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Searching for the Optimal CRC Surveillance Test
About a third of the US population are eligible for colorectal cancer screening but aren’t up to date on screening.
Many patients are reluctant to test for colon cancer for a variety of reasons, said Jeffrey K. Lee, MD, MPH, a research scientist at the Kaiser Permanente Northern California Division of Research and an attending gastroenterologist at Kaiser Permanente San Francisco Medical Center.
“As a gastroenterologist, I strongly believe we should emphasize the importance of colorectal cancer screening. And there’s many tests available, not just a colonoscopy, to help reduce your chances of developing colorectal cancer and even dying from colorectal cancer,” said Dr. Lee.
Many patients prefer a test that’s more convenient, that doesn’t require them to take time out of their busy schedules. “We must educate our patients that there are some noninvasive screening options that are helpful, and to be able to share with them some of the benefits, but also some of the drawbacks compared to colonoscopy and allow them to have a choice,” he advised.
He is a recipient of the AGA Research Scholar Award, and has in turn supported other researchers by contributing to the AGA Research Foundation. In 2012, Dr. Lee received a grant from the Sylvia Allison Kaplan Clinical Research Fund to fund a study on long-term colorectal cancer risk in patients with normal colonoscopy results.
The findings, published in JAMA Internal Medicine, determined that 10 years after a negative colonoscopy, Kaiser Permanente members had a 46% lower risk of being diagnosed with CRC and were 88% less likely to die from disease compared with patients who didn’t undergo screening.
“Furthermore, the reduced risk of developing colorectal cancer, even dying from it, persisted for more than 12 years after the examination compared with an unscreened population,” said Dr. Lee. “I firmly believe our study really supports the ten-year screening interval after a normal colonoscopy, as currently recommended by our guidelines.”
In an interview, he discussed his research efforts to find the best detection regimens for CRC, and the mentors who guided his career path as a GI scientist.
Q: Why did you choose GI?
During medical school I was fortunate to work in the lab of Dr. John M. Carethers at UC San Diego. He introduced me to GI and inspired me to choose GI as a career. His mentorship was invaluable because he not only solidified my interest in GI, but also inspired me to become a physician scientist, focusing on colorectal cancer prevention and control. His amazing mentorship drew me to this field.
Q: One of your clinical focus areas is hereditary gastrointestinal cancer syndromes. How did you become interested in this area of GI medicine?
My interest in hereditary GI cancer syndromes stemmed from my work as a medical student in Dr. Carethers’ lab. One of my research projects was looking at certain gene mutations among patients with hereditary GI cancer syndromes, specifically, familial hamartomatous polyposis syndrome. It was through these research projects and seeing how these genetic mutations impacted their risk of developing colorectal cancer, inspired me to care for patients with hereditary GI cancer syndromes.
Q: Have you been doing any research on the reasons why more young people are getting colon cancer?
We recently published work looking at the potential factors that may be driving the rising rates of early onset colorectal cancer. One hypothesis that’s been floating around is antibiotic exposure in early adulthood or childhood because of its effect on the microbiome. Using our large database at Kaiser Permanente Northern California, we did not find an association between oral antibiotic use during early adulthood and the risk of early-onset colorectal cancer.
You have the usual suspects like obesity and diabetes, but it’s not explaining all that risk. While familial colorectal cancer syndromes contribute to a small proportion of early-onset colorectal, these syndromes are not increasing across generations. I really do feel it’s something in the diet or how foods are processed and environmental factors that’s driving some of the risk of early onset colorectal cancer and this should be explored further.
Q: In 2018, you issued a landmark study which found an association between a 10-year follow-up after negative colonoscopy and reduced risk of disease and mortality. Has there been any updates to these findings over the last 6 years?
We recently saw a study in JAMA Oncology of a Swedish cohort that showed a negative colonoscopy result was associated with a reduced risk of developing and even dying from colorectal cancer 15 years from that examination, compared to the general population of Sweden. I think there’s some things that we need to be cautious about regarding that study. We have to think about the comparison group that they used and the lack of information regarding the indication of the colonoscopy and the quality of the examination. So, it remains uncertain whether future guidelines are going to stretch out that 10-year interval to 15 years.
Q: What other CRC studies are you working on now?
We have several studies that we are working on right now. One is called the PREVENT CRC study, which is looking at whether a polygenic risk score can improve risk stratification following adenoma removal for colorectal cancer prevention and tailoring post-polypectomy surveillance. This is a large observational cohort study that we have teamed up with the Fred Hutchinson Cancer Center, Erasmus University, and Kaiser Permanente Northwest to answer this important question that may have implications for personalized medicine.
Then there’s the COOP study, funded by the Patient-Centered Outcomes Research Institute. This is looking at the best surveillance test to use among older adults 65 years and older with a history of polyps. The trial is randomizing them to either getting a colonoscopy for surveillance or annual fecal immunochemical test (FIT) for surveillance. This is to see which test is best for detecting colorectal cancer among older adults with a history of polyps.
Q: Do you think FIT tests could eventually replace colonoscopy, given that it’s less invasive?
Although FIT and other stool-based tests are less invasive and have been shown to have high accuracy for detecting colorectal cancer, I personally do not think they are going to replace colonoscopy as the most popular screening modality in the United States. Colonoscopy remains the gold standard for detecting and removing precancerous polyps and has the highest accuracy for detecting colorectal cancer.
Q: Besides Dr. Carethers, what teacher or mentor had the greatest impact on you?
Clinically it’s been Dr. Jonathan Terdiman from UCSF, who taught me everything I know about clinical GI, and the art of colonoscopy. In addition, Douglas A. Corley, MD, PhD, the Permanente Medical Group’s chief research officer, has made the greatest impact on my research career. He’s really taught me how to rigorously design a research study to answer important clinically relevant questions, and has given me the skill set to write NIH grants. I would not be here without these mentors who are truly giants in the field of GI.
Q: When you’re not being a GI, how do you spend your free weekend afternoons? Are you still a “Cal Bears” fan at your alma mater, UC Berkeley?
I spend a lot of time taking my kids to their activities on the weekends. I just took my son to a Cal Bears Game Day, which was hosted by ESPN at Berkeley.
It was an incredible experience hearing sports analyst Pat McAfee lead all the Cal chants, seeing Nick Saban from the University of Alabama take off his red tie and replace it with a Cal Bears tie, and watching a Cal student win a hundred thousand dollars by kicking a football through the goal posts wearing checkered vans.
Lightning Round
Texting or talking?
Text
Favorite breakfast?
Taiwanese breakfast
Place you most want to travel to?
Japan
Favorite junk food?
Trader Joe’s chili lime chips
Favorite season?
Springtime, baseball season
Favorite ice cream flavor?
Mint chocolate chip
How many cups of coffee do you drink per day?
2-3
Last movie you watched?
Oppenheimer
Best place you ever went on vacation?
Hawaii
If you weren’t a gastroenterologist, what would you be?
Barber
Best Halloween costume you ever wore?
SpongeBob SquarePants
Favorite sport?
Tennis
What song do you have to sing along with when you hear it?
Any classic 80s song
Introvert or extrovert?
Introvert
About a third of the US population are eligible for colorectal cancer screening but aren’t up to date on screening.
Many patients are reluctant to test for colon cancer for a variety of reasons, said Jeffrey K. Lee, MD, MPH, a research scientist at the Kaiser Permanente Northern California Division of Research and an attending gastroenterologist at Kaiser Permanente San Francisco Medical Center.
“As a gastroenterologist, I strongly believe we should emphasize the importance of colorectal cancer screening. And there’s many tests available, not just a colonoscopy, to help reduce your chances of developing colorectal cancer and even dying from colorectal cancer,” said Dr. Lee.
Many patients prefer a test that’s more convenient, that doesn’t require them to take time out of their busy schedules. “We must educate our patients that there are some noninvasive screening options that are helpful, and to be able to share with them some of the benefits, but also some of the drawbacks compared to colonoscopy and allow them to have a choice,” he advised.
He is a recipient of the AGA Research Scholar Award, and has in turn supported other researchers by contributing to the AGA Research Foundation. In 2012, Dr. Lee received a grant from the Sylvia Allison Kaplan Clinical Research Fund to fund a study on long-term colorectal cancer risk in patients with normal colonoscopy results.
The findings, published in JAMA Internal Medicine, determined that 10 years after a negative colonoscopy, Kaiser Permanente members had a 46% lower risk of being diagnosed with CRC and were 88% less likely to die from disease compared with patients who didn’t undergo screening.
“Furthermore, the reduced risk of developing colorectal cancer, even dying from it, persisted for more than 12 years after the examination compared with an unscreened population,” said Dr. Lee. “I firmly believe our study really supports the ten-year screening interval after a normal colonoscopy, as currently recommended by our guidelines.”
In an interview, he discussed his research efforts to find the best detection regimens for CRC, and the mentors who guided his career path as a GI scientist.
Q: Why did you choose GI?
During medical school I was fortunate to work in the lab of Dr. John M. Carethers at UC San Diego. He introduced me to GI and inspired me to choose GI as a career. His mentorship was invaluable because he not only solidified my interest in GI, but also inspired me to become a physician scientist, focusing on colorectal cancer prevention and control. His amazing mentorship drew me to this field.
Q: One of your clinical focus areas is hereditary gastrointestinal cancer syndromes. How did you become interested in this area of GI medicine?
My interest in hereditary GI cancer syndromes stemmed from my work as a medical student in Dr. Carethers’ lab. One of my research projects was looking at certain gene mutations among patients with hereditary GI cancer syndromes, specifically, familial hamartomatous polyposis syndrome. It was through these research projects and seeing how these genetic mutations impacted their risk of developing colorectal cancer, inspired me to care for patients with hereditary GI cancer syndromes.
Q: Have you been doing any research on the reasons why more young people are getting colon cancer?
We recently published work looking at the potential factors that may be driving the rising rates of early onset colorectal cancer. One hypothesis that’s been floating around is antibiotic exposure in early adulthood or childhood because of its effect on the microbiome. Using our large database at Kaiser Permanente Northern California, we did not find an association between oral antibiotic use during early adulthood and the risk of early-onset colorectal cancer.
You have the usual suspects like obesity and diabetes, but it’s not explaining all that risk. While familial colorectal cancer syndromes contribute to a small proportion of early-onset colorectal, these syndromes are not increasing across generations. I really do feel it’s something in the diet or how foods are processed and environmental factors that’s driving some of the risk of early onset colorectal cancer and this should be explored further.
Q: In 2018, you issued a landmark study which found an association between a 10-year follow-up after negative colonoscopy and reduced risk of disease and mortality. Has there been any updates to these findings over the last 6 years?
We recently saw a study in JAMA Oncology of a Swedish cohort that showed a negative colonoscopy result was associated with a reduced risk of developing and even dying from colorectal cancer 15 years from that examination, compared to the general population of Sweden. I think there’s some things that we need to be cautious about regarding that study. We have to think about the comparison group that they used and the lack of information regarding the indication of the colonoscopy and the quality of the examination. So, it remains uncertain whether future guidelines are going to stretch out that 10-year interval to 15 years.
Q: What other CRC studies are you working on now?
We have several studies that we are working on right now. One is called the PREVENT CRC study, which is looking at whether a polygenic risk score can improve risk stratification following adenoma removal for colorectal cancer prevention and tailoring post-polypectomy surveillance. This is a large observational cohort study that we have teamed up with the Fred Hutchinson Cancer Center, Erasmus University, and Kaiser Permanente Northwest to answer this important question that may have implications for personalized medicine.
Then there’s the COOP study, funded by the Patient-Centered Outcomes Research Institute. This is looking at the best surveillance test to use among older adults 65 years and older with a history of polyps. The trial is randomizing them to either getting a colonoscopy for surveillance or annual fecal immunochemical test (FIT) for surveillance. This is to see which test is best for detecting colorectal cancer among older adults with a history of polyps.
Q: Do you think FIT tests could eventually replace colonoscopy, given that it’s less invasive?
Although FIT and other stool-based tests are less invasive and have been shown to have high accuracy for detecting colorectal cancer, I personally do not think they are going to replace colonoscopy as the most popular screening modality in the United States. Colonoscopy remains the gold standard for detecting and removing precancerous polyps and has the highest accuracy for detecting colorectal cancer.
Q: Besides Dr. Carethers, what teacher or mentor had the greatest impact on you?
Clinically it’s been Dr. Jonathan Terdiman from UCSF, who taught me everything I know about clinical GI, and the art of colonoscopy. In addition, Douglas A. Corley, MD, PhD, the Permanente Medical Group’s chief research officer, has made the greatest impact on my research career. He’s really taught me how to rigorously design a research study to answer important clinically relevant questions, and has given me the skill set to write NIH grants. I would not be here without these mentors who are truly giants in the field of GI.
Q: When you’re not being a GI, how do you spend your free weekend afternoons? Are you still a “Cal Bears” fan at your alma mater, UC Berkeley?
I spend a lot of time taking my kids to their activities on the weekends. I just took my son to a Cal Bears Game Day, which was hosted by ESPN at Berkeley.
It was an incredible experience hearing sports analyst Pat McAfee lead all the Cal chants, seeing Nick Saban from the University of Alabama take off his red tie and replace it with a Cal Bears tie, and watching a Cal student win a hundred thousand dollars by kicking a football through the goal posts wearing checkered vans.
Lightning Round
Texting or talking?
Text
Favorite breakfast?
Taiwanese breakfast
Place you most want to travel to?
Japan
Favorite junk food?
Trader Joe’s chili lime chips
Favorite season?
Springtime, baseball season
Favorite ice cream flavor?
Mint chocolate chip
How many cups of coffee do you drink per day?
2-3
Last movie you watched?
Oppenheimer
Best place you ever went on vacation?
Hawaii
If you weren’t a gastroenterologist, what would you be?
Barber
Best Halloween costume you ever wore?
SpongeBob SquarePants
Favorite sport?
Tennis
What song do you have to sing along with when you hear it?
Any classic 80s song
Introvert or extrovert?
Introvert
About a third of the US population are eligible for colorectal cancer screening but aren’t up to date on screening.
Many patients are reluctant to test for colon cancer for a variety of reasons, said Jeffrey K. Lee, MD, MPH, a research scientist at the Kaiser Permanente Northern California Division of Research and an attending gastroenterologist at Kaiser Permanente San Francisco Medical Center.
“As a gastroenterologist, I strongly believe we should emphasize the importance of colorectal cancer screening. And there’s many tests available, not just a colonoscopy, to help reduce your chances of developing colorectal cancer and even dying from colorectal cancer,” said Dr. Lee.
Many patients prefer a test that’s more convenient, that doesn’t require them to take time out of their busy schedules. “We must educate our patients that there are some noninvasive screening options that are helpful, and to be able to share with them some of the benefits, but also some of the drawbacks compared to colonoscopy and allow them to have a choice,” he advised.
He is a recipient of the AGA Research Scholar Award, and has in turn supported other researchers by contributing to the AGA Research Foundation. In 2012, Dr. Lee received a grant from the Sylvia Allison Kaplan Clinical Research Fund to fund a study on long-term colorectal cancer risk in patients with normal colonoscopy results.
The findings, published in JAMA Internal Medicine, determined that 10 years after a negative colonoscopy, Kaiser Permanente members had a 46% lower risk of being diagnosed with CRC and were 88% less likely to die from disease compared with patients who didn’t undergo screening.
“Furthermore, the reduced risk of developing colorectal cancer, even dying from it, persisted for more than 12 years after the examination compared with an unscreened population,” said Dr. Lee. “I firmly believe our study really supports the ten-year screening interval after a normal colonoscopy, as currently recommended by our guidelines.”
In an interview, he discussed his research efforts to find the best detection regimens for CRC, and the mentors who guided his career path as a GI scientist.
Q: Why did you choose GI?
During medical school I was fortunate to work in the lab of Dr. John M. Carethers at UC San Diego. He introduced me to GI and inspired me to choose GI as a career. His mentorship was invaluable because he not only solidified my interest in GI, but also inspired me to become a physician scientist, focusing on colorectal cancer prevention and control. His amazing mentorship drew me to this field.
Q: One of your clinical focus areas is hereditary gastrointestinal cancer syndromes. How did you become interested in this area of GI medicine?
My interest in hereditary GI cancer syndromes stemmed from my work as a medical student in Dr. Carethers’ lab. One of my research projects was looking at certain gene mutations among patients with hereditary GI cancer syndromes, specifically, familial hamartomatous polyposis syndrome. It was through these research projects and seeing how these genetic mutations impacted their risk of developing colorectal cancer, inspired me to care for patients with hereditary GI cancer syndromes.
Q: Have you been doing any research on the reasons why more young people are getting colon cancer?
We recently published work looking at the potential factors that may be driving the rising rates of early onset colorectal cancer. One hypothesis that’s been floating around is antibiotic exposure in early adulthood or childhood because of its effect on the microbiome. Using our large database at Kaiser Permanente Northern California, we did not find an association between oral antibiotic use during early adulthood and the risk of early-onset colorectal cancer.
You have the usual suspects like obesity and diabetes, but it’s not explaining all that risk. While familial colorectal cancer syndromes contribute to a small proportion of early-onset colorectal, these syndromes are not increasing across generations. I really do feel it’s something in the diet or how foods are processed and environmental factors that’s driving some of the risk of early onset colorectal cancer and this should be explored further.
Q: In 2018, you issued a landmark study which found an association between a 10-year follow-up after negative colonoscopy and reduced risk of disease and mortality. Has there been any updates to these findings over the last 6 years?
We recently saw a study in JAMA Oncology of a Swedish cohort that showed a negative colonoscopy result was associated with a reduced risk of developing and even dying from colorectal cancer 15 years from that examination, compared to the general population of Sweden. I think there’s some things that we need to be cautious about regarding that study. We have to think about the comparison group that they used and the lack of information regarding the indication of the colonoscopy and the quality of the examination. So, it remains uncertain whether future guidelines are going to stretch out that 10-year interval to 15 years.
Q: What other CRC studies are you working on now?
