc.gov/cancer/colorectal/basic_info/screening/tests.htm

3. van Rossum LG, van Rijn AF, Laheij RJ, et al. Random comparison of guaiac and immunochemical fecal occult blood tests for colorectal cancer in a screening population. Gastroenterology. 2008;135(1):82-90. doi:10.1053/j.gastro.2008.03.040

4. van Rossum LG, van Rijn AF, van Oijen MG, et al. False negative fecal occult blood tests due to delayed sample return in colorectal cancer screening. Int J Cancer. 2009;125(4):746-750. doi:10.1002/ijc.24458

5. Doubeni CA, Jensen CD, Fedewa SA, et al. Fecal immunochemical test (FIT) for colon cancer screening: variable performance with ambient temperature. J Am Board Fam Med. 2016;29(6):672-681. doi:10.3122/jabfm.2016.06.160060

6. United States Postal Service. Shipping and mailing with USPS. Accessed March 14, 2024. https://www.usps.com/ship

7. Cheng C, Ganz DA, Chang ET, Huynh A, De Peralta S. Reducing rejected fecal immunochemical tests received in the laboratory for colorectal cancer screening. J Healthc Qual. 2019;41(2):75-82.doi:10.1097/JHQ.0000000000000181

8. Hussaini SMQ, Alexander GC. The United States Postal Service: an essential public health agency? J Gen Intern Med. 2020;35(12):3699-3701. doi:10.1007/s11606-020-06275-2

9. Hampton DJ. Colorado mountain towns are plagued by post office delays as residents wait weeks for medication and retirement checks. NBC News. February 25, 2023. Accessed March 14, 2024. https://www.nbcnews.com/news/us-news/colo-mountain-towns-are-plagued-post-office-delays-residents-wait-week-rcna72085

References

1. Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022;72(1):7-33. doi:10.3322/caac.21708

2. Centers for Disease Control and Prevention. Colorectal cancer screening tests. Updated February 23, 2023. Accessed March 14, 2024. https://www.cdc.gov/cancer/colorectal/basic_info/screening/tests.htm

3. van Rossum LG, van Rijn AF, Laheij RJ, et al. Random comparison of guaiac and immunochemical fecal occult blood tests for colorectal cancer in a screening population. Gastroenterology. 2008;135(1):82-90. doi:10.1053/j.gastro.2008.03.040

4. van Rossum LG, van Rijn AF, van Oijen MG, et al. False negative fecal occult blood tests due to delayed sample return in colorectal cancer screening. Int J Cancer. 2009;125(4):746-750. doi:10.1002/ijc.24458

5. Doubeni CA, Jensen CD, Fedewa SA, et al. Fecal immunochemical test (FIT) for colon cancer screening: variable performance with ambient temperature. J Am Board Fam Med. 2016;29(6):672-681. doi:10.3122/jabfm.2016.06.160060

6. United States Postal Service. Shipping and mailing with USPS. Accessed March 14, 2024. https://www.usps.com/ship

7. Cheng C, Ganz DA, Chang ET, Huynh A, De Peralta S. Reducing rejected fecal immunochemical tests received in the laboratory for colorectal cancer screening. J Healthc Qual. 2019;41(2):75-82.doi:10.1097/JHQ.0000000000000181

8. Hussaini SMQ, Alexander GC. The United States Postal Service: an essential public health agency? J Gen Intern Med. 2020;35(12):3699-3701. doi:10.1007/s11606-020-06275-2

9. Hampton DJ. Colorado mountain towns are plagued by post office delays as residents wait weeks for medication and retirement checks. NBC News. February 25, 2023. Accessed March 14, 2024. https://www.nbcnews.com/news/us-news/colo-mountain-towns-are-plagued-post-office-delays-residents-wait-week-rcna72085

