ACG MAGAZINE | Vol. 1, No. 1 | Spring 2017

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Volume 1, Number 1

ACG MAGAZINE Members. Medicine. Meaning.

Striking

Gold gi.org/acgmagazine


GO BEYOND

the PAGES of AJG

Podcasts, Videos and Digital Issues! VOLUME 111 NUMB ER 1 JANUARY 2016 www.nature.com/ajg

AJG offers readers

official public ation of the american colleg e of gastroente rolog

LEADING ARTICLES

MORE THAN just their print subscription!

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OF THE MONTH

The Red Section : EndoTech Update

6

Just Clip It: Endosco pic Clipping in the 21st Century r

B. Joseph Elmunze

Practice Guidelines

30

ACG Clinical Guidelin e: Diagnosis and Management of Barrett’s Esophagus CME

N.J. Shaheen, G.W.

Falk, P.G. Iyer and

Clinical and System atic Reviews

53

L.B. Gerson

Diagnosis and Manage ment of Functional Heartburn Shaheen

C. Hachem and N.J.

CME

Endoscopy 63

Effect of Dynami c Position Changes on Adenoma Detectio Colonoscope Withdra n during wal: A Randomized Controlled Multice nter Trial J.-S. Ji

S.-W. Lee, J.H. Chang,

Liver 78

et al.

Diagnosis of Minima l Hepatic Enceph alopathy

EncephalApp: A Using Stroop Multice S. Allampati, A. Duarte-R nter US-Based, Norm-Based Study ojo, L.R. Thacker et al.

Functional GI Disorde rs

93

The Epidemiology of Irritable Bowel Syndrome in the Findings from the US Military: Millennium Cohort Study M.S. Riddle, M. Welsh,

Colon/Small Bowel

105

115

Open

A. Abhat et al.

Prevalence of Adult Celiac Disease in India: Regional Variation Associations s and

B.S. Ramakrishna,

Pediatrics 124

C.K. Porter et al.

Adherence to Compet ing Strategies for over 3 Years Colorectal Cancer Screening

P.S. Liang, C.L. Wheat,

G.K. Makharia, K.

Chetri et al.

A Prospective Study on Celiac Disease Diagnos the Usefulness of Duodenal Bulb Biopsies in is in Children: Urging J. Taavela, A. Popp, Caution I.R. Korpona y-Szabo et al.

FULL TABLE OF CONTE

NTS INSIDE

EDITORS: Brian E. Lacy, PHD, MD, FACG and Brenna n Spiegel, MD, MSHS, FACG

VIDEO OF THE MONTH • Watch fascinating findings and novel techniques in action nature.com/ajg/votm

PODCASTS

DIGITAL ISSUES

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gi.org/ajgpodcasts

• Free for member subscribers! • Fully linked and interactive gi.org/ajgdigital


Volume 1, Number 1

FEATURED CONTENTS

COVER STORY

STRIKING GOLD WITH KATHLEEN BAKER

Kathleen Baker splits the middle of the five-ringed Olympic symbol in the Olympic Village. Courtesy of Kathleen Baker.

Olympic medalist talks about her relationship with her doctor, being teammates with Michael Phelps, and the importance of her strong support system. Page 26

MESSAGE FROM THE PRESIDENT Dr. Carol Burke on the inaugural issue of ACG MAGAZINE. Page 6

CONVERSATIONS WITH WOMEN IN GI Dr. Jill Gaidos interviews Dr. Millie Long. Page 38

PRACTICAL ADVICE FROM A SEASONED CLINICIAN Dr. Seymour Katz offers some pointers for new gastroenterologists. Page 54

Vol. 1, No. 1

ACG MAGAZINE // 1


Call for Abstracts

World Congress of Gastroenterology 13–18, 2017 • Orlando, Florida at ACG2017 | October Orange County Convention Center

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SUBMIT YOUR ABSTRACTS for WCOG at ACG2017 in ORLANDO!

Don’t miss this opportunity to showcase your research alongside colleagues from the U.S. and abroad at the premier GI clinical event of the year. ACG and WGO invite abstracts from all physicians, including gastroenterologists, hepatologists, internists, surgeons, radiologists, pediatricians, and GI fellows for WCOG at ACG2017 at the Orange County Convention Center in Orlando, Florida.

Submission Deadline: MONDAY, JUNE 5, 2017 | 11:59 PM, EASTERN TIME For complete rules and to submit your abstract online, visit: www.conferenceabstracts.com/wcogacg2017.html 2 // ACG MAGAZINE

Vol. 1, No. 1


CONTENTS

Volume 1, Number 1

“I am gratified that I was an eyewitness to another of those seemingly innocuous events that has the potential to change the history of the world.” —Dr. Chobanian, "How A Navy Gastroenterologist Did His Part to Bring Down The Berlin Wall & End The Cold War," pg 32

6 // MESSAGE FROM THE PRESIDENT

22 ACGCRJ Author Insights

44 "FACG" and What It Means

Editor-in-Chief Dr. Mathew Chin's top picks.

7 // NOVEL & NOTEWORTHY

23 The Latest from CTG

Drs. Pawa and Schnoll-Sussman on what the College and FACG mean to them.

New GI Circles, member benefits, more.

Featured articles and new editors.

10 // ACG IN TOUCH

24 // ACG PERSPECTIVES

ACG physicians honored.

24 Visiting Professorships

15 // GOVERNORS' VANTAGE POINT

26 Striking Gold

DDNC Continued Collaboration ACG physicians elected to leadership roles.

16 // INSIDE THE JOURNALS 18 Clinical Guideline IBD Clinical Care Q&A with Dr. Francis Farraye.

Recapping trips around the country.

The story of Olympic swimmer Kathleen Baker, who has Crohn's Disease.

32 How A Navy Gastroenterologist Did His Part to Bring Down the Berlin Wall & End the Cold War Dr. Sarkis Chobanian recounts the courageous acts of Dr. Edward Cattau.

19 Clinical Guideline A "new normal" for ALT with Dr. Paul Kwo.

38 // COMMITTEES IN ACTION

20 Clinical Guideline

38 Conversations with Women in GI

Dr. William Chey on H. pylori.

Dr. Jill Gaidos interviews Dr. Millie Long.

Cover Photo: Kathleen Baker stood on the podium twice at the Rio 2016 Olympics. Photograph by Giorgio Scala/Deepbluemedia/Insidefoto.

46 ACG-FDA Fellowship Program Dr. Beck talks about her fellowship experiences.

48 Learning and Carrying Skills Forward International GI Training Grant recipient, Dr. Sendino Garcia, shares his experience.

51 // LAW MIND Non-Compete Agreements Ann Bittinger, JD, discusses the ins and outs of non-compete agreements.

54 // SAGE ADVICE Practical Advice from a Seasoned Clinician Dr. Seymour Katz's advice for the new GI.

58 // REACHING THE CECUM A Look Back Dr. Kravetz shares a GI relic from the past.

Photo Top: President Ronald Reagan giving a speech at the Berlin Wall, Brandenburg Gate, Federal Republic of Germany, June 12, 1987. Courtesy of the Ronald Reagan Library.

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ACG MAGAZINE ACG Executive Director Bradley C. Stillman, JD Editor in Chief Vice President, Communications Anne-Louise B. Oliphant Managing Editor Senior Writer Brian C. Davis Copy Editors/Staff Writers Jenny Dunnington Sarah Richman Martha Spath Lindsey Topp Vice President, Marketing Martha Spath

CONNECT WITH ACG youtube.com/ACGastroenterology facebook.com/AmCollegeGastro twitter.com/amcollegegastro instagram.com/amcollegegastro linkedin.com

DIGITAL/ONLINE EDITIONS GI.ORG/ACGMAGAZINE

Art Director/Graphic Designer Emily Garel Graphic Designer Antonella Iseas

IDEAS & FEEDBACK We'd love to hear from you. Send us your ideas, stories and comments. ACGMAG@GI.ORG

CONTACT ACG American College of Gastroenterology 6400 Goldsboro Rd., Suite 200 Bethesda, MD 20817 (301) 263-9000 | GI.ORG

BOARD OF TRUSTEES President: Carol A. Burke, MD, FACG | President-Elect: Irving M. Pike, MD, FACG | Vice President: Sunanda V. Kane, MD, MSPH, FACG Secretary: David A. Greenwald, MD, FACG | Treasurer: Mark B. Pochapin, MD, FACG | Immediate Past President: Kenneth R. Devault, MD, FACG Past President: Stephen B. Hanauer, MD, FACG | Director, ACG Institute: Nicholas J. Shaheen, MD, MPH, FACG Co-Editors, The American Journal of Gastroenterology: Brian E. Lacy, MD, PhD, FACG & Brennan M. R. Spiegel, MD, MSHS, FACG Chair, Board of Governors: Costas H. Kefalas, MD, MMM, FACG | Vice Chair, Board of Governors: Douglas G. Adler, MD, FACG Trustee for Administrative Affairs: Delbert L. Chumley, MD, FACG TRUSTEES William D. Chey, MD, FACG | Lauren B. Gerson, MD, MSc, FACG | Caroll D. Koscheski, MD, FACG | Paul Y. Kwo, MD, FACG Jonathan A. Leighton, MD, FACG | Daniel J. Pambianco, MD, FACG | David T. Rubin, MD, FACG | John R. Saltzman, MD, FACG Samir A. Shah, MD, FACG | Scott M. Tenner, MD, MPH, JD, FACG

AMERICAN COLLEGE OF GASTROENTEROLOGY is an international organization with more than 14,000 physician members representing some 85 countries. The College's vision is to be the pre-eminent professional organization that champions the evolving needs of clinicians in the delivery of high-quality, evidence-based and compassionate health care to gastroenterology patients. The mission of the College is to advance world-class care for patients with gastrointestinal disorders through excellence, innovation and advocacy in the areas of scientific investigation, education, prevention and treatment.

4 // ACG MAGAZINE

Vol. 1, No. 1


CONTRIBUTING WRITERS Ann M. Bittinger, JD

Oriol Sendino Garcia, MD, PhD

Ms. Bittinger is health law expert at Bittinger Law Firm in Jacksonville, FL. She is a regular contributor of articles to ACG publications on her areas of expertise, including legal relationships between hospital systems and physicians or physician groups (bittingerlaw.com).

Dr. Sendino Garcia practices gastroenterology at the Hospital Clinic of Barcelona, Spain. He pursued additional training in interventional endoscopy at California Pacific Medical Center thanks to ACG’s International Training Grant.

Kendall R. Beck, MD

Seymour Katz, MD, MACG

A third-year GI fellow at the University of California, San Francisco, Dr. Beck attended University of Texas Medical School at Houston and completed her residency at UCSF. She recently completed a one-month rotation through ACG’s joint Visiting Fellowship Program with the U.S. Food and Drug Administration.

Dr. Katz has been a practicing gastroenterologist since 1971 and a member of the College since 1977. He served as ACG President from 1995 to 1996. He is affiliated with North Shore-Long Island Jewish Medical Center and NYU Langone Medical Center.

Costas H. Kefalas, MD, MMM, FACG William D. Chey, MD, FACG A Professor of Internal Medicine and Director of the GI Physiology Laboratory at the University of Michigan, Dr. Chey served for six years as Co-Editor-in-Chief of The American Journal of Gastroenterology and is currently an ACG Trustee.

Matthew A. Chin, MD Dr. Chin is a third-year GI fellow-in-training at the University of California, Irvine in Orange, CA. Dr. Chin received his MD at University of California, San Diego. He completed his internal medicine residency at Santa Clara Valley Medical Center. This year, Dr. Chin is the Editor-in-Chief of the ACG Case Reports Journal (acgcasereports.gi.org).

Sarkis J. Chobanian, MD, MACG A graduate of the University of Pittsburgh School of Medicine, Dr. Chobanian did his internship, residency, chief residency and fellowship in GI all at the National Naval Medical Center in Bethesda, MD. Dr. Chobanian attained the rank of Commander in the U.S. Navy Medical Corps. He was ACG President from 1997 to 1998 and practices GI in Knoxville, TN.

Dr. Kefalas serves as Chair of the ACG Board of Governors and practices with Akron Digestive Disease Consultants. He is affiliated with Summa Health System in Akron, OH.

Robert E. Kravetz, MD, MACG Dr. Kravetz is passionate about the history of medicine and the history of the College. He is Past Chair, ACG Archives Committee, and was instrumental in the publication of the ACG 75th Anniversary history in 2007. Read ACG’s History here: gi.org/about-acg/#Anniversary

Paul Y. Kwo, MD, FACG Dr. Kwo is an ACG Trustee and Professor of Medicine at The Stanford University Medical Center where he is Medical Director, Hepatology. He is a Co-Chair of the ACG Hepatology Circle, an online professional networking platform (acg-hepatology-circle.within3.com).

Swati Pawa, MD, FACG Dr. Pawa is Director, Interventional Endoscopy, and Associate Professor of Medicine, Robert Wood Johnson University Hospital. She is a member of the ACG Women in GI Committee.

Francis A. Farraye, MD, MSc, FACG Dr. Frank Farraye is Co-Director, Center for Digestive Disorders and Professor of Medicine, Boston University School of Medicine, Boston, MA. Dr. Farraye served as Vice Chair and Chair of the ACG Board of Governors from 2004 to 2008. He was an ACG Trustee from 2008 to 2014.

Felice H. Schnoll-Sussman, MD, FACG Dr. Schnoll-Sussman is Director of The Jay Monahan Center for Gastrointestinal Health and Associate Attending Physician at the New York-Presbyterian Hospital/Weill Cornell Medical Center in New York City, NY. She serves as the ACG Governor for Manhattan.

Jill Gaidos, MD, FACG Dr. Gaidos chairs the ACG Women in GI Committee and is a gastroenterologist at the Hunter Holmes McGuire VA Medical Center in Richmond, VA, where she is Director of Inflammatory Bowel Disease and the Director of the GI Clinics.

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ACG MAGAZINE // 5


Message from the

PRESIDENT

Inaugural Issue of

ACG MAGAZINE Dear Colleagues: Welcome to ACG MAGAZINE. It is a great privilege to introduce the inaugural issue of our newly imagined membership publication. ACG MAGAZINE is an entirely new print offering that aims to extend the mission and goals of the American College of Gastroenterology by strengthening your connection to the College and to your GI colleagues. One of the things I have always most valued and enjoyed about my association with ACG over the years is the true spirit of collegiality and connection. ACG MAGAZINE aims to capture that spirit. The new tagline—Members. Medicine. Meaning.—reflects ACG’s vision and the publication’s emphasis on stories that bring to life the best of the College, and the best of our profession.

The new tagline— Members. Medicine. Meaning.— reflects ACG’s vision and the publication’s emphasis on stories that bring to life the best of the College, and the best of our profession.

6 // ACG MAGAZINE

In the pages of ACG MAGAZINE are feature stories that shed light on the experience of GI practice through ACG members sharing their voices and experiences. It provides opportunities to showcase the many facets of our members’ lives beyond our profession with personal reflections and insights, such as the heartfelt advice written by ACG Past President Dr. Seymour Katz, “Practical Advice from a Seasoned Clinician.” ACG MAGAZINE will be the focus for longer articles, like the profile of Olympic swimmer Kathleen Baker, who has Crohn’s disease, and an interview with her gastroenterologist, Dr. Michael Kappelman. The magazine is also an ideal forum to celebrate the professional accomplishments and contributions of our members in the “ACG In Touch” section, which we modeled on alumni publications. Send us your news! We hope to share impactful stories of deeper historical and personal significance, such as ACG Past President Dr. Sarkis Chobanian’s historical overview of the role ACG physician Dr. Edward Cattau played in diagnosing U.S. President Ronald Reagan’s colon cancer. Sarkis goes beyond the facts of the case—remarkable as they are—to illustrate Ed’s character and commitment as a physician and to put the events of the Reagan era in the context of larger geopolitical forces. It’s a fascinating story with important consequences for our nation. In this issue, I want to recognize the leadership of The American Journal of Gastroenterology Co-Editors-in-Chief Dr. Brian Lacy and Dr. Brennan Spiegel and the excellence of AJG. Since the

beginning of 2017, the Red Journal has published three new ACG clinical guidelines, and highlights from their authors are featured in this issue of ACG MAGAZINE: Dr. William Chey shares insights on the new ACG H. pylori guideline; Dr. Frank Farraye overviews key aspects of the College’s new guideline on preventive care for inflammatory bowel disease patients; and Dr. Paul Kwo explains how ACG’s new liver chemistries guideline defines a “new normal” for serum ALT. Our re-design of ACG MAGAZINE is not just a facelift for the old ACG Update newsletter, but a complete change in the character of the publication. We honor the role that ACG Update played in the life of the College, but recognize that a newsletter every other month was no longer the best way to meet ACG members’ needs for timely news and critical details from the College. ACG’s many programs and offerings will find a place in the pages of ACG MAGAZINE, but critical, deadline-driven news will make its way to your inbox. Breaking news and key details about College courses, programs, grants and deadlines can best and most reliably be shared electronically via email and through the ACG website (gi.org), the ACG educational meetings site (meetings.gi.org) and the ACG Blog (acgblog.org). Hopefully, all of you receive the weekly “Blog Blast” in your inbox with weekly videos from the ACG Education Universe, features from our journals, and College news. If you don’t receive this e-newsletter, be sure to check your spam filter to make sure messages from info@gi.org get through your email security firewalls. In the era of web-based communications, with the ascendance of 140-character tweets and the accelerated news cycle all vying for our attention against the backdrop of mounting clinical responsibilities and the vagaries of EMRs, as physicians we all encounter greater digital overload. As an antidote, the College is proud to be able to put ink on paper and present the new ACG MAGAZINE. Let me know what you think of ACG MAGAZINE. I welcome your feedback and observations. I am eager to hear from you with ideas for stories, news of your professional accomplishments, and your personal interests and passions, as well as those of your colleagues. Please share your suggestions for feature stories which illustrate the diverse talents and interests of our members. Send your ideas and feedback to ACGMag@gi.org. Best wishes,

Carol A. Burke, MD, FACG @burkegastrodoc  Vol. 1, No. 1


N owtoerthy What’s new at ACG and in the larger GI community? This section is a showcase for some of the latest developments in clinical gastroenterology as well as new programs and offerings benefitting ACG members.

As the new ACG MAGAZINE evolves, your insights and suggestions will help shape Novel & Noteworthy and ensure that GI “news of note” reaches your colleagues. Send your news, professional achievements and suggestions for feature stories via email to ACGMag@gi.org.

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WOMEN IN GI: THE FOCUS OF A NEW ACG CIRCLE Women in GI is the focus of a new online community where ACG members can collaborate, gain expert insight, and expand their knowledge and awareness of caring for women with GI disorders, as well as discuss issues related to being a woman with a career in Gastroenterology.