We have several studies that we are working on right now. One is called the PREVENT CRC study, which is looking at whether a polygenic risk score can improve risk stratification following adenoma removal for colorectal cancer prevention and tailoring post-polypectomy surveillance. This is a large observational cohort study that we have teamed up with the Fred Hutchinson Cancer Center, Erasmus University, and Kaiser Permanente Northwest to answer this important question that may have implications for personalized medicine.
Then there’s the COOP study, funded by the Patient-Centered Outcomes Research Institute. This is looking at the best surveillance test to use among older adults 65 years and older with a history of polyps. The trial is randomizing them to either getting a colonoscopy for surveillance or annual fecal immunochemical test (FIT) for surveillance. This is to see which test is best for detecting colorectal cancer among older adults with a history of polyps.
Q: Do you think FIT tests could eventually replace colonoscopy, given that it’s less invasive?
Although FIT and other stool-based tests are less invasive and have been shown to have high accuracy for detecting colorectal cancer, I personally do not think they are going to replace colonoscopy as the most popular screening modality in the United States. Colonoscopy remains the gold standard for detecting and removing precancerous polyps and has the highest accuracy for detecting colorectal cancer.
Q: Besides Dr. Carethers, what teacher or mentor had the greatest impact on you?
Clinically it’s been Dr. Jonathan Terdiman from UCSF, who taught me everything I know about clinical GI, and the art of colonoscopy. In addition, Douglas A. Corley, MD, PhD, the Permanente Medical Group’s chief research officer, has made the greatest impact on my research career. He’s really taught me how to rigorously design a research study to answer important clinically relevant questions, and has given me the skill set to write NIH grants. I would not be here without these mentors who are truly giants in the field of GI.
Q: When you’re not being a GI, how do you spend your free weekend afternoons? Are you still a “Cal Bears” fan at your alma mater, UC Berkeley?
I spend a lot of time taking my kids to their activities on the weekends. I just took my son to a Cal Bears Game Day, which was hosted by ESPN at Berkeley.
It was an incredible experience hearing sports analyst Pat McAfee lead all the Cal chants, seeing Nick Saban from the University of Alabama take off his red tie and replace it with a Cal Bears tie, and watching a Cal student win a hundred thousand dollars by kicking a football through the goal posts wearing checkered vans.
Lightning Round
Texting or talking?
Text
Favorite breakfast?
Taiwanese breakfast
Place you most want to travel to?
Japan
Favorite junk food?
Trader Joe’s chili lime chips
Favorite season?
Springtime, baseball season
Favorite ice cream flavor?
Mint chocolate chip
How many cups of coffee do you drink per day?
2-3
Last movie you watched?
Oppenheimer
Best place you ever went on vacation?
Hawaii
If you weren’t a gastroenterologist, what would you be?
Barber
Best Halloween costume you ever wore?
SpongeBob SquarePants
Favorite sport?
Tennis
What song do you have to sing along with when you hear it?
Any classic 80s song
Introvert or extrovert?
Introvert
Giving the Smallest GI Transplant Patients a New Lease On Life
The best part about working with kids is that “I get to laugh every day,” said Ke-You (Yoyo) Zhang, MD, clinical assistant professor for pediatrics–gastroenterology and hepatology at Stanford Medicine in California.
Everyday life for them is a challenge.
Dealing with sick children is difficult. “But I think the difference between pediatrics and adults is despite how hard things get, children are the single most resilient people you’re ever going to meet,” she said.
Kids don’t always know they’re sick and they don’t act sick, even when they are. “Every day, I literally get on the floor, I get to play, I get to run around. And truly, I have fun every single day. I get excited to go to work. And I think that’s what makes work not feel like work,” said Dr. Zhang.
In an interview, she discussed the satisfaction of following patients throughout their care continuum and her research to reduce the likelihood of transplant rejection.
She also shared an inspirational story of one young patient who spent his life tied to an IV, and how a transplant exposed him to the normal joys of life, like swimming, going to camp and getting on a plane for the first time.
Q: Why did you choose this subspecialty of pediatric GI?
I think it’s the best subspecialty because I think it combines a lot of the things that I enjoy, which is long-term continuity of care. It’s about growing up with your patients and seeing them through all the various stages of their life, often meeting patients when they’re babies. I get pictures of high school graduations and life milestones and even see some of my patients have families of their own. Becoming a part of their family is very meaningful to me. I also like complexity and acuity, and gastroenterology and hepatology provide those things.
And then lastly, it’s great to be able to exercise procedural skills and constantly learn new procedural skills.
Q: How did you become interested in the field of pediatric intestinal and liver transplantation?
I did all my training here at Stanford. We have one of the largest pediatric transplant centers and we also have a very large intestinal rehabilitation population.
Coming through residency and fellowship, I had a lot of exposure to transplant and intestinal failure, intestinal rehabilitation. I really liked the longitudinal relationship I got to form with my patients. Sometimes they’re in the neonatal ICU, where you’re meeting them in their very first days of life. You follow them through their chronic illness, through transplant and after transplant for many years. You become not just their GI, but the center of their care.
Q: What challenges are unique to this type of transplant work?
Pediatric intestinal failure and intestinal transplant represents an incredibly small subset of children. Oftentimes, they do not get the resources and recognition on a national policy level or even at the hospital level that other gastrointestinal diseases receive. What’s difficult is they are such a small subset but their complexity and their needs are probably in the highest percentile. So that’s a really challenging combination to start with. And there’s only a few centers that specialize in doing intestinal rehabilitation and intestinal transplantation for children in the country.
Developing expertise has been slow. But I think in the last decade or so, our understanding and success with intestinal rehabilitation and intestinal transplantation has really improved, especially at large centers like Stanford. We’ve had a lot of success stories and have not had any graft loss since 2014.
Q: Are these transplants hard to acquire?
Yes, especially when you’re transplanting not just the intestines but the liver as well. You’re waiting for two organs, not just one organ. And on top of that, you’re waiting for an appropriately sized donor; usually a child who’s around the same size or same age who’s passed away. Those organs would have to be a good match. Children can wait multiple years for a transplant.
Q: Is there a success story you’d like to share?
One patient I met in the neonatal ICU had congenital short bowel syndrome. He was born with hardly any intestines. He developed complications of being on long-term intravenous nutrition, which included recurrent central line infections and liver disease. He was never able to eat because he really didn’t have a digestive system that could adequately absorb anything. He had a central line in one of his large veins, so he couldn’t go swimming.
He had to have special adaptive wear to even shower or bathe and couldn’t travel. It’s these types of patients that benefit so much from transplant. Putting any kid through transplant is a massive undertaking and it certainly has risks. But he underwent a successful transplant at the age of 8—not just an intestinal transplant, but a multi-visceral transplant of the liver, intestine, and pancreas. He’s 9 years old now, and no longer needs intravenous nutrition. He ate by mouth for the very first time after transplant. He’s trying all sorts of new foods and he was able to go to a special transplant camp for children. Getting on a plane to Los Angeles, which is where our transplant camp is, was a huge deal.
He was able to swim in the lake. He’s never been able to do that. And he wants to start doing sports this fall. This was really a life-changing story for him.
Q: What advancements lie ahead for this field of work? Have you work on any notable research?
I think our understanding of transplant immunology has really progressed, especially recently. That’s what part of my research is about—using novel therapies to modulate the immune system of pediatric transplant recipients. The No. 1 complication that occurs after intestinal transplant is rejection because obviously you’re implanting somebody else’s organs into a patient.
I am involved in a clinical trial that’s looking at the use of extracellular vesicles that are isolated from hematopoietic stem cells. These vesicles contain various growth factors, anti-inflammatory proteins and tissue repair factors that we are infusing into intestinal transplant patients with the aim to repair the intestinal tissue patients are rejecting.
Q: When you’re not being a GI, how do you spend your free weekend afternoons?
My husband and I have an almost 2-year-old little girl. She keeps us busy and I spend my afternoons chasing after a crazy toddler.
Lightning Round
Texting or talking?
Huge texter
Favorite junk food?
French fries
Cat or dog person?
Dog
Favorite ice cream?
Strawberry
If you weren’t a gastroenterologist, what would you be?Florist
Best place you’ve traveled to?
Thailand
Number of cups of coffee you drink per day?
Too many
Favorite city in the US besides the one you live in?
New York City
Favorite sport?
Tennis
Optimist or pessimist?
Optimist
The best part about working with kids is that “I get to laugh every day,” said Ke-You (Yoyo) Zhang, MD, clinical assistant professor for pediatrics–gastroenterology and hepatology at Stanford Medicine in California.
Everyday life for them is a challenge.
Dealing with sick children is difficult. “But I think the difference between pediatrics and adults is despite how hard things get, children are the single most resilient people you’re ever going to meet,” she said.
Kids don’t always know they’re sick and they don’t act sick, even when they are. “Every day, I literally get on the floor, I get to play, I get to run around. And truly, I have fun every single day. I get excited to go to work. And I think that’s what makes work not feel like work,” said Dr. Zhang.
In an interview, she discussed the satisfaction of following patients throughout their care continuum and her research to reduce the likelihood of transplant rejection.
She also shared an inspirational story of one young patient who spent his life tied to an IV, and how a transplant exposed him to the normal joys of life, like swimming, going to camp and getting on a plane for the first time.
Q: Why did you choose this subspecialty of pediatric GI?
I think it’s the best subspecialty because I think it combines a lot of the things that I enjoy, which is long-term continuity of care. It’s about growing up with your patients and seeing them through all the various stages of their life, often meeting patients when they’re babies. I get pictures of high school graduations and life milestones and even see some of my patients have families of their own. Becoming a part of their family is very meaningful to me. I also like complexity and acuity, and gastroenterology and hepatology provide those things.
And then lastly, it’s great to be able to exercise procedural skills and constantly learn new procedural skills.
Q: How did you become interested in the field of pediatric intestinal and liver transplantation?
I did all my training here at Stanford. We have one of the largest pediatric transplant centers and we also have a very large intestinal rehabilitation population.
Coming through residency and fellowship, I had a lot of exposure to transplant and intestinal failure, intestinal rehabilitation. I really liked the longitudinal relationship I got to form with my patients. Sometimes they’re in the neonatal ICU, where you’re meeting them in their very first days of life. You follow them through their chronic illness, through transplant and after transplant for many years. You become not just their GI, but the center of their care.
Q: What challenges are unique to this type of transplant work?
Pediatric intestinal failure and intestinal transplant represents an incredibly small subset of children. Oftentimes, they do not get the resources and recognition on a national policy level or even at the hospital level that other gastrointestinal diseases receive. What’s difficult is they are such a small subset but their complexity and their needs are probably in the highest percentile. So that’s a really challenging combination to start with. And there’s only a few centers that specialize in doing intestinal rehabilitation and intestinal transplantation for children in the country.
Developing expertise has been slow. But I think in the last decade or so, our understanding and success with intestinal rehabilitation and intestinal transplantation has really improved, especially at large centers like Stanford. We’ve had a lot of success stories and have not had any graft loss since 2014.
Q: Are these transplants hard to acquire?
Yes, especially when you’re transplanting not just the intestines but the liver as well. You’re waiting for two organs, not just one organ. And on top of that, you’re waiting for an appropriately sized donor; usually a child who’s around the same size or same age who’s passed away. Those organs would have to be a good match. Children can wait multiple years for a transplant.
Q: Is there a success story you’d like to share?
One patient I met in the neonatal ICU had congenital short bowel syndrome. He was born with hardly any intestines. He developed complications of being on long-term intravenous nutrition, which included recurrent central line infections and liver disease. He was never able to eat because he really didn’t have a digestive system that could adequately absorb anything. He had a central line in one of his large veins, so he couldn’t go swimming.
He had to have special adaptive wear to even shower or bathe and couldn’t travel. It’s these types of patients that benefit so much from transplant. Putting any kid through transplant is a massive undertaking and it certainly has risks. But he underwent a successful transplant at the age of 8—not just an intestinal transplant, but a multi-visceral transplant of the liver, intestine, and pancreas. He’s 9 years old now, and no longer needs intravenous nutrition. He ate by mouth for the very first time after transplant. He’s trying all sorts of new foods and he was able to go to a special transplant camp for children. Getting on a plane to Los Angeles, which is where our transplant camp is, was a huge deal.
He was able to swim in the lake. He’s never been able to do that. And he wants to start doing sports this fall. This was really a life-changing story for him.
Q: What advancements lie ahead for this field of work? Have you work on any notable research?
I think our understanding of transplant immunology has really progressed, especially recently. That’s what part of my research is about—using novel therapies to modulate the immune system of pediatric transplant recipients. The No. 1 complication that occurs after intestinal transplant is rejection because obviously you’re implanting somebody else’s organs into a patient.
I am involved in a clinical trial that’s looking at the use of extracellular vesicles that are isolated from hematopoietic stem cells. These vesicles contain various growth factors, anti-inflammatory proteins and tissue repair factors that we are infusing into intestinal transplant patients with the aim to repair the intestinal tissue patients are rejecting.
Q: When you’re not being a GI, how do you spend your free weekend afternoons?
My husband and I have an almost 2-year-old little girl. She keeps us busy and I spend my afternoons chasing after a crazy toddler.
Lightning Round
Texting or talking?
Huge texter
Favorite junk food?
French fries
Cat or dog person?
Dog
Favorite ice cream?
Strawberry
If you weren’t a gastroenterologist, what would you be?Florist
Best place you’ve traveled to?
Thailand
Number of cups of coffee you drink per day?
Too many
Favorite city in the US besides the one you live in?
New York City
Favorite sport?
Tennis
Optimist or pessimist?
Optimist
The best part about working with kids is that “I get to laugh every day,” said Ke-You (Yoyo) Zhang, MD, clinical assistant professor for pediatrics–gastroenterology and hepatology at Stanford Medicine in California.
Everyday life for them is a challenge.
Dealing with sick children is difficult. “But I think the difference between pediatrics and adults is despite how hard things get, children are the single most resilient people you’re ever going to meet,” she said.
Kids don’t always know they’re sick and they don’t act sick, even when they are. “Every day, I literally get on the floor, I get to play, I get to run around. And truly, I have fun every single day. I get excited to go to work. And I think that’s what makes work not feel like work,” said Dr. Zhang.
In an interview, she discussed the satisfaction of following patients throughout their care continuum and her research to reduce the likelihood of transplant rejection.
She also shared an inspirational story of one young patient who spent his life tied to an IV, and how a transplant exposed him to the normal joys of life, like swimming, going to camp and getting on a plane for the first time.
Q: Why did you choose this subspecialty of pediatric GI?
I think it’s the best subspecialty because I think it combines a lot of the things that I enjoy, which is long-term continuity of care. It’s about growing up with your patients and seeing them through all the various stages of their life, often meeting patients when they’re babies. I get pictures of high school graduations and life milestones and even see some of my patients have families of their own. Becoming a part of their family is very meaningful to me. I also like complexity and acuity, and gastroenterology and hepatology provide those things.
And then lastly, it’s great to be able to exercise procedural skills and constantly learn new procedural skills.
Q: How did you become interested in the field of pediatric intestinal and liver transplantation?
I did all my training here at Stanford. We have one of the largest pediatric transplant centers and we also have a very large intestinal rehabilitation population.
Coming through residency and fellowship, I had a lot of exposure to transplant and intestinal failure, intestinal rehabilitation. I really liked the longitudinal relationship I got to form with my patients. Sometimes they’re in the neonatal ICU, where you’re meeting them in their very first days of life. You follow them through their chronic illness, through transplant and after transplant for many years. You become not just their GI, but the center of their care.
Q: What challenges are unique to this type of transplant work?
Pediatric intestinal failure and intestinal transplant represents an incredibly small subset of children. Oftentimes, they do not get the resources and recognition on a national policy level or even at the hospital level that other gastrointestinal diseases receive. What’s difficult is they are such a small subset but their complexity and their needs are probably in the highest percentile. So that’s a really challenging combination to start with. And there’s only a few centers that specialize in doing intestinal rehabilitation and intestinal transplantation for children in the country.
Developing expertise has been slow. But I think in the last decade or so, our understanding and success with intestinal rehabilitation and intestinal transplantation has really improved, especially at large centers like Stanford. We’ve had a lot of success stories and have not had any graft loss since 2014.
Q: Are these transplants hard to acquire?
Yes, especially when you’re transplanting not just the intestines but the liver as well. You’re waiting for two organs, not just one organ. And on top of that, you’re waiting for an appropriately sized donor; usually a child who’s around the same size or same age who’s passed away. Those organs would have to be a good match. Children can wait multiple years for a transplant.
Q: Is there a success story you’d like to share?
One patient I met in the neonatal ICU had congenital short bowel syndrome. He was born with hardly any intestines. He developed complications of being on long-term intravenous nutrition, which included recurrent central line infections and liver disease. He was never able to eat because he really didn’t have a digestive system that could adequately absorb anything. He had a central line in one of his large veins, so he couldn’t go swimming.
He had to have special adaptive wear to even shower or bathe and couldn’t travel. It’s these types of patients that benefit so much from transplant. Putting any kid through transplant is a massive undertaking and it certainly has risks. But he underwent a successful transplant at the age of 8—not just an intestinal transplant, but a multi-visceral transplant of the liver, intestine, and pancreas. He’s 9 years old now, and no longer needs intravenous nutrition. He ate by mouth for the very first time after transplant. He’s trying all sorts of new foods and he was able to go to a special transplant camp for children. Getting on a plane to Los Angeles, which is where our transplant camp is, was a huge deal.
He was able to swim in the lake. He’s never been able to do that. And he wants to start doing sports this fall. This was really a life-changing story for him.
Q: What advancements lie ahead for this field of work? Have you work on any notable research?
I think our understanding of transplant immunology has really progressed, especially recently. That’s what part of my research is about—using novel therapies to modulate the immune system of pediatric transplant recipients. The No. 1 complication that occurs after intestinal transplant is rejection because obviously you’re implanting somebody else’s organs into a patient.
