The New Gastroenterologist

Joining Gastroenterology as an editorial fellow is an invaluable experience for the future scientific career. When I joined the fellowship, my main objectives were to learn important aspects about scientific publishing, while improving my editorial and writing skills. Importantly, participating in the fellowship would allow me to determine fields in gastroenterology and hepatology that need more intensive research, evaluate and review manuscripts submitted to a high-impact journal, learn which aspects are important for manuscripts to be considered for publication, and learn how to prepare concise summaries to share with readers. As an editorial fellow, I would not only work with experts on manuscript review and editing, but also be mentored by experts in the field to prepare for a career in scientific publishing.

The application process is easy and straightforward. A curriculum vitae, motivation letter, and conflict of interest form are needed to be considered for the position. Furthermore, a letter of recommendation has to be provided from senior faculty. For the latter, it is beneficial to have worked with someone who is currently active in scientific publishing.

After joining the editorial board, fellows are assigned to associate editors based on their previous experience. Fellows are expected to peer-review manuscripts and discuss their reviews with the associate editors during a brief call or by email, where it is also determined whether additional feedback from the board of editors is needed to move manuscripts forward. If so, fellows are given the opportunity to present manuscripts they reviewed to the editorial board and prepare the decision letter with comments to the authors and editors. This experience teaches which qualities manuscripts need to fulfill to be considered for publication, and how to communicate decisions to authors. During the meetings with the editorial board, fellows are also encouraged to provide feedback for additional manuscripts discussed.

Additionally, fellows have the chance to work on the “Covering the Cover” section of the journal under close mentorship of the responsible editors. Here, they learn to draft short synopses of submitted manuscripts that should be highlighted in the respective sections to give readers a brief overview of important pieces of research with potential clinical applicability. This experience teaches how to write concisely and rephrase the main message of manuscripts without overstating findings and conclusions. Additionally, fellows are invited to write commentaries on recent articles published in other journals and highlight these to Gastroenterology’s readership. This experience teaches how to critically comment on published literature and point out its strengths and limitations. Overall, these learning experiences improve not only editorial and writing skills, but also knowledge in the respective areas of research.

Finally, fellows have the opportunity to write a commentary about a topic of their choice. This experience allows fellows to deepen their expertise in an area of research on an emerging topic they would like to highlight to their readers. Since this type of article is peer reviewed, reviewers’ comments help identify weaknesses of the initially submitted manuscript and increase the awareness about factors that need to be addressed to finally provide a high-quality article that is of value to Gastroenterology’s readership.

Concluding, being an editorial fellow for Gastroenterology is an extremely valuable experience. From an editorial aspect, fellows learn to review, summarize, and comment on submitted manuscripts, as well as which factors need to be addressed by manuscripts to be considered for publication to a high-impact journal. Additionally, fellows network with leaders in the field and expand their knowledge on topics they had not worked on previously. Overall, the fellowship helps improve editorial and writing skills, while staying current in the literature, a skill set that can be applied broadly in the future medical and scientific career.

Dr. Kefalakes is a clinical fellow and research group leader in the department of gastroenterology, hepatology, and endocrinology at Hannover (Germany) Medical School. She has nothing to declare.

Joining Gastroenterology as an editorial fellow is an invaluable experience for the future scientific career. When I joined the fellowship, my main objectives were to learn important aspects about scientific publishing, while improving my editorial and writing skills. Importantly, participating in the fellowship would allow me to determine fields in gastroenterology and hepatology that need more intensive research, evaluate and review manuscripts submitted to a high-impact journal, learn which aspects are important for manuscripts to be considered for publication, and learn how to prepare concise summaries to share with readers. As an editorial fellow, I would not only work with experts on manuscript review and editing, but also be mentored by experts in the field to prepare for a career in scientific publishing.

The application process is easy and straightforward. A curriculum vitae, motivation letter, and conflict of interest form are needed to be considered for the position. Furthermore, a letter of recommendation has to be provided from senior faculty. For the latter, it is beneficial to have worked with someone who is currently active in scientific publishing.

After joining the editorial board, fellows are assigned to associate editors based on their previous experience. Fellows are expected to peer-review manuscripts and discuss their reviews with the associate editors during a brief call or by email, where it is also determined whether additional feedback from the board of editors is needed to move manuscripts forward. If so, fellows are given the opportunity to present manuscripts they reviewed to the editorial board and prepare the decision letter with comments to the authors and editors. This experience teaches which qualities manuscripts need to fulfill to be considered for publication, and how to communicate decisions to authors. During the meetings with the editorial board, fellows are also encouraged to provide feedback for additional manuscripts discussed.

Additionally, fellows have the chance to work on the “Covering the Cover” section of the journal under close mentorship of the responsible editors. Here, they learn to draft short synopses of submitted manuscripts that should be highlighted in the respective sections to give readers a brief overview of important pieces of research with potential clinical applicability. This experience teaches how to write concisely and rephrase the main message of manuscripts without overstating findings and conclusions. Additionally, fellows are invited to write commentaries on recent articles published in other journals and highlight these to Gastroenterology’s readership. This experience teaches how to critically comment on published literature and point out its strengths and limitations. Overall, these learning experiences improve not only editorial and writing skills, but also knowledge in the respective areas of research.

Finally, fellows have the opportunity to write a commentary about a topic of their choice. This experience allows fellows to deepen their expertise in an area of research on an emerging topic they would like to highlight to their readers. Since this type of article is peer reviewed, reviewers’ comments help identify weaknesses of the initially submitted manuscript and increase the awareness about factors that need to be addressed to finally provide a high-quality article that is of value to Gastroenterology’s readership.

Concluding, being an editorial fellow for Gastroenterology is an extremely valuable experience. From an editorial aspect, fellows learn to review, summarize, and comment on submitted manuscripts, as well as which factors need to be addressed by manuscripts to be considered for publication to a high-impact journal. Additionally, fellows network with leaders in the field and expand their knowledge on topics they had not worked on previously. Overall, the fellowship helps improve editorial and writing skills, while staying current in the literature, a skill set that can be applied broadly in the future medical and scientific career.

Dr. Kefalakes is a clinical fellow and research group leader in the department of gastroenterology, hepatology, and endocrinology at Hannover (Germany) Medical School. She has nothing to declare.

Joining Gastroenterology as an editorial fellow is an invaluable experience for the future scientific career. When I joined the fellowship, my main objectives were to learn important aspects about scientific publishing, while improving my editorial and writing skills. Importantly, participating in the fellowship would allow me to determine fields in gastroenterology and hepatology that need more intensive research, evaluate and review manuscripts submitted to a high-impact journal, learn which aspects are important for manuscripts to be considered for publication, and learn how to prepare concise summaries to share with readers. As an editorial fellow, I would not only work with experts on manuscript review and editing, but also be mentored by experts in the field to prepare for a career in scientific publishing.

The application process is easy and straightforward. A curriculum vitae, motivation letter, and conflict of interest form are needed to be considered for the position. Furthermore, a letter of recommendation has to be provided from senior faculty. For the latter, it is beneficial to have worked with someone who is currently active in scientific publishing.

After joining the editorial board, fellows are assigned to associate editors based on their previous experience. Fellows are expected to peer-review manuscripts and discuss their reviews with the associate editors during a brief call or by email, where it is also determined whether additional feedback from the board of editors is needed to move manuscripts forward. If so, fellows are given the opportunity to present manuscripts they reviewed to the editorial board and prepare the decision letter with comments to the authors and editors. This experience teaches which qualities manuscripts need to fulfill to be considered for publication, and how to communicate decisions to authors. During the meetings with the editorial board, fellows are also encouraged to provide feedback for additional manuscripts discussed.

Additionally, fellows have the chance to work on the “Covering the Cover” section of the journal under close mentorship of the responsible editors. Here, they learn to draft short synopses of submitted manuscripts that should be highlighted in the respective sections to give readers a brief overview of important pieces of research with potential clinical applicability. This experience teaches how to write concisely and rephrase the main message of manuscripts without overstating findings and conclusions. Additionally, fellows are invited to write commentaries on recent articles published in other journals and highlight these to Gastroenterology’s readership. This experience teaches how to critically comment on published literature and point out its strengths and limitations. Overall, these learning experiences improve not only editorial and writing skills, but also knowledge in the respective areas of research.

Finally, fellows have the opportunity to write a commentary about a topic of their choice. This experience allows fellows to deepen their expertise in an area of research on an emerging topic they would like to highlight to their readers. Since this type of article is peer reviewed, reviewers’ comments help identify weaknesses of the initially submitted manuscript and increase the awareness about factors that need to be addressed to finally provide a high-quality article that is of value to Gastroenterology’s readership.

Concluding, being an editorial fellow for Gastroenterology is an extremely valuable experience. From an editorial aspect, fellows learn to review, summarize, and comment on submitted manuscripts, as well as which factors need to be addressed by manuscripts to be considered for publication to a high-impact journal. Additionally, fellows network with leaders in the field and expand their knowledge on topics they had not worked on previously. Overall, the fellowship helps improve editorial and writing skills, while staying current in the literature, a skill set that can be applied broadly in the future medical and scientific career.

Dr. Kefalakes is a clinical fellow and research group leader in the department of gastroenterology, hepatology, and endocrinology at Hannover (Germany) Medical School. She has nothing to declare.

On the top left of my desktop is an electronic sticky note entitled, “Apply in Future.” This was where the AGA editorial fellowship was listed when I first started GI fellowship. My interest in the behind-the-scenes of scientific publishing developed early. I wanted to learn not only about the decision-making by the editorial board but also other aspects that impact the process from submission to publication. While waiting for my opportunity to apply, I became a reviewer for several journals and then an associate editor of ACG Case Reports Journal, which gave me some insight.

I applied to the editorial fellowship as a second-year fellow, to start as a third-year fellow. I figured this would give me several chances to apply again if I was not selected! I started off by talking to my program director to ensure that I would have enough time, given other responsibilities. The application consisted of a cover letter, where I expressed why I was interested, particularly focusing on my passion for research and my experience with scientific publishing, a letter of recommendation, and a CV. I was ecstatic when I was selected for the AGA editorial fellowship for Clinical Gastroenterology and Hepatology (CGH), whose editorial board’s mission best aligned with my interests.

Dr. Jonathan Buscaglia was the editorial fellows’ mentor for CGH – he met with us and provided an outline of the year. For the first 6 months, I was a reviewer for submitted manuscripts within my topic of interest – pancreaticobiliary diseases and advanced endoscopy and technology. Dr. Buscaglia gave me feedback on my reviews to improve my critical assessment of study designs and interpreted results. After 6 months as a reviewer, I took on the role of an associate editor. I selected reviewers, evaluated the reviews, and made the decision to accept or reject a manuscript. I presented my assigned manuscript at the weekly board of editors meeting, which was one of the biggest learning experiences. Leading researchers from all over the world gathered at a virtual table and discussed whether each study would have clinical impact on the medical community. Each editor contributed a unique perspective that facilitated a robust and thoughtful discussion of each manuscript brought to the table. I was in awe each week.

What I have learned so far during my year as an AGA editorial fellow with CGH has shaped my approach to personal research and will continue to do so as I develop my research career. It has greatly improved my assessment of the literature and I hope to continue to be involved in the critical review process, especially as a reviewer in my early career, and eventually, a part of an editorial board for a journal that truly impacts clinical medicine, such as Clinical Gastroenterology and Hepatology.
 

Dr. Trieu is a gastroenterology and hepatology fellow at Loyola University Medical Center, Maywood, Ill. She has no conflicts of interest to disclose.

On the top left of my desktop is an electronic sticky note entitled, “Apply in Future.” This was where the AGA editorial fellowship was listed when I first started GI fellowship. My interest in the behind-the-scenes of scientific publishing developed early. I wanted to learn not only about the decision-making by the editorial board but also other aspects that impact the process from submission to publication. While waiting for my opportunity to apply, I became a reviewer for several journals and then an associate editor of ACG Case Reports Journal, which gave me some insight.

I applied to the editorial fellowship as a second-year fellow, to start as a third-year fellow. I figured this would give me several chances to apply again if I was not selected! I started off by talking to my program director to ensure that I would have enough time, given other responsibilities. The application consisted of a cover letter, where I expressed why I was interested, particularly focusing on my passion for research and my experience with scientific publishing, a letter of recommendation, and a CV. I was ecstatic when I was selected for the AGA editorial fellowship for Clinical Gastroenterology and Hepatology (CGH), whose editorial board’s mission best aligned with my interests.

Dr. Jonathan Buscaglia was the editorial fellows’ mentor for CGH – he met with us and provided an outline of the year. For the first 6 months, I was a reviewer for submitted manuscripts within my topic of interest – pancreaticobiliary diseases and advanced endoscopy and technology. Dr. Buscaglia gave me feedback on my reviews to improve my critical assessment of study designs and interpreted results. After 6 months as a reviewer, I took on the role of an associate editor. I selected reviewers, evaluated the reviews, and made the decision to accept or reject a manuscript. I presented my assigned manuscript at the weekly board of editors meeting, which was one of the biggest learning experiences. Leading researchers from all over the world gathered at a virtual table and discussed whether each study would have clinical impact on the medical community. Each editor contributed a unique perspective that facilitated a robust and thoughtful discussion of each manuscript brought to the table. I was in awe each week.

What I have learned so far during my year as an AGA editorial fellow with CGH has shaped my approach to personal research and will continue to do so as I develop my research career. It has greatly improved my assessment of the literature and I hope to continue to be involved in the critical review process, especially as a reviewer in my early career, and eventually, a part of an editorial board for a journal that truly impacts clinical medicine, such as Clinical Gastroenterology and Hepatology.
 

Dr. Trieu is a gastroenterology and hepatology fellow at Loyola University Medical Center, Maywood, Ill. She has no conflicts of interest to disclose.

On the top left of my desktop is an electronic sticky note entitled, “Apply in Future.” This was where the AGA editorial fellowship was listed when I first started GI fellowship. My interest in the behind-the-scenes of scientific publishing developed early. I wanted to learn not only about the decision-making by the editorial board but also other aspects that impact the process from submission to publication. While waiting for my opportunity to apply, I became a reviewer for several journals and then an associate editor of ACG Case Reports Journal, which gave me some insight.

I applied to the editorial fellowship as a second-year fellow, to start as a third-year fellow. I figured this would give me several chances to apply again if I was not selected! I started off by talking to my program director to ensure that I would have enough time, given other responsibilities. The application consisted of a cover letter, where I expressed why I was interested, particularly focusing on my passion for research and my experience with scientific publishing, a letter of recommendation, and a CV. I was ecstatic when I was selected for the AGA editorial fellowship for Clinical Gastroenterology and Hepatology (CGH), whose editorial board’s mission best aligned with my interests.

Dr. Jonathan Buscaglia was the editorial fellows’ mentor for CGH – he met with us and provided an outline of the year. For the first 6 months, I was a reviewer for submitted manuscripts within my topic of interest – pancreaticobiliary diseases and advanced endoscopy and technology. Dr. Buscaglia gave me feedback on my reviews to improve my critical assessment of study designs and interpreted results. After 6 months as a reviewer, I took on the role of an associate editor. I selected reviewers, evaluated the reviews, and made the decision to accept or reject a manuscript. I presented my assigned manuscript at the weekly board of editors meeting, which was one of the biggest learning experiences. Leading researchers from all over the world gathered at a virtual table and discussed whether each study would have clinical impact on the medical community. Each editor contributed a unique perspective that facilitated a robust and thoughtful discussion of each manuscript brought to the table. I was in awe each week.

What I have learned so far during my year as an AGA editorial fellow with CGH has shaped my approach to personal research and will continue to do so as I develop my research career. It has greatly improved my assessment of the literature and I hope to continue to be involved in the critical review process, especially as a reviewer in my early career, and eventually, a part of an editorial board for a journal that truly impacts clinical medicine, such as Clinical Gastroenterology and Hepatology.
 

Dr. Trieu is a gastroenterology and hepatology fellow at Loyola University Medical Center, Maywood, Ill. She has no conflicts of interest to disclose.

In previous articles, we explored the meaning of two statistical concepts: that of the P value¹ and that of confounding.² In today’s article, we will focus on another important, though often underrecognized, statistical concept: that of effect modification (sometimes also called “interaction,” although many authors draw a distinction between these terms).^3-5 In brief, effect modification is the recognition that the relationship between two variables can be different based on the values of a third variable. Let me illustrate with an example. Suppose that you give a weight-loss drug to a group of people. After a predetermined time, say 3 months, you weigh them to measure the effects of the drug, and you record that on average each individual lost about 10 pounds. Suppose, however, that you are curious to see the effect of the drug in men and women separately. You perform an analysis stratified by sex, and you notice that men lost on average only about 1 pound each, whereas women lost on average about 30 pounds each. What do these results mean? It seems that the effect of the drug on weight loss is different depending on the value of a third variable, namely sex. That is, in this case, sex acts as an effect modifier. Based on this analysis, we may conclude that the drug has real effects on women but not on men.

Before reaching this conclusion, however, it is appropriate to ask whether we have made a mistake. The first obvious thing is to make sure that we have not made a mistake in our collection of data. Once we have excluded the presence of structural bias in our dataset, how can we ascertain that these results, which at eyeballing seem so different, have not been so as a result of chance? Fortunately, we do not have to guess. There is a way to formally test for this hypothesis. If sex is truly an effect modifier, then we can perform what is called in statistical terms an “interaction term” between the exposure (in this case the drug) and the potential effect modifier (in this case sex) in a multivariable model that includes both as exposures. If the P value for that interaction term is less than .05, then the interaction term is statistically significant, and therefore the variable (in this case sex) is confirmed to be an effect modifier. Hence, the results are not due to chance, and the different effects in men and women are plausibly attributable to different biological responses to the medication.

Difference between confounding and effect modification

At this point someone might ask, “What then is the difference between confounding and effect modification? In both cases, we do stratified analysis of the relationship between an exposure (in this case the weight-loss drug) and an outcome (in this case weight loss) based on strata of a third variable (in this case sex).” The difference is fundamental. Confounding, as we explored in a previous article,² is something that we would like to get rid of. It is the effect of an outside variable on both the exposure and outcome that does not allow us to properly evaluate the real relationship between the two. As such, we try to adjust for this variable, so that its effect is eliminated and we can only observe the relationship between the exposure and the outcome. Effect modification, on the other side, is not something we would like to get rid of. On the contrary, effect modification is part of what we would like to explore and describe because it is part of the biological mechanism that explains the real relationship between the exposure and the outcome. In the example above, if effect modification by sex is confirmed, it implies that there is something in female biology that is not found in male biology (or vice-versa) that makes their response to the medication different and therefore something of interest to study further. Thus, differently from confounding, effect modification is part of the objective reality of the world which we would like to explore and evaluate.