ACG’S NEW FUNCTIONAL GI HEALTH & NUTRITION CIRCLE A new online forum dedicated to functional gastrointestinal health and nutrition joins ACG’s other online professional networking Circles dedicated to inflammatory bowel disease and hepatitis. The ACG Functional GI Health and Nutrition Circle offers ACG members a private, secure platform for clinical discussion and professional exchange. Led by co-chairs Eamonn M. M. Quigley, MD, FACG, and Lawrence R. Schiller, MD, FACG, along with a panel of expert moderators, the ACG Functional GI Health and Nutrition Circle is designed as a trusted online platform for professional collaboration and support— as well as a valuable resource to help ACG members deliver quality patient care. Community members can share insights and increase their knowledge and awareness of key issues related to functional GI health conditions, the important role of diet and nutrition in GI health and disease, as well as other important topics related to functional GI disorders, including patient evaluation, treatment decisions and other clinical challenges. If you have never explored these online communities before, request an invitation and register to access the new Functional GI Health & Nutrition Circle, as well as ACG’s other online communities.

Jill Gaidos, MD, FACG, and Colleen R. Kelly, MD, FACG, serve as Co-Chairs of an outstanding expert panel which hopes to spark meaningful discussions and answer your most pressing questions. Whether you have questions about a challenging clinical case, need advice regarding a promotion or negotiating for a raise, or want insight about contract negotiations or selecting a practice, we invite you to reach out to our panel at any time by posting your question in this new community. Members are also encouraged to start and comment on discussions with their colleagues and share their unique insights and experiences. This new community will also serve as a hub for links to the latest research on disorders more commonly seen in female patients, offer treatment recommendations for difficult clinical cases, and provide resources to support women in GI, both in their careers and outside of work. If you have never explored these online communities before, request an invitation and register to access the new Women in GI community, as well as ACG’s other online communities.

ACCESS THE ACG GI CIRCLES ONLINE COMMUNITY AND JOIN THE DISCUSSION acg-gi-circle.within3.com QUESTIONS? Email support@within3.com

8 // ACG MAGAZINE

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NEW MEMBER BENEFITS OFFER SECURITY, PEACE OF MIND— PLANNING FOR YOUR BEST FUTURE Wealth Management Strategies The College is excited to announce the launch of new ACG Member Benefits in 2017. We recognize the ever-changing needs of members and we are constantly striving to bring you value as a member of the College—not only in the areas of clinical research, education and practice management, but in all areas that affect your practice and your lives. The College has partnered with Wealth Management Strategies to identify, design, and secure unique benefits for ACG members in the areas of retirement, planning, investments and insurance. These benefits have been designed and negotiated specifically for ACG members.

Whether you are planning for a comfortable retirement or against unexpected risks, the important thing is to plan. The path to successful planning, however, is not always easy. To help navigate your path and facilitate your efforts, the College is proud to offer a suite of options to help you prepare. ACG, with the help of Wealth Management Strategies, has negotiated these new member benefits to offer security and peace of mind for you and your family’s future. • High-Limit Disability Insurance with special ACG pricing • Physicians Life Income Plan: Retirement accumulation supplement • Company Retirement Platform with specific ACG pricing • Personal Financial Management Portal: Robust online financial management tool • Personal and Business Planning

Learn more about these new member opportunities: gi.org

Wealth Management Strategies is a full service private wealth management firm, working primarily with business owners, physicians, and high net worth families on insurance strategies, wealth accumulation and protection, and estate planning.

Vol. 1, No. 1

ABSTATS: A WEARABLE BIOSENSOR FOR THE GUT An unmet need in gastroenterology is the ability to non-invasively monitor intestinal motility and digestion. AbStats is an FDA-cleared, wearable biosensor that non-invasively measures intestinal activity. “It's like a real-time gut speedometer,” said Brennan M. R. Spiegel, MD, MSHS, FACG, who developed the technology with colleagues at UCLA and who now directs Health Services Research at Cedars-Sinai in Los Angeles. The AbStats sensor is disposable, about the size of a large coin, lays on the external abdominal wall either with Tegaderm (for inpatients) or with a reusable belt (for outpatients), and has a small microphone inside that dutifully listens to bowel sounds and vibrations. INTESTINAL RATINGS 0–1 per minute indicates ileus 2–5 is a normal fasting state 6–20 generally indicates inter-digestive state >20 is typically recorded during active digestion A specialized computer analyzes the results and presents a value called the "intestinal rate” (IR), which is like a new vital sign for the gut. The IR is measured in intestinal events per minute, and correlates with GI status. For example, a prolonged IR of 0–1 per minute indicates ileus, 2–5 is a normal fasting state, 6–20 generally indicates inter-digestive state, and >20 is typically recorded during active digestion. Published research shows that AbStats can predict which postoperative patients are likely to develop ileus. Current research is testing whether AbStats users will alter ingestion behavior using smartphone-based guidance about when it is an appropriate time to eat (in the “green zone” gut speedometer reading) versus when eating is premature (a “red zone” reading.) LEARN MORE ABOUT ABSTATS: GI-LOGIC.COM @BrennanSpiegel 

ACG MAGAZINE // 9


Renee L. Williams, MD, FACG Renee L. Williams, MD, FACG, was one of four honorees of the second annual J. Christopher Burch Award for Humanism in Medicine at the Division of Gastroenterology at NYU Langone Medical Center.

Philip O. Katz, MD, FACG

The award, which was established by entrepreneur Christopher Burch, recognizes extraordinary practices of humanism in medicine, and intends to promote and recognize “empathy, compassion, and caring among the entire healthcare team.” In presenting the award and reflecting on the honorees, Director of the Division of Gastroenterology at NYU Langone and ACG Treasurer Mark B. Pochapin, MD, FACG, said, “They truly are the best of us—and the best of medicine.”

In December 2016, Medscape recognized Philip O. Katz, MD, FACG, of Einstein Medical Center Philadelphia, as one of its best “Physicians of the Year 2016.” Medscape summarized the moving story Dr. Katz shared in delivering the David Y. Graham Lecture at the 2016 ACG Annual Scientific Meeting in Las Vegas.

“They truly are the best of us—and the best of medicine.” —Mark B. Pochapin, MD, FACG Glenn M. Eisen, MD, MPH, FACG, FASGE Dr. Glenn Eisen, of the Oregon Clinic— West in Portland, OR, is now Chair of the Board of Directors and President of the GI Quality Improvement Consortium, Ltd. (GIQuIC). Dr. Eisen has been a member of the GIQuIC Board for seven years and assumes the role held by Irving M. Pike, MD, FACG, since 2009. Dr. Pike is ACG’s President-Elect.

Dr. Eisen commented: “I am very excited about taking on a new role for GIQuIC. Dr. Irving Pike has done a tremendous job in the creation and development of this leading GI endoscopy registry. He has served as President of GIQuIC since its inception in 2009. The registry has grown by leaps and bounds and now includes data from over 500 facilities that represent more than 4,000 practicing endoscopists.”

On his goals for the audience, Dr. Katz said, “Understand and communicate in the best way you can with your patients. Validate their feelings and validate their illness. Be with them. Be empathetic if you can.” Near the end of the lecture, Dr. Katz said, in short, “We can’t change what we do, for the most part, but we can change how we do it.” @katzpo  WATCH AND LISTEN to Dr. Katz’s David Y. Graham lecture: goo.gl/Zb8IbP READ the Medscape summary: goo.gl/hDh4Tg

The GI Quality Improvement Consortium, Ltd. is an educational and scientific 501(c)(3) organization established by gastroenterologists. GIQuIC is a joint initiative of the American College of Gastroenterology and the American Society for Gastrointestinal Endoscopy.

Learn More about GIQuIC: GIQUIC.ORG 10 // ACG MAGAZINE

Vol. 1, No. 1

Page 10: Dr. Williams speaks to students at Las Vegas’ Rancho High School about careers in medicine and science during ACG2016.

During his talk, “David Y. Graham Lecture 2016—A View From the Other Side of the Bed: Lessons Learned,” Dr. Katz recounted what he learned during the eight-month recovery following his cardiac arrest on October 4, 2013, including how the patient experience in hospitals can be enhanced.


“Understand and communicate in the best way you can with your patients. Validate their feelings and validate their illness. Be with them. Be empathetic if you can.” —Philip O. Katz, MD, FACG

Page 11: Dr. Katz gives the David Y. Graham Lecture at the 2016 ACG Annual Scientific Meeting.

Farzana R. Hossain, MD Farzana R. Hossain, MD, Assistant Professor of Clinical Medicine at the University of Pennsylvania Perelman School of Medicine, was one of 26 women recognized as “Women of Distinction” by the Philadelphia Business Journal in November 2016. The Business Journal annually selects a class of influential businesswomen in the Philadelphia region. “We were looking for women from every industry and profession, women

who are making a difference in their communities and blazing a trail for the rest of us,” the Business Journal advises on its website. Dr. Hossain told the Business Journal that having the chance to be considered a Woman of Distinction “signifies the dedication and tireless efforts we all make for betterment, and allows me the opportunity to express gratitude to my community, my colleagues, my patients, and the change agents before me that I am committed to representing well.” @fr_hossain  WATCH Dr. Hossain’s interview with the Philadelphia Business Journal: goo.gl/1sUjud

 SEND NEWS ITEMS regarding exciting professional news, accomplishments or honors to be considered for a future ACG In Touch: ACGMag@gi.org

Being considered a Woman of Distinction “signifies the dedication and tireless efforts we all make for betterment, and allows me the opportunity to express gratitude to my community, my colleagues, my patients, and the change agents before me that I am committed to representing well.” —Farzana R. Hossain, MD

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ACG MAGAZINE // 11


Attend an

ACG Regional Postgraduate Course

close to where you work and live

2017/2018 ACG Regional Postgraduate Course Calendar 2017 IBD School and ACG Midwest Regional Postgraduate Course August 25–27, 2017 Hilton at the Ballpark St. Louis, MO

2017 ACG/VGS/ODSGNA Regional Postgraduate Course September 9–10, 2017 Williamsburg Lodge Williamsburg, VA

2017 IBD School and ACG Southern Regional Postgraduate Course December 1–3, 2017 Omni Nashville Hotel Nashville, TN

2018 IBD School and ACG Governors/ASGE Best Practices Course January 26–28, 2018 Caesars Palace Las Vegas, NV

For more info, visit: gi.org/regional-meetings


1 MOST PRESCRIBED, BRANDED BOWEL PREP KIT1 #

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FIVE-STAR EFF1CACY ® WITH SUPREP Distinctive results in all colon segments >90% no residual stool in all colon segments compared to Standard 4-Liter Prep2*†‡ • These results were statistically significant in the cecum (P=.010)2*§ • Significantly more patients in the SUPREP group had no residual fluid in 4 out of 5 colon segments2*‡ Help meet the Gastroenterology Quality Improvement Consortium (GIQuIC) benchmark for 85% quality cleansing3 with the split-dose efficacy of SUPREP Bowel Prep Kit.4 *This clinical trial was not included in the product labeling. †Standard 4-Liter Prep [sulfate-free polyethylene glycol (PEG) electrolyte lavage solution]. ‡Based on investigator grading. §Statistically significant difference. References: 1. IMS Health, NPA Weekly, July 2016. 2. Rex DK, Di Palma JA, Rodriguez R, McGowan J, Cleveland M. A randomized clinical study comparing reducedvolume oral sulfate solution with standard 4-liter sulfate-free electrolyte lavage solution as preparation for colonoscopy. Gastrointest Endosc. 2010;72(2):328-336. 3. Rex DK, Schoenfeld PS, Cohen J, et al. Quality indicators for colonoscopy. Gastrointest Endosc. 2015;81(1):31-53. 4. SUPREP Bowel Prep Kit [package insert]. Braintree, MA: Braintree Laboratories, Inc; 2012.

©2016 Braintree Laboratories, Inc. All rights reserved.

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August 2016


IMPORTANT SAFETY INFORMATION SUPREP® Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Solution is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults. Most common adverse reactions (>2%) are overall discomfort, abdominal distention, abdominal pain, nausea, vomiting and headache. Use is contraindicated in the following conditions: gastrointestinal (GI) obstruction, bowel perforation, toxic colitis and toxic megacolon, gastric retention, ileus, known allergies to components of the kit. Use caution when prescribing for patients with a history of seizures, arrhythmias, impaired gag reflex, regurgitation or aspiration, severe active ulcerative colitis, impaired renal function or patients taking medications that may affect renal function or electrolytes. Use can cause temporary elevations in uric acid. Uric acid fluctuations in patients with gout may precipitate an acute flare. Administration of osmotic laxative products may produce mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Patients with impaired water handling who experience severe vomiting should be closely monitored including measurement of electrolytes. Advise all patients to hydrate adequately before, during, and after use. Each bottle must be diluted with water to a final volume of 16 ounces and ingestion of additional water as recommended is important to patient tolerance.

BRIEF SUMMARY: Before prescribing, please see full Prescribing Information and Medication Guide for SUPREP® Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Solution. INDICATIONS AND USAGE: An osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults. CONTRAINDICATIONS: Use is contraindicated in the following conditions: gastrointestinal (GI) obstruction, bowel perforation, toxic colitis and toxic megacolon, gastric retention, ileus, known allergies to components of the kit. WARNINGS AND PRECAUTIONS: SUPREP Bowel Prep Kit is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults. Use is contraindicated in the following conditions: gastrointestinal (GI) obstruction, bowel perforation, toxic colitis and toxic megacolon, gastric retention, ileus, known allergies to components of the kit. Use caution when prescribing for patients with a history of seizures, arrhythmias, impaired gag reflex, regurgitation or aspiration, severe active ulcerative colitis, impaired renal function or patients taking medications that may affect renal function or electrolytes. Pre-dose and post-colonoscopy ECG’s should be considered in patients at increased risk of serious cardiac arrhythmias. Use can cause temporary elevations in uric acid. Uric acid fluctuations in patients with gout may precipitate an acute flare. Administration of osmotic laxative products may produce mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Patients with impaired water handling who experience severe vomiting should be closely monitored including measurement of electrolytes. Advise all patients to hydrate adequately before, during, and after use. Each bottle must be diluted with water to a final volume of 16 ounces and ingestion of additional water as recommended is important to patient tolerance. Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted. It is not known whether this product can cause fetal harm or can affect reproductive capacity. Pediatric Use: Safety and effectiveness in pediatric patients has not been established. Geriatric Use: Of the 375 patients who took SUPREP Bowel Prep Kit in clinical trials, 94 (25%) were 65 years of age or older, while 25 (7%) were 75 years of age or older. No overall differences in safety or effectiveness of SUPREP Bowel Prep Kit administered as a split-dose (2-day) regimen were observed between geriatric patients and younger patients. DRUG INTERACTIONS: Oral medication administered within one hour of the start of administration of SUPREP may not be absorbed completely. ADVERSE REACTIONS: Most common adverse reactions (>2%) are overall discomfort, abdominal distention, abdominal pain, nausea, vomiting and headache. Oral Administration: Split-Dose (Two-Day) Regimen: Early in the evening prior to the colonoscopy: Pour the contents of one bottle of SUPREP Bowel Prep Kit into the mixing container provided. Fill the container with water to the 16 ounce fill line, and drink the entire amount. Drink two additional containers filled to the 16 ounce line with water over the next hour. Consume only a light breakfast or have only clear liquids on the day before colonoscopy. Day of Colonoscopy (10 to 12 hours after the evening dose): Pour the contents of the second SUPREP Bowel Prep Kit into the mixing container provided. Fill the container with water to the 16 ounce fill line, and drink the entire amount. Drink two additional containers filled to the 16 ounce line with water over the next hour. Complete all SUPREP Bowel Prep Kit and required water at least two hours prior to colonoscopy. Consume only clear liquids until after the colonoscopy. STORAGE: Store at 20°-25°C (68°-77°F). Excursions permitted between 15°-30°C (59°-86°F). Rx only. Distributed by Braintree Laboratories, Inc. Braintree, MA 02185.

For additional information, please call 1-800-874-6756 or visit www.suprepkit.com

©2016 Braintree Laboratories, Inc. All rights reserved.

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GOVERNORS’ VANTAGE POINT

ACG and the

DIGESTIVE DISEASE NATIONAL COALITION A Tradition of Collaboration and Support Costas H. Kefalas, MD, MMM, FACG, Chair, ACG Board of Governors and Immediate Past President, DDNC

THE DIGESTIVE DISEASE NATIONAL COALITION (DDNC), an umbrella organization comprised of more than 50 professional societies including the ACG, patient advocacy organizations, and industry members met in Washington, DC on December 4–5, 2016, for the annual Winter Board Meeting and Fall Forum.

ACG Physicians Elected to Leadership Roles at DDNC Winter Board Meeting At the DDNC Winter Board Meeting, ACG member Ralph D. McKibbin, MD, FACG, was elected DDNC President for 2016–2018. ACG Governor for Louisiana and Louisiana Gastroenterology Society Representative to the DDNC, James C. Hobley, MD, FACG, was elected DDNC Vice-President for 2016–2018. The Chair of the ACG Board of Governors and ACG Representative to the DDNC, Costas H. Kefalas, MD, MMM, FACG, completed his term as DDNC President and is now the DDNC Immediate Past President. Also participating in the Board meeting was ACG Trustee and ACG Representative to the DDNC, Samir A. Shah, MD, FACG. Dr. Shah is the current Co-Chair of the DDNC Public Policy Committee and has been instrumental in drafting the 2017 DDNC Legislative Policy Agenda, which includes ACG legislative priorities. This year’s Fall Forum included a presentation from Heidi Marchand, Pharm.D., Assistant Commissioner of the Office of Health and Constituent

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Affairs at the U.S. Food and Drug Administration, who presented, “Development of Treatments for Patients with Digestive Diseases.” Other presenters included Kelsei Wharton, the Associate Director of Intergovernmental and External Affairs at the U.S. Department of Health and Human Services, who presented, “Health Insurance Coverage, The Current Open Enrollment Period and Patient Access Issues Going into the New Year” and Madeleine Pannell, Health Legislative Aide, Senate Committee on Health, Education, Labor, and Pensions, who presented, “Health Legislation Forecast for the 115th Congress.”

DDNC’s Advocacy Mission Founded in 1978, the DDNC is an advocacy organization whose mission is “to work cooperatively to improve access to and the quality of digestive disease health care in order to promote

the best possible medical outcome and quality of life for current and future patients with digestive diseases.” Since the early years of the DDNC, ACG has played an important role in supporting the DDNC mission. There is strength in diversity and numbers: When DDNC representatives advocate on Capitol Hill each March, usually in teams consisting of physicians, nurses, representatives from industry, and most importantly, patients with GI diseases, a highly impactful message is conveyed to legislators and health-related federal agencies. The DDNC is grateful for ACG’s steadfast support and looks forward to ongoing collaboration with the College, to advance common legislative priorities and initiatives on behalf of our patients.

In March, the DDNC presented an award to U.S. Senator Bill Cassidy (R-LA), a gastroenterologist. L to R: Dr. Samir Shah, Dr. James De Gerome, Dr. Bryan Green, Senator Bill Cassidy, Dr. Ralph McKibbin, Dr. Jay Yepuri, Dr. Costas Kefalas, and Dr. Maurice Cerulli.

