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Therapeutic management of NAFLD

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Author(s)

Eduardo Vilar-Gomez, MD

Naga Chalasani, MD

Nonalcoholic fatty liver disease (NAFLD) is defined by the presence of hepatic steatosis detected on either imaging or histology in the absence of secondary causes of fatty liver (e.g., excessive alcohol consumption) or other chronic liver diseases.¹ For practical NAFLD diagnosis purposes, excessive alcohol intake can be defined as an active or recent history of more than 21 standard drinks per week in men and more than¹⁴ standard drinks per week in women. For the sake of terminology, NAFLD is characterized by fatty liver infiltration, affecting at least 5% of hepatocytes, with no evidence of hepatocyte injury, whereas nonalcoholic steatohepatitis (NASH) is defined as the presence of necroinflammation with or without fibrosis in a background of fatty liver.¹

Natural history

NASH and the degree of fibrosis are the two most important determinants of the natural history of NAFLD. NASH can evolve into fibrosis and cirrhosis, whereas advanced fibrosis and cirrhosis (stages 3 or 4 of fibrosis) significantly increase the risk of liver-related decompensation and mortality. NAFLD, per se, has been associated with an increased risk of overall mortality, compared with that of the general population.² The three most common causes of mortality for patients with NAFLD are cardiovascular diseases (CVD), extrahepatic malignancies, and liver-related deaths. Mortality and liver-related events, including hepatic decompensation and hepatocellular carcinoma (HCC), may significantly increase in a dose-dependent manner with increasing fibrosis stages, and stages 3 or 4 of fibrosis may display the highest rates of all-cause mortality and liver-related events.^3,4 It is important to note, however, that almost 15% of HCCs occur in patients with NAFLD who do not have cirrhosis.⁵ The presence of commonly associated comorbidities such as obesity, insulin resistance or diabetes, dyslipidemia, hypothyroidism, polycystic ovary syndrome, and sleep apnea may contribute to an increased risk of NASH and advanced fibrosis and, therefore, an accelerated clinical course of NAFLD.

Nonpharmacological interventions

Lifestyle modification

Lifestyle modification to achieve weight loss remains a first-line intervention in patients with NAFLD. Weight loss achieved either by hypocaloric diet alone or in conjunction with increased physical activity can be beneficial for all patients with NAFLD. The benefits extend not only to those who are overweight and obese but also to those within normal body weight (lean NAFLD).^1,6,7 Weight loss of approximately 3%-5% is necessary to improve hepatic steatosis, but a greater weight loss (7%-10%) is required to improve other histopathological features like necroinflammatory lesions and fibrosis.^8-10 Individuals with higher BMI and/or type 2 diabetes (T2D) will require a larger weight reduction to achieve a similar benefit on NAFLD-related features.^7,8 Weight loss via lifestyle changes can also decrease hepatic venous pressure gradient (HVPG), with greater declines reported among those with more than 10% weight loss.¹¹

Weight loss can be achieved through a variety of modalities, but long-term maintenance of lost weight is much more challenging. A combination of a hypocaloric diet with a caloric deficit of 500-1,000 kcal/d, alongside moderate-intensity exercise and intensive on-site behavioral treatment, will likely increase the possibility of a sustained weight loss over time.^1,12 A growing body of scientific evidence indicates that a healthy diet that includes a reduction of high-glycemic-index foods and refined carbohydrates; increased consumption of monounsaturated fatty acids, omega-3 fatty acids, and fibers; and high intakes of olive oil, nuts, vegetables, fruits, legumes, whole grains, and fish can have beneficial effects on NAFLD and its severity.^13-16 Adherence to these healthy dietary patterns has been associated with a marked reduction in CVD morbidity and mortality and is, thus, a strategic lifestyle recommendation for patients with NAFLD in whom the leading cause of morbidity and death is CVD.^1,3

Exercise alone in adults with NAFLD may reduce hepatic steatosis, but its ability to improve inflammation and fibrosis has not been proven in well-designed RCTs.^17,18 Physical activity and exercise have been shown to curb both the development and the progression of NAFLD, and beneficial effects could be achieved independent of weight loss.^17,19,20 Most importantly, moderate-to-vigorous physical activity is likely associated with lower all-cause and cardiovascular mortality in patients with NAFLD.²¹

Heavy alcohol intake should be avoided by patients with NAFLD or NASH, and those with cirrhotic NASH should avoid any alcohol consumption given the risk of HCC and hepatic decompensation.^1,4,22 Limiting light-to-moderate alcohol intake among patients without cirrhosis is still under debate.¹ People with NAFLD may be advised to drink an equivalent of two to three 8-oz cups of regular brewed coffee daily as it has shown certain antifibrotic effects in NAFLD patients.²³

Bariatric surgery

Bariatric surgery is an attractive therapeutic option for eligible obese patients with NAFLD. Bariatric surgery has the potential for inducing great weight loss and, therefore, reverses not only the steatosis, inflammation, and fibrosis among NAFLD individuals but also important comorbid conditions like T2D. A recent systematic review and meta-analysis examining data on the effects of bariatric surgery on histologic features of NAFLD from 32 cohort studies (no RCTs included) showed that bariatric surgery was associated with significant improvements in steatosis (66%), lobular inflammation (50%), ballooning degeneration (76%), and fibrosis (40%), and the benefits were significantly higher in those who underwent Roux-en-Y gastric bypass (RYGB). Of note, worsening of liver histology, including fibrosis, could be seen in up to 12% of patients who underwent bariatric surgery.²⁴ The postsurgical weight regained after RYGB could explain partly the lack of fibrosis improvement or even worsening of fibrosis, although further research is needed to clarify these controversial findings.

RYGB and sleeve gastrectomy (SG) are the most commonly performed bariatric surgeries worldwide. Patients who undergo RYGB achieve higher weight loss when compared with those treated with SG.²⁵ Among all bariatric procedures, RYGB could result in a higher proportion of complete resolution of NAFLD than SG, although evidence is inconclusive on fibrosis improvement rates.^24,26 Most recently, a single-center RCT has compared the effects of RYGB vs. SG on liver fat content and fibrosis in patients with severe obesity and T2D.²⁷ Data showed that both surgical procedures were highly and equally effective in reducing fatty liver content (quantified by magnetic resonance imaging), with an almost complete resolution of the fatty liver at 1 year of both surgical interventions. The beneficial effects of both GB and SG on fibrosis (assessed by enhanced liver test [ELF]) were less evident with no substantial difference between the two groups. Importantly, 69% of participants had an increase in their ELF scores during the study, despite the majority of participants achieving significant reductions in their body weights and better glycemic control at the end of the study. These findings might be considered with caution as several factors, such as the duration of the study (only 1 year) and lack of a liver biopsy to confirm fibrosis changes over time, could be influencing the study results.

Among all NAFLD phenotypes, those with cirrhosis and, most importantly, hepatic decompensation appear to be at increased risk of perioperative mortality and inpatient hospital stays than those without cirrhosis.^28-29 Bariatric surgery is an absolute contraindication in patients with decompensated cirrhosis (Child B and Child C). Among compensated -Child A- cirrhotics, those with portal hypertension are at increased risk of morbidity and perioperative mortality.³⁰ A recent analysis of National Inpatient Sample data suggested that the rates of complications in those with cirrhosis have decreased with time, which could be due to a better selection process and the use of more restrictive bariatric surgery in those with cirrhosis. Low volume centers (defined as less than 50 procedures per year) and nonrestrictive bariatric surgery were associated with a higher mortality rate. These data may suggest that patients with cirrhosis should undergo bariatric surgery only in high-volume centers after a multidisciplinary evaluation.³¹ Bariatric endoscopy is emerging as a new treatment for obesity, but the long-term durability of its effects remains to be determined.