Several questions then arise. How can we know whether a variable is a confounder, an effect modifier, or both? As a general rule of thumb, a confounder would be a variable which, when a stratified analysis is done (or when added to a multivariable model), will change the relationship between the exposure and outcome by 10% or more. However, the relationship between the exposure and the outcome in both strata will be similar. In the example above, it would mean that if sex was only a confounder, then stratifying by sex would show roughly a similar change in the effect (say 9 kg for men and 11 kg for women). An effect modifier on the other hand is one which, when a stratified analysis is done, the association between the exposure and the outcome is very different in the two strata, as illustrated in the example above (for simplicity I am only considering two-level effect modifiers in this article).

Can a variable be both a confounder and an effect modifier? Yes, that is possible. What can be done in this case? The most common approach is to behave the same as when only effect modification is present, namely to show with the interaction term that effect modification exists and present the results between the exposure and outcome separately by the level of the effect modifier (in this example, it means that we need to describe the effects of the weight-loss drug separately for men and women). The stratified analysis/presentation will, by definition, take care of confounding as well.²

Should we always look for effect modification? Not necessarily. As a general rule, we need to test for effect modification only if there is some biological rationale that would compel us to do so, and testing should be hypothesis-driven. A common mistake that some authors make is to perform too many interaction tests and then describe as “positive findings” any test for which P value happens to be less than .05. However, as we pointed out in the article on P value,1 if we perform multiple tests, this increases the probability of false positives, and therefore the probability of spurious findings. Thus, effect modification analysis (with interaction terms) should, generally speaking, be performed with a biological rationale and/or be hypothesis driven.
 

Conclusion

Effect modification is an essential statistical concept that describes an underlying biological reality in which the association between an exposure and an outcome is different based on the values of a third variable. Differently from confounding, which clouds the association between exposure and outcome, and therefore is something that we try to get rid of, effect modification serves to bring to light a more proper understanding of the biological reality underlying the true association between an exposure and an outcome and as such is something that needs to be explored and described.

Dr. Jovani is assistant professor of medicine, therapeutic endoscopy, digestive diseases, and nutrition at the University of Kentucky Albert B. Chandler Hospital, Lexington. He has no conflicts of interest.

References

1. “The P value: What to make of it? A simple guide for the uninitiated.” GI & Hepatology News. 2019 Sep 23. www.mdedge.com/gihepnews/article/208601/mixed-topics/p-value-what-make-it-simple-guide-uninitiated

2. “Evaluating a paper: Take care not to be confounded.” GI & Hepatology News. 2020 Sep 18. www.mdedge.com/gihepnews/article/228765/mixed-topics/evaluating-paper-take-care-not-be-confounded

3. Corraini P et al. Clin Epidemiol. 2017;9:331-8. doi: 10.2147/CLEP.S162236.

4. VanderWeele TJ. Epidemiology. 2009 Nov;20(6):863-71. doi: 10.1097/EDE.0b013e3181ba333c.

5. Shahar E and Shahar DJ. Epidemiology. 2010 Jul;21(4):587. doi: 10.1097/EDE.0b013e3181e0995c. Author reply 587-8.

In previous articles, we explored the meaning of two statistical concepts: that of the P value¹ and that of confounding.² In today’s article, we will focus on another important, though often underrecognized, statistical concept: that of effect modification (sometimes also called “interaction,” although many authors draw a distinction between these terms).^3-5 In brief, effect modification is the recognition that the relationship between two variables can be different based on the values of a third variable. Let me illustrate with an example. Suppose that you give a weight-loss drug to a group of people. After a predetermined time, say 3 months, you weigh them to measure the effects of the drug, and you record that on average each individual lost about 10 pounds. Suppose, however, that you are curious to see the effect of the drug in men and women separately. You perform an analysis stratified by sex, and you notice that men lost on average only about 1 pound each, whereas women lost on average about 30 pounds each. What do these results mean? It seems that the effect of the drug on weight loss is different depending on the value of a third variable, namely sex. That is, in this case, sex acts as an effect modifier. Based on this analysis, we may conclude that the drug has real effects on women but not on men.

Before reaching this conclusion, however, it is appropriate to ask whether we have made a mistake. The first obvious thing is to make sure that we have not made a mistake in our collection of data. Once we have excluded the presence of structural bias in our dataset, how can we ascertain that these results, which at eyeballing seem so different, have not been so as a result of chance? Fortunately, we do not have to guess. There is a way to formally test for this hypothesis. If sex is truly an effect modifier, then we can perform what is called in statistical terms an “interaction term” between the exposure (in this case the drug) and the potential effect modifier (in this case sex) in a multivariable model that includes both as exposures. If the P value for that interaction term is less than .05, then the interaction term is statistically significant, and therefore the variable (in this case sex) is confirmed to be an effect modifier. Hence, the results are not due to chance, and the different effects in men and women are plausibly attributable to different biological responses to the medication.

Difference between confounding and effect modification

At this point someone might ask, “What then is the difference between confounding and effect modification? In both cases, we do stratified analysis of the relationship between an exposure (in this case the weight-loss drug) and an outcome (in this case weight loss) based on strata of a third variable (in this case sex).” The difference is fundamental. Confounding, as we explored in a previous article,² is something that we would like to get rid of. It is the effect of an outside variable on both the exposure and outcome that does not allow us to properly evaluate the real relationship between the two. As such, we try to adjust for this variable, so that its effect is eliminated and we can only observe the relationship between the exposure and the outcome. Effect modification, on the other side, is not something we would like to get rid of. On the contrary, effect modification is part of what we would like to explore and describe because it is part of the biological mechanism that explains the real relationship between the exposure and the outcome. In the example above, if effect modification by sex is confirmed, it implies that there is something in female biology that is not found in male biology (or vice-versa) that makes their response to the medication different and therefore something of interest to study further. Thus, differently from confounding, effect modification is part of the objective reality of the world which we would like to explore and evaluate.

Several questions then arise. How can we know whether a variable is a confounder, an effect modifier, or both? As a general rule of thumb, a confounder would be a variable which, when a stratified analysis is done (or when added to a multivariable model), will change the relationship between the exposure and outcome by 10% or more. However, the relationship between the exposure and the outcome in both strata will be similar. In the example above, it would mean that if sex was only a confounder, then stratifying by sex would show roughly a similar change in the effect (say 9 kg for men and 11 kg for women). An effect modifier on the other hand is one which, when a stratified analysis is done, the association between the exposure and the outcome is very different in the two strata, as illustrated in the example above (for simplicity I am only considering two-level effect modifiers in this article).

Can a variable be both a confounder and an effect modifier? Yes, that is possible. What can be done in this case? The most common approach is to behave the same as when only effect modification is present, namely to show with the interaction term that effect modification exists and present the results between the exposure and outcome separately by the level of the effect modifier (in this example, it means that we need to describe the effects of the weight-loss drug separately for men and women). The stratified analysis/presentation will, by definition, take care of confounding as well.²

Should we always look for effect modification? Not necessarily. As a general rule, we need to test for effect modification only if there is some biological rationale that would compel us to do so, and testing should be hypothesis-driven. A common mistake that some authors make is to perform too many interaction tests and then describe as “positive findings” any test for which P value happens to be less than .05. However, as we pointed out in the article on P value,1 if we perform multiple tests, this increases the probability of false positives, and therefore the probability of spurious findings. Thus, effect modification analysis (with interaction terms) should, generally speaking, be performed with a biological rationale and/or be hypothesis driven.
 

Conclusion

Effect modification is an essential statistical concept that describes an underlying biological reality in which the association between an exposure and an outcome is different based on the values of a third variable. Differently from confounding, which clouds the association between exposure and outcome, and therefore is something that we try to get rid of, effect modification serves to bring to light a more proper understanding of the biological reality underlying the true association between an exposure and an outcome and as such is something that needs to be explored and described.

Dr. Jovani is assistant professor of medicine, therapeutic endoscopy, digestive diseases, and nutrition at the University of Kentucky Albert B. Chandler Hospital, Lexington. He has no conflicts of interest.

References

1. “The P value: What to make of it? A simple guide for the uninitiated.” GI & Hepatology News. 2019 Sep 23. www.mdedge.com/gihepnews/article/208601/mixed-topics/p-value-what-make-it-simple-guide-uninitiated

2. “Evaluating a paper: Take care not to be confounded.” GI & Hepatology News. 2020 Sep 18. www.mdedge.com/gihepnews/article/228765/mixed-topics/evaluating-paper-take-care-not-be-confounded

3. Corraini P et al. Clin Epidemiol. 2017;9:331-8. doi: 10.2147/CLEP.S162236.

4. VanderWeele TJ. Epidemiology. 2009 Nov;20(6):863-71. doi: 10.1097/EDE.0b013e3181ba333c.

5. Shahar E and Shahar DJ. Epidemiology. 2010 Jul;21(4):587. doi: 10.1097/EDE.0b013e3181e0995c. Author reply 587-8.

In previous articles, we explored the meaning of two statistical concepts: that of the P value¹ and that of confounding.² In today’s article, we will focus on another important, though often underrecognized, statistical concept: that of effect modification (sometimes also called “interaction,” although many authors draw a distinction between these terms).^3-5 In brief, effect modification is the recognition that the relationship between two variables can be different based on the values of a third variable. Let me illustrate with an example. Suppose that you give a weight-loss drug to a group of people. After a predetermined time, say 3 months, you weigh them to measure the effects of the drug, and you record that on average each individual lost about 10 pounds. Suppose, however, that you are curious to see the effect of the drug in men and women separately. You perform an analysis stratified by sex, and you notice that men lost on average only about 1 pound each, whereas women lost on average about 30 pounds each. What do these results mean? It seems that the effect of the drug on weight loss is different depending on the value of a third variable, namely sex. That is, in this case, sex acts as an effect modifier. Based on this analysis, we may conclude that the drug has real effects on women but not on men.

Before reaching this conclusion, however, it is appropriate to ask whether we have made a mistake. The first obvious thing is to make sure that we have not made a mistake in our collection of data. Once we have excluded the presence of structural bias in our dataset, how can we ascertain that these results, which at eyeballing seem so different, have not been so as a result of chance? Fortunately, we do not have to guess. There is a way to formally test for this hypothesis. If sex is truly an effect modifier, then we can perform what is called in statistical terms an “interaction term” between the exposure (in this case the drug) and the potential effect modifier (in this case sex) in a multivariable model that includes both as exposures. If the P value for that interaction term is less than .05, then the interaction term is statistically significant, and therefore the variable (in this case sex) is confirmed to be an effect modifier. Hence, the results are not due to chance, and the different effects in men and women are plausibly attributable to different biological responses to the medication.

Difference between confounding and effect modification

At this point someone might ask, “What then is the difference between confounding and effect modification? In both cases, we do stratified analysis of the relationship between an exposure (in this case the weight-loss drug) and an outcome (in this case weight loss) based on strata of a third variable (in this case sex).” The difference is fundamental. Confounding, as we explored in a previous article,² is something that we would like to get rid of. It is the effect of an outside variable on both the exposure and outcome that does not allow us to properly evaluate the real relationship between the two. As such, we try to adjust for this variable, so that its effect is eliminated and we can only observe the relationship between the exposure and the outcome. Effect modification, on the other side, is not something we would like to get rid of. On the contrary, effect modification is part of what we would like to explore and describe because it is part of the biological mechanism that explains the real relationship between the exposure and the outcome. In the example above, if effect modification by sex is confirmed, it implies that there is something in female biology that is not found in male biology (or vice-versa) that makes their response to the medication different and therefore something of interest to study further. Thus, differently from confounding, effect modification is part of the objective reality of the world which we would like to explore and evaluate.

Several questions then arise. How can we know whether a variable is a confounder, an effect modifier, or both? As a general rule of thumb, a confounder would be a variable which, when a stratified analysis is done (or when added to a multivariable model), will change the relationship between the exposure and outcome by 10% or more. However, the relationship between the exposure and the outcome in both strata will be similar. In the example above, it would mean that if sex was only a confounder, then stratifying by sex would show roughly a similar change in the effect (say 9 kg for men and 11 kg for women). An effect modifier on the other hand is one which, when a stratified analysis is done, the association between the exposure and the outcome is very different in the two strata, as illustrated in the example above (for simplicity I am only considering two-level effect modifiers in this article).

Can a variable be both a confounder and an effect modifier? Yes, that is possible. What can be done in this case? The most common approach is to behave the same as when only effect modification is present, namely to show with the interaction term that effect modification exists and present the results between the exposure and outcome separately by the level of the effect modifier (in this example, it means that we need to describe the effects of the weight-loss drug separately for men and women). The stratified analysis/presentation will, by definition, take care of confounding as well.²

Should we always look for effect modification? Not necessarily. As a general rule, we need to test for effect modification only if there is some biological rationale that would compel us to do so, and testing should be hypothesis-driven. A common mistake that some authors make is to perform too many interaction tests and then describe as “positive findings” any test for which P value happens to be less than .05. However, as we pointed out in the article on P value,1 if we perform multiple tests, this increases the probability of false positives, and therefore the probability of spurious findings. Thus, effect modification analysis (with interaction terms) should, generally speaking, be performed with a biological rationale and/or be hypothesis driven.
 

Conclusion

Effect modification is an essential statistical concept that describes an underlying biological reality in which the association between an exposure and an outcome is different based on the values of a third variable. Differently from confounding, which clouds the association between exposure and outcome, and therefore is something that we try to get rid of, effect modification serves to bring to light a more proper understanding of the biological reality underlying the true association between an exposure and an outcome and as such is something that needs to be explored and described.

Dr. Jovani is assistant professor of medicine, therapeutic endoscopy, digestive diseases, and nutrition at the University of Kentucky Albert B. Chandler Hospital, Lexington. He has no conflicts of interest.

References

1. “The P value: What to make of it? A simple guide for the uninitiated.” GI & Hepatology News. 2019 Sep 23. www.mdedge.com/gihepnews/article/208601/mixed-topics/p-value-what-make-it-simple-guide-uninitiated

2. “Evaluating a paper: Take care not to be confounded.” GI & Hepatology News. 2020 Sep 18. www.mdedge.com/gihepnews/article/228765/mixed-topics/evaluating-paper-take-care-not-be-confounded

3. Corraini P et al. Clin Epidemiol. 2017;9:331-8. doi: 10.2147/CLEP.S162236.

4. VanderWeele TJ. Epidemiology. 2009 Nov;20(6):863-71. doi: 10.1097/EDE.0b013e3181ba333c.

5. Shahar E and Shahar DJ. Epidemiology. 2010 Jul;21(4):587. doi: 10.1097/EDE.0b013e3181e0995c. Author reply 587-8.

Duodenal polyps are a relatively rare entity with a reported incidence of 0.3%-4.6%.¹ There are three major types of duodenal adenomas: sporadic, nonampullary duodenal adenomas (SNDAs), adenomas in familial adenomatous polyposis syndrome, and ampullary adenomas. It is important to distinguish between the different types of duodenal polyps as the management may differ depending on the etiology.

SNDAs constitute <10% of all duodenal polyps, most commonly located in the second portion of the duodenum, and up to 85% have been shown to have malignant transformation over time.² Most of the studies of SNDAs are small series, and there are no consensus guidelines for management. Villous features increase malignancy risk, thus resection of SNDAs is advised.^3-7 It has also been shown that 72% of patients with SNDAs also have colon polyps,⁸ and therefore these patients should be up to date on colonoscopy screening.

Ampullary adenomas are less common, but up to half may be associated with familial adenomatous polyposis (FAP), and some may be surveyed.⁹ However, those that are larger than 10 mm or have villous features may raise concern for malignancy with up to half harboring small foci of adenocarcinoma.^10,11 These require ERCP with ampullectomy. For the purposes of this paper, we will focus on endoscopic resection of SNDAs and ampullary adenomas.

Endoscopic mucosal resection (EMR) of duodenal polyps can be technically challenging. There are considerations specific to the duodenum: thin muscle layer, increased motility, and significant vascular supply including two major arterial supplies – the gastroduodenal artery from the celiac branch and the inferior pancreaticoduodenal artery from the superior mesenteric artery. These factors may explain higher reported rates of perforation and bleeding compared to colon EMR.

After a detailed inspection is performed to define the duodenal polyp in terms of size, location, and position relative to the ampulla, a submucosal injection is performed using a dye solution. Once adequate lift is achieved, the lesion is resected using stiff monofilament snares. If possible, resection sites are closed with hemostatic clips, although their utility in preventing delayed complications may be less than that in the colon because of increased motility causing them to become dislodged more easily. We avoid using snares larger than 2 cm given increased risk of perforation. Intraprocedural bleeding may be controlled with coagulation graspers on soft coagulation setting; using a bipolar electrocoagulation therapy or argon plasma coagulation is avoided, as these have been shown to increase rates of complications. Figure 1 provides examples of duodenal adenomas that have been resected.

Courtesy Dr. Kim and Dr. Siddiqui

The ampullectomy technique is slightly different from duodenal EMRs and carries the additional risk of pancreatitis.^12,13 In our opinion, there is low utility for submucosal injection unless there is a laterally spreading component onto the duodenal wall, as injection of the ampulla itself does not lift well and simply distorts views. Typically, both the common bile duct and the pancreatic duct are injected with contrast, and we typically perform a biliary sphincterotomy prior to ampullectomy. Based on endoscopist preference, one can also leave a guide wire in the pancreatic duct (PD) and pass the snare over it to perform resection to maintain access for a subsequent stent placement. This technique has the advantage of never losing pancreatic duct access, which can occur after resection from edema or bleeding and allows easy PD stent placement. The snare should be opened in a line corresponding to the long axis of the mound with the snare tip anchored above the apex of the papilla and snare opened and drawn down over the papilla. After resection, the PD must be stented to minimize pancreatitis risk.¹⁴ Figure 2 shows an ampullary adenoma pre and post EMR, with a PD stent.

Recurrence of duodenal adenomas, both SNDAs and ampullary, can be quite high, with reports up to 39%.^15-18 Risk factors include histology and size, but interestingly were not shown to be associated with en-bloc resection.^15,19 On the other hand, intraprocedural bleeding also occurs in up to 43% of patients and is associated with size, number of resections, and procedure time.²⁰ Per 2015 ASGE Standards of Practice, duodenal lesions warrant short follow-up at 3- to 6-month intervals given high recurrence rates, then at 6- to 12-month intervals for 2-5 years thereafter.²¹

When a duodenal polyp is detected, it is important to determine which type of adenoma it is to guide management. There are various techniques utilized to perform duodenal EMR and ampullectomy with some highlighted in this article. It is important to understand how to recognize, prevent, and manage associated adverse events, as well as to have a surveillance plan given the risk of recurrence.