I am involved in a clinical trial that’s looking at the use of extracellular vesicles that are isolated from hematopoietic stem cells. These vesicles contain various growth factors, anti-inflammatory proteins and tissue repair factors that we are infusing into intestinal transplant patients with the aim to repair the intestinal tissue patients are rejecting.
Q: When you’re not being a GI, how do you spend your free weekend afternoons?
My husband and I have an almost 2-year-old little girl. She keeps us busy and I spend my afternoons chasing after a crazy toddler.
Lightning Round
Texting or talking?
Huge texter
Favorite junk food?
French fries
Cat or dog person?
Dog
Favorite ice cream?
Strawberry
If you weren’t a gastroenterologist, what would you be?Florist
Best place you’ve traveled to?
Thailand
Number of cups of coffee you drink per day?
Too many
Favorite city in the US besides the one you live in?
New York City
Favorite sport?
Tennis
Optimist or pessimist?
Optimist
In a Parallel Universe, “I’d Be a Concert Pianist” Says Tennessee GI
She also relishes opportunities to think, to analyze, and solve problems for her patients.
One of her chief interests is inflammatory bowel disease (IBD). It’s reassuring to focus on a field of work “where I know exactly what’s causing the issue, and I can select a therapeutic approach (medication and lifestyle changes) that help a patient achieve remission,” said Dr. Pointer, co-owner and managing partner of Digestive and Liver Health Specialists in Hendersonville, Tenn. She’s also the medical director and a principal investigator of Quality Medical Research in Nashville, and currently serves as chair of the AGA Trainee and Early Career Committee.
Starting her own practice has been just as challenging and rewarding as going through medical school. Medical training does not prepare you for starting your own practice, Dr. Pointer said, so she and her business partner have had to learn as they go. “But I think we’ve done very well. We’ve taken the ups and downs in stride.”
In an interview, Dr. Pointer spoke more about her work in IBD and the ways in which she’s given back to the community through music and mentoring.
Q: Why did you choose GI?
I knew from a very young age that I was going to be a physician. I had always been interested in science. When I got into medical school and became exposed to the different areas, I really liked the cognitive skills where you had to think through a problem or an issue. But I also liked the procedural things as well.
During my internal medicine residency training, I felt that I had a knack for it. As I was looking at different options, I decided on gastroenterology because it combined both cognitive thinking through issues, but also taking it to the next step and intervening through procedures.
Q: During fellowship, your focus was inflammatory bowel disease. What drew your interest to this condition?
There are a lot of different areas within gastroenterology that one can subspecialize in, as we see the full gamut of gastrointestinal and hepatic disorders. But treating some conditions, like functional disorders, means taking more of a ‘trial and error’ approach, and you may not always get the patient a hundred percent better. That’s not to say that we can’t improve a patient’s quality of life, but it’s not always a guarantee.
But inflammatory bowel disease is a little bit different. Because I can point to an exact spot in the intestines that’s causing the problem, it’s very fulfilling for me as a physician to take a patient who is having 10-12 bloody bowel movements a day, to normal form stools and no abdominal pain. They’re able to gain weight and go on about their lives and about their day. So that was why I picked inflammatory bowel disease as my subspecialty.
Q: Tell me about the gastroenterology elective you developed for family medicine residents and undergraduate students. What’s the status of the program now?
I’ve always been interested in teaching and giving back to the next generations. I feel like I had great mentor opportunities and people who helped me along the way. In my previous hospital position, I was able to work with the family medicine department and create an elective through which residents and even undergraduate students could come and shadow and work with me in the clinic and see me performing procedures.
That elective ended once I left that position, at least as far as I’m aware. But in the private practice that I co-own now, we have numerous shadowing opportunities. I was able to give a lecture at Middle Tennessee State University for some students. And through that lecture, many students have reached out to me to shadow. I have allowed them to come shadow and do clinic work as a medical assistant and watch me perform procedures. I have multiple students working with me weekly.
Q: Years ago, you founded the non-profit Enchanted Fingers Piano Lessons, which gave free piano lessons to underserved youth. What was that experience like?
Piano was one of my first loves. In some parallel universe, there’s a Dr. Pointer who is a classical, concert pianist. I started taking piano lessons when I was in early middle school, and I took to it very quickly. I was able to excel. I just loved it. I enjoyed practicing and I still play.
The impetus for starting Enchanted Fingers Piano lessons was because I wanted to give back again to the community. I came from an underserved community. Oftentimes children and young adults in those communities don’t get exposed to extracurricular activities and they don’t even know what they could potentially have a passion for. And I definitely had a passion for piano. I partnered with a church organization and they allowed me to use their church to host these piano lessons, and it was a phenomenal and rewarding experience. I would definitely like to start it up again one day in the future. It was an amazing experience.
It’s actually how I met my husband. He was one of the young adult students who signed up to take lessons. We both still enjoy playing the piano together.
Q: When you’re not being a GI, how do you spend your free weekend afternoons?
I’m a creative at heart. I really enjoy sewing and I’m working on a few sewing projects. I just got a serger. It is a machine that helps you finish a seam. It can also be used to sew entire garments. That has been fun, learning how to thread that machine. When I’m not doing that or just relaxing with my family, I do enjoy curling up with a good book. Stephen King is one of my favorite authors.
Lightning Round
Texting or talking?
Talking
Favorite junk food?
Chocolate chip cookies
Cat or dog person?
Cat
Favorite vacation?
Hawaii
How many cups of coffee do you drink per day?
I don’t drink coffee
Favorite ice cream?
Butter pecan
Favorite sport?
I don’t watch sports
Optimist or pessimist?
Optimist
She also relishes opportunities to think, to analyze, and solve problems for her patients.
One of her chief interests is inflammatory bowel disease (IBD). It’s reassuring to focus on a field of work “where I know exactly what’s causing the issue, and I can select a therapeutic approach (medication and lifestyle changes) that help a patient achieve remission,” said Dr. Pointer, co-owner and managing partner of Digestive and Liver Health Specialists in Hendersonville, Tenn. She’s also the medical director and a principal investigator of Quality Medical Research in Nashville, and currently serves as chair of the AGA Trainee and Early Career Committee.
Starting her own practice has been just as challenging and rewarding as going through medical school. Medical training does not prepare you for starting your own practice, Dr. Pointer said, so she and her business partner have had to learn as they go. “But I think we’ve done very well. We’ve taken the ups and downs in stride.”
In an interview, Dr. Pointer spoke more about her work in IBD and the ways in which she’s given back to the community through music and mentoring.
Q: Why did you choose GI?
I knew from a very young age that I was going to be a physician. I had always been interested in science. When I got into medical school and became exposed to the different areas, I really liked the cognitive skills where you had to think through a problem or an issue. But I also liked the procedural things as well.
During my internal medicine residency training, I felt that I had a knack for it. As I was looking at different options, I decided on gastroenterology because it combined both cognitive thinking through issues, but also taking it to the next step and intervening through procedures.
Q: During fellowship, your focus was inflammatory bowel disease. What drew your interest to this condition?
There are a lot of different areas within gastroenterology that one can subspecialize in, as we see the full gamut of gastrointestinal and hepatic disorders. But treating some conditions, like functional disorders, means taking more of a ‘trial and error’ approach, and you may not always get the patient a hundred percent better. That’s not to say that we can’t improve a patient’s quality of life, but it’s not always a guarantee.
But inflammatory bowel disease is a little bit different. Because I can point to an exact spot in the intestines that’s causing the problem, it’s very fulfilling for me as a physician to take a patient who is having 10-12 bloody bowel movements a day, to normal form stools and no abdominal pain. They’re able to gain weight and go on about their lives and about their day. So that was why I picked inflammatory bowel disease as my subspecialty.
Q: Tell me about the gastroenterology elective you developed for family medicine residents and undergraduate students. What’s the status of the program now?
I’ve always been interested in teaching and giving back to the next generations. I feel like I had great mentor opportunities and people who helped me along the way. In my previous hospital position, I was able to work with the family medicine department and create an elective through which residents and even undergraduate students could come and shadow and work with me in the clinic and see me performing procedures.
That elective ended once I left that position, at least as far as I’m aware. But in the private practice that I co-own now, we have numerous shadowing opportunities. I was able to give a lecture at Middle Tennessee State University for some students. And through that lecture, many students have reached out to me to shadow. I have allowed them to come shadow and do clinic work as a medical assistant and watch me perform procedures. I have multiple students working with me weekly.
Q: Years ago, you founded the non-profit Enchanted Fingers Piano Lessons, which gave free piano lessons to underserved youth. What was that experience like?
Piano was one of my first loves. In some parallel universe, there’s a Dr. Pointer who is a classical, concert pianist. I started taking piano lessons when I was in early middle school, and I took to it very quickly. I was able to excel. I just loved it. I enjoyed practicing and I still play.
The impetus for starting Enchanted Fingers Piano lessons was because I wanted to give back again to the community. I came from an underserved community. Oftentimes children and young adults in those communities don’t get exposed to extracurricular activities and they don’t even know what they could potentially have a passion for. And I definitely had a passion for piano. I partnered with a church organization and they allowed me to use their church to host these piano lessons, and it was a phenomenal and rewarding experience. I would definitely like to start it up again one day in the future. It was an amazing experience.
It’s actually how I met my husband. He was one of the young adult students who signed up to take lessons. We both still enjoy playing the piano together.
Q: When you’re not being a GI, how do you spend your free weekend afternoons?
I’m a creative at heart. I really enjoy sewing and I’m working on a few sewing projects. I just got a serger. It is a machine that helps you finish a seam. It can also be used to sew entire garments. That has been fun, learning how to thread that machine. When I’m not doing that or just relaxing with my family, I do enjoy curling up with a good book. Stephen King is one of my favorite authors.
Lightning Round
Texting or talking?
Talking
Favorite junk food?
Chocolate chip cookies
Cat or dog person?
Cat
Favorite vacation?
Hawaii
How many cups of coffee do you drink per day?
I don’t drink coffee
Favorite ice cream?
Butter pecan
Favorite sport?
I don’t watch sports
Optimist or pessimist?
Optimist
She also relishes opportunities to think, to analyze, and solve problems for her patients.
One of her chief interests is inflammatory bowel disease (IBD). It’s reassuring to focus on a field of work “where I know exactly what’s causing the issue, and I can select a therapeutic approach (medication and lifestyle changes) that help a patient achieve remission,” said Dr. Pointer, co-owner and managing partner of Digestive and Liver Health Specialists in Hendersonville, Tenn. She’s also the medical director and a principal investigator of Quality Medical Research in Nashville, and currently serves as chair of the AGA Trainee and Early Career Committee.
Starting her own practice has been just as challenging and rewarding as going through medical school. Medical training does not prepare you for starting your own practice, Dr. Pointer said, so she and her business partner have had to learn as they go. “But I think we’ve done very well. We’ve taken the ups and downs in stride.”
In an interview, Dr. Pointer spoke more about her work in IBD and the ways in which she’s given back to the community through music and mentoring.
Q: Why did you choose GI?
I knew from a very young age that I was going to be a physician. I had always been interested in science. When I got into medical school and became exposed to the different areas, I really liked the cognitive skills where you had to think through a problem or an issue. But I also liked the procedural things as well.
During my internal medicine residency training, I felt that I had a knack for it. As I was looking at different options, I decided on gastroenterology because it combined both cognitive thinking through issues, but also taking it to the next step and intervening through procedures.
Q: During fellowship, your focus was inflammatory bowel disease. What drew your interest to this condition?
There are a lot of different areas within gastroenterology that one can subspecialize in, as we see the full gamut of gastrointestinal and hepatic disorders. But treating some conditions, like functional disorders, means taking more of a ‘trial and error’ approach, and you may not always get the patient a hundred percent better. That’s not to say that we can’t improve a patient’s quality of life, but it’s not always a guarantee.
But inflammatory bowel disease is a little bit different. Because I can point to an exact spot in the intestines that’s causing the problem, it’s very fulfilling for me as a physician to take a patient who is having 10-12 bloody bowel movements a day, to normal form stools and no abdominal pain. They’re able to gain weight and go on about their lives and about their day. So that was why I picked inflammatory bowel disease as my subspecialty.
Q: Tell me about the gastroenterology elective you developed for family medicine residents and undergraduate students. What’s the status of the program now?
I’ve always been interested in teaching and giving back to the next generations. I feel like I had great mentor opportunities and people who helped me along the way. In my previous hospital position, I was able to work with the family medicine department and create an elective through which residents and even undergraduate students could come and shadow and work with me in the clinic and see me performing procedures.
That elective ended once I left that position, at least as far as I’m aware. But in the private practice that I co-own now, we have numerous shadowing opportunities. I was able to give a lecture at Middle Tennessee State University for some students. And through that lecture, many students have reached out to me to shadow. I have allowed them to come shadow and do clinic work as a medical assistant and watch me perform procedures. I have multiple students working with me weekly.
Q: Years ago, you founded the non-profit Enchanted Fingers Piano Lessons, which gave free piano lessons to underserved youth. What was that experience like?
Piano was one of my first loves. In some parallel universe, there’s a Dr. Pointer who is a classical, concert pianist. I started taking piano lessons when I was in early middle school, and I took to it very quickly. I was able to excel. I just loved it. I enjoyed practicing and I still play.
The impetus for starting Enchanted Fingers Piano lessons was because I wanted to give back again to the community. I came from an underserved community. Oftentimes children and young adults in those communities don’t get exposed to extracurricular activities and they don’t even know what they could potentially have a passion for. And I definitely had a passion for piano. I partnered with a church organization and they allowed me to use their church to host these piano lessons, and it was a phenomenal and rewarding experience. I would definitely like to start it up again one day in the future. It was an amazing experience.
It’s actually how I met my husband. He was one of the young adult students who signed up to take lessons. We both still enjoy playing the piano together.
Q: When you’re not being a GI, how do you spend your free weekend afternoons?
I’m a creative at heart. I really enjoy sewing and I’m working on a few sewing projects. I just got a serger. It is a machine that helps you finish a seam. It can also be used to sew entire garments. That has been fun, learning how to thread that machine. When I’m not doing that or just relaxing with my family, I do enjoy curling up with a good book. Stephen King is one of my favorite authors.
Lightning Round
Texting or talking?
Talking
Favorite junk food?
Chocolate chip cookies
Cat or dog person?
Cat
Favorite vacation?
Hawaii
How many cups of coffee do you drink per day?
I don’t drink coffee
Favorite ice cream?
Butter pecan
Favorite sport?
I don’t watch sports
Optimist or pessimist?
Optimist
Patient Navigators for Serious Illnesses Can Now Bill Under New Medicare Codes
In a move that acknowledges the gauntlet the US health system poses for people facing serious and fatal illnesses, Medicare will pay for a new class of workers to help patients manage treatments for conditions like cancer and heart failure.
The 2024 Medicare physician fee schedule includes new billing codes, including G0023, to pay for 60 minutes a month of care coordination by certified or trained auxiliary personnel working under the direction of a clinician.
A diagnosis of cancer or another serious illness takes a toll beyond the physical effects of the disease. Patients often scramble to make adjustments in family and work schedules to manage treatment, said Samyukta Mullangi, MD, MBA, medical director of oncology at Thyme Care, a Nashville, Tennessee–based firm that provides navigation and coordination services to oncology practices and insurers.
“It just really does create a bit of a pressure cooker for patients,” Dr. Mullangi told this news organization.
Medicare has for many years paid for medical professionals to help patients cope with the complexities of disease, such as chronic care management (CCM) provided by physicians, nurses, and physician assistants.
The new principal illness navigation (PIN) payments are intended to pay for work that to date typically has been done by people without medical degrees, including those involved in peer support networks and community health programs. The US Centers for Medicare and Medicaid Services(CMS) expects these navigators will undergo training and work under the supervision of clinicians.
The new navigators may coordinate care transitions between medical settings, follow up with patients after emergency department (ED) visits, or communicate with skilled nursing facilities regarding the psychosocial needs and functional deficits of a patient, among other functions.
CMS expects the new navigators may:
- Conduct assessments to understand a patient’s life story, strengths, needs, goals, preferences, and desired outcomes, including understanding cultural and linguistic factors.
- Provide support to accomplish the clinician’s treatment plan.
- Coordinate the receipt of needed services from healthcare facilities, home- and community-based service providers, and caregivers.
Peers as Navigators
The new navigators can be former patients who have undergone similar treatments for serious diseases, CMS said. This approach sets the new program apart from other care management services Medicare already covers, program officials wrote in the 2024 physician fee schedule.
“For some conditions, patients are best able to engage with the healthcare system and access care if they have assistance from a single, dedicated individual who has ‘lived experience,’ ” according to the rule.
The agency has taken a broad initial approach in defining what kinds of illnesses a patient may have to qualify for services. Patients must have a serious condition that is expected to last at least 3 months, such as cancer, heart failure, or substance use disorder.
But those without a definitive diagnosis may also qualify to receive navigator services.
In the rule, CMS cited a case in which a CT scan identified a suspicious mass in a patient’s colon. A clinician might decide this person would benefit from navigation services due to the potential risks for an undiagnosed illness.
“Regardless of the definitive diagnosis of the mass, presence of a colonic mass for that patient may be a serious high-risk condition that could, for example, cause obstruction and lead the patient to present to the emergency department, as well as be potentially indicative of an underlying life-threatening illness such as colon cancer,” CMS wrote in the rule.
Navigators often start their work when cancer patients are screened and guide them through initial diagnosis, potential surgery, radiation, or chemotherapy, said Sharon Gentry, MSN, RN, a former nurse navigator who is now the editor in chief of the Journal of the Academy of Oncology Nurse & Patient Navigators.
The navigators are meant to be a trusted and continual presence for patients, who otherwise might be left to start anew in finding help at each phase of care.
The navigators “see the whole picture. They see the whole journey the patient takes, from pre-diagnosis all the way through diagnosis care out through survival,” Ms. Gentry said.
Gaining a special Medicare payment for these kinds of services will elevate this work, she said.
Many newer drugs can target specific mechanisms and proteins of cancer. Often, oncology treatment involves testing to find out if mutations are allowing the cancer cells to evade a patient’s immune system.
