Artificial Intelligence in GI and Hepatology

Article Type
Changed

 

Dear colleagues,

Since our prior Perspectives piece on artificial intelligence (AI) in GI and Hepatology in 2022, the field has seen almost exponential growth. Expectations are high that AI will revolutionize our field and significantly improve patient care. But as the global discussion on AI has shown, there are real challenges with adoption, including issues with accuracy, reliability, and privacy.

In this issue, Dr. Nabil M. Mansour and Dr. Thomas R. McCarty explore the current and future impact of AI on gastroenterology, while Dr. Basile Njei and Yazan A. Al Ajlouni assess its role in hepatology. We hope these pieces will help your discussions in incorporating or researching AI for use in your own practices. We welcome your thoughts on this issue on X @AGA_GIHN.

Gyanprakash A. Ketwaroo, MD, MSc, is associate professor of medicine, Yale University, New Haven, Conn., and chief of endoscopy at West Haven (Conn.) VA Medical Center. He is an associate editor for GI & Hepatology News.

Artificial Intelligence in Gastrointestinal Endoscopy

BY THOMAS R. MCCARTY, MD, MPH; NABIL M. MANSOUR, MD

The last few decades have seen an exponential increase and interest in the role of artificial intelligence (AI) and adoption of deep learning algorithms within healthcare and patient care services. The field of gastroenterology and endoscopy has similarly seen a tremendous uptake in acceptance and implementation of AI for a variety of gastrointestinal conditions. The spectrum of AI-based applications includes detection or diagnostic-based as well as therapeutic assistance tools. From the first US Food and Drug Administration (FDA)-approved device that uses machine learning to assist clinicians in detecting lesions during colonoscopy, to other more innovative machine learning techniques for small bowel, esophageal, and hepatobiliary conditions, AI has dramatically changed the landscape of gastrointestinal endoscopy.

Baylor College of Medicine
Dr. Nabil M. Mansour


Approved applications for colorectal cancer

In an attempt to improve colorectal cancer screening and outcomes related to screening and surveillance, efforts have been focused on procedural performance metrics, quality indicators, and tools to aid in lesion detection and improve quality of care. One such tool has been computer-aided detection (CADe), with early randomized controlled trial (RCT) data showing significantly increased adenoma detection rate (ADR) and adenomas per colonoscopy (APC).1-3

Ultimately, this data led to FDA approval of the CADe system GI Genius (Medtronic, Dublin, Ireland) in 2021.4 Additional systems have since been FDA approved or 510(k) cleared including Endoscreener (Wision AI, Shanghai, China), SKOUT (Iterative Health, Cambridge, Massachusetts), MAGENTIQ-COLO (MAGENTIQ-EYE LTD, Haifa, Israel), and CAD EYE (Fujifilm, Tokyo), all of which have shown increased ADR and/or increased APC and/or reduced adenoma miss rates in randomized trials.5

Yet despite the promise of improved quality and subsequent translation to better patient outcomes, there has been a noticeable disconnect between RCT data and more real-world literature.6 In a recent study, no improvement was seen in ADR after implementation of a CADe system for colorectal cancer screening — including both higher and lower-ADR performers. Looking at change over time after implementation, CADe had no positive effect in any group over time, divergent from early RCT data. In a more recent multicenter, community-based RCT study, again CADe did not result in a statistically significant difference in the number of adenomas detected.7 The differences between some of these more recent “real-world” studies vs the majority of data from RCTs raise important questions regarding the potential of bias (due to unblinding) in prospective trials, as well as the role of the human-AI interaction.

Importantly for RCT data, both cohorts in these studies met adequate ADR benchmarks, though it remains unclear whether a truly increased ADR necessitates better patient outcomes — is higher always better? In addition, an important consideration with evaluating any AI/CADe system is that they often undergo frequent updates, each promising improved accuracy, sensitivity, and specificity. This is an interesting dilemma and raises questions about the enduring relevance of studies conducted using an outdated version of a CADe system.

Additional unanswered questions regarding an ideal ADR for implementation, preferred patient populations for screening (especially for younger individuals), and the role and adoption of computer-aided polyp diagnosis/characterization (CADx) within the United States remain. Furthermore, questions regarding procedural withdrawal time, impact on sessile serrated lesion detection, cost-effectiveness, and preferred adoption strategies have begun to be explored, though require more data to better define a best practice approach. Ultimately, answers to some of these unknowns may explain the discordant results and help guide future implementation measures.

 

 

Innovative applications for alternative gastrointestinal conditions

Given the fervor and excitement, as well as the outcomes associated with AI-based colorectal screening, it is not surprising these techniques have been expanded to other gastrointestinal conditions. At this time, all of these are fledgling, mostly single-center tools, not yet ready for widespread adoption. Nonetheless, these represent a potentially important step forward for difficult-to-manage gastrointestinal diseases.

Machine learning CADe systems have been developed to help identify early Barrett’s neoplasia, depth and invasion of gastric cancer, as well as lesion detection in small bowel video capsule endoscopy.8-10 Endoscopic retrograde cholangiopancreatography (ERCP)-based applications for cholangiocarcinoma and indeterminate stricture diagnosis have also been studied.11 Additional AI-based algorithms have been employed for complex procedures such as endoscopic submucosal dissection (ESD) or peroral endoscopic myotomy (POEM) to delineate vessels, better define tissue planes for dissection, and visualize landmark structures.12,13 Furthermore, AI-based scope guidance/manipulation, bleeding detection, landmark identification, and lesion detection have the potential to revolutionize endoscopic training and education. The impact that generative AI can potentially have on clinical practice is also an exciting prospect that warrants further investigation.

Artificial intelligence adoption in clinical practice

Clinical practice with regard to AI and colorectal cancer screening largely mirrors the disconnect in the current literature, with “believers” and “non-believers” as well as innovators and early adopters alongside laggards. In our own academic practices, we continue to struggle with the adoption and standardized implementation of AI-based colorectal cancer CADe systems, despite the RCT data showing positive results. It is likely that AI uptake will follow the technology predictions of Amara’s Law — i.e., individuals tend to overestimate the short-term impact of new technologies while underestimating long-term effects. In the end, more widespread adoption in community practice and larger scale real-world clinical outcomes studies are likely to determine the true impact of these exciting technologies. For other, less established AI-based tools, more data are currently required.

Conclusions

Ultimately, AI-based algorithms are likely here to stay, with continued improvement and evolution to occur based on provider feedback and patient care needs. Current tools, while not all-encompassing, have the potential to dramatically change the landscape of endoscopic training, diagnostic evaluation, and therapeutic care. It is critically important that relevant stakeholders, both endoscopists and patients, be involved in future applications and design to improve efficiency and quality outcomes overall.

Dr. McCarty is based in the Lynda K. and David M. Underwood Center for Digestive Disorders, Houston Methodist Hospital. Dr. Mansour is based in the section of gastroenterology, Baylor College of Medicine, Houston. Dr. McCarty reports no conflicts of interest. Dr. Mansour reports having been a consultant for Iterative Health.

References

1. Repici A, et al. Efficacy of real-time computer-aided detection of colorectal neoplasia in a randomized trial. Gastroenterology. 2020 Aug. doi: 10.1053/j.gastro.2020.04.062.

2. Repici A, et al. Artificial intelligence and colonoscopy experience: Lessons from two randomised trials. Gut. Apr 2022. doi: 10.1136/gutjnl-2021-324471.

3. Wallace MB, et al. Impact of artificial intelligence on miss rate of colorectal neoplasia. Gastroenterology 2022 Jul. doi: 10.1053/j.gastro.2022.03.007.

4. United States Food and Drug Administration (FDA). GI Genius FDA Approval [April 9, 2021]. Accessed January 5, 2022. Available at: www.accessdata.fda.gov/cdrh_docs/pdf21/K211951.pdf.

5. Maas MHJ, et al. A computer-aided polyp detection system in screening and surveillance colonoscopy: An international, multicentre, randomised, tandem trial. Lancet Digit Health. 2024 Mar. doi: 10.1016/S2589-7500(23)00242-X.

6. Ladabaum U, et al. Computer-aided detection of polyps does not improve colonoscopist performance in a pragmatic implementation trial. Gastroenterology. 2023 Mar. doi: 10.1053/j.gastro.2022.12.004.

7. Wei MT, et al. Evaluation of computer-aided detection during colonoscopy in the community (AI-SEE): A multicenter randomized clinical trial. Am J Gastroenterol. 2023 Oct. doi: 10.14309/ajg.0000000000002239.

8. de Groof J, et al. The Argos project: The development of a computer-aided detection system to improve detection of Barrett’s neoplasia on white light endoscopy. United European Gastroenterol J. 2019 May. doi: 10.1177/2050640619837443.

9. Kanesaka T, et al. Computer-aided diagnosis for identifying and delineating early gastric cancers in magnifying narrow-band imaging. Gastrointest Endosc. 2018 May. doi: 10.1016/j.gie.2017.11.029.

10. Sahafi A, et al. Edge artificial intelligence wireless video capsule endoscopy. Sci Rep. 2022 Aug. doi: 10.1038/s41598-022-17502-7.

11. Njei B, et al. Artificial intelligence in endoscopic imaging for detection of malignant biliary strictures and cholangiocarcinoma: A systematic review. Ann Gastroenterol. 2023 Mar-Apr. doi: 10.20524/aog.2023.0779.

12. Ebigbo A, et al. Vessel and tissue recognition during third-space endoscopy using a deep learning algorithm. Gut. 2022 Dec. doi: 10.1136/gutjnl-2021-326470.

13. Cao J, et al. Intelligent surgical workflow recognition for endoscopic submucosal dissection with real-time animal study. Nat Commun. 2023 Oct. doi: 10.1038/s41467-023-42451-8.

 

 

The Promise and Challenges of AI in Hepatology

BY BASILE NJEI, MD, MPH, PHD; YAZAN A. AL-AJLOUNI, MPHIL

In the dynamic realm of medicine, artificial intelligence (AI) emerges as a transformative force, notably within hepatology. The discipline of hepatology, dedicated to liver and related organ diseases, is ripe for AI’s promise to revolutionize diagnostics and treatment, pushing toward a future of precision medicine. Yet, the path to fully realizing AI’s potential in hepatology is laced with data, ethical, and integration challenges.

The application of AI, particularly in histopathology, significantly enhances disease diagnosis and staging in hepatology. AI-driven approaches remedy traditional histopathological challenges, such as interpretative variability, providing more consistent and accurate disease analyses. This is especially evident in conditions like metabolic dysfunction-associated steatohepatitis (MASH) and hepatocellular carcinoma (HCC), where AI aids in identifying critical gene signatures, thereby refining therapy selection.

Yale School of Medicine
Dr. Basile Njei

Similarly, deep learning (DL), a branch of AI, has attracted significant interest globally, particularly in image recognition. AI’s incorporation into medical imaging marks a significant advancement, enabling early detection of malignancies like HCC and improving diagnostics in steatotic liver disease through enhanced imaging analyses using convolutional neural networks (CNN). The abundance of imaging data alongside clinical outcomes has catalyzed AI’s integration into radiology, leading to the swift growth of radiomics as a novel domain in medical research.

AI has also been shown to identify nuanced alterations in electrocardiograms (EKGs) associated with liver conditions, potentially detecting the progression of liver diseases at an earlier stage than currently possible. By leveraging complex algorithms and machine learning, AI can analyze EKG patterns with a precision and depth unattainable through traditional manual interpretation. Given that liver diseases, such as cirrhosis or hepatitis, can induce subtle cardiac changes long before other clinical symptoms manifest, early detection through AI-enhanced EKG analysis could lead to timely interventions, potentially halting or reversing disease progression. This approach further enriches our understanding of the intricate interplay between liver function and cardiac health, highlighting the potential for AI to transform not just liver disease diagnostics but also to foster a more integrated approach to patient care.

New York Medical College
Yazan A. Al-Ajlouni

Beyond diagnostics, the burgeoning field of generative AI introduces groundbreaking possibilities in treatment planning and patient education, particularly for chronic conditions like cirrhosis. Generative AI produces original content, including text, visuals, and music, by identifying and learning patterns from its training data. When it leverages large language models (LLMs), it entails training on vast collections of textual data and using AI models characterized by many parameters. A notable instance of generative AI employing LLMs is ChatGPT (General Pretrained Transformers). By simulating disease progression and treatment outcomes, generative AI can foster personalized treatment strategies and empower patients with knowledge about their health trajectories. Yet, realizing these potential demands requires overcoming data quality and interpretability challenges, and ensuring AI outputs are accessible and actionable for clinicians and patients.

Despite these advancements, leveraging AI in hepatology is not devoid of hurdles. The development and training of AI models require extensive and diverse datasets, raising concerns about data privacy and ethical use. Addressing these concerns is paramount for successfully integrating AI into clinical hepatology practice, necessitating transparent algorithmic processes and stringent ethical standards. Ethical considerations are central to AI’s integration into hepatology. Algorithmic biases, patient privacy, and the impact of AI-driven decisions underscore the need for cautious AI deployment. Developing transparent, understandable algorithms and establishing ethical guidelines for AI use are critical steps towards ethically leveraging AI in patient care.

In conclusion, AI’s integration into hepatology holds tremendous promise for advancing patient care through enhanced diagnostics, treatment planning, and patient education. Overcoming the associated challenges, including ethical concerns, data diversity, and algorithm interpretability, is crucial. As the hepatology community navigates this technological evolution, a balanced approach that marries technological advancements with ethical stewardship will be key to harnessing AI’s full potential, ensuring it serves the best interests of patients and propels the field of hepatology into the future.

We predict a trajectory of increased use and adoption of AI in hepatology. AI in hepatology is likely to meet the test of pervasiveness, improvement, and innovation. The adoption of AI in routine hepatology diagnosis and management will likely follow Amara’s law and the five stages of the hype cycle. We believe that we are still in the infant stages of adopting AI technology in hepatology, and this phase may last 5 years before there is a peak of inflated expectations. The trough of disillusionment and slopes of enlightenment may only be observed in the next decades.

 

 

Dr. Njei is based in the Section of Digestive Diseases, Yale School of Medicine, New Haven, Conn. Mr. Al-Ajlouni is a senior medical student at New York Medical College School of Medicine, Valhalla, N.Y. They have no conflicts of interest to declare.

Sources

Taylor-Weiner A, et al. A Machine Learning Approach Enables Quantitative Measurement of Liver Histology and Disease Monitoring in NASH. Hepatology. 2021 Jul. doi: 10.1002/hep.31750.

Zeng Q, et al. Artificial intelligence predicts immune and inflammatory gene signatures directly from hepatocellular carcinoma histology. J Hepatol. 2022 Jul. doi: 10.1016/j.jhep.2022.01.018.

Ahn JC, et al. Development of the AI-Cirrhosis-ECG Score: An Electrocardiogram-Based Deep Learning Model in Cirrhosis. Am J Gastroenterol. 2022 Mar. doi: 10.14309/ajg.0000000000001617.

Nduma BN, et al. The Application of Artificial Intelligence (AI)-Based Ultrasound for the Diagnosis of Fatty Liver Disease: A Systematic Review. Cureus. 2023 Dec 15. doi: 10.7759/cureus.50601.

Publications
Topics
Sections

 

Dear colleagues,

Since our prior Perspectives piece on artificial intelligence (AI) in GI and Hepatology in 2022, the field has seen almost exponential growth. Expectations are high that AI will revolutionize our field and significantly improve patient care. But as the global discussion on AI has shown, there are real challenges with adoption, including issues with accuracy, reliability, and privacy.

In this issue, Dr. Nabil M. Mansour and Dr. Thomas R. McCarty explore the current and future impact of AI on gastroenterology, while Dr. Basile Njei and Yazan A. Al Ajlouni assess its role in hepatology. We hope these pieces will help your discussions in incorporating or researching AI for use in your own practices. We welcome your thoughts on this issue on X @AGA_GIHN.

Gyanprakash A. Ketwaroo, MD, MSc, is associate professor of medicine, Yale University, New Haven, Conn., and chief of endoscopy at West Haven (Conn.) VA Medical Center. He is an associate editor for GI & Hepatology News.

Artificial Intelligence in Gastrointestinal Endoscopy

BY THOMAS R. MCCARTY, MD, MPH; NABIL M. MANSOUR, MD

The last few decades have seen an exponential increase and interest in the role of artificial intelligence (AI) and adoption of deep learning algorithms within healthcare and patient care services. The field of gastroenterology and endoscopy has similarly seen a tremendous uptake in acceptance and implementation of AI for a variety of gastrointestinal conditions. The spectrum of AI-based applications includes detection or diagnostic-based as well as therapeutic assistance tools. From the first US Food and Drug Administration (FDA)-approved device that uses machine learning to assist clinicians in detecting lesions during colonoscopy, to other more innovative machine learning techniques for small bowel, esophageal, and hepatobiliary conditions, AI has dramatically changed the landscape of gastrointestinal endoscopy.

Baylor College of Medicine
Dr. Nabil M. Mansour


Approved applications for colorectal cancer

In an attempt to improve colorectal cancer screening and outcomes related to screening and surveillance, efforts have been focused on procedural performance metrics, quality indicators, and tools to aid in lesion detection and improve quality of care. One such tool has been computer-aided detection (CADe), with early randomized controlled trial (RCT) data showing significantly increased adenoma detection rate (ADR) and adenomas per colonoscopy (APC).1-3

Ultimately, this data led to FDA approval of the CADe system GI Genius (Medtronic, Dublin, Ireland) in 2021.4 Additional systems have since been FDA approved or 510(k) cleared including Endoscreener (Wision AI, Shanghai, China), SKOUT (Iterative Health, Cambridge, Massachusetts), MAGENTIQ-COLO (MAGENTIQ-EYE LTD, Haifa, Israel), and CAD EYE (Fujifilm, Tokyo), all of which have shown increased ADR and/or increased APC and/or reduced adenoma miss rates in randomized trials.5

Yet despite the promise of improved quality and subsequent translation to better patient outcomes, there has been a noticeable disconnect between RCT data and more real-world literature.6 In a recent study, no improvement was seen in ADR after implementation of a CADe system for colorectal cancer screening — including both higher and lower-ADR performers. Looking at change over time after implementation, CADe had no positive effect in any group over time, divergent from early RCT data. In a more recent multicenter, community-based RCT study, again CADe did not result in a statistically significant difference in the number of adenomas detected.7 The differences between some of these more recent “real-world” studies vs the majority of data from RCTs raise important questions regarding the potential of bias (due to unblinding) in prospective trials, as well as the role of the human-AI interaction.

Importantly for RCT data, both cohorts in these studies met adequate ADR benchmarks, though it remains unclear whether a truly increased ADR necessitates better patient outcomes — is higher always better? In addition, an important consideration with evaluating any AI/CADe system is that they often undergo frequent updates, each promising improved accuracy, sensitivity, and specificity. This is an interesting dilemma and raises questions about the enduring relevance of studies conducted using an outdated version of a CADe system.

Additional unanswered questions regarding an ideal ADR for implementation, preferred patient populations for screening (especially for younger individuals), and the role and adoption of computer-aided polyp diagnosis/characterization (CADx) within the United States remain. Furthermore, questions regarding procedural withdrawal time, impact on sessile serrated lesion detection, cost-effectiveness, and preferred adoption strategies have begun to be explored, though require more data to better define a best practice approach. Ultimately, answers to some of these unknowns may explain the discordant results and help guide future implementation measures.

 

 

Innovative applications for alternative gastrointestinal conditions

Given the fervor and excitement, as well as the outcomes associated with AI-based colorectal screening, it is not surprising these techniques have been expanded to other gastrointestinal conditions. At this time, all of these are fledgling, mostly single-center tools, not yet ready for widespread adoption. Nonetheless, these represent a potentially important step forward for difficult-to-manage gastrointestinal diseases.