ACG MAGAZINE // 15


16 // ACG MAGAZINE

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Inside the

JOURNALS Since the beginning of 2017, the College has published three important new clinical guidelines in The American Journal of Gastroenterology (AJG) on preventive care for IBD patients, liver chemistries, and managing H. pylori. ACG MAGAZINE invited authors Francis A. Farraye, MD, FACG, Paul Y. Kwo, MD, FACG, and William D. Chey, MD, FACG, to share insights and clinical pearls from these new guidelines. The Red Journal’s strong offering of guidelines is a testament to the productivity of the ACG Practice Parameters Committee under the leadership of current Chair Joseph Ahn, MD, MS, FACG, and Past Chair Lauren B. Gerson, MD, MSc, FACG, as well as the guidance of AJG Co-Editors-in-Chief Brian E. Lacy, MD, PhD, FACG, and Brennan M.R. Spiegel, MD, MSHS, FACG. The College continually commissions new recommendations in critical areas of GI and liver disease, and updates existing guidelines in areas where the landscape has changed. All of the College’s guidelines can be accessed in full text via the ACG website gi.org/guidelines The notable growth in the College's online open-access journal, Clinical and Translational Gastroenterology, edited by David C. Whitcomb, MD, PhD, FACG, means that this sister publication to AJG has many new articles to explore. Visit nature.com/ctg to learn more. The ACG Case Reports Journal is an open-access journal edited exclusively by GI fellows-in-training with Matthew A. Chin, MD, as Editor-in-Chief. Published by the College, this open-access, peer-reviewed journal is freely available online and provides an important outlet for the GI community to share interesting and enlightening cases. Visit acgcasereports.gi.org to review recent cases and consider a submission.

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ACG MAGAZINE // 17


// ACG CLINICAL GUIDELINE //

Preventive Care in IBD

Francis A. Farraye, MD, MSc, FACG, Boston Medical Center, Boston, MA

Q & A with

DR. FARRAYE

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Why is the time right for a Preventive Care in IBD Guideline, and what do practicing GI clinicians need to know? The use of immunomodulators and biologic agents have led to dramatic improvements in the lives of our patients with ulcerative colitis and Crohn’s disease. We are using these agents more frequently and at earlier stages, often in combination in a subset of patients with severe disease or adverse prognostic factors. In the last three years, two new biologic agents have been released and several small molecules are anticipated to be available for use in our patients in the coming years. Corticosteroids remain an important treatment option for acutely ill patients or as a bridge to response to immunomodulators and biologics. Rarely, patients develop infectious or neoplastic complications on these medications or as a consequence of their underlying disease. As we embrace the use of immunomodulators and biologics agents, every effort must be made to identify and prevent adverse events related to treatment. Gil Y. Melmed, MD, MS, FACG, Gary R. Lichtenstein, MD, FACG, Sunanda V. Kane, MD, MSPH, FACG, and I believe that the Preventive Care in Inflammatory Bowel Disease (IBD) Guideline published in The American Journal of Gastroenterology will be a practical resource for gastroenterologists that reviews the importance and timing of administration of vaccinations for their patients. There are several important vaccination points to remember: • IBD patients have low immunization rates. • IBD disease activity will not be affected by vaccination. • Ideally, vaccinations should be administered on diagnosis of IBD and prior to initiation of immunosuppressive agents. • IBD patients can mount a response to vaccines though immunogenicity is diminished in patients on combination therapy of immunomodulator and anti-TNFa agents. • Inactive vaccines can be administered to all IBD patients regardless of the medications they are taking. • Live vaccines are contraindicated in immunosuppressed patients with certain exceptions.

In this guideline, we also review important issues such as screening for cervical cancer, melanoma and non-melanoma skin cancer, osteoporosis, depression and anxiety, as well as the importance of encouraging smoking cessation in our patients with Crohn’s disease. Checklists Consider implementing simple office measures to improve vaccination rates in clinical practice. Here are several useful checklists:

• ACG IBD Vaccination Guide for Patients developed by Sophie M. Balzora, MD, FACG, is available on the ACG website: goo.gl/qhwD6p • The Crohn's & Colitis Foundation offers a Health Maintenance Checklist for IBD Patients: goo.gl/QVW0yY In the introduction, you and your co-authors identify the importance of “co-management” of these preventive strategies with primary care providers (PCPs). How can GI physicians best collaborate with primary care colleagues in managing IBD patients? To improve the care delivered to IBD patients, health maintenance issues need to be co-managed by the gastroenterologist, primary care team and certain specialists. Gastroenterologists need to explicitly inform the PCP of the unique needs of their IBD patients, especially those on immunomodulators and biologics. Use your EMR to advise the PCP on timing and type of vaccinations needed. Gastroenterologists managing IBD patients should have a relationship with dermatology and gynecology given the increased risk of developing cervical cancer, melanoma and non-melanoma skin cancer in certain patients with IBD. Identification of osteoporosis should prompt a referral to the PCP or an endocrinologist for treatment. Finally, efforts to identify anxiety and depression in our patients and refer them either to the PCP or a behavioral health provider for treatment typically leads to better overall outcomes. Access the full guideline and corresponding podcast  Guideline: goo.gl/b5yhPS  Podcast: gi.org/podcasts/farraye Vol. 1, No. 1


“NEW NORMAL”

By Paul Y. Kwo, MD, FACG

for SERUM ALT Levels Paul Y. Kwo, MD, FACG, Stanford University School of Medicine, Palo Alto, CA

A new ACG Clinical Guideline, "Evaluation of Abnormal Liver Chemistries," offers the first recommendations in more than 10 years on the evaluation of abnormal liver chemistries. For the first time in a liver test guideline, we define a normal healthy serum alanine aminotransferase (ALT) level for women and men—up to 25 IU/L for women, up to 33 IU/L for men—and recommend that levels above this should be assessed by physicians. This guideline, which was jointly authored by Stanley M. Cohen, MD, FACG, of Case Western Reserve University School of Medicine, Joseph K. Lim, MD, FACG, of Yale University School of Medicine, and me, provides a framework for physicians to approach the very common problem encountered of a patient whose liver chemistries are abnormal. Defining a “New Normal” for ALT In the guideline, we write, “For the purposes of this guideline, we have opted to define a ‘normal’ ALT based on the available literature correlating ALT levels and liver-related mortality. However, clinical judgment still remains of paramount importance.” This decision was based on the emerging data over the past decade demonstrating that ALT levels

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above our defined thresholds are associated with higher liver-related mortality rates across a broad range of populations worldwide, including populations from the United States, Europe and Asia, which is driven in part by the obesity epidemic. With the broad range of “upper limit of normal” levels for ALT that vary from institution to institution, clinicians may not think to evaluate an ALT level of 70 IU/L—as this may be within the normal level for the reporting laboratory—even though this level of elevation is associated with increased liver-related mortality. This is particularly relevant as there remain large pools of individuals who have yet to be diagnosed with chronic hepatitis B and C, nonalcoholic fatty liver disease (NAFLD), advanced liver disease, as well as less-common conditions, all of whom will require evaluation. In particular, the rise in the prevalence of NAFLD worldwide will be addressed in part by identifying and evaluating these individuals prior to the development of advanced fibrosis. The guideline takes clinicians through a step-wise approach to the evaluation of elevated aminotransferase (ALT and AST), alkaline phosphatase, and bilirubin levels including appropriate historical questions, important physical examination findings, laboratory, radiological evaluation, and finally liver biopsy if required. New Algorithms Help Clinicians Categorize Elevated ALT Levels To help clinicians proceed with evaluation of elevated

aminotransferase levels, we have devised algorithms that allow a graded approach to those with elevated aminotransferase elevations by categorizing these elevations as minimal, mild, moderate and severe, as well as giving specific guidelines as to when immediate evaluation is required and when a more limited evaluation can be performed with subsequent evaluation, if liver chemistries fail to normalize. We recognize that it will take time for clinicians to recognize the newer lower limits of ALT levels that should now be considered normal. In addition, the new guideline includes algorithms to evaluate abnormalities in alkaline phosphatase and bilirubin levels to help clinicians efficiently evaluate these abnormalities, including suggested serologic and radiologic evaluations, as well as when liver biopsy should be considered. We hope the guideline will help clinicians efficiently approach the patients who present with abnormal liver chemistries. We look forward to feedback that will help us refine future guidelines.

Access the full guideline and corresponding podcast  Guideline: goo.gl/fF2y8y  Podcast: gi.org/podcasts/kwo

ACG MAGAZINE // 19


// ACG CLINICAL GUIDELINE

Treatment of

HELICOBACTER PYLORI Infection What the Clinician Needs to Know By William D. Chey, MD, FACG William D. Chey, MD, FACG, University of Michigan, Ann Arbor, MI

Helicobacter pylori infection remains one of the most common chronic bacterial infections affecting humans. This guideline provides clinicians working in North America, defined for the purposes of this document as the United States and Canada, with updated treatment recommendations for H. pylori infection. This guideline was developed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system,1 which provides a level of evidence and strength of recommendation for statements developed using the patient population, intervention or indicator assessed, comparison group, outcome achieved (PICO) format. For the sake of brevity, we only provide selected key points from the guideline in this summary. Readers are directed to the full text of the guideline for the complete set of recommendations. Access the guideline at goo.gl/LmfZ0z. What are the indications to test for, and to treat, H. pylori infection? All patients with active peptic ulcer disease (PUD), a past history of PUD (unless previous cure of H. pylori infection has been documented), low-grade gastric mucosa-associated lymphoid tissue (MALT) lymphoma, or a history of endoscopic resection of early gastric cancer (EGC) should be tested for H. pylori infection. Those who test positive should be offered treatment for the infection (Strong recommendation;

20 // ACG MAGAZINE

quality of evidence: high for active or history of PUD, low for MALT lymphoma, low for history of endoscopic resection of EGC). In patients with uninvestigated dyspepsia who are under the age of 60 years and without alarm features, non-endoscopic testing for H. pylori infection is a consideration. Those who test positive should be offered eradication therapy (Conditional recommendation; quality of evidence: high for efficacy, low for the age threshold). When upper endoscopy is undertaken in patients with dyspepsia, gastric biopsies should be taken to evaluate for H. pylori infection. Infected patients should be offered eradication therapy (Strong recommendation; high quality of evidence). Patients with typical symptoms of gastroesophageal reflux disease (GERD) who do not have a history of PUD need not be tested for H. pylori infection. However, for those who are tested and found to be infected, treatment should be offered, acknowledging that effects on GERD symptoms are unpredictable (Strong recommendation; high quality of evidence). In patients taking long-term, low-dose aspirin, testing for H. pylori infection could be considered to reduce the risk of ulcer bleeding. Those who test positive should be offered eradication therapy to reduce the risk of ulcer bleeding (Conditional recommendation; moderate quality of evidence). Patients initiating chronic treatment with a non-steroidal anti-inflammatory drug (NSAID) should be tested for H. pylori infection. Those who test positive should be offered eradication therapy (Strong recommendation; moderate

quality of evidence). The benefit of testing and treating H. pylori in a patient already taking an NSAID remains unclear (Conditional recommendation; low quality of evidence). Patients with unexplained iron deficiency anemia despite an appropriate evaluation should be tested for H. pylori infection. Those who test positive should be offered eradication therapy (Conditional recommendation; low quality of evidence). Adults with idiopathic thrombocytopenic purpura should be tested for H. pylori infection. Those who test positive should be offered eradication therapy (Conditional recommendation; very low quality of evidence). What are evidence-based, first-line treatment strategies for providers in North America? Patients should be asked about any previous antibiotic exposure(s), and this information should be taken into consideration when choosing an H. pylori treatment regimen. (Conditional recommendation; moderate quality of evidence). Clarithromycin triple therapy consisting of a PPI, clarithromycin and amoxicillin or metronidazole for 14 days remains a recommended treatment in regions where H. pylori clarithromycin resistance is known to be <15% and in patients with no previous history of macrolide exposure for any reason (Conditional recommendation; low quality of evidence (For duration: moderate quality of evidence)). Bismuth quadruple therapy consisting of a PPI, bismuth, tetracycline and a nitroimidazole for 10 to 14 days is a recommended first-line treatment option.

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Figure 1. Selection of a first-line H. pylori treatment regimen.

Figure 1. Selection of a first-line H. pylori treatment regimen. KEY QUESTIONS: 1. Is there a penicillin (PCN) allergy?

KEY QUESTIONS:

2. Previous macrolide (MCL) exposure 1. Is there a penicillin (PCN) allergy? for any reason?

2. Previous macrolide (MCL) exposure for any reason? PCN allergy: No MCL exposure: No

PCN allergy: No MCL exposure: No Recommended treatments:

Bismuth quadruple CONCOMITANT Clarithromycin triple With amoxicillin Other options: Sequential HYBRID Levofloxacin triple Levofloxacin sequential LOAD?

PCN allergy: No Recommended MCL exposure: Yes* treatments:

PCN allergy: Yes MCL exposure: No

PCN allergy: No MCL exposure: Yes*

PCN allergy: Yes Recommended MCL exposure: No treatments:

PCN allergy: Yes MCL exposure: Yes*

PCN allergy: Yes Recommended Recommended MCL exposure: Yes* treatments: treatments:

Bismuth quadruple Bismuth quadruple Bismuth quadruple Clarithromycin Recommended Recommended LevofloxacinRecommended triple CONCOMITANT triple with metronidazole treatments: Levofloxacin sequential Clarithromycintreatments: triple Bismuth quadrupletreatments: Bismuth quadruple Bismuth quadruple Clarithromycin With amoxicillin Other triple options: Levofloxacin triple with metronidazole therapy? OtherLevofloxacin options: sequential Concomitant Bismuth quadruple Sequential therapy? Sequential Hybrid therapy? HYBRID Other options: LOAD? Levofloxacin triple Concomitant therapy? Levofloxacin Sequential therapy? sequential Hybrid therapy? LOAD?

LOAD?

*In regions where clarithromycin resistance is known to be >15% utilize recommendations for patients

with a history of macrolide exposure For drugs, doses, and durations of specific first-line regimens, see Table 2.

*In regions where clarithromycin resistance is known to be >15% utilize recommendations for patients

with a history of macrolide exposure For drugs, doses, and durations of specific first-line regimens, see Table 2.

Bismuth quadruple therapy is particularly attractive in patients with any previous macrolide exposure or who are allergic to penicillin (Strong recommendation; low quality of evidence). Concomitant therapy consisting of a PPI, clarithromycin, amoxicillin and a nitroimidazole for seven to 14 days is a recommended first-line treatment option. (Strong recommendation; low quality of evidence (For duration: very low quality of evidence)). Sequential therapy consisting of a PPI and amoxicillin for five to seven days followed by a PPI, clarithromycin, and a nitroimidazole for five to seven days; hybrid therapy consisting of a PPI and amoxicillin for seven days followed by a PPI, amoxicillin, clarithromycin and a nitroimidazole for seven days; Levofloxacin triple therapy consisting of a PPI, levofloxacin and amoxicillin for 10 to 14 days; Fluoroquinolone sequential therapy consisting of a PPI and amoxicillin for five to seven days followed by a PPI, fluoroquinolone and nitroimidazole for five to seven days are other, less enthusiastically suggested

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first-line treatment options (Conditional recommendation; low quality of evidence). A list of the recommended and suggested regimens can be found in a table in the full guideline text: goo.gl/LmfZ0z. Figure 1 provides a schema by which to choose between the available treatment regimens.

When first-line therapy fails, what are the options for salvage therapy? In patients with persistent H. pylori infection, every effort should be made to avoid antibiotics that have been previously taken by the patient. (Strong recommendation; moderate quality of evidence). Selection of best salvage regimen should be directed by local antimicrobial resistance data and the patient’s previous exposure to antibiotics. Bismuth quadruple therapy or levofloxacin salvage regimens are the preferred treatment options if a patient received a first-line treatment containing clarithromycin. (Conditional recommendation; for quality of evidence, see full guideline).

containing salvage regimens are the preferred treatment options if a patient received first-line bismuth quadruple therapy. (Conditional recommendation; for quality of evidence, see full guideline). The regimens mentioned above and several others are listed in a table in the full guideline text. 1 Guyatt GH, Oxman AD, Vist GE, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008;336:924-6. 2 Chey WD, Leontiadis GI, Howden CW, Moss SF. ACG Clinical Guideline: Treatment of Helicobacter pylori infection. Am J Gastroenterol, 2017, in press. See goo.gl/LmfZ0z.

Access the full guideline, including a list of recommended and suggested treatment regiments, and corresponding podcast  Guideline: goo.gl/CHBxrW  Podcast: gi.org/podcasts/chey3

Clarithromycin or levofloxacin

ACG MAGAZINE // 21


// AUTHOR INSIGHT

2016 Editor’s Picks from the

ACG Case Reports Journal By Matthew A. Chin, MD

Matthew A. Chin, MD, University of California, Irvine, Orange, CA

An essential part of being a physician is the understanding that medical education is a lifelong, ongoing journey. The ACG Case Reports Journal provides a unique opportunity to learn and grow through the esoteric and enlightening cases submitted by our authors. My time as part of the editorial team for the Journal has been a humbling, exciting and enjoyable experience. Through this experience, I have learned the value of an open-minded approach to patient care and grown an appreciation for the depth and breadth of gastroenterology. While there are many elements that come together to make an excellent case report, several examples over the past year stood out in an intriguing and interesting fashion.

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Ulcerative Colitis in Colonic Interposition for Esophageal Atresia

Hafiz Muhammad Sharjeel Arshad, MD, Eula Tetangco, MD, and Imad Elkhatib, MD, FACG ACG Case Rep J 2016;3(4):e149.

This report by Arshad et al. describes a usual diagnosis in a highly surprising location in a patient with a complex surgical history, ultimately concluding with a message about the importance of fully exploring a differential diagnosis.  Read the case report: goo.gl/7KQ7fZ

A Game of ColoMonopoly

Laparoscopic Appearance of Peritoneal Tuberculosis

Moaz Sial, MD, Mohammad Bilal, MD, and Patrick Perri, MD ACG Case Rep J 2016;3(4):e117.

Although it is the gold standard for the diagnosis of peritoneal tuberculosis, laparoscopy with peritoneal biopsy often is only considered after all other less-invasive and significantly less-sensitive diagnostic modalities have been exhausted. In this report, Sial et al. provide jarring visuals which serve to focus the reader on the usefulness of this sometimesunderutilized procedure.  Read the case report: goo.gl/zEIjA6

Rahman Nakshabendi, MD, Ozdemir Kanar, MD, Nicholas Agresti, MD, and Andrew C. Berry, DO ACG Case Rep J 2016;3(4):e88.