Checking these biomarkers takes time, however. Patients sometimes become frustrated because they are anxious to begin treatment. Patients may receive inaccurate information from friends or family who went through treatment previously. Navigators can provide knowledge on the current state of care for a patient’s disease, helping them better manage anxieties.
“You have to explain to them that things have changed since the guy you drink coffee with was diagnosed with cancer, and there may be a drug that could target that,” Ms. Gentry said.
Potential Challenges
Initial uptake of the new PIN codes may be slow going, however, as clinicians and health systems may already use well-established codes. These include CCM and principal care management services, which may pay higher rates, Mullangi said.
“There might be sensitivity around not wanting to cannibalize existing programs with a new program,” Dr. Mullangi said.
In addition, many patients will have a copay for the services of principal illness navigators, Dr. Mullangi said.
While many patients have additional insurance that would cover the service, not all do. People with traditional Medicare coverage can sometimes pay 20% of the cost of some medical services.
“I think that may give patients pause, particularly if they’re already feeling the financial burden of a cancer treatment journey,” Dr. Mullangi said.
Pay rates for PIN services involve calculations of regional price differences, which are posted publicly by CMS, and potential added fees for services provided by hospital-affiliated organizations.
Consider payments for code G0023, covering 60 minutes of principal navigation services provided in a single month.
A set reimbursement for patients cared for in independent medical practices exists, with variation for local costs. Medicare’s non-facility price for G0023 would be $102.41 in some parts of Silicon Valley in California, including San Jose. In Arkansas, where costs are lower, reimbursement would be $73.14 for this same service.
Patients who get services covered by code G0023 in independent medical practices would have monthly copays of about $15-$20, depending on where they live.
The tab for patients tends to be higher for these same services if delivered through a medical practice owned by a hospital, as this would trigger the addition of facility fees to the payments made to cover the services. Facility fees are difficult for the public to ascertain before getting a treatment or service.
Dr. Mullangi and Ms. Gentry reported no relevant financial disclosures outside of their employers.
A version of this article first appeared on Medscape.com.
In a move that acknowledges the gauntlet the US health system poses for people facing serious and fatal illnesses, Medicare will pay for a new class of workers to help patients manage treatments for conditions like cancer and heart failure.
The 2024 Medicare physician fee schedule includes new billing codes, including G0023, to pay for 60 minutes a month of care coordination by certified or trained auxiliary personnel working under the direction of a clinician.
A diagnosis of cancer or another serious illness takes a toll beyond the physical effects of the disease. Patients often scramble to make adjustments in family and work schedules to manage treatment, said Samyukta Mullangi, MD, MBA, medical director of oncology at Thyme Care, a Nashville, Tennessee–based firm that provides navigation and coordination services to oncology practices and insurers.
“It just really does create a bit of a pressure cooker for patients,” Dr. Mullangi told this news organization.
Medicare has for many years paid for medical professionals to help patients cope with the complexities of disease, such as chronic care management (CCM) provided by physicians, nurses, and physician assistants.
The new principal illness navigation (PIN) payments are intended to pay for work that to date typically has been done by people without medical degrees, including those involved in peer support networks and community health programs. The US Centers for Medicare and Medicaid Services(CMS) expects these navigators will undergo training and work under the supervision of clinicians.
The new navigators may coordinate care transitions between medical settings, follow up with patients after emergency department (ED) visits, or communicate with skilled nursing facilities regarding the psychosocial needs and functional deficits of a patient, among other functions.
CMS expects the new navigators may:
- Conduct assessments to understand a patient’s life story, strengths, needs, goals, preferences, and desired outcomes, including understanding cultural and linguistic factors.
- Provide support to accomplish the clinician’s treatment plan.
- Coordinate the receipt of needed services from healthcare facilities, home- and community-based service providers, and caregivers.
Peers as Navigators
The new navigators can be former patients who have undergone similar treatments for serious diseases, CMS said. This approach sets the new program apart from other care management services Medicare already covers, program officials wrote in the 2024 physician fee schedule.
“For some conditions, patients are best able to engage with the healthcare system and access care if they have assistance from a single, dedicated individual who has ‘lived experience,’ ” according to the rule.
The agency has taken a broad initial approach in defining what kinds of illnesses a patient may have to qualify for services. Patients must have a serious condition that is expected to last at least 3 months, such as cancer, heart failure, or substance use disorder.
But those without a definitive diagnosis may also qualify to receive navigator services.
In the rule, CMS cited a case in which a CT scan identified a suspicious mass in a patient’s colon. A clinician might decide this person would benefit from navigation services due to the potential risks for an undiagnosed illness.
“Regardless of the definitive diagnosis of the mass, presence of a colonic mass for that patient may be a serious high-risk condition that could, for example, cause obstruction and lead the patient to present to the emergency department, as well as be potentially indicative of an underlying life-threatening illness such as colon cancer,” CMS wrote in the rule.
Navigators often start their work when cancer patients are screened and guide them through initial diagnosis, potential surgery, radiation, or chemotherapy, said Sharon Gentry, MSN, RN, a former nurse navigator who is now the editor in chief of the Journal of the Academy of Oncology Nurse & Patient Navigators.
The navigators are meant to be a trusted and continual presence for patients, who otherwise might be left to start anew in finding help at each phase of care.
The navigators “see the whole picture. They see the whole journey the patient takes, from pre-diagnosis all the way through diagnosis care out through survival,” Ms. Gentry said.
Gaining a special Medicare payment for these kinds of services will elevate this work, she said.
Many newer drugs can target specific mechanisms and proteins of cancer. Often, oncology treatment involves testing to find out if mutations are allowing the cancer cells to evade a patient’s immune system.
Checking these biomarkers takes time, however. Patients sometimes become frustrated because they are anxious to begin treatment. Patients may receive inaccurate information from friends or family who went through treatment previously. Navigators can provide knowledge on the current state of care for a patient’s disease, helping them better manage anxieties.
“You have to explain to them that things have changed since the guy you drink coffee with was diagnosed with cancer, and there may be a drug that could target that,” Ms. Gentry said.
Potential Challenges
Initial uptake of the new PIN codes may be slow going, however, as clinicians and health systems may already use well-established codes. These include CCM and principal care management services, which may pay higher rates, Mullangi said.
“There might be sensitivity around not wanting to cannibalize existing programs with a new program,” Dr. Mullangi said.
In addition, many patients will have a copay for the services of principal illness navigators, Dr. Mullangi said.
While many patients have additional insurance that would cover the service, not all do. People with traditional Medicare coverage can sometimes pay 20% of the cost of some medical services.
“I think that may give patients pause, particularly if they’re already feeling the financial burden of a cancer treatment journey,” Dr. Mullangi said.
Pay rates for PIN services involve calculations of regional price differences, which are posted publicly by CMS, and potential added fees for services provided by hospital-affiliated organizations.
Consider payments for code G0023, covering 60 minutes of principal navigation services provided in a single month.
A set reimbursement for patients cared for in independent medical practices exists, with variation for local costs. Medicare’s non-facility price for G0023 would be $102.41 in some parts of Silicon Valley in California, including San Jose. In Arkansas, where costs are lower, reimbursement would be $73.14 for this same service.
Patients who get services covered by code G0023 in independent medical practices would have monthly copays of about $15-$20, depending on where they live.
The tab for patients tends to be higher for these same services if delivered through a medical practice owned by a hospital, as this would trigger the addition of facility fees to the payments made to cover the services. Facility fees are difficult for the public to ascertain before getting a treatment or service.
Dr. Mullangi and Ms. Gentry reported no relevant financial disclosures outside of their employers.
A version of this article first appeared on Medscape.com.
In a move that acknowledges the gauntlet the US health system poses for people facing serious and fatal illnesses, Medicare will pay for a new class of workers to help patients manage treatments for conditions like cancer and heart failure.
The 2024 Medicare physician fee schedule includes new billing codes, including G0023, to pay for 60 minutes a month of care coordination by certified or trained auxiliary personnel working under the direction of a clinician.
A diagnosis of cancer or another serious illness takes a toll beyond the physical effects of the disease. Patients often scramble to make adjustments in family and work schedules to manage treatment, said Samyukta Mullangi, MD, MBA, medical director of oncology at Thyme Care, a Nashville, Tennessee–based firm that provides navigation and coordination services to oncology practices and insurers.
“It just really does create a bit of a pressure cooker for patients,” Dr. Mullangi told this news organization.
Medicare has for many years paid for medical professionals to help patients cope with the complexities of disease, such as chronic care management (CCM) provided by physicians, nurses, and physician assistants.
The new principal illness navigation (PIN) payments are intended to pay for work that to date typically has been done by people without medical degrees, including those involved in peer support networks and community health programs. The US Centers for Medicare and Medicaid Services(CMS) expects these navigators will undergo training and work under the supervision of clinicians.
The new navigators may coordinate care transitions between medical settings, follow up with patients after emergency department (ED) visits, or communicate with skilled nursing facilities regarding the psychosocial needs and functional deficits of a patient, among other functions.
CMS expects the new navigators may:
- Conduct assessments to understand a patient’s life story, strengths, needs, goals, preferences, and desired outcomes, including understanding cultural and linguistic factors.
- Provide support to accomplish the clinician’s treatment plan.
- Coordinate the receipt of needed services from healthcare facilities, home- and community-based service providers, and caregivers.
Peers as Navigators
The new navigators can be former patients who have undergone similar treatments for serious diseases, CMS said. This approach sets the new program apart from other care management services Medicare already covers, program officials wrote in the 2024 physician fee schedule.
“For some conditions, patients are best able to engage with the healthcare system and access care if they have assistance from a single, dedicated individual who has ‘lived experience,’ ” according to the rule.
The agency has taken a broad initial approach in defining what kinds of illnesses a patient may have to qualify for services. Patients must have a serious condition that is expected to last at least 3 months, such as cancer, heart failure, or substance use disorder.
But those without a definitive diagnosis may also qualify to receive navigator services.
In the rule, CMS cited a case in which a CT scan identified a suspicious mass in a patient’s colon. A clinician might decide this person would benefit from navigation services due to the potential risks for an undiagnosed illness.
“Regardless of the definitive diagnosis of the mass, presence of a colonic mass for that patient may be a serious high-risk condition that could, for example, cause obstruction and lead the patient to present to the emergency department, as well as be potentially indicative of an underlying life-threatening illness such as colon cancer,” CMS wrote in the rule.
Navigators often start their work when cancer patients are screened and guide them through initial diagnosis, potential surgery, radiation, or chemotherapy, said Sharon Gentry, MSN, RN, a former nurse navigator who is now the editor in chief of the Journal of the Academy of Oncology Nurse & Patient Navigators.
The navigators are meant to be a trusted and continual presence for patients, who otherwise might be left to start anew in finding help at each phase of care.
The navigators “see the whole picture. They see the whole journey the patient takes, from pre-diagnosis all the way through diagnosis care out through survival,” Ms. Gentry said.
Gaining a special Medicare payment for these kinds of services will elevate this work, she said.
Many newer drugs can target specific mechanisms and proteins of cancer. Often, oncology treatment involves testing to find out if mutations are allowing the cancer cells to evade a patient’s immune system.
Checking these biomarkers takes time, however. Patients sometimes become frustrated because they are anxious to begin treatment. Patients may receive inaccurate information from friends or family who went through treatment previously. Navigators can provide knowledge on the current state of care for a patient’s disease, helping them better manage anxieties.
“You have to explain to them that things have changed since the guy you drink coffee with was diagnosed with cancer, and there may be a drug that could target that,” Ms. Gentry said.
Potential Challenges
Initial uptake of the new PIN codes may be slow going, however, as clinicians and health systems may already use well-established codes. These include CCM and principal care management services, which may pay higher rates, Mullangi said.
“There might be sensitivity around not wanting to cannibalize existing programs with a new program,” Dr. Mullangi said.
In addition, many patients will have a copay for the services of principal illness navigators, Dr. Mullangi said.
While many patients have additional insurance that would cover the service, not all do. People with traditional Medicare coverage can sometimes pay 20% of the cost of some medical services.
“I think that may give patients pause, particularly if they’re already feeling the financial burden of a cancer treatment journey,” Dr. Mullangi said.
Pay rates for PIN services involve calculations of regional price differences, which are posted publicly by CMS, and potential added fees for services provided by hospital-affiliated organizations.
Consider payments for code G0023, covering 60 minutes of principal navigation services provided in a single month.
A set reimbursement for patients cared for in independent medical practices exists, with variation for local costs. Medicare’s non-facility price for G0023 would be $102.41 in some parts of Silicon Valley in California, including San Jose. In Arkansas, where costs are lower, reimbursement would be $73.14 for this same service.
Patients who get services covered by code G0023 in independent medical practices would have monthly copays of about $15-$20, depending on where they live.
The tab for patients tends to be higher for these same services if delivered through a medical practice owned by a hospital, as this would trigger the addition of facility fees to the payments made to cover the services. Facility fees are difficult for the public to ascertain before getting a treatment or service.
Dr. Mullangi and Ms. Gentry reported no relevant financial disclosures outside of their employers.
A version of this article first appeared on Medscape.com.
SVS Now Accepting Abstracts for VAM 2017
Abstracts for the 2017 Vascular Annual Meeting are now being accepted. The submission site opened Monday, Nov. 14 for the meeting, to be held May 31 to June 3, 2017, in San Diego. Plenary sessions and exhibits will be June 1 to 3.
Participants may submit abstracts into any of 14 categories and a number of presentation types, including videos. In 2016, organizers selected approximately two-thirds of the submitted abstracts, and this year the VAM Program Committee is seeking additional venues for people to present their work in, including more sessions and other presentation formats.
Click here for abstract guidelines and more information. Abstracts themselves may be submitted here.
Abstracts for the 2017 Vascular Annual Meeting are now being accepted. The submission site opened Monday, Nov. 14 for the meeting, to be held May 31 to June 3, 2017, in San Diego. Plenary sessions and exhibits will be June 1 to 3.
Participants may submit abstracts into any of 14 categories and a number of presentation types, including videos. In 2016, organizers selected approximately two-thirds of the submitted abstracts, and this year the VAM Program Committee is seeking additional venues for people to present their work in, including more sessions and other presentation formats.
Click here for abstract guidelines and more information. Abstracts themselves may be submitted here.
Abstracts for the 2017 Vascular Annual Meeting are now being accepted. The submission site opened Monday, Nov. 14 for the meeting, to be held May 31 to June 3, 2017, in San Diego. Plenary sessions and exhibits will be June 1 to 3.
Participants may submit abstracts into any of 14 categories and a number of presentation types, including videos. In 2016, organizers selected approximately two-thirds of the submitted abstracts, and this year the VAM Program Committee is seeking additional venues for people to present their work in, including more sessions and other presentation formats.
Click here for abstract guidelines and more information. Abstracts themselves may be submitted here.
Atypical Antipsychotics Tied to Adrenal Issues
NEW ORLEANS — It is important to recognize the potential for atypical antipsychotics to cause adrenal insufficiency to ensure that the condition is managed appropriately, according to Dr. Violeta Tan and Dr. Natalie Rasgon.
They described the case of a 54-year-old man with a history of depression and posttraumatic stress disorder who was admitted to the hospital after complaining of malaise 9 days after a previous admission for a urinary tract infection that had been treated with ciprofloxacin.
At the first admission, the patient was restarted on 225 mg/day of bupropion and 300 mg/day of quetiapine (Seroquel), both of which he had discontinued 6–8 months prior, said Dr. Tan and Dr. Rasgon, who presented the case in a poster session at the American Psychiatric Association's Institute of Psychiatric Services.
Symptoms at the time of the second admission included fatigue, warmth, chills, loose stools, mild headache, and reproducible chest wall pain. Laboratory findings showed that previously normal eosinophil levels were elevated (6.5%–8.3%), reported Dr. Tan and Dr. Rasgon, both of Stanford (Calif.) University.
A work-up for infection, malignancy, and rheumatologic conditions was negative, and primary adrenal insufficiency was ruled out based on the findings of a cosyntropin stimulation test. However, adrenocorticotropic hormone (ACTH) levels (less than 5 pg/mL) indicated secondary or tertiary adrenal insufficiency, and a review of the patient's medications alerted the authors to the possibility of quetiapine-associated ACTH and cortisol reductions.
Atypical antipsychotics such as quetiapine can reduce cortisol levels—often in association with improved psychopathology. Thus, although the cortisol-lowering effects of such drugs may ameliorate negative symptomatology, the reduction could be detrimental, they wrote.
However, adrenal insufficiency caused by such agents has not been specifically studied, and although it might seem appropriate to discontinue the “offending agent,” the risks of discontinuing antipsychotics should be weighed against the benefits of preventing adrenal insufficiency sequelae, they added.
In the current case, which also demonstrated that quetiapine administration, particularly under precipitating circumstances such as an infection or stress, can contribute to reductions in ACTH and cortisol secretion, the patient's condition improved after quetiapine, a standard treatment for adrenal insufficiency, was administered at 20 mg every morning and at 10 mg at bedtime.
Atypical antipsychotics can cause adrenal insufficiency, which presents ambiguously, and awareness of this can be key in preventing false diagnoses, they said.
Adrenal insufficiency can present ambiguously, which can lead to false diagnoses. DR. RASGON
Spotting Adrenal Insufficiency
Dr. Tan and Dr. Rasgon say determining whether a patient has developed adrenal insufficiency requires an investigation into four areas:
▸ Symptoms. Look for weakness and fatigue, abdominal distress, anorexia, nausea, vomiting, myalgia or arthralgia, postural dizziness, salt craving, headache, impaired memory, and depression.
▸ Physical findings. Some factors to look out for are increased pigmentation, postural hypotension, tachycardia, fever, decreased body hair, vitiligo, amenorrhea, and cold intolerance.
▸ Laboratory findings. Red flags include hyponatremia, hyperkalemia, hypoglycemia, eosinophilia, and elevated thyroid stimulating hormone.