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<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>0524 AVAHO USPS Delay</fileName> <TBEID>0C02F47A.SIG</TBEID> <TBUniqueIdentifier>NJ_0C02F47A</TBUniqueIdentifier> <newsOrJournal>Journal</newsOrJournal> <publisherName>Frontline Medical Communications Inc.</publisherName> <storyname/> <articleType>1</articleType> <TBLocation>Copyfitting-FED</TBLocation> <QCDate/> <firstPublished>20240428T214648</firstPublished> <LastPublished>20240428T214648</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240428T214648</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline/> <bylineText>Patrick O. Godwin, MD, MBAa,b; Hobart Z. Zhu, MDa,b; Bradley Recht, MDa,b</bylineText> <bylineFull/> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType/> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:"> <name/> <rightsInfo> <copyrightHolder> <name/> </copyrightHolder> <copyrightNotice/> </rightsInfo> </provider> <abstract/> <metaDescription>Colorectal cancer (CRC) is the second leading cause of cancer deaths in the United States.1 In 2022, there were an estimated 151,030 new CRC cases and 52,580 de</metaDescription> <articlePDF/> <teaserImage/> <title>Potential Impact of USPS Mail Delivery Delays on Colorectal Cancer Screening Programs</title> <deck/> <eyebrow><hl name="33558"/>Commentary</eyebrow> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear>2024</pubPubdateYear> <pubPubdateMonth>May</pubPubdateMonth> <pubPubdateDay/> <pubVolume>41</pubVolume> <pubNumber>5</pubNumber> <wireChannels/> <primaryCMSID/> <CMSIDs> <CMSID>2949</CMSID> <CMSID>4059</CMSID> </CMSIDs> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>FED</publicationCode> <pubIssueName>May 2024</pubIssueName> <pubArticleType>Editorials | 4059</pubArticleType> <pubTopics/> <pubCategories/> <pubSections> <pubSection>Editorial | 2949<pubSubsection/></pubSection> </pubSections> <journalTitle>Fed Pract</journalTitle> <journalFullTitle>Federal Practitioner</journalFullTitle> <copyrightStatement>Copyright 2017 Frontline Medical Communications Inc., Parsippany, NJ, USA. All rights reserved.</copyrightStatement> </publicationData> </publications_g> <publications> <term canonical="true">16</term> </publications> <sections> <term canonical="true">52</term> </sections> <topics> <term canonical="true">337</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Potential Impact of USPS Mail Delivery Delays on Colorectal Cancer Screening Programs</title> <deck/> </itemMeta> <itemContent> <p class="abstract"><b>Background</b>: Colorectal cancer is the second-leading cause of cancer deaths in the United States. Fecal immunochemical tests (FITs) are a primary means of colorectal cancer screening at some health care institutions because of scheduling backlogs for screening, diagnostic, and surveillance endoscopies. However, delays in mail delivery can impact timely analysis of samples, possibly leading to false-negative results and the need for repeat tests. Some patients might be unwilling to submit another test when informed that an earlier sample cannot be reliably analyzed, resulting in a missed opportunity for screening.<br/><br/><b>Observations</b>: The Jesse Brown Veterans Affairs Medical Center has experienced some success through contacting the local US Postal Service (USPS) to avoid these delays; however, the problem often unpredictably recurs with USPS staff turnover. Laboratories and health systems experiencing delays should first ensure that prepaid envelopes have the correct postage and that their USPS accounts are properly funded, to confirm that insufficient funds are not contributing to the delayed deliveries. Adding additional language to the preprinted envelopes, such as “time-sensitive,” may also be helpful. Asking patients to drop off test kits at the laboratory or using private letter carriers is not feasible in some communities. Other strategies include establishing a drop-off box at clinic offices or considering other screening methods, such as colonoscopies or flexible sigmoidoscopies.