A recent retrospective cohort study, including 1,158 adult patients with biopsy-proven NASH, has investigated the benefits of bariatric surgery on the occurrence of major adverse liver and cardiovascular outcomes in 650 patients who underwent bariatric surgery, compared with 508 patients who received nonsurgical usual care. This study showed that bariatric surgery was associated with 88% lower risk of progression of fatty liver to cirrhosis, liver cancer, or liver-related death, and 70% lower risk of serious CVD events during a follow-up period of 10 years.³² Within 1 year after surgery, 0.6% of patients died from surgical complications. The potential benefits of bariatric surgery in patients with NAFLD must be balanced against surgical risk, especially in eligible obese individuals with established cirrhosis. Data from a retrospective cohort study have shown that bariatric surgery in obese cirrhotic patients does not seem to associate with excessive mortality, compared with noncirrhotic obese patients.³³ More data on immediate complication rates and long-term outcomes in patients with NAFLD by type of bariatric surgery is also required.

NAFLD as a standalone is not an indication for bariatric surgery. However, it could be considered in NAFLD patients who have a BMI of 40 kg/m² or more without coexisting comorbidities or with a BMI of 35 kg/m² or more and one or more severe obesity-related comorbidities, including T2D, hypertension, hyperlipidemia, or obstructive sleep apnea. Bariatric surgery must always be offered in centers with an experienced bariatric surgery program.¹

Management of comorbidities

Given the multiple comorbidities associated with NAFLD and the potential to influence its severity, a comprehensive and multidisciplinary approach is needed to ameliorate not only the progression of liver disease but also those complications related to metabolic syndrome, hyperlipidemia, hypertension, diabetes, and other related conditions. Of note, all patients with NAFLD should receive aggressive management of comorbidities regardless of the severity of NAFLD. Ideally, a multidisciplinary team – including a primary care provider, an endocrinologist for patients with T2D, and a gastroenterologist/hepatologist – is needed to successfully manage patients with NAFLD.

It is well recognized that individuals with biopsy-proven NAFLD are at a higher risk of coronary heart disease, stroke, congestive heart failure, and death resulting from CVD when compared with the non-NAFLD population, and excess in CVD morbidity and mortality is evident across all stages of NAFLD and increases with worsening disease severity.³⁴ The strong association between CVD and NAFLD has important clinical implications that may influence the decision to initiate treatment for primary prevention, including lipid-lowering, antihypertensive, or antiplatelet therapies.³⁵ Statins are widely used to reduce LDL cholesterol and have been proven to be safe in NAFLD, including for those with elevated liver enzymes and even in compensated cirrhosis, in several studies conducted during the last 15 years.³⁶ Statins are characterized by anti-inflammatory, anti-oxidative, antifibrotic, and plaque-stabilizing effects, whereby they may improve vascular and hepatic function among patients with NAFLD and reduce cardiovascular risk.³⁷ Statin use for the treatment of NAFLD is still controversial and off-label and is not specifically recommended to treat NASH, but positive results have been shown for reductions in liver enzymes.¹ A recent meta-analysis of 13 studies showed that continued use of statin in cirrhosis was associated with a 46% and 44% risk reduction in hepatic decompensation and mortality, respectively.³⁸

The Food and Drug Administration has approved omega-3 (n-3) fatty acid agents and fibrates for the treatment of very high triglycerides (500 mg/dL or higher); however, no specific indications exist to treat NAFLD.¹ Fenofibrate is related to mild aminotransferase elevations and, in some cases, severe liver injury, so caution must be paid, especially within 2 days of taking the drug.^39-40

NAFLD phenotypes that need liver pharmacotherapy

There are still no FDA-approved drugs or biological treatments for NASH. Pharmacological interventions aiming primarily at improving liver disease should generally be limited to those with biopsy-proven NASH and clinically significant fibrosis (fibrosis stages of 2 or greater).^1,4 For FDA approval, medications used for treating NAFLD with fibrosis need to meet one of the following endpoint criteria: resolution of NASH without worsening of fibrosis, improvement in fibrosis without worsening of NASH, or both. In addition to those criteria, a new medication might improve the metabolic profile and have a tolerable safety profile. Table 1 displays those NAFLD phenotypes that will likely benefit from liver-directed therapy.

Obeticholic acid as an experimental therapy for NASH

A planned month-18 interim analysis of a multicentre, phase III RCT examined the efficacy and safety of obeticholic acid (OCA), a farnesoid X receptor agonist, in patients with NASH and stages 1-3 of fibrosis. The primary endpoint (fibrosis reduction 1 stage or more with no worsening of NASH) was met by 12% of patients in the placebo group, 18% of patients receiving OCA 10 mg (P = .045), and 23% of those receiving OCA 25 mg (P = .0002). An alternative primary endpoint of NASH resolution with no worsening of fibrosis was not met. OCA 25 mg led to the highest rates of pruritus and hyperlipidemia, compared with OCA 10 mg.⁴² These side effects seem to be related to the activation of the farnesoid X receptor.⁴³

Currently available but off label medications

Vitamin E, an antioxidant, administered at a daily dose of 800 IU/day improves steatosis, inflammation, and ballooning, but not fibrosis in nondiabetic adults with biopsy-proven NASH.⁴⁴ Vitamin E for 96 weeks was associated with a significantly higher rate of improvement in NASH (43% vs. 19%, P less than .01), compared with placebo.⁴⁴ In the Treatment of Nonalcoholic Fatty Liver Disease in Children trial (TONIC), which examined vitamin E (800 IU/day) or metformin (500 mg twice daily) against placebo in children with biopsy-proven NAFLD, resolution of NASH was significantly greater in children treated with vitamin E than in children treated with placebo (58% vs. 28%, P less than .01). Metformin did not significantly improve the NASH resolution rates, compared with placebo (41% vs. 28%, P = .23). Vitamin E could be recommended for nondiabetic adults or children if lifestyle modifications do not produce the expected results as a result of noncompliance or ineffectiveness. Since continued use of vitamin E has been suggested to be associated with a very small increase in the risk for prostate cancer (an absolute increase of 1.6 per 1,000 person-years of vitamin E use) in men, risks and benefits should be discussed with each patient before starting therapy. A meta-analysis of nine placebo-controlled trials including roughly 119,000 patients reported that vitamin E supplementation increases the risk of hemorrhagic stroke by 20% while reducing ischemic stroke by 10%. It was estimated that vitamin E supplementation would prevent one ischemic stroke per 476 treated patients while inducing one hemorrhagic stroke for every 1,250 patients. It is noteworthy that the combination of vitamin E with anticoagulant and/or antiplatelet therapy was not examined in this trial, so we could not determine how combination therapy might affect the risk of ischemic or hemorrhagic stroke.⁴⁵

Thiazolidinediones drugs have been reported to be effective in improving NAFLD in many human studies. Evidence from RCTs suggests that pioglitazone could significantly improve glucose metabolism, alanine aminotransferase, and liver histology – such as hepatic steatosis, lobular inflammation, and ballooning degeneration – among patients with or without T2D. However, the beneficial effects on improving fibrosis remain to be verified.^1,46 Because of safety concerns, the risk/benefit balance of using pioglitazone to treat NASH should be discussed with each patient.^47-48 Pioglitazone has been associated with long-term risk of bladder cancer,⁴⁹ congestive heart failure,⁵⁰ and bone fractures.⁵¹ Data from the Pioglitazone, Vitamin E, or Placebo for Nonalcoholic Steatohepatitis (PIVENS) trial showed that pioglitazone was significantly associated with weight gain but with no other serious adverse events. However, this study was not powered to test any safety-related hypotheses.⁴⁴