▸ Clinical problems. Watch for hemodynamic instability, ongoing inflammation, multiple-organ dysfunction, and hypoglycemia.
NEW ORLEANS — It is important to recognize the potential for atypical antipsychotics to cause adrenal insufficiency to ensure that the condition is managed appropriately, according to Dr. Violeta Tan and Dr. Natalie Rasgon.
They described the case of a 54-year-old man with a history of depression and posttraumatic stress disorder who was admitted to the hospital after complaining of malaise 9 days after a previous admission for a urinary tract infection that had been treated with ciprofloxacin.
At the first admission, the patient was restarted on 225 mg/day of bupropion and 300 mg/day of quetiapine (Seroquel), both of which he had discontinued 6–8 months prior, said Dr. Tan and Dr. Rasgon, who presented the case in a poster session at the American Psychiatric Association's Institute of Psychiatric Services.
Symptoms at the time of the second admission included fatigue, warmth, chills, loose stools, mild headache, and reproducible chest wall pain. Laboratory findings showed that previously normal eosinophil levels were elevated (6.5%–8.3%), reported Dr. Tan and Dr. Rasgon, both of Stanford (Calif.) University.
A work-up for infection, malignancy, and rheumatologic conditions was negative, and primary adrenal insufficiency was ruled out based on the findings of a cosyntropin stimulation test. However, adrenocorticotropic hormone (ACTH) levels (less than 5 pg/mL) indicated secondary or tertiary adrenal insufficiency, and a review of the patient's medications alerted the authors to the possibility of quetiapine-associated ACTH and cortisol reductions.
Atypical antipsychotics such as quetiapine can reduce cortisol levels—often in association with improved psychopathology. Thus, although the cortisol-lowering effects of such drugs may ameliorate negative symptomatology, the reduction could be detrimental, they wrote.
However, adrenal insufficiency caused by such agents has not been specifically studied, and although it might seem appropriate to discontinue the “offending agent,” the risks of discontinuing antipsychotics should be weighed against the benefits of preventing adrenal insufficiency sequelae, they added.
In the current case, which also demonstrated that quetiapine administration, particularly under precipitating circumstances such as an infection or stress, can contribute to reductions in ACTH and cortisol secretion, the patient's condition improved after quetiapine, a standard treatment for adrenal insufficiency, was administered at 20 mg every morning and at 10 mg at bedtime.
Atypical antipsychotics can cause adrenal insufficiency, which presents ambiguously, and awareness of this can be key in preventing false diagnoses, they said.
Adrenal insufficiency can present ambiguously, which can lead to false diagnoses. DR. RASGON
Spotting Adrenal Insufficiency
Dr. Tan and Dr. Rasgon say determining whether a patient has developed adrenal insufficiency requires an investigation into four areas:
▸ Symptoms. Look for weakness and fatigue, abdominal distress, anorexia, nausea, vomiting, myalgia or arthralgia, postural dizziness, salt craving, headache, impaired memory, and depression.
▸ Physical findings. Some factors to look out for are increased pigmentation, postural hypotension, tachycardia, fever, decreased body hair, vitiligo, amenorrhea, and cold intolerance.
▸ Laboratory findings. Red flags include hyponatremia, hyperkalemia, hypoglycemia, eosinophilia, and elevated thyroid stimulating hormone.
▸ Clinical problems. Watch for hemodynamic instability, ongoing inflammation, multiple-organ dysfunction, and hypoglycemia.
NEW ORLEANS — It is important to recognize the potential for atypical antipsychotics to cause adrenal insufficiency to ensure that the condition is managed appropriately, according to Dr. Violeta Tan and Dr. Natalie Rasgon.
They described the case of a 54-year-old man with a history of depression and posttraumatic stress disorder who was admitted to the hospital after complaining of malaise 9 days after a previous admission for a urinary tract infection that had been treated with ciprofloxacin.
At the first admission, the patient was restarted on 225 mg/day of bupropion and 300 mg/day of quetiapine (Seroquel), both of which he had discontinued 6–8 months prior, said Dr. Tan and Dr. Rasgon, who presented the case in a poster session at the American Psychiatric Association's Institute of Psychiatric Services.
Symptoms at the time of the second admission included fatigue, warmth, chills, loose stools, mild headache, and reproducible chest wall pain. Laboratory findings showed that previously normal eosinophil levels were elevated (6.5%–8.3%), reported Dr. Tan and Dr. Rasgon, both of Stanford (Calif.) University.
A work-up for infection, malignancy, and rheumatologic conditions was negative, and primary adrenal insufficiency was ruled out based on the findings of a cosyntropin stimulation test. However, adrenocorticotropic hormone (ACTH) levels (less than 5 pg/mL) indicated secondary or tertiary adrenal insufficiency, and a review of the patient's medications alerted the authors to the possibility of quetiapine-associated ACTH and cortisol reductions.
Atypical antipsychotics such as quetiapine can reduce cortisol levels—often in association with improved psychopathology. Thus, although the cortisol-lowering effects of such drugs may ameliorate negative symptomatology, the reduction could be detrimental, they wrote.
However, adrenal insufficiency caused by such agents has not been specifically studied, and although it might seem appropriate to discontinue the “offending agent,” the risks of discontinuing antipsychotics should be weighed against the benefits of preventing adrenal insufficiency sequelae, they added.
In the current case, which also demonstrated that quetiapine administration, particularly under precipitating circumstances such as an infection or stress, can contribute to reductions in ACTH and cortisol secretion, the patient's condition improved after quetiapine, a standard treatment for adrenal insufficiency, was administered at 20 mg every morning and at 10 mg at bedtime.
Atypical antipsychotics can cause adrenal insufficiency, which presents ambiguously, and awareness of this can be key in preventing false diagnoses, they said.
Adrenal insufficiency can present ambiguously, which can lead to false diagnoses. DR. RASGON
Spotting Adrenal Insufficiency
Dr. Tan and Dr. Rasgon say determining whether a patient has developed adrenal insufficiency requires an investigation into four areas:
▸ Symptoms. Look for weakness and fatigue, abdominal distress, anorexia, nausea, vomiting, myalgia or arthralgia, postural dizziness, salt craving, headache, impaired memory, and depression.
▸ Physical findings. Some factors to look out for are increased pigmentation, postural hypotension, tachycardia, fever, decreased body hair, vitiligo, amenorrhea, and cold intolerance.
▸ Laboratory findings. Red flags include hyponatremia, hyperkalemia, hypoglycemia, eosinophilia, and elevated thyroid stimulating hormone.
▸ Clinical problems. Watch for hemodynamic instability, ongoing inflammation, multiple-organ dysfunction, and hypoglycemia.
Updated Crohn’s Disease Guideline Stresses Early Use of Advanced Drugs
As the science of Crohn’s disease (CD) rapidly evolves,
The guideline was published in Gastroenterology by an expert panel chaired by Frank I. Scott, MD, MSCE, a gastroenterologist at the Crohn’s and Colitis Center in the Division of Gastroenterology and Hepatology at the University of Colorado Anschutz School of Medicine in Aurora, Colorado.
It makes 16 main recommendations in a comprehensive, patient-centered, evidence-based approach to utilizing an array of medical options endorsing early use of advanced therapies such as biologics. Of these, one is a strong recommendation, nine are conditional recommendations, and six are identified as knowledge gaps.
“There’s been a significant increase in the number of therapies available for clinicians and patients when considering treatment options for moderate-to-severe [CD] since the prior guidelines in 2021,” Scott told GI & Hepatology News. “We hope these guidelines will help clinicians determine how to maximize the potential benefit of the full armamentarium of therapies available to treat this disease.”
Guideline co-author Siddharth Singh, MD, MS, of the Division of Gastroenterology and Hepatology at the Mayo Clinic Arizona in Scottsdale, Arizona, said the goal of the guideline is to translate evidence into clear, meaningful recommendations for frontline clinicians. “It’s patient centered but also provider centric. We want to help physicians and advanced practice providers make timely, actionable decisions for their patients.”
Among the recommendations:
- Early initiation of high-efficacy advanced therapy to prevent progression is recommended over insurance-driven step therapy.
- For adult patients naive to advanced therapies, the AGA recommends infliximab, adalimumab, ustekinumab, risankizumab, mirikizumab, guselkumab, or upadacitinib over no treatment and suggests the use of certolizumab pegol or vedolizumab over no treatment.
- For adults naive to advanced therapies, the AGA suggests using a higher-efficacy medication (infliximab, adalimumab, vedolizumab, ustekinumab, risankizumab, mirikizumab, or guselkumab) rather than a lower-efficacy option (certolizumab pegol or upadacitinib).
- For those previously exposed to one or more advanced therapies, the AGA suggests a higher-efficacy medication (adalimumab, risankizumab, guselkumab, or upadacitinib) or an intermediate-efficacy medication (ustekinumab or mirikizumab) rather than a lower-efficacy medication (vedolizumab or certolizumab pegol).
- For adult outpatients, the AGA suggests against thiopurine monotherapy for induction of remission but suggests thiopurine monotherapy over no treatment for maintenance of (typically corticosteroid-induced) remission.
- The guideline favors subcutaneous methotrexate for induction and maintenance of remission but suggests against oral methotrexate.
- Combination therapy with infliximab and thiopurines is suggested over infliximab monotherapy, particularly in those naive to thiopurines.
“We identified several critical knowledge gaps, including the role of combination therapy for non-[TNF] biologics, as well as whether targeting endoscopic remission as opposed to clinical remission yields additional benefit,” Scott said.
Most of the panel’s time was spent considering evidence and recommendations in relation to how therapies should be positioned among each other in light of patients’ treatment history. “For those who were advanced therapy-naive, we used two groups, or ‘buckets’: higher and lower efficacy,” Scott said. “For advanced therapy-exposed individuals, we used higher, intermediate, and lower buckets, recommending the use of higher- or intermediate-efficacy medications.” Network meta-analyses were done to determine which therapies belong in which categories.
Perhaps the most unexpected outcome from the panel’s review was the inability to make a recommendation on treating to a target of mucosal healing. “This target conceptually makes sense, but prospective clinical trial data supporting this approach over targeting clinical remission unfortunately are currently limited,” Scott said. Several ongoing clinical trials are assessing this endpoint. “We hope future versions of these guidelines can make a formal recommendation regarding targeting mucosal healing. The benefit of our living guideline approach is that as these data become available, we will be able incorporate them more rapidly.”
Offering a nonparticipant’s perspective on the living, updatable guideline, Ahmed Hassan Gemei, MD, a gastroenterologist at Northwell North Shore University Hospital in Manhasset, New York, said the update was needed because of the shifting therapeutic landscape.
“As great as that is for patient care, it can be daunting for gastroenterologists to keep up with the onslaught of evidence and growing repertoire of advanced therapies,” he told GI & Hepatology News. “For a rapidly evolving field like inflammatory bowel disease, having a guideline come out once every 3-5 years can lag behind the evidence significantly. There is something special and much needed about a living guideline that gets regularly updated as newer data come out, which we have come to appreciate with the AGA living guidelines for ulcerative colitis.”
As to facilitating clinical decision-making, Gemei added, “It does a great job at summarizing the available evidence, making life easier for gastroenterologists who are trying to make evidence-based decisions for their patients. But having a straightforward algorithmic approach to the management of [CD] is ultimately limited by patient-specific differences and patient and payor preferences, as well as gaps in the data such as comparative effectiveness, sequencing of therapy, and advanced dual therapies.”
When it comes to choosing a drug, for example, gastroenterologists are given a general overview of which ones have higher or lower efficacy, but the choice depends on multiple factors, including CD phenotype, previous medications, and patient preference with regard to relative safety, as well as payor preference (although clinicians often try to influence this).
The guidelines align broadly but with some differences with other societal guidelines in the US and Europe. But, said Gemei, the absence of a recommendation for or against treating to a target of endoscopic healing was surprising. “This has been standard practice in recent years based on the updated STRIDE [Selecting Therapeutic Targets in Inflammatory Bowel Disease] consensus statements, as well as recent American College of Gastroenterology guidelines. Though I understand the reason behind this decision, which was simply lack of strong data, it’s still a departure from other society recommendations and current practice. I doubt this will change how we manage our patient, though, and luckily, this is a living guideline, so as more data come out, we should see an update in this area.”
He noted that despite this and other guidelines recommending against the use of 5-aminosalicylic acids in CD, “we still see many of our colleagues using it for their [CD] patients. Hopefully, this guideline can be a helpful resource for everyone trying to update their practice.”
Gemei agreed with the authors that there are persistent knowledge gaps, including insufficient data from head-to-head effectiveness studies, optimal biologic sequencing after failure, advanced combination therapy (such as JAK inhibitors plus anti-interleukin-23), radiologic and endoscopic disease monitoring intervals, and therapy withdrawal strategies after long-term remission. “So there’s a lot we still need to understand better,” he said. “Until we have more data and guidance, we are still practicing all these things based on the available evidence as well as local practice patterns.”
Overall, said Scott, the guidance highlights the options with the best supporting evidence while incorporating the patient’s prior treatment journey. “It’s also important to emphasize that treatment decisions should be individualized and should involve shared decision-making among providers and their patients,” he added. “Patient preferences, age, active comorbidities, and pregnancy should always be considered when selecting the appropriate treatment plan.”
All funding for this guidance was supplied by AGA. The guideline chairs had no conflicts of interest, and fewer than 50% of guideline panel members had conflicts of interest. Gemei had no conflicts of interest.
A version of this article appeared on Medscape.com.
As the science of Crohn’s disease (CD) rapidly evolves,
The guideline was published in Gastroenterology by an expert panel chaired by Frank I. Scott, MD, MSCE, a gastroenterologist at the Crohn’s and Colitis Center in the Division of Gastroenterology and Hepatology at the University of Colorado Anschutz School of Medicine in Aurora, Colorado.
It makes 16 main recommendations in a comprehensive, patient-centered, evidence-based approach to utilizing an array of medical options endorsing early use of advanced therapies such as biologics. Of these, one is a strong recommendation, nine are conditional recommendations, and six are identified as knowledge gaps.
“There’s been a significant increase in the number of therapies available for clinicians and patients when considering treatment options for moderate-to-severe [CD] since the prior guidelines in 2021,” Scott told GI & Hepatology News. “We hope these guidelines will help clinicians determine how to maximize the potential benefit of the full armamentarium of therapies available to treat this disease.”
Guideline co-author Siddharth Singh, MD, MS, of the Division of Gastroenterology and Hepatology at the Mayo Clinic Arizona in Scottsdale, Arizona, said the goal of the guideline is to translate evidence into clear, meaningful recommendations for frontline clinicians. “It’s patient centered but also provider centric. We want to help physicians and advanced practice providers make timely, actionable decisions for their patients.”
Among the recommendations:
- Early initiation of high-efficacy advanced therapy to prevent progression is recommended over insurance-driven step therapy.
- For adult patients naive to advanced therapies, the AGA recommends infliximab, adalimumab, ustekinumab, risankizumab, mirikizumab, guselkumab, or upadacitinib over no treatment and suggests the use of certolizumab pegol or vedolizumab over no treatment.
- For adults naive to advanced therapies, the AGA suggests using a higher-efficacy medication (infliximab, adalimumab, vedolizumab, ustekinumab, risankizumab, mirikizumab, or guselkumab) rather than a lower-efficacy option (certolizumab pegol or upadacitinib).
- For those previously exposed to one or more advanced therapies, the AGA suggests a higher-efficacy medication (adalimumab, risankizumab, guselkumab, or upadacitinib) or an intermediate-efficacy medication (ustekinumab or mirikizumab) rather than a lower-efficacy medication (vedolizumab or certolizumab pegol).
- For adult outpatients, the AGA suggests against thiopurine monotherapy for induction of remission but suggests thiopurine monotherapy over no treatment for maintenance of (typically corticosteroid-induced) remission.
- The guideline favors subcutaneous methotrexate for induction and maintenance of remission but suggests against oral methotrexate.
- Combination therapy with infliximab and thiopurines is suggested over infliximab monotherapy, particularly in those naive to thiopurines.
“We identified several critical knowledge gaps, including the role of combination therapy for non-[TNF] biologics, as well as whether targeting endoscopic remission as opposed to clinical remission yields additional benefit,” Scott said.
Most of the panel’s time was spent considering evidence and recommendations in relation to how therapies should be positioned among each other in light of patients’ treatment history. “For those who were advanced therapy-naive, we used two groups, or ‘buckets’: higher and lower efficacy,” Scott said. “For advanced therapy-exposed individuals, we used higher, intermediate, and lower buckets, recommending the use of higher- or intermediate-efficacy medications.” Network meta-analyses were done to determine which therapies belong in which categories.
Perhaps the most unexpected outcome from the panel’s review was the inability to make a recommendation on treating to a target of mucosal healing. “This target conceptually makes sense, but prospective clinical trial data supporting this approach over targeting clinical remission unfortunately are currently limited,” Scott said. Several ongoing clinical trials are assessing this endpoint. “We hope future versions of these guidelines can make a formal recommendation regarding targeting mucosal healing. The benefit of our living guideline approach is that as these data become available, we will be able incorporate them more rapidly.”
Offering a nonparticipant’s perspective on the living, updatable guideline, Ahmed Hassan Gemei, MD, a gastroenterologist at Northwell North Shore University Hospital in Manhasset, New York, said the update was needed because of the shifting therapeutic landscape.
“As great as that is for patient care, it can be daunting for gastroenterologists to keep up with the onslaught of evidence and growing repertoire of advanced therapies,” he told GI & Hepatology News. “For a rapidly evolving field like inflammatory bowel disease, having a guideline come out once every 3-5 years can lag behind the evidence significantly. There is something special and much needed about a living guideline that gets regularly updated as newer data come out, which we have come to appreciate with the AGA living guidelines for ulcerative colitis.”
As to facilitating clinical decision-making, Gemei added, “It does a great job at summarizing the available evidence, making life easier for gastroenterologists who are trying to make evidence-based decisions for their patients. But having a straightforward algorithmic approach to the management of [CD] is ultimately limited by patient-specific differences and patient and payor preferences, as well as gaps in the data such as comparative effectiveness, sequencing of therapy, and advanced dual therapies.”