While there is no shortage of foreign body ingestions represented in the literature, a creative title and compelling images can engage the reader's imagination and highlight the lighter side of gastroenterology.  Read the case report: goo.gl/39mZGH

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The Latest from

Clinical & Translational Gastroenterology Each issue of ACG MAGAZINE will feature select articles, sections or themes from Clinical and Translational Gastroenterology. In this issue, we highlight two articles published early in 2017. The first article digs into areas of controversy in endoscopic polyp resection: difficulties in, and possible alternatives to, optical resect-and-discard strategy; Polyp Resection - Controversial Practices the use of cold snare resection for certain polyps; von Renteln and Pohl and prophylactic clipping after resection of large polyps. In the second Polyp Resection - Controversial Practices 5 in IBS and IBD. Polyp Polyp Resection Resection - Controversial - -Controversial Practices Practices article, the authors review the psychological treatments with the strongest evidence base Polyp Resection Controversial Practices von Renteln and Pohl Polyp Resection - Controversial Practices von von Renteln Renteln and and PohlPohl Renteln Pohl vonvon Renteln andand Pohl

5

5 55 5

Polyp Resection­­­—Controversial Practices and Unanswered Questions

Daniel von Renteln and Heiko Pohl Clinical and Translational Gastroenterology (2017) 8, e76; doi:10.1038/ctg.2017.6 Published online 9 March 2017

Featured CTG Articles

Psychological Interventions for Irritable Bowel Syndrome and Inflammatory Bowel Diseases

Sarah Ballou and Laurie Keefer Clinical and Translational Gastroenterology (2017) 8, e214; doi:10.1038/ctg.2016.69 Published Treatments online 19 January Psychological for2017 IBS and IBD: A Review

Ballou and Keefer  Read these and all CTG articles: nature.com/ctg

2

Figure 3 EMR of a 40 mm lateral spreading granular type colon polyp (a–c). Treatment of the boarders with APC to prevent recurrence (d) and clip closure of the mucosal defect after resection (e,f). Figure Figure 3 3 EMREMR of a of 40amm 40 mm lateral lateral spreading spreading granular granular typetype colon colon polyppolyp (a–c). (a–c). Treatment Treatment of theofofboarders the boarders with with APC APC to prevent totoprevent recurrence recurrence (d) and (d) and clip closure clip closure of theofof mucosal the mucosal Figure EMR mmlateral lateral spreading granular type colon polyp (a–c). Treatment boarders with APC prevent recurrence closure mucosal Figure 3 3 EMR ofofa a4040mm spreading granular type colon polyp (a–c). Treatment of thethe boarders with APC to prevent recurrence (d)(d) andand clipclip closure of thethe mucosal defect defect afterafter resection resection (e,f).(e,f). defect after resection (e,f). defect after resection (e,f).

further hinder adoption into clinical practice. Alternative Health System strategies include a simplified resect-and-discard strategy or Charlottesville, VA deferring removal of diminutive polyps until they grow to higher-risk polyps. New strategies need to be studied, particularly with a focus on trade-offs of safety compared to cost-savings.

interest.

New Associate Editors to CTG

Figure 3 (combination EMR of a 40 mmoflateral spreading granularDelayed type colonbleeding polyp (a–c).occurred Treatment of the boarders APCde-emphasize to prevent recurrence and clip closureofof the mucosal EMR and ESD). As wewith may the(d)importance removing (combination of EMR of EMR and and ESD). ESD). Delayed Delayed bleeding occurred occurred As As we we may may de-emphasize de-emphasize thethe importance importance of of removing removing defect after resection (e,f). polyps, our effort should have a renewed on less(combination frequently after clip closure compared tobleeding no clipping (combination EMR and ESD). Delayed bleeding occurreddiminutive may de-emphasize the importance removing (combination ofofEMR and ESD). Delayed bleeding occurred AsAswewe may de-emphasize the importance of offocus removing diminutive diminutive polyps, polyps, our our effort effort should should have have aarenewed focus focus on onon less frequently frequently after after clipclip closure closure compared compared to no to no clipping clipping detection and complete resection ofa renewed higher-risk polyps. (1 less vs.less 7%). However, the study included smaller polyps, diminutive polyps, our effort should have renewed focus less frequently after clip closure compared noclipping clippingthe diminutive polyps, our effort should have a renewed focus on frequently after clip closure compared totono the the detection detection and and complete complete resection resection of higher-risk of higher-risk polyps. polyps. (1 (1 vs. vs. 7%). 7%). However, However, the the study study included included smaller smaller polyps, polyps, snare resection may be atresection least as safe and effective as allowed different resection techniques, observed the detection andcomplete complete resection higher-risk polyps. vs.7%). 7%).endoscopic However,David thestudy study includedsmaller smaller polyps,Cold the detection and of ofhigher-risk polyps. (1(1vs. However, the included polyps, J. Levinthal, MD, PhD Cold Cold snare snare resection resection may may be be at least at least as safe as safe and and effective effective as as allowed allowed different different endoscopic endoscopic resection resection techniques, techniques, observed observed snare resection formay polyps to 10 mm in size. Future a higher thandifferent expected rate of complications in the control (combination of EMR and ESD). Delayed bleeding occurred Ashot we may de-emphasize the importance ofand removing Cold snare resection may be at least safe effective allowed different endoscopic resection techniques, observed Cold snare resection be atup least asas safe and effective asas allowed endoscopic resection techniques, observed 67 hothot snare snare resection resection for for polyps polyps up up to 10 to mm 10be mm inencouraged size. in size. Future Future a higher a higher than than expected expected rate rate of complications of complications in the in the control control University Pittsburgh comparative effectiveness studies should to group, used an unclear definition of bleeding hotsnare snareresection resection polypsup upto to 10 mm size. Future higher than expected rateofofcomplications complications inthe thecontrol control hot forfor polyps 10renewed mm in in size. Future aaand higher than expected rate inevents. diminutive polyps, our effort should have a focus on less frequently after clip closure compared toof no clipping 67 67 comparative comparative effectiveness effectiveness studies studies should should be be encouraged encouraged to to group, group, and and used used anare an unclear unclear definition definition bleeding of bleeding events. events.6767define bestand practice. The resection larger the polyp higher the Therefore, the results not sufficient to of inform current EMR comparative effectiveness studies should be encouraged comparative effectiveness studies should bethe encouraged to to group, and used unclear definition bleeding events. group, and used ananunclear definition ofofbleeding events. the detection complete of higher-risk polyps. (1 vs. 7%). However, the study included smaller polyps, Medical Center define define best best practice. practice. 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Results ofthis ongoing Additional studies are under way and willishopefully provide a for all non-pedunculated all practice. non-pedunculated 20 ≥ mm 20 mm polyps. polyps. Results Results of ongoing of ongoing Additional Additional studies studies are under under way way andand willcurrent will hopefully hopefully provide provide adefine a for best The ≥larger the polyp the higher the Therefore, the results are notare sufficient toway inform EMR forforallallnon-pedunculated ≥ 20 mm polyps. Results of of ongoing non-pedunculated ≥ 20 mm polyps. Results ongoing Additional studies are under and hopefully provide Additional studies arethe under way andwill will hopefully providea astudies are awaited to to understand if this this approach is more definitive answer in near future. AtAt present stage, studies studies are are awaited awaited to understand understand if if this approach approach is more more definitive definitive answer answer in the in the near near future. future. present At present stage, stage, risk justified. forstudies complications. Although clippingif of theapproach mucosalisisis practice. however, are totounderstand studies areawaited awaited understand ifthis this approach more definitive answer ininthe AtAtpresent stage, more definitive answer thenear nearfuture. future. present stage, there is no adequate evidence totosupport prophyjustified. however, however, there is no is no adequate adequate evidence evidence support to support prophyprophydefectjustified. after resection seems to be increasingly performed, Despitelactic the lack ofthere good several observational justified. justified. however, there isevidence, evidence totosupport however, there isno noadequate adequate evidence supportprophyprophyuse of clips after EMR. lactic lactic useuse of clips of clips after after EMR. EMR. there is currently insufficient evidence to support this practice studies indicated closure is increasingly applied. lactic use after lacticthat useofclip ofclips clips afterEMR. EMR. OF INTEREST Andrew W. Tai, MD, aPhD for allCONFLICT CONFLICT CONFLICT OFOF INTEREST INTEREST non-pedunculated ≥ 20 mm polyps. Results of ongoing Additional studies are under way and will hopefully provide CONFLICT CONFLICTOF OFINTEREST INTEREST SUMMARY Guarantor of the article: Daniel von Renteln, MD. studies are awaited toarticle: understand if Renteln, this MD. approach is SUMMARY SUMMARY more definitive answer in the nearUniversity future. At present stage, Guarantor Guarantor of the of the article: Daniel Daniel von von Renteln, MD. of Michigan SUMMARY SUMMARY Guarantor ofof the article: Daniel von Renteln, MD. Guarantor the article: Daniel von Renteln, MD. 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While While we spent spent most most of ourour time time andand Heiko Pohl: drafting and revision of of thethe manuscript. Daniel von Heiko Pohl: drafting and revision manuscript. Daniel von CRC screening. While we spent most time CRCon screening. While we spentof mostofofour ourpolyps, timeand andRenteln and Heiko Pohl have approved the final draft Renteln Renteln andand Heiko Pohl Pohl have have approved approved the the final final draft draft resources theon detection and removal resources resources on the the detection detection and and removal removal ofdiminutive diminutive of diminutive polyps, polyps, Renteln Heiko Pohl have approved thethe final draft Renteln and Heiko Pohl have approved final draft CONFLICT OFand INTEREST resources on detection and ofofdiminutive polyps, resources onthe the detection andremoval removal diminutive polyps, submitted. submitted. submitted. it isitunclear that this effort is worthwhile. 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Financial support: None. von Renteln, MD. and-discard and-discardstrategy strategyisisananapproach approachtotoshift shiftthis thisbalance. balance.Potential Potential Potential competing competing interests: interests: Heiko Heiko Pohl Pohl is a consultant for competing interests: Heiko Pohl isais aconsultant consultant However, However, training, training, monitoring, monitoring, auditing auditing requirements, requirements, chalchalHowever, training, monitoring, auditing requirements, chalSpecific author contributions: Daniel von Renteln and forfor Potential competing interests: Heiko Pohl is is a consultant forfor Potential competing interests: Heiko Pohl a consultant Adequate polyp management ismonitoring, key for effective endoscopic However, training, auditing requirements, However, training, monitoring, auditing requirements,chalchal-Interscope, Interscope, Interscope, Inc, Daniel Daniel von von Renteln Renteln isisais a consultant for for Boston Boston Inc, Daniel von Renteln aconsultant consultant for Boston lenges lenges implementation, in implementation, andthe and theadded the added added complexity complexity may may lenges in in implementation, and complexity may Interscope, Inc, Daniel von Renteln is is a consultant forfor Boston Heiko Pohl: drafting and revision ofRenteln the manuscript. Daniel von Interscope, Inc, Daniel von a consultant Boston lenges ininimplementation, and the added complexity may CRC screening. While we spent most time and lenges implementation, andof theour added complexity mayScientific. Scientific. Scientific. The remaining remaining authors authors declare declare no no conflict conflict of of The remaining authors declare no conflict of further further hinder hinder adoption adoption intointo clinical clinical practice. practice. Alternative Alternative further hinder adoption into clinical practice. Alternative Scientific. The remaining declare nono conflict of of Scientific. The remaining authors declare conflict Renteln and Heiko Pohl have authors approved the final draft further hinder adoption into clinical Alternative further hinder into clinical practice. practice. Alternative resources onstrategies the detection and ofresect-and-discard diminutive polyps, interest. interest. strategies include include aadoption simplified aremoval simplified resect-and-discard strategy strategy or interest. strategies include a simplified resect-and-discard strategy ororsubmitted. interest. strategies include a asimplified resect-and-discard strategy oror interest. strategies include simplified resect-and-discard strategy it is unclear that this effort is worthwhile. The proposed resectdeferring deferring removal removal of of diminutive diminutive polyps polyps until until they they grow grow to to deferring removal of diminutive polyps untiluntil theythey grow toFinancial deferring removal ofofdiminutive polyps grow toto support: None. deferringispolyps. removal diminutive polyps until grow and-discard strategy an approach to shift this Andrew Y. Wang, MD, FACG higher-risk higher-risk polyps. New New strategies strategies need need to to bethey be studied, studied, higher-risk polyps. New strategies need tobalance. be studied, .. The . The findings, findings, statements, statements, and and views views expressed expressed areare are Acknowledgments Acknowledgments higher-risk polyps. New strategies need to be The findings, statements, and views expressed Acknowledgments higher-risk polyps. New strategies need to bestudied, studied, competing interests: Heiko Pohl is consultant for . The findings, statements, anda views expressed are Acknowledgments . The findings, statements, views expressed Acknowledgments particularly particularly with with a focus a focus on on trade-offs trade-offs ofsafety safety of safety compared compared toPotential to those However,particularly training, monitoring, auditing requirements, chalthose of the ofauthors authors the authors and and do not do necessarily not necessarily represent represent those those ofofand the of Commission, the Commission, thethetheare with a focus on trade-offs of compared to of the and do not necessarily represent those Commission, particularly with a afocus onontrade-offs ofof safety compared totothose those ofInc, thethe authors and do not necessarily represent those ofthe the Commission, thethe particularly with focus trade-offs safety compared University of Virginia those of authors and do not necessarily represent those of the Commission, Interscope, Daniel von Renteln is a consultant for Boston Department Department of Veterans Veterans of Veterans Affairs Affairs or or United the United States States Government. Government. cost-savings. cost-savings. and the added complexity may lenges incost-savings. implementation, Department of Affairs or the the United States Government. Department of of Veterans Affairs or the United States Government. cost-savings. Department Veterans Affairs or the United States cost-savings. Scientific. The remaining authors declare noGovernment. conflict of Clinical Clinical and and Translational Translational Gastroenterology Gastroenterology Clinical and Translational Gastroenterology Clinical andand Translational Gastroenterology Clinical Translational Gastroenterology

Acknowledgments. The findings, statements, and views expressed are those of the authors and do not necessarily represent those of the Commission, the Department of Veterans Affairs or the United States Government.

Figure 1 Cognitive behavioral model. Clinical and Translational Gastroenterology

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and emotions is the primary focus of treatment. Patients build

In rand to be effe standard have foun bowel sy and that t into longused med CBT affec has a dire on psycho being dev behaviors which ma without co

IBD. The the effica cognitive coping w and addr depressio protocol cognitive


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VISITING PROFESSORSHIP The ACG Edgar Achkar

Providing Noteworthy Speakers for Training in Your Communities

SUNANDA V. KANE, MD, MSPH, FACG presented at Howard University in Washington, DC, September 19–20, 2016. Howard, which runs the only GI fellowship program at an Historically Black College or University, requested Dr. Kane for her IBD expertise. Howard alums congregated with faculty and fellows at an informal dinner, which included Charles Howell, MD, Chair of the Department of Medicine, Victor Scott, MD, GI Training Director, Adeyinka Laiyemo, MD, MPH, Kenneth Brown, MD, FACG, Chief of Gastroenterology at Providence Hospital in DC, and Kathy Bull-Henry, MD, FACG, ACG Governor for DC.

SATISH S.C. RAO, MD, PHD, FACG visited the University of Miami Miller School of Medicine, September 26–27. Requested for his motility expertise, Dr. Rao was welcomed by Maria T. Abreu, MD, FACG, Director of the Crohn’s and Colitis Center, Chief of Gastroenterology, David Kerman, MD, Gastroenterology Fellowship Program Director, and Baharak Moshiree, MD, MSCI. Over the course of his trip, Dr. Rao interacted with community gastroenterologists, faculty, fellows, nurses and techs. His lecture was attended by colorectal surgeons, medical students, research coordinators, residents, fellows and many faculty. Dr. Rao described the interactions with the fellows as robust and fun, and the overall opportunity as an inspirational learning experience.

Dr. Kane counted this visit as one of the most fulfilling of her career. She was touched by the expressions of gratitude from Howard—a thank you card and a special hand-carved ladle from Africa.

Pages 24–25, L to R, Sunanda V. Kane, MD, MSPH, FACG, and colleagues during her visiting professorship in Washington, DC. Satish S.C. Rao, MD, PhD, FACG, Maria T. Abreu, MD, FACG, and Baharak Moshiree, MD, MSCI, take a group photo. Kenneth E. Fasanella, MD, presents Charles N. Bernstein, MD, FACG, with the EAVP certificate. Nicholas J. Shaheen, MD, MPH, FACG, poses for a photo during his visit.

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NICHOLAS J. SHAHEEN, MD, MPH, FACG Director, ACG Institute, traveled to Pennsylvania State Milton S. Hershey Medical Center on November 2, 2016, to serve as a Visiting Professor. Dr. Shaheen was requested for his expertise on esophageal disorders, and was welcomed by Kofi Clarke, MD, Division Chief, Karen Krok, MD, and Thomas McGarrity, MD, FACG.

Dr. Shaheen met with faculty, fellows and local GI physicians during his visit. The fellows were "engaged, inquisitive and quick to grab concepts," Dr. Shaheen said. "There was also a great vibe," described Dr. Shaheen, who noted one of the nicest relationships he can remember seeing between local practitioners and an academic institution.

2017 ACG EDGAR ACHKAR VISITING PROFESSORSHIPS The ACG Institute for Clinical Research and Education, and Director Nicholas J. Shaheen MD, MPH, FACG, are pleased to present the selected 2017 ACG Edgar Achkar Visiting Professorships: FEBRUARY 2–3 Christine M. Surawicz, MD, MACG Saint Louis University, presenting on C. diff. APRIL 20–21 Carol A. Burke, MD, FACG Houston Methodist Hospital, presenting on colon cancer screening, genetics of colon cancer, and hereditary polyp syndromes. APRIL 25–26 Brian E. Lacy, MD, PhD, FACG University of Oklahoma, presenting on IBS and motility. APRIL 26 Lauren B. Gerson, MD, MSc, FACG Advocate Lutheran General Hospital, presenting on diverticular disease, colonoscopy quality, GI bleeding, and refractory GERD.

“Dr. Bernstein’s expertise stimulated and crystallized new, creative clinical and research opportunities for our faculty members and GI fellows.” —Robert E. Schoen, MD, MPH, Professor of Medicine and Epidemiology, Interim Chief, Division of Gastroenterology, Hepatology and Nutrition, University of Pittsburgh Medical Center

CHARLES N. BERNSTEIN, MD, FACG visited the University of Pittsburgh School of Medicine, November 2–3, 2016, at the request of Robert (Rocky) E. Schoen, MD, MPH. Throughout the course of Dr. Bernstein’s visit, IBD research, cases, and lessons from global variations were discussed. Dr. Bernstein discussed career development and engaged with fellows and faculty in one-on-one meetings. “Dr. Bernstein's visit was educational, enlightening and inspirational,”

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said Benjamin Click, MD, a secondyear GI fellow. “He offered sage career, clinical and research wisdom and advice to the fellows. We are extremely grateful for his visit.” Dr. Bernstein participated in IBD LIVE, held at UPMC Presbyterian and moderated by Miguel D. Regueiro, MD, FACG. This is an accredited, interactive, IBD case-based, weekly video conference held among more than 14 East Coast medical centers.

MAY 22–23 Maria T. Abreu, MD, FACG Augusta University Medical College of Georgia, presenting on IBD. JULY 18 David T. Rubin, MD, FACG The Ohio State University Wexner Medical Center, presenting on IBD. AUGUST 16 Stephen B. Hanauer, MD, FACG University of Virginia, presenting on IBD. SEPTEMBER 13–14 Nicholas J. Shaheen, MD, MPH, FACG California Pacific Medical Center, presenting on refractory GERD and complicated GERD patients (ablation). DECEMBER 5–6 Miguel D. Regueiro, MD, FACG UT Southwestern Medical Center, presenting on IBD. Aasma Shaukat, MD, MPH, FACG Northwestern University, presenting on colon cancer. Andrew Y. Wang, MD, FACG University of Michigan, presenting on endoscopic submucosal dissection.