Glucagon-like peptide 1 analogs have been reported to induce weight loss and reduce insulin resistance, which may lead to improvements in NAFLD. Phase II RCTs of glucagon-like peptide 1 receptor agonists (liraglutide and semaglutide) for the treatment of biopsy-proven NASH showed significant improvements in serum liver enzymes, steatosis, and inflammation, as well as NASH resolution without worsening liver fibrosis, although no direct benefit was observed in reversing fibrosis.^52-53 One of these studies explores the efficacy and safety of different doses of daily subcutaneous semaglutide vs. placebo on the rates of resolution of NASH with no worsening of fibrosis. The highest dose (0.4 mg) showed the greatest difference (59% vs. 17%, P less than .01), compared with the placebo arm. However, there was no difference in improvement in fibrosis stage between the two groups (43% in the 0.4-mg group vs. 33% in the placebo group, ^P = .48).⁵³ Gastrointestinal adverse events were common in the semaglutide arm.

“Spontaneous” NASH resolution and fibrosis improvement are commonly seen in participants assigned to placebo arms in clinical trials. A recent meta-analysis of 43 RCTs including 2649 placebo-treated patients showed a pooled estimate of NASH resolution without worsening of fibrosis and 1 stage reduction or more in fibrosis of 12% and 19%, respectively. Relevant factors involved in “spontaneous” NASH improvement are unknown but could be related to changes in BMI resulting from lifestyle changes, race and ethnicity, age, and, likely, NAFLD-related genetic variations, although more data is needed to better understand the histologic response in placebo-treated patients.⁵⁴

Semaglutide injections (2.4 mg once weekly) or (2.0 mg once weekly) have been recently approved by the FDA for chronic weight management in adults with obesity or overweight with at least one weight-related condition or glucose control of T2D, respectively. Of note, the semaglutide dose used in the NASH trial is not currently available for the treatment of patients who are overweight/obese or have T2D, but the beneficial effects on body weight reductions and glucose control are similar overall to the effects seen with currently available doses for management of obesity or diabetes. One may consider using semaglutide in patients who are overweight/obese or have T2D with NASH, but in the senior author’s experience, it has been quite challenging to receive the payer’s approval, as its use is not specifically approved to treat liver disease.¹

How to follow patients with NAFLD in the clinic

Once a diagnosis of NAFLD is made, the use of noninvasive testing may aid to identify which patients are at high risk of fibrosis. Easy to use clinical tools, such as the NAFLD Fibrosis Score and the Fib-4 index, and liver stiffness measurements using vibration-controlled transient elastography (FibroScan) or magnetic resonance elastography (MRE) are clinically useful noninvasive tools for identifying patients with NAFLD who have a higher likelihood of progressing to advanced fibrosis.^1,55 The use of either NAFLD Fibrosis Score (less than -1.455) or Fib-4 index (less than 1.30) low cutoffs may be particularly useful to rule out advanced fibrosis. People with a NAFLD Fibrosis Score (greater than –1.455) or Fib-4 index (greater than 1.30) should undergo liver stiffness measurement (LSM) via FibroScan. Those with an LSM of 8 kPa or higher should be referred to specialized care, where a decision to perform a liver biopsy and initiate monitoring and therapy will be taken. MRE is the most accurate noninvasive method for the estimation of liver fibrosis. When MRE is available, it can be a diagnostic alternative to accurately rule in and rule out patients with advanced fibrosis. This technique can be preferred in clinical trials, but it is rarely used in clinical practice because it is expensive and not easily available. Reassessment by noninvasive scores at 1-3 years’ follow-up will be considered for those with an LSM less than 8 kPa. Patients with NASH cirrhosis should be screened for both gastroesophageal varix and HCC according to the American Association for the Study of Liver Diseases guidelines.^56-57

Dr. Vilar-Gomez is assistant professor in the division of gastroenterology and hepatology at Indiana University, Indianapolis. Dr. Chalasani is vice president for academic affairs at Indiana University Health, Indianapolis, and the David W. Crabb Professor of Gastroenterology and Hepatology and an adjunct professor of anatomy, cell biology, and physiology in the division of gastroenterology and hepatology at Indiana University. Dr. Vilar-Gomez reports no financial conflicts of interest. Dr. Chalasani serves as a paid consultant to AbbVie, Boehringer-Ingelheim, Altimmune, Madrigal, Lilly, Zydus, and Galectin. He receives research support from Galectin and DSM.

References

33. Vuppalanchi R et al. Ann Surg 2022;275:e174-80.

34. Simon TG et al. Gut 2021. doi: 10.1136/gutjnl-2021-325724.

35. Lonardo A et al. J Hepatol 2018;68:335-52.

36. Chalasani N et al. Gastroenterology 2004;126:1287-92.

37. Pastori D et al. Dig Liver Dis 2015;47:4-11.

38. Kim RG et al. Clin Gastroenterol Hepatol 2017;15:1521-30.e8.

39. Ahmad J et al. Dig Dis Sci 2017;62:3596-604.

40. Chalasani NP et al. Am J Gastroenterol 2021;116(5):878-98.

41. Rinella ME et al. Hepatology 2019;70:1424-36.

42. Younossi ZM et al. Lancet 2019;394:2184-96.

43. Ratziu V. Clin Liver Dis (Hoboken) 2021;17:398-400.

44. Sanyal AJ et al. N Engl J Med 2010;341:1675-85.

45. Schürks M et al. BMJ 2010;341:c5702.

46. Cusi K et al. Ann Intern Med 2016;165:305-15.

47. Lewis JD et al. JAMA 2015;314:265-77.

48. Billington EO et al. Diabetologia 2015;58:2238-46.

49. Lewis JD et al. Diabetes Care 2011;34:916-22.

50. Erdmann E et al. Diabetes Care 2007;30:2773-8.

51. Viscoli CM et al. J Clin Endocrinol Metab 2017;102:914-22.

52. Armstong MJ et al. Lancet 2016;387:679-90.

53. Newsome PN et al. N Engl J Med 2021;384:1113-24.

54. Ng CH et al. Hepatology 2022;75:1647-61.

55. Kanwal F et al. Gastroenterology 2021;161:1030-1042.e8.

56. Garcia-Tsao G et al. Hepatology 2017;65:310-35.

57. Heimbach JK et al. Hepatology 2018;67:358-80.

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Naga Chalasani, MD

Author(s)

Eduardo Vilar-Gomez, MD

Naga Chalasani, MD

Natural history

Nonpharmacological interventions

Management of comorbidities

NAFLD phenotypes that need liver pharmacotherapy

How to follow patients with NAFLD in the clinic

References

Natural history

Nonpharmacological interventions

Management of comorbidities

NAFLD phenotypes that need liver pharmacotherapy

How to follow patients with NAFLD in the clinic

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Becoming an AGA committee chair as an early-career physician

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Peter S. Liang, MD, MPH

Stephanie D. Pointer, MD

One of the cornerstones of member engagement within the American Gastroenterological Association is its committees, which provide a platform for AGA members to network, effect change at the institutional level, and obtain leadership positions. For many within the AGA, exposure to these committees occurs during training. Both of us were first introduced to the possibility of serving on an AGA committee by faculty members at our institution. Each year, applications for available committee positions open in the fall and are due on Nov. 1. While you can be nominated by other members, self-nomination is common and encouraged. Truthfully, neither of us was quite certain what committee membership would entail. However, we both applied to several committees because we knew that it would be an excellent opportunity to network with leading gastroenterologists across the country and to have the ability to become involved in key AGA programs.