Machine learning CADe systems have been developed to help identify early Barrett’s neoplasia, depth and invasion of gastric cancer, as well as lesion detection in small bowel video capsule endoscopy.8-10 Endoscopic retrograde cholangiopancreatography (ERCP)-based applications for cholangiocarcinoma and indeterminate stricture diagnosis have also been studied.11 Additional AI-based algorithms have been employed for complex procedures such as endoscopic submucosal dissection (ESD) or peroral endoscopic myotomy (POEM) to delineate vessels, better define tissue planes for dissection, and visualize landmark structures.12,13 Furthermore, AI-based scope guidance/manipulation, bleeding detection, landmark identification, and lesion detection have the potential to revolutionize endoscopic training and education. The impact that generative AI can potentially have on clinical practice is also an exciting prospect that warrants further investigation.

Artificial intelligence adoption in clinical practice

Clinical practice with regard to AI and colorectal cancer screening largely mirrors the disconnect in the current literature, with “believers” and “non-believers” as well as innovators and early adopters alongside laggards. In our own academic practices, we continue to struggle with the adoption and standardized implementation of AI-based colorectal cancer CADe systems, despite the RCT data showing positive results. It is likely that AI uptake will follow the technology predictions of Amara’s Law — i.e., individuals tend to overestimate the short-term impact of new technologies while underestimating long-term effects. In the end, more widespread adoption in community practice and larger scale real-world clinical outcomes studies are likely to determine the true impact of these exciting technologies. For other, less established AI-based tools, more data are currently required.

Conclusions

Ultimately, AI-based algorithms are likely here to stay, with continued improvement and evolution to occur based on provider feedback and patient care needs. Current tools, while not all-encompassing, have the potential to dramatically change the landscape of endoscopic training, diagnostic evaluation, and therapeutic care. It is critically important that relevant stakeholders, both endoscopists and patients, be involved in future applications and design to improve efficiency and quality outcomes overall.

Dr. McCarty is based in the Lynda K. and David M. Underwood Center for Digestive Disorders, Houston Methodist Hospital. Dr. Mansour is based in the section of gastroenterology, Baylor College of Medicine, Houston. Dr. McCarty reports no conflicts of interest. Dr. Mansour reports having been a consultant for Iterative Health.

References

1. Repici A, et al. Efficacy of real-time computer-aided detection of colorectal neoplasia in a randomized trial. Gastroenterology. 2020 Aug. doi: 10.1053/j.gastro.2020.04.062.

2. Repici A, et al. Artificial intelligence and colonoscopy experience: Lessons from two randomised trials. Gut. Apr 2022. doi: 10.1136/gutjnl-2021-324471.

3. Wallace MB, et al. Impact of artificial intelligence on miss rate of colorectal neoplasia. Gastroenterology 2022 Jul. doi: 10.1053/j.gastro.2022.03.007.

4. United States Food and Drug Administration (FDA). GI Genius FDA Approval [April 9, 2021]. Accessed January 5, 2022. Available at: www.accessdata.fda.gov/cdrh_docs/pdf21/K211951.pdf.

5. Maas MHJ, et al. A computer-aided polyp detection system in screening and surveillance colonoscopy: An international, multicentre, randomised, tandem trial. Lancet Digit Health. 2024 Mar. doi: 10.1016/S2589-7500(23)00242-X.

6. Ladabaum U, et al. Computer-aided detection of polyps does not improve colonoscopist performance in a pragmatic implementation trial. Gastroenterology. 2023 Mar. doi: 10.1053/j.gastro.2022.12.004.

7. Wei MT, et al. Evaluation of computer-aided detection during colonoscopy in the community (AI-SEE): A multicenter randomized clinical trial. Am J Gastroenterol. 2023 Oct. doi: 10.14309/ajg.0000000000002239.

8. de Groof J, et al. The Argos project: The development of a computer-aided detection system to improve detection of Barrett’s neoplasia on white light endoscopy. United European Gastroenterol J. 2019 May. doi: 10.1177/2050640619837443.

9. Kanesaka T, et al. Computer-aided diagnosis for identifying and delineating early gastric cancers in magnifying narrow-band imaging. Gastrointest Endosc. 2018 May. doi: 10.1016/j.gie.2017.11.029.

10. Sahafi A, et al. Edge artificial intelligence wireless video capsule endoscopy. Sci Rep. 2022 Aug. doi: 10.1038/s41598-022-17502-7.

11. Njei B, et al. Artificial intelligence in endoscopic imaging for detection of malignant biliary strictures and cholangiocarcinoma: A systematic review. Ann Gastroenterol. 2023 Mar-Apr. doi: 10.20524/aog.2023.0779.

12. Ebigbo A, et al. Vessel and tissue recognition during third-space endoscopy using a deep learning algorithm. Gut. 2022 Dec. doi: 10.1136/gutjnl-2021-326470.

13. Cao J, et al. Intelligent surgical workflow recognition for endoscopic submucosal dissection with real-time animal study. Nat Commun. 2023 Oct. doi: 10.1038/s41467-023-42451-8.

 

 

The Promise and Challenges of AI in Hepatology

BY BASILE NJEI, MD, MPH, PHD; YAZAN A. AL-AJLOUNI, MPHIL

In the dynamic realm of medicine, artificial intelligence (AI) emerges as a transformative force, notably within hepatology. The discipline of hepatology, dedicated to liver and related organ diseases, is ripe for AI’s promise to revolutionize diagnostics and treatment, pushing toward a future of precision medicine. Yet, the path to fully realizing AI’s potential in hepatology is laced with data, ethical, and integration challenges.

The application of AI, particularly in histopathology, significantly enhances disease diagnosis and staging in hepatology. AI-driven approaches remedy traditional histopathological challenges, such as interpretative variability, providing more consistent and accurate disease analyses. This is especially evident in conditions like metabolic dysfunction-associated steatohepatitis (MASH) and hepatocellular carcinoma (HCC), where AI aids in identifying critical gene signatures, thereby refining therapy selection.

Yale School of Medicine
Dr. Basile Njei

Similarly, deep learning (DL), a branch of AI, has attracted significant interest globally, particularly in image recognition. AI’s incorporation into medical imaging marks a significant advancement, enabling early detection of malignancies like HCC and improving diagnostics in steatotic liver disease through enhanced imaging analyses using convolutional neural networks (CNN). The abundance of imaging data alongside clinical outcomes has catalyzed AI’s integration into radiology, leading to the swift growth of radiomics as a novel domain in medical research.

AI has also been shown to identify nuanced alterations in electrocardiograms (EKGs) associated with liver conditions, potentially detecting the progression of liver diseases at an earlier stage than currently possible. By leveraging complex algorithms and machine learning, AI can analyze EKG patterns with a precision and depth unattainable through traditional manual interpretation. Given that liver diseases, such as cirrhosis or hepatitis, can induce subtle cardiac changes long before other clinical symptoms manifest, early detection through AI-enhanced EKG analysis could lead to timely interventions, potentially halting or reversing disease progression. This approach further enriches our understanding of the intricate interplay between liver function and cardiac health, highlighting the potential for AI to transform not just liver disease diagnostics but also to foster a more integrated approach to patient care.

New York Medical College
Yazan A. Al-Ajlouni

Beyond diagnostics, the burgeoning field of generative AI introduces groundbreaking possibilities in treatment planning and patient education, particularly for chronic conditions like cirrhosis. Generative AI produces original content, including text, visuals, and music, by identifying and learning patterns from its training data. When it leverages large language models (LLMs), it entails training on vast collections of textual data and using AI models characterized by many parameters. A notable instance of generative AI employing LLMs is ChatGPT (General Pretrained Transformers). By simulating disease progression and treatment outcomes, generative AI can foster personalized treatment strategies and empower patients with knowledge about their health trajectories. Yet, realizing these potential demands requires overcoming data quality and interpretability challenges, and ensuring AI outputs are accessible and actionable for clinicians and patients.

Despite these advancements, leveraging AI in hepatology is not devoid of hurdles. The development and training of AI models require extensive and diverse datasets, raising concerns about data privacy and ethical use. Addressing these concerns is paramount for successfully integrating AI into clinical hepatology practice, necessitating transparent algorithmic processes and stringent ethical standards. Ethical considerations are central to AI’s integration into hepatology. Algorithmic biases, patient privacy, and the impact of AI-driven decisions underscore the need for cautious AI deployment. Developing transparent, understandable algorithms and establishing ethical guidelines for AI use are critical steps towards ethically leveraging AI in patient care.

In conclusion, AI’s integration into hepatology holds tremendous promise for advancing patient care through enhanced diagnostics, treatment planning, and patient education. Overcoming the associated challenges, including ethical concerns, data diversity, and algorithm interpretability, is crucial. As the hepatology community navigates this technological evolution, a balanced approach that marries technological advancements with ethical stewardship will be key to harnessing AI’s full potential, ensuring it serves the best interests of patients and propels the field of hepatology into the future.

We predict a trajectory of increased use and adoption of AI in hepatology. AI in hepatology is likely to meet the test of pervasiveness, improvement, and innovation. The adoption of AI in routine hepatology diagnosis and management will likely follow Amara’s law and the five stages of the hype cycle. We believe that we are still in the infant stages of adopting AI technology in hepatology, and this phase may last 5 years before there is a peak of inflated expectations. The trough of disillusionment and slopes of enlightenment may only be observed in the next decades.

 

 

Dr. Njei is based in the Section of Digestive Diseases, Yale School of Medicine, New Haven, Conn. Mr. Al-Ajlouni is a senior medical student at New York Medical College School of Medicine, Valhalla, N.Y. They have no conflicts of interest to declare.

Sources

Taylor-Weiner A, et al. A Machine Learning Approach Enables Quantitative Measurement of Liver Histology and Disease Monitoring in NASH. Hepatology. 2021 Jul. doi: 10.1002/hep.31750.

Zeng Q, et al. Artificial intelligence predicts immune and inflammatory gene signatures directly from hepatocellular carcinoma histology. J Hepatol. 2022 Jul. doi: 10.1016/j.jhep.2022.01.018.

Ahn JC, et al. Development of the AI-Cirrhosis-ECG Score: An Electrocardiogram-Based Deep Learning Model in Cirrhosis. Am J Gastroenterol. 2022 Mar. doi: 10.14309/ajg.0000000000001617.

Nduma BN, et al. The Application of Artificial Intelligence (AI)-Based Ultrasound for the Diagnosis of Fatty Liver Disease: A Systematic Review. Cureus. 2023 Dec 15. doi: 10.7759/cureus.50601.

 

Dear colleagues,

Since our prior Perspectives piece on artificial intelligence (AI) in GI and Hepatology in 2022, the field has seen almost exponential growth. Expectations are high that AI will revolutionize our field and significantly improve patient care. But as the global discussion on AI has shown, there are real challenges with adoption, including issues with accuracy, reliability, and privacy.

In this issue, Dr. Nabil M. Mansour and Dr. Thomas R. McCarty explore the current and future impact of AI on gastroenterology, while Dr. Basile Njei and Yazan A. Al Ajlouni assess its role in hepatology. We hope these pieces will help your discussions in incorporating or researching AI for use in your own practices. We welcome your thoughts on this issue on X @AGA_GIHN.

Gyanprakash A. Ketwaroo, MD, MSc, is associate professor of medicine, Yale University, New Haven, Conn., and chief of endoscopy at West Haven (Conn.) VA Medical Center. He is an associate editor for GI & Hepatology News.

Artificial Intelligence in Gastrointestinal Endoscopy

BY THOMAS R. MCCARTY, MD, MPH; NABIL M. MANSOUR, MD

The last few decades have seen an exponential increase and interest in the role of artificial intelligence (AI) and adoption of deep learning algorithms within healthcare and patient care services. The field of gastroenterology and endoscopy has similarly seen a tremendous uptake in acceptance and implementation of AI for a variety of gastrointestinal conditions. The spectrum of AI-based applications includes detection or diagnostic-based as well as therapeutic assistance tools. From the first US Food and Drug Administration (FDA)-approved device that uses machine learning to assist clinicians in detecting lesions during colonoscopy, to other more innovative machine learning techniques for small bowel, esophageal, and hepatobiliary conditions, AI has dramatically changed the landscape of gastrointestinal endoscopy.

Baylor College of Medicine
Dr. Nabil M. Mansour


Approved applications for colorectal cancer

In an attempt to improve colorectal cancer screening and outcomes related to screening and surveillance, efforts have been focused on procedural performance metrics, quality indicators, and tools to aid in lesion detection and improve quality of care. One such tool has been computer-aided detection (CADe), with early randomized controlled trial (RCT) data showing significantly increased adenoma detection rate (ADR) and adenomas per colonoscopy (APC).1-3

Ultimately, this data led to FDA approval of the CADe system GI Genius (Medtronic, Dublin, Ireland) in 2021.4 Additional systems have since been FDA approved or 510(k) cleared including Endoscreener (Wision AI, Shanghai, China), SKOUT (Iterative Health, Cambridge, Massachusetts), MAGENTIQ-COLO (MAGENTIQ-EYE LTD, Haifa, Israel), and CAD EYE (Fujifilm, Tokyo), all of which have shown increased ADR and/or increased APC and/or reduced adenoma miss rates in randomized trials.5

Yet despite the promise of improved quality and subsequent translation to better patient outcomes, there has been a noticeable disconnect between RCT data and more real-world literature.6 In a recent study, no improvement was seen in ADR after implementation of a CADe system for colorectal cancer screening — including both higher and lower-ADR performers. Looking at change over time after implementation, CADe had no positive effect in any group over time, divergent from early RCT data. In a more recent multicenter, community-based RCT study, again CADe did not result in a statistically significant difference in the number of adenomas detected.7 The differences between some of these more recent “real-world” studies vs the majority of data from RCTs raise important questions regarding the potential of bias (due to unblinding) in prospective trials, as well as the role of the human-AI interaction.

Importantly for RCT data, both cohorts in these studies met adequate ADR benchmarks, though it remains unclear whether a truly increased ADR necessitates better patient outcomes — is higher always better? In addition, an important consideration with evaluating any AI/CADe system is that they often undergo frequent updates, each promising improved accuracy, sensitivity, and specificity. This is an interesting dilemma and raises questions about the enduring relevance of studies conducted using an outdated version of a CADe system.

Additional unanswered questions regarding an ideal ADR for implementation, preferred patient populations for screening (especially for younger individuals), and the role and adoption of computer-aided polyp diagnosis/characterization (CADx) within the United States remain. Furthermore, questions regarding procedural withdrawal time, impact on sessile serrated lesion detection, cost-effectiveness, and preferred adoption strategies have begun to be explored, though require more data to better define a best practice approach. Ultimately, answers to some of these unknowns may explain the discordant results and help guide future implementation measures.

 

 

Innovative applications for alternative gastrointestinal conditions

Given the fervor and excitement, as well as the outcomes associated with AI-based colorectal screening, it is not surprising these techniques have been expanded to other gastrointestinal conditions. At this time, all of these are fledgling, mostly single-center tools, not yet ready for widespread adoption. Nonetheless, these represent a potentially important step forward for difficult-to-manage gastrointestinal diseases.

Machine learning CADe systems have been developed to help identify early Barrett’s neoplasia, depth and invasion of gastric cancer, as well as lesion detection in small bowel video capsule endoscopy.8-10 Endoscopic retrograde cholangiopancreatography (ERCP)-based applications for cholangiocarcinoma and indeterminate stricture diagnosis have also been studied.11 Additional AI-based algorithms have been employed for complex procedures such as endoscopic submucosal dissection (ESD) or peroral endoscopic myotomy (POEM) to delineate vessels, better define tissue planes for dissection, and visualize landmark structures.12,13 Furthermore, AI-based scope guidance/manipulation, bleeding detection, landmark identification, and lesion detection have the potential to revolutionize endoscopic training and education. The impact that generative AI can potentially have on clinical practice is also an exciting prospect that warrants further investigation.

Artificial intelligence adoption in clinical practice

Clinical practice with regard to AI and colorectal cancer screening largely mirrors the disconnect in the current literature, with “believers” and “non-believers” as well as innovators and early adopters alongside laggards. In our own academic practices, we continue to struggle with the adoption and standardized implementation of AI-based colorectal cancer CADe systems, despite the RCT data showing positive results. It is likely that AI uptake will follow the technology predictions of Amara’s Law — i.e., individuals tend to overestimate the short-term impact of new technologies while underestimating long-term effects. In the end, more widespread adoption in community practice and larger scale real-world clinical outcomes studies are likely to determine the true impact of these exciting technologies. For other, less established AI-based tools, more data are currently required.

Conclusions

Ultimately, AI-based algorithms are likely here to stay, with continued improvement and evolution to occur based on provider feedback and patient care needs. Current tools, while not all-encompassing, have the potential to dramatically change the landscape of endoscopic training, diagnostic evaluation, and therapeutic care. It is critically important that relevant stakeholders, both endoscopists and patients, be involved in future applications and design to improve efficiency and quality outcomes overall.

Dr. McCarty is based in the Lynda K. and David M. Underwood Center for Digestive Disorders, Houston Methodist Hospital. Dr. Mansour is based in the section of gastroenterology, Baylor College of Medicine, Houston. Dr. McCarty reports no conflicts of interest. Dr. Mansour reports having been a consultant for Iterative Health.

References

1. Repici A, et al. Efficacy of real-time computer-aided detection of colorectal neoplasia in a randomized trial. Gastroenterology. 2020 Aug. doi: 10.1053/j.gastro.2020.04.062.

2. Repici A, et al. Artificial intelligence and colonoscopy experience: Lessons from two randomised trials. Gut. Apr 2022. doi: 10.1136/gutjnl-2021-324471.

3. Wallace MB, et al. Impact of artificial intelligence on miss rate of colorectal neoplasia. Gastroenterology 2022 Jul. doi: 10.1053/j.gastro.2022.03.007.

4. United States Food and Drug Administration (FDA). GI Genius FDA Approval [April 9, 2021]. Accessed January 5, 2022. Available at: www.accessdata.fda.gov/cdrh_docs/pdf21/K211951.pdf.

5. Maas MHJ, et al. A computer-aided polyp detection system in screening and surveillance colonoscopy: An international, multicentre, randomised, tandem trial. Lancet Digit Health. 2024 Mar. doi: 10.1016/S2589-7500(23)00242-X.

6. Ladabaum U, et al. Computer-aided detection of polyps does not improve colonoscopist performance in a pragmatic implementation trial. Gastroenterology. 2023 Mar. doi: 10.1053/j.gastro.2022.12.004.

7. Wei MT, et al. Evaluation of computer-aided detection during colonoscopy in the community (AI-SEE): A multicenter randomized clinical trial. Am J Gastroenterol. 2023 Oct. doi: 10.14309/ajg.0000000000002239.

8. de Groof J, et al. The Argos project: The development of a computer-aided detection system to improve detection of Barrett’s neoplasia on white light endoscopy. United European Gastroenterol J. 2019 May. doi: 10.1177/2050640619837443.

9. Kanesaka T, et al. Computer-aided diagnosis for identifying and delineating early gastric cancers in magnifying narrow-band imaging. Gastrointest Endosc. 2018 May. doi: 10.1016/j.gie.2017.11.029.

10. Sahafi A, et al. Edge artificial intelligence wireless video capsule endoscopy. Sci Rep. 2022 Aug. doi: 10.1038/s41598-022-17502-7.

11. Njei B, et al. Artificial intelligence in endoscopic imaging for detection of malignant biliary strictures and cholangiocarcinoma: A systematic review. Ann Gastroenterol. 2023 Mar-Apr. doi: 10.20524/aog.2023.0779.

12. Ebigbo A, et al. Vessel and tissue recognition during third-space endoscopy using a deep learning algorithm. Gut. 2022 Dec. doi: 10.1136/gutjnl-2021-326470.

13. Cao J, et al. Intelligent surgical workflow recognition for endoscopic submucosal dissection with real-time animal study. Nat Commun. 2023 Oct. doi: 10.1038/s41467-023-42451-8.

 

 

The Promise and Challenges of AI in Hepatology

BY BASILE NJEI, MD, MPH, PHD; YAZAN A. AL-AJLOUNI, MPHIL

In the dynamic realm of medicine, artificial intelligence (AI) emerges as a transformative force, notably within hepatology. The discipline of hepatology, dedicated to liver and related organ diseases, is ripe for AI’s promise to revolutionize diagnostics and treatment, pushing toward a future of precision medicine. Yet, the path to fully realizing AI’s potential in hepatology is laced with data, ethical, and integration challenges.