Dr. Kim has no disclosures. Dr. Siddiqui has financial relationships with Boston Scientific (research support, consulting fees, speaking honoraria); Cook, Medtronic, ConMed (consulting fees, speaking honoraria); and Pinnacle Biologic, Ovesco (speaking honoraria).

Dr. Kim is a GI fellow, section of gastroenterology, hepatology, and nutrition, department of internal medicine, University of Chicago. Dr. Siddiqui is a professor of medicine and the director of the Center for Endoscopic Research and Therapeutics (CERT), section of gastroenterology, hepatology, and nutrition, department of internal medicine, University of Chicago.

References

1. Jepsen JM et al. Scand J Gastroenterol. Jun 1994;29(6):483-7.

2. Sellner F. Cancer. 1990 Aug 15;66(4):702-15.

3. Witteman BJ et al. Neth J Med. 1993 Feb;42(1-2):5-11.

4. Reddy RR et al. J Clin Gastroenterol. 1981 Jun;3(2):139-47.

5. Sakorafas GH et al. Scand J Gastroenterol. 2000 Apr;35(4):337-44.

6. Galandiuk S et al. Ann Surg. 1988 Mar;207(3):234-9.

7. Farnell MB et al. J Gastrointest Surg. 2000 Jan-Feb;4(1):13-21, discussion 22-3.

8. Apel D et al. Gastrointest Endosc. 2004 Sep;60(3):397-9.

9. Kashiwagi H et al. Lancet. 1994 Dec 3;344(8936):1582.

10. Clary BM et al. Surgery. 2000 Jun;127(6):628-33.

11. Posner S et al. Surgery. 2000 Oct;128(4):694-701.

12. Harewood GC et al. Gastrointest Endosc. 2005 Sep;62(3):367-70.

13. Chini P et al. World J Gastrointest Endosc. 2011 Dec 16;3(12):241-7.

14. Chang WI et al. Gut Liver. May 2014;8(3):306-12.

15. Hoibian S et al. Ann Gastroenterol. 2021;34(2):169-176. doi: 10.20524/aog.2021.0581.

16. Kakushima N et al. World J Gastroenterol. 2014 Sep 21;20(35):12501-8.

17. Lienert A and Bagshaw PF. ANZ J Surg. 2007 May;77(5):371-3.

18. Singh A et al. Gastrointest Endosc. 2016 Oct;84(4):700-8.

19. Tomizawa Y and Ginsberg GG. Gastrointest Endosc. 2018 May;87(5):1270-8.

20. Klein A et al. Gastrointest Endosc. 2016 Oct;84(4):688-96.

21. Chathadi KV et al. Gastrointest Endosc. 2015 Nov;82(5):773-81.

Duodenal polyps are a relatively rare entity with a reported incidence of 0.3%-4.6%.¹ There are three major types of duodenal adenomas: sporadic, nonampullary duodenal adenomas (SNDAs), adenomas in familial adenomatous polyposis syndrome, and ampullary adenomas. It is important to distinguish between the different types of duodenal polyps as the management may differ depending on the etiology.

SNDAs constitute <10% of all duodenal polyps, most commonly located in the second portion of the duodenum, and up to 85% have been shown to have malignant transformation over time.² Most of the studies of SNDAs are small series, and there are no consensus guidelines for management. Villous features increase malignancy risk, thus resection of SNDAs is advised.^3-7 It has also been shown that 72% of patients with SNDAs also have colon polyps,⁸ and therefore these patients should be up to date on colonoscopy screening.

Ampullary adenomas are less common, but up to half may be associated with familial adenomatous polyposis (FAP), and some may be surveyed.⁹ However, those that are larger than 10 mm or have villous features may raise concern for malignancy with up to half harboring small foci of adenocarcinoma.^10,11 These require ERCP with ampullectomy. For the purposes of this paper, we will focus on endoscopic resection of SNDAs and ampullary adenomas.

Endoscopic mucosal resection (EMR) of duodenal polyps can be technically challenging. There are considerations specific to the duodenum: thin muscle layer, increased motility, and significant vascular supply including two major arterial supplies – the gastroduodenal artery from the celiac branch and the inferior pancreaticoduodenal artery from the superior mesenteric artery. These factors may explain higher reported rates of perforation and bleeding compared to colon EMR.

After a detailed inspection is performed to define the duodenal polyp in terms of size, location, and position relative to the ampulla, a submucosal injection is performed using a dye solution. Once adequate lift is achieved, the lesion is resected using stiff monofilament snares. If possible, resection sites are closed with hemostatic clips, although their utility in preventing delayed complications may be less than that in the colon because of increased motility causing them to become dislodged more easily. We avoid using snares larger than 2 cm given increased risk of perforation. Intraprocedural bleeding may be controlled with coagulation graspers on soft coagulation setting; using a bipolar electrocoagulation therapy or argon plasma coagulation is avoided, as these have been shown to increase rates of complications. Figure 1 provides examples of duodenal adenomas that have been resected.

Courtesy Dr. Kim and Dr. Siddiqui

The ampullectomy technique is slightly different from duodenal EMRs and carries the additional risk of pancreatitis.^12,13 In our opinion, there is low utility for submucosal injection unless there is a laterally spreading component onto the duodenal wall, as injection of the ampulla itself does not lift well and simply distorts views. Typically, both the common bile duct and the pancreatic duct are injected with contrast, and we typically perform a biliary sphincterotomy prior to ampullectomy. Based on endoscopist preference, one can also leave a guide wire in the pancreatic duct (PD) and pass the snare over it to perform resection to maintain access for a subsequent stent placement. This technique has the advantage of never losing pancreatic duct access, which can occur after resection from edema or bleeding and allows easy PD stent placement. The snare should be opened in a line corresponding to the long axis of the mound with the snare tip anchored above the apex of the papilla and snare opened and drawn down over the papilla. After resection, the PD must be stented to minimize pancreatitis risk.¹⁴ Figure 2 shows an ampullary adenoma pre and post EMR, with a PD stent.

Recurrence of duodenal adenomas, both SNDAs and ampullary, can be quite high, with reports up to 39%.^15-18 Risk factors include histology and size, but interestingly were not shown to be associated with en-bloc resection.^15,19 On the other hand, intraprocedural bleeding also occurs in up to 43% of patients and is associated with size, number of resections, and procedure time.²⁰ Per 2015 ASGE Standards of Practice, duodenal lesions warrant short follow-up at 3- to 6-month intervals given high recurrence rates, then at 6- to 12-month intervals for 2-5 years thereafter.²¹

When a duodenal polyp is detected, it is important to determine which type of adenoma it is to guide management. There are various techniques utilized to perform duodenal EMR and ampullectomy with some highlighted in this article. It is important to understand how to recognize, prevent, and manage associated adverse events, as well as to have a surveillance plan given the risk of recurrence.

Dr. Kim has no disclosures. Dr. Siddiqui has financial relationships with Boston Scientific (research support, consulting fees, speaking honoraria); Cook, Medtronic, ConMed (consulting fees, speaking honoraria); and Pinnacle Biologic, Ovesco (speaking honoraria).

Dr. Kim is a GI fellow, section of gastroenterology, hepatology, and nutrition, department of internal medicine, University of Chicago. Dr. Siddiqui is a professor of medicine and the director of the Center for Endoscopic Research and Therapeutics (CERT), section of gastroenterology, hepatology, and nutrition, department of internal medicine, University of Chicago.

References

1. Jepsen JM et al. Scand J Gastroenterol. Jun 1994;29(6):483-7.

2. Sellner F. Cancer. 1990 Aug 15;66(4):702-15.

3. Witteman BJ et al. Neth J Med. 1993 Feb;42(1-2):5-11.

4. Reddy RR et al. J Clin Gastroenterol. 1981 Jun;3(2):139-47.

5. Sakorafas GH et al. Scand J Gastroenterol. 2000 Apr;35(4):337-44.

6. Galandiuk S et al. Ann Surg. 1988 Mar;207(3):234-9.

7. Farnell MB et al. J Gastrointest Surg. 2000 Jan-Feb;4(1):13-21, discussion 22-3.

8. Apel D et al. Gastrointest Endosc. 2004 Sep;60(3):397-9.

9. Kashiwagi H et al. Lancet. 1994 Dec 3;344(8936):1582.

10. Clary BM et al. Surgery. 2000 Jun;127(6):628-33.

11. Posner S et al. Surgery. 2000 Oct;128(4):694-701.

12. Harewood GC et al. Gastrointest Endosc. 2005 Sep;62(3):367-70.

13. Chini P et al. World J Gastrointest Endosc. 2011 Dec 16;3(12):241-7.

14. Chang WI et al. Gut Liver. May 2014;8(3):306-12.

15. Hoibian S et al. Ann Gastroenterol. 2021;34(2):169-176. doi: 10.20524/aog.2021.0581.

16. Kakushima N et al. World J Gastroenterol. 2014 Sep 21;20(35):12501-8.

17. Lienert A and Bagshaw PF. ANZ J Surg. 2007 May;77(5):371-3.

18. Singh A et al. Gastrointest Endosc. 2016 Oct;84(4):700-8.

19. Tomizawa Y and Ginsberg GG. Gastrointest Endosc. 2018 May;87(5):1270-8.

20. Klein A et al. Gastrointest Endosc. 2016 Oct;84(4):688-96.

21. Chathadi KV et al. Gastrointest Endosc. 2015 Nov;82(5):773-81.

Duodenal polyps are a relatively rare entity with a reported incidence of 0.3%-4.6%.¹ There are three major types of duodenal adenomas: sporadic, nonampullary duodenal adenomas (SNDAs), adenomas in familial adenomatous polyposis syndrome, and ampullary adenomas. It is important to distinguish between the different types of duodenal polyps as the management may differ depending on the etiology.

SNDAs constitute <10% of all duodenal polyps, most commonly located in the second portion of the duodenum, and up to 85% have been shown to have malignant transformation over time.² Most of the studies of SNDAs are small series, and there are no consensus guidelines for management. Villous features increase malignancy risk, thus resection of SNDAs is advised.^3-7 It has also been shown that 72% of patients with SNDAs also have colon polyps,⁸ and therefore these patients should be up to date on colonoscopy screening.

Ampullary adenomas are less common, but up to half may be associated with familial adenomatous polyposis (FAP), and some may be surveyed.⁹ However, those that are larger than 10 mm or have villous features may raise concern for malignancy with up to half harboring small foci of adenocarcinoma.^10,11 These require ERCP with ampullectomy. For the purposes of this paper, we will focus on endoscopic resection of SNDAs and ampullary adenomas.

Endoscopic mucosal resection (EMR) of duodenal polyps can be technically challenging. There are considerations specific to the duodenum: thin muscle layer, increased motility, and significant vascular supply including two major arterial supplies – the gastroduodenal artery from the celiac branch and the inferior pancreaticoduodenal artery from the superior mesenteric artery. These factors may explain higher reported rates of perforation and bleeding compared to colon EMR.

After a detailed inspection is performed to define the duodenal polyp in terms of size, location, and position relative to the ampulla, a submucosal injection is performed using a dye solution. Once adequate lift is achieved, the lesion is resected using stiff monofilament snares. If possible, resection sites are closed with hemostatic clips, although their utility in preventing delayed complications may be less than that in the colon because of increased motility causing them to become dislodged more easily. We avoid using snares larger than 2 cm given increased risk of perforation. Intraprocedural bleeding may be controlled with coagulation graspers on soft coagulation setting; using a bipolar electrocoagulation therapy or argon plasma coagulation is avoided, as these have been shown to increase rates of complications. Figure 1 provides examples of duodenal adenomas that have been resected.

Courtesy Dr. Kim and Dr. Siddiqui

The ampullectomy technique is slightly different from duodenal EMRs and carries the additional risk of pancreatitis.^12,13 In our opinion, there is low utility for submucosal injection unless there is a laterally spreading component onto the duodenal wall, as injection of the ampulla itself does not lift well and simply distorts views. Typically, both the common bile duct and the pancreatic duct are injected with contrast, and we typically perform a biliary sphincterotomy prior to ampullectomy. Based on endoscopist preference, one can also leave a guide wire in the pancreatic duct (PD) and pass the snare over it to perform resection to maintain access for a subsequent stent placement. This technique has the advantage of never losing pancreatic duct access, which can occur after resection from edema or bleeding and allows easy PD stent placement. The snare should be opened in a line corresponding to the long axis of the mound with the snare tip anchored above the apex of the papilla and snare opened and drawn down over the papilla. After resection, the PD must be stented to minimize pancreatitis risk.¹⁴ Figure 2 shows an ampullary adenoma pre and post EMR, with a PD stent.

Recurrence of duodenal adenomas, both SNDAs and ampullary, can be quite high, with reports up to 39%.^15-18 Risk factors include histology and size, but interestingly were not shown to be associated with en-bloc resection.^15,19 On the other hand, intraprocedural bleeding also occurs in up to 43% of patients and is associated with size, number of resections, and procedure time.²⁰ Per 2015 ASGE Standards of Practice, duodenal lesions warrant short follow-up at 3- to 6-month intervals given high recurrence rates, then at 6- to 12-month intervals for 2-5 years thereafter.²¹

When a duodenal polyp is detected, it is important to determine which type of adenoma it is to guide management. There are various techniques utilized to perform duodenal EMR and ampullectomy with some highlighted in this article. It is important to understand how to recognize, prevent, and manage associated adverse events, as well as to have a surveillance plan given the risk of recurrence.

Dr. Kim has no disclosures. Dr. Siddiqui has financial relationships with Boston Scientific (research support, consulting fees, speaking honoraria); Cook, Medtronic, ConMed (consulting fees, speaking honoraria); and Pinnacle Biologic, Ovesco (speaking honoraria).

Dr. Kim is a GI fellow, section of gastroenterology, hepatology, and nutrition, department of internal medicine, University of Chicago. Dr. Siddiqui is a professor of medicine and the director of the Center for Endoscopic Research and Therapeutics (CERT), section of gastroenterology, hepatology, and nutrition, department of internal medicine, University of Chicago.

References

1. Jepsen JM et al. Scand J Gastroenterol. Jun 1994;29(6):483-7.

2. Sellner F. Cancer. 1990 Aug 15;66(4):702-15.

3. Witteman BJ et al. Neth J Med. 1993 Feb;42(1-2):5-11.

4. Reddy RR et al. J Clin Gastroenterol. 1981 Jun;3(2):139-47.

5. Sakorafas GH et al. Scand J Gastroenterol. 2000 Apr;35(4):337-44.

6. Galandiuk S et al. Ann Surg. 1988 Mar;207(3):234-9.

7. Farnell MB et al. J Gastrointest Surg. 2000 Jan-Feb;4(1):13-21, discussion 22-3.

8. Apel D et al. Gastrointest Endosc. 2004 Sep;60(3):397-9.

9. Kashiwagi H et al. Lancet. 1994 Dec 3;344(8936):1582.

10. Clary BM et al. Surgery. 2000 Jun;127(6):628-33.

11. Posner S et al. Surgery. 2000 Oct;128(4):694-701.

12. Harewood GC et al. Gastrointest Endosc. 2005 Sep;62(3):367-70.

13. Chini P et al. World J Gastrointest Endosc. 2011 Dec 16;3(12):241-7.

14. Chang WI et al. Gut Liver. May 2014;8(3):306-12.

15. Hoibian S et al. Ann Gastroenterol. 2021;34(2):169-176. doi: 10.20524/aog.2021.0581.

16. Kakushima N et al. World J Gastroenterol. 2014 Sep 21;20(35):12501-8.

17. Lienert A and Bagshaw PF. ANZ J Surg. 2007 May;77(5):371-3.

18. Singh A et al. Gastrointest Endosc. 2016 Oct;84(4):700-8.

19. Tomizawa Y and Ginsberg GG. Gastrointest Endosc. 2018 May;87(5):1270-8.

20. Klein A et al. Gastrointest Endosc. 2016 Oct;84(4):688-96.

21. Chathadi KV et al. Gastrointest Endosc. 2015 Nov;82(5):773-81.

When I first became an attending, I was struck by how difficult it was to teach endoscopy effectively. As a fellow, I saw the various teaching styles of my attendings, and it was easy to pick out the best teachers from the group. But when the roles switched, and suddenly I was the supervising faculty member, it was hard to recall exactly what those teachers were doing to create an optimal learning environment in the endoscopy suite. Not only did I lack a framework on how to teach endoscopy, I also was still building confidence in my own endoscopic skills while feeling the pressure to keep my room running on time. All in all, although I loved the opportunity to teach, I found the experience to be quite stressful.

Hoping to find some guidance, I turned to the literature and was fortunate to find some great pieces on how to teach endoscopy effectively. I learned of cognitive load theory – the idea that short-term or “working memory” can manage only a few pieces of information at a time – and how excess feedback or other external distractions (e.g., pagers) during a procedure can overwhelm a learner and lead to declining performance.¹ I also read about the pursuit of “conscious competence,” where an endoscopist can verbalize the steps of a maneuver so that a trainee can remain on the scope and maximize hands-on participation.²

Motivated to bring these key concepts together in an evidence-based framework, I helped lead a Delphi study of GI fellowship program directors and endoscopy education experts to reach consensus on the best practices of teaching endoscopy.³ After two rounds of surveys, the participants identified 10 essential endoscopy teaching practices, which I will summarize in the next sections. What I found most helpful was how these practices were distributed throughout the endoscopy learning experience. By breaking down the complicated task of teaching endoscopy to three discrete parts – prior to the procedure, during the procedure, and after the procedure – I now had a framework to take back to the endoscopy suite.
 

Prior to the procedure

With a busy endoscopy schedule and increasing clinical demands, it is tempting to use the time between cases to complete documentation, address patient messages, and review emails. While this is great for efficiency, make sure to also reserve time to set the stage for your fellow. One of the key practices during this phase is to assess your fellow’s current procedural competency. I start open-ended by asking my fellows how they have been doing with colonoscopy and then ask if they are working on a specific skill. With this information, I have a sense of how much hands-on assistance they will need, what realistic goals to set for them (e.g., navigate out of the sigmoid colon for an early learner vs. efficiently and independently completing the entire case for a later learner), and the areas to focus my observation to provide feedback after the procedure.

During this preparatory time, faculty should also discuss the patient history and indications for the procedure. Reviewing information such as prior sedation requirements and confirming plans for the procedure (e.g., random colon biopsies in a patient with chronic diarrhea and concern for microscopic colitis) helps ensure a proper plan is in place for the patient while also presenting opportunities for learning. Faculty can take this time to review the steps of a more complicated procedure (e.g., PEG placement) and establish ground rules such as when the attending will take the scope from the trainee. Lastly, make sure that the patient understands the role of the fellow and the supervision you will be providing throughout the case.
 