We were selected to serve 2-year terms as trainee members on the Government Affairs and Publication Committees, respectively, which gave us a deeper understanding of how an organization with both a full-time professional staff and group of volunteer members functions. A unique feature of the AGA is its Trainee and Early Career (TEC) Committee, which mainly comprises trainee members who serve on other committees. By virtue of our roles with the other committees, we also became full-fledged members of the TEC committee, which is dedicated to enhancing the experience for trainees and those who are within 5 years of graduation.

One of the most innovative programs developed by the TEC committee is Career Development Workshops, which is a webinar series focused on important topics not covered in fellowship, such as different career paths, personal finance, and how to increase the number of underrepresented individuals in the field. The predecessor of the Career Development Workshops was the in-person Regional Practice Skills Workshop, and we both took on the responsibility of planning and organizing separate workshops. For one of us (Stephanie), that involved enlisting our fellowship program to host the event. For the other (Peter), it meant collaborating with our local gastroenterology society to cosponsor the workshop. It was extremely rewarding to organize the workshops, which allowed us to work closely with AGA staff and local gastroenterology faculty, as well as our peers, to bring the events to fruition. For both of us, the success of the Regional Practice Skills Workshop was one of the highlights of our tenure on the TEC committee.

Although we were not aware of it at the time, volunteering to plan a workshop and assisting with other projects and subcommittees were signs of enthusiasm and leadership that the AGA recognized and valued. Our advice on becoming a committee chair is to not only show an interest in committee projects but also to turn that interest into action. A committee member who is strongly interested in a leadership position cannot expect to transition into that role by being a “silent but present” member. You need to do more than just show up. You should actively participate in projects, engage in discussions, and devote your time and energy to ensure the success of committee programs. However, you should also make sure to have sufficient bandwidth to make meaningful contributions to each project and not commit to tasks that you cannot complete. To set yourself apart on a committee, it is important to be actively engaged and committed to a project (or two) that allows for professional growth and visibility. Ideally, you will become an integral part of a committee that sparks your drive to serve.

Applying to become a committee chair follows the same process and timeline as for any other committee position, and you can be nominated or self-nominate. Although previous experience on that specific committee is not a prerequisite for most chair positions, having previously served on any AGA committee or task force is generally required. Successful applicants serve for 1 year as chair-elect, during which they work closely with the outgoing chair and staff to ensure a smooth transition when their 3-year term as chair officially begins in June.

Each committee has a guiding mission statement and a staff liaison who provides institutional knowledge and logistical support. However, the committee members, and especially the chair, have considerable latitude to develop and implement new initiatives or retire old ones. The entire committee meets twice per year, once in September in Washington, D.C., and once at DDW. Between the meetings, working groups are formed to move the various programs forward. In addition to the Career Development Workshops, the TEC committee organizes the Young Delegates program (which allows any AGA member to volunteer on small, time-limited projects), a symposium at DDW focused on trainee and early career issues, and a networking event at DDW. Moreover, we collaborate with other committees and provide input from the perspective of younger members on larger initiatives such as the AGA Equity Project and Career Compass.

As chair, we lead the twice-yearly meetings as well as the working groups. We strongly encourage all committee members to participate on at least one working group, which develops leadership skills and provides the opportunity to moderate sessions for the Career Development Workshops and DDW symposium. Moreover, we solicit feedback on ways to improve current programming, start new initiatives, and work with other committees that the TEC committee members are part of. Trainees and early career members are seen as a key constituency group within the AGA, and we take the responsibility of increasing the value of membership for this group seriously.

As early-career physicians ourselves, we also view the chance to serve as a committee chair as a great career development opportunity. It allows us to expand our professional networks, help shape an organization that is a leading voice and advocate for digestive health, and meet the needs of young members who are the future of the AGA.

There is no doubt that all of you have achieved amazing things on the way to becoming a trainee or early career professional in the competitive fields of gastroenterology and hepatology. The AGA is constantly looking for bright, motivated individuals to serve as volunteers and future leaders. Our experience shows that with a bit of persistence to get in the door – through Young Delegates or a committee – along with lots of hard work along the way, you will be in a great position to rise through the ranks and help lead an organization at the vanguard of our field.

Dr. Liang is assistant professor of medicine and population health, New York University Langone Health, and a staff physician at VA New York Harbor Health Care System. Dr. Pointer is a founder and managing partner of Digestive and Liver Health Specialists. She is on staff as a clinical gastroenterologist at Tristar Hendersonville (Tenn.) Medical Center. They have no conflicts of interest.

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June 2022
Ultra-processed Foods and Risk of Crohn’s Disease and Ulcerative Colitis: A Prospective Cohort Study
Lo CH et al. Clin Gastroenterol Hepatol. 2022 Jun;20(6):e1323-e1337. doi: 10.1016/j.cgh.2021.08.031.

Changes in Lifestyle Factors After Endoscopic Screening: A Prospective Study in the United States
Knudsen MD et al. Clin Gastroenterol Hepatol. 2022 Jun;20(6):e1240-e1249. doi: 10.1016/j.cgh.2021.07.014.

Trends in Early-onset vs Late-onset Colorectal Cancer Incidence by Race/Ethnicity in the United States Cancer Statistics Database
Chang SH et al. Clin Gastroenterol Hepatol. 2022 Jun;20(6):e1365-e1377. doi: 10.1016/j.cgh.2021.07.035.

July 2022
Updates in Telemedicine for Gastroenterology Practices in the United States
Serper M, Volk ML. Clin Gastroenterol Hepatol. 2022 Jul;20(7):1432-1435. doi: 10.1016/j.cgh.2022.03.024.

Prevalence and Financial Burden of Digestive Diseases in a Commercially Insured Population
Mathews SC et al. Clin Gastroenterol Hepatol. 2022 Jul;20(7):1480-1487.e7. doi: 10.1016/j.cgh.2021.06.047.

Prevalence of Forceps Polypectomy of Nondiminutive Polyps Is Substantial But Modifiable
Fudman DI et al. Clin Gastroenterol Hepatol. 2022 Jul;20(7):1508-1515. doi: 10.1016/j.cgh.2021.11.031.

Long-Term Treatment of Eosinophilic Esophagitis With Budesonide Oral Suspension
Dellon ES et al. Clin Gastroenterol Hepatol. 2022 Jul;20(7):1488-1498.e11. doi: 10.1016/j.cgh.2021.06.020.

Techniques and Innovations in Gastrointestinal Endoscopy

Intervention Versus Observation in Patients Presenting With Lower Gastrointestinal Bleeding
Lipcsey MS et al. Tech Innov Gastrointest Endosc. 2022 Jan 01;24(2):145-152. doi: 10.1016/j.tige.2021.12.001.

Physician Reimbursement for Endoscopic Submucosal Dissection: A Single Center Analysis
Gajula P et al. Tech Innov Gastrointest Endosc. 2022 Jan 01;24(2):153-158. doi: 10.1016/j.tige.2021.12.003.

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Evaluating Eosinophilic Colitis as a Unique Disease Using Colonic Molecular Profiles: A Multi-Site Study
Shoda T et al. Gastroenterology. 2022 May;162(6):1635-1649. doi: 10.1053/j.gastro.2022.01.022.

June 2022
How to Incorporate Advanced Tissue Resection Techniques in Your Institution
Repici A et al. Gastroenterology. 2022 Jun; 162(7):1825-1830. doi: 10.1053/j.gastro.2022.03.034.