The application of AI, particularly in histopathology, significantly enhances disease diagnosis and staging in hepatology. AI-driven approaches remedy traditional histopathological challenges, such as interpretative variability, providing more consistent and accurate disease analyses. This is especially evident in conditions like metabolic dysfunction-associated steatohepatitis (MASH) and hepatocellular carcinoma (HCC), where AI aids in identifying critical gene signatures, thereby refining therapy selection.

Yale School of Medicine
Dr. Basile Njei

Similarly, deep learning (DL), a branch of AI, has attracted significant interest globally, particularly in image recognition. AI’s incorporation into medical imaging marks a significant advancement, enabling early detection of malignancies like HCC and improving diagnostics in steatotic liver disease through enhanced imaging analyses using convolutional neural networks (CNN). The abundance of imaging data alongside clinical outcomes has catalyzed AI’s integration into radiology, leading to the swift growth of radiomics as a novel domain in medical research.

AI has also been shown to identify nuanced alterations in electrocardiograms (EKGs) associated with liver conditions, potentially detecting the progression of liver diseases at an earlier stage than currently possible. By leveraging complex algorithms and machine learning, AI can analyze EKG patterns with a precision and depth unattainable through traditional manual interpretation. Given that liver diseases, such as cirrhosis or hepatitis, can induce subtle cardiac changes long before other clinical symptoms manifest, early detection through AI-enhanced EKG analysis could lead to timely interventions, potentially halting or reversing disease progression. This approach further enriches our understanding of the intricate interplay between liver function and cardiac health, highlighting the potential for AI to transform not just liver disease diagnostics but also to foster a more integrated approach to patient care.

New York Medical College
Yazan A. Al-Ajlouni

Beyond diagnostics, the burgeoning field of generative AI introduces groundbreaking possibilities in treatment planning and patient education, particularly for chronic conditions like cirrhosis. Generative AI produces original content, including text, visuals, and music, by identifying and learning patterns from its training data. When it leverages large language models (LLMs), it entails training on vast collections of textual data and using AI models characterized by many parameters. A notable instance of generative AI employing LLMs is ChatGPT (General Pretrained Transformers). By simulating disease progression and treatment outcomes, generative AI can foster personalized treatment strategies and empower patients with knowledge about their health trajectories. Yet, realizing these potential demands requires overcoming data quality and interpretability challenges, and ensuring AI outputs are accessible and actionable for clinicians and patients.

Despite these advancements, leveraging AI in hepatology is not devoid of hurdles. The development and training of AI models require extensive and diverse datasets, raising concerns about data privacy and ethical use. Addressing these concerns is paramount for successfully integrating AI into clinical hepatology practice, necessitating transparent algorithmic processes and stringent ethical standards. Ethical considerations are central to AI’s integration into hepatology. Algorithmic biases, patient privacy, and the impact of AI-driven decisions underscore the need for cautious AI deployment. Developing transparent, understandable algorithms and establishing ethical guidelines for AI use are critical steps towards ethically leveraging AI in patient care.

In conclusion, AI’s integration into hepatology holds tremendous promise for advancing patient care through enhanced diagnostics, treatment planning, and patient education. Overcoming the associated challenges, including ethical concerns, data diversity, and algorithm interpretability, is crucial. As the hepatology community navigates this technological evolution, a balanced approach that marries technological advancements with ethical stewardship will be key to harnessing AI’s full potential, ensuring it serves the best interests of patients and propels the field of hepatology into the future.

We predict a trajectory of increased use and adoption of AI in hepatology. AI in hepatology is likely to meet the test of pervasiveness, improvement, and innovation. The adoption of AI in routine hepatology diagnosis and management will likely follow Amara’s law and the five stages of the hype cycle. We believe that we are still in the infant stages of adopting AI technology in hepatology, and this phase may last 5 years before there is a peak of inflated expectations. The trough of disillusionment and slopes of enlightenment may only be observed in the next decades.

 

 

Dr. Njei is based in the Section of Digestive Diseases, Yale School of Medicine, New Haven, Conn. Mr. Al-Ajlouni is a senior medical student at New York Medical College School of Medicine, Valhalla, N.Y. They have no conflicts of interest to declare.

Sources

Taylor-Weiner A, et al. A Machine Learning Approach Enables Quantitative Measurement of Liver Histology and Disease Monitoring in NASH. Hepatology. 2021 Jul. doi: 10.1002/hep.31750.

Zeng Q, et al. Artificial intelligence predicts immune and inflammatory gene signatures directly from hepatocellular carcinoma histology. J Hepatol. 2022 Jul. doi: 10.1016/j.jhep.2022.01.018.

Ahn JC, et al. Development of the AI-Cirrhosis-ECG Score: An Electrocardiogram-Based Deep Learning Model in Cirrhosis. Am J Gastroenterol. 2022 Mar. doi: 10.14309/ajg.0000000000001617.

Nduma BN, et al. The Application of Artificial Intelligence (AI)-Based Ultrasound for the Diagnosis of Fatty Liver Disease: A Systematic Review. Cureus. 2023 Dec 15. doi: 10.7759/cureus.50601.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Navigating the Search for a Financial Adviser

Article Type
Changed

 

As gastroenterologists, we spend innumerable years in medical training with an abrupt and significant increase in our earning potential upon beginning practice. The majority of us also carry a sizeable amount of student loan debt. This combination results in a unique situation that can make us hesitant about how best to set ourselves up financially while also making us vulnerable to potentially predatory financial practices.

Although your initial steps to achieve financial wellness and build wealth can be obtained on your own with some education, a financial adviser becomes indispensable when you have significant assets, a high income, complex finances, and/or are experiencing a major life change. Additionally, as there are so many avenues to invest and grow your capital, a financial adviser can assist in designing a portfolio to best accomplish specific monetary goals. Studies have demonstrated that those working with a financial adviser reduce their single-stock risk and have more significant increase in portfolio value, reducing the total cost associated with their investments’ management.1 Those working with a financial adviser will also net up to a 3% larger annual return, compared with a standard baseline investment plan.2,3

Dr. Luthra
Dr. Anjuli K. Luthra

Based on this information, it may appear that working with a personal financial adviser would be a no-brainer. Unfortunately, there is a caveat: There is no legal regulation regarding who can use the title “financial adviser.” It is therefore crucial to be aware of common practices and terminology to best help you identify a reputable financial adviser and reduce your risk of excessive fees or financial loss. This is also a highly personal decision and your search should first begin with understanding why you are looking for an adviser, as this will determine the appropriate type of service to look for.
 

Types of Advisers

A certified financial planner (CFP) is an expert in estate planning, taxes, retirement saving, and financial planning who has a formal designation by the Certified Financial Planner Board of Standards Inc.4 They must undergo stringent licensing examinations following a 3-year course with required continuing education to maintain their credentials. CFPs are fiduciaries, meaning they must make financial decisions in your best interest, even if they may make less money with that product or investment strategy. In other words, they are beholden to give honest, impartial recommendations to their clients, and may face sanctions by the CFP Board if found to violate its Code of Ethics and Standards of Conduct, which includes failure to act in a fiduciary duty.5

CFPs evaluate your total financial picture, such as investments, insurance policies, and overall current financial position, to develop a comprehensive strategy that will successfully guide you to your financial goal. There are many individuals who may refer to themselves as financial planners without having the CFP designation; while they may offer similar services as above, they will not be required to act as a fiduciary. Hence, it is important to do your due diligence and verify they hold this certification via the CFP Board website: www.cfp.net/verify-a-cfp-professional.

An investment adviser is a legal term from the U.S. Securities and Exchange Commission (SEC) and the Financial Industry Regulatory Authority (FINRA) referring to an individual who provides recommendations and analyses for financial securities such as stock. Both of these agencies ensure investment advisers adhere to regulatory requirements designed to protect client investers. Similar to CFPs, they are held to a fiduciary standard, and their firm is required to register with the SEC or the state of practice based on the amount of assets under management.6

An individual investment adviser must also register with their state as an Investment Adviser Representative (IAR), the distinctive term referring to an individual as opposed to an investment advising firm. Investment advisers are required to pass the extensive Series 65, Uniform Investment Advisor Law Exam, or equivalent, by states requiring licensure.7 They can guide you on the selection of particular investments and portfolio management based on a discussion with you regarding your current financial standing and what fiscal ambitions you wish to achieve.

A financial adviser provides direction on a multitude of financially related topics such as investing, tax laws, and life insurance with the goal to help you reach specific financial objectives. However, this term is often used quite ubiquitously given the lack of formal regulation of the title. Essentially, those with varying types of educational background can give themselves the title of financial adviser.

If a financial adviser buys or sells financial securities such as stocks or bonds, then they must be registered as a licensed broker with the SEC and IAR and pass the Series 6 or Series 7 exam. Unlike CFPs and investment advisers, a financial adviser (if also a licensed broker) is not required to be a fiduciary, and instead works under the suitability standard.8 Suitability requires that financial recommendations made by the adviser are appropriate but not necessarily the best for the client. In fact, these recommendations do not even have to be the most suitable. This is where conflicts of interest can arise with the adviser recommending products and securities that best compensate them while not serving the best return on investment for you.

Making the search for a financial adviser more complex, an individual can be a combination of any of the above, pending the appropriate licensing. For example, a CFP can also be an asset manager and thus hold the title of a financial adviser and/or IAR. A financial adviser may also not directly manage your assets if they have a partnership with a third party or another licensed individual. Questions to ask of your potential financial adviser should therefore include the following:

 

 

  • What licensure and related education do you have?
  • What is your particular area of expertise?
  • How long have you been in practice?
  • How will you be managing my assets?

Financial Adviser Fee Schedules

Prior to working with a financial adviser, you must also inquire about their fee structure. There are two kinds of fee schedules used by financial advisers: fee-only and fee-based.

Fee-only advisers receive payment solely for the services they provide. They do not collect commissions from third parties providing the recommended products. There is variability in how this type of payment schedule is structured, encompassing flat fees, hourly rates, or the adviser charging a retainer. The Table below compares the types of fee-only structures and range of charges based on 2023 rates.9 Of note, fee-only advisers serve as fiduciaries.10

Fee-based financial advisers receive payment for services but may also receive commission on specific products they sell to you.9 Most, if not all, financial experts recommend avoiding advisers using commission-based charges given the potential conflict of interest: How can one be absolutely sure this recommended financial product is best for you, knowing your adviser has a financial stake in said item?

In addition to charging the fees above, your financial adviser, if they are actively managing your investment portfolio, will also charge an assets under management (AUM) fee. This is a percentage of the dollar amount within your portfolio. For example, if your adviser charges a 1% AUM rate for your account totaling $100,000, this equates to a $1,000 fee in that calendar year. AUM fees typically decrease as the size of your portfolio increases. As seen in the Table, there is a wide range of the average AUM rate (0.5%–2%); however, an AUM fee approaching 2% is unnecessarily high and consumes a significant portion of your portfolio. Thus, it is recommended to look for a money manager with an approximate 1% AUM fee.

Many of us delay or avoid working with a financial adviser due to the potential perceived risks of having poor portfolio management from an adviser not working in our best interest, along with the concern for excessive fees. While anyone can invest in an Exchange Traded Fund or Index Fund, we can lose on not seeking a financial adviser’s expertise to increase our asset growth and fund of financial knowledge. In many ways, it is how we counsel our patients. While they can seek medical information on their own, their best care is under the guidance of an expert: a healthcare professional. That being said, personal finance is indeed personal, so I hope this guide helps facilitate your search and increase your financial wellness.

Dr. Luthra is a therapeutic endoscopist at Moffitt Cancer Center, Tampa, Florida, and the founder of The Scope of Finance, a financial wellness education and coaching company focused on physicians. Her interest in financial well-being is thanks to the teachings of her father, an entrepreneur and former Certified Financial Planner (CFP). She can be found on Instagram (thescopeoffinance) and X (@ScopeofFinance). She reports no financial disclosures relevant to this article.

 

 

References

1. Pagliaro CA and Utkus SP. Assessing the value of advice. Vanguard. 2019 Sept.

2. Kinniry Jr. FM et al. Putting a value on your value: Quantifying Vanguard Advisor’s Alpha. Vanguard. 2022 July.

3. Horan S. What Are the Benefits of Working with a Financial Advisor? – 2021 Study. Smart Asset. 2023 July 27.

4. Kagan J. Certified Financial PlannerTM(CFP): What It Is and How to Become One. Investopedia. 2023 Aug 3.

5. CFP Board. Our Commitment to Ethical Standards. CFP Board. 2024.

6. Staff of the Investment Adviser Regulation Office Division of Investment Management, U.S. Securities and Exchange Commission. Regulation of Investment Advisers by the U.S. Securities and Exchange Commission. 2013 Mar.

7. Hicks C. Investment Advisor vs. Financial Advisor: There is a Difference. US News & World Report. 2019 June 13.

8. Roberts K. Financial advisor vs. financial planner: What is the difference? Bankrate. 2023 Nov 21.

9. Clancy D. Average Fees for Financial Advisors in 2023. Harness Wealth. 2023 May 25.

10. Palmer B. Fee- vs. Commission-Based Advisor: What’s the Difference? Investopedia. 2023 June 20.

Publications
Topics
Sections

 

As gastroenterologists, we spend innumerable years in medical training with an abrupt and significant increase in our earning potential upon beginning practice. The majority of us also carry a sizeable amount of student loan debt. This combination results in a unique situation that can make us hesitant about how best to set ourselves up financially while also making us vulnerable to potentially predatory financial practices.

Although your initial steps to achieve financial wellness and build wealth can be obtained on your own with some education, a financial adviser becomes indispensable when you have significant assets, a high income, complex finances, and/or are experiencing a major life change. Additionally, as there are so many avenues to invest and grow your capital, a financial adviser can assist in designing a portfolio to best accomplish specific monetary goals. Studies have demonstrated that those working with a financial adviser reduce their single-stock risk and have more significant increase in portfolio value, reducing the total cost associated with their investments’ management.1 Those working with a financial adviser will also net up to a 3% larger annual return, compared with a standard baseline investment plan.2,3

Dr. Luthra
Dr. Anjuli K. Luthra

Based on this information, it may appear that working with a personal financial adviser would be a no-brainer. Unfortunately, there is a caveat: There is no legal regulation regarding who can use the title “financial adviser.” It is therefore crucial to be aware of common practices and terminology to best help you identify a reputable financial adviser and reduce your risk of excessive fees or financial loss. This is also a highly personal decision and your search should first begin with understanding why you are looking for an adviser, as this will determine the appropriate type of service to look for.
 

Types of Advisers

A certified financial planner (CFP) is an expert in estate planning, taxes, retirement saving, and financial planning who has a formal designation by the Certified Financial Planner Board of Standards Inc.4 They must undergo stringent licensing examinations following a 3-year course with required continuing education to maintain their credentials. CFPs are fiduciaries, meaning they must make financial decisions in your best interest, even if they may make less money with that product or investment strategy. In other words, they are beholden to give honest, impartial recommendations to their clients, and may face sanctions by the CFP Board if found to violate its Code of Ethics and Standards of Conduct, which includes failure to act in a fiduciary duty.5

CFPs evaluate your total financial picture, such as investments, insurance policies, and overall current financial position, to develop a comprehensive strategy that will successfully guide you to your financial goal. There are many individuals who may refer to themselves as financial planners without having the CFP designation; while they may offer similar services as above, they will not be required to act as a fiduciary. Hence, it is important to do your due diligence and verify they hold this certification via the CFP Board website: www.cfp.net/verify-a-cfp-professional.

An investment adviser is a legal term from the U.S. Securities and Exchange Commission (SEC) and the Financial Industry Regulatory Authority (FINRA) referring to an individual who provides recommendations and analyses for financial securities such as stock. Both of these agencies ensure investment advisers adhere to regulatory requirements designed to protect client investers. Similar to CFPs, they are held to a fiduciary standard, and their firm is required to register with the SEC or the state of practice based on the amount of assets under management.6

An individual investment adviser must also register with their state as an Investment Adviser Representative (IAR), the distinctive term referring to an individual as opposed to an investment advising firm. Investment advisers are required to pass the extensive Series 65, Uniform Investment Advisor Law Exam, or equivalent, by states requiring licensure.7 They can guide you on the selection of particular investments and portfolio management based on a discussion with you regarding your current financial standing and what fiscal ambitions you wish to achieve.

A financial adviser provides direction on a multitude of financially related topics such as investing, tax laws, and life insurance with the goal to help you reach specific financial objectives. However, this term is often used quite ubiquitously given the lack of formal regulation of the title. Essentially, those with varying types of educational background can give themselves the title of financial adviser.

If a financial adviser buys or sells financial securities such as stocks or bonds, then they must be registered as a licensed broker with the SEC and IAR and pass the Series 6 or Series 7 exam. Unlike CFPs and investment advisers, a financial adviser (if also a licensed broker) is not required to be a fiduciary, and instead works under the suitability standard.8 Suitability requires that financial recommendations made by the adviser are appropriate but not necessarily the best for the client. In fact, these recommendations do not even have to be the most suitable. This is where conflicts of interest can arise with the adviser recommending products and securities that best compensate them while not serving the best return on investment for you.

Making the search for a financial adviser more complex, an individual can be a combination of any of the above, pending the appropriate licensing. For example, a CFP can also be an asset manager and thus hold the title of a financial adviser and/or IAR. A financial adviser may also not directly manage your assets if they have a partnership with a third party or another licensed individual. Questions to ask of your potential financial adviser should therefore include the following:

 

 

  • What licensure and related education do you have?
  • What is your particular area of expertise?
  • How long have you been in practice?
  • How will you be managing my assets?

Financial Adviser Fee Schedules

Prior to working with a financial adviser, you must also inquire about their fee structure. There are two kinds of fee schedules used by financial advisers: fee-only and fee-based.

Fee-only advisers receive payment solely for the services they provide. They do not collect commissions from third parties providing the recommended products. There is variability in how this type of payment schedule is structured, encompassing flat fees, hourly rates, or the adviser charging a retainer. The Table below compares the types of fee-only structures and range of charges based on 2023 rates.9 Of note, fee-only advisers serve as fiduciaries.10

Fee-based financial advisers receive payment for services but may also receive commission on specific products they sell to you.9 Most, if not all, financial experts recommend avoiding advisers using commission-based charges given the potential conflict of interest: How can one be absolutely sure this recommended financial product is best for you, knowing your adviser has a financial stake in said item?

In addition to charging the fees above, your financial adviser, if they are actively managing your investment portfolio, will also charge an assets under management (AUM) fee. This is a percentage of the dollar amount within your portfolio. For example, if your adviser charges a 1% AUM rate for your account totaling $100,000, this equates to a $1,000 fee in that calendar year. AUM fees typically decrease as the size of your portfolio increases. As seen in the Table, there is a wide range of the average AUM rate (0.5%–2%); however, an AUM fee approaching 2% is unnecessarily high and consumes a significant portion of your portfolio. Thus, it is recommended to look for a money manager with an approximate 1% AUM fee.

Many of us delay or avoid working with a financial adviser due to the potential perceived risks of having poor portfolio management from an adviser not working in our best interest, along with the concern for excessive fees. While anyone can invest in an Exchange Traded Fund or Index Fund, we can lose on not seeking a financial adviser’s expertise to increase our asset growth and fund of financial knowledge. In many ways, it is how we counsel our patients. While they can seek medical information on their own, their best care is under the guidance of an expert: a healthcare professional. That being said, personal finance is indeed personal, so I hope this guide helps facilitate your search and increase your financial wellness.

Dr. Luthra is a therapeutic endoscopist at Moffitt Cancer Center, Tampa, Florida, and the founder of The Scope of Finance, a financial wellness education and coaching company focused on physicians. Her interest in financial well-being is thanks to the teachings of her father, an entrepreneur and former Certified Financial Planner (CFP). She can be found on Instagram (thescopeoffinance) and X (@ScopeofFinance). She reports no financial disclosures relevant to this article.