When it comes to choosing a drug, for example, gastroenterologists are given a general overview of which ones have higher or lower efficacy, but the choice depends on multiple factors, including CD phenotype, previous medications, and patient preference with regard to relative safety, as well as payor preference (although clinicians often try to influence this).
The guidelines align broadly but with some differences with other societal guidelines in the US and Europe. But, said Gemei, the absence of a recommendation for or against treating to a target of endoscopic healing was surprising. “This has been standard practice in recent years based on the updated STRIDE [Selecting Therapeutic Targets in Inflammatory Bowel Disease] consensus statements, as well as recent American College of Gastroenterology guidelines. Though I understand the reason behind this decision, which was simply lack of strong data, it’s still a departure from other society recommendations and current practice. I doubt this will change how we manage our patient, though, and luckily, this is a living guideline, so as more data come out, we should see an update in this area.”
He noted that despite this and other guidelines recommending against the use of 5-aminosalicylic acids in CD, “we still see many of our colleagues using it for their [CD] patients. Hopefully, this guideline can be a helpful resource for everyone trying to update their practice.”
Gemei agreed with the authors that there are persistent knowledge gaps, including insufficient data from head-to-head effectiveness studies, optimal biologic sequencing after failure, advanced combination therapy (such as JAK inhibitors plus anti-interleukin-23), radiologic and endoscopic disease monitoring intervals, and therapy withdrawal strategies after long-term remission. “So there’s a lot we still need to understand better,” he said. “Until we have more data and guidance, we are still practicing all these things based on the available evidence as well as local practice patterns.”
Overall, said Scott, the guidance highlights the options with the best supporting evidence while incorporating the patient’s prior treatment journey. “It’s also important to emphasize that treatment decisions should be individualized and should involve shared decision-making among providers and their patients,” he added. “Patient preferences, age, active comorbidities, and pregnancy should always be considered when selecting the appropriate treatment plan.”
All funding for this guidance was supplied by AGA. The guideline chairs had no conflicts of interest, and fewer than 50% of guideline panel members had conflicts of interest. Gemei had no conflicts of interest.
A version of this article appeared on Medscape.com.
As the science of Crohn’s disease (CD) rapidly evolves,
The guideline was published in Gastroenterology by an expert panel chaired by Frank I. Scott, MD, MSCE, a gastroenterologist at the Crohn’s and Colitis Center in the Division of Gastroenterology and Hepatology at the University of Colorado Anschutz School of Medicine in Aurora, Colorado.
It makes 16 main recommendations in a comprehensive, patient-centered, evidence-based approach to utilizing an array of medical options endorsing early use of advanced therapies such as biologics. Of these, one is a strong recommendation, nine are conditional recommendations, and six are identified as knowledge gaps.
“There’s been a significant increase in the number of therapies available for clinicians and patients when considering treatment options for moderate-to-severe [CD] since the prior guidelines in 2021,” Scott told GI & Hepatology News. “We hope these guidelines will help clinicians determine how to maximize the potential benefit of the full armamentarium of therapies available to treat this disease.”
Guideline co-author Siddharth Singh, MD, MS, of the Division of Gastroenterology and Hepatology at the Mayo Clinic Arizona in Scottsdale, Arizona, said the goal of the guideline is to translate evidence into clear, meaningful recommendations for frontline clinicians. “It’s patient centered but also provider centric. We want to help physicians and advanced practice providers make timely, actionable decisions for their patients.”
Among the recommendations:
- Early initiation of high-efficacy advanced therapy to prevent progression is recommended over insurance-driven step therapy.
- For adult patients naive to advanced therapies, the AGA recommends infliximab, adalimumab, ustekinumab, risankizumab, mirikizumab, guselkumab, or upadacitinib over no treatment and suggests the use of certolizumab pegol or vedolizumab over no treatment.
- For adults naive to advanced therapies, the AGA suggests using a higher-efficacy medication (infliximab, adalimumab, vedolizumab, ustekinumab, risankizumab, mirikizumab, or guselkumab) rather than a lower-efficacy option (certolizumab pegol or upadacitinib).
- For those previously exposed to one or more advanced therapies, the AGA suggests a higher-efficacy medication (adalimumab, risankizumab, guselkumab, or upadacitinib) or an intermediate-efficacy medication (ustekinumab or mirikizumab) rather than a lower-efficacy medication (vedolizumab or certolizumab pegol).
- For adult outpatients, the AGA suggests against thiopurine monotherapy for induction of remission but suggests thiopurine monotherapy over no treatment for maintenance of (typically corticosteroid-induced) remission.
- The guideline favors subcutaneous methotrexate for induction and maintenance of remission but suggests against oral methotrexate.
- Combination therapy with infliximab and thiopurines is suggested over infliximab monotherapy, particularly in those naive to thiopurines.
“We identified several critical knowledge gaps, including the role of combination therapy for non-[TNF] biologics, as well as whether targeting endoscopic remission as opposed to clinical remission yields additional benefit,” Scott said.
Most of the panel’s time was spent considering evidence and recommendations in relation to how therapies should be positioned among each other in light of patients’ treatment history. “For those who were advanced therapy-naive, we used two groups, or ‘buckets’: higher and lower efficacy,” Scott said. “For advanced therapy-exposed individuals, we used higher, intermediate, and lower buckets, recommending the use of higher- or intermediate-efficacy medications.” Network meta-analyses were done to determine which therapies belong in which categories.
Perhaps the most unexpected outcome from the panel’s review was the inability to make a recommendation on treating to a target of mucosal healing. “This target conceptually makes sense, but prospective clinical trial data supporting this approach over targeting clinical remission unfortunately are currently limited,” Scott said. Several ongoing clinical trials are assessing this endpoint. “We hope future versions of these guidelines can make a formal recommendation regarding targeting mucosal healing. The benefit of our living guideline approach is that as these data become available, we will be able incorporate them more rapidly.”
Offering a nonparticipant’s perspective on the living, updatable guideline, Ahmed Hassan Gemei, MD, a gastroenterologist at Northwell North Shore University Hospital in Manhasset, New York, said the update was needed because of the shifting therapeutic landscape.
“As great as that is for patient care, it can be daunting for gastroenterologists to keep up with the onslaught of evidence and growing repertoire of advanced therapies,” he told GI & Hepatology News. “For a rapidly evolving field like inflammatory bowel disease, having a guideline come out once every 3-5 years can lag behind the evidence significantly. There is something special and much needed about a living guideline that gets regularly updated as newer data come out, which we have come to appreciate with the AGA living guidelines for ulcerative colitis.”
As to facilitating clinical decision-making, Gemei added, “It does a great job at summarizing the available evidence, making life easier for gastroenterologists who are trying to make evidence-based decisions for their patients. But having a straightforward algorithmic approach to the management of [CD] is ultimately limited by patient-specific differences and patient and payor preferences, as well as gaps in the data such as comparative effectiveness, sequencing of therapy, and advanced dual therapies.”
When it comes to choosing a drug, for example, gastroenterologists are given a general overview of which ones have higher or lower efficacy, but the choice depends on multiple factors, including CD phenotype, previous medications, and patient preference with regard to relative safety, as well as payor preference (although clinicians often try to influence this).
The guidelines align broadly but with some differences with other societal guidelines in the US and Europe. But, said Gemei, the absence of a recommendation for or against treating to a target of endoscopic healing was surprising. “This has been standard practice in recent years based on the updated STRIDE [Selecting Therapeutic Targets in Inflammatory Bowel Disease] consensus statements, as well as recent American College of Gastroenterology guidelines. Though I understand the reason behind this decision, which was simply lack of strong data, it’s still a departure from other society recommendations and current practice. I doubt this will change how we manage our patient, though, and luckily, this is a living guideline, so as more data come out, we should see an update in this area.”
He noted that despite this and other guidelines recommending against the use of 5-aminosalicylic acids in CD, “we still see many of our colleagues using it for their [CD] patients. Hopefully, this guideline can be a helpful resource for everyone trying to update their practice.”
Gemei agreed with the authors that there are persistent knowledge gaps, including insufficient data from head-to-head effectiveness studies, optimal biologic sequencing after failure, advanced combination therapy (such as JAK inhibitors plus anti-interleukin-23), radiologic and endoscopic disease monitoring intervals, and therapy withdrawal strategies after long-term remission. “So there’s a lot we still need to understand better,” he said. “Until we have more data and guidance, we are still practicing all these things based on the available evidence as well as local practice patterns.”
Overall, said Scott, the guidance highlights the options with the best supporting evidence while incorporating the patient’s prior treatment journey. “It’s also important to emphasize that treatment decisions should be individualized and should involve shared decision-making among providers and their patients,” he added. “Patient preferences, age, active comorbidities, and pregnancy should always be considered when selecting the appropriate treatment plan.”
All funding for this guidance was supplied by AGA. The guideline chairs had no conflicts of interest, and fewer than 50% of guideline panel members had conflicts of interest. Gemei had no conflicts of interest.
A version of this article appeared on Medscape.com.
FROM GASTROENTEROLOGY
Dr. David Lieberman: A Groundbreaking Career in Gastroenterology
David Lieberman, MD, AGAF, spent much of his long career asking questions about everyday clinical practice in GI medicine and then researching ways to answer those questions.
“The answer to one question often leads to further questions. And I think that’s what makes this research so exciting and dynamic,” said Lieberman, professor emeritus with Oregon Health and Science University, where he served as chief of the Division of Gastroenterology and Hepatology for 24 years.
He was also instrumental in creating a blood and tissue repository for colorectal cancer (CRC) research, and a national endoscopic database.
His groundbreaking GI research in colorectal cancer screening earned him AGA’s Julius Friedenwald Medal, a top career honor. “We started off with some questions about the role of specific screening tests like colonoscopy and stool-based tests for screening,” he said. This led to the first large study about the value of screening with colonoscopy, which set the stage for current screening guidelines. Assessing more than 3,000 asymptomatic adults, Lieberman and colleagues determined that colonoscopy was more effective than sigmoidoscopy in detecting advanced colonic neoplasms.
The next phase of research focused on how well GI doctors were performing colonoscopy, asking questions about the quality of the colonoscopies being performed, and what course of action to take in polyp discovery. “We did some work related to polyp surveillance, what happens after we take out polyps and some recommendations for the appropriate length of follow up afterwards,” he summarized.
Most recently, Lieberman has centered his research on program effectiveness. “If you’re doing high quality colonoscopy and you’re doing appropriate surveillance, how effective is that? And what are the potential problems that might impair effectiveness?”
Adherence and participation remain significant challenges, he said. “If people don’t get the tests done, then they’re not going to be effective. Or if they get part of it done, there can be issues.”
In an interview, Lieberman discussed the reasons why people resist CRC screening, and the new technologies and research underway to make screening options more palatable for reluctant patients.
What do you think are the biggest deterrents to getting screened for CRC?
Dr. Lieberman: The whole idea of dealing with a stool sample is not appealing to patients. The second issue, and this has been shown in many studies, is patients who are referred for colonoscopy may resist because they have heard stories about bowel preps and about colonoscopy itself. But there are many other reasons. I mean, there are issues with access to care that are important. What if you have a positive stool test and you need to get a colonoscopy? How do you get a colonoscopy? There are barriers in moving from one test to the other in a different setting. There are issues with having to take a day off work that’s potentially a financial hardship for some patients. If you’re taking care of elderly relatives or children or if you need transportation, that’s an issue for people.
So, there are many potential barriers, and we’ve been trying to work at a national level to try to understand these barriers and then develop tools to mitigate these problems and improve the overall participation in screening.
How has the field of GI changed since you started practicing medicine?
Dr. Lieberman: I think there have been many exciting changes in technology. The endoscopes we used when I started my career were called fiberoptic scopes. These were scopes that contained tiny glass fibers that ran the length of the scope, and they were good, but not great in terms of imaging, and sometimes they would break down. We now have digital imaging that far surpasses the quality there. We’ve come a long way in terms of things like CT scans, for example, and MRI imaging. The other big technology change has been the development of minimally invasive treatments. For example, if you have a gallstone that’s in your bile duct, we now have ways to remove that without sending the patient to surgery.
The second big change has been the assessment of quality. When I started my career in gastroenterology, we were doing a lot of things, but we didn’t necessarily know if we were doing them well. Most of us thought we were doing them well, of course, but nobody was really measuring quality. There were no quality benchmarks. And so if you don’t measure it, you don’t know. Where we are today in gastroenterology is we’re intensively concerned about quality and measuring quality in various aspects of what we do. And I think that’s a positive development.
What key achievements came out of the U.S. Multi-Society Task Force on Colorectal Cancer?
Dr. Lieberman: This panel evolved because back in the early 2000s, each of the GI organizations were producing guidelines related to colon cancer screening and follow-up. And they were slightly different. This was an attempt to bring all the relevant groups together and try to align the guidelines and recommendations among the GI organizations so that there wouldn’t be a confusing message.
Over the history of this task force, which started around 2002, it’s been remarkably productive. The task force has really examined all aspects of colorectal cancer, including things like the bowel prep, quality of exams, high risk management, hereditary syndromes that can lead to the higher likelihood of developing colon cancer, polypectomy and polypectomy techniques, and screening and surveillance recommendations, which have evolved over time. It’s been, in my opinion, a remarkably productive task force and continues to this day. I’m so very proud of that group.
Could you give a status update on the blood and tissue repository you created for CRC research?
Dr. Lieberman: Our initial studies were part of a Veterans Affairs cooperative study, which is a mechanism of funding within the VA that allows us to work with multiple VA centers to collect data and information. At the very outset of this study, we were performing screening colonoscopies in individuals, and we decided to create a bio-repository that included blood samples, polyp tissue, and normal rectal tissue. The thinking was at some point we might be able to do some genomic studies that might help us predict which patients are most likely to develop colon polyps and colon cancer. All that happened in the 1990s. It was supported by the National Cancer Institute. We created this repository, which sat for a long period of time while we were waiting for the technology to develop and so that we could perform genomic studies in a cost-effective way.
We’re now at that point, which is really exciting. We’re beginning to look at this tissue and perform some genomic studies. Some of this data has been presented at national meetings. This was a precursor to creating a similar type of bio-repository in a larger VA cooperative study. CSP #577 Colonoscopy vs. Fecal Immunochemical Test in Reducing Mortality from Colorectal Cancer (CONFIRM) is a randomized study comparing two forms of screening, a fecal immunochemical test versus a colonoscopy. We’re in the process of enrolling 50,000 patients in that study. We have also created a blood and tissue repository, which we hope will be useful for future studies.
You lead the AGA CRC Task Force, which advances research and policy initiatives to improve screening rates and patient outcomes. What would you like to see in future GI research, particularly in colorectal cancer?
Dr. Lieberman: We have new blood tests coming along that are going to be very attractive to both patients and physicians. You can obtain a blood sample at a point of service and patients won’t have to deal with stool samples. We need to understand how those tests perform in clinical practice. If the test is abnormal, indicating a patient has a higher risk of colon cancer and should get a colonoscopy, are they getting that colonoscopy or not? And what are the barriers? And if it’s normal, then that patient should have a repeat test at an appropriate interval.
We know that the effectiveness of screening really depends on the participation of individuals in terms of completing the steps. We’ve published some work already on trying to understand the role of these blood tests. We expect that these tests will continue to improve over time.
We’re also working on trying to develop these risk stratification tools that could be used in clinical practice to help figure out the most appropriate test for a particular individual.
Let’s say you go to your doctor for colon cancer screening, and if we could determine that you are a low-risk individual, you may benefit best from having a non-invasive test, like a blood test or a stool test. Whereas if you’re a higher risk individual, you may need to have a more invasive screening test like colonoscopy.
This falls into a concept of personalized medicine where we’re trying to use all the information we have from the medical history, and maybe genomic information that I mentioned earlier, to try to determine who needs the most intensive screening and who might benefit from less intensive screening.
I think the most recent work is really focused on these gaps in screening. And the biggest gap are patients that get a non-invasive test, like a stool test, but do not get a colonoscopy that renders the program ineffective if they don’t get the colonoscopy. We’re trying to highlight that for primary care providers and make sure that everyone understands the importance of this follow-up. And then, trying to develop tools to help the primary care provider navigate that patient to a colonoscopy.
What do you think is the biggest misconception about your specialty?
Dr. Lieberman: If there’s a misconception, it’s that GI physicians are focused on procedures. I think a good GI provider should be holistic, and I think many are. What I mean by holistic is that many GI symptoms could be due to stress, medications, diet, or other aspects of behavior, and the remedy is not necessarily a procedure. I think that many GI physicians are really skilled at obtaining this information and trying to help guide the patient through some uncomfortable symptoms.
It means being more like an internist, spending time with the patient to take a detailed history and delve into many different possibilities that might be going on.
David Lieberman, MD, AGAF, spent much of his long career asking questions about everyday clinical practice in GI medicine and then researching ways to answer those questions.
“The answer to one question often leads to further questions. And I think that’s what makes this research so exciting and dynamic,” said Lieberman, professor emeritus with Oregon Health and Science University, where he served as chief of the Division of Gastroenterology and Hepatology for 24 years.
He was also instrumental in creating a blood and tissue repository for colorectal cancer (CRC) research, and a national endoscopic database.
His groundbreaking GI research in colorectal cancer screening earned him AGA’s Julius Friedenwald Medal, a top career honor. “We started off with some questions about the role of specific screening tests like colonoscopy and stool-based tests for screening,” he said. This led to the first large study about the value of screening with colonoscopy, which set the stage for current screening guidelines. Assessing more than 3,000 asymptomatic adults, Lieberman and colleagues determined that colonoscopy was more effective than sigmoidoscopy in detecting advanced colonic neoplasms.
The next phase of research focused on how well GI doctors were performing colonoscopy, asking questions about the quality of the colonoscopies being performed, and what course of action to take in polyp discovery. “We did some work related to polyp surveillance, what happens after we take out polyps and some recommendations for the appropriate length of follow up afterwards,” he summarized.