July 2022
Pregnancy-Associated Liver Diseases
Terrault NA, Williamson C. Gastroenterology. 2022 Jul;163(1):97-117.e1. doi: 10.1053/j.gastro.2022.01.060.

Databases for Gastrointestinal Clinical and Public Health Research: Have Database, Will Research
Rustgi SD et al. Gastroenterology. 2022 Jul;163(1):31-34. doi: 10.1053/j.gastro.2022.04.024.

Impact of Artificial Intelligence on Miss Rate of Colorectal Neoplasia
Wallace MB et al. Gastroenterology. 2022 Jul;163(1):295-304.e5. doi: 10.1053/j.gastro.2022.03.007.

Clinical Gastroenterology and Hepatology

Duodenal Mucosal Barrier in Functional Dyspepsia
Narayanan SP et al. Clin Gastroenterol Hepatol. 2022 May;20(5):1019-1028.e3. doi: 10.1016/j.cgh.2021.09.029.

Prevalence of Forceps Polypectomy of Nondiminutive Polyps Is Substantial But Modifiable
Fudman DI et al. Clin Gastroenterol Hepatol. 2022 Jul;20(7):1508-1515. doi: 10.1016/j.cgh.2021.11.031.

Long-Term Treatment of Eosinophilic Esophagitis With Budesonide Oral Suspension
Dellon ES et al. Clin Gastroenterol Hepatol. 2022 Jul;20(7):1488-1498.e11. doi: 10.1016/j.cgh.2021.06.020.

Techniques and Innovations in Gastrointestinal Endoscopy

Gastroenterology

Evaluating Eosinophilic Colitis as a Unique Disease Using Colonic Molecular Profiles: A Multi-Site Study
Shoda T et al. Gastroenterology. 2022 May;162(6):1635-1649. doi: 10.1053/j.gastro.2022.01.022.

June 2022
How to Incorporate Advanced Tissue Resection Techniques in Your Institution
Repici A et al. Gastroenterology. 2022 Jun; 162(7):1825-1830. doi: 10.1053/j.gastro.2022.03.034.

July 2022
Pregnancy-Associated Liver Diseases
Terrault NA, Williamson C. Gastroenterology. 2022 Jul;163(1):97-117.e1. doi: 10.1053/j.gastro.2022.01.060.

Databases for Gastrointestinal Clinical and Public Health Research: Have Database, Will Research
Rustgi SD et al. Gastroenterology. 2022 Jul;163(1):31-34. doi: 10.1053/j.gastro.2022.04.024.

Impact of Artificial Intelligence on Miss Rate of Colorectal Neoplasia
Wallace MB et al. Gastroenterology. 2022 Jul;163(1):295-304.e5. doi: 10.1053/j.gastro.2022.03.007.

Clinical Gastroenterology and Hepatology

Duodenal Mucosal Barrier in Functional Dyspepsia
Narayanan SP et al. Clin Gastroenterol Hepatol. 2022 May;20(5):1019-1028.e3. doi: 10.1016/j.cgh.2021.09.029.

Prevalence of Forceps Polypectomy of Nondiminutive Polyps Is Substantial But Modifiable
Fudman DI et al. Clin Gastroenterol Hepatol. 2022 Jul;20(7):1508-1515. doi: 10.1016/j.cgh.2021.11.031.

Long-Term Treatment of Eosinophilic Esophagitis With Budesonide Oral Suspension
Dellon ES et al. Clin Gastroenterol Hepatol. 2022 Jul;20(7):1488-1498.e11. doi: 10.1016/j.cgh.2021.06.020.

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Establishing a formalized mentorship program in a community practice

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Author(s)

Marc Sonenshine, MD

Most GI physicians will tell you that we didn’t get where we are without help along the way. Each of us can point to one – or in most cases, several – specific mentors who provided invaluable guidance when we were in medical school, fellowship, and starting our careers. This is true for gastroenterologists across the spectrum, whether they chose careers in private practice, academic medicine, or within a hospital system.

The leadership at Atlanta Gastroenterology Associates, where I practice, has always recognized the importance of mentorship and its role in developing fulfilling careers for its physicians and a healthy practice culture in which people feel valued and supported. But only recently have we begun to create a formalized program to ensure that everyone has access to mentors.

When I started my career, formalized programs for mentorship did not exist. While I reached out to various doctors in my office and the senior partners throughout the practice, not everyone is comfortable proactively reaching out to ask practice leadership for help and guidance. And as independent GI practices continue to get bigger, there may not be as many opportunities to interact with senior leadership or executives, which means new associates could be left to “cold call” potential mentors by phone or email.

New associates face many challenges

When I was an associate, the path to partnership looked much different than it does in our practice now, and it definitely varies from practice to practice. In our practice, physicians remain associates for 2-3 years before they have the option to become a partner. As they work diligently to provide the best care to patients, new associates face many challenges, like learning how to build a practice and interact with referring physicians, understanding the process to become a partner, and figuring out how to juggle other commitments, such as the balance between work and home life.

Then there are things like buying a home, getting life and disability insurance, and understanding the financial planning aspects of being a business owner. For those whose group model requires buying into the practice to become a partner, medical school doesn’t teach you how to analyze the return on an investment. Providing access to people who have this experience through a mentorship program can help associates be more prepared to become partners, and hopefully be happier and more successful while doing so.

Formalizing a mentorship program

The mentorship program at Atlanta Gastroenterology Associates matches new physicians with a partner-level mentor with whom they are encouraged to meet monthly. We’ve even provided a budget so that mentees and mentors can meet for dinner or coffee and get to know each other better.

The program starts with a meeting of volunteer partners and associates, who then rank their preferred choices for potential mentors. This helps to ensure that the associates are able get to know the mentors a little bit and decide who might be the best fit for their needs. This is also important for new associates who don’t feel comfortable proactively searching for a mentor as they’re able to provide a list of partners they think would be the best match for them.

Each associate is then assigned a partner-level mentor who is responsible for guiding them and providing education around not only clinical care, but also business, marketing, health policy, and all the other critical components of running a successful private practice. Our program specifically pairs mentors and mentees who do not work in the same location. We wanted the mentors to be paired with associates they are not interacting with daily, to ensure our associates get exposed to different perspectives.

As a group, program participants get together every quarter – twice a year in person, and twice virtually. One of the in-person meetings brings together the mentors and mentees with C-suite executives to meet and network with the practice leadership. We organized the program this way because otherwise, most associates wouldn’t get many opportunities to interact with the CEO, chief medical officer, or chief operating officer in any capacity, let alone in a small gathering where they can engage on a personal level.

The second in-person meeting is a dinner with the mentors and mentees, along with their significant others. We understand that all our physicians have responsibilities outside of work, and bringing families together helps provide new associates with a network of support for questions that aren’t work-related. For associates who are not from Atlanta, this can be especially helpful in figuring out housing, schools, and other aspects of work/life balance.

The other two virtual meetings include the C-suite executives and our physician executive board. We develop specific agenda topics related to a career in private practice and provide a forum for the associates to ask practice leadership questions about challenges they may face on their path to becoming a partner.

At the end of each year, we survey the current program participants to see what was successful and what can be improved for the next cohort of incoming associates. So far, the feedback we’ve received from the mentors and mentees has been overwhelmingly positive.

Mentorship benefits the entire practice

As groups continue to grow, more practices may begin to formalize their mentorship programs, particularly those who see the merit they provide in helping recruit and retain valuable associates. To supplement our internal mentorship program, we’ve also started reaching out to local fellowship programs to provide resources to fellows who are considering private practice.