 

 

References

1. Pagliaro CA and Utkus SP. Assessing the value of advice. Vanguard. 2019 Sept.

2. Kinniry Jr. FM et al. Putting a value on your value: Quantifying Vanguard Advisor’s Alpha. Vanguard. 2022 July.

3. Horan S. What Are the Benefits of Working with a Financial Advisor? – 2021 Study. Smart Asset. 2023 July 27.

4. Kagan J. Certified Financial PlannerTM(CFP): What It Is and How to Become One. Investopedia. 2023 Aug 3.

5. CFP Board. Our Commitment to Ethical Standards. CFP Board. 2024.

6. Staff of the Investment Adviser Regulation Office Division of Investment Management, U.S. Securities and Exchange Commission. Regulation of Investment Advisers by the U.S. Securities and Exchange Commission. 2013 Mar.

7. Hicks C. Investment Advisor vs. Financial Advisor: There is a Difference. US News & World Report. 2019 June 13.

8. Roberts K. Financial advisor vs. financial planner: What is the difference? Bankrate. 2023 Nov 21.

9. Clancy D. Average Fees for Financial Advisors in 2023. Harness Wealth. 2023 May 25.

10. Palmer B. Fee- vs. Commission-Based Advisor: What’s the Difference? Investopedia. 2023 June 20.

 

As gastroenterologists, we spend innumerable years in medical training with an abrupt and significant increase in our earning potential upon beginning practice. The majority of us also carry a sizeable amount of student loan debt. This combination results in a unique situation that can make us hesitant about how best to set ourselves up financially while also making us vulnerable to potentially predatory financial practices.

Although your initial steps to achieve financial wellness and build wealth can be obtained on your own with some education, a financial adviser becomes indispensable when you have significant assets, a high income, complex finances, and/or are experiencing a major life change. Additionally, as there are so many avenues to invest and grow your capital, a financial adviser can assist in designing a portfolio to best accomplish specific monetary goals. Studies have demonstrated that those working with a financial adviser reduce their single-stock risk and have more significant increase in portfolio value, reducing the total cost associated with their investments’ management.1 Those working with a financial adviser will also net up to a 3% larger annual return, compared with a standard baseline investment plan.2,3

Dr. Luthra
Dr. Anjuli K. Luthra

Based on this information, it may appear that working with a personal financial adviser would be a no-brainer. Unfortunately, there is a caveat: There is no legal regulation regarding who can use the title “financial adviser.” It is therefore crucial to be aware of common practices and terminology to best help you identify a reputable financial adviser and reduce your risk of excessive fees or financial loss. This is also a highly personal decision and your search should first begin with understanding why you are looking for an adviser, as this will determine the appropriate type of service to look for.
 

Types of Advisers

A certified financial planner (CFP) is an expert in estate planning, taxes, retirement saving, and financial planning who has a formal designation by the Certified Financial Planner Board of Standards Inc.4 They must undergo stringent licensing examinations following a 3-year course with required continuing education to maintain their credentials. CFPs are fiduciaries, meaning they must make financial decisions in your best interest, even if they may make less money with that product or investment strategy. In other words, they are beholden to give honest, impartial recommendations to their clients, and may face sanctions by the CFP Board if found to violate its Code of Ethics and Standards of Conduct, which includes failure to act in a fiduciary duty.5

CFPs evaluate your total financial picture, such as investments, insurance policies, and overall current financial position, to develop a comprehensive strategy that will successfully guide you to your financial goal. There are many individuals who may refer to themselves as financial planners without having the CFP designation; while they may offer similar services as above, they will not be required to act as a fiduciary. Hence, it is important to do your due diligence and verify they hold this certification via the CFP Board website: www.cfp.net/verify-a-cfp-professional.

An investment adviser is a legal term from the U.S. Securities and Exchange Commission (SEC) and the Financial Industry Regulatory Authority (FINRA) referring to an individual who provides recommendations and analyses for financial securities such as stock. Both of these agencies ensure investment advisers adhere to regulatory requirements designed to protect client investers. Similar to CFPs, they are held to a fiduciary standard, and their firm is required to register with the SEC or the state of practice based on the amount of assets under management.6

An individual investment adviser must also register with their state as an Investment Adviser Representative (IAR), the distinctive term referring to an individual as opposed to an investment advising firm. Investment advisers are required to pass the extensive Series 65, Uniform Investment Advisor Law Exam, or equivalent, by states requiring licensure.7 They can guide you on the selection of particular investments and portfolio management based on a discussion with you regarding your current financial standing and what fiscal ambitions you wish to achieve.

A financial adviser provides direction on a multitude of financially related topics such as investing, tax laws, and life insurance with the goal to help you reach specific financial objectives. However, this term is often used quite ubiquitously given the lack of formal regulation of the title. Essentially, those with varying types of educational background can give themselves the title of financial adviser.

If a financial adviser buys or sells financial securities such as stocks or bonds, then they must be registered as a licensed broker with the SEC and IAR and pass the Series 6 or Series 7 exam. Unlike CFPs and investment advisers, a financial adviser (if also a licensed broker) is not required to be a fiduciary, and instead works under the suitability standard.8 Suitability requires that financial recommendations made by the adviser are appropriate but not necessarily the best for the client. In fact, these recommendations do not even have to be the most suitable. This is where conflicts of interest can arise with the adviser recommending products and securities that best compensate them while not serving the best return on investment for you.

Making the search for a financial adviser more complex, an individual can be a combination of any of the above, pending the appropriate licensing. For example, a CFP can also be an asset manager and thus hold the title of a financial adviser and/or IAR. A financial adviser may also not directly manage your assets if they have a partnership with a third party or another licensed individual. Questions to ask of your potential financial adviser should therefore include the following:

 

 

  • What licensure and related education do you have?
  • What is your particular area of expertise?
  • How long have you been in practice?
  • How will you be managing my assets?

Financial Adviser Fee Schedules

Prior to working with a financial adviser, you must also inquire about their fee structure. There are two kinds of fee schedules used by financial advisers: fee-only and fee-based.

Fee-only advisers receive payment solely for the services they provide. They do not collect commissions from third parties providing the recommended products. There is variability in how this type of payment schedule is structured, encompassing flat fees, hourly rates, or the adviser charging a retainer. The Table below compares the types of fee-only structures and range of charges based on 2023 rates.9 Of note, fee-only advisers serve as fiduciaries.10

Fee-based financial advisers receive payment for services but may also receive commission on specific products they sell to you.9 Most, if not all, financial experts recommend avoiding advisers using commission-based charges given the potential conflict of interest: How can one be absolutely sure this recommended financial product is best for you, knowing your adviser has a financial stake in said item?

In addition to charging the fees above, your financial adviser, if they are actively managing your investment portfolio, will also charge an assets under management (AUM) fee. This is a percentage of the dollar amount within your portfolio. For example, if your adviser charges a 1% AUM rate for your account totaling $100,000, this equates to a $1,000 fee in that calendar year. AUM fees typically decrease as the size of your portfolio increases. As seen in the Table, there is a wide range of the average AUM rate (0.5%–2%); however, an AUM fee approaching 2% is unnecessarily high and consumes a significant portion of your portfolio. Thus, it is recommended to look for a money manager with an approximate 1% AUM fee.

Many of us delay or avoid working with a financial adviser due to the potential perceived risks of having poor portfolio management from an adviser not working in our best interest, along with the concern for excessive fees. While anyone can invest in an Exchange Traded Fund or Index Fund, we can lose on not seeking a financial adviser’s expertise to increase our asset growth and fund of financial knowledge. In many ways, it is how we counsel our patients. While they can seek medical information on their own, their best care is under the guidance of an expert: a healthcare professional. That being said, personal finance is indeed personal, so I hope this guide helps facilitate your search and increase your financial wellness.

Dr. Luthra is a therapeutic endoscopist at Moffitt Cancer Center, Tampa, Florida, and the founder of The Scope of Finance, a financial wellness education and coaching company focused on physicians. Her interest in financial well-being is thanks to the teachings of her father, an entrepreneur and former Certified Financial Planner (CFP). She can be found on Instagram (thescopeoffinance) and X (@ScopeofFinance). She reports no financial disclosures relevant to this article.

 

 

References

1. Pagliaro CA and Utkus SP. Assessing the value of advice. Vanguard. 2019 Sept.

2. Kinniry Jr. FM et al. Putting a value on your value: Quantifying Vanguard Advisor’s Alpha. Vanguard. 2022 July.

3. Horan S. What Are the Benefits of Working with a Financial Advisor? – 2021 Study. Smart Asset. 2023 July 27.

4. Kagan J. Certified Financial PlannerTM(CFP): What It Is and How to Become One. Investopedia. 2023 Aug 3.

5. CFP Board. Our Commitment to Ethical Standards. CFP Board. 2024.

6. Staff of the Investment Adviser Regulation Office Division of Investment Management, U.S. Securities and Exchange Commission. Regulation of Investment Advisers by the U.S. Securities and Exchange Commission. 2013 Mar.

7. Hicks C. Investment Advisor vs. Financial Advisor: There is a Difference. US News & World Report. 2019 June 13.

8. Roberts K. Financial advisor vs. financial planner: What is the difference? Bankrate. 2023 Nov 21.

9. Clancy D. Average Fees for Financial Advisors in 2023. Harness Wealth. 2023 May 25.

10. Palmer B. Fee- vs. Commission-Based Advisor: What’s the Difference? Investopedia. 2023 June 20.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Achieving Promotion for Junior Faculty in Academic Medicine: An Interview With Experts

Article Type
Changed

 

Academic medicine plays a crucial role at the crossroads of medical practice, education, and research, influencing the future landscape of healthcare. Many physicians aspire to pursue and sustain a career in academic medicine to contribute to the advancement of medical knowledge, enhance patient care, and influence the trajectory of the medical field. Opting for a career in academic medicine can offer benefits such as increased autonomy and scheduling flexibility, which can significantly improve the quality of life. In addition, engagement in scholarly activities and working in a dynamic environment with continuous learning opportunities can help mitigate burnout.

However, embarking on an academic career can be daunting for junior faculty members who face the challenge of providing clinical care while excelling in research and dedicating time to mentorship and teaching trainees. According to a report by the Association of American Medical Colleges, 38% of physicians leave academic medicine within a decade of obtaining a faculty position. Barriers to promotion and retention within academic medicine include ineffective mentorship, unclear or inconsistent promotion criteria, and disparities in gender/ethnic representation.

Memorial Sloan Kettering Cancer Center
Dr. Vineet Rolston


In this article, we interview two accomplished physicians in academic medicine who have attained the rank of professors. Our aim is to provide insights into the promotion process and offer recommendations for junior faculty, highlighting the key factors that contribute to success.
 

Interview with Sophie Balzora, MD

Dr. Balzora is a professor of medicine at NYU Grossman School of Medicine and a practicing gastroenterologist specializing in the care of patients with inflammatory bowel disease at NYU Langone Health. She serves as the American College of Gastroenterology’s Diversity, Equity, and Inclusion Committee Chair, on the Advisory Board of ACG’s Leadership, Ethics, and Equity (LE&E) Center, and is president and cofounder of the Association of Black Gastroenterologists and Hepatologists (ABGH). Dr. Balzora was promoted to full professor 11 years after graduating from fellowship.

NYU Langone Health
Dr. Sophie Balzora

What would you identify as some of the most important factors that led to your success in achieving a promotion to professor of medicine?

Surround yourself with individuals whose professional and personal priorities align with yours. To achieve this, it is essential to gain an understanding of what is important to you, what you envision your success to look like, and establish a timeline to achieve it. The concept of personal success and how to best achieve it will absolutely change as you grow, and that is okay and expected. Connecting with those outside of your clinical interests, at other institutions, and even outside of the medical field, can help you achieve these goals and better shape how you see your career unfolding and how you want it to look.

Historically, the proportion of physicians who achieve professorship is lower among women compared with men. What do you believe are some of the barriers involved in this, and how would you counsel women who are interested in pursuing the rank of professor?

Systemic gender bias and discrimination, over-mentorship and under-sponsorship, inconsistent parental leave, and delayed parenthood are a few of the factors that contribute to the observed disparities in academic rank. Predictably, for women from underrepresented backgrounds in medicine, the chasm grows.

 

 

What has helped me most is to keep my eyes on the prize, and to recognize that the prize is different for everyone. It’s important not to make direct comparisons to any other individual, because they are not you. Harness what makes you different and drown out the naysayers — the “we’ve never seen this done before” camp, the “it’s too soon [for someone like you] to go up for promotion” folks. While these voices are sometimes well intentioned, they can distract you from your goals and ambitions because they are rooted in bias and adherence to traditional expectations. To do something new, and to change the game, requires going against the grain and utilizing your skills and talents to achieve what you want to achieve in a way that works for you.
 

What are some practical tips you have for junior gastroenterologists to track their promotion in academia?

  • Keep your curriculum vitae (CV) up to date and formatted to your institutional guidelines. Ensure that you document your academic activities, even if it doesn’t seem important in the moment. When it’s time to submit that promotion portfolio, you want to be ready and organized.
  • Remember: “No” is a full sentence, and saying it takes practice and time and confidence. It is a skill I still struggle to adopt at times, but it’s important to recognize the power of no, for it opens opportunities to say yes to other things.
  • Lift as you climb — a critical part of changing the status quo is fostering the future of those underrepresented in medicine. A professional goal of mine that keeps me steady and passionate is to create supporting and enriching systemic and institutional changes that work to dismantle the obstacles perpetuating disparities in academic rank for women and those underrepresented in medicine. Discovering your “why” is a complex, difficult, and rewarding journey.

Interview with Mark Schattner, MD, AGAF

Dr. Schattner is a professor of clinical medicine at Weill Cornell College of Medicine and chief of the gastroenterology, hepatology, and nutrition service at Memorial Sloan Kettering Cancer Center, both in New York. He is a former president of the New York Society for Gastrointestinal Endoscopy and a fellow of the AGA and ASGE.

NYU Langone Health
Dr. Mark Schattner

In your role as chief, you serve as a mentor for early career gastroenterologists for pursuing career promotion. What advice do you have for achieving this?

Promoting junior faculty is one of the prime responsibilities of a service chief. Generally, the early steps of promotion are straightforward, with criteria becoming more stringent as you progress. I think it is critical to understand the criteria used by promotion committees and to be aware of the various available tracks. I believe every meeting a junior faculty member has with their service chief should include, at the least, a brief check-in on where they are in the promotion process and plans (both short term and long term) to move forward. Successful promotion is facilitated when done upon a solid foundation of production and accomplishment. It is very challenging or even impossible when trying to piece together a package from discordant activities.

 

 

Most institutions require or encourage academic involvement at both national and international levels for career promotion. Do you have advice for junior faculty about how to achieve this type of recognition or experience?

The easiest place to start is with regional professional societies. Active involvement in these local societies fosters valuable networking and lays the groundwork for involvement at the national or international level. I would strongly encourage junior faculty to seek opportunities for a leadership position at any level in these societies and move up the ladder as their career matures. This is also a very good avenue to network and get invited to join collaborative research projects, which can be a fruitful means to enhance your academic productivity.

In your opinion, what factors are likely to hinder or delay an individual’s promotion?

I think it is crucial to consider the career track you are on. If you are very clinically productive and love to teach, that is completely appropriate, and most institutions will recognize the value of that and promote you along a clinical-educator tract. On the other hand, if you have a passion for research and can successfully lead research and compete for grants, then you would move along a traditional tenure track. It is also critical to think ahead, know the criteria on which you will be judged, and incorporate that into your practice early. Trying to scramble to enhance your CV in a short time just for promotion will likely prove ineffective.

Do you have advice for junior faculty who have families about how to manage career goals but also prioritize time with family?

There is no one-size-fits-all approach to this. I think this requires a lot of shared decision-making with your family. Compromise will undoubtedly be required. For example, I always chose to live in close proximity to my workplace, eliminating any commuting time. This choice really allowed me spend time with my family.



In conclusion, a career in academic medicine presents both opportunities and challenges. A successful academic career, and achieving promotion to the rank of professor of medicine, requires a combination of factors including understanding institution-specific criteria for promotion, proactive engagement at the regional and national level, and envisioning your career goals and creating a timeline to achieve them. There are challenges to promotion, including navigating systemic biases and balancing career goals with family commitments, which also requires consideration and open communication. Ultimately, we hope these insights provide valuable guidance and advice for junior faculty who are navigating this complex environment of academic medicine and are motivated toward achieving professional fulfillment and satisfaction in their careers.

Dr. Rolston is based in the Department of Gastroenterology, Hepatology, and Nutrition, Memorial Sloan Kettering Cancer Center, New York. She reports no conflicts in relation this article. Dr. Balzora and Dr. Schattner are based in the Division of Gastroenterology and Hepatology, New York University Langone Health, New York. Dr. Schattner is a consultant for Boston Scientific and Novo Nordisk. Dr. Balzora reports no conflicts in relation to this article.

 

 

References

Campbell KM. Mitigating the isolation of minoritized faculty in academic medicine. J Gen Intern Med. 2023 May. doi: 10.1007/s11606-022-07982-8.

Howard-Anderson JR et al. Strategies for developing a successful career in academic medicine. Am J Med Sci. 2024 Apr. doi: 10.1016/j.amjms.2023.12.010.

Murphy M et al. Women’s experiences of promotion and tenure in academic medicine and potential implications for gender disparities in career advancement: A qualitative analysis. JAMA Netw Open. 2021 Sep 1. doi: 10.1001/jamanetworkopen.2021.25843.

Sambunjak D et al. Mentoring in academic medicine: A systematic review. JAMA. 2006 Sep 6. doi: 10.1001/jama.296.9.1103.

Shen MR et al. Impact of mentoring on academic career success for women in medicine: A systematic review. Acad Med. 2022 Mar 1. doi: 10.1097/ACM.0000000000004563.

Publications
Topics
Sections

 

Academic medicine plays a crucial role at the crossroads of medical practice, education, and research, influencing the future landscape of healthcare. Many physicians aspire to pursue and sustain a career in academic medicine to contribute to the advancement of medical knowledge, enhance patient care, and influence the trajectory of the medical field. Opting for a career in academic medicine can offer benefits such as increased autonomy and scheduling flexibility, which can significantly improve the quality of life. In addition, engagement in scholarly activities and working in a dynamic environment with continuous learning opportunities can help mitigate burnout.

However, embarking on an academic career can be daunting for junior faculty members who face the challenge of providing clinical care while excelling in research and dedicating time to mentorship and teaching trainees. According to a report by the Association of American Medical Colleges, 38% of physicians leave academic medicine within a decade of obtaining a faculty position. Barriers to promotion and retention within academic medicine include ineffective mentorship, unclear or inconsistent promotion criteria, and disparities in gender/ethnic representation.

Memorial Sloan Kettering Cancer Center
Dr. Vineet Rolston


In this article, we interview two accomplished physicians in academic medicine who have attained the rank of professors. Our aim is to provide insights into the promotion process and offer recommendations for junior faculty, highlighting the key factors that contribute to success.
 

Interview with Sophie Balzora, MD

Dr. Balzora is a professor of medicine at NYU Grossman School of Medicine and a practicing gastroenterologist specializing in the care of patients with inflammatory bowel disease at NYU Langone Health. She serves as the American College of Gastroenterology’s Diversity, Equity, and Inclusion Committee Chair, on the Advisory Board of ACG’s Leadership, Ethics, and Equity (LE&E) Center, and is president and cofounder of the Association of Black Gastroenterologists and Hepatologists (ABGH). Dr. Balzora was promoted to full professor 11 years after graduating from fellowship.

NYU Langone Health
Dr. Sophie Balzora

What would you identify as some of the most important factors that led to your success in achieving a promotion to professor of medicine?

Surround yourself with individuals whose professional and personal priorities align with yours. To achieve this, it is essential to gain an understanding of what is important to you, what you envision your success to look like, and establish a timeline to achieve it. The concept of personal success and how to best achieve it will absolutely change as you grow, and that is okay and expected. Connecting with those outside of your clinical interests, at other institutions, and even outside of the medical field, can help you achieve these goals and better shape how you see your career unfolding and how you want it to look.

Historically, the proportion of physicians who achieve professorship is lower among women compared with men. What do you believe are some of the barriers involved in this, and how would you counsel women who are interested in pursuing the rank of professor?