Most recently, Lieberman has centered his research on program effectiveness. “If you’re doing high quality colonoscopy and you’re doing appropriate surveillance, how effective is that? And what are the potential problems that might impair effectiveness?”
Adherence and participation remain significant challenges, he said. “If people don’t get the tests done, then they’re not going to be effective. Or if they get part of it done, there can be issues.”
In an interview, Lieberman discussed the reasons why people resist CRC screening, and the new technologies and research underway to make screening options more palatable for reluctant patients.
What do you think are the biggest deterrents to getting screened for CRC?
Dr. Lieberman: The whole idea of dealing with a stool sample is not appealing to patients. The second issue, and this has been shown in many studies, is patients who are referred for colonoscopy may resist because they have heard stories about bowel preps and about colonoscopy itself. But there are many other reasons. I mean, there are issues with access to care that are important. What if you have a positive stool test and you need to get a colonoscopy? How do you get a colonoscopy? There are barriers in moving from one test to the other in a different setting. There are issues with having to take a day off work that’s potentially a financial hardship for some patients. If you’re taking care of elderly relatives or children or if you need transportation, that’s an issue for people.
So, there are many potential barriers, and we’ve been trying to work at a national level to try to understand these barriers and then develop tools to mitigate these problems and improve the overall participation in screening.
How has the field of GI changed since you started practicing medicine?
Dr. Lieberman: I think there have been many exciting changes in technology. The endoscopes we used when I started my career were called fiberoptic scopes. These were scopes that contained tiny glass fibers that ran the length of the scope, and they were good, but not great in terms of imaging, and sometimes they would break down. We now have digital imaging that far surpasses the quality there. We’ve come a long way in terms of things like CT scans, for example, and MRI imaging. The other big technology change has been the development of minimally invasive treatments. For example, if you have a gallstone that’s in your bile duct, we now have ways to remove that without sending the patient to surgery.
The second big change has been the assessment of quality. When I started my career in gastroenterology, we were doing a lot of things, but we didn’t necessarily know if we were doing them well. Most of us thought we were doing them well, of course, but nobody was really measuring quality. There were no quality benchmarks. And so if you don’t measure it, you don’t know. Where we are today in gastroenterology is we’re intensively concerned about quality and measuring quality in various aspects of what we do. And I think that’s a positive development.
What key achievements came out of the U.S. Multi-Society Task Force on Colorectal Cancer?
Dr. Lieberman: This panel evolved because back in the early 2000s, each of the GI organizations were producing guidelines related to colon cancer screening and follow-up. And they were slightly different. This was an attempt to bring all the relevant groups together and try to align the guidelines and recommendations among the GI organizations so that there wouldn’t be a confusing message.
Over the history of this task force, which started around 2002, it’s been remarkably productive. The task force has really examined all aspects of colorectal cancer, including things like the bowel prep, quality of exams, high risk management, hereditary syndromes that can lead to the higher likelihood of developing colon cancer, polypectomy and polypectomy techniques, and screening and surveillance recommendations, which have evolved over time. It’s been, in my opinion, a remarkably productive task force and continues to this day. I’m so very proud of that group.
Could you give a status update on the blood and tissue repository you created for CRC research?
Dr. Lieberman: Our initial studies were part of a Veterans Affairs cooperative study, which is a mechanism of funding within the VA that allows us to work with multiple VA centers to collect data and information. At the very outset of this study, we were performing screening colonoscopies in individuals, and we decided to create a bio-repository that included blood samples, polyp tissue, and normal rectal tissue. The thinking was at some point we might be able to do some genomic studies that might help us predict which patients are most likely to develop colon polyps and colon cancer. All that happened in the 1990s. It was supported by the National Cancer Institute. We created this repository, which sat for a long period of time while we were waiting for the technology to develop and so that we could perform genomic studies in a cost-effective way.
We’re now at that point, which is really exciting. We’re beginning to look at this tissue and perform some genomic studies. Some of this data has been presented at national meetings. This was a precursor to creating a similar type of bio-repository in a larger VA cooperative study. CSP #577 Colonoscopy vs. Fecal Immunochemical Test in Reducing Mortality from Colorectal Cancer (CONFIRM) is a randomized study comparing two forms of screening, a fecal immunochemical test versus a colonoscopy. We’re in the process of enrolling 50,000 patients in that study. We have also created a blood and tissue repository, which we hope will be useful for future studies.
You lead the AGA CRC Task Force, which advances research and policy initiatives to improve screening rates and patient outcomes. What would you like to see in future GI research, particularly in colorectal cancer?
Dr. Lieberman: We have new blood tests coming along that are going to be very attractive to both patients and physicians. You can obtain a blood sample at a point of service and patients won’t have to deal with stool samples. We need to understand how those tests perform in clinical practice. If the test is abnormal, indicating a patient has a higher risk of colon cancer and should get a colonoscopy, are they getting that colonoscopy or not? And what are the barriers? And if it’s normal, then that patient should have a repeat test at an appropriate interval.
We know that the effectiveness of screening really depends on the participation of individuals in terms of completing the steps. We’ve published some work already on trying to understand the role of these blood tests. We expect that these tests will continue to improve over time.
We’re also working on trying to develop these risk stratification tools that could be used in clinical practice to help figure out the most appropriate test for a particular individual.
Let’s say you go to your doctor for colon cancer screening, and if we could determine that you are a low-risk individual, you may benefit best from having a non-invasive test, like a blood test or a stool test. Whereas if you’re a higher risk individual, you may need to have a more invasive screening test like colonoscopy.
This falls into a concept of personalized medicine where we’re trying to use all the information we have from the medical history, and maybe genomic information that I mentioned earlier, to try to determine who needs the most intensive screening and who might benefit from less intensive screening.
I think the most recent work is really focused on these gaps in screening. And the biggest gap are patients that get a non-invasive test, like a stool test, but do not get a colonoscopy that renders the program ineffective if they don’t get the colonoscopy. We’re trying to highlight that for primary care providers and make sure that everyone understands the importance of this follow-up. And then, trying to develop tools to help the primary care provider navigate that patient to a colonoscopy.
What do you think is the biggest misconception about your specialty?
Dr. Lieberman: If there’s a misconception, it’s that GI physicians are focused on procedures. I think a good GI provider should be holistic, and I think many are. What I mean by holistic is that many GI symptoms could be due to stress, medications, diet, or other aspects of behavior, and the remedy is not necessarily a procedure. I think that many GI physicians are really skilled at obtaining this information and trying to help guide the patient through some uncomfortable symptoms.
It means being more like an internist, spending time with the patient to take a detailed history and delve into many different possibilities that might be going on.
David Lieberman, MD, AGAF, spent much of his long career asking questions about everyday clinical practice in GI medicine and then researching ways to answer those questions.
“The answer to one question often leads to further questions. And I think that’s what makes this research so exciting and dynamic,” said Lieberman, professor emeritus with Oregon Health and Science University, where he served as chief of the Division of Gastroenterology and Hepatology for 24 years.
He was also instrumental in creating a blood and tissue repository for colorectal cancer (CRC) research, and a national endoscopic database.
His groundbreaking GI research in colorectal cancer screening earned him AGA’s Julius Friedenwald Medal, a top career honor. “We started off with some questions about the role of specific screening tests like colonoscopy and stool-based tests for screening,” he said. This led to the first large study about the value of screening with colonoscopy, which set the stage for current screening guidelines. Assessing more than 3,000 asymptomatic adults, Lieberman and colleagues determined that colonoscopy was more effective than sigmoidoscopy in detecting advanced colonic neoplasms.
The next phase of research focused on how well GI doctors were performing colonoscopy, asking questions about the quality of the colonoscopies being performed, and what course of action to take in polyp discovery. “We did some work related to polyp surveillance, what happens after we take out polyps and some recommendations for the appropriate length of follow up afterwards,” he summarized.
Most recently, Lieberman has centered his research on program effectiveness. “If you’re doing high quality colonoscopy and you’re doing appropriate surveillance, how effective is that? And what are the potential problems that might impair effectiveness?”
Adherence and participation remain significant challenges, he said. “If people don’t get the tests done, then they’re not going to be effective. Or if they get part of it done, there can be issues.”
In an interview, Lieberman discussed the reasons why people resist CRC screening, and the new technologies and research underway to make screening options more palatable for reluctant patients.
What do you think are the biggest deterrents to getting screened for CRC?
Dr. Lieberman: The whole idea of dealing with a stool sample is not appealing to patients. The second issue, and this has been shown in many studies, is patients who are referred for colonoscopy may resist because they have heard stories about bowel preps and about colonoscopy itself. But there are many other reasons. I mean, there are issues with access to care that are important. What if you have a positive stool test and you need to get a colonoscopy? How do you get a colonoscopy? There are barriers in moving from one test to the other in a different setting. There are issues with having to take a day off work that’s potentially a financial hardship for some patients. If you’re taking care of elderly relatives or children or if you need transportation, that’s an issue for people.
So, there are many potential barriers, and we’ve been trying to work at a national level to try to understand these barriers and then develop tools to mitigate these problems and improve the overall participation in screening.
How has the field of GI changed since you started practicing medicine?
Dr. Lieberman: I think there have been many exciting changes in technology. The endoscopes we used when I started my career were called fiberoptic scopes. These were scopes that contained tiny glass fibers that ran the length of the scope, and they were good, but not great in terms of imaging, and sometimes they would break down. We now have digital imaging that far surpasses the quality there. We’ve come a long way in terms of things like CT scans, for example, and MRI imaging. The other big technology change has been the development of minimally invasive treatments. For example, if you have a gallstone that’s in your bile duct, we now have ways to remove that without sending the patient to surgery.
The second big change has been the assessment of quality. When I started my career in gastroenterology, we were doing a lot of things, but we didn’t necessarily know if we were doing them well. Most of us thought we were doing them well, of course, but nobody was really measuring quality. There were no quality benchmarks. And so if you don’t measure it, you don’t know. Where we are today in gastroenterology is we’re intensively concerned about quality and measuring quality in various aspects of what we do. And I think that’s a positive development.
What key achievements came out of the U.S. Multi-Society Task Force on Colorectal Cancer?
Dr. Lieberman: This panel evolved because back in the early 2000s, each of the GI organizations were producing guidelines related to colon cancer screening and follow-up. And they were slightly different. This was an attempt to bring all the relevant groups together and try to align the guidelines and recommendations among the GI organizations so that there wouldn’t be a confusing message.
Over the history of this task force, which started around 2002, it’s been remarkably productive. The task force has really examined all aspects of colorectal cancer, including things like the bowel prep, quality of exams, high risk management, hereditary syndromes that can lead to the higher likelihood of developing colon cancer, polypectomy and polypectomy techniques, and screening and surveillance recommendations, which have evolved over time. It’s been, in my opinion, a remarkably productive task force and continues to this day. I’m so very proud of that group.
Could you give a status update on the blood and tissue repository you created for CRC research?
Dr. Lieberman: Our initial studies were part of a Veterans Affairs cooperative study, which is a mechanism of funding within the VA that allows us to work with multiple VA centers to collect data and information. At the very outset of this study, we were performing screening colonoscopies in individuals, and we decided to create a bio-repository that included blood samples, polyp tissue, and normal rectal tissue. The thinking was at some point we might be able to do some genomic studies that might help us predict which patients are most likely to develop colon polyps and colon cancer. All that happened in the 1990s. It was supported by the National Cancer Institute. We created this repository, which sat for a long period of time while we were waiting for the technology to develop and so that we could perform genomic studies in a cost-effective way.
We’re now at that point, which is really exciting. We’re beginning to look at this tissue and perform some genomic studies. Some of this data has been presented at national meetings. This was a precursor to creating a similar type of bio-repository in a larger VA cooperative study. CSP #577 Colonoscopy vs. Fecal Immunochemical Test in Reducing Mortality from Colorectal Cancer (CONFIRM) is a randomized study comparing two forms of screening, a fecal immunochemical test versus a colonoscopy. We’re in the process of enrolling 50,000 patients in that study. We have also created a blood and tissue repository, which we hope will be useful for future studies.
You lead the AGA CRC Task Force, which advances research and policy initiatives to improve screening rates and patient outcomes. What would you like to see in future GI research, particularly in colorectal cancer?
Dr. Lieberman: We have new blood tests coming along that are going to be very attractive to both patients and physicians. You can obtain a blood sample at a point of service and patients won’t have to deal with stool samples. We need to understand how those tests perform in clinical practice. If the test is abnormal, indicating a patient has a higher risk of colon cancer and should get a colonoscopy, are they getting that colonoscopy or not? And what are the barriers? And if it’s normal, then that patient should have a repeat test at an appropriate interval.
We know that the effectiveness of screening really depends on the participation of individuals in terms of completing the steps. We’ve published some work already on trying to understand the role of these blood tests. We expect that these tests will continue to improve over time.
We’re also working on trying to develop these risk stratification tools that could be used in clinical practice to help figure out the most appropriate test for a particular individual.
Let’s say you go to your doctor for colon cancer screening, and if we could determine that you are a low-risk individual, you may benefit best from having a non-invasive test, like a blood test or a stool test. Whereas if you’re a higher risk individual, you may need to have a more invasive screening test like colonoscopy.
This falls into a concept of personalized medicine where we’re trying to use all the information we have from the medical history, and maybe genomic information that I mentioned earlier, to try to determine who needs the most intensive screening and who might benefit from less intensive screening.
I think the most recent work is really focused on these gaps in screening. And the biggest gap are patients that get a non-invasive test, like a stool test, but do not get a colonoscopy that renders the program ineffective if they don’t get the colonoscopy. We’re trying to highlight that for primary care providers and make sure that everyone understands the importance of this follow-up. And then, trying to develop tools to help the primary care provider navigate that patient to a colonoscopy.
What do you think is the biggest misconception about your specialty?
Dr. Lieberman: If there’s a misconception, it’s that GI physicians are focused on procedures. I think a good GI provider should be holistic, and I think many are. What I mean by holistic is that many GI symptoms could be due to stress, medications, diet, or other aspects of behavior, and the remedy is not necessarily a procedure. I think that many GI physicians are really skilled at obtaining this information and trying to help guide the patient through some uncomfortable symptoms.
It means being more like an internist, spending time with the patient to take a detailed history and delve into many different possibilities that might be going on.
Non-Operative Management Effective in Patients With Rectal Cancer Showing Clinical Complete Response to Neoadjuvant Therapy
TOPLINE:
Non-operative management achieved 95% distant relapse-free survival at 30 months in patients with stage II-III rectal cancer showing a clinical complete response to total neoadjuvant therapy, while maintaining successful salvage surgery options among 15% of those who experienced local regrowth according to a phase 2 trial.
METHODOLOGY:
- Researchers conducted an investigator-driven, multicentre, single-arm, phase 2 trial enrolling 180 patients (median age, 62 years; 44% women) with stage II-III adenocarcinoma of the lower-to-middle rectum across four cancer centres in Italy from June 2018 to August 2023.
- Treatment consisted of induction chemotherapy with 4 cycles of capecitabine (1000 mg/m2 orally twice daily on days 1-14 every 3 weeks) and oxaliplatin (130 mg/m2 intravenously on day 1 every 3 weeks), followed by chemoradiotherapy with 50-54 Gy in 25 fractions for 5 weeks.
- The analysis included 179 evaluable patients: 47 (26%) who achieved a clinical complete response were assigned to nonoperative management, 107 (60%) underwent surgery after therapy, and 18 (10%) underwent surgery after study discontinuation.
- The primary outcome was 30-month distant relapse-free survival in the non-operative management group, and secondary outcomes included local relapse-free or regrowth-free survival (local regrowth after non-operative management and local relapse after surgery).
TAKEAWAY:
- After a median follow-up of 35 months, 30-month distant relapse-free survival reached 95% in the non-operative management group vs 74% in the surgery group and 74% in the overall population.
- Among patients undergoing non-operative management, 15% experienced tumour regrowth in the rectal wall within 2 years, corresponding to a 2-year risk for local regrowth of 17%, and cumulative risks for local relapse were 11% at 2 years and 16% at 3 years among those in the surgery group.
- The most common adverse events of grade 3-4 were diarrhoea (4%), lymphopenia (4%), and neutropenia (4%). Overall, 17% of patients had a serious adverse event, with bowel obstruction (4%) and thromboembolism (3%) being the most common adverse events.
- Circulating tumour DNA positivity after total neoadjuvant therapy showed significant prognostic value, with the positive status associated with worse distant relapse-free survival (P = .0032) and progression-free survival (P = .0028) among patients in the non-operative management group.
IN PRACTICE:
“Nonoperative management ensures excellent distant disease control with organ preservation after clinical complete response,” the authors wrote. “As a watch-and-wait approach becomes a recognised standard in international guidelines, the integration of ctDNA [circulating tumour DNA] and possibly other novel biomarkers, adds a crucial dimension to risk stratification and underscores the potential for personalised treatment approaches,” they added.
SOURCE:
This study was led by Alessio Amatu, MD, and Giorgio Patelli, MD, Niguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milan, Italy. It was published online in The Lancet Oncology .
LIMITATIONS:
This study was powered only to estimate 30-month distant relapse-free survival for the non-operative management group, potentially limiting statistical power for subgroup and molecular analyses. The single-arm design without randomisation did not directly address whether rectal surgery might provide added value in cases of clinical complete response. The specific induction-based total neoadjuvant therapy strategy used might not have fully reflected evolving practices. Additionally, the racial homogeneity of the study population limited generalisability beyond predominantly White populations.
DISCLOSURES:
This study was funded by Fondazione AIRC ETS, Fondazione Oncologia Niguarda ETS, Grande Ospedale Metropolitano Niguarda, Ministero della Salute, and AIRC 5xMille 2018. Several authors reported receiving grants or honoraria and having other ties with various sources. Full disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.A version of this article first appeared on Medscape.com.
TOPLINE:
Non-operative management achieved 95% distant relapse-free survival at 30 months in patients with stage II-III rectal cancer showing a clinical complete response to total neoadjuvant therapy, while maintaining successful salvage surgery options among 15% of those who experienced local regrowth according to a phase 2 trial.