<br/><br/><b>Conclusions</b>: Clinicians who work in health care systems that use FIT kits need to be aware of the impact that local USPS delays can have on the reliability of FIT results. Health systems should be prepared to implement mitigation strategies if significant delays with mail delivery are encountered. </p> <p>Colorectal cancer (CRC) is the second leading cause of cancer deaths in the United States.<sup>1</sup> In 2022, there were an estimated 151,030 new CRC cases and 52,580 deaths.<sup>1</sup> Options for CRC screening of patients at average risk include stool tests (annual fecal immunochemical test [FIT], annual guaiac-based fecal occult blood test, or stool FIT-DNA test every 1 to 3 years), colonoscopies every 10 years, flexible sigmoidoscopies every 5 years (or every 10 years with annual FIT), and computed tomography (CT) colonography every 5 years.<sup>2</sup> Many health care systems use annual FIT for patients at average risk. Compared with guaiac-based fecal occult blood testing, FIT does not require dietary or medication modifications and yields greater sensitivity and patient participation.<sup>3</sup> </p> <p>The COVID-19 pandemic and staffing issues have caused a scheduling backlog for screening, diagnostic, and surveillance endoscopies at some medical centers. As a result, FIT has become the primary means of CRC screening at these institutions. FIT kits for home use are typically distributed to eligible patients at an office visit or by mail, and patients are then instructed to mail the kits back to the laboratory. For the test to be as sensitive as possible, FIT kit manufacturers advise laboratory analysis within 14 to 15 days of collection, if stored at ambient temperature, and to reject the sample if it does not meet testing criteria for stability. Delayed FIT sample analysis has been associated with higher false-negative rates because of hemoglobin degradation.<sup>4</sup> FIT sample exposure to high ambient temperatures also has been linked to decreased sensitivity for detecting CRC.<sup>5<br/><br/></sup>US Postal Service (USPS) mail delivery delays have plagued many areas of the country. A variety of factors, including the COVID-19 pandemic, understaffing, changes in USPS policies, closure of post offices, and changes in mail delivery standards, may also be contributory causes. According to the USPS website, delivery standard for first-class mail is 1 to 5 days, but this is not guaranteed.<sup>6<br/><br/></sup>The Jesse Brown Veterans Affairs Medical Center (JBVAMC) laboratory in Chicago has reported receiving FIT kit envelopes in batches by the USPS, with some prepaid first-class business reply envelopes delivered up to 60 days after the time of sample collection. Polymedco, a company that assists US Department of Veterans Affairs (VA) medical centers with logistics of FIT programs for CRC screening, reports that USPS batching of FIT kits leading to delayed delivery has been a periodic problem for medical centers around the country. Polymedco staff remind USPS staff about 4 points when they encounter this issue: Mailers are first-class mail; mailers contain a human biologic specimen that has limited viability; the biological sample used for detecting cancer is time sensitive; and delays in delivery by holding/batching kits could impact morbidity and mortality. Reviewing these key points with local USPS staff usually helps, however, batching and delayed delivery of the FIT kits can sometimes recur with USPS staffing turnover.<br/><br/>Tracking and identifying when a patient receives the FIT kit is difficult. Patients are instructed to write the date of collection on the kit, so the receiving laboratory knows whether the sample can be reliably analyzed. When patients are notified about delayed delivery of their sample, a staff member asks if they postponed dropping the kit in the mail. Most patients report mailing the sample within 1 to 2 days of collection. Tracking and dating each step of FIT kit events is not feasible with a mass mailing campaign. In our experience, most patients write the date of collection on the kit. If a collection date is not provided, the laboratory will call the patient to confirm a date. Cheng and colleagues reviewed the causes for FIT specimen rejection in a laboratory analyzing specimens for VA patients and found that 14% of submitted samples were rejected because the specimen was received &gt; 14 days after collection, and 6% because the patient did not record the collection date. With a series of interventions aimed at reminding patients and improving laboratory procedures, rates of rejection for these 2 causes were reduced to &lt; 4%.