Systemic gender bias and discrimination, over-mentorship and under-sponsorship, inconsistent parental leave, and delayed parenthood are a few of the factors that contribute to the observed disparities in academic rank. Predictably, for women from underrepresented backgrounds in medicine, the chasm grows.

 

 

What has helped me most is to keep my eyes on the prize, and to recognize that the prize is different for everyone. It’s important not to make direct comparisons to any other individual, because they are not you. Harness what makes you different and drown out the naysayers — the “we’ve never seen this done before” camp, the “it’s too soon [for someone like you] to go up for promotion” folks. While these voices are sometimes well intentioned, they can distract you from your goals and ambitions because they are rooted in bias and adherence to traditional expectations. To do something new, and to change the game, requires going against the grain and utilizing your skills and talents to achieve what you want to achieve in a way that works for you.
 

What are some practical tips you have for junior gastroenterologists to track their promotion in academia?

  • Keep your curriculum vitae (CV) up to date and formatted to your institutional guidelines. Ensure that you document your academic activities, even if it doesn’t seem important in the moment. When it’s time to submit that promotion portfolio, you want to be ready and organized.
  • Remember: “No” is a full sentence, and saying it takes practice and time and confidence. It is a skill I still struggle to adopt at times, but it’s important to recognize the power of no, for it opens opportunities to say yes to other things.
  • Lift as you climb — a critical part of changing the status quo is fostering the future of those underrepresented in medicine. A professional goal of mine that keeps me steady and passionate is to create supporting and enriching systemic and institutional changes that work to dismantle the obstacles perpetuating disparities in academic rank for women and those underrepresented in medicine. Discovering your “why” is a complex, difficult, and rewarding journey.

Interview with Mark Schattner, MD, AGAF

Dr. Schattner is a professor of clinical medicine at Weill Cornell College of Medicine and chief of the gastroenterology, hepatology, and nutrition service at Memorial Sloan Kettering Cancer Center, both in New York. He is a former president of the New York Society for Gastrointestinal Endoscopy and a fellow of the AGA and ASGE.

NYU Langone Health
Dr. Mark Schattner

In your role as chief, you serve as a mentor for early career gastroenterologists for pursuing career promotion. What advice do you have for achieving this?

Promoting junior faculty is one of the prime responsibilities of a service chief. Generally, the early steps of promotion are straightforward, with criteria becoming more stringent as you progress. I think it is critical to understand the criteria used by promotion committees and to be aware of the various available tracks. I believe every meeting a junior faculty member has with their service chief should include, at the least, a brief check-in on where they are in the promotion process and plans (both short term and long term) to move forward. Successful promotion is facilitated when done upon a solid foundation of production and accomplishment. It is very challenging or even impossible when trying to piece together a package from discordant activities.

 

 

Most institutions require or encourage academic involvement at both national and international levels for career promotion. Do you have advice for junior faculty about how to achieve this type of recognition or experience?

The easiest place to start is with regional professional societies. Active involvement in these local societies fosters valuable networking and lays the groundwork for involvement at the national or international level. I would strongly encourage junior faculty to seek opportunities for a leadership position at any level in these societies and move up the ladder as their career matures. This is also a very good avenue to network and get invited to join collaborative research projects, which can be a fruitful means to enhance your academic productivity.

In your opinion, what factors are likely to hinder or delay an individual’s promotion?

I think it is crucial to consider the career track you are on. If you are very clinically productive and love to teach, that is completely appropriate, and most institutions will recognize the value of that and promote you along a clinical-educator tract. On the other hand, if you have a passion for research and can successfully lead research and compete for grants, then you would move along a traditional tenure track. It is also critical to think ahead, know the criteria on which you will be judged, and incorporate that into your practice early. Trying to scramble to enhance your CV in a short time just for promotion will likely prove ineffective.

Do you have advice for junior faculty who have families about how to manage career goals but also prioritize time with family?

There is no one-size-fits-all approach to this. I think this requires a lot of shared decision-making with your family. Compromise will undoubtedly be required. For example, I always chose to live in close proximity to my workplace, eliminating any commuting time. This choice really allowed me spend time with my family.



In conclusion, a career in academic medicine presents both opportunities and challenges. A successful academic career, and achieving promotion to the rank of professor of medicine, requires a combination of factors including understanding institution-specific criteria for promotion, proactive engagement at the regional and national level, and envisioning your career goals and creating a timeline to achieve them. There are challenges to promotion, including navigating systemic biases and balancing career goals with family commitments, which also requires consideration and open communication. Ultimately, we hope these insights provide valuable guidance and advice for junior faculty who are navigating this complex environment of academic medicine and are motivated toward achieving professional fulfillment and satisfaction in their careers.

Dr. Rolston is based in the Department of Gastroenterology, Hepatology, and Nutrition, Memorial Sloan Kettering Cancer Center, New York. She reports no conflicts in relation this article. Dr. Balzora and Dr. Schattner are based in the Division of Gastroenterology and Hepatology, New York University Langone Health, New York. Dr. Schattner is a consultant for Boston Scientific and Novo Nordisk. Dr. Balzora reports no conflicts in relation to this article.

 

 

References

Campbell KM. Mitigating the isolation of minoritized faculty in academic medicine. J Gen Intern Med. 2023 May. doi: 10.1007/s11606-022-07982-8.

Howard-Anderson JR et al. Strategies for developing a successful career in academic medicine. Am J Med Sci. 2024 Apr. doi: 10.1016/j.amjms.2023.12.010.

Murphy M et al. Women’s experiences of promotion and tenure in academic medicine and potential implications for gender disparities in career advancement: A qualitative analysis. JAMA Netw Open. 2021 Sep 1. doi: 10.1001/jamanetworkopen.2021.25843.

Sambunjak D et al. Mentoring in academic medicine: A systematic review. JAMA. 2006 Sep 6. doi: 10.1001/jama.296.9.1103.

Shen MR et al. Impact of mentoring on academic career success for women in medicine: A systematic review. Acad Med. 2022 Mar 1. doi: 10.1097/ACM.0000000000004563.

 

Academic medicine plays a crucial role at the crossroads of medical practice, education, and research, influencing the future landscape of healthcare. Many physicians aspire to pursue and sustain a career in academic medicine to contribute to the advancement of medical knowledge, enhance patient care, and influence the trajectory of the medical field. Opting for a career in academic medicine can offer benefits such as increased autonomy and scheduling flexibility, which can significantly improve the quality of life. In addition, engagement in scholarly activities and working in a dynamic environment with continuous learning opportunities can help mitigate burnout.

However, embarking on an academic career can be daunting for junior faculty members who face the challenge of providing clinical care while excelling in research and dedicating time to mentorship and teaching trainees. According to a report by the Association of American Medical Colleges, 38% of physicians leave academic medicine within a decade of obtaining a faculty position. Barriers to promotion and retention within academic medicine include ineffective mentorship, unclear or inconsistent promotion criteria, and disparities in gender/ethnic representation.

Memorial Sloan Kettering Cancer Center
Dr. Vineet Rolston


In this article, we interview two accomplished physicians in academic medicine who have attained the rank of professors. Our aim is to provide insights into the promotion process and offer recommendations for junior faculty, highlighting the key factors that contribute to success.
 

Interview with Sophie Balzora, MD

Dr. Balzora is a professor of medicine at NYU Grossman School of Medicine and a practicing gastroenterologist specializing in the care of patients with inflammatory bowel disease at NYU Langone Health. She serves as the American College of Gastroenterology’s Diversity, Equity, and Inclusion Committee Chair, on the Advisory Board of ACG’s Leadership, Ethics, and Equity (LE&E) Center, and is president and cofounder of the Association of Black Gastroenterologists and Hepatologists (ABGH). Dr. Balzora was promoted to full professor 11 years after graduating from fellowship.

NYU Langone Health
Dr. Sophie Balzora

What would you identify as some of the most important factors that led to your success in achieving a promotion to professor of medicine?

Surround yourself with individuals whose professional and personal priorities align with yours. To achieve this, it is essential to gain an understanding of what is important to you, what you envision your success to look like, and establish a timeline to achieve it. The concept of personal success and how to best achieve it will absolutely change as you grow, and that is okay and expected. Connecting with those outside of your clinical interests, at other institutions, and even outside of the medical field, can help you achieve these goals and better shape how you see your career unfolding and how you want it to look.

Historically, the proportion of physicians who achieve professorship is lower among women compared with men. What do you believe are some of the barriers involved in this, and how would you counsel women who are interested in pursuing the rank of professor?

Systemic gender bias and discrimination, over-mentorship and under-sponsorship, inconsistent parental leave, and delayed parenthood are a few of the factors that contribute to the observed disparities in academic rank. Predictably, for women from underrepresented backgrounds in medicine, the chasm grows.

 

 

What has helped me most is to keep my eyes on the prize, and to recognize that the prize is different for everyone. It’s important not to make direct comparisons to any other individual, because they are not you. Harness what makes you different and drown out the naysayers — the “we’ve never seen this done before” camp, the “it’s too soon [for someone like you] to go up for promotion” folks. While these voices are sometimes well intentioned, they can distract you from your goals and ambitions because they are rooted in bias and adherence to traditional expectations. To do something new, and to change the game, requires going against the grain and utilizing your skills and talents to achieve what you want to achieve in a way that works for you.
 

What are some practical tips you have for junior gastroenterologists to track their promotion in academia?

  • Keep your curriculum vitae (CV) up to date and formatted to your institutional guidelines. Ensure that you document your academic activities, even if it doesn’t seem important in the moment. When it’s time to submit that promotion portfolio, you want to be ready and organized.
  • Remember: “No” is a full sentence, and saying it takes practice and time and confidence. It is a skill I still struggle to adopt at times, but it’s important to recognize the power of no, for it opens opportunities to say yes to other things.
  • Lift as you climb — a critical part of changing the status quo is fostering the future of those underrepresented in medicine. A professional goal of mine that keeps me steady and passionate is to create supporting and enriching systemic and institutional changes that work to dismantle the obstacles perpetuating disparities in academic rank for women and those underrepresented in medicine. Discovering your “why” is a complex, difficult, and rewarding journey.

Interview with Mark Schattner, MD, AGAF

Dr. Schattner is a professor of clinical medicine at Weill Cornell College of Medicine and chief of the gastroenterology, hepatology, and nutrition service at Memorial Sloan Kettering Cancer Center, both in New York. He is a former president of the New York Society for Gastrointestinal Endoscopy and a fellow of the AGA and ASGE.

NYU Langone Health
Dr. Mark Schattner

In your role as chief, you serve as a mentor for early career gastroenterologists for pursuing career promotion. What advice do you have for achieving this?

Promoting junior faculty is one of the prime responsibilities of a service chief. Generally, the early steps of promotion are straightforward, with criteria becoming more stringent as you progress. I think it is critical to understand the criteria used by promotion committees and to be aware of the various available tracks. I believe every meeting a junior faculty member has with their service chief should include, at the least, a brief check-in on where they are in the promotion process and plans (both short term and long term) to move forward. Successful promotion is facilitated when done upon a solid foundation of production and accomplishment. It is very challenging or even impossible when trying to piece together a package from discordant activities.

 

 

Most institutions require or encourage academic involvement at both national and international levels for career promotion. Do you have advice for junior faculty about how to achieve this type of recognition or experience?

The easiest place to start is with regional professional societies. Active involvement in these local societies fosters valuable networking and lays the groundwork for involvement at the national or international level. I would strongly encourage junior faculty to seek opportunities for a leadership position at any level in these societies and move up the ladder as their career matures. This is also a very good avenue to network and get invited to join collaborative research projects, which can be a fruitful means to enhance your academic productivity.

In your opinion, what factors are likely to hinder or delay an individual’s promotion?

I think it is crucial to consider the career track you are on. If you are very clinically productive and love to teach, that is completely appropriate, and most institutions will recognize the value of that and promote you along a clinical-educator tract. On the other hand, if you have a passion for research and can successfully lead research and compete for grants, then you would move along a traditional tenure track. It is also critical to think ahead, know the criteria on which you will be judged, and incorporate that into your practice early. Trying to scramble to enhance your CV in a short time just for promotion will likely prove ineffective.

Do you have advice for junior faculty who have families about how to manage career goals but also prioritize time with family?

There is no one-size-fits-all approach to this. I think this requires a lot of shared decision-making with your family. Compromise will undoubtedly be required. For example, I always chose to live in close proximity to my workplace, eliminating any commuting time. This choice really allowed me spend time with my family.



In conclusion, a career in academic medicine presents both opportunities and challenges. A successful academic career, and achieving promotion to the rank of professor of medicine, requires a combination of factors including understanding institution-specific criteria for promotion, proactive engagement at the regional and national level, and envisioning your career goals and creating a timeline to achieve them. There are challenges to promotion, including navigating systemic biases and balancing career goals with family commitments, which also requires consideration and open communication. Ultimately, we hope these insights provide valuable guidance and advice for junior faculty who are navigating this complex environment of academic medicine and are motivated toward achieving professional fulfillment and satisfaction in their careers.

Dr. Rolston is based in the Department of Gastroenterology, Hepatology, and Nutrition, Memorial Sloan Kettering Cancer Center, New York. She reports no conflicts in relation this article. Dr. Balzora and Dr. Schattner are based in the Division of Gastroenterology and Hepatology, New York University Langone Health, New York. Dr. Schattner is a consultant for Boston Scientific and Novo Nordisk. Dr. Balzora reports no conflicts in relation to this article.

 

 

References

Campbell KM. Mitigating the isolation of minoritized faculty in academic medicine. J Gen Intern Med. 2023 May. doi: 10.1007/s11606-022-07982-8.

Howard-Anderson JR et al. Strategies for developing a successful career in academic medicine. Am J Med Sci. 2024 Apr. doi: 10.1016/j.amjms.2023.12.010.

Murphy M et al. Women’s experiences of promotion and tenure in academic medicine and potential implications for gender disparities in career advancement: A qualitative analysis. JAMA Netw Open. 2021 Sep 1. doi: 10.1001/jamanetworkopen.2021.25843.

Sambunjak D et al. Mentoring in academic medicine: A systematic review. JAMA. 2006 Sep 6. doi: 10.1001/jama.296.9.1103.

Shen MR et al. Impact of mentoring on academic career success for women in medicine: A systematic review. Acad Med. 2022 Mar 1. doi: 10.1097/ACM.0000000000004563.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Converging on Our Nation’s Capital

Article Type
Changed

Release of our May issue coincides with our annual pilgrimage to Digestive Disease Week® (DDW), this year held in our nation’s capital of Washington, D.C.

As we peruse the preliminary program in planning our meeting coverage, I am always amazed at the breadth and depth of programming offered as part of a relatively brief, 4-day meeting — this is a testament to the hard work of the AGA Council and DDW organizing committees, who have the gargantuan task of ensuring an engaging, seamless meeting each year.

University of Michigan
Dr. Megan A. Adams

This year’s conference features over 400 original scientific sessions and 4,300 oral abstract and poster presentations, in addition to the always well-attended AGA Postgraduate Course. This year’s AGA Presidential Plenary, which will feature a series of thought-provoking panel discussions on the future of GI healthcare and innovations in how we treat, disseminate, and teach, also is not to be missed. Beyond DDW, I hope you will join me in taking advantage of some of D.C.’s amazing cultural offerings, including the Smithsonian museums, National Gallery, Kennedy Center for the Performing Arts, and many others.

In this month’s issue of GIHN, we highlight an important AGA expert consensus commentary published in Clinical Gastroenterology and Hepatology examining the role of blood-based tests (“liquid biopsy”) in colorectal cancer screening. This guidance, which recognizes the promise of such tests but also urges caution in their adoption, is particularly important considering recently published data from the ECLIPSE study (also covered in this issue) evaluating the performance of Guardant’s ctDNA liquid biopsy compared to a screening colonoscopy. Also relevant to CRC screening, we highlight data on the performance of the “next gen” Cologuard test compared with FIT, which was recently published in NEJM. In our May Member Spotlight, we feature gastroenterologist Adjoa Anyane-Yeboa, MD, MPH, who shares her passion for addressing barriers to CRC screening for Black patients. Finally, GIHN Associate Editor Dr. Avi Ketwaroo introduces our quarterly Perspectives column highlighting emerging applications of AI in GI endoscopy and hepatology. We hope you enjoy all the exciting content featured in this issue and look forward to seeing you in Washington, D.C. (or virtually) for DDW.
 

Megan A. Adams, MD, JD, MSc

Editor-in-Chief

Publications
Topics
Sections

Release of our May issue coincides with our annual pilgrimage to Digestive Disease Week® (DDW), this year held in our nation’s capital of Washington, D.C.

As we peruse the preliminary program in planning our meeting coverage, I am always amazed at the breadth and depth of programming offered as part of a relatively brief, 4-day meeting — this is a testament to the hard work of the AGA Council and DDW organizing committees, who have the gargantuan task of ensuring an engaging, seamless meeting each year.

University of Michigan
Dr. Megan A. Adams

This year’s conference features over 400 original scientific sessions and 4,300 oral abstract and poster presentations, in addition to the always well-attended AGA Postgraduate Course. This year’s AGA Presidential Plenary, which will feature a series of thought-provoking panel discussions on the future of GI healthcare and innovations in how we treat, disseminate, and teach, also is not to be missed. Beyond DDW, I hope you will join me in taking advantage of some of D.C.’s amazing cultural offerings, including the Smithsonian museums, National Gallery, Kennedy Center for the Performing Arts, and many others.

In this month’s issue of GIHN, we highlight an important AGA expert consensus commentary published in Clinical Gastroenterology and Hepatology examining the role of blood-based tests (“liquid biopsy”) in colorectal cancer screening. This guidance, which recognizes the promise of such tests but also urges caution in their adoption, is particularly important considering recently published data from the ECLIPSE study (also covered in this issue) evaluating the performance of Guardant’s ctDNA liquid biopsy compared to a screening colonoscopy. Also relevant to CRC screening, we highlight data on the performance of the “next gen” Cologuard test compared with FIT, which was recently published in NEJM. In our May Member Spotlight, we feature gastroenterologist Adjoa Anyane-Yeboa, MD, MPH, who shares her passion for addressing barriers to CRC screening for Black patients. Finally, GIHN Associate Editor Dr. Avi Ketwaroo introduces our quarterly Perspectives column highlighting emerging applications of AI in GI endoscopy and hepatology. We hope you enjoy all the exciting content featured in this issue and look forward to seeing you in Washington, D.C. (or virtually) for DDW.
 

Megan A. Adams, MD, JD, MSc

Editor-in-Chief

Release of our May issue coincides with our annual pilgrimage to Digestive Disease Week® (DDW), this year held in our nation’s capital of Washington, D.C.

As we peruse the preliminary program in planning our meeting coverage, I am always amazed at the breadth and depth of programming offered as part of a relatively brief, 4-day meeting — this is a testament to the hard work of the AGA Council and DDW organizing committees, who have the gargantuan task of ensuring an engaging, seamless meeting each year.

University of Michigan
Dr. Megan A. Adams

This year’s conference features over 400 original scientific sessions and 4,300 oral abstract and poster presentations, in addition to the always well-attended AGA Postgraduate Course. This year’s AGA Presidential Plenary, which will feature a series of thought-provoking panel discussions on the future of GI healthcare and innovations in how we treat, disseminate, and teach, also is not to be missed. Beyond DDW, I hope you will join me in taking advantage of some of D.C.’s amazing cultural offerings, including the Smithsonian museums, National Gallery, Kennedy Center for the Performing Arts, and many others.

In this month’s issue of GIHN, we highlight an important AGA expert consensus commentary published in Clinical Gastroenterology and Hepatology examining the role of blood-based tests (“liquid biopsy”) in colorectal cancer screening. This guidance, which recognizes the promise of such tests but also urges caution in their adoption, is particularly important considering recently published data from the ECLIPSE study (also covered in this issue) evaluating the performance of Guardant’s ctDNA liquid biopsy compared to a screening colonoscopy. Also relevant to CRC screening, we highlight data on the performance of the “next gen” Cologuard test compared with FIT, which was recently published in NEJM. In our May Member Spotlight, we feature gastroenterologist Adjoa Anyane-Yeboa, MD, MPH, who shares her passion for addressing barriers to CRC screening for Black patients. Finally, GIHN Associate Editor Dr. Avi Ketwaroo introduces our quarterly Perspectives column highlighting emerging applications of AI in GI endoscopy and hepatology. We hope you enjoy all the exciting content featured in this issue and look forward to seeing you in Washington, D.C. (or virtually) for DDW.
 