During the procedure

Once the procedure starts, your most important task is to maintain attention throughout the case – if you do, the other best practices generally fall into place. I am most attentive when I am gowned and positioned next to the fellow. From this vantage point, I can see the patient, the fellow’s hands, and the endoscopy screen, which allows me to readily assist if needed while directly observing the fellow’s performance.

If I need to provide feedback in the moment, I often ask the fellows to pause what they are doing and first listen to my feedback. Taking this “timeout” helps manage their cognitive load such that they can actually hear the feedback. As a general rule, however, I try to reserve the bulk of my feedback for when the procedure is complete (see next section). Another way to manage your fellow’s cognitive load is by using standardized endoscopic language throughout the procedure. For example, rather than say “go to the left” during a colonoscopy, try saying “tip left” or “torque counterclockwise” to provide more clear instructions to the fellow. Holding your fellow’s pager during the procedure is a kind gesture that also helps minimize extraneous cognitive load so that the fellow can focus on the procedure.

If your fellows get to a point where they cannot complete the task despite your giving appropriate feedback, or if patient safety concerns arise, then it is time for you to take hands-on control of the scope. In my experience, most fellows welcome the hands-on assistance as they are overloaded by the difficulty of the procedure. Setting this expectation ahead of time, as noted above, makes for a smoother transition. While assuming control of the scope, try to narrate what you are doing differently so that the fellow can still learn while watching. Once you complete the difficult portion of the procedure (e.g., reducing a loop to reach the cecum), return the scope to the fellow to maximize the hands-on participation (if time permits).
 

After the procedure

In the third and final stage of the endoscopy teaching experience, faculty should take the time to confirm the findings of the procedure with the fellow and discuss next steps in management for the patient. Finding these teachable moments helps solidify the cognitive learning for the fellow while also ensuring the patient receives the appropriate postprocedure recommendations. As part of this process, make sure to review the procedure note drafted by the fellow, and if you need to make any substantive edits, review the changes with the fellow so that he or she can learn for future cases.

To wrap up the session, provide feedback to the fellow on performance based on your direct observation. Make sure to name this process aloud – “Let’s do some feedback” – and start by asking how the fellow felt about the performance, both in terms of what went well and what the fellow would like to improve. Then provide your feedback on the performance and be specific, such as, “I really like how you identified a loop and then reduced around the hepatic flexure.” Conclude by having the fellow set a plan for improvement and make sure to ask for feedback on your own teaching performance.

In conclusion, teaching endoscopy is hard – especially as a junior attending. By breaking down the endoscopy teaching experience into its three components, however, and committing to teaching from start to finish, you can provide high-quality endoscopy education to your fellows while ensuring the best care for your patients.

Dr. Kumar is associate medicine clerkship director at Harvard Medical School, and associate physician in the division of gastroenterology at Brigham and Women’s Hospital, both in Boston. He disclosed having no conflicts of interest. He is on Twitter @NavinKumarMD.

References

1. Dilly CK and Sewell JL. 2017 Sep;153(3):632-36.

2. Waschke KA et al. Best Pract Res Clin Gastroenterol. 2016 Jun;30(3):409-19.

3. Kumar NL et al. Clin Gastroenterol Hepatol. 2020 Mar;18(3):574-79.

When I first became an attending, I was struck by how difficult it was to teach endoscopy effectively. As a fellow, I saw the various teaching styles of my attendings, and it was easy to pick out the best teachers from the group. But when the roles switched, and suddenly I was the supervising faculty member, it was hard to recall exactly what those teachers were doing to create an optimal learning environment in the endoscopy suite. Not only did I lack a framework on how to teach endoscopy, I also was still building confidence in my own endoscopic skills while feeling the pressure to keep my room running on time. All in all, although I loved the opportunity to teach, I found the experience to be quite stressful.

Hoping to find some guidance, I turned to the literature and was fortunate to find some great pieces on how to teach endoscopy effectively. I learned of cognitive load theory – the idea that short-term or “working memory” can manage only a few pieces of information at a time – and how excess feedback or other external distractions (e.g., pagers) during a procedure can overwhelm a learner and lead to declining performance.¹ I also read about the pursuit of “conscious competence,” where an endoscopist can verbalize the steps of a maneuver so that a trainee can remain on the scope and maximize hands-on participation.²

Motivated to bring these key concepts together in an evidence-based framework, I helped lead a Delphi study of GI fellowship program directors and endoscopy education experts to reach consensus on the best practices of teaching endoscopy.³ After two rounds of surveys, the participants identified 10 essential endoscopy teaching practices, which I will summarize in the next sections. What I found most helpful was how these practices were distributed throughout the endoscopy learning experience. By breaking down the complicated task of teaching endoscopy to three discrete parts – prior to the procedure, during the procedure, and after the procedure – I now had a framework to take back to the endoscopy suite.
 

Prior to the procedure

With a busy endoscopy schedule and increasing clinical demands, it is tempting to use the time between cases to complete documentation, address patient messages, and review emails. While this is great for efficiency, make sure to also reserve time to set the stage for your fellow. One of the key practices during this phase is to assess your fellow’s current procedural competency. I start open-ended by asking my fellows how they have been doing with colonoscopy and then ask if they are working on a specific skill. With this information, I have a sense of how much hands-on assistance they will need, what realistic goals to set for them (e.g., navigate out of the sigmoid colon for an early learner vs. efficiently and independently completing the entire case for a later learner), and the areas to focus my observation to provide feedback after the procedure.

During this preparatory time, faculty should also discuss the patient history and indications for the procedure. Reviewing information such as prior sedation requirements and confirming plans for the procedure (e.g., random colon biopsies in a patient with chronic diarrhea and concern for microscopic colitis) helps ensure a proper plan is in place for the patient while also presenting opportunities for learning. Faculty can take this time to review the steps of a more complicated procedure (e.g., PEG placement) and establish ground rules such as when the attending will take the scope from the trainee. Lastly, make sure that the patient understands the role of the fellow and the supervision you will be providing throughout the case.
 

During the procedure

Once the procedure starts, your most important task is to maintain attention throughout the case – if you do, the other best practices generally fall into place. I am most attentive when I am gowned and positioned next to the fellow. From this vantage point, I can see the patient, the fellow’s hands, and the endoscopy screen, which allows me to readily assist if needed while directly observing the fellow’s performance.

If I need to provide feedback in the moment, I often ask the fellows to pause what they are doing and first listen to my feedback. Taking this “timeout” helps manage their cognitive load such that they can actually hear the feedback. As a general rule, however, I try to reserve the bulk of my feedback for when the procedure is complete (see next section). Another way to manage your fellow’s cognitive load is by using standardized endoscopic language throughout the procedure. For example, rather than say “go to the left” during a colonoscopy, try saying “tip left” or “torque counterclockwise” to provide more clear instructions to the fellow. Holding your fellow’s pager during the procedure is a kind gesture that also helps minimize extraneous cognitive load so that the fellow can focus on the procedure.

If your fellows get to a point where they cannot complete the task despite your giving appropriate feedback, or if patient safety concerns arise, then it is time for you to take hands-on control of the scope. In my experience, most fellows welcome the hands-on assistance as they are overloaded by the difficulty of the procedure. Setting this expectation ahead of time, as noted above, makes for a smoother transition. While assuming control of the scope, try to narrate what you are doing differently so that the fellow can still learn while watching. Once you complete the difficult portion of the procedure (e.g., reducing a loop to reach the cecum), return the scope to the fellow to maximize the hands-on participation (if time permits).
 

After the procedure

In the third and final stage of the endoscopy teaching experience, faculty should take the time to confirm the findings of the procedure with the fellow and discuss next steps in management for the patient. Finding these teachable moments helps solidify the cognitive learning for the fellow while also ensuring the patient receives the appropriate postprocedure recommendations. As part of this process, make sure to review the procedure note drafted by the fellow, and if you need to make any substantive edits, review the changes with the fellow so that he or she can learn for future cases.

To wrap up the session, provide feedback to the fellow on performance based on your direct observation. Make sure to name this process aloud – “Let’s do some feedback” – and start by asking how the fellow felt about the performance, both in terms of what went well and what the fellow would like to improve. Then provide your feedback on the performance and be specific, such as, “I really like how you identified a loop and then reduced around the hepatic flexure.” Conclude by having the fellow set a plan for improvement and make sure to ask for feedback on your own teaching performance.

In conclusion, teaching endoscopy is hard – especially as a junior attending. By breaking down the endoscopy teaching experience into its three components, however, and committing to teaching from start to finish, you can provide high-quality endoscopy education to your fellows while ensuring the best care for your patients.

Dr. Kumar is associate medicine clerkship director at Harvard Medical School, and associate physician in the division of gastroenterology at Brigham and Women’s Hospital, both in Boston. He disclosed having no conflicts of interest. He is on Twitter @NavinKumarMD.

References

1. Dilly CK and Sewell JL. 2017 Sep;153(3):632-36.

2. Waschke KA et al. Best Pract Res Clin Gastroenterol. 2016 Jun;30(3):409-19.

3. Kumar NL et al. Clin Gastroenterol Hepatol. 2020 Mar;18(3):574-79.

When I first became an attending, I was struck by how difficult it was to teach endoscopy effectively. As a fellow, I saw the various teaching styles of my attendings, and it was easy to pick out the best teachers from the group. But when the roles switched, and suddenly I was the supervising faculty member, it was hard to recall exactly what those teachers were doing to create an optimal learning environment in the endoscopy suite. Not only did I lack a framework on how to teach endoscopy, I also was still building confidence in my own endoscopic skills while feeling the pressure to keep my room running on time. All in all, although I loved the opportunity to teach, I found the experience to be quite stressful.

Hoping to find some guidance, I turned to the literature and was fortunate to find some great pieces on how to teach endoscopy effectively. I learned of cognitive load theory – the idea that short-term or “working memory” can manage only a few pieces of information at a time – and how excess feedback or other external distractions (e.g., pagers) during a procedure can overwhelm a learner and lead to declining performance.¹ I also read about the pursuit of “conscious competence,” where an endoscopist can verbalize the steps of a maneuver so that a trainee can remain on the scope and maximize hands-on participation.²

Motivated to bring these key concepts together in an evidence-based framework, I helped lead a Delphi study of GI fellowship program directors and endoscopy education experts to reach consensus on the best practices of teaching endoscopy.³ After two rounds of surveys, the participants identified 10 essential endoscopy teaching practices, which I will summarize in the next sections. What I found most helpful was how these practices were distributed throughout the endoscopy learning experience. By breaking down the complicated task of teaching endoscopy to three discrete parts – prior to the procedure, during the procedure, and after the procedure – I now had a framework to take back to the endoscopy suite.
 

Prior to the procedure

With a busy endoscopy schedule and increasing clinical demands, it is tempting to use the time between cases to complete documentation, address patient messages, and review emails. While this is great for efficiency, make sure to also reserve time to set the stage for your fellow. One of the key practices during this phase is to assess your fellow’s current procedural competency. I start open-ended by asking my fellows how they have been doing with colonoscopy and then ask if they are working on a specific skill. With this information, I have a sense of how much hands-on assistance they will need, what realistic goals to set for them (e.g., navigate out of the sigmoid colon for an early learner vs. efficiently and independently completing the entire case for a later learner), and the areas to focus my observation to provide feedback after the procedure.

During this preparatory time, faculty should also discuss the patient history and indications for the procedure. Reviewing information such as prior sedation requirements and confirming plans for the procedure (e.g., random colon biopsies in a patient with chronic diarrhea and concern for microscopic colitis) helps ensure a proper plan is in place for the patient while also presenting opportunities for learning. Faculty can take this time to review the steps of a more complicated procedure (e.g., PEG placement) and establish ground rules such as when the attending will take the scope from the trainee. Lastly, make sure that the patient understands the role of the fellow and the supervision you will be providing throughout the case.
 

During the procedure

Once the procedure starts, your most important task is to maintain attention throughout the case – if you do, the other best practices generally fall into place. I am most attentive when I am gowned and positioned next to the fellow. From this vantage point, I can see the patient, the fellow’s hands, and the endoscopy screen, which allows me to readily assist if needed while directly observing the fellow’s performance.

If I need to provide feedback in the moment, I often ask the fellows to pause what they are doing and first listen to my feedback. Taking this “timeout” helps manage their cognitive load such that they can actually hear the feedback. As a general rule, however, I try to reserve the bulk of my feedback for when the procedure is complete (see next section). Another way to manage your fellow’s cognitive load is by using standardized endoscopic language throughout the procedure. For example, rather than say “go to the left” during a colonoscopy, try saying “tip left” or “torque counterclockwise” to provide more clear instructions to the fellow. Holding your fellow’s pager during the procedure is a kind gesture that also helps minimize extraneous cognitive load so that the fellow can focus on the procedure.

If your fellows get to a point where they cannot complete the task despite your giving appropriate feedback, or if patient safety concerns arise, then it is time for you to take hands-on control of the scope. In my experience, most fellows welcome the hands-on assistance as they are overloaded by the difficulty of the procedure. Setting this expectation ahead of time, as noted above, makes for a smoother transition. While assuming control of the scope, try to narrate what you are doing differently so that the fellow can still learn while watching. Once you complete the difficult portion of the procedure (e.g., reducing a loop to reach the cecum), return the scope to the fellow to maximize the hands-on participation (if time permits).
 

After the procedure

In the third and final stage of the endoscopy teaching experience, faculty should take the time to confirm the findings of the procedure with the fellow and discuss next steps in management for the patient. Finding these teachable moments helps solidify the cognitive learning for the fellow while also ensuring the patient receives the appropriate postprocedure recommendations. As part of this process, make sure to review the procedure note drafted by the fellow, and if you need to make any substantive edits, review the changes with the fellow so that he or she can learn for future cases.

To wrap up the session, provide feedback to the fellow on performance based on your direct observation. Make sure to name this process aloud – “Let’s do some feedback” – and start by asking how the fellow felt about the performance, both in terms of what went well and what the fellow would like to improve. Then provide your feedback on the performance and be specific, such as, “I really like how you identified a loop and then reduced around the hepatic flexure.” Conclude by having the fellow set a plan for improvement and make sure to ask for feedback on your own teaching performance.

In conclusion, teaching endoscopy is hard – especially as a junior attending. By breaking down the endoscopy teaching experience into its three components, however, and committing to teaching from start to finish, you can provide high-quality endoscopy education to your fellows while ensuring the best care for your patients.

Dr. Kumar is associate medicine clerkship director at Harvard Medical School, and associate physician in the division of gastroenterology at Brigham and Women’s Hospital, both in Boston. He disclosed having no conflicts of interest. He is on Twitter @NavinKumarMD.

References

1. Dilly CK and Sewell JL. 2017 Sep;153(3):632-36.

2. Waschke KA et al. Best Pract Res Clin Gastroenterol. 2016 Jun;30(3):409-19.

3. Kumar NL et al. Clin Gastroenterol Hepatol. 2020 Mar;18(3):574-79.

Dear colleagues,

Welcome to the May edition of The New Gastroenterologist! Digestive Disease Week® (DDW) is approaching quickly, which is our first since 2019 with an option to attend in person. This will give many an opportunity to reconnect in a way we have not been able to in so long – a welcome reprieve from the virtual platforms we have become so accustomed to. Cautious optimism is pervasive throughout the country that the acuity of the pandemic may be receding, and that we are perhaps better equipped for future surges should they occur.

I’m excited to introduce this quarter’s content – beginning with our feature clinical “In Focus” piece. Gastroparesis often poses a therapeutic challenge to gastroenterologists; Dr. Thomas Abell and Dr. Prateek Mathur (University of Louisville) provide an excellent, comprehensive discussion of the utility and efficacy of dietary modifications, pharmacotherapy, pylorus-directed therapies, bioelectric therapy, and other novel approaches to the treatment of gastroparesis.

The role of a gastrointestinal psychologist within a gastroenterology practice is invaluable. The gut-brain axis is a key feature of any gastroenterological disorder and one of the hallmarks of therapy is behavioral symptom management. Dr. Alyse Bedell (University of Chicago) educates us on how to effectively integrate psychogastroenterology into our treatment plans and discusses which patients are poised to benefit the most from referral.

In just 2 short months, gastroenterology fellowship programs across the country will welcome their newest trainees. Dr. Rashmi Advani (Stony Brook University), Dr. Naba Saeed (University of Kentucky) and Dr. Aline Charabaty (Johns Hopkins University) offer detailed, practical advice to incoming fellows on how to make the most of (and survive!) the first year of gastroenterology fellowship, which can be one of the most challenging years of medical training.

In our Postfellowship Pathways section, we are fortunate to have Dr. Barbara Jung, chair of the department of medicine at the University of Washington and future AGA president, share her story. Her journey is inspirational as she discusses her path to success: How her roots in basic science led to building clinical programs and her transition from chief of a gastroenterology division to chair of a large department at one of the most prolific academic centers in the country.

One of the hallmarks of any heavily procedural field such as gastroenterology is innovation, namely the continuous evolution of procedural technique and utilization of novel technology. It can be difficult, however, to reconcile this innovation in the informed consent process when there are limited data on safety and efficacy. Dr. Peter Angelos and Dr. Jelani Williams (University of Chicago) share a riveting perspective on how to approach these scenarios in a wonderful addition to our medical ethics case series.

Finally, the DHPA Private Practice Perspectives article this quarter, written by Dr. Paul Feuerstadt (PACT-Gastroenterology Center, Hamden, Conn.) and Dr. Louis Korman (Capital Digestive Care, Maryland), reviews the benefits of performing clinical research in private practice and what early career physicians who would like to explore clinical research should look for when evaluating job opportunities.

If you have interest in contributing or have ideas for future TNG topics, please contact me ([email protected]), or Ryan Farrell ([email protected]), managing editor of TNG.
 

Stay well,

Vijaya L. Rao, MD
Editor-in-Chief
Assistant Professor of Medicine, University of Chicago, Section of Gastroenterology, Hepatology & Nutrition

Dear colleagues,

Welcome to the May edition of The New Gastroenterologist! Digestive Disease Week® (DDW) is approaching quickly, which is our first since 2019 with an option to attend in person. This will give many an opportunity to reconnect in a way we have not been able to in so long – a welcome reprieve from the virtual platforms we have become so accustomed to. Cautious optimism is pervasive throughout the country that the acuity of the pandemic may be receding, and that we are perhaps better equipped for future surges should they occur.

I’m excited to introduce this quarter’s content – beginning with our feature clinical “In Focus” piece. Gastroparesis often poses a therapeutic challenge to gastroenterologists; Dr. Thomas Abell and Dr. Prateek Mathur (University of Louisville) provide an excellent, comprehensive discussion of the utility and efficacy of dietary modifications, pharmacotherapy, pylorus-directed therapies, bioelectric therapy, and other novel approaches to the treatment of gastroparesis.