<sup>7</sup> USPS delays were not identified as a factor or tracked in this study. <br/><br/>It is unclear why the USPS sometimes holds FIT kits at their facilities and then delivers large bins of them at the same time. Because FIT kits should be analyzed within 14 to 15 days of sample collection to assure reliable results, mail delivery delays can result in increased sample rejection. Based on the JBVAMC experience, up to 30% of submitted samples might need to be discarded when batched delivery takes place. In these cases, patients need to be contacted, informed of the problem, and asked to submit new kits. Understandably, patients are reluctant to repeat this type of testing, and we are concerned this could lead to reduced rates of CRC screening in affected communities.<br/><br/>As an alternative to discarding delayed samples, laboratories could report the results of delayed FIT kits with an added comment that “negative test results may be less reliable due to delayed processing,” but this approach would raise quality and medicolegal concerns.<b> </b>Clinicians have reached out to local USPS supervisory personnel with mixed results. Sometimes batching and delayed deliveries stop for a few months, only to resume without warning. Dropping off the sample directly at the laboratory is not a realistic option for most patients. Some patients can be convinced to submit another sample, some elect to switch to other CRC screening strategies, while others, unfortunately, decline further screening efforts.<br/><br/>Laboratory staff can be overwhelmed with having to process hundreds of samples in a short time frame, especially because there is no way of knowing when USPS will make a batched delivery. Laboratory capacities can limit staff at some facilities to performing analysis of only 10 tests at a time. The FIT kits should be delivered on a rolling basis and without delay so that the samples can be reliably analyzed with a predictable workload for the laboratory personnel and without unexpected surges.<br/><br/>When health care facilities identify delayed mail delivery of FIT kits via USPS, laboratories should first ensure that the correct postage rates are used on the prepaid envelopes and that their USPS accounts are properly funded, so that insufficient funds are not contributing to delayed deliveries. Stakeholders should then reach out to local USPS supervisory staff and request that the practice of batching the delivery of FIT kits be stopped. Educating USPS supervisory staff about concerns related to decreased test reliability associated with delayed mail delivery can be a persuasive argument. Adding additional language to the preprinted envelopes, such as “time sensitive,” may also be helpful. Unfortunately, the JBVAMC experience has been that the problem initially gets better after contacting the USPS, only to unexpectedly resurface months later. This cycle has been repeated several times in the past 2 years at JBVAMC. <br/><br/>All clinicians involved in CRC screening and treatment at institutions that use FIT kits need to be aware of the impact that local USPS delays can have on the reliability of these results. Health care systems should be prepared to implement mitigation strategies if they encounter significant delays with mail delivery. If delays cannot be reliably resolved by working with the local USPS staff, consider involving national USPS oversight bodies. And if the problems persist despite an attempt to work with the USPS, some institutions might find it feasible to offer drop boxes at their clinics and instruct patients to drop off FIT kits immediately following collection, in lieu of mailing them. Switching to private carriers is not a cost-effective alternative for most health care systems, and some may exclude rural areas. Depending on the local availability and capacity of endoscopists, some clinicians might prioritize referring patients for screening colonoscopies or screening flexible sigmoidoscopies, and might deemphasize FIT kits as a preferred option for CRC screening. CT colonography is an alternative screening method that is not as widely offered, nor as widely accepted at this time.