Megan A. Adams, MD, JD, MSc

Editor-in-Chief

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Do No Harm: What Smoldering Myeloma Teaches Us

Article Type
Changed

Smoldering multiple myeloma (SMM), a potential precursor to multiple myeloma (MM), has become a controversial topic. Some people diagnosed with SMM will live their whole lives without ever developing MM, while others will develop it quickly.

My approach to treating SMM takes into account what its history can teach us about 1) how advancements in imaging and diagnostic reclassifications can revise the entire natural history of a disease, and 2) how evidence generated by even the best of studies may have an expiration date.

Huntsman Cancer Institute
Manni Mohyuddin, MD

Much of what we know about SMM today dates to a pivotal study by Robert A. Kyle, MD, and colleagues, published in 2007. That inspirational team of investigators followed people diagnosed with SMM from 1970 to 1995 and established the first natural history of the condition. Their monumental effort and the data and conclusions it generated (eg,10% risk annually of SMM becoming MM for the first 5 years) are still cited today in references, papers, and slide sets.

Despite the seminal importance of this work, from today’s perspective the 2007 study might just as well have been describing a different disease. Back then people were diagnosed with SMM if their blood work detected a monoclonal protein and a follow-up bone marrow biopsy found at least 10% plasma cells (or a monoclonal protein exceeding 3g/dL). If there were no signs of end-organ damage (ie, no anemia or kidney problems) and an x-ray showed no fractures or lesions in the bones, the diagnosis was determined to be SMM.

What’s different in 2024? First and foremost: advanced, highly sensitive imaging techniques. MRIs can pick up small lytic lesions (and even the precursor to lytic lesions) that would not appear on an x-ray. In fact, relying solely on x-rays risks missing half of the lytic lesions.

Therefore, using the same criteria, many people who in the past were diagnosed with SMM would today be diagnosed with MM. Furthermore, in 2014 a diagnostic change reclassified people’s diagnosis from the highest risk category of SMM to the category of active MM.

Due to these scientific advances and classification changes, I believe that the natural history of SMM is unknown. Risk stratification models for SMM derived from data sets of people who had not undergone rigorous advanced imaging likely are skewed by data from people who had MM. In addition, current risk stratification models have very poor concordance with each other. I routinely see people whose 2-year risk according to different models varies by more than 30%-40%.

All this information tells us that SMM today is more indolent than the SMM of the past. Paradoxically, however, our therapies keep getting more and more aggressive, exposing this vulnerable group of people to intense treatment regimens that they may not require. Therapies tested on people diagnosed with SMM include an aggressive three-drug regimen, autologous stem cell transplant, and 2 years of additional therapy, as well as, more recently CAR T-cell therapy which so far has at least a 4%-5% treatment-related mortality risk in people with myeloma and a strong signal for secondary cancer risk. Other trials are testing bispecific therapies such as talquetamab, a drug which in my experience causes horrendous skin toxicity, profound weight loss, and one’s nails to fall off.

Doctors routinely keep showing slides from Kyle’s pivotal work to describe the natural history of SMM and to justify the need for treatment, and trials continue to use outdated progression prediction models. In my opinion, as people with MM keep living longer and treatments for MM keep getting better, the threshold for intervening with asymptomatic, healthy people with SMM should be getting higher, not lower.

I strongly believe that the current landscape of SMM treatment exemplifies good intentions leading to bad outcomes. A routine blood test in a completely healthy person that finds elevated total protein in the blood could culminate in well-intentioned but aggressive therapies that can lead to many serious side effects. (I repeat: Secondary cancers and deaths from infections have all occurred in SMM trials.)

With no control arm, we simply don’t know how well these people might have fared without any therapy. For all we know, treatment may have shortened their lives due to complications up to and including death — all because of a blood test often conducted for reasons that have no evidentiary basis.

For example, plasma cell diseases are not linked to low bone density or auto-immune diseases, yet these labs are sent routinely as part of a workup for those conditions, leading to increasing anxiety and costs.

So, what is my approach? When treating people with SMM, I hold nuanced discussions of this data to help prioritize and reach informed decisions. After our honest conversation about the limitations of SMM models, older data, and the limitations of prospective data studying pharmacological treatment, almost no one signs up for treatment.

I want these people to stay safe, and I’m proud to be a part of a trial (SPOTLIGHT, NCT06212323) that aims to show prospectively that these people can be watched off treatment with monitoring via advanced imaging modalities.

In conclusion: SMM teaches us how, even in the absence of pharmacological interventions, the natural history of a disease can change over time, simply via better imaging techniques and changes in diagnostic classifications. Unfortunately, SMM also illustrates how good intentions can lead to harm.
 

Dr. Mohyuddin is assistant professor in the multiple myeloma program at the Huntsman Cancer Institute at the University of Utah in Salt Lake City.

Publications
Topics
Sections

Smoldering multiple myeloma (SMM), a potential precursor to multiple myeloma (MM), has become a controversial topic. Some people diagnosed with SMM will live their whole lives without ever developing MM, while others will develop it quickly.

My approach to treating SMM takes into account what its history can teach us about 1) how advancements in imaging and diagnostic reclassifications can revise the entire natural history of a disease, and 2) how evidence generated by even the best of studies may have an expiration date.

Huntsman Cancer Institute
Manni Mohyuddin, MD

Much of what we know about SMM today dates to a pivotal study by Robert A. Kyle, MD, and colleagues, published in 2007. That inspirational team of investigators followed people diagnosed with SMM from 1970 to 1995 and established the first natural history of the condition. Their monumental effort and the data and conclusions it generated (eg,10% risk annually of SMM becoming MM for the first 5 years) are still cited today in references, papers, and slide sets.

Despite the seminal importance of this work, from today’s perspective the 2007 study might just as well have been describing a different disease. Back then people were diagnosed with SMM if their blood work detected a monoclonal protein and a follow-up bone marrow biopsy found at least 10% plasma cells (or a monoclonal protein exceeding 3g/dL). If there were no signs of end-organ damage (ie, no anemia or kidney problems) and an x-ray showed no fractures or lesions in the bones, the diagnosis was determined to be SMM.

What’s different in 2024? First and foremost: advanced, highly sensitive imaging techniques. MRIs can pick up small lytic lesions (and even the precursor to lytic lesions) that would not appear on an x-ray. In fact, relying solely on x-rays risks missing half of the lytic lesions.

Therefore, using the same criteria, many people who in the past were diagnosed with SMM would today be diagnosed with MM. Furthermore, in 2014 a diagnostic change reclassified people’s diagnosis from the highest risk category of SMM to the category of active MM.

Due to these scientific advances and classification changes, I believe that the natural history of SMM is unknown. Risk stratification models for SMM derived from data sets of people who had not undergone rigorous advanced imaging likely are skewed by data from people who had MM. In addition, current risk stratification models have very poor concordance with each other. I routinely see people whose 2-year risk according to different models varies by more than 30%-40%.

All this information tells us that SMM today is more indolent than the SMM of the past. Paradoxically, however, our therapies keep getting more and more aggressive, exposing this vulnerable group of people to intense treatment regimens that they may not require. Therapies tested on people diagnosed with SMM include an aggressive three-drug regimen, autologous stem cell transplant, and 2 years of additional therapy, as well as, more recently CAR T-cell therapy which so far has at least a 4%-5% treatment-related mortality risk in people with myeloma and a strong signal for secondary cancer risk. Other trials are testing bispecific therapies such as talquetamab, a drug which in my experience causes horrendous skin toxicity, profound weight loss, and one’s nails to fall off.

Doctors routinely keep showing slides from Kyle’s pivotal work to describe the natural history of SMM and to justify the need for treatment, and trials continue to use outdated progression prediction models. In my opinion, as people with MM keep living longer and treatments for MM keep getting better, the threshold for intervening with asymptomatic, healthy people with SMM should be getting higher, not lower.

I strongly believe that the current landscape of SMM treatment exemplifies good intentions leading to bad outcomes. A routine blood test in a completely healthy person that finds elevated total protein in the blood could culminate in well-intentioned but aggressive therapies that can lead to many serious side effects. (I repeat: Secondary cancers and deaths from infections have all occurred in SMM trials.)

With no control arm, we simply don’t know how well these people might have fared without any therapy. For all we know, treatment may have shortened their lives due to complications up to and including death — all because of a blood test often conducted for reasons that have no evidentiary basis.

For example, plasma cell diseases are not linked to low bone density or auto-immune diseases, yet these labs are sent routinely as part of a workup for those conditions, leading to increasing anxiety and costs.

So, what is my approach? When treating people with SMM, I hold nuanced discussions of this data to help prioritize and reach informed decisions. After our honest conversation about the limitations of SMM models, older data, and the limitations of prospective data studying pharmacological treatment, almost no one signs up for treatment.

I want these people to stay safe, and I’m proud to be a part of a trial (SPOTLIGHT, NCT06212323) that aims to show prospectively that these people can be watched off treatment with monitoring via advanced imaging modalities.

In conclusion: SMM teaches us how, even in the absence of pharmacological interventions, the natural history of a disease can change over time, simply via better imaging techniques and changes in diagnostic classifications. Unfortunately, SMM also illustrates how good intentions can lead to harm.
 

Dr. Mohyuddin is assistant professor in the multiple myeloma program at the Huntsman Cancer Institute at the University of Utah in Salt Lake City.

Smoldering multiple myeloma (SMM), a potential precursor to multiple myeloma (MM), has become a controversial topic. Some people diagnosed with SMM will live their whole lives without ever developing MM, while others will develop it quickly.

My approach to treating SMM takes into account what its history can teach us about 1) how advancements in imaging and diagnostic reclassifications can revise the entire natural history of a disease, and 2) how evidence generated by even the best of studies may have an expiration date.

Huntsman Cancer Institute
Manni Mohyuddin, MD

Much of what we know about SMM today dates to a pivotal study by Robert A. Kyle, MD, and colleagues, published in 2007. That inspirational team of investigators followed people diagnosed with SMM from 1970 to 1995 and established the first natural history of the condition. Their monumental effort and the data and conclusions it generated (eg,10% risk annually of SMM becoming MM for the first 5 years) are still cited today in references, papers, and slide sets.

Despite the seminal importance of this work, from today’s perspective the 2007 study might just as well have been describing a different disease. Back then people were diagnosed with SMM if their blood work detected a monoclonal protein and a follow-up bone marrow biopsy found at least 10% plasma cells (or a monoclonal protein exceeding 3g/dL). If there were no signs of end-organ damage (ie, no anemia or kidney problems) and an x-ray showed no fractures or lesions in the bones, the diagnosis was determined to be SMM.

What’s different in 2024? First and foremost: advanced, highly sensitive imaging techniques. MRIs can pick up small lytic lesions (and even the precursor to lytic lesions) that would not appear on an x-ray. In fact, relying solely on x-rays risks missing half of the lytic lesions.

Therefore, using the same criteria, many people who in the past were diagnosed with SMM would today be diagnosed with MM. Furthermore, in 2014 a diagnostic change reclassified people’s diagnosis from the highest risk category of SMM to the category of active MM.

Due to these scientific advances and classification changes, I believe that the natural history of SMM is unknown. Risk stratification models for SMM derived from data sets of people who had not undergone rigorous advanced imaging likely are skewed by data from people who had MM. In addition, current risk stratification models have very poor concordance with each other. I routinely see people whose 2-year risk according to different models varies by more than 30%-40%.

All this information tells us that SMM today is more indolent than the SMM of the past. Paradoxically, however, our therapies keep getting more and more aggressive, exposing this vulnerable group of people to intense treatment regimens that they may not require. Therapies tested on people diagnosed with SMM include an aggressive three-drug regimen, autologous stem cell transplant, and 2 years of additional therapy, as well as, more recently CAR T-cell therapy which so far has at least a 4%-5% treatment-related mortality risk in people with myeloma and a strong signal for secondary cancer risk. Other trials are testing bispecific therapies such as talquetamab, a drug which in my experience causes horrendous skin toxicity, profound weight loss, and one’s nails to fall off.

Doctors routinely keep showing slides from Kyle’s pivotal work to describe the natural history of SMM and to justify the need for treatment, and trials continue to use outdated progression prediction models. In my opinion, as people with MM keep living longer and treatments for MM keep getting better, the threshold for intervening with asymptomatic, healthy people with SMM should be getting higher, not lower.

I strongly believe that the current landscape of SMM treatment exemplifies good intentions leading to bad outcomes. A routine blood test in a completely healthy person that finds elevated total protein in the blood could culminate in well-intentioned but aggressive therapies that can lead to many serious side effects. (I repeat: Secondary cancers and deaths from infections have all occurred in SMM trials.)

With no control arm, we simply don’t know how well these people might have fared without any therapy. For all we know, treatment may have shortened their lives due to complications up to and including death — all because of a blood test often conducted for reasons that have no evidentiary basis.

For example, plasma cell diseases are not linked to low bone density or auto-immune diseases, yet these labs are sent routinely as part of a workup for those conditions, leading to increasing anxiety and costs.

So, what is my approach? When treating people with SMM, I hold nuanced discussions of this data to help prioritize and reach informed decisions. After our honest conversation about the limitations of SMM models, older data, and the limitations of prospective data studying pharmacological treatment, almost no one signs up for treatment.

I want these people to stay safe, and I’m proud to be a part of a trial (SPOTLIGHT, NCT06212323) that aims to show prospectively that these people can be watched off treatment with monitoring via advanced imaging modalities.

In conclusion: SMM teaches us how, even in the absence of pharmacological interventions, the natural history of a disease can change over time, simply via better imaging techniques and changes in diagnostic classifications. Unfortunately, SMM also illustrates how good intentions can lead to harm.
 

Dr. Mohyuddin is assistant professor in the multiple myeloma program at the Huntsman Cancer Institute at the University of Utah in Salt Lake City.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Potential Impact of USPS Mail Delivery Delays on Colorectal Cancer Screening Programs

Article Type
Changed

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

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

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

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

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

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

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

 

 

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

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

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

Conclusions

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

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

References

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

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

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

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

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

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

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

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

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

Article PDF
Author and Disclosure Information

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

Correspondence:  Patrick Godwin  ([email protected])

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

bJesse Brown Veterans Affairs Medical Center, Chicago, Illinois

Author disclosures

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

Disclaimer

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

Issue
Federal Practitioner - 41(suppl 2)
Publications
Topics
Page Number
S42-S44
Sections
Author and Disclosure Information

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

Correspondence:  Patrick Godwin  ([email protected])

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

bJesse Brown Veterans Affairs Medical Center, Chicago, Illinois

Author disclosures

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

Disclaimer

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

Author and Disclosure Information

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

Correspondence:  Patrick Godwin  ([email protected])

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

bJesse Brown Veterans Affairs Medical Center, Chicago, Illinois

Author disclosures

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

Disclaimer

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

Article PDF
Article PDF

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

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

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

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

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

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

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

 

 

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

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

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

Conclusions

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

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

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

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

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

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

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

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

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

 

 

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

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

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

Conclusions

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

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

References

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

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

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

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

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

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

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

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

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

References

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

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

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

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

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

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

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

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

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

Issue
Federal Practitioner - 41(suppl 2)
Issue
Federal Practitioner - 41(suppl 2)
Page Number
S42-S44
Page Number
S42-S44
Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
Article PDF Media

‘We Need to Rethink Our Options’: Lung Cancer Recurrence

Article Type
Changed

 



This transcript has been edited for clarity.

Hello. It’s Mark Kris reporting back after attending the New York Lung Cancer Foundation Summit here in New York. A large amount of discussion went on, but as usual, I was most interested in the perioperative space.

In previous videos, I’ve talked about this ongoing discussion of whether you should operate and give adjuvant therapy or give neoadjuvant therapy, and I’ve addressed that already. One thing I want to bring up – and as we move off of that argument, which frankly doesn’t have an answer today, with neoadjuvant therapy, having all the data to support it – is what are the patterns of recurrence now that we have more successful systemic therapies, both targeted therapies and checkpoint inhibitors?

I was taught early on by my surgical mentors that the issue here was systemic control. While they could do very successful surgery to get high levels of local control, they could not control systemic disease. Sadly, the tools we had early on with chemotherapy were just not good enough. Suddenly, we have better tools to control systemic spread. In the past, the vast majority of occurrences were systemic; they’re now local.

What I think we need to do as a group of practitioners trying to deal with the problems getting in the way of curing our patients is look at what the issue is now. Frankly, the big issue now, as systemic therapy has controlled metastatic disease, is recurrence in the chest.

We give adjuvant osimertinib. Please remember what the numbers are. In the osimertinib arm, of the 11 recurrences reported in the European Society for Medical Oncology presentation a few years back, nine of them were in the chest or mediastinal nodes. In the arm that got no osimertinib afterward, there were 46 recurrences, and 32 of those 46 recurrences were in the chest, either the lung or mediastinal nodes. Therefore, 74% of the recurrences are suddenly in the chest. What’s the issue here?

The issue is we need to find strategies to give better disease control in the chest, as we have made inroads in controlling systemic disease with the targeted therapies in the endothelial growth factor receptor space, and very likely the checkpoint inhibitors, too, as that data kind of filters out. We need to think about how better to get local control.

I think rather than continue to get into this argument of neoadjuvant vs adjuvant, we should move to what’s really hurting our patients. Again, the data I quoted you was from the ADAURA trial, which was adjuvant therapy, and I’m sure the neoadjuvant is going to show the same thing. It’s better systemic therapy but now, more trouble in the chest.

How are we going to deal with that? I’d like to throw out one strategy, and that is to rethink the role of radiation in these patients. Again, if the problem is local in the chest, lung, and lymph nodes, we have to think about local therapy. Yes, we’re not recommending it routinely for everybody, but now that we have better systemic control, we need to rethink our options. The obvious one to rethink is about giving radiotherapy.

We should also use what we learned in the earlier trials, which is that there is harm in giving excessive radiation to the heart. If you avoid the heart, you avoid the harm. We have better planning strategies for stereotactic body radiotherapy and more traditional radiation, and of course, we have proton therapy as well.

As we continue to struggle with the idea of that patient with stage II or III disease, whether to give adjuvant vs neoadjuvant therapy, please remember to consider their risk in 2024. Their risk for first recurrence is in the chest.

What are we going to do to better control disease in the chest? We have a challenge. I’m sure we can meet it if we put our heads together.

Dr. Kris is professor of medicine at Weill Cornell Medical College, and attending physician, Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center, New York. He disclosed ties with AstraZeneca, Roche/Genentech, Ariad Pharmaceuticals, Pfizer, and PUMA.

A version of this article appeared on Medscape.com.

Publications
Topics
Sections

 



This transcript has been edited for clarity.

Hello. It’s Mark Kris reporting back after attending the New York Lung Cancer Foundation Summit here in New York. A large amount of discussion went on, but as usual, I was most interested in the perioperative space.

In previous videos, I’ve talked about this ongoing discussion of whether you should operate and give adjuvant therapy or give neoadjuvant therapy, and I’ve addressed that already. One thing I want to bring up – and as we move off of that argument, which frankly doesn’t have an answer today, with neoadjuvant therapy, having all the data to support it – is what are the patterns of recurrence now that we have more successful systemic therapies, both targeted therapies and checkpoint inhibitors?

I was taught early on by my surgical mentors that the issue here was systemic control. While they could do very successful surgery to get high levels of local control, they could not control systemic disease. Sadly, the tools we had early on with chemotherapy were just not good enough. Suddenly, we have better tools to control systemic spread. In the past, the vast majority of occurrences were systemic; they’re now local.

What I think we need to do as a group of practitioners trying to deal with the problems getting in the way of curing our patients is look at what the issue is now. Frankly, the big issue now, as systemic therapy has controlled metastatic disease, is recurrence in the chest.

