ACG MAGAZINE | Vol. 3, No. 2 | Summer 2019

ACG MAGAZINE Summer 2019

MEMBERS. MEDICINE. MEANING.

Food

FOR

THOUGHT

A M E R I C A N

C O L L E G E

O F

G A S T R O E N T E R O L O G Y

Annual Scientific Meeting & Postgraduate Course Henry B. Gonzalez Convention Center, San Antonio, TX OCTOBER 25–30, 2019

REGISTER NOW! Learn the latest in clinical practice, exchange ideas with colleagues, and gain insight from the experts at the ACG 2019 Annual Scientific Meeting and Postgraduate Course.  Housing Deadline: Wednesday, October 2, 2019  Preregistration Deadline: Friday, October 18, 2019

 LEARN MORE: ACGMEETINGS.GI.ORG

SUMMER 2019 // VOLUME 3, NUMBER 2

FEATURED CONTENTS TRIALS WITHOUT TRIBULATIONS

Ann M. Bittinger, Esq. on pursuing clinical research for ancillary income PAGE 22

LEARNING TO EAT

COVER STORY

FOOD FOR THOUGHT

The intersection of food & nutrition with GI health and disease PAGE 24

Patricia L. Raymond, MD, FACG on her journey with a whole food plant based diet PAGE 29

IN MEMORIAM

The ACG remembers Barbara B. Frank, MD, MACG PAGE 10

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Attend an upcoming

ACG POSTGRADUATE COURSE 2019 ACG’s IBD School & Midwest Regional Postgraduate Course  Hyatt Regency Bloomington | Minneapolis, MN  August 16–18, 2019

ACG’s Functional GI Disorders School & ACG/VGS/ODSGNA Regional Postgraduate Course

NEW!

Functional GI Disorders School

 Williamsburg Lodge | Williamsburg, VA  September 6–8, 2019

ACG 2019 Annual Scientific Meeting and Postgraduate Course  Henry B. Gonzalez Convention Center | San Antonio, TX  October 25–30, 2019 • • • • •

Roadmap for a Successful Community or Academic GI Practice | October 25 GI Pharmacology Course | October 25 GI Pathophysiology Course | October 25 Postgraduate Course | October 26–27 Annual Scientific Meeting | October 28–30

ACG’s Hepatology School & Southern Regional Postgraduate Course  Omni Louisville | Louisville, KY  December 6–8, 2019

2020 ACG’s Functional GI Disorders School & Bridging the Leadership Gap in Gastroenterology Course

NEW!

Leadership Course

A project of the ACG Women in GI Committee  Marriott Marquis | San Diego, CA  January 10–12, 2020

ACG’s IBD School & ACG Board of Governors / ASGE Best Practices Course  The Bellagio | Las Vegas, NV  January 24–26, 2020

ACG/LGS Regional Postgraduate Course  Hilton New Orleans Riverside | New Orleans, LA  March 6–8, 2020

ACG/FGS Annual Spring Symposium  Hyatt Regency Coconut Point | Naples, FL  March 13–15, 2020

FOR MORE INFO, VISIT: GI.ORG/ACG-COURSE-CALENDAR

SUMMER 2019 // VOLUME 3, NUMBER 2

CONTENTS

“In our clinic, the FODMAP diet is our first-line approach for the majority of patients with IBS who require intervention for their symptoms. Integral to the success of this approach is our team of highly skilled dietitians who see patients two to three times.”

—Professor Peter Gibson, "Food for Thought" PG 24

6 // MESSAGE FROM THE PRESIDENT

24 // COVER STORY

41 // INSIDE THE JOURNALS

Dr. Sunanda Kane on her experience with the ACG Governors in Washington, DC and why physicians must have their voices heard on Capitol Hill.

FOOD FOR THOUGHT The intersection of food & nutrition with GI health and disease. Featuring contributions from Dr. Raymond, Dr. Bass, and Dr. Gibson.

42 AJG Why It Is Time for New Practice Guidelines for Ulcerative Colitis

7 // NOVEL & NOTEWORTHY

33 // ACG PERSPECTIVES

Awardees, College News, CRC awareness, In Memoriam for Barbara Frank, and more.

15 // PUBLIC POLICY GOVERNORS’ VANTAGE POINT ACG's Board of Governors and Young Physician Leadership Scholars join forces on Capitol Hill.

19 // GETTING IT RIGHT 19 BUILDING SUCCESS Dr. Stephen T. Amann and Dr. Brian B. Baggott discuss Reviewing and Updating the Informed Consent Process in your Practice

43 AJG "How I Approach It" Low FODMAP Diet: What Your Patients Need to Know

A COLLABORATIVE APPROACH TO DIETARY MANAGEMENT OF EOE In this patient perspective, written by Jacqueline Gaulin, Dr. Evan Dellon and Lori Eaton share insights about Eaton's unique case, and how they collaboratively manage her EoE.

43 CTG Home Blenderized Tube Feeding: A Practical Guide for Clinical Practice

37 // EDUCATION

44 // REACHING THE CECUM

EDGAR ACHKAR VISITING PROFESSORS Highlights from Eamonn M. M. Quigley, MD, MACG, Stephen B. Hanauer, MD, FACG, and Dr. Amy Oxentenko's Edgar Achkar Visiting Professorships.

43 ACGCRJ Pumpkin Seed Bezoar Causing Lower Gastrointestinal Bleeding

A LOOK BACK: MEDICATED PRUNES For over 2,000 years, various foods and diets, including prunes, have played a major role in treating a variety of diseases and symptoms.

22 LAW MIND Pursuing Clinical Research for Ancillary Income by attorney Ann Bittinger.

Photo Top: Image courtesy of Professor Peter Gibson. Photo Previous Page: Image courtesy of Lori Eaton.