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Striking

GOLD GOL

OLYMPIC SWIMMER KATHLEEN BAKER, WHO HAS CROHN’S DISEASE By Brian C. Davis ACG SPOKE WITH OLYMPIC SWIMMER KATHLEEN BAKER LAST AUGUST, less than two weeks after a gold medal was draped around her neck at the Rio 2016 Olympics. Returning from Rio, she’d only had five days to spend at home in Winston-Salem, NC, before heading back to school at the University of California, Berkeley, where she was beginning her sophomore year. Baker talked about her relationship with her gastroenterologist, Dr. Michael Kappelman, her Olympic experience, and what it was like being teammates with Michael Phelps.

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W

When she is coming down the stretch of a race, stroke for stroke with an opponent, Olympic swimmer Kathleen Baker is mostly on her own in deciding her fate. When she is not in the pool, however, the 20-year-old is bolstered by a tremendous support group—one that has helped her manage her Crohn’s disease since she was diagnosed seven years ago. Doctors and nurses play an obviously important role in this group. Growing up, it was important to Baker that they recognize her as a swimmer and for her swimming goals. She found that support in her doctor, pediatric gastroenterologist Michael Kappelman, MD, MPH, and his colleagues at the University of North Carolina at Chapel Hill (UNC).

“It mattered what else I do in life. It didn’t matter if I wanted to be a gymnast, or if I wanted to go horseback riding,” Baker said. “They were going to treat me so I could be able to do whatever I wanted to do in life, and be successful in whatever I wanted to do in life.” What Baker wanted to do was to reach the Olympics. “I’ve been saying I wanted to go to the Olympics since I was probably like eight years old. I mean, it’s every little kid’s dream that starts swimming. Like every single person,” Baker said. Limiting the Impact Crohn’s disease is a chronic disease that can cause inflammation anywhere along the lining of the digestive tract, although it most commonly affects the small intestine and the colon.1 An estimated 780,000 Americans may be affected by Crohn’s,2 which belongs to a group of diseases called inflammatory bowel disease (IBD). Kappelman, who is Associate Professor of Pediatrics at UNC, says that Crohn’s “is one of the most challenging and recalcitrant gastrointestinal conditions of childhood,” and that symptoms can be “quite debilitating.” Baker became a patient of Kappelman’s in 2012. She said there are always difficult points in managing her Crohn’s, be they medication changes or flares, but that Kappelman has never wavered in his support. “There wasn’t ever a time where I felt like, ‘Oh, he’s just letting me like slip under the radar,’” Baker said. Kappelman was drawn to pediatric gastroenterology to treat IBD and other conditions that impact the normal development of children. “I wanted to do everything I could to minimize such disruptions so that patients could live as healthy as possible and achieve success in all areas,” Kappelman said. The Build-up to the Olympics Early last summer, Baker sought to make her Olympic dream a reality at the U.S. Olympic Team Trials in in Omaha, NE. The top two finishers in the 100-Meter Backstroke Final would almost certainly earn a spot on the U.S.

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Olympic Swimming Team in Rio. On the morning of June 28, 2016, Baker bowed out of her favorite event – the 200-Meter Individual Medley – to rest more before the 100-Meter Backstroke, taking place that night. What happened? She finished in second place, touching the wall eight one-hundredths of a second before her college teammate Amy Bilquist. Baker had made the Rio 2016 Olympics. “Just making it to the Olympics was the pinnacle of success,” Kappelman said. That moment in Omaha was only part of what became an increasingly eventful summer. A little more than two weeks later, The New York Times published a profile3 on Baker in which she first publicly revealed that she had Crohn’s. Few people knew Baker had Crohn’s before this point, despite her having lived with it for a significant portion of her young life. “I mean, I’ve gone 19 years, and seven of them I’ve had Crohn’s,” Baker said. The story was as much of a surprise to some of her best friends as it was to strangers reading the paper. “‘Wow, I had no idea,’” some of her friends reacted. Baker, who was “super nervous” to share her story, hoped that opening up would inspire kids who have Crohn’s disease. “I have grown up with [Crohn’s] and had my challenges along the way. I think that I have such a positive, successful story that I want people to be able to look at Crohn’s and see something positive come out of it,” she said. In the Pool in Rio Competing in two events in Rio presented Baker the opportunity to build on her already-successful story. Baker, who said she is confident with her Crohn’s, was not concerned that it would affect her while she was in Rio. The more-pressing issue when she travels is her cargo. “How I carry my medicine, how I get it through security,” Baker said. “That’s honestly the biggest struggle I have traveling is getting my medication there.” Baker competed first in the 100-Meter Backstroke. She was in second place through the first half of the two-lap

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race. In the second lap, she claimed the lead as Hungary’s Katinka Hosszú came on strong. The two were wire to wire at the end of the race before Hosszú narrowly edged out Baker for the second of three golds she would win in Rio. In her first Olympic event, Baker had claimed a silver medal. Kappelman, who looked on from home, described watching Baker race as “one of the most exciting times in my life.” “It’s more than just cheering for your favorite athlete or team. When that athlete is your patient, then you have given a part of yourself to her (or him),” Kappelman said. “With teachers, coaches or physicians, it’s more than excitement— it is deeply personal and emotional.” In the 4x100-Meter Medley Relay, each country puts forward four of its fastest swimmers, one for each of the four strokes. The U.S. team was composed

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of Baker (backstroke), Lilly King (breaststroke), Dana Vollmer (butterfly), and Simone Manuel (freestyle), who swam in that order. The team trailed the Russian team after the first two legs, swam by Baker and King. The veteran Vollmer dove in the pool and took a sizable lead, and then handed it off to Manuel. Manuel extended the lead to nearly two seconds and sealed the win for Team USA. “Almost relief,” said Baker, of how she felt when she and her teammates won gold in a relay she described as having a huge legacy. Two events. Two medals. The teenager battling Crohn’s disease would stand on the podium twice in Rio. Unforgettable Moments The stories that accompanied winning the medals made the experience even sweeter. The relay team happened to have won the 1,000th Summer Olympics gold medal for the United States.

Five nights earlier, Baker had claimed the silver medal on the same night that Katie Meili, her roommate in Rio and an old swimming partner, won a bronze medal in the 100-Meter Breaststroke. “I’ve swam with her since I was 16 years old, and so to experience that together was incredible,” Baker said. She cherished the family atmosphere of the USA swimming team, pointing out the closeness that develops and the support from teammates. She spent time with Team USA gymnasts and the entire men’s basketball team, which joined the swimming team to watch an entire session of swimming finals. “‘This is so much more exciting than our basketball games,’” Baker recalled the men’s basketball team saying as it witnessed the action. Baker enjoyed being teammates with an athlete she grew up looking up to—

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Michael Phelps. Phelps is the highest decorated Olympian in history, having won 28 medals all time, with six of them coming in Rio. “I think in fifth grade my whole locker was filled with pictures of Michael Phelps. To be on a team with him was amazing” Baker said. The Doctor-Patient Relationship ACG spoke with Baker just as she was resuming her normal life last summer. She had moved into a new house at school, and was getting ready to leave for class. “It’s definitely not as fun,” Baker joked. In separate interviews, Baker and Kappelman reflected on what made their relationship successful. Essential to its success was a mutual understanding of, and support for, Baker’s swimming pursuits. She and her parents were always aligned on their preferences, values and goals, said Kappelman, who advised that a “family-centered approach” is necessary when treating children. “From the beginning, she was determined to be an elite swimmer and not let the Crohn’s stand in her way. This meant that her disease control could not just be ‘very good’ but had to be ‘excellent,’” and that “tolerating occasional side effects was not acceptable,” Kappelman said. These goals and preferences were “front and center in making any medical decisions,” including helping to guide testing and treatment decisions, he said. Communication also was critical. “He was always open to me asking questions,” said Baker, who said that was good for her because, “As a kid, I want to ask questions. I want to know what’s going on. And he always was there to answer them.” Kappelman reflected that Baker was mature and articulate from the time he first met her, and that she and her family clearly communicated the aforementioned goals. “Having excellent communication is quite important to make the right treatment decisions at the right time,” Kappelman said. What the Future Holds Baker believes she was meant to get Crohn’s, and that she’s supposed to do something with it. While being in school makes it hard for her speak to others about her experience, she intends to do so in the future. She plans to share a message that 30 // ACG MAGAZINE

her parents and the people around her instilled in her—to never give up. She emphasized the importance of developing a support system like hers. She had found that support in her doctors. “It’s really something special that you can have with doctors. Having someone care about you so much is a really great feeling when you have Crohn’s disease, and know that they’re looking out for you and doing their best for you.” 1 See patients.gi.org/inflammatory-bowel-disease/#tabs2. 2 See ccfa.org/what-are-crohns-and-colitis/what-is-crohns-disease. 3 See nytimes.com/2016/07/15/sports/olympics/kathleen-bakercrohns-disease-swimming-olympics.html.

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// ACG PERSPECTIVES

Brian C. Davis ACG’s Director of Media Relations Mr. Davis joined the College’s staff in 2016. He holds a BA in journalism from the University of South Carolina and started his career at the American Health Lawyers Association, where he developed expertise in association publications.

PHOTO CREDITS: Pages 26–27, Kathleen Baker rejoices after placing second in the 100-Meter Backstroke at the U.S. Olympic Team Trials on June 28, 2016, securing her spot on the U.S. Olympic Team for the Rio 2016 Olympics. Courtesy of Bold Action Media. Pages 28–29, L to R, top to bottom, Michael Kappelman, MD, MPH, The University of North Carolina at Chapel Hill. Baker became a patient of Kappelman's in 2012. Courtesy of The University of North Carolina at Chapel Hill. Kathleen Baker (center) and her family celebrate the gold medal she won for swimming the backstroke leg of the 4x100-Meter Medley Relay at the Rio 2016 Olympics. Kathleen is flanked by her mother, Kimberley, sister, Rachel, and father, Norris. Courtesy of Kathleen Baker. Baker (third from right) and teammates stand in front of the Olympic logo in the Olympic Village. Courtesy of Kathleen Baker. Kathleen (right) and sister Rachel Baker sink their teeth into Kathleen's silver medal. Courtesy

 SUBMIT STORY IDEAS about any interesting passions or interests you or your colleagues have, whether it pertains to practice or life outside of work: ACGMag@gi.org

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of Kathleen Baker. Baker prepares for a collegiate race. She is a sophomore at the University of California, Berkeley. Courtesy of ISIphotos.com. Pages 30–31, Baker splits the middle of the fiveringed Olympic symbol in the Olympic Village. Courtesy of Kathleen Baker. Baker (second from right) and teammates. Courtesy of Kathleen Baker.

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// ACG PERSPECTIVES

How A Navy Gastroenterologist Did His Part to

Bring Down The Berlin Wall & End The Cold War —­ Sarkis J. Chobanian, MD, MACG ACG Past President (1997–1998)

D, MACG M , n a i n a b o h C Sarkis J.

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History has always fascinated me. Particularly those seemingly insignificant moments or actions that can change the history of the world in a heartbeat: Marshal Grouchy mindlessly tracking the retreating Blücher rather than marching to the sound of the guns at Waterloo. John Wilkes Booth opening his mail on the steps of Ford’s Theater and overhearing that President and Mrs. Lincoln would be attending a performance that evening with General and Mrs. U.S. Grant. The driver of Archduke Franz Ferdinand’s car taking a wrong turn in Sarajevo and backing up in front of the restaurant where Gavrilo Princip was until then ruing his missed opportunity to kill the heir to the Austro-Hungarian empire, thereby setting off the cascade of events that led to World War I. Thus, I am gratified that I was an eyewitness to another of those seemingly innocuous events that has the potential to change the history of the world. Dr. Edward Cattau was Chief of the Division of Gastroenterology at the National Naval Medical Center in Bethesda, MD when the task fell upon him to perform a colonoscopy on a 74-year-old President Ronald Reagan in 1985. A native of Niagara Falls, NY, Ed loved the South and graduated from the University of North Carolina at Chapel Hill. In a twist that both Ed and President Reagan would find ironic, Ed had chosen to take up an offer of a scholarship from the U.S. Navy that would pay his medical school tab in return for an equal number of years as a physician in the Navy. The U.S. Government has done many things wrong, but it has done at least two things very, very well: the GI Bill and the Armed Services Health Professions Scholarship Program. It is no small irony that the young physician who accepted the Navy’s scholarship offer went on to save the life of the President who declared that “Government is the problem.” Dr. Cattau’s nickname, of course, was “Cat”—but it was truly a misnomer. To me felines are aloof, diffident and indolent, none of which describes Ed Cattau. He is wiry, hyperenergetic and lithe. He is famous for his walking speed, which is probably on the order of 130 to 140 paces per minute, and for his uncanny ability literally to leap down staircases taking steps two and three at a time, leaving those of us mere mortals who still have a profound respect for gravity far in his wake.

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Ed Cattau is an ideal leader. He is a man who leads by example and by his enthusiasm. His mind is quick and incisive. As a physician, I am impressed by his perseverance and dedication to the task at hand. He always strives for

perfection, never settling for “good enough.” These are the personal attributes that would lead to his discovery of President Reagan’s cancer. I will not go into the precise details of what led to Mr. Reagan’s first colonoscopy on July 12, 1985, other than to say that the indication was for the evaluation of occult blood in the stool. As is the custom in the modern era, most Presidents while in office receive their medical care at the National Naval Medical Center, commonly known as the Bethesda Naval Hospital. One exception was President Dwight Eisenhower, who, with his Army roots, chose the Army’s Walter Reed Medical Center. Dr. Cattau, as the senior gastroenterologist at Bethesda, would be performing the examination. Now, as an aside to the younger generation of endoscopists, let me point out that endoscope technology has improved remarkably in the 25 years since these events unfolded. At that time, most colonoscopies were performed by two physicians in teaching hospitals, or, in the private setting, by a nurse who would insert the tube while the physician would have both hands on the handle and controls of the instrument. The left hand operating the air/water and suction buttons and the up-down wheel, the right hand on the rightleft wheel and for passing instruments through the operating channel of the scope. It was considered quite revolutionary for the physician to perform the exam solo, but even then the right hand would only migrate to the scope for incremental advances and torquing—typically both hands would return to the scope for use of the direction wheels. To anticipate your queries as to why this was done in this fashion, let me state that it was not through lack of competence or training, or merely tradition, but rather because the scopes then were so much more rigid, had larger diameters, and were fiberoptic. I liken the difference between the scopes of yore and those we use today to the difference in steering and handling between a 1950s-era truck without power steering or an automatic transmission versus the performance and handling of a modern German luxury sedan. So now we return to President Reagan and Dr. Cattau at Bethesda Naval Hospital in 1985. In the room with them was a Navy Corpsman, the White House Physician, a civilian nurse, the Chief of Anesthesiology (to insert the IV!), and Secret Service personnel. Another Navy gastroenterologist, Dr. Charles Winters, was present and attached to the “teaching head” of the fiberoptic colonoscope as an observer.

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Bethesda Naval Hospital GI Di vision circa 1985. Dr. Chobanian is pictured front row, second from lef t. Dr. Cattau is pictured back row, fifth from right. Courtesy of Dr. Chobanian. Now another aside: the President had not invoked the 25th Amendment to the Constitution, which sets out the succession to the presidency when the President himself is incapacitated. I was not privy to the precise discussion, but it was an issue because of the controversy surrounding the events of the assassination attempt on President Reagan by the delusional John Hinckley, Jr. on the early afternoon of March 30, 1981. As you may recall, the President was shot in the chest and about to undergo thoracic surgery when Secretary of State Alexander Haig rushed to the White House Press Room to excitedly declare, “I’m in control here...” Well, not really. The Secretary of State is fourth in line to the Presidency. This event led to Haig’s eventual departure from the administration and was the reason that the President, upon advice of the White House Counsel, did not invoke the 25th Amendment. In short, President Reagan wanted to be nearly entirely

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awake and just lightly sedated with the combination of meperidine and diazepam, administered intravenously. Dr. Cattau performed the procedure easily until the hepatic flexure was reached and then began experiencing some difficulties. Up to that point, the President was conversant, comfortable and even telling a joke or two. But at the hepatic flexure, some looping began to occur and Dr. Cattau noted paradoxical movement of the scope—as he pushed to advance the scope, it actually appeared as though the scope was being withdrawn. Also, as he pushed, the President would experience some discomfort. Dr. Cattau continued to work. He kept asking the President if he was OK, the answer was usually, “Yes,” although sometimes silence. Dr. Cattau got the loop out and advanced beyond (proximal) to the hepatic flexure and into the distal ascending colon. He worked the scope into the mid-portion of the ascending

colon and could see into the caput cecum, the base or seat of the cecum. But he could not fully advance into the cecum. The President became increasingly more uncomfortable. “Mr. President, do you want me to give you some more pain medicine?” “No,” comes the answer.

A Fateful Discovery

And so now we come to one of those little moments in history that, in retrospect, turns out to be fateful. Back then, it was considered acceptable not to reach the cecum. Getting into the cecum was actually quite an achievement. Now, endoscopists get paid for a complete colonoscopy even if they get the scope just beyond (proximal) to the splenic flexure. But then the endoscopist was Ed Cattau. He was not about to compromise. OK was not good enough. Only perfection and excellence mattered. Dr. Cattau gritted his teeth, said a silent prayer, “Oh God, don’t let me perforate this man…” Then aloud he said, “Just one last

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little push, Mr. President,” and got all the way into the cecum. He looked. Looked again. And he couldn’t believe his eyes. Charlie Winters recalls Ed exclaiming, “This is surreal,” as the lesion appeared. There, plastered against the medial wall of the cecum was a flat, carpet-like villousappearing lesion. Invisible unless the cecum had been fully intubated. Colon cancer. Biopsies were obtained. The specimens were rushed and the pathologists’ interpretation confirmed the diagnosis. The following day a team was assembled for the President’s surgery: Dr. Dale Oller, Chairman of the Department of Surgery at Bethesda, Dr. Lee Smith, Chief of the Division of Colorectal Surgery, and Dr. Steve Rosenberg, Chief of Surgery at the National Cancer Institute. We were briefed by the Commanding Officer about security issues, the media, handling of the tissue, etc. Purely by chance, I would be the Command Duty Officer (acting commanding officer) following the President’s operation. All went well. Back then, before the TNM system was widely adopted, colon cancer was staged by the Astler-Coller modification of Cuthbert Dukes’ staging system. The President’s cancer was a B2 lesion: invasion into the muscularis propria, but not through the serosa. The nodes were negative.

Ronald Reagan’s colon cancer was discovered just in time, at the last possible moment. Or, in the words of Wellington at Waterloo, “a close run thing.”