We give adjuvant osimertinib. Please remember what the numbers are. In the osimertinib arm, of the 11 recurrences reported in the European Society for Medical Oncology presentation a few years back, nine of them were in the chest or mediastinal nodes. In the arm that got no osimertinib afterward, there were 46 recurrences, and 32 of those 46 recurrences were in the chest, either the lung or mediastinal nodes. Therefore, 74% of the recurrences are suddenly in the chest. What’s the issue here?

The issue is we need to find strategies to give better disease control in the chest, as we have made inroads in controlling systemic disease with the targeted therapies in the endothelial growth factor receptor space, and very likely the checkpoint inhibitors, too, as that data kind of filters out. We need to think about how better to get local control.

I think rather than continue to get into this argument of neoadjuvant vs adjuvant, we should move to what’s really hurting our patients. Again, the data I quoted you was from the ADAURA trial, which was adjuvant therapy, and I’m sure the neoadjuvant is going to show the same thing. It’s better systemic therapy but now, more trouble in the chest.

How are we going to deal with that? I’d like to throw out one strategy, and that is to rethink the role of radiation in these patients. Again, if the problem is local in the chest, lung, and lymph nodes, we have to think about local therapy. Yes, we’re not recommending it routinely for everybody, but now that we have better systemic control, we need to rethink our options. The obvious one to rethink is about giving radiotherapy.

We should also use what we learned in the earlier trials, which is that there is harm in giving excessive radiation to the heart. If you avoid the heart, you avoid the harm. We have better planning strategies for stereotactic body radiotherapy and more traditional radiation, and of course, we have proton therapy as well.

As we continue to struggle with the idea of that patient with stage II or III disease, whether to give adjuvant vs neoadjuvant therapy, please remember to consider their risk in 2024. Their risk for first recurrence is in the chest.

What are we going to do to better control disease in the chest? We have a challenge. I’m sure we can meet it if we put our heads together.

Dr. Kris is professor of medicine at Weill Cornell Medical College, and attending physician, Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center, New York. He disclosed ties with AstraZeneca, Roche/Genentech, Ariad Pharmaceuticals, Pfizer, and PUMA.

A version of this article appeared on Medscape.com.

 



This transcript has been edited for clarity.

Hello. It’s Mark Kris reporting back after attending the New York Lung Cancer Foundation Summit here in New York. A large amount of discussion went on, but as usual, I was most interested in the perioperative space.

In previous videos, I’ve talked about this ongoing discussion of whether you should operate and give adjuvant therapy or give neoadjuvant therapy, and I’ve addressed that already. One thing I want to bring up – and as we move off of that argument, which frankly doesn’t have an answer today, with neoadjuvant therapy, having all the data to support it – is what are the patterns of recurrence now that we have more successful systemic therapies, both targeted therapies and checkpoint inhibitors?

I was taught early on by my surgical mentors that the issue here was systemic control. While they could do very successful surgery to get high levels of local control, they could not control systemic disease. Sadly, the tools we had early on with chemotherapy were just not good enough. Suddenly, we have better tools to control systemic spread. In the past, the vast majority of occurrences were systemic; they’re now local.

What I think we need to do as a group of practitioners trying to deal with the problems getting in the way of curing our patients is look at what the issue is now. Frankly, the big issue now, as systemic therapy has controlled metastatic disease, is recurrence in the chest.

We give adjuvant osimertinib. Please remember what the numbers are. In the osimertinib arm, of the 11 recurrences reported in the European Society for Medical Oncology presentation a few years back, nine of them were in the chest or mediastinal nodes. In the arm that got no osimertinib afterward, there were 46 recurrences, and 32 of those 46 recurrences were in the chest, either the lung or mediastinal nodes. Therefore, 74% of the recurrences are suddenly in the chest. What’s the issue here?

The issue is we need to find strategies to give better disease control in the chest, as we have made inroads in controlling systemic disease with the targeted therapies in the endothelial growth factor receptor space, and very likely the checkpoint inhibitors, too, as that data kind of filters out. We need to think about how better to get local control.

I think rather than continue to get into this argument of neoadjuvant vs adjuvant, we should move to what’s really hurting our patients. Again, the data I quoted you was from the ADAURA trial, which was adjuvant therapy, and I’m sure the neoadjuvant is going to show the same thing. It’s better systemic therapy but now, more trouble in the chest.

How are we going to deal with that? I’d like to throw out one strategy, and that is to rethink the role of radiation in these patients. Again, if the problem is local in the chest, lung, and lymph nodes, we have to think about local therapy. Yes, we’re not recommending it routinely for everybody, but now that we have better systemic control, we need to rethink our options. The obvious one to rethink is about giving radiotherapy.

We should also use what we learned in the earlier trials, which is that there is harm in giving excessive radiation to the heart. If you avoid the heart, you avoid the harm. We have better planning strategies for stereotactic body radiotherapy and more traditional radiation, and of course, we have proton therapy as well.

As we continue to struggle with the idea of that patient with stage II or III disease, whether to give adjuvant vs neoadjuvant therapy, please remember to consider their risk in 2024. Their risk for first recurrence is in the chest.

What are we going to do to better control disease in the chest? We have a challenge. I’m sure we can meet it if we put our heads together.

Dr. Kris is professor of medicine at Weill Cornell Medical College, and attending physician, Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center, New York. He disclosed ties with AstraZeneca, Roche/Genentech, Ariad Pharmaceuticals, Pfizer, and PUMA.

A version of this article appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

GLP-1 Receptor Agonists: Which Drug for Which Patient?

Article Type
Changed

 

With all the excitement about GLP-1 agonists, I get many questions from providers about which antiobesity drug they should prescribe. I’ll tell you the methods that I use to determine which drug is best for which patient.

Of course, we want to make sure that we’re treating the right condition. If the patient has type 2 diabetes, we tend to give them medication that is indicated for type 2 diabetes. Many GLP-1 agonists are available in a diabetes version and a chronic weight management or obesity version. If a patient has diabetes and obesity, they can receive either one. If a patient has only diabetes but not obesity, they should be prescribed the diabetes version. For obesity without diabetes, we tend to stick with the drugs that are indicated for chronic weight management.

Let’s go through them.

Exenatide. In chronological order of approval, the first GLP-1 drug that was used for diabetes dates back to exenatide (Bydureon). Bydureon had a partner called Byetta (also exenatide), both of which are still on the market but infrequently used. Some patients reported that these medications were inconvenient because they required twice-daily injections and caused painful injection-site nodules.

Diabetes drugs in more common use include liraglutide (Victoza) for type 2 diabetes. It is a daily injection and has various doses. We always start low and increase with tolerance and desired effect for A1c.

Liraglutide. Victoza has an antiobesity counterpart called Saxenda. The Saxenda pen looks very similar to the Victoza pen. It is a daily GLP-1 agonist for chronic weight management. The SCALE trial demonstrated 8%-12% weight loss with Saxenda.

Those are the daily injections: Victoza for diabetes and Saxenda for weight loss.

Our patients are very excited about the advent of weekly injections for diabetes and weight management. Ozempic is very popular. It is a weekly GLP-1 agonist for type 2 diabetes. Many patients come in asking for Ozempic, and we must make sure that we’re moving them in the right direction depending on their condition.

Semaglutide. Ozempic has a few different doses. It is a weekly injection and has been found to be quite efficacious for treating diabetes. The drug’s weight loss counterpart is called Wegovy, which comes in a different pen. Both forms contain the compound semaglutide. While all of these GLP-1 agonists are indicated to treat type 2 diabetes or for weight management, Wegovy has a special indication that none of the others have. In March 2024, Wegovy acquired an indication to decrease cardiac risk in those with a BMI ≥ 27 and a previous cardiac history. This will really change the accessibility of this medication because patients with heart conditions who are on Medicare are expected to have access to Wegovy.

Tirzepatide. Another weekly injection for treatment of type 2 diabetes is called Mounjaro. Its counterpart for weight management is called Zepbound, which was found to have about 20.9% weight loss over 72 weeks. These medications have similar side effects in differing degrees, but the most-often reported are nausea, stool changes, abdominal pain, and reflux. There are some other potential side effects; I recommend that you read the individual prescribing information available for each drug to have more clarity about that.

It is important that we stay on label for using the GLP-1 receptor agonists, for many reasons. One, it increases our patients’ accessibility to the right medication for them, and we can also make sure that we’re treating the patient with the right drug according to the clinical trials. When the clinical trials are done, the study populations demonstrate safety and efficacy for that population. But if we’re prescribing a GLP-1 for a different population, it is considered off-label use.
 

Dr. Lofton, an obesity medicine specialist, is clinical associate professor of surgery and medicine at NYU Grossman School of Medicine, and director of the medical weight management program at NYU Langone Weight Management Center, New York. She disclosed ties to Novo Nordisk and Eli Lilly. This transcript has been edited for clarity.

A version of this article appeared on Medscape.com.

Publications
Topics
Sections

 

With all the excitement about GLP-1 agonists, I get many questions from providers about which antiobesity drug they should prescribe. I’ll tell you the methods that I use to determine which drug is best for which patient.

Of course, we want to make sure that we’re treating the right condition. If the patient has type 2 diabetes, we tend to give them medication that is indicated for type 2 diabetes. Many GLP-1 agonists are available in a diabetes version and a chronic weight management or obesity version. If a patient has diabetes and obesity, they can receive either one. If a patient has only diabetes but not obesity, they should be prescribed the diabetes version. For obesity without diabetes, we tend to stick with the drugs that are indicated for chronic weight management.

Let’s go through them.

Exenatide. In chronological order of approval, the first GLP-1 drug that was used for diabetes dates back to exenatide (Bydureon). Bydureon had a partner called Byetta (also exenatide), both of which are still on the market but infrequently used. Some patients reported that these medications were inconvenient because they required twice-daily injections and caused painful injection-site nodules.

Diabetes drugs in more common use include liraglutide (Victoza) for type 2 diabetes. It is a daily injection and has various doses. We always start low and increase with tolerance and desired effect for A1c.

Liraglutide. Victoza has an antiobesity counterpart called Saxenda. The Saxenda pen looks very similar to the Victoza pen. It is a daily GLP-1 agonist for chronic weight management. The SCALE trial demonstrated 8%-12% weight loss with Saxenda.

Those are the daily injections: Victoza for diabetes and Saxenda for weight loss.

Our patients are very excited about the advent of weekly injections for diabetes and weight management. Ozempic is very popular. It is a weekly GLP-1 agonist for type 2 diabetes. Many patients come in asking for Ozempic, and we must make sure that we’re moving them in the right direction depending on their condition.

Semaglutide. Ozempic has a few different doses. It is a weekly injection and has been found to be quite efficacious for treating diabetes. The drug’s weight loss counterpart is called Wegovy, which comes in a different pen. Both forms contain the compound semaglutide. While all of these GLP-1 agonists are indicated to treat type 2 diabetes or for weight management, Wegovy has a special indication that none of the others have. In March 2024, Wegovy acquired an indication to decrease cardiac risk in those with a BMI ≥ 27 and a previous cardiac history. This will really change the accessibility of this medication because patients with heart conditions who are on Medicare are expected to have access to Wegovy.

Tirzepatide. Another weekly injection for treatment of type 2 diabetes is called Mounjaro. Its counterpart for weight management is called Zepbound, which was found to have about 20.9% weight loss over 72 weeks. These medications have similar side effects in differing degrees, but the most-often reported are nausea, stool changes, abdominal pain, and reflux. There are some other potential side effects; I recommend that you read the individual prescribing information available for each drug to have more clarity about that.

It is important that we stay on label for using the GLP-1 receptor agonists, for many reasons. One, it increases our patients’ accessibility to the right medication for them, and we can also make sure that we’re treating the patient with the right drug according to the clinical trials. When the clinical trials are done, the study populations demonstrate safety and efficacy for that population. But if we’re prescribing a GLP-1 for a different population, it is considered off-label use.
 

Dr. Lofton, an obesity medicine specialist, is clinical associate professor of surgery and medicine at NYU Grossman School of Medicine, and director of the medical weight management program at NYU Langone Weight Management Center, New York. She disclosed ties to Novo Nordisk and Eli Lilly. This transcript has been edited for clarity.

A version of this article appeared on Medscape.com.

 

With all the excitement about GLP-1 agonists, I get many questions from providers about which antiobesity drug they should prescribe. I’ll tell you the methods that I use to determine which drug is best for which patient.

Of course, we want to make sure that we’re treating the right condition. If the patient has type 2 diabetes, we tend to give them medication that is indicated for type 2 diabetes. Many GLP-1 agonists are available in a diabetes version and a chronic weight management or obesity version. If a patient has diabetes and obesity, they can receive either one. If a patient has only diabetes but not obesity, they should be prescribed the diabetes version. For obesity without diabetes, we tend to stick with the drugs that are indicated for chronic weight management.

Let’s go through them.

Exenatide. In chronological order of approval, the first GLP-1 drug that was used for diabetes dates back to exenatide (Bydureon). Bydureon had a partner called Byetta (also exenatide), both of which are still on the market but infrequently used. Some patients reported that these medications were inconvenient because they required twice-daily injections and caused painful injection-site nodules.

Diabetes drugs in more common use include liraglutide (Victoza) for type 2 diabetes. It is a daily injection and has various doses. We always start low and increase with tolerance and desired effect for A1c.

Liraglutide. Victoza has an antiobesity counterpart called Saxenda. The Saxenda pen looks very similar to the Victoza pen. It is a daily GLP-1 agonist for chronic weight management. The SCALE trial demonstrated 8%-12% weight loss with Saxenda.

Those are the daily injections: Victoza for diabetes and Saxenda for weight loss.

Our patients are very excited about the advent of weekly injections for diabetes and weight management. Ozempic is very popular. It is a weekly GLP-1 agonist for type 2 diabetes. Many patients come in asking for Ozempic, and we must make sure that we’re moving them in the right direction depending on their condition.

Semaglutide. Ozempic has a few different doses. It is a weekly injection and has been found to be quite efficacious for treating diabetes. The drug’s weight loss counterpart is called Wegovy, which comes in a different pen. Both forms contain the compound semaglutide. While all of these GLP-1 agonists are indicated to treat type 2 diabetes or for weight management, Wegovy has a special indication that none of the others have. In March 2024, Wegovy acquired an indication to decrease cardiac risk in those with a BMI ≥ 27 and a previous cardiac history. This will really change the accessibility of this medication because patients with heart conditions who are on Medicare are expected to have access to Wegovy.

Tirzepatide. Another weekly injection for treatment of type 2 diabetes is called Mounjaro. Its counterpart for weight management is called Zepbound, which was found to have about 20.9% weight loss over 72 weeks. These medications have similar side effects in differing degrees, but the most-often reported are nausea, stool changes, abdominal pain, and reflux. There are some other potential side effects; I recommend that you read the individual prescribing information available for each drug to have more clarity about that.

It is important that we stay on label for using the GLP-1 receptor agonists, for many reasons. One, it increases our patients’ accessibility to the right medication for them, and we can also make sure that we’re treating the patient with the right drug according to the clinical trials. When the clinical trials are done, the study populations demonstrate safety and efficacy for that population. But if we’re prescribing a GLP-1 for a different population, it is considered off-label use.
 

Dr. Lofton, an obesity medicine specialist, is clinical associate professor of surgery and medicine at NYU Grossman School of Medicine, and director of the medical weight management program at NYU Langone Weight Management Center, New York. She disclosed ties to Novo Nordisk and Eli Lilly. This transcript has been edited for clarity.

A version of this article appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

CRC Screening in Primary Care: The Blood Test Option

Article Type
Changed

 

Last year, I concluded a commentary for this news organization on colorectal cancer (CRC) screening guidelines by stating that between stool-based tests, flexible sigmoidoscopy, and colonoscopy, “the best screening test is the test that gets done.” But should that maxim apply to the new blood-based screening test, Guardant Health Shield? This proprietary test, which costs $895 and is not generally covered by insurance, identifies alterations in cell-free DNA that are characteristic of CRC.

Shield’s test characteristics were recently evaluated in a prospective study of more than 10,000 adults aged 45-84 at average risk for CRC. The test had an 87.5% sensitivity for stage I, II, or III colorectal cancer but only a 13% sensitivity for advanced precancerous lesions. Test specificity was 89.6%, meaning that about 1 in 10 participants without CRC or advanced precancerous lesions on colonoscopy had a false-positive result.

Although the Shield blood test has a higher rate of false positives than the traditional fecal immunochemical test (FIT) and lower sensitivity and specificity than a multitarget stool DNA (FIT-DNA) test designed to improve on Cologuard, it meets the previously established criteria set forth by the Centers for Medicare & Medicaid Services (CMS) to be covered for Medicare beneficiaries at 3-year intervals, pending FDA approval. If public and private payers start covering Shield alongside other CRC screening tests, it presents an opportunity for primary care physicians to reach the approximately 3 in 10 adults between ages 45 and 75 who are not being routinely screened.

A big concern, however, is that the availability of a blood test may cause patients who would have otherwise been screened with colonoscopy or stool tests to switch to the blood test. A cost-effectiveness analysis found that offering a blood test to patients who decline screening colonoscopy saves additional lives, but at the cost of more than $377,000 per life-year gained. Another study relying on three microsimulation models previously utilized by the US Preventive Services Task Force (USPSTF) found that annual FIT results in more life-years gained at substantially lower cost than blood-based screening every 3 years “even when uptake of blood-based screening was 20 percentage points higher than uptake of FIT.” As a result, a multidisciplinary expert panel concluded that blood-based screening should not substitute for established CRC screening tests, but instead be offered only to patients who decline those tests.

In practice, this will increase the complexity of the CRC screening conversations we have with patients. We will need to be clear that the blood test is not yet endorsed by the USPSTF or any major guideline group and is a second-line test that will miss most precancerous polyps. As with the stool tests, it is essential to emphasize that a positive result must be followed by diagnostic colonoscopy. To addend the cancer screening maxim I mentioned before, the blood test is not the best test for CRC, but it’s probably better than no test at all.

Dr. Lin is a family physician and associate director, Family Medicine Residency Program, Lancaster General Hospital, Lancaster, Pennsylvania. He blogs at Common Sense Family Doctor.

A version of this article appeared on Medscape.com.

Publications
Topics
Sections

 

Last year, I concluded a commentary for this news organization on colorectal cancer (CRC) screening guidelines by stating that between stool-based tests, flexible sigmoidoscopy, and colonoscopy, “the best screening test is the test that gets done.” But should that maxim apply to the new blood-based screening test, Guardant Health Shield? This proprietary test, which costs $895 and is not generally covered by insurance, identifies alterations in cell-free DNA that are characteristic of CRC.

Shield’s test characteristics were recently evaluated in a prospective study of more than 10,000 adults aged 45-84 at average risk for CRC. The test had an 87.5% sensitivity for stage I, II, or III colorectal cancer but only a 13% sensitivity for advanced precancerous lesions. Test specificity was 89.6%, meaning that about 1 in 10 participants without CRC or advanced precancerous lesions on colonoscopy had a false-positive result.

Although the Shield blood test has a higher rate of false positives than the traditional fecal immunochemical test (FIT) and lower sensitivity and specificity than a multitarget stool DNA (FIT-DNA) test designed to improve on Cologuard, it meets the previously established criteria set forth by the Centers for Medicare & Medicaid Services (CMS) to be covered for Medicare beneficiaries at 3-year intervals, pending FDA approval. If public and private payers start covering Shield alongside other CRC screening tests, it presents an opportunity for primary care physicians to reach the approximately 3 in 10 adults between ages 45 and 75 who are not being routinely screened.

A big concern, however, is that the availability of a blood test may cause patients who would have otherwise been screened with colonoscopy or stool tests to switch to the blood test. A cost-effectiveness analysis found that offering a blood test to patients who decline screening colonoscopy saves additional lives, but at the cost of more than $377,000 per life-year gained. Another study relying on three microsimulation models previously utilized by the US Preventive Services Task Force (USPSTF) found that annual FIT results in more life-years gained at substantially lower cost than blood-based screening every 3 years “even when uptake of blood-based screening was 20 percentage points higher than uptake of FIT.” As a result, a multidisciplinary expert panel concluded that blood-based screening should not substitute for established CRC screening tests, but instead be offered only to patients who decline those tests.