Even though about half of gastroenterology fellows choose independent GI, many aren’t educated about what it means to choose a career in private practice. Our outreach to provide information at the fellowship level is aimed at giving early career physicians an opportunity to know the benefits and challenges associated with private practice. Furthermore, we strive to educate fellows about the resources that are available to guide them through not only joining a group, but also having a successful career.

Leaders of independent GI groups need physicians who want the practice to succeed. Medical school trains physicians to take care of patients but falls short on training physicians to run a business. And building good, strong businesses makes sure that the next generation of leaders are prepared to take over.

Supporting the next generation of practice leaders helps current leadership make changes that will ensure practice sustainability. Often, associates are at the forefront of new technologies, both in terms of patient care, and in terms of practice management, communications, marketing, and advertising. As times change, having associates who are engaged and excited will help any practice be positioned positively for whatever the future holds.

What to look for in joining a practice

Ideally, people should start looking for mentors when they’re looking for a residency program. Joining a practice isn’t much different. If you’re an early career physician who is considering private practice, find an independent GI physician who can tell you about their experiences. And when you’re interviewing with practices, be sure to ask questions about how the group approaches mentorship. If a practice doesn’t have a formal mentorship program, it doesn’t mean it’s an environment where mentorship relationships won’t flourish. In many practices, informal mentorship programs are very successful.

Ask questions about how the practice provides or supports mentorship. Does the practice leadership make themselves available as mentors? Does the practice expect new physicians to find and nurture mentorship relations on their own? Ask about the path to becoming a partner and who is available to discuss challenges, concerns, or any questions that arise.

Independent GI practices are partnerships that seek to provide high-quality care at a lower cost to our community. Strengthening and sustaining that partnership requires us to take the time and continuously invest in the future of new physicians who will go on to serve our community as partner physicians retire. By formalizing a mentorship program, we’re hoping to make it easier for our mentors and mentees to create productive partnerships that will strengthen our group, and ultimately independent gastroenterology overall.

Dr. Sonenshine is a practicing gastroenterologist at Atlanta Gastroenterology Associates, and a partner in United Digestive. He previously served as the chair of communications as a member of the Executive Committee of the Digestive Health Physicians Association. Dr. Sonenshine has no conflicts to declare.

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New associates face many challenges

Formalizing a mentorship program

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What to look for in joining a practice

New associates face many challenges

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What to look for in joining a practice

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This insurance agent thinks disability insurance deserves a rebrand, and he's a doctor

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Mon, 08/01/2022 - 13:53

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Trevor Smith, MD

If you already have disability insurance, keep reading as well. I have a great tip for you from personal experience that made a difference in the job I selected.

Let’s start with an important rebrand for “disability insurance.” What does it protect? Income! Car insurance is not called crash insurance. House insurance is not called burnt house insurance. And unlike a car or a house, it protects an asset with 10-20 times as much value as a million-dollar house.

So, let’s call it what it is: “income protection insurance.”

It’s always a bit nerdy when I talk about how much I appreciate insurance that protects lifelong income. I often make an argument that it is simply one of the best products that exists, especially for high-income earners with lots of debt. Many of us doctors are in that category and are not even slightly jealous of our friends whose parents paid for school (I’m looking at you not-her-real-name-Mary).

Disability is not the catchiest name for a product, but it is more pronounceable than “ophthalmology” and way easier to spell. This is my specialty, and I can’t believe we still haven’t gone with “eye surgeon,” but I digress.

So, let’s rebrand “disability insurance” for the sake of clarity:

I personally like to think of it as a monthly subscription for a soft landing in a worst-case scenario. Call me a millennial, but it just goes down smoother in my mind as a subscription a la Netflix ... and the four other streaming services that someone gave me a password to – if you’re a 55-year-old GI specialist, I know you’re on the Spotify family plan, too. No judgment from me.

So, for $15, you get a bunch of movies with Netflix, and, for $150-$300, you cover a lifetime of income. That’s a pretty decent service even without “The Office.”

Disability insurance often covers at least $15-$20 million dollars over a lifetime of earnings for only 1%-2% of your salary per year.

But I’ll pause here. The numbers are irrelevant if you never get the insurance.

I have one goal for this article, and it is simply to try to help you break down that procrastination habit we all have. I will have added immense value to at least one family’s life if you go and get a policy this week that saves your family from substantial loss of income. This is why I love insurance.

Doctors sacrifice essential life steps to get through training. But we are not alone in that.

Tim Kasser, PhD, puts it well when he said: “We live in a machine that is designed to get us to neglect what is important about life.” Here he is talking about relationships, but securing financial protection is loving to those closest to us.

So, what holds us back from taking a seemingly easy step like locking in disability insurance early in training?

Is it the stress of residency? Studying for Step 1? Moving cities and finding a home during a housing crisis? Job change during COVID? Is it because we have already put it off so long that we don’t want to think about it?

Totally fair.

For all of us busy doctors, the necessity and obviousness of buying disability insurance, *ehem*, income protection insurance makes you feel like you can get to it when you get to it because you know you will, so ... what’s the rush?

Or, is it our desire to bet on ourselves, and every month that goes by without insurance is one less payment? Roll the dice! Woo!

The reason to not put off the important things in life

I will give you a few reasons of “the why of” how we can all benefit from disability insurance and the reason there is no benefit in waiting to get a policy.

But, most importantly, I want to talk to you about your life and why you are putting off a lot of important things.

That diet you’ve been wanting to start? Yep.

That ring you haven’t purchased? Maybe that!

That article you’ve been meaning to write for the GI journal? Yes, especially that.

Remember: Take a deep breath in and exhaaaaale.

So, why do we put off the important?

First, even though the “why” of purchasing income protection is a bit basic, I do find it helpful to have discrete reasons for accomplishing an important task.

Why get disability insurance at all?

Let’s look at the value we get out of covering our income.

Reason No. 1. It softens the landing in the event you have an illness. The stats on disability claims are heavily on the side of illness over accidents or trauma. As you know, many autoimmune conditions show up in the 20’s and 30’s, so those are the things your friends will have first.

Unfortunately, if you have a medical issue before you have a disability policy, you will either not have coverage for that specific condition or you will not be approved for insurance. Unlike health insurance, the company can afford to pay out policies because it is picky on who it is willing to cover. It tries to select healthy people, so apply when you are most healthy, if possible.

Reason No. 2. It’s cheap. When you compare with a $2 million policy for life insurance, it might cost $1,000-$2,000 or so per year for a term policy covering about 25 years. With disability insurance, you can cover about 10x as much for the same annual payment. One could easily make a case that if you do not have dependents, disability insurance should be your first stop even before life insurance. You are more likely to be disabled than to die when you’re in your thirties. Act accordingly.

(Please note for obvious reasons they don’t call life insurance “death insurance.” Disability insurance needs that same rebrand – I’m telling you!)

Reason No. 3. Unless you are independently wealthy, it will be nearly impossible to replace your income and live a similar lifestyle. Lock in the benefits of the work you have already accomplished, and lock in the coverage of ALL of your health while you are healthy.

Time to take action

As Elvis famously sang: “A little less conversation, a little more action please.”

Alright, so how do we get ourselves to ACT and get a policy to protect our income?

Tip No. 1. As doctors we often shoot for perfection. It’s no surprise, therefore, that we have an illusion that we need to find the “perfect policy.”

One of my friends is a great financial adviser, and he often tells me about first meetings with clients to create a long-lasting plan. Often, somewhere along the way when discussing risks of stocks going down and up, someone will ask, “Why don’t we pick one that is low risk but tends to go up in value?” Of course, the reality is that if it were that easy ... everyone would do it!