</p> <h2>Conclusions</h2> <p>CRC screening is an essential part of preventive medicine, and the percentage of eligible patients screened is a well-established quality metric in primary care settings. Health care systems, clinicians, and laboratories must be vigilant to ensure that USPS delays in delivering FIT kits do not negatively impact their CRC screening programs. Facilities should actively monitor for delays in the return of FIT kits.</p> <p>Despite the widespread use of mail-order pharmacies and the use of mail to communicate notifications about test results and follow-up appointments, unreliable or delayed mail delivery traditionally has not been considered a social determinant of health.<sup>8</sup> This article highlights the impact delayed mail delivery can have on health outcomes. Disadvantaged communities in inner cities and rural areas have been disproportionately affected by the worsening performance of the USPS over the past few years.<sup>9</sup> This represents an underappreciated public health concern in need of a sustainable solution. </p> <p class="isub">Author affiliations</p> <p> <em><sup>a</sup>Department of Medicine, Division of Academic Internal Medicine, University of Illinois College of Medicine, Chicago<br/><br/><sup>b</sup>Jesse Brown Veterans Affairs Medical Center, Chicago, Illinois</em> </p> <p class="isub">Author disclosures</p> <p> <em>The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.</em> </p> <p class="isub">Disclaimer</p> <p> <em>The opinions expressed herein are those of the authors and do not necessarily reflect those of <i>Federal Practitioner</i>, Frontline Medical Communications Inc., the US Government, or any of its agencies.</em> </p> <h2>References</h2> <p class="reference"> 1. Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. <i>CA Cancer J Clin</i>. 2022;72(1):7-33. doi:10.3322/caac.21708<br/><br/> 2. Centers for Disease Control and Prevention. Colorectal cancer screening tests. Updated February 23, 2023. Accessed March 14, 2024. https://www.cdc.gov/cancer/colorectal/basic_info/screening/tests.htm<br/><br/> 3. van Rossum LG, van Rijn AF, Laheij RJ, et al. Random comparison of guaiac and immunochemical fecal occult blood tests for colorectal cancer in a screening population. <i>Gastroenterology</i>. 2008;135(1):82-90. doi:10.1053/j.gastro.2008.03.040 <br/><br/> 4. van Rossum LG, van Rijn AF, van Oijen MG, et al. False negative fecal occult blood tests due to delayed sample return in colorectal cancer screening. <i>Int J Cancer</i>. 2009;125(4):746-750. doi:10.1002/ijc.24458<br/><br/> 5. Doubeni CA, Jensen CD, Fedewa SA, et al. Fecal immunochemical test (FIT) for colon cancer screening: variable performance with ambient temperature. <i>J Am Board Fam Med</i>. 2016;29(6):672-681. doi:10.3122/jabfm.2016.06.160060 <br/><br/> 6. United States Postal Service. Shipping and mailing with USPS. Accessed March 14, 2024. https://www.usps.com/ship<br/><br/> 7. Cheng C, Ganz DA, Chang ET, Huynh A, De Peralta S. Reducing rejected fecal immunochemical tests received in the laboratory for colorectal cancer screening. <i>J Healthc Qual</i>. 2019;41(2):75-82.doi:10.1097/JHQ.0000000000000181<br/><br/> 8. Hussaini SMQ, Alexander GC. The United States Postal Service: an essential public health agency? <i>J Gen Intern Med</i>. 2020;35(12):3699-3701. doi:10.1007/s11606-020-06275-2<br/><br/> 9. Hampton DJ. Colorado mountain towns are plagued by post office delays as residents wait weeks for medication and retirement checks. NBC News. February 25, 2023. Accessed March 14, 2024. https://www.nbcnews.com/news/us-news/colo-mountain-towns-are-plagued-post-office-delays-residents-wait-week-rcna72085</p> </itemContent> </newsItem> </itemSet></root>
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Few Cancer Survivors Meet ACS Nutrition, Exercise Guidelines