The role of a gastrointestinal psychologist within a gastroenterology practice is invaluable. The gut-brain axis is a key feature of any gastroenterological disorder and one of the hallmarks of therapy is behavioral symptom management. Dr. Alyse Bedell (University of Chicago) educates us on how to effectively integrate psychogastroenterology into our treatment plans and discusses which patients are poised to benefit the most from referral.

In just 2 short months, gastroenterology fellowship programs across the country will welcome their newest trainees. Dr. Rashmi Advani (Stony Brook University), Dr. Naba Saeed (University of Kentucky) and Dr. Aline Charabaty (Johns Hopkins University) offer detailed, practical advice to incoming fellows on how to make the most of (and survive!) the first year of gastroenterology fellowship, which can be one of the most challenging years of medical training.

In our Postfellowship Pathways section, we are fortunate to have Dr. Barbara Jung, chair of the department of medicine at the University of Washington and future AGA president, share her story. Her journey is inspirational as she discusses her path to success: How her roots in basic science led to building clinical programs and her transition from chief of a gastroenterology division to chair of a large department at one of the most prolific academic centers in the country.

One of the hallmarks of any heavily procedural field such as gastroenterology is innovation, namely the continuous evolution of procedural technique and utilization of novel technology. It can be difficult, however, to reconcile this innovation in the informed consent process when there are limited data on safety and efficacy. Dr. Peter Angelos and Dr. Jelani Williams (University of Chicago) share a riveting perspective on how to approach these scenarios in a wonderful addition to our medical ethics case series.

Finally, the DHPA Private Practice Perspectives article this quarter, written by Dr. Paul Feuerstadt (PACT-Gastroenterology Center, Hamden, Conn.) and Dr. Louis Korman (Capital Digestive Care, Maryland), reviews the benefits of performing clinical research in private practice and what early career physicians who would like to explore clinical research should look for when evaluating job opportunities.

If you have interest in contributing or have ideas for future TNG topics, please contact me ([email protected]), or Ryan Farrell ([email protected]), managing editor of TNG.
 

Stay well,

Vijaya L. Rao, MD
Editor-in-Chief
Assistant Professor of Medicine, University of Chicago, Section of Gastroenterology, Hepatology & Nutrition

Dear colleagues,

Welcome to the May edition of The New Gastroenterologist! Digestive Disease Week® (DDW) is approaching quickly, which is our first since 2019 with an option to attend in person. This will give many an opportunity to reconnect in a way we have not been able to in so long – a welcome reprieve from the virtual platforms we have become so accustomed to. Cautious optimism is pervasive throughout the country that the acuity of the pandemic may be receding, and that we are perhaps better equipped for future surges should they occur.

I’m excited to introduce this quarter’s content – beginning with our feature clinical “In Focus” piece. Gastroparesis often poses a therapeutic challenge to gastroenterologists; Dr. Thomas Abell and Dr. Prateek Mathur (University of Louisville) provide an excellent, comprehensive discussion of the utility and efficacy of dietary modifications, pharmacotherapy, pylorus-directed therapies, bioelectric therapy, and other novel approaches to the treatment of gastroparesis.

The role of a gastrointestinal psychologist within a gastroenterology practice is invaluable. The gut-brain axis is a key feature of any gastroenterological disorder and one of the hallmarks of therapy is behavioral symptom management. Dr. Alyse Bedell (University of Chicago) educates us on how to effectively integrate psychogastroenterology into our treatment plans and discusses which patients are poised to benefit the most from referral.

In just 2 short months, gastroenterology fellowship programs across the country will welcome their newest trainees. Dr. Rashmi Advani (Stony Brook University), Dr. Naba Saeed (University of Kentucky) and Dr. Aline Charabaty (Johns Hopkins University) offer detailed, practical advice to incoming fellows on how to make the most of (and survive!) the first year of gastroenterology fellowship, which can be one of the most challenging years of medical training.

In our Postfellowship Pathways section, we are fortunate to have Dr. Barbara Jung, chair of the department of medicine at the University of Washington and future AGA president, share her story. Her journey is inspirational as she discusses her path to success: How her roots in basic science led to building clinical programs and her transition from chief of a gastroenterology division to chair of a large department at one of the most prolific academic centers in the country.

One of the hallmarks of any heavily procedural field such as gastroenterology is innovation, namely the continuous evolution of procedural technique and utilization of novel technology. It can be difficult, however, to reconcile this innovation in the informed consent process when there are limited data on safety and efficacy. Dr. Peter Angelos and Dr. Jelani Williams (University of Chicago) share a riveting perspective on how to approach these scenarios in a wonderful addition to our medical ethics case series.

Finally, the DHPA Private Practice Perspectives article this quarter, written by Dr. Paul Feuerstadt (PACT-Gastroenterology Center, Hamden, Conn.) and Dr. Louis Korman (Capital Digestive Care, Maryland), reviews the benefits of performing clinical research in private practice and what early career physicians who would like to explore clinical research should look for when evaluating job opportunities.

If you have interest in contributing or have ideas for future TNG topics, please contact me ([email protected]), or Ryan Farrell ([email protected]), managing editor of TNG.
 

Stay well,

Vijaya L. Rao, MD
Editor-in-Chief
Assistant Professor of Medicine, University of Chicago, Section of Gastroenterology, Hepatology & Nutrition

Most people believe that, if you want to conduct clinical research, the best path is going into academic medicine. However, for physicians who want both the benefits of practicing in the community setting and a career in research, there are many ways to both treat patients and have a rewarding experience making a difference in facilitating treatment options that can become available to patients.

Our practices, Capital Digestive Care in Silver Spring, Md., and the PACT-Gastroenterology Center in Hamden, Conn, have been conducting clinical trials for many years on serious diseases such as inflammatory bowel disease, gastroparesis, and most recently, recurrent infection of Clostridioides difficile. We both also worked on the National Institutes of Health–sponsored Anal Cancer/HSIL Outcomes Research (ANCHOR) study.
 

Academic setting vs. private practice

Research in our practices is similar to the academic setting with regards to how studies are conducted and structured since everyone involved in the study follows the same protocol. The benefit of being in a community setting is that you have a wide range of patients that you are seeing every day.

Getting involved in research is not for everyone, but for those who do get involved, the decision is a rewarding one that can make a significant difference in patients’ lives. Offering new therapeutics for disease states is a powerful tool for a provider, and it is exciting and rewarding to engage in the research considering new mechanisms of action and new approaches to treating diseases.
 

Finding a better treatment for C. difficile

For example, C. difficile is common in older people who’ve received antibiotics for other infections, especially residents of long-term care facilities. These residents have frequent antibiotic exposure and are already vulnerable to infection because of advanced age, multiple comorbid conditions, and communal living conditions. Once a case of C. difficile is diagnosed in a nursing home, it can spread through contaminated equipment, environments, or hands.

The treatment for C. difficile is to control the bacteria with antibiotics, but spores remain, so after a few days in certain people the spores germinate, and the C. difficile returns: a recurrence. It used to be that, after a second reoccurrence, you would send the patient for a fecal transplant, which was a scarce resource and a challenging process.

To perform a fecal transplant, you would need a spouse or a family member to provide a stool sample. After their stool was tested, the family member would need to process their stool in a blender with saline and draw it up in syringes. Once you had the material, the patient would need to go through a full colonoscopy to infuse the material into the colon. Of course, increased restrictions and safety precautions from the COVID-19 pandemic have made fecal transplants even more complex.

Given all these challenges, conducting research considering microbiota-based live biotherapeutics, the term the Food and Drug Administration uses for pharmaceutically produced forms of fecal microbiota transplantation, is very appealing. There are several different formulations that have come through clinical trials recently including RBX-2660, SER-109, and CP101.

SER-109 is an orally taken treatment produced by Seres Therapeutics. Once patients with acute recurrence of C. difficile are treated with standard antibiotics, they are given a course of four SER-109 capsules for 3 days. The results of the SER-109 study were published recently in the New England Journal of Medicine. This is the first phase 3 clinical trial published on a microbiota-based live biotherapeutic treatment, and the results were exciting, showing a clear efficacy benefit for SER-109.

In the case of C. difficile, we understand the deficiency that SER-109 replaces. SER-109 changes the microbiome within the colon so that the environment becomes less hospitable to C. difficile, which helps to better resist recurrence. With this therapy, we are replenishing the good bacteria, which helps to keep C. difficile from regerminating.

The therapy showed excellent results through the significant difference in rates of recurrence seen in patients with recurrent C. difficile infection following 8 weeks of follow-up. This is exciting because we believe the future of therapeutics for many diseases might involve this type of manipulation of the microbiota, and this is the first to show such an impact with this class of therapeutic.


 

Joining a practice that conducts clinical research

Within private practice settings, the opportunity to participate in clinical trials usually involves somewhat less bureaucracy and a more patient-centric approach. Private practitioners can also be selective in their research, and we only participate in a handful of selected trials that fit with the expertise of the providers in our practice.

We find the people best suited for involvement in pharmaceutical trials are those providers who want to participate in the scientific process and who see specialized patient populations with the diseases treated by the therapies being studied. In our experience, the young practitioner who enjoyed conducting research in fellowship, who attends national conferences, who keeps track of cutting-edge therapeutics within gastroenterology, and who is highly motivated will be successful in providing this service to their patients.

If you’re an early-career physician who would like to explore clinical research in private practice, there are a several things to look for when considering joining a practice.

Make sure the group has a support infrastructure and a clear compensation model for physicians who want to conduct research. Another important consideration is the kind of support staff the practice provides to manage clinical trials. Does the practice have physician and physician assistant subinvestigators and certified clinical research coordinators? It would be smart to research what kind of capabilities the practice has and inquire about what kind of commitment they have in terms of supporting research efforts.

If the practice you’re thinking of joining has a well-supported research program, you’ll soon be on the way to studying innovative treatments for a wide range of diseases affecting our communities, such as Crohn’s disease, ulcerative colitis, eosinophilic esophagitis, celiac disease, and many others. Many practices also participate in trials assessing new technologies in endoscopy, such as capsule endoscopy of the colon.

It’s incredibly important for community practices to engage in studies and actively recruit younger physicians to participate in their research programs. It changes the character of the practice by bringing a certain level of scholarly activity that benefits the patients we serve, the field of gastroenterology, and medicine as a whole.

Dr. Feuerstadt is a practicing gastroenterologist at the PACT-Gastroenterology Center and is affiliated with Yale New Haven Hospital. Dr. Korman is codirector of Chevy Chase Clinical Research at Capital Digestive Care and a principal investigator in the Seres Therapeutics phase 3 ECOSPOR III study evaluating SER-109. Dr. Feuerstadt disclosed relationships with SERES Therapeutics, Ferring Rebiotix, Finch Therapeutics, and Merck. Dr. Korman disclosed a relationship with SERES Therapeutics.

Most people believe that, if you want to conduct clinical research, the best path is going into academic medicine. However, for physicians who want both the benefits of practicing in the community setting and a career in research, there are many ways to both treat patients and have a rewarding experience making a difference in facilitating treatment options that can become available to patients.

Our practices, Capital Digestive Care in Silver Spring, Md., and the PACT-Gastroenterology Center in Hamden, Conn, have been conducting clinical trials for many years on serious diseases such as inflammatory bowel disease, gastroparesis, and most recently, recurrent infection of Clostridioides difficile. We both also worked on the National Institutes of Health–sponsored Anal Cancer/HSIL Outcomes Research (ANCHOR) study.
 

Academic setting vs. private practice

Research in our practices is similar to the academic setting with regards to how studies are conducted and structured since everyone involved in the study follows the same protocol. The benefit of being in a community setting is that you have a wide range of patients that you are seeing every day.

Getting involved in research is not for everyone, but for those who do get involved, the decision is a rewarding one that can make a significant difference in patients’ lives. Offering new therapeutics for disease states is a powerful tool for a provider, and it is exciting and rewarding to engage in the research considering new mechanisms of action and new approaches to treating diseases.
 

Finding a better treatment for C. difficile

For example, C. difficile is common in older people who’ve received antibiotics for other infections, especially residents of long-term care facilities. These residents have frequent antibiotic exposure and are already vulnerable to infection because of advanced age, multiple comorbid conditions, and communal living conditions. Once a case of C. difficile is diagnosed in a nursing home, it can spread through contaminated equipment, environments, or hands.

The treatment for C. difficile is to control the bacteria with antibiotics, but spores remain, so after a few days in certain people the spores germinate, and the C. difficile returns: a recurrence. It used to be that, after a second reoccurrence, you would send the patient for a fecal transplant, which was a scarce resource and a challenging process.

To perform a fecal transplant, you would need a spouse or a family member to provide a stool sample. After their stool was tested, the family member would need to process their stool in a blender with saline and draw it up in syringes. Once you had the material, the patient would need to go through a full colonoscopy to infuse the material into the colon. Of course, increased restrictions and safety precautions from the COVID-19 pandemic have made fecal transplants even more complex.

Given all these challenges, conducting research considering microbiota-based live biotherapeutics, the term the Food and Drug Administration uses for pharmaceutically produced forms of fecal microbiota transplantation, is very appealing. There are several different formulations that have come through clinical trials recently including RBX-2660, SER-109, and CP101.

SER-109 is an orally taken treatment produced by Seres Therapeutics. Once patients with acute recurrence of C. difficile are treated with standard antibiotics, they are given a course of four SER-109 capsules for 3 days. The results of the SER-109 study were published recently in the New England Journal of Medicine. This is the first phase 3 clinical trial published on a microbiota-based live biotherapeutic treatment, and the results were exciting, showing a clear efficacy benefit for SER-109.

In the case of C. difficile, we understand the deficiency that SER-109 replaces. SER-109 changes the microbiome within the colon so that the environment becomes less hospitable to C. difficile, which helps to better resist recurrence. With this therapy, we are replenishing the good bacteria, which helps to keep C. difficile from regerminating.

The therapy showed excellent results through the significant difference in rates of recurrence seen in patients with recurrent C. difficile infection following 8 weeks of follow-up. This is exciting because we believe the future of therapeutics for many diseases might involve this type of manipulation of the microbiota, and this is the first to show such an impact with this class of therapeutic.


 

Joining a practice that conducts clinical research

Within private practice settings, the opportunity to participate in clinical trials usually involves somewhat less bureaucracy and a more patient-centric approach. Private practitioners can also be selective in their research, and we only participate in a handful of selected trials that fit with the expertise of the providers in our practice.

We find the people best suited for involvement in pharmaceutical trials are those providers who want to participate in the scientific process and who see specialized patient populations with the diseases treated by the therapies being studied. In our experience, the young practitioner who enjoyed conducting research in fellowship, who attends national conferences, who keeps track of cutting-edge therapeutics within gastroenterology, and who is highly motivated will be successful in providing this service to their patients.

If you’re an early-career physician who would like to explore clinical research in private practice, there are a several things to look for when considering joining a practice.

Make sure the group has a support infrastructure and a clear compensation model for physicians who want to conduct research. Another important consideration is the kind of support staff the practice provides to manage clinical trials. Does the practice have physician and physician assistant subinvestigators and certified clinical research coordinators? It would be smart to research what kind of capabilities the practice has and inquire about what kind of commitment they have in terms of supporting research efforts.

If the practice you’re thinking of joining has a well-supported research program, you’ll soon be on the way to studying innovative treatments for a wide range of diseases affecting our communities, such as Crohn’s disease, ulcerative colitis, eosinophilic esophagitis, celiac disease, and many others. Many practices also participate in trials assessing new technologies in endoscopy, such as capsule endoscopy of the colon.

It’s incredibly important for community practices to engage in studies and actively recruit younger physicians to participate in their research programs. It changes the character of the practice by bringing a certain level of scholarly activity that benefits the patients we serve, the field of gastroenterology, and medicine as a whole.

Dr. Feuerstadt is a practicing gastroenterologist at the PACT-Gastroenterology Center and is affiliated with Yale New Haven Hospital. Dr. Korman is codirector of Chevy Chase Clinical Research at Capital Digestive Care and a principal investigator in the Seres Therapeutics phase 3 ECOSPOR III study evaluating SER-109. Dr. Feuerstadt disclosed relationships with SERES Therapeutics, Ferring Rebiotix, Finch Therapeutics, and Merck. Dr. Korman disclosed a relationship with SERES Therapeutics.

Most people believe that, if you want to conduct clinical research, the best path is going into academic medicine. However, for physicians who want both the benefits of practicing in the community setting and a career in research, there are many ways to both treat patients and have a rewarding experience making a difference in facilitating treatment options that can become available to patients.

Our practices, Capital Digestive Care in Silver Spring, Md., and the PACT-Gastroenterology Center in Hamden, Conn, have been conducting clinical trials for many years on serious diseases such as inflammatory bowel disease, gastroparesis, and most recently, recurrent infection of Clostridioides difficile. We both also worked on the National Institutes of Health–sponsored Anal Cancer/HSIL Outcomes Research (ANCHOR) study.
 

Academic setting vs. private practice

Research in our practices is similar to the academic setting with regards to how studies are conducted and structured since everyone involved in the study follows the same protocol. The benefit of being in a community setting is that you have a wide range of patients that you are seeing every day.

Getting involved in research is not for everyone, but for those who do get involved, the decision is a rewarding one that can make a significant difference in patients’ lives. Offering new therapeutics for disease states is a powerful tool for a provider, and it is exciting and rewarding to engage in the research considering new mechanisms of action and new approaches to treating diseases.
 

Finding a better treatment for C. difficile

For example, C. difficile is common in older people who’ve received antibiotics for other infections, especially residents of long-term care facilities. These residents have frequent antibiotic exposure and are already vulnerable to infection because of advanced age, multiple comorbid conditions, and communal living conditions. Once a case of C. difficile is diagnosed in a nursing home, it can spread through contaminated equipment, environments, or hands.

The treatment for C. difficile is to control the bacteria with antibiotics, but spores remain, so after a few days in certain people the spores germinate, and the C. difficile returns: a recurrence. It used to be that, after a second reoccurrence, you would send the patient for a fecal transplant, which was a scarce resource and a challenging process.

To perform a fecal transplant, you would need a spouse or a family member to provide a stool sample. After their stool was tested, the family member would need to process their stool in a blender with saline and draw it up in syringes. Once you had the material, the patient would need to go through a full colonoscopy to infuse the material into the colon. Of course, increased restrictions and safety precautions from the COVID-19 pandemic have made fecal transplants even more complex.

Given all these challenges, conducting research considering microbiota-based live biotherapeutics, the term the Food and Drug Administration uses for pharmaceutically produced forms of fecal microbiota transplantation, is very appealing. There are several different formulations that have come through clinical trials recently including RBX-2660, SER-109, and CP101.