Fortunately, with disability insurance, the policies are fairly straight forward. You can skip the analysis paralysis with disability insurance by talking with an agent who consistently works with physicians. I enjoy talking policies and helping doctors protect their financial health, so I started selling policies shortly after residency because so many of my co-residents were making me nervous putting it off. Some I helped, and some put it off and are unable to get policies after health issues even just 3 years after residency.

Tip No. 2. Having a policy is better than not having one, and if you’re worried about getting the wrong one, just get two! Seriously, some companies let you split coverage between two and this can even increase the maximum coverage you can get later in life, too. Does it add cost? Surprisingly, it typically does not, and it does not make the agent more money either. In most cases it’s actually more work for them for the same amount of commission. Don’t be afraid to ask about this.

Tip No. 3. This is my hot tip for current policy owners: ask for the full version of your policy, and read the entire policy. I recently asked for my policy because I was doing some international work abroad and wanted to know if I could reside abroad if I made a disability claim. My policy stated that I would need to reside in the United States within 12 months of disability. I likely would do this in the event of disability, but it is quite important to know these aspects.

While reading the fine print, I found that a minimum number of work-hours per week (35 for my policy) was required to qualify for my physician-specific coverage. This was an important part of my job criteria when looking for a new position and is worth investigating for anyone considering part-time employment.

Tip No. 4. The obvious tip: The fear of failure gets a lot of perfectionists from even starting a task unless they know everything about it.

Just start.

That’s my go-to for overcoming fear of failure. You won’t fail. You just won’t. You will learn!

Pretend you are curious about it and try with any of these actionable steps:

Google disability insurance.
Email me at [email protected].
Read an article on a doctor-based blog.

I personally geeked out on insurance so much in residency that I became an insurance agent. I am an independent broker, so I have no bias toward any particular policies (email me anytime even if just with questions). Personally, I believe in this product and the value of this type of insurance, and I would hate for anyone to not have coverage of their most valuable asset: lifelong income!

The steps of applying for disability insurance

Now you know all the great reasons to get going! What are the next steps?

No matter where you get your policy, you can expect the process to be fairly simple. If it’s not then shoot me an email and I’m happy to help chat and discuss further.

The general process is:

Step 1. Initial phone call or email: Chat with an agent to discuss your needs and situation. Immediately after, you can sign initial application documents with DocuSign. (20 minutes).

Step 2. Complete health questionnaire on the phone with the insurance company. (20-40 minutes).

Step 3. Sign the final documents and confirm physician-specific language in their policies. (20 minutes).

The whole application period typically lasts only 2-4 weeks from start to finish and, if you pay up front, you are covered from the moment you send in the check. If you don’t accept the policy, you even get the money back.

I genuinely enjoy talking with my colleagues from all over the world and learning about their lives and plans, so, if you have any questions, please do not hesitate to email me at [email protected]. Also, feel free to check out my mini-blog at curiousmd.com or listen to me chat with Jon Solitro, CFP, on his FinancialMD.com podcast. Similar to this article, it is fairly informal and covers real life, tough career decisions, and actionable financial planning tips.

If you made it to the end of this article, you are a perfectionist and should go back and read Tip No. 1.

Reference

The Context of Things. “We live in a machine that is designed to get us to neglect what’s important about life,” 2021 Aug 24.

Dr. Smith is an ophthalmologist and consultant with Advanced Eyecare Professionals, Grand Rapids, Mich., and founder of DigitalGlaucoma.com. He is cohost of The FinancialMD Show podcast. He is an insurance producer and assists clients with advising and decision-making related to disability insurance at FinancialMD.

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Trevor Smith, MD

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Trevor Smith, MD

The reason to not put off the important things in life

Why get disability insurance at all?

Time to take action

Just start.

That’s my go-to for overcoming fear of failure. You won’t fail. You just won’t. You will learn!

Pretend you are curious about it and try with any of these actionable steps:

Google disability insurance.
Email me at [email protected].
Read an article on a doctor-based blog.

The steps of applying for disability insurance

If you made it to the end of this article, you are a perfectionist and should go back and read Tip No. 1.

Reference

The Context of Things. “We live in a machine that is designed to get us to neglect what’s important about life,” 2021 Aug 24.

The reason to not put off the important things in life

Why get disability insurance at all?

Time to take action

Just start.

That’s my go-to for overcoming fear of failure. You won’t fail. You just won’t. You will learn!

Pretend you are curious about it and try with any of these actionable steps:

Google disability insurance.
Email me at [email protected].
Read an article on a doctor-based blog.

The steps of applying for disability insurance

If you made it to the end of this article, you are a perfectionist and should go back and read Tip No. 1.

Reference

The Context of Things. “We live in a machine that is designed to get us to neglect what’s important about life,” 2021 Aug 24.

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Repeat endoscopy for deliberate foreign body ingestions

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Wed, 06/22/2022 - 15:49

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Ariel Sims, MD

Vijaya L. Rao, MD

A 35-year-old female with a complex psychiatric history and polysubstance use presents to the emergency department following ingestion of three sewing needles. The patient has a long history of multiple suicide attempts and foreign-body ingestions requiring repeated endoscopy. Prior ingestions include, but are not limited to, razor blades, screws, toothbrushes, batteries, plastic cutlery, and shower curtain rings. The patient has had over 50 upper endoscopies within the past year in addition to a laryngoscopy and bronchoscopy for retrieval of foreign bodies. Despite intensive inpatient psychiatric treatment and outpatient behavioral therapy, the patient continues to present with recurrent ingestions, creating frustration among multiple health care providers. Are gastroenterologists obligated to perform repeated endoscopies for recurrent foreign-body ingestions? Is there a point at which it would be medically and ethically appropriate to defer endoscopy in this clinical scenario?

Deliberate foreign-body ingestion (DFBI) is a psychological disorder in which patients swallow nonnutritive objects. The disorder is commonly seen in young female patients with psychiatric disorders.¹ It is also associated with substance abuse, intellectual disabilities, and malingering (such as external motivation to avoid jail). Of those with psychiatric disorders, repeat ingestions are primarily seen in patients with borderline personality disorder (BPD) or part of a syndrome of self-mutilation or attention-seeking behavior.² Patients with BPD are thought to have atrophic changes in the brain causing neurocognitive dysfunction accounting for such behaviors.¹ Self-injurious behavior is also associated with a history of abandonment and childhood abuse.³ Studies show that 85% of patients evaluated for DFBI have a prior psychiatric diagnosis and 84% of these patients have a history of prior ingestions.⁴

Unfortunately, clinicians have a poor understanding of the psychopathology driving this behavior and treatment options are limited. Standard pharmacologic agents such as antipsychotics and mood stabilizers have demonstrated low efficacy. Similarly, cognitive-behavioral therapies provide little benefit.³ The refractory nature of this disease to current therapies causes the treatment to be focused around endoscopic and surgical removal. The vast majority of DFBI cases do not appear in the psychiatric literature, and instead are found in the gastroenterological and surgical literature.³ Although endoscopy is a low-risk procedure, we should thoughtfully consider the utility of repeated procedures in this patient population.

In this case, the patient’s needles were successfully removed endoscopically. The psychiatry service adjusted her medication regimen and conducted a prolonged behavioral therapy session focused on coping strategies and impulse control. The following morning, the patient managed to overpower her 24-hour 1:1 sitter to ingest a pen. Endoscopy was performed again, with successful removal of the pen.