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Mon, 04/29/2024 - 17:35

 

TOPLINE:

A recent survey-based study found that only 4% of cancer survivors reported adhering to all four American Cancer Society (ACS) nutrition and physical activity guidelines, which include maintaining a healthy weight and diet, avoiding alcohol, and exercising regularly.

METHODOLOGY:

  • The ACS has published nutrition and exercise guidelines for cancer survivors, which include recommendations to maintain a healthy weight and diet, cut out alcohol, and participate in regular physical activities. Engaging in these behaviors is associated with longer survival among cancer survivors, but whether survivors follow these nutrition and activity recommendations has not been systematically tracked.
  • Researchers evaluated data on 10,020 individuals (mean age, 64.2 years) who had completed cancer treatment. Data came from the Behavioral Risk Factor Surveillance System telephone-based survey administered in 2017, 2019, and 2021, which represents 2.7 million cancer survivors.
  • The researchers estimated survivors’ adherence to guidelines across four domains: Weight, physical activity, fruit and vegetable consumption, and alcohol intake. Factors associated with adherence were also evaluated.
  • Overall, 9,121 survivors (91%) completed questionnaires for all four domains.

TAKEAWAY:

Only 4% of patients (365 of 9121) followed ACS guidelines in all four categories.

When assessing adherence to each category, the researchers found that 72% of cancer survivors reported engaging in recommended levels of physical activity, 68% maintained a nonobese weight, 50% said they did not consume alcohol, and 12% said they consumed recommended quantities of fruits and vegetables.

Compared with people in the general population, cancer survivors generally engaged in fewer healthy behaviors than those who had never been diagnosed with cancer.

The authors identified certain factors associated with greater guideline adherence, including female sex, older age, Black (vs White) race, and higher education level (college graduate).

IN PRACTICE:

This study highlights a potential “gap between published guidelines regarding behavioral modifications for cancer survivors and uptake of these behaviors,” the authors wrote, adding that “it is essential for oncologists and general internists to improve widespread and systematic counseling on these guidelines to improve uptake of healthy behaviors in this vulnerable patient population.”

SOURCE:

This work, led by Carter Baughman, MD, from the Division of Internal Medicine at Beth Israel Deaconess Medical Center, Boston, Massachusetts, was published online in JAMA Oncology.

LIMITATIONS:

The authors reported several study limitations, most notably that self-reported data may introduce biases.

DISCLOSURES:

The study funding source was not reported. One author received grants from the US Highbush Blueberry Council outside the submitted work. No other disclosures were reported.

A version of this article appeared on Medscape.com.

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TOPLINE:

A recent survey-based study found that only 4% of cancer survivors reported adhering to all four American Cancer Society (ACS) nutrition and physical activity guidelines, which include maintaining a healthy weight and diet, avoiding alcohol, and exercising regularly.

METHODOLOGY:

  • The ACS has published nutrition and exercise guidelines for cancer survivors, which include recommendations to maintain a healthy weight and diet, cut out alcohol, and participate in regular physical activities. Engaging in these behaviors is associated with longer survival among cancer survivors, but whether survivors follow these nutrition and activity recommendations has not been systematically tracked.
  • Researchers evaluated data on 10,020 individuals (mean age, 64.2 years) who had completed cancer treatment. Data came from the Behavioral Risk Factor Surveillance System telephone-based survey administered in 2017, 2019, and 2021, which represents 2.7 million cancer survivors.
  • The researchers estimated survivors’ adherence to guidelines across four domains: Weight, physical activity, fruit and vegetable consumption, and alcohol intake. Factors associated with adherence were also evaluated.
  • Overall, 9,121 survivors (91%) completed questionnaires for all four domains.

TAKEAWAY:

Only 4% of patients (365 of 9121) followed ACS guidelines in all four categories.

When assessing adherence to each category, the researchers found that 72% of cancer survivors reported engaging in recommended levels of physical activity, 68% maintained a nonobese weight, 50% said they did not consume alcohol, and 12% said they consumed recommended quantities of fruits and vegetables.

Compared with people in the general population, cancer survivors generally engaged in fewer healthy behaviors than those who had never been diagnosed with cancer.

The authors identified certain factors associated with greater guideline adherence, including female sex, older age, Black (vs White) race, and higher education level (college graduate).

IN PRACTICE:

This study highlights a potential “gap between published guidelines regarding behavioral modifications for cancer survivors and uptake of these behaviors,” the authors wrote, adding that “it is essential for oncologists and general internists to improve widespread and systematic counseling on these guidelines to improve uptake of healthy behaviors in this vulnerable patient population.”

SOURCE:

This work, led by Carter Baughman, MD, from the Division of Internal Medicine at Beth Israel Deaconess Medical Center, Boston, Massachusetts, was published online in JAMA Oncology.

LIMITATIONS:

The authors reported several study limitations, most notably that self-reported data may introduce biases.

DISCLOSURES:

The study funding source was not reported. One author received grants from the US Highbush Blueberry Council outside the submitted work. No other disclosures were reported.

A version of this article appeared on Medscape.com.

 

TOPLINE:

A recent survey-based study found that only 4% of cancer survivors reported adhering to all four American Cancer Society (ACS) nutrition and physical activity guidelines, which include maintaining a healthy weight and diet, avoiding alcohol, and exercising regularly.