How Diagnosing Reagan’s Cancer May Have Helped to End the Cold War What I have described above is historical, based on my observations. What follows is my interpretation based on my education, knowledge and yes, a little bit of speculation. As President Reagan’s second term unfolded, huge events were transpiring on the world stage. After the back-to-back deaths of two Soviet hardliners, Konstantin Chernenko and Yuri Andropov, Mikhail Gorbachev became leader of the Soviet Union. It is difficult now for Western youth to understand the significance of the Soviet Union, but the Cold War, the nuclear standoff between the West (basically the United States and its allies) and the Soviet Union, was the basic tenet of human life on this planet from the end of the Second World War until the collapse of the Soviet Union. The Baby Boom generation basically grew up, came of age, and entered adulthood with a constant uneasiness that a slight spark in a tinderbox would lead to the mutual nuclear immolation of the whole world. To us, the USSR was, in President Reagan’s words, “the Evil Empire.” With Mr. Gorbachev’s rise, President Reagan saw the opportunity for a oncein–a-lifetime change in the power dynamic of the United States-USSR diad. The two world leaders met for the first time on November 19, 1985, in Geneva, Switzerland. There is a famous photo of that meeting. Mr. Gorbachev is dressed like a typical Soviet apparatchik: heavy wool overcoat, hat, scarf, getting out of a car, looking cold and dour. Mr. Reagan is coming down the stairs of the villa where the meeting will be held. No coat, no hat, big smile, hand outstretched, literally thrusting forward with great health and vigor. Even the most dense among us could read the body language of the two leaders. Compare that image with the famous

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ed The College honor in 1990, President Reagan as there to and Dr. Cattau w nguished ti is D ’s G C A nt se re p Service Award. picture of the WWII leaders at Yalta: an unhappy Winston Churchill, a dying President Franklin Roosevelt, and a beaming Joseph Stalin who has just been granted the keys to Eastern Europe and its subjugation. The negotiations would continue in October 1986 in Reykjavik, Iceland, halfway between Moscow and Washington, DC. The summit there resulted in a tense standoff when Reagan refused to give up the Strategic Defense Initiative in return for Soviet nuclear warhead reductions. There would be no weakness shown from this American President, unlike his predecessor, President Jimmy Carter, who caved in the face of aggressive Soviet expansion.

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The ultimate expression of President Reagan’s strength would come on June 12, 1987, when he stood before the Berlin Wall and demanded, “Mr. Gorbachev, tear down this wall!” It is my contention that had the President’s cancer gone undetected in the summer of 1985, that it would continue to have spread locally, regionally and distantly. Although there is considerable variation in the doubling times of adenocarcinomas of the colon, it is generally accepted that, on average, the cancer would advance by one stage per year. Under this scenario, by New Year’s Day 1986, local and regional nodes would have been involved, the cancer might have grown through the bowel wall. By the close of that year, it would have metastasized—most likely to the liver. Mr. Reagan’s symptoms? Weakness, fatigue, malaise, most likely from anemia. Weight loss, abdominal pain. Would we have seen the robust Ronald Reagan, hatless and coatless in the snow? Would he have been smiling, arm outstretched, nonverbally signaling the strength and robustness of the nation he headed? Would he have been able to face down his opponent in interminable meetings on missile defense and disarmament? Would he have been able to look strong and speak forcibly at the Brandenburg Gate demanding that the Soviets open the gates and tear down the wall? It is my contention that he would never have been able to show such strength. Just as in earlier times when armies were decimated not by the bullets of the enemy but rather by the unseen and unknown microbes of plague, typhus, cholera and malaria, so too had leaders such as Franklin Roosevelt been humbled by cancers and stroke. It therefore falls to the silent and unknown heroes of medicine—such as Dr. Ed Cattau—to do their part, as he so superbly did.

Arrival of Gener al Secretary Mikhail Gorbach ev of the USSR for his first meeti ng with Presiden t Reagan for the Geneva Summit at Fleur D’Eau in Switzerland, November 19, 19 85. Courtesy Ronald Reagan Library.

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center, op and d 33, t n a Berlin 2 e 3 h t e ech at TS: Pag e I p D s E R a C g c of PHOTO n givin Republi t Reaga ederal n F e Ronald d , i e e s t h e a t G Pr enburg tesy of d r n u a o r C B . 7 ipt Wall, 12, 198 Manuscr on , June hapell y S n a e , Winst m h t r T h e G Top rig ary and r . b g h i r p L o e . s n l o l J Reaga w.shape lt, and lace, ion, ww Rooseve adia Pa Collect v lin D. i k L n a . r e F c n , e the l r l e f i f o h n c o Chur ourtesy Yalta C 1945. C at the portion , n 9 a i l y , a r r t a e S t ebru eft cen USSR, F erty rary. L Yalta, he prop ial Lib t t n n e o d i s s e e d r i P s iskey e h R r W D F l a the lin Wal y. Alph r r e a B r b e i h L r 2012, n of t eptembe d Reaga S l sary a n r n i e o v R , i t of the 5th ann tom lef d the 2 hy. Bot e p t a a e r r h g o t o m t t Pho n comme peech a f Berli gan's s ayne Mayor o ald Rea aque. W n l o p R e t z n n o de r i b of page s e a t r f P h e t of ottom l ld Gate wi B g . r 4 u 1 b 0 n 2 nt Rona Brande er 22, Preside b m y e p t o p c r e a e , S speech mous "T Hopkins of the og: he infa tocopy s Catal ering t e v v i i l h e c 36, pho d r A n e l h a w n o d i e us h. Nat Reagan " speec 91 is Wall id/1984 / v o Down Th g . s archive . g o l a t ca

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|| COMMITTEES IN ACTION | WOMEN IN GI

Millie D. Long, MD, MPH, FACG, on Building a Successful Career in Clinical Research By Jill Gaidos, MD, FACG

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WHEN DR. MILLIE LONG came to the Virginia Commonwealth University to lecture at our Division of Gastroenterology and Hepatology Grand Rounds, she and I took time to sit in the faculty lounge and discuss her career in clinical research. You completed your gastroenterology fellowship at The University of North Carolina at Chapel Hill (UNC) and while you were there, you also completed a fellowship in preventive medicine and obtained a Master’s of Public Health (MPH) in epidemiology. What was the timeline of your training? Were these overlapping with your GI fellowship training? ML: So, it was overlapping. I actually went to UNC for the specific intention of joining their clinical research track so that I would get my MPH during my fellowship training. When I started, I started out on research when I first arrived and was able to get my MPH in the first 18 months of my fellowship. I still did some clinical work during that 18 months and then finished out my clinical fellowship over a three-year time span. My research at that point was in inflammatory bowel diseases, of course, and I was very interested in prevention. At UNC, they also offer a preventive medicine fellowship, which is typically a two-year fellowship but, because I already had my MPH, it could be shortened to a oneyear fellowship. At that point, I wanted to do advanced inflammatory bowel diseases. I was actually the first to do that at UNC, believe it or not, as we didn’t actually have funding for a fourthyear fellowship at that time. By doing the preventive medicine fellowship and focusing all my research in inflammatory bowel disease (IBD) on prevention, I could also do an advanced IBD year. It worked out very well for me because I did have protected research time during both my fellowship while I was getting my MPH and during my fourth year. This allowed me to focus on writing, publishing and preparing my career development award in anticipation of becoming faculty. At the start of my fourth year, with my mentors, I decided that I wanted to apply for a position at UNC, and I ended up staying on faculty. Were you on a National Institutes of Health (NIH) T32 grant? Is that how you were able to get funding for your research time?

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ML: I was. I was on a T32 grant during my GI fellowship and that allowed me to get my MPH during that time and also do clinical research. Once I was in my fourth year, I was actually funded by our Division of Preventive Medicine. It’s primarily a research year, so there’s some practicum involved. It was actually a really interesting experience. The VA’s National Center for Health Promotion and Disease Prevention is located in Durham. I had a joint appointment that year where I did some practical work with the VA and I did some research. We published a paper looking at modalities of colorectal cancer screening. At that point, they were doing some of the guideline development for various screening and preventive testing, and I focused on those that were GI-related. I was able to work at the VA, not in a clinical position, but rather doing all research, administrative and policy-type work. I was there for a few months during that year, which allowed me to meet some of the requirements for the preventive medicine fellowship, working on policy, but also was pertinent to my career from a GI standpoint. It was a nice collaboration. I really enjoyed it, actually. It was fun to work with the VA. We don’t have a VA at UNC. So, you miss those patients? ML: Yes, I miss those times. What drove you to complete these additional training degrees? How has this additional training helped your career? Or, do you think it has helped? ML: I think it really has. I went into gastroenterology with the heart of an internist, I believe. When I recognized that I wanted to do inflammatory bowel diseases, I really wanted to focus on, not just the GI tract, but all of the complications that can arise. Focusing on prevention really became a way for me to take a holistic approach to the patients and offered a way for me to focus on what I loved about internal medicine. I saw that IBD prevention was an arena where there was not as much research at that time. The focus was very much more toward managing the GI manifestations of the disease. This allowed me to have an arena where there was not a lot of prior literature, where I could focus on the complications of some therapies, and the means by which we could prevent those. For example, we did work delineating the skin cancer risks of medications that we use in the treatment of inflammatory bowel diseases. This allowed us to start to move toward policy recommendations to help with prevention of those complications. Other work we did focused on risks of infectious complications and vaccinations. I believe that where the preventive medicine fellowship was very helpful was in recognizing that we really have to have the right level of evidence to be able to apply preventive recommendations and truly understand the policy behind those. It is

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important to know what evidence base is needed to implement preventive recommendations and move the field toward eventually preventing complications. That has been valuable for me. I don’t see myself practicing as a preventive medicine specialist, but I do see that these themes have helped with both my research and my clinical care. We have actually implemented several different quality improvement mechanisms within our own IBD center that lend themselves toward improving the prevention of complications. Your publications range from looking at the role of nonsteroidal anti-inflammatory drugs (NSAIDs) in IBD flares (J Clin Gastroenterol 2016;50(2):152-6), to hormonal contraception use and the risk of DVT in IBD patients (Inflamm Bowel Dis 2016;22:1631-8), to the risk of IBD flares with avoidance of dietary fiber (Clin Gastroenterol Hepatol 2016;14(8):1130-6). How would you describe your research focus, or do you define your research in any way? ML: I do. I focus it on prevention. One theme is studying the modifiable risk factors for relapse of disease. For example, the use of NSAIDs is a modifiable risk factor to help to prevent relapse of underlying Crohn’s disease. Dietary management could be considered in the same fashion. This is similar to the work I’ve done in vaccinations and skin cancer and infectious complications of therapies—I look at all of those as potentially preventable complications. And so, that’s where the theme lies. It’s very different because it’s crosscutting in terms of a theme. You’ve also mentioned a paper we did looking at DVT risk factors. By recognizing those risk factors and modifying the form of contraception for those women, we could potentially prevent pretty significant complications down the road. It has been fun to work epidemiologically on all angles of prevention.

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In many instances, it takes small steps to get to your ultimate goal… This is the role of good mentorship—to help, no matter where you are in your career, to kind of ground you. A mentor can say, ‘OK, if that is where you ultimately want to get, here is what we need to do to get there.’

How do you get your fellows to ask questions about contraception and Pap testing? We see about a quarter of women in our IBD clinic at our VA hospital, and getting fellows to ask about Pap smears has been a challenge. ML: It doesn’t really cross their mind. But I think that once they’ve been through the clinic, they do understand the importance of that. I think that the EMR is an avenue toward helping us with reminders to ask those things. I know that each EMR is different, but within each structure there are opportunities to build smart forms or reminders therein. Now, of course, if you are seeing a patient who is in the midst of a terrible flare, you are concerned for an abscess, you are scanning them, your admitting them, you’re making pretty significant medication changes. That’s not the time where I address those factors. But I do emphasize to patients that I really want them to follow regularly even when they are feeling well because it’s during those times that I focus on the health maintenance. It’s not that it needs to add to every visit, but I think it does need to be on our radar once a year to review those factors just so we can help to optimize their therapies and potentially prevent either an intestinal or extraintestinal complication such as a malignancy or a flare of disease, an infection, any of those factors. You are among a group of IBD providers who recently published on the obstacles to investigatorinitiated studies in IBD (Inflamm Bowel Dis 2016 Sep 2 epub). What obstacles have you personally faced in your research career, and how did you overcome them? ML: I believe that there are a number of obstacles. Some of the hardest ones include the fact that all research comes out of a clinical scenario. You see a patient, and you think to yourself, “How could I help this patient?” or, “How could I have helped this patient earlier to prevent what is going on now?” In many instances, there are

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some great ideas, but the feasibility and costs play a huge role. Particularly at a junior stage in your career, but really any time in your career, if a study is not feasible because of the cost infrastructure, then you are not going to be able to complete it. And so, I believe that understanding those limitations is very important. In many instances, it takes small steps to get to your ultimate goal. In looking at a five- or a ten-year view, even a simple study using claims data to look at the incidence or prevalence of a condition can be valuable. This can be pilot data before launching into that expensive prospective cohort or eventually a randomized controlled trial. Each smaller study is a step on the ladder to get there. I think that reaching too high at first can be a real obstacle. This is the role of good mentorship—to help, no matter where you are in your career, to kind of ground you. A mentor can say, “OK, if that is where you ultimately want to get, here is what we need to do to get there.” Another obstacle is time, of course. I think many of us are very busy clinically, and we have other responsibilities as well, whether that be teaching or many of us are involved in the medical school curriculum, and so really being able to set that time aside and focus on what your ultimate goal is to move those small projects forward is very important.

all of your analysis for you when you are early in your career. Luckily, I had the training to be able to do that myself, which allowed me to have sort of a leg up, and the rest follows.

What advice, recommendations or tips for success would you give to either new fellow graduates or junior faculty who are interested in a career in clinical research? ML: I believe the first thing I would recommend is that education and training are key. Not everyone has the opportunity to get an MPH, but I think it’s a very valuable degree. Certainly, there are often short courses and other ways to help with understanding the methodology in clinical research that can be very valuable. The one thing that helped me a great deal was not only having the clinical epidemiology skills, but also some biostatistics training early. You don’t always have access to a biostatistician who can do

In addition to your research, you also serve on the ACG Research Committee. What are your responsibilities as a member of the Research Committee? ML: I love this committee. I’m in my sixth year on the ACG Research Committee, so I’m about to leave this committee. We review all of the grant applications for ACG. We review them in a way similar to the NIH in a study section with content reviewers, methodology reviewers, we score these applications accordingly. The most fun part is we get to hand out a lot of money every year to really deserving faculty members. Some of the favorite grants I review are the junior faculty career development awards which,

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Even if you don’t have the ability to obtain those skills personally, I think joining forces with another faculty member can be valuable, whether that’s a colleague or a faculty member more senior to you who has these skills. For example, we have a junior faculty member at UNC who had a great idea for a project but didn’t have that training himself. I have worked with him to develop the aims and the data source for this project and, in this instance, I did the analysis for him and then he has taken it from there. Really the collaborative aspect of research is that you can find collaborators with those necessary skills, so you do not have to be the expert in everything. This leads to the discussion of mentorship, which is incredibly important and identifying a mentor early can really help you with career, life balance, all of those recommendations, but also help to track out a path toward an ultimate goal that may be clinical research funding through foundations or the NIH. A mentor can also make sure that you stay on a timeline to get where you want to be.

based on the recommendations from our committee over the past five to six years, have really increased in the amount of funding. These are now three-year grants, where previously they were two-year grants, and they are now $100,000 per year, to really allow the junior faculty recipients to buy back their own protected time, but still have the necessary funds they may need from a research standpoint. This has been incredibly valuable. The ACG has actually published the impact of these grants on the recipients over the years, and it’s demonstrated that many recipients have gone on to quite successful research careers. I believe it’s really wonderful to be a part of that process. The other aspect of the ACG Research Committee I love is that it’s multidisciplinary. And, so that’s how I know the pancreatobiliary folks around the country and that’s how I know the hepatologists. It’s a great way to get to know people that you wouldn’t normally get to know in your specific content field. I would strongly encourage anyone who is interested to reach out and apply to be a member of an ACG committee, whether the Research Committee or another, just because of this ability to network and meet wonderful people and learn a lot. I learn a lot from all the grants I review each year, and I’ve found it to be very valuable. What is the most important thing in the grant that you are looking for? Is it the clinical question, or the feasibility or the support? What are you looking for? ML: It depends a little bit on what the grant is for. I would say for the career development awards, it’s actually much more about the applicant and the environment than it is about the specific scientific project. If we, based on the application, see someone with a lot of potential and a great mentorship and the project is good and feasible, then that’s the person we are going to go with because it helps so much to build that career, and we have so much confidence in a great environment, someone who’s put together a good mentorship team.

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The clinical research grants, on the other hand, are actually all about the research, of course. I believe a key aspect there is having pilot data to show us that you can do this work, and having a well-developed clinical question with good methodology, measurable outcomes and, importantly, that it’s feasible. Sometimes the idea is extraordinary, but it’s just not going to be feasible on the small amount of money that we have available, which makes it very hard for reviewers to give that grant a high priority. So, anyone thinking of applying for an ACG research award should focus on those aspects. For someone who doesn’t have a lot of research experience, there is some hesitancy to join the Research Committee because how can you review these protocols if you don’t have that background. Would you discourage someone from joining this committee in this setting? ML: It would be good to have some publications under your belt, and to understand the content area. Even writing systematic reviews of a content area and becoming a content expert can be very helpful in terms of reviewing those grants. The other thing is that there are a large number of committees through the ACG and, really, being involved on any committee can be a valuable experience. I think that the support and camaraderie are amazing. I’ve actually had collaborative research projects arise out of working with people that have been on the Research Committee with me. I believe that all of those aspects are true of every ACG committee. I wouldn’t limit yourself to any one area, I guess is what I’d say. If you feel that you are not yet ready to be on a certain committee, then aim for another committee and try to gain the skills necessary to put yourself on other committees in the future, if that’s ultimately what you are interested in. You are also the Associate Editor for the IBD section of The American Journal of Gastroenterology. What

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special training, if any, do you need to be an editor? Is this a position you applied for or were you nominated/ appointed? ML: You are invited by the editors to be involved in a journal editorial board. And generally, that is based on content expertise, prior publications in the arena, but probably most importantly on reviewing manuscripts and how well you do reviewing

for a decision on that manuscript. The Board determines whether the manuscript needs further revisions, whether we would like to publish it, or perhaps it might not be the right fit for the Journal. From this process, in and of itself, I feel like I’ve learned a lot. In the same setting, as with the ACG Research Committee, it’s a multidisciplinary board, and I’ve met a lot of people from the colon cancer

The most fun part [of the ACG Research Committee] is we get to hand out a lot of money every year to really deserving faculty members.

manuscripts. I believe many people are asked to review manuscripts for various journals, and I would strongly encourage you to do that because, not only can you learn from the process, but you can provide a valuable service for the authors in terms of improving their manuscript. Just in the act of reviewing, you do a literature search, you really try to understand where that paper fits in the field and then write a detailed review. This can also help you, as your literature search may inspire you to look at a different factor and do your own systematic review based on an idea you generate from your review preparation. Prior to being an Associate Editor for the Journal, I did a lot of reviewing for the Journal and for other journals. I think that experience makes you a better editor. And now, I get to do the fun work, which is reading a lot of really interesting papers that are sent my way, sending them out for review, and then using the reviewers’ expert opinions to present back to the board

world, from the hepatology world, and from other silos. What is really interesting is that we share a lot of the same opinions in regards to the methodology of the papers. So, even though I’m not a content expert in hepatitis C, I can certainly add my opinions based on reading a paper from a methodologic standpoint, the outcomes they used, whether or not I thought those were valid. It’s nice to be able to have that cross-disciplinary conversation about a paper.