Although intentional ingestions occur in a small subset of patients, DFBI utilizes significant hospital and fiscal resources. The startling economic impact of caring for these patients was demonstrated in a cost analysis at a large academic center in Rhode Island. It found 33 patients with repeated ingestions accounted for over 300 endoscopies in an 8-year period culminating in a total hospitalization cost of 2 million dollars per year.⁵ Another study estimated the average cost of a patient with DFBI per hospital visit to be $6,616 in the United States with an average length of stay of 5.6 days.⁶ The cost burden is largely caused by the repetitive nature of the clinical presentation and involvement of multiple disciplines, including emergency medicine, gastroenterology, anesthesia, psychiatry, social work, security services, and in some cases, otolaryngology, pulmonology, and surgery.

In addition to endoscopy, an inpatient admission for DFBI centers around preventing repeated ingestions. This entails constant observation by security or a sitter, limiting access to objects through restraints or room modifications, and psychiatry consultation for management of the underlying psychiatric disorder. Studies show this management approach rarely succeeds in preventing recurrent ingestions.6 Interestingly, data also shows inpatient psychiatric admission is not beneficial in preventing recurrent DFBI and can paradoxically increase the frequency of swallowing behavior in some patients.⁶ This patient failed multiple inpatient treatment programs and was noncompliant with outpatient therapies. Given the costly burden to the health care system and propensity of repeated behavior, should this patient continue to receive endoscopies? Would it ever be justifiable to forgo endoscopic retrieval?

One of the fundamental principles of medical ethics is beneficence, supporting the notion that all providers should act in the best interest of the patient. Adults may make poor or self-destructive choices, but that does not preclude our moral obligation to treat them. Patients with substance abuse disorders may repeatedly use emergency room services for acute intoxication and overdose treatment. An emergency department physician would not withhold Narcan from a patient simply because of the frequency of repeated overdoses. A similar rationale could be applied to patients with DFBI – they should undergo endoscopy if they are accepting of the risks/benefits of repeated procedures. Given that this patient’s repeated ingestions are suicide attempts, it could be argued that not removing the object would make a clinician complicit with a patient’s suicide attempt or intent of self-harm.

From an alternative vantage point, patients with repeated DFBI have an increased risk of complications with repeated endoscopy, especially when performed emergently. Patients may have an increased risk of aspiration because of insufficient preoperative fasting, and attempted removal of ingested needles and other sharp objects carries a high risk of penetrating trauma, bleeding, and perforation. The patient’s swallowing history predicts a high likelihood of repeat ingestion which, over time, makes subsequent endoscopies seem futile. Endoscopic treatment does not address the underlying problem and only serves as a temporary fix to bridge the patient to their next ingestion. Furthermore, the utilization of resources is substantial – namely, the repeated emergency use of anesthesia and operating room and endoscopy staff, as well as the psychiatry, surgical, internal medicine, and gastroenterology services. Inevitably, treatment of a patient such as this diverts limited health care resources away from other patients who may have equally or more pressing medical needs.

Despite the seemingly futile nature of these procedures and strain on resources, it would be difficult from a medicolegal perspective to justify withholding endoscopy. In 1986, the Emergency Medical Treatment and Labor Act was enacted that requires anyone presenting to an emergency department to be stabilized and treated.⁷ In this particular patient case, an ethics consultation was obtained and recommended that the patient continue to undergo endoscopy. However, the team also suggested that a multidisciplinary meeting with ethics, the primary and procedural teams, and the hospital’s medicolegal department be held to further elucidate a plan for future admissions and to decide if or when it may be appropriate to withhold invasive procedures. This case was presented at our weekly gastroenterology grand rounds, and procedural guidelines were reviewed. Given the size and nature of most of the objects the patient ingests, we reviewed that it would be safe in the majority of scenarios to wait until the morning for removal if called overnight – providing some relief to those on call while minimizing utilization of emergency anesthesia resources as well as operating room and endoscopy staff.

Caring for these patients is challenging as providers may feel frustrated and angry after repeated admissions. The patient may sense the low morale from providers and feel judged for their actions. It is theorized that this leads to repeated ingestions as a defense mechanism and a means of acting out.¹ Additionally, friction can develop between teams as there is a common perception that psychiatry is not “doing enough” to treat the psychiatric disorder to prevent recurrences.⁸

In conclusion, DFBIs occur in a small number of patients with psychiatric disorders, but account for a large utilization of health care recourses. Gastroenterologists have an ethical and legal obligation to provide treatment including repeat endoscopies as long as the therapeutic benefit of the procedure outweighs risks. A multidisciplinary approach with individualized care plans can help prevent recurrent hospitalizations and procedures which may, in turn, improve outcomes and reduce health care costs.¹ Until the patient and clinicians can successfully mitigate the psychiatric and social factors perpetuating repeated ingestions, gastroenterologists will continue to provide endoscopic management. Individual cases should be discussed with the hospital’s ethics and medicolegal teams for further guidance on deferring endoscopic treatment in cases of medically refractory psychological disease.

Dr. Sims is a gastroenterology fellow in the section of gastroenterology, hepatology, and nutrition, department of internal medicine, University of Chicago Medicine. Dr. Rao is assistant professor in the section of gastroenterology, hepatology, and nutrition, department of internal medicine, University of Chicago Medicine. They had no conflicts of interest to disclose.

References

1. Bangash F et al. Cureus. 2021 Feb;13(2):e13179. doi: 10.7759/cureus.13179

2. Palese C et al. Gastroenterol Hepatol (N Y). 2012 July;8(7):485-6

3. Gitlin GF et al. Psychosomatics, 2007 March;48(2):162-6. doi: 10.1176/appi.psy.48.2.162

4. Palta R et al. Gastrointest Endosc. 2009 March;69(3):426-33. doi: 10.1016/j.gie.2008.05.072

5. Huang BL et al. Clin Gastroenterol Hepatol. 2010 Nov;8(11):941-6. doi: 10.1016/j.cgh.2010.07.013

6. Poynter BA et al. Gen Hosp Psychiatry. 2011 Sep-Oct;33(5):518-24. doi: 10.1016/j.genhosppsych.2011.06.011

7. American College of Emergency Physicians, EMTALA Fact Sheet. https://www.acep.org/life-as-a-physician/ethics--legal/emtala/emtala-fact-sheet/

8. Grzenda A. Carlat Hosp Psych Report. 2021 Jan;1(1 ):5-9

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Experience with the AGA editorial fellowship for Gastroenterology

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Helenie Kefalakes, MD

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

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

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

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

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

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

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

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

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My time as an AGA editorial fellow for Clinical Gastroenterology and Hepatology

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Judy A. Trieu, MD, MPH

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

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

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

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

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

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

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Effect modification: An important, but often underappreciated, statistical concept

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Manol Jovani, MD

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

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

Difference between confounding and effect modification

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

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

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

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

Conclusion

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

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

References

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

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

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

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

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

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Endoscopic management of duodenal and ampullary adenomas

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Grace E. Kim, MD

Uzma D. Siddiqui, MD

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

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

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

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

Standard endoscopes with a distal cap are frequently used, although, depending on the location, different scopes may be used. For example, an ampullectomy requires a side-viewing duodenoscope, and distal lesions such as those in the third part of the duodenum may benefit from using a pediatric colonoscope. One of the most important parts of the initial exam is to clarify the relationship of the ampulla to the polyp; if this is difficult to ascertain, a side-viewer duodenoscope can be used to better identify the ampulla.

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

Figure 1: Duodenal adenomas before and after endoscopic mucosal resection (EMR).

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

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

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

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

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