METHODOLOGY:

  • The ACS has published nutrition and exercise guidelines for cancer survivors, which include recommendations to maintain a healthy weight and diet, cut out alcohol, and participate in regular physical activities. Engaging in these behaviors is associated with longer survival among cancer survivors, but whether survivors follow these nutrition and activity recommendations has not been systematically tracked.
  • Researchers evaluated data on 10,020 individuals (mean age, 64.2 years) who had completed cancer treatment. Data came from the Behavioral Risk Factor Surveillance System telephone-based survey administered in 2017, 2019, and 2021, which represents 2.7 million cancer survivors.
  • The researchers estimated survivors’ adherence to guidelines across four domains: Weight, physical activity, fruit and vegetable consumption, and alcohol intake. Factors associated with adherence were also evaluated.
  • Overall, 9,121 survivors (91%) completed questionnaires for all four domains.

TAKEAWAY:

Only 4% of patients (365 of 9121) followed ACS guidelines in all four categories.

When assessing adherence to each category, the researchers found that 72% of cancer survivors reported engaging in recommended levels of physical activity, 68% maintained a nonobese weight, 50% said they did not consume alcohol, and 12% said they consumed recommended quantities of fruits and vegetables.

Compared with people in the general population, cancer survivors generally engaged in fewer healthy behaviors than those who had never been diagnosed with cancer.

The authors identified certain factors associated with greater guideline adherence, including female sex, older age, Black (vs White) race, and higher education level (college graduate).

IN PRACTICE:

This study highlights a potential “gap between published guidelines regarding behavioral modifications for cancer survivors and uptake of these behaviors,” the authors wrote, adding that “it is essential for oncologists and general internists to improve widespread and systematic counseling on these guidelines to improve uptake of healthy behaviors in this vulnerable patient population.”

SOURCE:

This work, led by Carter Baughman, MD, from the Division of Internal Medicine at Beth Israel Deaconess Medical Center, Boston, Massachusetts, was published online in JAMA Oncology.

LIMITATIONS:

The authors reported several study limitations, most notably that self-reported data may introduce biases.

DISCLOSURES:

The study funding source was not reported. One author received grants from the US Highbush Blueberry Council outside the submitted work. No other disclosures were reported.

A version of this article appeared on Medscape.com.