METHODOLOGY:
- Researchers conducted an investigator-driven, multicentre, single-arm, phase 2 trial enrolling 180 patients (median age, 62 years; 44% women) with stage II-III adenocarcinoma of the lower-to-middle rectum across four cancer centres in Italy from June 2018 to August 2023.
- Treatment consisted of induction chemotherapy with 4 cycles of capecitabine (1000 mg/m2 orally twice daily on days 1-14 every 3 weeks) and oxaliplatin (130 mg/m2 intravenously on day 1 every 3 weeks), followed by chemoradiotherapy with 50-54 Gy in 25 fractions for 5 weeks.
- The analysis included 179 evaluable patients: 47 (26%) who achieved a clinical complete response were assigned to nonoperative management, 107 (60%) underwent surgery after therapy, and 18 (10%) underwent surgery after study discontinuation.
- The primary outcome was 30-month distant relapse-free survival in the non-operative management group, and secondary outcomes included local relapse-free or regrowth-free survival (local regrowth after non-operative management and local relapse after surgery).
TAKEAWAY:
- After a median follow-up of 35 months, 30-month distant relapse-free survival reached 95% in the non-operative management group vs 74% in the surgery group and 74% in the overall population.
- Among patients undergoing non-operative management, 15% experienced tumour regrowth in the rectal wall within 2 years, corresponding to a 2-year risk for local regrowth of 17%, and cumulative risks for local relapse were 11% at 2 years and 16% at 3 years among those in the surgery group.
- The most common adverse events of grade 3-4 were diarrhoea (4%), lymphopenia (4%), and neutropenia (4%). Overall, 17% of patients had a serious adverse event, with bowel obstruction (4%) and thromboembolism (3%) being the most common adverse events.
- Circulating tumour DNA positivity after total neoadjuvant therapy showed significant prognostic value, with the positive status associated with worse distant relapse-free survival (P = .0032) and progression-free survival (P = .0028) among patients in the non-operative management group.
IN PRACTICE:
“Nonoperative management ensures excellent distant disease control with organ preservation after clinical complete response,” the authors wrote. “As a watch-and-wait approach becomes a recognised standard in international guidelines, the integration of ctDNA [circulating tumour DNA] and possibly other novel biomarkers, adds a crucial dimension to risk stratification and underscores the potential for personalised treatment approaches,” they added.
SOURCE:
This study was led by Alessio Amatu, MD, and Giorgio Patelli, MD, Niguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milan, Italy. It was published online in The Lancet Oncology .
LIMITATIONS:
This study was powered only to estimate 30-month distant relapse-free survival for the non-operative management group, potentially limiting statistical power for subgroup and molecular analyses. The single-arm design without randomisation did not directly address whether rectal surgery might provide added value in cases of clinical complete response. The specific induction-based total neoadjuvant therapy strategy used might not have fully reflected evolving practices. Additionally, the racial homogeneity of the study population limited generalisability beyond predominantly White populations.
DISCLOSURES:
This study was funded by Fondazione AIRC ETS, Fondazione Oncologia Niguarda ETS, Grande Ospedale Metropolitano Niguarda, Ministero della Salute, and AIRC 5xMille 2018. Several authors reported receiving grants or honoraria and having other ties with various sources. Full disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.A version of this article first appeared on Medscape.com.
TOPLINE:
Non-operative management achieved 95% distant relapse-free survival at 30 months in patients with stage II-III rectal cancer showing a clinical complete response to total neoadjuvant therapy, while maintaining successful salvage surgery options among 15% of those who experienced local regrowth according to a phase 2 trial.
METHODOLOGY:
- Researchers conducted an investigator-driven, multicentre, single-arm, phase 2 trial enrolling 180 patients (median age, 62 years; 44% women) with stage II-III adenocarcinoma of the lower-to-middle rectum across four cancer centres in Italy from June 2018 to August 2023.
- Treatment consisted of induction chemotherapy with 4 cycles of capecitabine (1000 mg/m2 orally twice daily on days 1-14 every 3 weeks) and oxaliplatin (130 mg/m2 intravenously on day 1 every 3 weeks), followed by chemoradiotherapy with 50-54 Gy in 25 fractions for 5 weeks.
- The analysis included 179 evaluable patients: 47 (26%) who achieved a clinical complete response were assigned to nonoperative management, 107 (60%) underwent surgery after therapy, and 18 (10%) underwent surgery after study discontinuation.
- The primary outcome was 30-month distant relapse-free survival in the non-operative management group, and secondary outcomes included local relapse-free or regrowth-free survival (local regrowth after non-operative management and local relapse after surgery).
TAKEAWAY:
- After a median follow-up of 35 months, 30-month distant relapse-free survival reached 95% in the non-operative management group vs 74% in the surgery group and 74% in the overall population.
- Among patients undergoing non-operative management, 15% experienced tumour regrowth in the rectal wall within 2 years, corresponding to a 2-year risk for local regrowth of 17%, and cumulative risks for local relapse were 11% at 2 years and 16% at 3 years among those in the surgery group.
- The most common adverse events of grade 3-4 were diarrhoea (4%), lymphopenia (4%), and neutropenia (4%). Overall, 17% of patients had a serious adverse event, with bowel obstruction (4%) and thromboembolism (3%) being the most common adverse events.
- Circulating tumour DNA positivity after total neoadjuvant therapy showed significant prognostic value, with the positive status associated with worse distant relapse-free survival (P = .0032) and progression-free survival (P = .0028) among patients in the non-operative management group.
IN PRACTICE:
“Nonoperative management ensures excellent distant disease control with organ preservation after clinical complete response,” the authors wrote. “As a watch-and-wait approach becomes a recognised standard in international guidelines, the integration of ctDNA [circulating tumour DNA] and possibly other novel biomarkers, adds a crucial dimension to risk stratification and underscores the potential for personalised treatment approaches,” they added.
SOURCE:
This study was led by Alessio Amatu, MD, and Giorgio Patelli, MD, Niguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milan, Italy. It was published online in The Lancet Oncology .
LIMITATIONS:
This study was powered only to estimate 30-month distant relapse-free survival for the non-operative management group, potentially limiting statistical power for subgroup and molecular analyses. The single-arm design without randomisation did not directly address whether rectal surgery might provide added value in cases of clinical complete response. The specific induction-based total neoadjuvant therapy strategy used might not have fully reflected evolving practices. Additionally, the racial homogeneity of the study population limited generalisability beyond predominantly White populations.
DISCLOSURES:
This study was funded by Fondazione AIRC ETS, Fondazione Oncologia Niguarda ETS, Grande Ospedale Metropolitano Niguarda, Ministero della Salute, and AIRC 5xMille 2018. Several authors reported receiving grants or honoraria and having other ties with various sources. Full disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.A version of this article first appeared on Medscape.com.
Not a Professional Degree? A New Federal Policy Could Exacerbate the Nursing Shortage
The statistics are shocking: 138,000 registered nurses (RNs) have left the workforce since 2022 and at least 40% plan to retire or leave the profession in the next 5 years — and new updates from the Department of Education could make the national nursing crisis even worse.
The reason? Nursing is no longer considered a professional degree.
A recent Department of Education rulemaking session omitted advanced nursing programs (as well as physician assistance programs, physical therapy, occupational therapy, audiology, social work, and public health programs) from the definition of professional degrees and limited the amount of student loan funding available to pursue advanced practice degrees like Master of Science in Nursing and Doctor of Nursing Practice.
“We have a primary care crisis in this country,” said Deborah Trautman PhD, RN, president and chief executive officer of the American Association of Colleges of Nursing (AACN). “The omission is not only harmful for nursing; the omission is not good for anyone who needs healthcare.”
Limiting Loan Access
The One Big, Beautiful Bill Act eliminated the Grad PLUS student loan program and amended the list of professional degrees to exclude advanced practice nursing. Although the change doesn’t affect the licensure or legal standing of nurses, it alters access to financial aid and limits advanced education opportunities.
Starting on July 1, 2026, graduate students will be limited to a total of $100,000 in federal student loans, a decrease from the previous cap of $138,500 but loan caps for graduate students in professional degree programs will increase to $200,000. The changes led the National Association of Student Financial Aid Administrators to declare, “Many will be shut out of graduate education.”
“It would force people who need loan support and don’t have a sufficient amount through a federal loan to seek [private loans], but federal loans have better interest rates and/or other conditions, and some students may not qualify for the private loans,” Trautman said. “The risk then is that students may not pursue these advanced nursing degrees because of the financial barriers that they will face.”
The Department of Education disagrees. In a statement, the federal department said, “Placing a cap on loans will push the remaining graduate nursing programs to reduce their program costs, ensuring that nurses will not be saddled with unmanageable student loan debt.” So far, Trautman has seen “no evidence” that limiting access to advanced nursing programs would reduce tuition costs.
Industry-Wide Impacts
Trautman worries that omitting nursing from the list of professional degrees will reduce access to care.
Nurse practitioners are providing primary care in rural and underserved areas; certified registered nurse anesthetists make up more than 50% of anesthesia providers in the US (a number that jumps to 80% in rural areas); and the percentage of births attended by certified nurse midwives is growing fast.
“These are nurses…who are working to achieve better patient outcomes and to make the health system work better for all of us,” Trautman said. “And we would be compromising this workforce that is so critical to our nation.”
Limiting the federal student loan borrowing cap for advanced nursing degrees could also exacerbate the nursing faculty shortage. In 2023, more than 65,000 qualified applicants were denied admission to baccalaureate and graduate nursing programs; insufficient number of faculty was the top reason.
Colleges depend on nurses with advanced degrees to fill faculty vacancies. In fact, more than 80% of open positions required or preferred a doctoral degree, according to AACN. Removing nursing from the list of professional degree programs and limiting access to student loans will make it even harder to fill vacancies, limiting the number of new nurses entering the profession.
“We’re finalizing the results of [a new national survey] that showed overwhelming feedback from our member deans and students who believe enrollment in advanced nursing programs is going be impacted,” said Trautman. “We’re going to see the faculty shortage worsen; we’re going see increased financial burdens to our students, and we believe it’s going to undermine the stability of the healthcare workforce.”
Industry associations, including the American Nurses Association, American Academy of Nursing, and American Organization for Nursing Leadership have released statements opposing the change and advocating for graduate nursing degrees to be added to the list of professional programs. Trautman hopes that public pressure and cross-sector support will lead the Department of Education to reverse its current position.
“It’s the wrong decision,” she said. “There is an opportunity to make this right, and that is to include nursing on that professional list.”
A version of this article first appeared on Medscape.com.
The statistics are shocking: 138,000 registered nurses (RNs) have left the workforce since 2022 and at least 40% plan to retire or leave the profession in the next 5 years — and new updates from the Department of Education could make the national nursing crisis even worse.
The reason? Nursing is no longer considered a professional degree.
A recent Department of Education rulemaking session omitted advanced nursing programs (as well as physician assistance programs, physical therapy, occupational therapy, audiology, social work, and public health programs) from the definition of professional degrees and limited the amount of student loan funding available to pursue advanced practice degrees like Master of Science in Nursing and Doctor of Nursing Practice.
“We have a primary care crisis in this country,” said Deborah Trautman PhD, RN, president and chief executive officer of the American Association of Colleges of Nursing (AACN). “The omission is not only harmful for nursing; the omission is not good for anyone who needs healthcare.”
Limiting Loan Access
The One Big, Beautiful Bill Act eliminated the Grad PLUS student loan program and amended the list of professional degrees to exclude advanced practice nursing. Although the change doesn’t affect the licensure or legal standing of nurses, it alters access to financial aid and limits advanced education opportunities.
Starting on July 1, 2026, graduate students will be limited to a total of $100,000 in federal student loans, a decrease from the previous cap of $138,500 but loan caps for graduate students in professional degree programs will increase to $200,000. The changes led the National Association of Student Financial Aid Administrators to declare, “Many will be shut out of graduate education.”
“It would force people who need loan support and don’t have a sufficient amount through a federal loan to seek [private loans], but federal loans have better interest rates and/or other conditions, and some students may not qualify for the private loans,” Trautman said. “The risk then is that students may not pursue these advanced nursing degrees because of the financial barriers that they will face.”
The Department of Education disagrees. In a statement, the federal department said, “Placing a cap on loans will push the remaining graduate nursing programs to reduce their program costs, ensuring that nurses will not be saddled with unmanageable student loan debt.” So far, Trautman has seen “no evidence” that limiting access to advanced nursing programs would reduce tuition costs.
Industry-Wide Impacts
Trautman worries that omitting nursing from the list of professional degrees will reduce access to care.
Nurse practitioners are providing primary care in rural and underserved areas; certified registered nurse anesthetists make up more than 50% of anesthesia providers in the US (a number that jumps to 80% in rural areas); and the percentage of births attended by certified nurse midwives is growing fast.
“These are nurses…who are working to achieve better patient outcomes and to make the health system work better for all of us,” Trautman said. “And we would be compromising this workforce that is so critical to our nation.”
Limiting the federal student loan borrowing cap for advanced nursing degrees could also exacerbate the nursing faculty shortage. In 2023, more than 65,000 qualified applicants were denied admission to baccalaureate and graduate nursing programs; insufficient number of faculty was the top reason.
Colleges depend on nurses with advanced degrees to fill faculty vacancies. In fact, more than 80% of open positions required or preferred a doctoral degree, according to AACN. Removing nursing from the list of professional degree programs and limiting access to student loans will make it even harder to fill vacancies, limiting the number of new nurses entering the profession.
“We’re finalizing the results of [a new national survey] that showed overwhelming feedback from our member deans and students who believe enrollment in advanced nursing programs is going be impacted,” said Trautman. “We’re going to see the faculty shortage worsen; we’re going see increased financial burdens to our students, and we believe it’s going to undermine the stability of the healthcare workforce.”
Industry associations, including the American Nurses Association, American Academy of Nursing, and American Organization for Nursing Leadership have released statements opposing the change and advocating for graduate nursing degrees to be added to the list of professional programs. Trautman hopes that public pressure and cross-sector support will lead the Department of Education to reverse its current position.
“It’s the wrong decision,” she said. “There is an opportunity to make this right, and that is to include nursing on that professional list.”
A version of this article first appeared on Medscape.com.
The statistics are shocking: 138,000 registered nurses (RNs) have left the workforce since 2022 and at least 40% plan to retire or leave the profession in the next 5 years — and new updates from the Department of Education could make the national nursing crisis even worse.
The reason? Nursing is no longer considered a professional degree.
A recent Department of Education rulemaking session omitted advanced nursing programs (as well as physician assistance programs, physical therapy, occupational therapy, audiology, social work, and public health programs) from the definition of professional degrees and limited the amount of student loan funding available to pursue advanced practice degrees like Master of Science in Nursing and Doctor of Nursing Practice.
“We have a primary care crisis in this country,” said Deborah Trautman PhD, RN, president and chief executive officer of the American Association of Colleges of Nursing (AACN). “The omission is not only harmful for nursing; the omission is not good for anyone who needs healthcare.”
Limiting Loan Access
The One Big, Beautiful Bill Act eliminated the Grad PLUS student loan program and amended the list of professional degrees to exclude advanced practice nursing. Although the change doesn’t affect the licensure or legal standing of nurses, it alters access to financial aid and limits advanced education opportunities.
Starting on July 1, 2026, graduate students will be limited to a total of $100,000 in federal student loans, a decrease from the previous cap of $138,500 but loan caps for graduate students in professional degree programs will increase to $200,000. The changes led the National Association of Student Financial Aid Administrators to declare, “Many will be shut out of graduate education.”
“It would force people who need loan support and don’t have a sufficient amount through a federal loan to seek [private loans], but federal loans have better interest rates and/or other conditions, and some students may not qualify for the private loans,” Trautman said. “The risk then is that students may not pursue these advanced nursing degrees because of the financial barriers that they will face.”
The Department of Education disagrees. In a statement, the federal department said, “Placing a cap on loans will push the remaining graduate nursing programs to reduce their program costs, ensuring that nurses will not be saddled with unmanageable student loan debt.” So far, Trautman has seen “no evidence” that limiting access to advanced nursing programs would reduce tuition costs.
Industry-Wide Impacts
Trautman worries that omitting nursing from the list of professional degrees will reduce access to care.
Nurse practitioners are providing primary care in rural and underserved areas; certified registered nurse anesthetists make up more than 50% of anesthesia providers in the US (a number that jumps to 80% in rural areas); and the percentage of births attended by certified nurse midwives is growing fast.
“These are nurses…who are working to achieve better patient outcomes and to make the health system work better for all of us,” Trautman said. “And we would be compromising this workforce that is so critical to our nation.”
Limiting the federal student loan borrowing cap for advanced nursing degrees could also exacerbate the nursing faculty shortage. In 2023, more than 65,000 qualified applicants were denied admission to baccalaureate and graduate nursing programs; insufficient number of faculty was the top reason.
Colleges depend on nurses with advanced degrees to fill faculty vacancies. In fact, more than 80% of open positions required or preferred a doctoral degree, according to AACN. Removing nursing from the list of professional degree programs and limiting access to student loans will make it even harder to fill vacancies, limiting the number of new nurses entering the profession.
“We’re finalizing the results of [a new national survey] that showed overwhelming feedback from our member deans and students who believe enrollment in advanced nursing programs is going be impacted,” said Trautman. “We’re going to see the faculty shortage worsen; we’re going see increased financial burdens to our students, and we believe it’s going to undermine the stability of the healthcare workforce.”
Industry associations, including the American Nurses Association, American Academy of Nursing, and American Organization for Nursing Leadership have released statements opposing the change and advocating for graduate nursing degrees to be added to the list of professional programs. Trautman hopes that public pressure and cross-sector support will lead the Department of Education to reverse its current position.
“It’s the wrong decision,” she said. “There is an opportunity to make this right, and that is to include nursing on that professional list.”
A version of this article first appeared on Medscape.com.