 MORE INFORMATION on ACG's Committees is available at gi.org/committees

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Advancing to

FELLOWSHIP Why it MATTERS By Swati Pawa, MD, FACG

The American College of Gastroenterology is a wonderful organization that is a champion for all clinical gastroenterologists, whether in academic or private practice. The College is worthy of our support and involvement, with each of us doing our part in contributing to ACG’s growing success. The atmosphere of collegiality between academic and private practice clinicians involved in the College is refreshing to me. I am impressed that in recent years both academic and practice clinicians are represented in leadership roles in the College. Swati Pawa, MD, FACG, Rutgers Robert Wood Johnson Medical School

Why “FACG” Matters and What it Means to Me

For anyone who seeks to assume a more active role in the College, a necessary step is to become a Fellow of the College, or FACG. According to ACG’s Bylaws, fellowship is an honor bestowed in recognition of significant professional achievement and superior competence within the field of gastroenterology. From my perspective, FACG continues to be a respected and desirable credential. The requirements to become a Fellow can be found at gi.org/membership. As a member of ACG’s Women in GI Committee, I was inspired to write this article to share my own experience, as women in gastroenterology and how our involvement with the College and becoming an ACG Fellow has enriched my professional life.

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My Involvement in ACG over the Years

I joined the ACG as a Trainee member in 2005 and was fortunate enough to get involved with the Women in GI Committee from the outset. In those days, I would sit in awe of all the accomplished, dynamic, forwardthinking women leaders in our field who made up this committee. I soon realized some of the real work of the College was done here in terms of incubating ideas and accomplishing projects that benefit not only female members of ACG, but also the field of gastroenterology. Ten years later, I continue to be involved with this committee. My experience ranges from publishing an article with Anne C. Travis MD, FACG, for the Professionalism section of The American Journal of Gastroenterology in 2011 to organizing and moderating the “Career Opportunities for Women in GI” luncheon at the 2013 Annual Scientific Meeting under the able leadership of Amy S. Oxentenko, MD, FACG. Involvement in the Women in GI Committee has been a wonderful way to meet others and to share information on so many levels. The opportunities have come knocking. I am currently a member of the “FACG

Advancement for Women in GI” Task Force convened by Jill Gaidos, MD, FACG, the Committee’s current Chair. I also serve on the “Education and Promotion of Colorectal Cancer Screening in Women” Task Force. Thanks to Dr. Gaidos’ openness and receptiveness, along with my colleagues Raquel E. Davila, MD, FACG, and Promila Banerjee, MD, FACG, I have been instrumental in creating a task force for “Women in Advanced Endoscopy.” This group is the first of its kind convened by the ACG Women in GI Committee. As we sit down to brainstorm and identify action items for our work together on the unique challenges facing women in advanced endoscopy, I cannot help but think how far I have come since my fellowship days. Not only has the College given me opportunities to change the focus of my energies by taking on new responsibilities, it has also allowed me to take the lead on new initiatives. Above all, I am grateful for the friendships that have developed over the years and for the opportunity to have been able to give back to the profession I love. This gives me renewed energy, hope and enthusiasm for the future.

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// COMMITTEES IN ACTION

CRITERIA FOR ADVANCEMENT TO FELLOWSHIP–FACG  Proposal and endorsement by two Fellows of the College  Current, uninterrupted membership or international membership in the College for a period of no less than three years  Minimum of three CME programs sponsored by the ACG within the last six years  Evidence of involvement in ACG activities such as Committees, Postgraduate Courses, Annual Meeting attendance, etc.  Certified by a specialty board recognized by the Council on Graduate Medical Education  Demonstrated scholarly activities

BENEFITS OF ACG FELLOWSHIP  Eligible to run for elected office on the ACG Board of Governors  Serve as a Chair of an ACG Committee  Eligible for nomination to the ACG Board of Trustees  Eligible for nomination for a Master Award or the Samuel S. Weiss Award  Use honorific “FACG” in your title, on business cards, and on your CV  Recognition via the ACG website  Certificate of Advancement to Fellowship signed by the ACG President and Secretary Application Fee: $5

Online Application: members.gi.org/acgmembership

PDF/Printable Application: goo.gl/wJGYrh

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Felice H. SchnollSussman, MD, FACG, Weill Cornell Medical College

Why ACG Matters and What It Means to Me

When I think about my career thus far, it seems as if the College has always been an enormously positive force in shaping its direction. Advancement in a career in academic gastroenterology, like most professional careers, is dependent upon several factors: mentors, promoters and sponsors. Each of these individuals is necessary at different times to ensure your success and, I dare say, your happiness to some degree. I have been blessed to have been able to find many of these individuals through my ties with the ACG. The ACG is a family. A network. A bond amongst like-minded professionals who are interested in the vitality of their profession and the care of the patients it serves. For women in medicine, the College is an amazing resource. It is here that I have met so many colleagues, many of whom have become dear friends along the way, who have become invaluable mentors for me. I have been able to reach out to them at different times along my career for both professional and personal advice. These colleagues have been a resource for things as mundane as a clinical question regarding a patient in my practice, to a challenging decision related to a major career change. Mentors need not be within one’s homebase and the College has proven that time and again for me. Moreover, I have been the beneficiary of both promoters and sponsors. Individuals who put your name up for an opportunity, open a door, help you shatter that “glass ceiling.”

and people from walks of life who I never would have met on my own. They have come into my life through ACG committee work, such as my time on the Educational Affairs and Nominating committees, my two terms as ACG Governor for Manhattan, and dozens of opportunities I have had with involvement in both regional and national meetings. My experiences in lecturing, directing hands-on courses, and most recently co-directing the ACG’s Annual Postgraduate Course have helped hone my skills as an educator. The opportunity to serve the College and my New York constituents as a Governor has opened my eyes to the political process, and helped me grasp the importance that even one voice can make in change. I have been the beneficiary of professional career advancement and even the recipient of an ACG-cosponsored grant that allowed me to take executive business training at the Wharton School of Business as part of a leadership training initiative sponsored by the ACG Institute for Clinical Research & Education. The list of favors bestowed upon me, opportunities given to me, doors opened to me, and kindness expressed to me has been incredible over the years. Of course, there have been countless hours on my part that I have dedicated to the College (nothing in life is free, as we know), but to say that I have received back in kind from ACG what I have given is a complete understatement. I only look forward to more opportunities and to serve the College in a greater capacity over the years. To those of you who are questioning getting more involved in the College or the benefits of obtaining fellowship status…what are you waiting for?

Through a myriad of experiences, the College has exposed me to individuals from institutions across the country and around the world, as well as industry

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|| COMMITTEES IN ACTION | TRAINING // COMMITTEES IN ACTION

ACG-FDA Visiting

FELLOWSHIP PROGRAM

I was given opportunities to attend meetings with our industry counterparts, which allowed me to witness the collegial interaction between the FDA and industry as they collaborate to bring safe and effective new drugs to market.

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A Review by Dr. Kendall Beck

IN OCTOBER 2016, KENDALL BECK, MD, COMPLETED A ONE-MONTH ROTATION through ACG’s joint Visiting Fellowship Program with the U.S. Food and Drug Administration (FDA) in their Division of Gastroenterology and Inborn Errors Products (DGIEP). Dr. Beck, a third-year fellow at the University of California, San Francisco (UCSF), was chosen by the ACG’s FDA Related Matters Committee at the 2015 ACG Annual Scientific Meeting in Hawaii. Selected fellows then work with their respective program directors, the FDA and ACG to find a suitable month to be at the FDA as well as a tailored curriculum for that month. About the Fellowship The goal of the program is to allow the selected candidate an opportunity to integrate into the daily activities of the FDA and gain first-hand knowledge and valuable experience in the drug and device approval process. The candidate, a second- or third-year fellow, is vetted and chosen by the FDA Related Matters Committee. The College provides a stipend for travel and daily living expenses for a one-month rotation at the FDA. Upon completion of the rotation, the selected fellow presents his or her experiences at the following ACG Annual Scientific Meeting. More information about the fellowship can be found on the ACG website. Submissions are closed at this time, but please stay tuned for the next application cycle. Dr. Beck’s Perspective As a third-year gastroenterology fellow at UCSF, I was honored to be selected for the Oak Ridge Institute for Science and Education (ORISE) visiting fellowship program—a collaboration between the ACG and the FDA that aims to provide fellows with an understanding of drug development programs and the interchange between the FDA and industry. Through the program I spent the month of October as a visiting fellow

at the FDA, embedded with the DGIEP of the FDA’s Center for Drug Evaluation and Research. From the outset my team leader made sure I had a packed schedule. The warm welcome by team leaders, medical officers, project managers and administrative staff across a number of cross-functional teams made it possible for me to hit the ground running and integrate easily. I had the opportunity to audit medical officer training, which encompassed a wealth of knowledge ranging from the history of the FDA, including the laws and Federal Code of Regulations that govern the FDA and regulatory approval process, to the drug development process, how the FDA regulates investigational new drugs, and the evaluation of new drug applications. The process of labeling was emphasized in the medical officer training, and I had an opportunity to learn more about labeling requirements for the "Pregnancy, Lactation, and Females and Males of Reproductive Potential" subsection of prescription drug and biological product labels. As a physician, it is easy to underestimate the wealth of information that is contained in the label for an approved therapy. Not only did I learn about the labeling process, I had an opportunity to meet with labeling experts Vol. 1, No. 1


and can truly appreciate the attention to detail paid to the creation of labels for an approved therapy. I was given opportunities to attend meetings with our industry counterparts, which allowed me to witness the collegial interaction between the FDA and industry as they collaborate to bring safe and effective new drugs to market. As a part of my fellowship, I met one on one with experts throughout the FDA on a variety of topics. Specifically, I had meetings with several experts involved in designating policy on orphan diseases, and learned about the grant programs the FDA has in place for investigators interested in rare diseases. In addition, I spent part of my time with the medical officers who regulate fecal microbiota transplants in the Center for Biologic Evaluation and Research, along with the GI division within the Center for Devices and Radiological Health (CDRH). At CDRH, I learned about the regulation of the device industry, and how it differs from the regulation of the pharmaceutical industry. The team showed me the innovative ideas they are helping to implement for reducing duodenoscope infections and reducing complications of enteric feeding tubes. The FDA also offers the important Advisory Committee program. I attended an advisory committee meeting on the opioid epidemic and the expansion of the availability of opioid reversal agents. Advisory committee membership is both an interesting and exciting way for physicians to be involved with FDA-related matters, and to contribute to the process of protecting Americans’ health and safety, by letting the medical community’s voice be heard. One of the most significant things I learned at the FDA was the utmost importance of defining appropriate outcome assessments for clinical trials. I completed a project evaluating the literature on the use of endoscopic outcome assessments in Crohn’s disease clinical trials, and had an opportunity to present my findings at a Division-wide meeting. My findings will hopefully be incorporated into future guidance for industry on designing appropriate outcome measures for Crohn’s clinical drug trials. I would like to thank all of the wonderful people at the ACG and the FDA for making my experience incredibly rewarding. I sincerely hope to have the opportunity to collaborate in the future.

3rd Annual

SCOPY AWARDS SUBMIT YOUR ENTRIES

GI.ORG/SCOPY DEADLINE MAY 31, 2017

Kendall R. Beck, MD, University of California, San Francisco

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ACG MAGAZINE // 47


COMMITTEES IN ACTION: TRAINING // COMMITTEES IN ACTION

Learning and Carrying Skills Forward

Reflections from an ACG International GI Training Grant Recipient Oriol Sendino Garcia, MD, PhD, University of Barcelona, Hospital Clinic of Barcelona, Barcelona, Spain

As a GI physician at Hospital Clinic in Barcelona, Spain, I did my fellowship on endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP), with Dr. Angels Gines, Coordinator of the European Group for Endoscopic Ultrasonography, and Dr. Andres Cardenas, respectively. Over the last few years, our department undertook a profound functional renewal of clinical and research settings. I was assigned to the important task of developing new areas of interest in interventional endoscopy. Our center is one of the most important European centers in liver diseases and liver transplantation, and is a Spanish reference center in pancreatic surgery There was significant interest in developing EUS-guided interventional procedures such as EUS-guided pancreatic fluid collections drainage, EUS-guided biliary and pancreatic duct drainage, or EUS-guided angiotherapy. These procedures are safe, efficient and provide significant advantages over percutaneous transhepatic cholangiography or surgical drainage. The avoidance of more-invasive procedures results in substantial health care cost savings and improved quality

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of life. However, these procedures are technically complex and should be confined to major referral centers. I was selected to attend the International Scholars Program in Advanced Endoscopy at California Pacific Medical Center (CPMC) for a period of 12 months, between March 2014 and April 2015. The purpose of my stay at CPMC was to both hone and provide the necessary skills to perform these interventional procedures, and then develop this particular area at my center. The International Scholars Program at CPMC offered training under the supervision of Dr. Kenneth Binmoeller and his fantastic group of endoscopists and nurses, including Dr. Janak Shah, Dr. Yasser Bhat and Dr. Chris Hamerski. Dr. Binmoeller is world renowned for his expertise in interventional endoscopy. Furthermore, he is the creator of a luminal apposing metal stent which, in my opinion, has started a new era in interventional endoscopy. The training program included a broad spectrum of interventional endoscopic procedures. This resulted in the performance of approximately 500 EUS-FNA, 250 ERCP, 60 EUSguided interventional procedures, and a significant number of other techniques such as endoscopic closure of gastrointestinal defects, underwater resection of colonic polyps, and endoscopic therapy of subepithelial lesions, among other procedures.

The research block included the data collection, data analysis and manuscript of two studies about closure of GI defects and suture of esophageal stents by means of a novel endoscopic suturing system. These studies were presented as posters at Digestive Disease Week 2015. Manuscript of these works is ongoing, and I am hopeful they will be accepted for publication in the future. I would like to thank Dr. Binmoeller for giving me this opportunity. In my opinion, there are four important aspects to becoming a good endoscopist: medical knowledge, technical skills, experience i.e., number of procedures, and learning from the best masters. My stay at CPMC gave me the opportunity to grow in all of these areas. Now, a year later, I can say that we are developing this area at the Hospital Clinic of Barcelona. We have successfully performed several cases of EUS drainage of pancreatic fluid collections and some cases of EUSguided biliary drainage. Furthermore, I made a speech at the Spanish Association of Gastroenterology about interventional EUS. Finally, I would like to sincerely thank the ACG for the opportunity to have this amazing experience at CPMC. The experience allowed me to grow as a physician and as a person.

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A peer-reviewed, open-access journal edited exclusively by gastroenterology and hepatology fellows. • Indexed on PubMed, Web of Science, and others

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American College of Gastroenterology & World Gastroenterology Organisation present the

WORLD CONGRESS of GASTROENTEROLOGY @ ACG2017in ORLANDO, FLORIDA

Orange County Convention Center | October 13–18, 2017

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What to KNOW 1

More state legislatures are making it difficult for physician groups to restrict employed physicians from competing with them after they leave the group to start their own practice or work for a competitor.

2

Employers should strategize options other than noncompetes to restrict post-employment competition, such as exclusive relationships with facilities and insurers and “clean sweep” and nonsolicitation provisions in employment agreements.

3

Regardless of state law, entrepreneurial physicians should be aware of practical barriers blocking their opportunities to start their own practices, such as tail insurance costs, medical records costs, the Health Insurance Portability and Accountability Act of 1996 (HIPAA), and medical staff issues.

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// LAW MIND

ENFORCING AND AVOIDING

NON-COMPETE AGREEMENTS By Ann M. Bittinger, JD, Bittinger Law Firm

NEW LAWS IN NEW ENGLAND HAVE MANY WONDERING if a national trend is emerging to illegalize physician non-compete agreements, leaving practice owners searching for ways to protect their practices. Physicians have dueling interests in non-competes. As to their personal professional freedom, they oppose non-competes. However, as physician group owners, non-competes—or reasonable tools like them, as this article explains in greater detail below—are necessary to maintain a thriving group practice.

WHAT IS A NON-COMPETE?

A non-compete agreement, also referred to as a covenant against competition, is a contract between a physician and his or her employer. In exchange for the benefits that accompany employment, the physician agrees that for a period after the employment ends, he or she will not practice medicine in certain areas for a certain time. In most states, a court will enforce reasonable non-compete terms in a signed employment agreement. In my practice in Florida, almost all physician employment agreements I draft or review contain non-competes. Non-competes consist of three components: geography, time and prohibited type of work. Geography The physician may be prohibited from working a certain mileage radius from a location(s) at which the physician worked or from the employer-operated locations. Delineations by county name or zip code are common. Time Period The physician may be prohibited from working a certain amount of time after termination of the relationship in the geographic area. Generally, we see periods range from six months to two years. In Florida, for example, statute mandates that judges presume non-competes are illegal if they are more than two years long. The fact of the matter is that if the patient-physician relationship is cut off for more than six months in most specialties, physicians lose those patients forever, so a length longer than six months may not matter.

Prohibited Type of Work It is important to scrutinize what type of work is prohibited. It may be the practice of medicine entirely. It may be a specialty. It may be described more generally as “any act that is competitive with the Employer.” Hospitalowned groups often allow physicians to leave and compete on their own but prohibit them from working in association with or for a competing hospital system. The rationale for this last approach is that if the physicians leave and go out on their own, they will still do cases at and refer patients to the hospital, but if they become an employee of a competing hospital system the referrals will go to that competing system.

IS SOLICITATION THE SAME AS COMPETITION?

Usually prohibitions against solicitation of patients accompany the prohibitions against competition. They are two distinct prohibitions. Solicitation involves directly seeking out a patient and asking the patient to follow the physician to the new practice. It usually entails the departing physician taking a list of patients—something many states consider trade secrets that employed physicians have no right to for purposes of solicitation—and calling, emailing or sending letters to them. Solicitation typically does not include indirect contact, like websites and advertising. Unless prohibited via contract, there is generally nothing wrong in most states with a departing physician telling patients of his or her new work arrangement, so long as doing so does not involve stealing lists of patients, their phone numbers and addresses.

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NEW LAWS

This background on the three components helps in understanding the new laws. Rhode Island The Rhode Island governor signed a law in July that restricts non-competes unless related to a practice sale. There are few nuances to the law. It makes illegal any contractual agreement restricting a physician’s right to practice medicine in any geography area for any period of time. The law maintains a physician’s right to provide treatment, advise, consult with or establish a physician/patient relationship with any current patient of the employer. Furthermore, it makes illegal any acts to solicit or to seek to establish a physician/ patient relationship with the former employer’s patients. Massachusetts Non-competes have been illegal in Massachusetts for many years. Connecticut Less restrictive is a new law in Connecticut, which took effect this summer. It is much more nuanced and subject to loopholes than the prohibitions in Rhode Island or Massachusetts, including: • They cannot be more than one year. • They cannot be more than 15 miles, and that 15 miles can extend only from the location where the physician generated most of his or her revenue. In other words, prohibitions of “x” miles from any location at which the employer has an office or any location at which the physician worked—both of which are common provisions in Florida and many states—are illegal in Connecticut. • The provision can be enforced only if made in anticipation of a partnership or ownership agreement. This is interesting for non-physician-owned employers, which are gaining market share in the health care industry.