SER-109 is an orally taken treatment produced by Seres Therapeutics. Once patients with acute recurrence of C. difficile are treated with standard antibiotics, they are given a course of four SER-109 capsules for 3 days. The results of the SER-109 study were published recently in the New England Journal of Medicine. This is the first phase 3 clinical trial published on a microbiota-based live biotherapeutic treatment, and the results were exciting, showing a clear efficacy benefit for SER-109.

In the case of C. difficile, we understand the deficiency that SER-109 replaces. SER-109 changes the microbiome within the colon so that the environment becomes less hospitable to C. difficile, which helps to better resist recurrence. With this therapy, we are replenishing the good bacteria, which helps to keep C. difficile from regerminating.

The therapy showed excellent results through the significant difference in rates of recurrence seen in patients with recurrent C. difficile infection following 8 weeks of follow-up. This is exciting because we believe the future of therapeutics for many diseases might involve this type of manipulation of the microbiota, and this is the first to show such an impact with this class of therapeutic.


 

Joining a practice that conducts clinical research

Within private practice settings, the opportunity to participate in clinical trials usually involves somewhat less bureaucracy and a more patient-centric approach. Private practitioners can also be selective in their research, and we only participate in a handful of selected trials that fit with the expertise of the providers in our practice.

We find the people best suited for involvement in pharmaceutical trials are those providers who want to participate in the scientific process and who see specialized patient populations with the diseases treated by the therapies being studied. In our experience, the young practitioner who enjoyed conducting research in fellowship, who attends national conferences, who keeps track of cutting-edge therapeutics within gastroenterology, and who is highly motivated will be successful in providing this service to their patients.

If you’re an early-career physician who would like to explore clinical research in private practice, there are a several things to look for when considering joining a practice.

Make sure the group has a support infrastructure and a clear compensation model for physicians who want to conduct research. Another important consideration is the kind of support staff the practice provides to manage clinical trials. Does the practice have physician and physician assistant subinvestigators and certified clinical research coordinators? It would be smart to research what kind of capabilities the practice has and inquire about what kind of commitment they have in terms of supporting research efforts.

If the practice you’re thinking of joining has a well-supported research program, you’ll soon be on the way to studying innovative treatments for a wide range of diseases affecting our communities, such as Crohn’s disease, ulcerative colitis, eosinophilic esophagitis, celiac disease, and many others. Many practices also participate in trials assessing new technologies in endoscopy, such as capsule endoscopy of the colon.

It’s incredibly important for community practices to engage in studies and actively recruit younger physicians to participate in their research programs. It changes the character of the practice by bringing a certain level of scholarly activity that benefits the patients we serve, the field of gastroenterology, and medicine as a whole.

Dr. Feuerstadt is a practicing gastroenterologist at the PACT-Gastroenterology Center and is affiliated with Yale New Haven Hospital. Dr. Korman is codirector of Chevy Chase Clinical Research at Capital Digestive Care and a principal investigator in the Seres Therapeutics phase 3 ECOSPOR III study evaluating SER-109. Dr. Feuerstadt disclosed relationships with SERES Therapeutics, Ferring Rebiotix, Finch Therapeutics, and Merck. Dr. Korman disclosed a relationship with SERES Therapeutics.

It took me a little while to get started on this assignment. What would be most useful to young gastroenterologists embarking on their careers? When I asked around, I heard that many of you wanted me to describe challenges and decision points. The following list is vaguely chronological, surely noncomprehensive, and meant to serve as a starting point.

1. To stay in basic science or return to patient care

My start in science was rocky. I had come to the United States for a post-doc after medical school in Germany. I had never pipetted before. It was the early days of array technologies, and the lab was very technical and basic. We made our own arrays and our own analytics, and none of my experiments worked. So, I spent 1 year feeling like I made no progress – but in hindsight I appreciate the tremendous growth in these formative years honing inquiry and persistence, as well as building resilience. I added a third year as some results were finally emerging; however, the bedside started to feel very far away. I could not ignore the tug back to the patient care, and after contemplating a PhD program, I decided to apply for residency in a physician-scientist pathway. Given the streamlined training that allowed for science and clinical education in an organized fashion, I also decided to stay in the U.S. This of course had vast personal consequences, which I did not fully appreciate at the time.

Residency was another time of immense growth, I was the only “foreign medical graduate” and had a lot to catch up on, but I enjoyed my amazing peers and the hands-on learning.

Pearl: Follow your passion. Not what makes most sense or what someone wants for you or what you could achieve given your past work. Do what will get you up in the morning and add a bounce to your step.
 

2. To go for big impact or climate

At UCSD at the time, there was a culture of impactful mega-labs, up 30 post-docs, often with many working on the same project with the ones finishing first garnering the publication. This created a “go big or go home” (literally) atmosphere. As part of the PSTP program, I was supported by the GI T32 and, being “free labor,” had a pretty wide array of labs to choose from. To the program director’s surprise, I settled on a fairly junior investigator, who was a fellow gastroenterologist and took a personal interest in my career. When making that decision, I prioritized climate over outcome. I remember thinking to myself that how I spent my time was just as important as the potential outcome of the time spent. Through my years in Dr. John Carethers’ lab, I gained insight into his administrative and leadership roles which added another dimension to our mentorship relationship. These years were fun and productive, and our mentorship grew into a friendship.

Pearl: Look for the right people to work with. Particularly who you work for. Everything else is secondary as the right people will set the tone and most influence your day-to-day experience, which is the foundation of your success.

3. To cultivate a life outside of academia

When I turned 30, I remember driving down Interstate 5 in San Diego and taking stock. Yes, I loved clinical work, I felt valued, and was in a stimulating supportive environment. Yet, I was so immersed that everything else seemed to take a back seat. I made the conscious decision on that drive to prioritize life outside of academia. It is not like I did not have one, I just decided to set an intention so it would not get away from me. I continue to make a conscious effort to be present for my husband, my kids, my family – to take time and spend it together without work bleeding into it. And since this is a goal in and of itself, there is no conflict! Through less travel and no more late nights or weekends, your nonacademic life will flourish.

Pearl: Deliberately prioritize your family and hobbies in the long run. Make key decisions with that in mind.
 

4. To grow your own program or lead others

When we moved to Chicago for my husband’s residency (he went to medical school as his third career at age 35), I was very excited to build my own comprehensive GI cancer genetics program at Northwestern. It was a little scary but also fun to now run my own lab and try to connect the clinical community around hereditary GI cancers. The program was moving along nicely when I received a generic letter asking for applications to become division chief at the neighboring University of Illinois. The letter concluded with an enticing “Chicago is a vibrant city,” so clearly it was meant for a broad audience. I was not sure what to do and again took stock. Did I want to continue to increase the impact of my own work – clearly there was a lot more ground to cover. Or, did I want to be part of making further-reaching decisions? I had been approached by fellows who wanted to be recruited, and I had ideas for programs and thoughts around processes. While my input was valued, I was not the ultimate decision maker. I decided that I either focus on one or the other and so applied for the position and then took the leap.

Pearl: There are many forks and they will present when you do not expect them. Assess and consider. Also know yourself – not everything that is attainable is desirable.
 

5. To have greater influence or stay with what you know

Becoming a division chief was transformative. Learning to integrate the needs of various and sometimes conflicting stakeholders, running an operation but also thinking strategically and mission-based – I was drinking from a firehose. How to measure success as a leader? I was fortunate to enter the division at a turbulent time where much rebuilding was needed and it was easy to implement and see change.

Pearl: Again know yourself – not everything that is attainable is desirable. But also – take risks. What is the worst that can happen? Growth may not be attained by waiting.
 

6. To be spread too thin or close doors

As you develop your focus and expertise while implementing No. 3, you will run out of hours in the day. This means you will need to become more and more efficient, as in delegating (and letting go) where you can and doing fewer nonessential tasks. However, you want to think hard about closing doors completely. I have been careful to hone and keep my endoscopy skills as well as my scientific output. To leave the doors ajar, I have tried to find ways to be very deliberate with my involvement and also understand that at some point it may make sense to close a door.

Pearl: Do not try to do everything well, you will risk doing everything poorly. Work on “good enough” for tasks that can be very involved. Think hard before permanently leaving something behind as you may lose flexibility down the road.
 

7. To enjoy fruits of labor or continue to grow

A question I get asked often is regarding the ideal time to move. In my mind, there is no perfect time. It depends on your satisfaction with your current position (see No. 2), your personal situation (see No. 3), and what you want at that juncture (see No. 5). At some point, one may want to stay awhile and enjoy. Or continue to change and grow – both have their merits and there is no right or wrong.

Pearl: When contemplating next steps, go back to your passion and priorities. Has anything shifted? Are your goals being met? Are you enjoying yourself? Advice can be helpful but also confusing. Remember, no one knows you like you do.
 

8. To show tangible results or build out relationships

Over time, as you become more and more efficient, you simultaneously need to spend more time fostering relationships. This feels strange at first as it is the opposite of a fast-paced to-do list and the “results” appear elusive. Build in time for relating – with peers, superiors, fellows, members of your lab.

Pearl: Form relationships early and often. Take care of them (No. 3) and include relationship building into your workstream – I promise it will make your path more successful and satisfying.


I hope this list shows that there are many forks and no one right way. Advice is helpful and subjective. No path is the same, and it truly is yours to shape. Be thoughtful and enjoy – your journey will be amazing and full of surprises.
 

Dr. Jung is professor and chair, and the Robert G. Petersdorf Endowed Chair in Medicine, in the department of medicine at the University of Washington, Seattle. She is on Twitter @barbarahjung. She has no conflicts of interest.

It took me a little while to get started on this assignment. What would be most useful to young gastroenterologists embarking on their careers? When I asked around, I heard that many of you wanted me to describe challenges and decision points. The following list is vaguely chronological, surely noncomprehensive, and meant to serve as a starting point.

1. To stay in basic science or return to patient care

My start in science was rocky. I had come to the United States for a post-doc after medical school in Germany. I had never pipetted before. It was the early days of array technologies, and the lab was very technical and basic. We made our own arrays and our own analytics, and none of my experiments worked. So, I spent 1 year feeling like I made no progress – but in hindsight I appreciate the tremendous growth in these formative years honing inquiry and persistence, as well as building resilience. I added a third year as some results were finally emerging; however, the bedside started to feel very far away. I could not ignore the tug back to the patient care, and after contemplating a PhD program, I decided to apply for residency in a physician-scientist pathway. Given the streamlined training that allowed for science and clinical education in an organized fashion, I also decided to stay in the U.S. This of course had vast personal consequences, which I did not fully appreciate at the time.

Residency was another time of immense growth, I was the only “foreign medical graduate” and had a lot to catch up on, but I enjoyed my amazing peers and the hands-on learning.

Pearl: Follow your passion. Not what makes most sense or what someone wants for you or what you could achieve given your past work. Do what will get you up in the morning and add a bounce to your step.
 

2. To go for big impact or climate

At UCSD at the time, there was a culture of impactful mega-labs, up 30 post-docs, often with many working on the same project with the ones finishing first garnering the publication. This created a “go big or go home” (literally) atmosphere. As part of the PSTP program, I was supported by the GI T32 and, being “free labor,” had a pretty wide array of labs to choose from. To the program director’s surprise, I settled on a fairly junior investigator, who was a fellow gastroenterologist and took a personal interest in my career. When making that decision, I prioritized climate over outcome. I remember thinking to myself that how I spent my time was just as important as the potential outcome of the time spent. Through my years in Dr. John Carethers’ lab, I gained insight into his administrative and leadership roles which added another dimension to our mentorship relationship. These years were fun and productive, and our mentorship grew into a friendship.

Pearl: Look for the right people to work with. Particularly who you work for. Everything else is secondary as the right people will set the tone and most influence your day-to-day experience, which is the foundation of your success.

3. To cultivate a life outside of academia

When I turned 30, I remember driving down Interstate 5 in San Diego and taking stock. Yes, I loved clinical work, I felt valued, and was in a stimulating supportive environment. Yet, I was so immersed that everything else seemed to take a back seat. I made the conscious decision on that drive to prioritize life outside of academia. It is not like I did not have one, I just decided to set an intention so it would not get away from me. I continue to make a conscious effort to be present for my husband, my kids, my family – to take time and spend it together without work bleeding into it. And since this is a goal in and of itself, there is no conflict! Through less travel and no more late nights or weekends, your nonacademic life will flourish.

Pearl: Deliberately prioritize your family and hobbies in the long run. Make key decisions with that in mind.
 

4. To grow your own program or lead others

When we moved to Chicago for my husband’s residency (he went to medical school as his third career at age 35), I was very excited to build my own comprehensive GI cancer genetics program at Northwestern. It was a little scary but also fun to now run my own lab and try to connect the clinical community around hereditary GI cancers. The program was moving along nicely when I received a generic letter asking for applications to become division chief at the neighboring University of Illinois. The letter concluded with an enticing “Chicago is a vibrant city,” so clearly it was meant for a broad audience. I was not sure what to do and again took stock. Did I want to continue to increase the impact of my own work – clearly there was a lot more ground to cover. Or, did I want to be part of making further-reaching decisions? I had been approached by fellows who wanted to be recruited, and I had ideas for programs and thoughts around processes. While my input was valued, I was not the ultimate decision maker. I decided that I either focus on one or the other and so applied for the position and then took the leap.

Pearl: There are many forks and they will present when you do not expect them. Assess and consider. Also know yourself – not everything that is attainable is desirable.
 

5. To have greater influence or stay with what you know

Becoming a division chief was transformative. Learning to integrate the needs of various and sometimes conflicting stakeholders, running an operation but also thinking strategically and mission-based – I was drinking from a firehose. How to measure success as a leader? I was fortunate to enter the division at a turbulent time where much rebuilding was needed and it was easy to implement and see change.

Pearl: Again know yourself – not everything that is attainable is desirable. But also – take risks. What is the worst that can happen? Growth may not be attained by waiting.
 

6. To be spread too thin or close doors

As you develop your focus and expertise while implementing No. 3, you will run out of hours in the day. This means you will need to become more and more efficient, as in delegating (and letting go) where you can and doing fewer nonessential tasks. However, you want to think hard about closing doors completely. I have been careful to hone and keep my endoscopy skills as well as my scientific output. To leave the doors ajar, I have tried to find ways to be very deliberate with my involvement and also understand that at some point it may make sense to close a door.

Pearl: Do not try to do everything well, you will risk doing everything poorly. Work on “good enough” for tasks that can be very involved. Think hard before permanently leaving something behind as you may lose flexibility down the road.
 

7. To enjoy fruits of labor or continue to grow

A question I get asked often is regarding the ideal time to move. In my mind, there is no perfect time. It depends on your satisfaction with your current position (see No. 2), your personal situation (see No. 3), and what you want at that juncture (see No. 5). At some point, one may want to stay awhile and enjoy. Or continue to change and grow – both have their merits and there is no right or wrong.

Pearl: When contemplating next steps, go back to your passion and priorities. Has anything shifted? Are your goals being met? Are you enjoying yourself? Advice can be helpful but also confusing. Remember, no one knows you like you do.
 

8. To show tangible results or build out relationships

Over time, as you become more and more efficient, you simultaneously need to spend more time fostering relationships. This feels strange at first as it is the opposite of a fast-paced to-do list and the “results” appear elusive. Build in time for relating – with peers, superiors, fellows, members of your lab.

Pearl: Form relationships early and often. Take care of them (No. 3) and include relationship building into your workstream – I promise it will make your path more successful and satisfying.


I hope this list shows that there are many forks and no one right way. Advice is helpful and subjective. No path is the same, and it truly is yours to shape. Be thoughtful and enjoy – your journey will be amazing and full of surprises.
 

Dr. Jung is professor and chair, and the Robert G. Petersdorf Endowed Chair in Medicine, in the department of medicine at the University of Washington, Seattle. She is on Twitter @barbarahjung. She has no conflicts of interest.

It took me a little while to get started on this assignment. What would be most useful to young gastroenterologists embarking on their careers? When I asked around, I heard that many of you wanted me to describe challenges and decision points. The following list is vaguely chronological, surely noncomprehensive, and meant to serve as a starting point.

1. To stay in basic science or return to patient care

My start in science was rocky. I had come to the United States for a post-doc after medical school in Germany. I had never pipetted before. It was the early days of array technologies, and the lab was very technical and basic. We made our own arrays and our own analytics, and none of my experiments worked. So, I spent 1 year feeling like I made no progress – but in hindsight I appreciate the tremendous growth in these formative years honing inquiry and persistence, as well as building resilience. I added a third year as some results were finally emerging; however, the bedside started to feel very far away. I could not ignore the tug back to the patient care, and after contemplating a PhD program, I decided to apply for residency in a physician-scientist pathway. Given the streamlined training that allowed for science and clinical education in an organized fashion, I also decided to stay in the U.S. This of course had vast personal consequences, which I did not fully appreciate at the time.

Residency was another time of immense growth, I was the only “foreign medical graduate” and had a lot to catch up on, but I enjoyed my amazing peers and the hands-on learning.

Pearl: Follow your passion. Not what makes most sense or what someone wants for you or what you could achieve given your past work. Do what will get you up in the morning and add a bounce to your step.
 

2. To go for big impact or climate

At UCSD at the time, there was a culture of impactful mega-labs, up 30 post-docs, often with many working on the same project with the ones finishing first garnering the publication. This created a “go big or go home” (literally) atmosphere. As part of the PSTP program, I was supported by the GI T32 and, being “free labor,” had a pretty wide array of labs to choose from. To the program director’s surprise, I settled on a fairly junior investigator, who was a fellow gastroenterologist and took a personal interest in my career. When making that decision, I prioritized climate over outcome. I remember thinking to myself that how I spent my time was just as important as the potential outcome of the time spent. Through my years in Dr. John Carethers’ lab, I gained insight into his administrative and leadership roles which added another dimension to our mentorship relationship. These years were fun and productive, and our mentorship grew into a friendship.

Pearl: Look for the right people to work with. Particularly who you work for. Everything else is secondary as the right people will set the tone and most influence your day-to-day experience, which is the foundation of your success.

3. To cultivate a life outside of academia

When I turned 30, I remember driving down Interstate 5 in San Diego and taking stock. Yes, I loved clinical work, I felt valued, and was in a stimulating supportive environment. Yet, I was so immersed that everything else seemed to take a back seat. I made the conscious decision on that drive to prioritize life outside of academia. It is not like I did not have one, I just decided to set an intention so it would not get away from me. I continue to make a conscious effort to be present for my husband, my kids, my family – to take time and spend it together without work bleeding into it. And since this is a goal in and of itself, there is no conflict! Through less travel and no more late nights or weekends, your nonacademic life will flourish.

Pearl: Deliberately prioritize your family and hobbies in the long run. Make key decisions with that in mind.
 