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<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>167860</fileName> <TBEID>0C04FD2C.SIG</TBEID> <TBUniqueIdentifier>MD_0C04FD2C</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname/> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20240426T151917</QCDate> <firstPublished>20240426T152032</firstPublished> <LastPublished>20240426T152032</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240426T152032</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline>Deepa Varma</byline> <bylineText>DEEPA VARMA</bylineText> <bylineFull>DEEPA VARMA</bylineFull> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType>News</newsDocType> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:imng"> <name>IMNG Medical Media</name> <rightsInfo> <copyrightHolder> <name>Frontline Medical News</name> </copyrightHolder> <copyrightNotice>Copyright (c) 2015 Frontline Medical News, a Frontline Medical Communications Inc. company. All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>A recent survey-based study found that only 4% of cancer survivors reported adhering to all four American Cancer Society (ACS) nutrition and physical activity g</metaDescription> <articlePDF/> <teaserImage/> <teaser>Researchers estimate more than 9,000 survivors’ adherence to weight, physical activity, fruit and vegetable consumption, and alcohol intake guidelines.</teaser> <title>Few Cancer Survivors Meet ACS Nutrition, Exercise Guidelines</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>oncr</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>hemn</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>chph</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>ob</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>nr</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> <journalTitle>Neurology Reviews</journalTitle> <journalFullTitle>Neurology Reviews</journalFullTitle> <copyrightStatement>2018 Frontline Medical Communications Inc.,</copyrightStatement> </publicationData> <publicationData> <publicationCode>skin</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>GIHOLD</publicationCode> <pubIssueName>January 2014</pubIssueName> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> <journalTitle/> <journalFullTitle/> <copyrightStatement/> </publicationData> </publications_g> <publications> <term canonical="true">31</term> <term>18</term> <term>6</term> <term>15</term> <term>21</term> <term>23</term> <term>22</term> <term>13</term> </publications> <sections> <term canonical="true">27970</term> <term>39313</term> <term>86</term> </sections> <topics> <term>270</term> <term canonical="true">280</term> <term>198</term> <term>61821</term> <term>59244</term> <term>67020</term> <term>214</term> <term>217</term> <term>221</term> <term>238</term> <term>240</term> <term>242</term> <term>244</term> <term>39570</term> <term>245</term> <term>31848</term> <term>292</term> <term>178</term> <term>179</term> <term>181</term> <term>59374</term> <term>196</term> <term>197</term> <term>37637</term> <term>233</term> <term>243</term> <term>250</term> <term>49434</term> <term>303</term> <term>263</term> <term>192</term> <term>256</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Few Cancer Survivors Meet ACS Nutrition, Exercise Guidelines</title> <deck/> </itemMeta> <itemContent> <h2>TOPLINE:</h2> <p> <span class="tag metaDescription">A recent survey-based study found that only 4% of cancer survivors reported adhering to all four American Cancer Society (ACS) nutrition and physical activity guidelines, which include maintaining a healthy weight and diet, avoiding alcohol, and exercising regularly.</span> </p> <h2>METHODOLOGY:</h2> <ul class="body"> <li>The ACS has published nutrition and exercise guidelines for cancer survivors, which include recommendations to maintain a healthy weight and diet, cut out alcohol, and participate in regular physical activities. Engaging in these behaviors is associated with longer survival among cancer survivors, but whether survivors follow these nutrition and activity recommendations has not been systematically tracked.</li> <li>Researchers evaluated data on 10,020 individuals (mean age, 64.2 years) who had completed cancer treatment. Data came from the Behavioral Risk Factor Surveillance System telephone-based survey administered in 2017, 2019, and 2021, which represents 2.7 million cancer survivors.</li> <li>The researchers estimated survivors’ adherence to guidelines across four domains: Weight, physical activity, fruit and vegetable consumption, and alcohol intake. Factors associated with adherence were also evaluated.</li> <li>Overall, 9,121 survivors (91%) completed questionnaires for all four domains.</li> </ul> <h2>TAKEAWAY:</h2> <p>Only 4% of patients (365 of 9121) followed ACS guidelines in all four categories.<br/><br/>When assessing adherence to each category, the researchers found that 72% of cancer survivors reported engaging in recommended levels of physical activity, 68% maintained a nonobese weight, 50% said they did not consume alcohol, and 12% said they consumed recommended quantities of fruits and vegetables.<br/><br/>Compared with people in the general population, cancer survivors generally engaged in fewer healthy behaviors than those who had never been diagnosed with cancer.<br/><br/>The authors identified certain factors associated with greater guideline adherence, including female sex, older age, Black (vs White) race, and higher education level (college graduate).</p> <h2>IN PRACTICE:</h2> <p>This study highlights a potential “gap between published guidelines regarding behavioral modifications for cancer survivors and uptake of these behaviors,” the authors wrote, adding that “it is essential for oncologists and general internists to improve widespread and systematic counseling on these guidelines to improve uptake of healthy behaviors in this vulnerable patient population.”</p> <h2>SOURCE:</h2> <p>This work, led by Carter Baughman, MD, from the Division of Internal Medicine at Beth Israel Deaconess Medical Center, Boston, Massachusetts, was published <span class="Hyperlink"><a href="https://jamanetwork.com/journals/jamaoncology/fullarticle/2817661">online</a></span> in <em>JAMA Oncology</em>.</p> <h2>LIMITATIONS:</h2> <p>The authors reported several study limitations, most notably that self-reported data may introduce biases.</p> <h2>DISCLOSURES:</h2> <p>The study funding source was not reported. One author received grants from the US Highbush Blueberry Council outside the submitted work. No other disclosures were reported.<span class="end"/></p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/few-cancer-survivors-meet-acs-nutrition-exercise-guidelines-2024a10007sl?src=">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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