THE FUTURE

It will be interesting to see if physician employers have an easier time recruiting physicians to their practices in Connecticut, Rhode Island and Massachusetts as compared with other states, as the fact of no non-compete may be appealing to recruits. Where do these changes leave physician groups in these states? How can groups in other states act

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to protect their practices in anticipation of similar changes in their states? And what are entrepreneurial physicians’ options after they sign non-competes in states that allow the prohibitions? Exclusive Arrangements If a physician is prohibited by something other than an employment agreement’s non-compete provision from working at a facility then that physician cannot, in effect, compete. For example, a hospitalist group that has an agreement with a hospital to be the exclusive provider of hospitalist services does not really need a non-compete agreement with the employed hospitalist. The effect of the covenant against competition arises from the fact of the physician-group exclusive agreement. Medical Staff Bylaws It is important to remember that the relationship between employer and employee is a separate and distinct legal relationship from the relationship between medical staff member and a hospital or surgery center by way of the medical staff bylaws. For many specialties, there is protection against competition if the physician loses his or her privileges at the hospital in the event employment terminates. These often take the form of exclusive arrangements described above. They also take the form of “clean sweep” provisions. These provisions—crafted into employment agreements to prevent a coup by a subset of physicians in the group to end a current group-hospital relationship—say that a physician automatically loses his or her privileges or will resign from the medical staff at a hospital upon termination of the employment relationship. This may be a loophole around the new laws. The employment agreement could say that upon termination of employment, the surgeon will resign from the medical staff of the hospital and the physician signs a power of attorney at the time of executing the employment agreement that allows the employer to send a resignation letter to the hospital medical staff director on the employed physician’s behalf. Controlled Settings Surgeons can utilize this type of loophole by focusing all or most of their surgeries at surgery centers that they control. Similarly, in controlling the endoscopy center market, gastroenterologists

make it more difficult for a physician to leave the group and start his or her own practice, because the center is essential to the specialty and is expensive to build on one’s own. These sorts of specialtyspecific controls of practice settings have the strategic and practice effect of stifling the entrepreneurial efforts of a physician employee to compete.

OPERATIONAL ISSUES

It is very difficult for a physician to start a practice from scratch. If the physician is cut off from communication with patients, it is hard to let patients know of a new, competing practice. Groups and departing physicians can focus on the following as ways to make it easier or more difficult to leave and compete: Phone Numbers The ability of a physician to leave a group and take his practice phone number with him is a great tool for the departing physician to maintain contact with his or her patients. If a physician leaves a group, does he or she have the ability to take the practice phone number? Can the physician cut off the number, or is it controlled by the group? Although risky and perhaps burdensome for other reasons, if the patient has the physician’s cell phone number, it will be easy for the patient to find the physician after he or she leaves the practice. A group may consider banning physicians from patient contact via cell phone. Website The best advice I can give a departing physician with regard to non-competes is to spend good money on a website and search engine optimization. If a physician is setting up shop legally, just outside the geographic area, immediately following termination, the patients need to be able to find the physician. An excellent website that allows patients to find the physician’s phone number with a simple google search is crucial to the departing physician. Letters Groups should be agile enough to be able to generate letters or emails through their patient portal to notify their patients that even though the physician is departing, another physician at the group will still see the patient. Dedicating an employee to contact all patients who have appointments with the physician and

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// LAW MIND

reassign the patients and reschedule them is worth the investment. On the other hand, if a physician can negotiate the right to contact patients with letters that say his or her new location, that would alleviate the concerns about theft of trade secrets in using patient lists. Physicians may be able to negotiate this during the off-boarding period in exchange for staying employed at the group for longer than the physician has to or in exchange for some other benefit to the group. Social Media I often have physicians ask me if they can contact patients via Facebook or otherwise advertise their new practice on social media. This depends on the solicitation provisions of the contract and the methodology of the relationship under the social media platform. A departing physician whose new information is easily available on Facebook to the public will have an easier time transitioning his or her practice. Having patients as Facebook friends may pose other difficulties as to solicitation. Appointment Scheduler The appointment scheduler is possibly the most important person involved in steering patients once a physician leaves a practice. Groups should give the scheduler a script of what to say when patients call to schedule with the departing doctor. The departed doctor should try to see if the group would allow the scheduler to give out the physician’s new contact information to patients. Payers Although this may change with the new presidential administration, the Affordable Care Act (ACA) has had the effect of creating new types of health maintenance organization-like relationships between physician groups and insurance companies. Insurers are also narrowing networks of physicians within specialties, meaning that insurers are lowering the number of physicians allowed to see their insureds as patients. If a physician leaves a group to start his own practice and cannot get a contract with one of the major insurance companies, that physician’s new practice will not survive. Physician groups facing laws against non-competes may want to work with payers to be the exclusive provider of services within their specialty for different products that the insurer provides. For

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 NON-COMPETE ENFORCEABILITY State law controls non-competes. Despite legislative changes in New England, in most states non-competes are enforceable if they are reasonable.

 GEOGRAPHY The prohibited area should match the practice’s primary service area.

 TIME Courts generally find non-competes reasonable if they prohibit competitive work between six months and two years.

 TYPE OF WORK The restricted work usually must be the type of work the practice performs—patient care in a certain specialty.

example, perhaps in exchange for certain fees for services or certain collaboration to promote ACArelated models (like accountable care organizations or medical homes), the insurer would agree that all of its insureds would be sent to the group (and all other providers would be non-participating or nonnetworked providers). We are already seeing deals like these being done between insurers and physician groups, regardless of the trend against non-competes. Tail Insurance In many states for many specialties, tail insurance costs tens of thousands of dollars. Tail insurance is the insurance that must be purchased to cover a physician for claims that arise after the physician leaves the employer for acts that occurred while the physician was employed under a claims-made policy. An employment agreement provision that mandates that when the physician leaves, the physician must buy tail insurance has a stifling effect on physicians leaving and competing. It adds tens of thousands of dollars to their start-up costs. Records Ownership If a physician can negotiate into his or her employment agreement the right to free copies of all patients’ medical records upon termination of employment, that makes it easy to stay in touch with patients and avoids the argument that the physician stole a trade secret in the form of a patient list or records. It also eases the transition into seeing new patients, as there is a huge risk management issue in continuing to see a patient without having the prior medical records. HIPAA allows a practice up to 60 days to send records pursuant to a patient’s authorization to a newly departed and now-competing physician. I have seen practices deliberately delay sending patients’ records to the newly competing physician to stifle the patient’s ability to receive follow-up care from the new competitor. Statutes and case law interpretations of non-competes are very state-specific. This article is a general overview of components of typical non-compete provisions and practical steps to take, which may or may not be enforceable in certain states in certain settings. Seeking out the expertise of an attorney experienced not in employment law but in physician business transactions is crucial to developing a strategic plan to reasonably protect the practice from competition. Physicians desiring to leave their employers and establish their own practice should consult with a physician business attorney to strategize the departure process risks.

Ms. Bittinger represents physicians and physician groups in transactions with other entities and with compliance with federal health care laws and in structuring their independent practices. Questions? Email ann@bittingerlaw.com

ACG MAGAZINE // 53


Practical Advice from a Seasoned Clinician by Seymour Katz, MD, MACG

Remember to listen to that quiet voice inside all of us that indicates the right choice to be taken. Don’t be led astray by shortcuts or questionable tactics. You can “never do the wrong thing the right way.” 1 Work The master word in medicine is “work,” according to Sir William Osler at the beginning of the 20th century1 and by Dean Robert Grossman at his 2015 NYU School of Medicine commencement address.2 As pedestrian as it sounds, there are no shortcuts to achieving proficiency in the practice of medicine. Do not shy away from hard tasks. Once accepted and completed, there will be both a sense of fulfillment and yes…joy. Look for challenges, not guarantees.

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2 Aequanimitas3 Keep your “cool,” i.e., composure, no matter how frustrating, insulting or threatening an apparent insurmountable barrier may be. Losing your temper or control in front of patients or colleagues disenfranchises you as a competent, caring physician. 3 Don’t be Afraid to Fail We learn the most from our failures, and you will fail at some tasks. Do not whine or bemoan your fate with problemsolving. Try not to repeat the mistake and move on.

4 You Can’t Do It All A task may indeed seem impossible to complete but remember: It is not incumbent on you to complete the task of mending the world, but you are not free from trying to do your part (Ethics of the Fathers 2:16). 5 Perpetual Student Your competence will be enhanced only by a continued effort to review and study the literature and attend teaching sessions and discussions with key opinion leaders. Compartmentalize your time to permit this “continued education” throughout your career.

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7 Family First As tired or frustrated as you may be with some daily events, when arriving home put all that baggage on the “back burner” and begin inquiries to your family’s activities and needs of the day. There will never be peace in your daily routine if there is no peace at home.

6 When Things Go Wrong Learn to accept in silence the minor aggravations that are inevitable in your daily routine. Things cannot always go your way. Prioritize your energy and ask if this disturbance is worth your time, energy and diversion from the work at hand.

8 You Can’t Do Your Job Alone Remember those around you who help, assist or mentor you. Think back to such assistance and “give back” in support or even as a compliment to those who have impacted your life’s activities. Be kind and not patronizing to patients and colleagues and to all in your network and at every level of involvement. 9 Passion and Nobility Continue to be passionate about your role in medicine. Remember what drove you to become a physician. It is a noble profession, and you “stand on the shoulders” of all those in medicine who preceded you.

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10 Vision-Task-Dream “A vision without a task is but a dream, a task without vision is drudgery, but a vision with a task is the hope of the world.” On the cornerstone of a church in England, dated 1730 (courtesy of Anne-Louise Oliphant).

1 Osler, Sir William. The Master Word in Medicine. Address to undergraduates, University of Toronto, 1903. 2 Grossman, Robert MD: Dean’s Commencement Address, New York University School of Medicine, 2015. 3 Osler, Sir William: Aequanimitas. Valedictory Address, University of Pennsylvania May 1, 1889.

Seymour Katz, MD, MACG. Dr. Katz has been a practicing gastroenterologist since 1971 and a member of the College since 1977. He served as ACG President from 1995 to 1996. He is affiliated with North Shore-Long Island Jewish Medical Center and NYU Langone Medical Center.

ACG MAGAZINE // 55


give. We allr

and we give , ts en l ta We give our time, . ns a ci si y h p s a re tu na r ou in is se it our money, becau we give our

use we know In the end, we give beca

that it

will help the lives of others.

our chosen have decided to support I d an l, na rso pe is y Philanthrop fortunate to be ful way possible. We are ing an me st mo the in n professio , knowing that y and care for GI patients og rol nte oe str ga ce cti able to pra is dependent on ctice gastroenterology pra to y ilit ab r ou of the future o our world. ents and techniques int atm tre w ne ng bri t tha s innovation

ry, and then rch, followed by discove Innovation means resea clinical research ilanthropic funding of ph g rin cu Se n. tio nta impleme can College of nt missions of the Ameri rta po im st mo the of e er is on s that have occurred ov think of the innovation G Gastroenterology­—just by supporting the AC proud to pay it forward the last 30 years! I am ite you to join with and Education, and I inv rch sea Re cal ini Cl for Institute nts. ility to care for our patie me in improving our ab D, FACG Harry E. Sarles, Jr., M 13–2014 ACG Past President 20 Garland, TX

Ways to Give

Institute. on mission of the ACG ati uc ed d an rch ea res d support the MAGAZINE, or you can Join Dr. Harry Sarles an ed in this issue of ACG ert ins e lop ve en the ing Please consider a gift us i.org/donate. t online at members.g gif ble make a tax-deducti

to promote earch and Education is y Institute for Clinical Res log ero ent stro Ga of and innovation in e ch an Colleg support clinical resear The mission of the Americ patient and the public, to the n, icia clin the of education digestive disease. digestive health through ness about prevention of and to raise public aware y, log ato hep and y log gastroentero

Make a tax-deductible

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gift today: members.g


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// REACHING THE CECUM

A Look Back

TOBACCO ENEMA Robert E. Kravetz, MD, MACG Scottsdale, AZ

The enema, or clyster, has played a major role in promoting health throughout the history of civilization. It has been recommended for its restorative as well as its healing qualities. The many forms that it has taken have depended upon the prevailing social attitudes and customs that were present at various times in history.

58 // ACG MAGAZINE

One of the most unusual devises in the “annals of enematology” has been the tobacco enema, similar to the one illustrated here. This bellows-operated tobacco enema is made of wood, leather, brass and ivory. Four bottles contained cordial mixture, spirits of hartshorn, camphorated spirits, and emetic tartar. It is fitted in a mahogany case lined with green baize, circa 1790. These medications were prescribed orally in conjunction with the administration of the enema (device supplied courtesy of Fleet Pharmaceuticals).

Tobacco fumes were proposed as a laxative in 1643. This bellowsoperated tobacco enema is the type recommended by the Royal Humane Society of London in 1774. “It is not only the admission of kindly warmth into the internal parts of the body, which proves advantageous, but it is a stimulus to excite irritability and to restore the languid peristaltic motion of the intestines.” This archival reflection originally appeared in The American Journal of Gastroenterology in 2002.

Vol. 1, No. 1


IMPORTANT SAFETY INFORMATION SUPREP® Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Solution is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults. Most common adverse reactions (>2%) are overall discomfort, abdominal distention, abdominal pain, nausea, vomiting and headache. Use is contraindicated in the following conditions: gastrointestinal (GI) obstruction, bowel perforation, toxic colitis and toxic megacolon, gastric retention, ileus, known allergies to components of the kit. Use caution when prescribing for patients with a history of seizures, arrhythmias, impaired gag reflex, regurgitation or aspiration, severe active ulcerative colitis, impaired renal function or patients taking medications that may affect renal function or electrolytes. Use can cause temporary elevations in uric acid. Uric acid fluctuations in patients with gout may precipitate an acute flare. Administration of osmotic laxative products may produce mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Patients with impaired water handling who experience severe vomiting should be closely monitored including measurement of electrolytes. Advise all patients to hydrate adequately before, during, and after use. Each bottle must be diluted with water to a final volume of 16 ounces and ingestion of additional water as recommended is important to patient tolerance.

BRIEF SUMMARY: Before prescribing, please see full Prescribing Information and Medication Guide for SUPREP® Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Solution. INDICATIONS AND USAGE: An osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults. CONTRAINDICATIONS: Use is contraindicated in the following conditions: gastrointestinal (GI) obstruction, bowel perforation, toxic colitis and toxic megacolon, gastric retention, ileus, known allergies to components of the kit. WARNINGS AND PRECAUTIONS: SUPREP Bowel Prep Kit is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults. Use is contraindicated in the following conditions: gastrointestinal (GI) obstruction, bowel perforation, toxic colitis and toxic megacolon, gastric retention, ileus, known allergies to components of the kit. Use caution when prescribing for patients with a history of seizures, arrhythmias, impaired gag reflex, regurgitation or aspiration, severe active ulcerative colitis, impaired renal function or patients taking medications that may affect renal function or electrolytes. Pre-dose and post-colonoscopy ECG’s should be considered in patients at increased risk of serious cardiac arrhythmias. Use can cause temporary elevations in uric acid. Uric acid fluctuations in patients with gout may precipitate an acute flare. Administration of osmotic laxative products may produce mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Patients with impaired water handling who experience severe vomiting should be closely monitored including measurement of electrolytes. Advise all patients to hydrate adequately before, during, and after use. Each bottle must be diluted with water to a final volume of 16 ounces and ingestion of additional water as recommended is important to patient tolerance. Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted. It is not known whether this product can cause fetal harm or can affect reproductive capacity. Pediatric Use: Safety and effectiveness in pediatric patients has not been established. Geriatric Use: Of the 375 patients who took SUPREP Bowel Prep Kit in clinical trials, 94 (25%) were 65 years of age or older, while 25 (7%) were 75 years of age or older. No overall differences in safety or effectiveness of SUPREP Bowel Prep Kit administered as a split-dose (2-day) regimen were observed between geriatric patients and younger patients. DRUG INTERACTIONS: Oral medication administered within one hour of the start of administration of SUPREP may not be absorbed completely. ADVERSE REACTIONS: Most common adverse reactions (>2%) are overall discomfort, abdominal distention, abdominal pain, nausea, vomiting and headache. Oral Administration: Split-Dose (Two-Day) Regimen: Early in the evening prior to the colonoscopy: Pour the contents of one bottle of SUPREP Bowel Prep Kit into the mixing container provided. Fill the container with water to the 16 ounce fill line, and drink the entire amount. Drink two additional containers filled to the 16 ounce line with water over the next hour. Consume only a light breakfast or have only clear liquids on the day before colonoscopy. Day of Colonoscopy (10 to 12 hours after the evening dose): Pour the contents of the second SUPREP Bowel Prep Kit into the mixing container provided. Fill the container with water to the 16 ounce fill line, and drink the entire amount. Drink two additional containers filled to the 16 ounce line with water over the next hour. Complete all SUPREP Bowel Prep Kit and required water at least two hours prior to colonoscopy. Consume only clear liquids until after the colonoscopy. STORAGE: Store at 20°-25°C (68°-77°F). Excursions permitted between 15°-30°C (59°-86°F). Rx only. Distributed by Braintree Laboratories, Inc. Braintree, MA 02185.

For additional information, please call 1-800-874-6756 or visit www.suprepkit.com

©2016 Braintree Laboratories, Inc. All rights reserved.

16-00927A

August 2016


1 MOST PRESCRIBED, BRANDED BOWEL PREP KIT1 #

2

FIVE-STAR EFF1CACY ® WITH SUPREP Distinctive results in all colon segments >90% no residual stool in all colon segments compared to Standard 4-Liter Prep2*†‡ • These results were statistically significant in the cecum (P=.010)2*§ • Significantly more patients in the SUPREP group had no residual fluid in 4 out of 5 colon segments2*‡ Help meet the Gastroenterology Quality Improvement Consortium (GIQuIC) benchmark for 85% quality cleansing3 with the split-dose efficacy of SUPREP Bowel Prep Kit.4 *This clinical trial was not included in the product labeling. †Standard 4-Liter Prep [sulfate-free polyethylene glycol (PEG) electrolyte lavage solution]. ‡Based on investigator grading. §Statistically significant difference. References: 1. IMS Health, NPA Weekly, July 2016. 2. Rex DK, Di Palma JA, Rodriguez R, McGowan J, Cleveland M. A randomized clinical study comparing reducedvolume oral sulfate solution with standard 4-liter sulfate-free electrolyte lavage solution as preparation for colonoscopy. Gastrointest Endosc. 2010;72(2):328-336. 3. Rex DK, Schoenfeld PS, Cohen J, et al. Quality indicators for colonoscopy. Gastrointest Endosc. 2015;81(1):31-53. 4. SUPREP Bowel Prep Kit [package insert]. Braintree, MA: Braintree Laboratories, Inc; 2012.

©2016 Braintree Laboratories, Inc. All rights reserved.

16-00927A

August 2016


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