4. To grow your own program or lead others

When we moved to Chicago for my husband’s residency (he went to medical school as his third career at age 35), I was very excited to build my own comprehensive GI cancer genetics program at Northwestern. It was a little scary but also fun to now run my own lab and try to connect the clinical community around hereditary GI cancers. The program was moving along nicely when I received a generic letter asking for applications to become division chief at the neighboring University of Illinois. The letter concluded with an enticing “Chicago is a vibrant city,” so clearly it was meant for a broad audience. I was not sure what to do and again took stock. Did I want to continue to increase the impact of my own work – clearly there was a lot more ground to cover. Or, did I want to be part of making further-reaching decisions? I had been approached by fellows who wanted to be recruited, and I had ideas for programs and thoughts around processes. While my input was valued, I was not the ultimate decision maker. I decided that I either focus on one or the other and so applied for the position and then took the leap.

Pearl: There are many forks and they will present when you do not expect them. Assess and consider. Also know yourself – not everything that is attainable is desirable.
 

5. To have greater influence or stay with what you know

Becoming a division chief was transformative. Learning to integrate the needs of various and sometimes conflicting stakeholders, running an operation but also thinking strategically and mission-based – I was drinking from a firehose. How to measure success as a leader? I was fortunate to enter the division at a turbulent time where much rebuilding was needed and it was easy to implement and see change.

Pearl: Again know yourself – not everything that is attainable is desirable. But also – take risks. What is the worst that can happen? Growth may not be attained by waiting.
 

6. To be spread too thin or close doors

As you develop your focus and expertise while implementing No. 3, you will run out of hours in the day. This means you will need to become more and more efficient, as in delegating (and letting go) where you can and doing fewer nonessential tasks. However, you want to think hard about closing doors completely. I have been careful to hone and keep my endoscopy skills as well as my scientific output. To leave the doors ajar, I have tried to find ways to be very deliberate with my involvement and also understand that at some point it may make sense to close a door.

Pearl: Do not try to do everything well, you will risk doing everything poorly. Work on “good enough” for tasks that can be very involved. Think hard before permanently leaving something behind as you may lose flexibility down the road.
 

7. To enjoy fruits of labor or continue to grow

A question I get asked often is regarding the ideal time to move. In my mind, there is no perfect time. It depends on your satisfaction with your current position (see No. 2), your personal situation (see No. 3), and what you want at that juncture (see No. 5). At some point, one may want to stay awhile and enjoy. Or continue to change and grow – both have their merits and there is no right or wrong.

Pearl: When contemplating next steps, go back to your passion and priorities. Has anything shifted? Are your goals being met? Are you enjoying yourself? Advice can be helpful but also confusing. Remember, no one knows you like you do.
 

8. To show tangible results or build out relationships

Over time, as you become more and more efficient, you simultaneously need to spend more time fostering relationships. This feels strange at first as it is the opposite of a fast-paced to-do list and the “results” appear elusive. Build in time for relating – with peers, superiors, fellows, members of your lab.

Pearl: Form relationships early and often. Take care of them (No. 3) and include relationship building into your workstream – I promise it will make your path more successful and satisfying.


I hope this list shows that there are many forks and no one right way. Advice is helpful and subjective. No path is the same, and it truly is yours to shape. Be thoughtful and enjoy – your journey will be amazing and full of surprises.
 

Dr. Jung is professor and chair, and the Robert G. Petersdorf Endowed Chair in Medicine, in the department of medicine at the University of Washington, Seattle. She is on Twitter @barbarahjung. She has no conflicts of interest.

Introduction

Patients presenting with the symptoms of gastroparesis (Gp) are commonly seen in gastroenterology practice. This article reviews the presentation, pathophysiology, diagnosis, and treatment of gastroparesis syndromes with an emphasis on newer approaches evolving in clinical practice.

Presentation

Patients with foregut symptoms of Gp have characteristic presentations, with nausea, vomiting/retching, and abdominal pain often associated with bloating and distension, early satiety, anorexia, and heartburn. Mid- and hindgut gastrointestinal and/or urinary symptoms may be seen in patients with Gp as well.

The precise epidemiology of gastroparesis syndromes (GpS) is unknown. Classic gastroparesis, defined as delayed gastric emptying without known mechanical obstruction, has a prevalence of about 10 per 100,000 population in men and 30 per 100,000 in women with women being affected 3 to 4 times more than men.^1,2 Some risk factors for GpS, such as diabetes mellitus (DM) in up to 5% of patients with Type 1 DM, are known.³ Caucasians have the highest prevalence of GpS, followed by African Americans.^4,5

Pathophysiology

Specific types of gastroparesis syndromes have variable pathophysiology (Figure 1). In some cases, like GpS associated with DM, pathophysiology is partially related to diabetic autonomic dysfunction. GpS are multifactorial, however, and rather than focusing on subtypes, this discussion focuses on shared pathophysiology. Understanding pathophysiology is key to determining treatment options and potential future targets for therapy.

Intragastric mechanical dysfunction, both proximal (fundic relaxation and accommodation and/or lack of fundic contractility) and distal stomach (antral hypomotility) may be involved. Additionally, intragastric electrical disturbances in frequency, amplitude, and propagation of gastric electrical waves can be seen with low/high resolution gastric mapping.

Both gastroesophageal and gastropyloric sphincter dysfunction may be seen. Esophageal dysfunction is frequently seen but is not always categorized in GpS. Pyloric dysfunction is increasingly a focus of both diagnosis and therapy. GI anatomic abnormalities can be identified with gastric biopsies of full thickness muscle and mucosa. CD117/interstitial cells of Cajal, neural fibers, inflammatory and other cells can be evaluated by light microscopy, electron microscopy, and special staining techniques.

Diagnosis of GpS

Diagnosis of GpS is often delayed and can be challenging; various tools have been developed, but not all are used. A diagnostic approach for patients with symptoms of Gp is listed below, and Figure 2 details a diagnostic approach and treatment options for symptomatic patients.

Symptom Assessment: Initially Gp symptoms can be assessed using Food and Drug Administration–approved patient-reported outcomes, including frequency and severity of nausea, vomiting, anorexia/early satiety, bloating/distention, and abdominal pain on a 0-4, 0-5 or 0-10 scale. The Gastrointestinal Cardinal Symptom Index or visual analog scales can also be used. It is also important to evaluate midgut and hindgut symptoms.^9-11

Mechanical obstruction assessment: Mechanical obstruction can be ruled out using upper endoscopy or barium studies.

Physiologic testing: The most common is radionuclide gastric emptying testing (GET). Compliance with guidelines, standardization, and consistency of GETs is vital to help with an accurate diagnosis. Currently, two consensus recommendations for the standardized performance of GETs exist.^12,13 Breath testing is FDA approved in the United States and can be used as an alternative. Wireless motility capsule testing can be complimentary.

Gastric dysrhythmias assessment: Assessment of gastric dysrhythmias can be performed in outpatient settings using cutaneous electrogastrogram, currently available in many referral centers. Most patients with GpS have an underlying gastric electrical abnormality.^14,15

Sphincter dysfunction assessment: Both proximal and distal sphincter abnormalities have been described for many years and are of particular interest recently. Use of the functional luminal imaging probe (FLIP) shows patients with GpS may have decreased sphincter distensibility when examining the comparisons of the cross-sectional area relative to pressure Using this information, sphincter therapies can be offered.^16-18

Other testing: Neurologic and autonomic testing, along with psychosocial, genetic and frailty assessments, are helpful to explore.¹⁹ Nutritional evaluation can be done using standardized scales, such as subjective global assessment and serologic testing for micronutrient deficiency or electrical impedance.²⁰

Treatment of GpS

Therapies for GpS can be viewed as the five D’s: Diet, Drug, Disruption, Devices, and Details.

Diet and nutrition: The mainstay treatment of GpS remains dietary modification. The most common recommendation is to limit meal size, often with increased meal frequency, as well as nutrient composition, in areas that may retard gastric emptying. In addition, some patients with GpS report intolerances of specific foods, such as specific carbohydrates. Nutritional consultation can assist patients with meals tailored for their current nutritional needs. Nutritional supplementation is widely used for patients with GpS.²⁰

Pharmacological treatment: The next tier of treatment for GpS is drugs. Review of a patient’s medications is important to minimize drugs that may retard gastric emptying such as opiates and GLP-1 agonists. A full discussion of medications is beyond the scope of this article, but classes of drugs available include: prokinetics, antiemetics, neuromodulators, and investigational agents.

Bioelectric therapy: Another approach for patients with symptomatic drug refractory GpS is bioelectric device therapies, which can be delivered several ways, including directly to the stomach or to the spinal cord or the vagus nerve in the neck or ear, as well as by electro-acupuncture. High-frequency, low-energy gastric electrical stimulation (GES) is the best studied. First done in 1992 as an experimental therapy, GES was investigational from 1995 to 2000, when it became FDA approved as a humanitarian-use device. GES has been used in over 10,000 patients worldwide; only a small number (greater than 700 study patients) have been in controlled trials. Nine controlled trials of GES have been primarily positive, and durability for over 10 years has been shown. Temporary GES can also be performed endoscopically, although that is an off-label procedure. It has been shown to predict long-term therapy outcome.^23-26 

Nutritional support: Nutritional abnormalities in some cases of GpS lead to consideration of enteral tubes, starting with a trial of feeding with an N-J tube placed endoscopically. An N-J trial is most often performed in patients who have macro-malnutrition and weight loss but can be considered for other highly symptomatic patients. Other endoscopic tubes can be PEG or PEG-J or direct PEJ tubes. Some patients may require surgical placement of enteral tubes, presenting an opportunity for a small bowel or gastric full-thickness biopsy. Enteral tubes are sometimes used for decompression in highly symptomatic patients.²⁷

For patients presenting with neurological symptoms, findings and serologic abnormalities have led to interest in immunotherapies. One is intravenous immunoglobulin, given parenterally. Several open-label studies have been published, the most recent one with 47 patients showing better response if glutamic acid decarboxylase–65 antibodies were present and with longer therapeutic dosing.²⁸ Drawbacks to immunotherapies like intravenous immunoglobulin are cost and requiring parenteral access.

Other evaluation/treatments for drug refractory patients can be detailed as follows: First, an overall quality of life assessment can be helpful, especially one that includes impact of GpS on the patients and family. Nutritional considerations, which may not have been fully assessed, can be examined in more detail. Frailty assessments may show the need for physical therapy. Assessment for home care needs may indicate, in severe patients, needs for IV fluids at home, either enteral or parenteral, if nutrition is not adequate. Psychosocial and/or psychiatric assessments may lead to the need for medications, psychotherapy, and/or support groups. Lastly, an assessment of overall health status may lead to approaches for minimizing visits to emergency rooms and hospitalizations.^29,30

Conclusion

Patients with Gp symptoms are becoming increasingly recognized and referred to gastroenterologists. Better understandings of the pathophysiology of the spectrum of gastroparesis syndromes, assisted by innovations in diagnosis, have led to expansion of existing and new therapeutic approaches. Fortunately, most patients can benefit from a standardized diagnostic approach and directed noninvasive therapies. Patients with refractory gastroparesis symptoms, often with complex issues referred to gastroenterologists, remain a challenge, and novel approaches may improve their quality of life.
 

Dr. Mathur is a GI motility research fellow at the University of Louisville, Ky. He reports no conflicts of interest. Dr. Abell is the Arthur M. Schoen, MD, Chair in Gastroenterology at the University of Louisville. His main funding is NIH GpCRC and NIH Definitive Evaluation of Gastric Dysrhythmia. He is an investigator for Cindome, Vanda, Allergan, and Neurogastrx; a consultant for Censa, Nuvaira, and Takeda; a speaker for Takeda and Medtronic; and a reviewer for UpToDate. He is also the founder of ADEPT-GI, which holds IP related to mucosal stimulation and autonomic and enteric profiling.

References

1. Jung HK et al. Gastroenterology. 2009;136(4):1225-33.

2. Ye Y et al. Gut. 2021;70(4):644-53.

3. Oshima T et al. J Neurogastroenterol Motil. 2021;27(1):46-54.

4. Soykan I et al. Dig Dis Sci. 1998;43(11):2398-404.

5. Syed AR et al. J Clin Gastroenterol. 2020;54(1):50-4.

6.Pasricha PJ et al. Clin Gastroenterol Hepatol. 2011;9(7):567-76.e1-4.

7. Pasricha PJ et al. Gastroenterology. 2021;160(6):2006-17.

8. Almario CV et al. Am J Gastroenterol. 2018;113(11):1701-10.

9. Abell TL et al. Dig Dis Sci. 2021 Apr;66(4):1127-41.

10. Abell TL et al. Neurogastroenterol Motil. 2019;31(3):e13534.

11. Elmasry M et al. Neurogastroenterol Motil. 2021 Oct 26;e14274.

12. Maurer AH et al. J Nucl Med. 2020;61(3):11N-7N.

13. Abell TL et al. J Nucl Med Technol. 2008 Mar;36(1):44-54.

14. Shine A et al. Neuromodulation. 2022 Feb 16;S1094-7159(21)06986-5.

15. O’Grady G et al. Am J Physiol Gastrointest Liver Physiol. 2021;321(5):G527-g42.

16. Saadi M et al. Rev Gastroenterol Mex (Engl Ed). Oct-Dec 2018;83(4):375-84.

17. Kamal F et al. Aliment Pharmacol Ther. 2022;55(2):168-77.

18. Harberson J et al. Dig Dis Sci. 2010;55(2):359-70.

19. Winston J. Gastrointestinal Disorders. 2021;3(2):78-83.

20. Parkman HP et al. Gastroenterology. 2011;141(2):486-98, 98.e1-7.

21. Heckroth M et al. J Clin Gastroenterol. 2021;55(4):279-99.

22. Camilleri M. Clin Gastroenterol Hepatol. 2022;20(1):19-24.

23. Payne SC et al. Nat Rev Gastroenterol Hepatol. 2019;16(2):89-105.

24. Ducrotte P et al. Gastroenterology. 2020;158(3):506-14.e2.

25. Burlen J et al. Gastroenterology Res. 2018;11(5):349-54.

26. Hedjoudje A et al. Neurogastroenterol Motil. 2020;32(11):e13949.

27. Petrov RV et al. Gastroenterol Clin North Am. 2020;49(3):539-56.

28. Gala K et al. J Clin Gastroenterol. 2021 Dec 31. doi: 10.1097/MCG.0000000000001655.

29. Abell TL et al. Neurogastroenterol Motil. 2006;18(4):263-83.

30. Camilleri M et al. Am J Gastroenterol. 2013;108(1):18-37.


 

Introduction

Patients presenting with the symptoms of gastroparesis (Gp) are commonly seen in gastroenterology practice. This article reviews the presentation, pathophysiology, diagnosis, and treatment of gastroparesis syndromes with an emphasis on newer approaches evolving in clinical practice.

Presentation

Patients with foregut symptoms of Gp have characteristic presentations, with nausea, vomiting/retching, and abdominal pain often associated with bloating and distension, early satiety, anorexia, and heartburn. Mid- and hindgut gastrointestinal and/or urinary symptoms may be seen in patients with Gp as well.

The precise epidemiology of gastroparesis syndromes (GpS) is unknown. Classic gastroparesis, defined as delayed gastric emptying without known mechanical obstruction, has a prevalence of about 10 per 100,000 population in men and 30 per 100,000 in women with women being affected 3 to 4 times more than men.^1,2 Some risk factors for GpS, such as diabetes mellitus (DM) in up to 5% of patients with Type 1 DM, are known.³ Caucasians have the highest prevalence of GpS, followed by African Americans.^4,5

Pathophysiology

Specific types of gastroparesis syndromes have variable pathophysiology (Figure 1). In some cases, like GpS associated with DM, pathophysiology is partially related to diabetic autonomic dysfunction. GpS are multifactorial, however, and rather than focusing on subtypes, this discussion focuses on shared pathophysiology. Understanding pathophysiology is key to determining treatment options and potential future targets for therapy.

Intragastric mechanical dysfunction, both proximal (fundic relaxation and accommodation and/or lack of fundic contractility) and distal stomach (antral hypomotility) may be involved. Additionally, intragastric electrical disturbances in frequency, amplitude, and propagation of gastric electrical waves can be seen with low/high resolution gastric mapping.

Both gastroesophageal and gastropyloric sphincter dysfunction may be seen. Esophageal dysfunction is frequently seen but is not always categorized in GpS. Pyloric dysfunction is increasingly a focus of both diagnosis and therapy. GI anatomic abnormalities can be identified with gastric biopsies of full thickness muscle and mucosa. CD117/interstitial cells of Cajal, neural fibers, inflammatory and other cells can be evaluated by light microscopy, electron microscopy, and special staining techniques.

Diagnosis of GpS

Diagnosis of GpS is often delayed and can be challenging; various tools have been developed, but not all are used. A diagnostic approach for patients with symptoms of Gp is listed below, and Figure 2 details a diagnostic approach and treatment options for symptomatic patients.

Symptom Assessment: Initially Gp symptoms can be assessed using Food and Drug Administration–approved patient-reported outcomes, including frequency and severity of nausea, vomiting, anorexia/early satiety, bloating/distention, and abdominal pain on a 0-4, 0-5 or 0-10 scale. The Gastrointestinal Cardinal Symptom Index or visual analog scales can also be used. It is also important to evaluate midgut and hindgut symptoms.^9-11

Mechanical obstruction assessment: Mechanical obstruction can be ruled out using upper endoscopy or barium studies.

Physiologic testing: The most common is radionuclide gastric emptying testing (GET). Compliance with guidelines, standardization, and consistency of GETs is vital to help with an accurate diagnosis. Currently, two consensus recommendations for the standardized performance of GETs exist.^12,13 Breath testing is FDA approved in the United States and can be used as an alternative. Wireless motility capsule testing can be complimentary.

Gastric dysrhythmias assessment: Assessment of gastric dysrhythmias can be performed in outpatient settings using cutaneous electrogastrogram, currently available in many referral centers. Most patients with GpS have an underlying gastric electrical abnormality.^14,15

Sphincter dysfunction assessment: Both proximal and distal sphincter abnormalities have been described for many years and are of particular interest recently. Use of the functional luminal imaging probe (FLIP) shows patients with GpS may have decreased sphincter distensibility when examining the comparisons of the cross-sectional area relative to pressure Using this information, sphincter therapies can be offered.^16-18

Other testing: Neurologic and autonomic testing, along with psychosocial, genetic and frailty assessments, are helpful to explore.¹⁹ Nutritional evaluation can be done using standardized scales, such as subjective global assessment and serologic testing for micronutrient deficiency or electrical impedance.²⁰

Treatment of GpS

Therapies for GpS can be viewed as the five D’s: Diet, Drug, Disruption, Devices, and Details.