In practice, this will increase the complexity of the CRC screening conversations we have with patients. We will need to be clear that the blood test is not yet endorsed by the USPSTF or any major guideline group and is a second-line test that will miss most precancerous polyps. As with the stool tests, it is essential to emphasize that a positive result must be followed by diagnostic colonoscopy. To addend the cancer screening maxim I mentioned before, the blood test is not the best test for CRC, but it’s probably better than no test at all.

Dr. Lin is a family physician and associate director, Family Medicine Residency Program, Lancaster General Hospital, Lancaster, Pennsylvania. He blogs at Common Sense Family Doctor.

A version of this article appeared on Medscape.com.

 

Last year, I concluded a commentary for this news organization on colorectal cancer (CRC) screening guidelines by stating that between stool-based tests, flexible sigmoidoscopy, and colonoscopy, “the best screening test is the test that gets done.” But should that maxim apply to the new blood-based screening test, Guardant Health Shield? This proprietary test, which costs $895 and is not generally covered by insurance, identifies alterations in cell-free DNA that are characteristic of CRC.

Shield’s test characteristics were recently evaluated in a prospective study of more than 10,000 adults aged 45-84 at average risk for CRC. The test had an 87.5% sensitivity for stage I, II, or III colorectal cancer but only a 13% sensitivity for advanced precancerous lesions. Test specificity was 89.6%, meaning that about 1 in 10 participants without CRC or advanced precancerous lesions on colonoscopy had a false-positive result.

Although the Shield blood test has a higher rate of false positives than the traditional fecal immunochemical test (FIT) and lower sensitivity and specificity than a multitarget stool DNA (FIT-DNA) test designed to improve on Cologuard, it meets the previously established criteria set forth by the Centers for Medicare & Medicaid Services (CMS) to be covered for Medicare beneficiaries at 3-year intervals, pending FDA approval. If public and private payers start covering Shield alongside other CRC screening tests, it presents an opportunity for primary care physicians to reach the approximately 3 in 10 adults between ages 45 and 75 who are not being routinely screened.

A big concern, however, is that the availability of a blood test may cause patients who would have otherwise been screened with colonoscopy or stool tests to switch to the blood test. A cost-effectiveness analysis found that offering a blood test to patients who decline screening colonoscopy saves additional lives, but at the cost of more than $377,000 per life-year gained. Another study relying on three microsimulation models previously utilized by the US Preventive Services Task Force (USPSTF) found that annual FIT results in more life-years gained at substantially lower cost than blood-based screening every 3 years “even when uptake of blood-based screening was 20 percentage points higher than uptake of FIT.” As a result, a multidisciplinary expert panel concluded that blood-based screening should not substitute for established CRC screening tests, but instead be offered only to patients who decline those tests.

In practice, this will increase the complexity of the CRC screening conversations we have with patients. We will need to be clear that the blood test is not yet endorsed by the USPSTF or any major guideline group and is a second-line test that will miss most precancerous polyps. As with the stool tests, it is essential to emphasize that a positive result must be followed by diagnostic colonoscopy. To addend the cancer screening maxim I mentioned before, the blood test is not the best test for CRC, but it’s probably better than no test at all.

Dr. Lin is a family physician and associate director, Family Medicine Residency Program, Lancaster General Hospital, Lancaster, Pennsylvania. He blogs at Common Sense Family Doctor.

A version of this article appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Are Carbs Really the Enemy?

Article Type
Changed

 

Recent headlines scream that we have an obesity problem and that carbs are the culprit for the problem. That leads me to ask: How did we get to blaming carbs as the enemy in the war against obesity?

First, a quick review of the history of diet and macronutrient content.

A long time ago, prehistoric humans foraged and hunted for food. Protein and fat were procured from animal meat, which was very important for encephalization, or evolutionary increase in the complexity or relative size of the brain. Most of the requirements for protein and iron were satisfied by hunting and eating land animals as well as consuming marine life that washed up on shore.

Carbohydrates in the form of plant foods served as the only sources of energy available to prehistoric hunter-gatherers, which offset the high protein content of the rest of their diet. These were only available during spring and summer.

Then, about 10,000 years ago, plant and animal agriculture began, and humans saw a permanent shift in the macronutrient content of our daily intake so that it was more consistent and stable. Initially, the nutrient characteristic changes were subtle, going from wild food to cultivated food with the Agricultural Revolution in the mid-17th century. Then, it changed even more rapidly less than 200 years ago with the Industrial Revolution, resulting in semiprocessed and ultraprocessed foods.

This change in food intake altered human physiology, with major changes in our digestive, immune, and neural physiology and an increase in chronic disease prevalence. The last 50 years has seen an increase in obesity in the United States, along with increases in chronic disease such as type 2 diabetes, which leads cardiovascular disease and certain cancers. 
 

Back to Carbohydrates: Do We Need Them? How Much? What Kind?

The increase in the macronutrient content of the food we eat containing saturated fat and refined carbohydrates and sugars represents a major change and is arguably the smoking gun of the obesity epidemic. Unfortunately, ultraprocessed foods have become a staple of the standard American or Western diet. 

Ultraprocessed foods such as cakes, cookies, crackers, sugary breakfast cereals, pizza, potato chips, soft drinks, and ice cream are eons away from our prehistoric diet of wild game, nuts, fruits, and berries, at which time, our digestive immune and nervous systems evolved. The pace at which ultraprocessed foods have entered our diet outpaces the time necessary for adaptation of our digestive systems and genes to these foods. They are indeed pathogenic in this context. 

So when was the time when humans consumed an “optimal” diet? This is hard to say because during the time of brain evolution, we needed protein and iron and succumbed to infections and trauma. In the early 1900s, we continued to succumb to infection until the discovery of antibiotics. Soon thereafter, industrialization and processed foods led to weight gain and the chronic diseases of the cardiovascular system and type 2 diabetes. 

Carbohydrates provide calories and fiber and some micronutrients, which are needed for energy, metabolism, and bowel and immune health. But how much do we need? 

Currently in the United States, the percentage of total food energy derived from the three major macronutrients is: carbohydrates, 51.8%; fat, 32.8%; and protein, 15.4%. Current advice for a healthy diet to lower risk for cardiovascular disease is to limit fat intake to 30% of total energy, protein to 15%, and to increase complex carbohydrates to 55%-60% of total energy. But we also need to qualify this in terms of the quality of the macronutrient, particularly carbohydrates. 

In addition to the quality, the macronutrient content of the diet has varied considerably from our prehistoric times when dietary protein intakes were high at 19%-35% of energy at the expense of carbohydrate (22%-40% of energy). 

If our genes haven’t kept up with industrialization, then why do we need so many carbohydrates to equate to 55%-60% of energy? Is it possible that we are confusing what is available with what we actually need? What do I mean by this?

We certainly have changed the landscape of the world due to agriculture, which has allowed us to procreate and feed ourselves, and certainly, industrialization has increased the availability of accessible cheap food. Protein in the form of meat, fish, and fowl are harder to get in industrialized nations as are fruits and vegetables. These macronutrients were the foods of our ancestors. It may be that a healthy diet is considered the one that is available. 

For instance, the Mediterranean diet is somewhat higher in fat content, 40%-50% fat (mostly mono and unsaturated), and similar in protein content but lower in carbohydrate content than the typical Western diet. The Dietary Approaches to Stop Hypertension (DASH) diet is lower in fat at 25% total calories, is higher in carbohydrates at 55%, and is lower in protein, but this diet was generated in the United States, therefore it is more Western. 

We need high-quality protein for organ and muscle function, high-quality unsaturated and monounsaturated fats for brain function and cellular functions, and high-quality complex carbohydrates for energy and gut health as well as micronutrients for many cellular functions. A ketogenic diet is not sustainable in the long-term for these reasons: chiefly the need for some carbohydrates for gut health and micronutrients. 

How much carbohydrate content is needed should take into consideration energy expenditure as well as micronutrients and fiber intake. Protein and fat can contribute to energy production but not as readily as carbohydrates that can quickly restore glycogen in the muscle and liver. What’s interesting is that our ancestors were able to hunt and run away from danger with the small amounts of carbohydrates from plants and berries plus the protein and fat intake from animals and fish — but the Olympics weren’t a thing then!

It may be another 200,000 years before our genes catch up to ultraprocessed foods and the simple carbohydrates and sugars contained in these products. Evidence suggests that ultraprocessed foods cause inflammation in organs like the liver, adipose tissue, the heart, and even the brain. In the brain, this inflammation may be what’s causing us to defend a higher body weight set point in this environment of easily obtained highly palatable ultraprocessed foods. 

Let’s not wait until our genes catch up and our bodies tolerate junk food without disease progression. It could be like waiting for Godot!

Dr. Apovian is professor of medicine, Harvard Medical School, and codirector, Center for Weight Management and Wellness, Brigham and Women’s Hospital, Boston, Massachusetts. She disclosed ties to Altimmune, CinFina Pharma, Cowen and Company, EPG Communication Holdings, Form Health, Gelesis, and L-Nutra.

A version of this article appeared on Medscape.com.

Publications
Topics
Sections

 

Recent headlines scream that we have an obesity problem and that carbs are the culprit for the problem. That leads me to ask: How did we get to blaming carbs as the enemy in the war against obesity?

First, a quick review of the history of diet and macronutrient content.

A long time ago, prehistoric humans foraged and hunted for food. Protein and fat were procured from animal meat, which was very important for encephalization, or evolutionary increase in the complexity or relative size of the brain. Most of the requirements for protein and iron were satisfied by hunting and eating land animals as well as consuming marine life that washed up on shore.

Carbohydrates in the form of plant foods served as the only sources of energy available to prehistoric hunter-gatherers, which offset the high protein content of the rest of their diet. These were only available during spring and summer.

Then, about 10,000 years ago, plant and animal agriculture began, and humans saw a permanent shift in the macronutrient content of our daily intake so that it was more consistent and stable. Initially, the nutrient characteristic changes were subtle, going from wild food to cultivated food with the Agricultural Revolution in the mid-17th century. Then, it changed even more rapidly less than 200 years ago with the Industrial Revolution, resulting in semiprocessed and ultraprocessed foods.

This change in food intake altered human physiology, with major changes in our digestive, immune, and neural physiology and an increase in chronic disease prevalence. The last 50 years has seen an increase in obesity in the United States, along with increases in chronic disease such as type 2 diabetes, which leads cardiovascular disease and certain cancers. 
 

Back to Carbohydrates: Do We Need Them? How Much? What Kind?

The increase in the macronutrient content of the food we eat containing saturated fat and refined carbohydrates and sugars represents a major change and is arguably the smoking gun of the obesity epidemic. Unfortunately, ultraprocessed foods have become a staple of the standard American or Western diet. 

Ultraprocessed foods such as cakes, cookies, crackers, sugary breakfast cereals, pizza, potato chips, soft drinks, and ice cream are eons away from our prehistoric diet of wild game, nuts, fruits, and berries, at which time, our digestive immune and nervous systems evolved. The pace at which ultraprocessed foods have entered our diet outpaces the time necessary for adaptation of our digestive systems and genes to these foods. They are indeed pathogenic in this context. 

So when was the time when humans consumed an “optimal” diet? This is hard to say because during the time of brain evolution, we needed protein and iron and succumbed to infections and trauma. In the early 1900s, we continued to succumb to infection until the discovery of antibiotics. Soon thereafter, industrialization and processed foods led to weight gain and the chronic diseases of the cardiovascular system and type 2 diabetes. 

Carbohydrates provide calories and fiber and some micronutrients, which are needed for energy, metabolism, and bowel and immune health. But how much do we need? 

Currently in the United States, the percentage of total food energy derived from the three major macronutrients is: carbohydrates, 51.8%; fat, 32.8%; and protein, 15.4%. Current advice for a healthy diet to lower risk for cardiovascular disease is to limit fat intake to 30% of total energy, protein to 15%, and to increase complex carbohydrates to 55%-60% of total energy. But we also need to qualify this in terms of the quality of the macronutrient, particularly carbohydrates. 

In addition to the quality, the macronutrient content of the diet has varied considerably from our prehistoric times when dietary protein intakes were high at 19%-35% of energy at the expense of carbohydrate (22%-40% of energy). 

If our genes haven’t kept up with industrialization, then why do we need so many carbohydrates to equate to 55%-60% of energy? Is it possible that we are confusing what is available with what we actually need? What do I mean by this?

We certainly have changed the landscape of the world due to agriculture, which has allowed us to procreate and feed ourselves, and certainly, industrialization has increased the availability of accessible cheap food. Protein in the form of meat, fish, and fowl are harder to get in industrialized nations as are fruits and vegetables. These macronutrients were the foods of our ancestors. It may be that a healthy diet is considered the one that is available. 

For instance, the Mediterranean diet is somewhat higher in fat content, 40%-50% fat (mostly mono and unsaturated), and similar in protein content but lower in carbohydrate content than the typical Western diet. The Dietary Approaches to Stop Hypertension (DASH) diet is lower in fat at 25% total calories, is higher in carbohydrates at 55%, and is lower in protein, but this diet was generated in the United States, therefore it is more Western. 

We need high-quality protein for organ and muscle function, high-quality unsaturated and monounsaturated fats for brain function and cellular functions, and high-quality complex carbohydrates for energy and gut health as well as micronutrients for many cellular functions. A ketogenic diet is not sustainable in the long-term for these reasons: chiefly the need for some carbohydrates for gut health and micronutrients. 

How much carbohydrate content is needed should take into consideration energy expenditure as well as micronutrients and fiber intake. Protein and fat can contribute to energy production but not as readily as carbohydrates that can quickly restore glycogen in the muscle and liver. What’s interesting is that our ancestors were able to hunt and run away from danger with the small amounts of carbohydrates from plants and berries plus the protein and fat intake from animals and fish — but the Olympics weren’t a thing then!

It may be another 200,000 years before our genes catch up to ultraprocessed foods and the simple carbohydrates and sugars contained in these products. Evidence suggests that ultraprocessed foods cause inflammation in organs like the liver, adipose tissue, the heart, and even the brain. In the brain, this inflammation may be what’s causing us to defend a higher body weight set point in this environment of easily obtained highly palatable ultraprocessed foods. 

Let’s not wait until our genes catch up and our bodies tolerate junk food without disease progression. It could be like waiting for Godot!

Dr. Apovian is professor of medicine, Harvard Medical School, and codirector, Center for Weight Management and Wellness, Brigham and Women’s Hospital, Boston, Massachusetts. She disclosed ties to Altimmune, CinFina Pharma, Cowen and Company, EPG Communication Holdings, Form Health, Gelesis, and L-Nutra.

A version of this article appeared on Medscape.com.

 

Recent headlines scream that we have an obesity problem and that carbs are the culprit for the problem. That leads me to ask: How did we get to blaming carbs as the enemy in the war against obesity?

First, a quick review of the history of diet and macronutrient content.

A long time ago, prehistoric humans foraged and hunted for food. Protein and fat were procured from animal meat, which was very important for encephalization, or evolutionary increase in the complexity or relative size of the brain. Most of the requirements for protein and iron were satisfied by hunting and eating land animals as well as consuming marine life that washed up on shore.

Carbohydrates in the form of plant foods served as the only sources of energy available to prehistoric hunter-gatherers, which offset the high protein content of the rest of their diet. These were only available during spring and summer.

Then, about 10,000 years ago, plant and animal agriculture began, and humans saw a permanent shift in the macronutrient content of our daily intake so that it was more consistent and stable. Initially, the nutrient characteristic changes were subtle, going from wild food to cultivated food with the Agricultural Revolution in the mid-17th century. Then, it changed even more rapidly less than 200 years ago with the Industrial Revolution, resulting in semiprocessed and ultraprocessed foods.

This change in food intake altered human physiology, with major changes in our digestive, immune, and neural physiology and an increase in chronic disease prevalence. The last 50 years has seen an increase in obesity in the United States, along with increases in chronic disease such as type 2 diabetes, which leads cardiovascular disease and certain cancers. 
 

Back to Carbohydrates: Do We Need Them? How Much? What Kind?

The increase in the macronutrient content of the food we eat containing saturated fat and refined carbohydrates and sugars represents a major change and is arguably the smoking gun of the obesity epidemic. Unfortunately, ultraprocessed foods have become a staple of the standard American or Western diet. 

Ultraprocessed foods such as cakes, cookies, crackers, sugary breakfast cereals, pizza, potato chips, soft drinks, and ice cream are eons away from our prehistoric diet of wild game, nuts, fruits, and berries, at which time, our digestive immune and nervous systems evolved. The pace at which ultraprocessed foods have entered our diet outpaces the time necessary for adaptation of our digestive systems and genes to these foods. They are indeed pathogenic in this context. 

So when was the time when humans consumed an “optimal” diet? This is hard to say because during the time of brain evolution, we needed protein and iron and succumbed to infections and trauma. In the early 1900s, we continued to succumb to infection until the discovery of antibiotics. Soon thereafter, industrialization and processed foods led to weight gain and the chronic diseases of the cardiovascular system and type 2 diabetes. 

Carbohydrates provide calories and fiber and some micronutrients, which are needed for energy, metabolism, and bowel and immune health. But how much do we need? 

Currently in the United States, the percentage of total food energy derived from the three major macronutrients is: carbohydrates, 51.8%; fat, 32.8%; and protein, 15.4%. Current advice for a healthy diet to lower risk for cardiovascular disease is to limit fat intake to 30% of total energy, protein to 15%, and to increase complex carbohydrates to 55%-60% of total energy. But we also need to qualify this in terms of the quality of the macronutrient, particularly carbohydrates. 

In addition to the quality, the macronutrient content of the diet has varied considerably from our prehistoric times when dietary protein intakes were high at 19%-35% of energy at the expense of carbohydrate (22%-40% of energy). 

If our genes haven’t kept up with industrialization, then why do we need so many carbohydrates to equate to 55%-60% of energy? Is it possible that we are confusing what is available with what we actually need? What do I mean by this?

We certainly have changed the landscape of the world due to agriculture, which has allowed us to procreate and feed ourselves, and certainly, industrialization has increased the availability of accessible cheap food. Protein in the form of meat, fish, and fowl are harder to get in industrialized nations as are fruits and vegetables. These macronutrients were the foods of our ancestors. It may be that a healthy diet is considered the one that is available. 

For instance, the Mediterranean diet is somewhat higher in fat content, 40%-50% fat (mostly mono and unsaturated), and similar in protein content but lower in carbohydrate content than the typical Western diet. The Dietary Approaches to Stop Hypertension (DASH) diet is lower in fat at 25% total calories, is higher in carbohydrates at 55%, and is lower in protein, but this diet was generated in the United States, therefore it is more Western. 

We need high-quality protein for organ and muscle function, high-quality unsaturated and monounsaturated fats for brain function and cellular functions, and high-quality complex carbohydrates for energy and gut health as well as micronutrients for many cellular functions. A ketogenic diet is not sustainable in the long-term for these reasons: chiefly the need for some carbohydrates for gut health and micronutrients. 

How much carbohydrate content is needed should take into consideration energy expenditure as well as micronutrients and fiber intake. Protein and fat can contribute to energy production but not as readily as carbohydrates that can quickly restore glycogen in the muscle and liver. What’s interesting is that our ancestors were able to hunt and run away from danger with the small amounts of carbohydrates from plants and berries plus the protein and fat intake from animals and fish — but the Olympics weren’t a thing then!

It may be another 200,000 years before our genes catch up to ultraprocessed foods and the simple carbohydrates and sugars contained in these products. Evidence suggests that ultraprocessed foods cause inflammation in organs like the liver, adipose tissue, the heart, and even the brain. In the brain, this inflammation may be what’s causing us to defend a higher body weight set point in this environment of easily obtained highly palatable ultraprocessed foods. 

Let’s not wait until our genes catch up and our bodies tolerate junk food without disease progression. It could be like waiting for Godot!

Dr. Apovian is professor of medicine, Harvard Medical School, and codirector, Center for Weight Management and Wellness, Brigham and Women’s Hospital, Boston, Massachusetts. She disclosed ties to Altimmune, CinFina Pharma, Cowen and Company, EPG Communication Holdings, Form Health, Gelesis, and L-Nutra.

A version of this article appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article