Diet and nutrition: The mainstay treatment of GpS remains dietary modification. The most common recommendation is to limit meal size, often with increased meal frequency, as well as nutrient composition, in areas that may retard gastric emptying. In addition, some patients with GpS report intolerances of specific foods, such as specific carbohydrates. Nutritional consultation can assist patients with meals tailored for their current nutritional needs. Nutritional supplementation is widely used for patients with GpS.²⁰

Pharmacological treatment: The next tier of treatment for GpS is drugs. Review of a patient’s medications is important to minimize drugs that may retard gastric emptying such as opiates and GLP-1 agonists. A full discussion of medications is beyond the scope of this article, but classes of drugs available include: prokinetics, antiemetics, neuromodulators, and investigational agents.

Bioelectric therapy: Another approach for patients with symptomatic drug refractory GpS is bioelectric device therapies, which can be delivered several ways, including directly to the stomach or to the spinal cord or the vagus nerve in the neck or ear, as well as by electro-acupuncture. High-frequency, low-energy gastric electrical stimulation (GES) is the best studied. First done in 1992 as an experimental therapy, GES was investigational from 1995 to 2000, when it became FDA approved as a humanitarian-use device. GES has been used in over 10,000 patients worldwide; only a small number (greater than 700 study patients) have been in controlled trials. Nine controlled trials of GES have been primarily positive, and durability for over 10 years has been shown. Temporary GES can also be performed endoscopically, although that is an off-label procedure. It has been shown to predict long-term therapy outcome.^23-26 

Nutritional support: Nutritional abnormalities in some cases of GpS lead to consideration of enteral tubes, starting with a trial of feeding with an N-J tube placed endoscopically. An N-J trial is most often performed in patients who have macro-malnutrition and weight loss but can be considered for other highly symptomatic patients. Other endoscopic tubes can be PEG or PEG-J or direct PEJ tubes. Some patients may require surgical placement of enteral tubes, presenting an opportunity for a small bowel or gastric full-thickness biopsy. Enteral tubes are sometimes used for decompression in highly symptomatic patients.²⁷

For patients presenting with neurological symptoms, findings and serologic abnormalities have led to interest in immunotherapies. One is intravenous immunoglobulin, given parenterally. Several open-label studies have been published, the most recent one with 47 patients showing better response if glutamic acid decarboxylase–65 antibodies were present and with longer therapeutic dosing.²⁸ Drawbacks to immunotherapies like intravenous immunoglobulin are cost and requiring parenteral access.

Other evaluation/treatments for drug refractory patients can be detailed as follows: First, an overall quality of life assessment can be helpful, especially one that includes impact of GpS on the patients and family. Nutritional considerations, which may not have been fully assessed, can be examined in more detail. Frailty assessments may show the need for physical therapy. Assessment for home care needs may indicate, in severe patients, needs for IV fluids at home, either enteral or parenteral, if nutrition is not adequate. Psychosocial and/or psychiatric assessments may lead to the need for medications, psychotherapy, and/or support groups. Lastly, an assessment of overall health status may lead to approaches for minimizing visits to emergency rooms and hospitalizations.^29,30

Conclusion

Patients with Gp symptoms are becoming increasingly recognized and referred to gastroenterologists. Better understandings of the pathophysiology of the spectrum of gastroparesis syndromes, assisted by innovations in diagnosis, have led to expansion of existing and new therapeutic approaches. Fortunately, most patients can benefit from a standardized diagnostic approach and directed noninvasive therapies. Patients with refractory gastroparesis symptoms, often with complex issues referred to gastroenterologists, remain a challenge, and novel approaches may improve their quality of life.
 

Dr. Mathur is a GI motility research fellow at the University of Louisville, Ky. He reports no conflicts of interest. Dr. Abell is the Arthur M. Schoen, MD, Chair in Gastroenterology at the University of Louisville. His main funding is NIH GpCRC and NIH Definitive Evaluation of Gastric Dysrhythmia. He is an investigator for Cindome, Vanda, Allergan, and Neurogastrx; a consultant for Censa, Nuvaira, and Takeda; a speaker for Takeda and Medtronic; and a reviewer for UpToDate. He is also the founder of ADEPT-GI, which holds IP related to mucosal stimulation and autonomic and enteric profiling.

References

1. Jung HK et al. Gastroenterology. 2009;136(4):1225-33.

2. Ye Y et al. Gut. 2021;70(4):644-53.

3. Oshima T et al. J Neurogastroenterol Motil. 2021;27(1):46-54.

4. Soykan I et al. Dig Dis Sci. 1998;43(11):2398-404.

5. Syed AR et al. J Clin Gastroenterol. 2020;54(1):50-4.

6.Pasricha PJ et al. Clin Gastroenterol Hepatol. 2011;9(7):567-76.e1-4.

7. Pasricha PJ et al. Gastroenterology. 2021;160(6):2006-17.

8. Almario CV et al. Am J Gastroenterol. 2018;113(11):1701-10.

9. Abell TL et al. Dig Dis Sci. 2021 Apr;66(4):1127-41.

10. Abell TL et al. Neurogastroenterol Motil. 2019;31(3):e13534.

11. Elmasry M et al. Neurogastroenterol Motil. 2021 Oct 26;e14274.

12. Maurer AH et al. J Nucl Med. 2020;61(3):11N-7N.

13. Abell TL et al. J Nucl Med Technol. 2008 Mar;36(1):44-54.

14. Shine A et al. Neuromodulation. 2022 Feb 16;S1094-7159(21)06986-5.

15. O’Grady G et al. Am J Physiol Gastrointest Liver Physiol. 2021;321(5):G527-g42.

16. Saadi M et al. Rev Gastroenterol Mex (Engl Ed). Oct-Dec 2018;83(4):375-84.

17. Kamal F et al. Aliment Pharmacol Ther. 2022;55(2):168-77.

18. Harberson J et al. Dig Dis Sci. 2010;55(2):359-70.

19. Winston J. Gastrointestinal Disorders. 2021;3(2):78-83.

20. Parkman HP et al. Gastroenterology. 2011;141(2):486-98, 98.e1-7.

21. Heckroth M et al. J Clin Gastroenterol. 2021;55(4):279-99.

22. Camilleri M. Clin Gastroenterol Hepatol. 2022;20(1):19-24.

23. Payne SC et al. Nat Rev Gastroenterol Hepatol. 2019;16(2):89-105.

24. Ducrotte P et al. Gastroenterology. 2020;158(3):506-14.e2.

25. Burlen J et al. Gastroenterology Res. 2018;11(5):349-54.

26. Hedjoudje A et al. Neurogastroenterol Motil. 2020;32(11):e13949.

27. Petrov RV et al. Gastroenterol Clin North Am. 2020;49(3):539-56.

28. Gala K et al. J Clin Gastroenterol. 2021 Dec 31. doi: 10.1097/MCG.0000000000001655.

29. Abell TL et al. Neurogastroenterol Motil. 2006;18(4):263-83.

30. Camilleri M et al. Am J Gastroenterol. 2013;108(1):18-37.


 

Introduction

Patients presenting with the symptoms of gastroparesis (Gp) are commonly seen in gastroenterology practice. This article reviews the presentation, pathophysiology, diagnosis, and treatment of gastroparesis syndromes with an emphasis on newer approaches evolving in clinical practice.

Presentation

Patients with foregut symptoms of Gp have characteristic presentations, with nausea, vomiting/retching, and abdominal pain often associated with bloating and distension, early satiety, anorexia, and heartburn. Mid- and hindgut gastrointestinal and/or urinary symptoms may be seen in patients with Gp as well.

The precise epidemiology of gastroparesis syndromes (GpS) is unknown. Classic gastroparesis, defined as delayed gastric emptying without known mechanical obstruction, has a prevalence of about 10 per 100,000 population in men and 30 per 100,000 in women with women being affected 3 to 4 times more than men.^1,2 Some risk factors for GpS, such as diabetes mellitus (DM) in up to 5% of patients with Type 1 DM, are known.³ Caucasians have the highest prevalence of GpS, followed by African Americans.^4,5

Pathophysiology

Specific types of gastroparesis syndromes have variable pathophysiology (Figure 1). In some cases, like GpS associated with DM, pathophysiology is partially related to diabetic autonomic dysfunction. GpS are multifactorial, however, and rather than focusing on subtypes, this discussion focuses on shared pathophysiology. Understanding pathophysiology is key to determining treatment options and potential future targets for therapy.

Intragastric mechanical dysfunction, both proximal (fundic relaxation and accommodation and/or lack of fundic contractility) and distal stomach (antral hypomotility) may be involved. Additionally, intragastric electrical disturbances in frequency, amplitude, and propagation of gastric electrical waves can be seen with low/high resolution gastric mapping.

Both gastroesophageal and gastropyloric sphincter dysfunction may be seen. Esophageal dysfunction is frequently seen but is not always categorized in GpS. Pyloric dysfunction is increasingly a focus of both diagnosis and therapy. GI anatomic abnormalities can be identified with gastric biopsies of full thickness muscle and mucosa. CD117/interstitial cells of Cajal, neural fibers, inflammatory and other cells can be evaluated by light microscopy, electron microscopy, and special staining techniques.

Diagnosis of GpS

Diagnosis of GpS is often delayed and can be challenging; various tools have been developed, but not all are used. A diagnostic approach for patients with symptoms of Gp is listed below, and Figure 2 details a diagnostic approach and treatment options for symptomatic patients.

Symptom Assessment: Initially Gp symptoms can be assessed using Food and Drug Administration–approved patient-reported outcomes, including frequency and severity of nausea, vomiting, anorexia/early satiety, bloating/distention, and abdominal pain on a 0-4, 0-5 or 0-10 scale. The Gastrointestinal Cardinal Symptom Index or visual analog scales can also be used. It is also important to evaluate midgut and hindgut symptoms.^9-11

Mechanical obstruction assessment: Mechanical obstruction can be ruled out using upper endoscopy or barium studies.

Physiologic testing: The most common is radionuclide gastric emptying testing (GET). Compliance with guidelines, standardization, and consistency of GETs is vital to help with an accurate diagnosis. Currently, two consensus recommendations for the standardized performance of GETs exist.^12,13 Breath testing is FDA approved in the United States and can be used as an alternative. Wireless motility capsule testing can be complimentary.

Gastric dysrhythmias assessment: Assessment of gastric dysrhythmias can be performed in outpatient settings using cutaneous electrogastrogram, currently available in many referral centers. Most patients with GpS have an underlying gastric electrical abnormality.^14,15

Sphincter dysfunction assessment: Both proximal and distal sphincter abnormalities have been described for many years and are of particular interest recently. Use of the functional luminal imaging probe (FLIP) shows patients with GpS may have decreased sphincter distensibility when examining the comparisons of the cross-sectional area relative to pressure Using this information, sphincter therapies can be offered.^16-18

Other testing: Neurologic and autonomic testing, along with psychosocial, genetic and frailty assessments, are helpful to explore.¹⁹ Nutritional evaluation can be done using standardized scales, such as subjective global assessment and serologic testing for micronutrient deficiency or electrical impedance.²⁰

Treatment of GpS

Therapies for GpS can be viewed as the five D’s: Diet, Drug, Disruption, Devices, and Details.

Diet and nutrition: The mainstay treatment of GpS remains dietary modification. The most common recommendation is to limit meal size, often with increased meal frequency, as well as nutrient composition, in areas that may retard gastric emptying. In addition, some patients with GpS report intolerances of specific foods, such as specific carbohydrates. Nutritional consultation can assist patients with meals tailored for their current nutritional needs. Nutritional supplementation is widely used for patients with GpS.²⁰

Pharmacological treatment: The next tier of treatment for GpS is drugs. Review of a patient’s medications is important to minimize drugs that may retard gastric emptying such as opiates and GLP-1 agonists. A full discussion of medications is beyond the scope of this article, but classes of drugs available include: prokinetics, antiemetics, neuromodulators, and investigational agents.

Bioelectric therapy: Another approach for patients with symptomatic drug refractory GpS is bioelectric device therapies, which can be delivered several ways, including directly to the stomach or to the spinal cord or the vagus nerve in the neck or ear, as well as by electro-acupuncture. High-frequency, low-energy gastric electrical stimulation (GES) is the best studied. First done in 1992 as an experimental therapy, GES was investigational from 1995 to 2000, when it became FDA approved as a humanitarian-use device. GES has been used in over 10,000 patients worldwide; only a small number (greater than 700 study patients) have been in controlled trials. Nine controlled trials of GES have been primarily positive, and durability for over 10 years has been shown. Temporary GES can also be performed endoscopically, although that is an off-label procedure. It has been shown to predict long-term therapy outcome.^23-26 

Nutritional support: Nutritional abnormalities in some cases of GpS lead to consideration of enteral tubes, starting with a trial of feeding with an N-J tube placed endoscopically. An N-J trial is most often performed in patients who have macro-malnutrition and weight loss but can be considered for other highly symptomatic patients. Other endoscopic tubes can be PEG or PEG-J or direct PEJ tubes. Some patients may require surgical placement of enteral tubes, presenting an opportunity for a small bowel or gastric full-thickness biopsy. Enteral tubes are sometimes used for decompression in highly symptomatic patients.²⁷

For patients presenting with neurological symptoms, findings and serologic abnormalities have led to interest in immunotherapies. One is intravenous immunoglobulin, given parenterally. Several open-label studies have been published, the most recent one with 47 patients showing better response if glutamic acid decarboxylase–65 antibodies were present and with longer therapeutic dosing.²⁸ Drawbacks to immunotherapies like intravenous immunoglobulin are cost and requiring parenteral access.

Other evaluation/treatments for drug refractory patients can be detailed as follows: First, an overall quality of life assessment can be helpful, especially one that includes impact of GpS on the patients and family. Nutritional considerations, which may not have been fully assessed, can be examined in more detail. Frailty assessments may show the need for physical therapy. Assessment for home care needs may indicate, in severe patients, needs for IV fluids at home, either enteral or parenteral, if nutrition is not adequate. Psychosocial and/or psychiatric assessments may lead to the need for medications, psychotherapy, and/or support groups. Lastly, an assessment of overall health status may lead to approaches for minimizing visits to emergency rooms and hospitalizations.^29,30

Conclusion

Patients with Gp symptoms are becoming increasingly recognized and referred to gastroenterologists. Better understandings of the pathophysiology of the spectrum of gastroparesis syndromes, assisted by innovations in diagnosis, have led to expansion of existing and new therapeutic approaches. Fortunately, most patients can benefit from a standardized diagnostic approach and directed noninvasive therapies. Patients with refractory gastroparesis symptoms, often with complex issues referred to gastroenterologists, remain a challenge, and novel approaches may improve their quality of life.
 

Dr. Mathur is a GI motility research fellow at the University of Louisville, Ky. He reports no conflicts of interest. Dr. Abell is the Arthur M. Schoen, MD, Chair in Gastroenterology at the University of Louisville. His main funding is NIH GpCRC and NIH Definitive Evaluation of Gastric Dysrhythmia. He is an investigator for Cindome, Vanda, Allergan, and Neurogastrx; a consultant for Censa, Nuvaira, and Takeda; a speaker for Takeda and Medtronic; and a reviewer for UpToDate. He is also the founder of ADEPT-GI, which holds IP related to mucosal stimulation and autonomic and enteric profiling.

References

1. Jung HK et al. Gastroenterology. 2009;136(4):1225-33.

2. Ye Y et al. Gut. 2021;70(4):644-53.

3. Oshima T et al. J Neurogastroenterol Motil. 2021;27(1):46-54.

4. Soykan I et al. Dig Dis Sci. 1998;43(11):2398-404.

5. Syed AR et al. J Clin Gastroenterol. 2020;54(1):50-4.

6.Pasricha PJ et al. Clin Gastroenterol Hepatol. 2011;9(7):567-76.e1-4.

7. Pasricha PJ et al. Gastroenterology. 2021;160(6):2006-17.

8. Almario CV et al. Am J Gastroenterol. 2018;113(11):1701-10.

9. Abell TL et al. Dig Dis Sci. 2021 Apr;66(4):1127-41.

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AGA Fellow (AGAF) applications now open

Applications are now open for the 2023 AGA Fellowship cohort. AGA is proud to formally recognize its exemplary members whose accomplishments and contributions demonstrate a deep commitment to gastroenterology through the AGA Fellows Program. Those in clinical practice, education, or research (basic or clinical) are encouraged to apply today.

Longstanding members who apply and meet the program criteria are granted the distinguished honor of AGA Fellowship and receive the following:

• The privilege of using the designation “AGAF” in professional activities. 
• An official certificate and pin denoting your status. 
• International acknowledgment at Digestive Disease Week® (DDW).
• A listing on the AGA website alongside esteemed peers.  
• A prewritten, fill-in press release, and a digital badge to inform others of your accomplishment.

Learn more

Apply for consideration and gain recognition worldwide for your commitment to the field. The deadline is Aug. 24, 2022.

If you have any questions, contact AGA Member Relations at [email protected] or 301-941-2651.

AGA Fellow (AGAF) applications now open

Applications are now open for the 2023 AGA Fellowship cohort. AGA is proud to formally recognize its exemplary members whose accomplishments and contributions demonstrate a deep commitment to gastroenterology through the AGA Fellows Program. Those in clinical practice, education, or research (basic or clinical) are encouraged to apply today.

Longstanding members who apply and meet the program criteria are granted the distinguished honor of AGA Fellowship and receive the following:

• The privilege of using the designation “AGAF” in professional activities. 
• An official certificate and pin denoting your status. 
• International acknowledgment at Digestive Disease Week® (DDW).
• A listing on the AGA website alongside esteemed peers.  
• A prewritten, fill-in press release, and a digital badge to inform others of your accomplishment.

Learn more

Apply for consideration and gain recognition worldwide for your commitment to the field. The deadline is Aug. 24, 2022.

If you have any questions, contact AGA Member Relations at [email protected] or 301-941-2651.

AGA Fellow (AGAF) applications now open

Applications are now open for the 2023 AGA Fellowship cohort. AGA is proud to formally recognize its exemplary members whose accomplishments and contributions demonstrate a deep commitment to gastroenterology through the AGA Fellows Program. Those in clinical practice, education, or research (basic or clinical) are encouraged to apply today.

Longstanding members who apply and meet the program criteria are granted the distinguished honor of AGA Fellowship and receive the following:

• The privilege of using the designation “AGAF” in professional activities. 
• An official certificate and pin denoting your status. 
• International acknowledgment at Digestive Disease Week® (DDW).
• A listing on the AGA website alongside esteemed peers.  
• A prewritten, fill-in press release, and a digital badge to inform others of your accomplishment.

Learn more

Apply for consideration and gain recognition worldwide for your commitment to the field. The deadline is Aug. 24, 2022.

If you have any questions, contact AGA Member Relations at [email protected] or 301-941-2651.