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ACG MAGAZINE MAGAZINE STAFF

CONNECT WITH ACG

Executive Director Bradley C. Stillman, JD

youtube.com/ACGastroenterology

Editor in Chief; Vice President, Communications Anne-Louise B. Oliphant Copy Editors; Staff Writers Sarah Richman Jil Staszewski Lindsey Topp Art Director Emily Garel

facebook.com/AmCollegeGastro

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bit.ly/ACG-Linked-In

Graphic Designer Antonella Iseas

CONTACT

BOARD OF TRUSTEES President: Sunanda V. Kane, MD, MSPH, FACG President-Elect: Mark B. Pochapin, MD, FACG Vice President: David A. Greenwald, MD, FACG Secretary: Daniel J. Pambianco, MD, FACG Treasurer: Samir A. Shah, MD, FACG Immediate Past President: Irving M. Pike, MD, FACG

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

Past President: Carol A. Burke, MD, FACG Director, ACG Institute: Nicholas J. Shaheen, MD, MPH, FACG Co-Editors, The American Journal of Gastroenterology: Brian E. Lacy, MD, PhD, FACG

DIGITAL EDITIONS

GI.ORG/ACGMAGAZINE

Brennan M. R. Spiegel, MD, MSHS, FACG Chair, Board of Governors: Neil H. Stollman, MD, FACG Vice Chair, Board of Governors: Patrick E. Young, MD, FACG Trustee for Administrative Affairs: Delbert L. Chumley, MD, FACG

ACG MAGAZINE Spring 2019

MEMBERS. MEDICINE. MEANING.

Profiles in Courage IN The Fight Against Colorectal Cancer

ACG MAGAZINE Spring 2019

MEMBERS. MEDICINE. MEANING.

TRUSTEES

Profiles in Courage IN The Fight Against Colorectal Cancer

Jean-Paul Achkar, MD, FACG William D. Chey, MD, FACG Immanuel K. H. Ho, MD, FACG Caroll D. Koscheski, MD, FACG Paul Y. Kwo, MD, FACG Jonathan A. Leighton, MD, FACG Amy S. Oxentenko, MD, FACG David T. Rubin, MD, FACG John R. Saltzman, MD, FACG Renee L. Williams, MD, MHPE, FACG

4 | GI.ORG/ACGMAGAZINE

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.

CONTRIBUTING WRITERS

Stephen T. Amann, MD, FACG Dr. Amann is a partner at Digestive Health Specialists, PA in Tupelo, MS and is a member of ACG's Practice Management Committee

Jeff D. Scott, MD Dr. Scott practices gastroenterology at Digestive Disease Specialists in Oklahoma City, OK and with his wife, Marisa, developed Happy Colon Foods™

Brian B. Baggot, MD, FACG Dr. Baggott is Section Head of General Gastroenterology and Director of Ambulatory GI Operations at the Cleveland Clinic

Ann M. Bittinger, Esquire Ms. Bittinger is a health law expert at Bittinger Law Firm in Jacksonville, FL. She regularly contributes to ACG's publications on her areas of expertise, including legal relationships between hospital systems and physicians or physician groups (bittingerlaw.com)

Jacqueline Gaulin Ms. Gaulin is founder of Gastro Girl, Inc., a patient-centric online platform providing GI patients with the support they need. She consults with ACG and supports ACG's GI Circles communities

Kathryn Scarlata, RDN, LDN A Boston-based registered and licensed dietitian with 25+ years of experience, Ms. Scarlata specializes in the low FODMAP diet and digestive health conditions

Robert E. Kravetz, MD, MACG

Millie D. Long, MD, MPH, FACG

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 publishing the ACG 75th Anniversary history in 2007.

Read about ACG’s History at gi.org/about/acgs-history

Dr. Long is Associate Professor of Medicine at the University of North Carolina at Chapel Hill.

She is Chair of ACG's Research Committee

Caroline Weeks, RDN, LD Ms. Weeks is a Registered Dietitian Nutritionist for the Mayo Clinic Children's Center in Rochester, MN

Peter Gibson, MD Peter Gibson is Professor of Gastroenterology at Monash University and Director of the Department of Gastroenterology at the Alfred Hospital in Melbourne, Australia

Patricia L. Raymond, MD, FACG

David T. Rubin, MD, FACG Dr. Rubin, a Trustee of the College, is the Joseph B. Kirsner Professor of Medicine and Section Chief, Gastroenterology, Hepatology and Nutrition at the University of Chicago

Dr. Raymond is a gastroenterologist with Gastroenterology Consultants, a division of Gastrointestinal and Liver Specialists of Tidewater PLLC in Virginia Beach, VA and an Assistant Professor of Clinical Internal Medicine at Eastern Virginia Medical School in Norfolk, VA

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Of course I knew that our Governors went to DC every year on behalf of the College and all clinical gastroenterologists. But those were just words on a page to me until this April when I had the privilege of participating in the program as your President.

Having never done this before, I was nervous that I would not know what to do. Thankfully, after an orientation by the Governors’ Chair, Dr. Neil Stollman, and Vice Chair, Dr. Patrick Young, and completing some homework assignments on ACG’s key priorities and how to approach Hill visits most effectively, I was ready to spread the gospel on the importance of colorectal cancer screening and explain to lawmakers how the language of the ACA needs to be edited so as to eliminate surprise co-pays for Medicare patients when preventive screening colonoscopies end up as therapeutic procedures with polypectomy.

The Fly-In started with a group photo in front of the Capitol building and then we were off. There were anywhere from 5 to 10 meetings scheduled per person so, for sure, we got in our 10,000 steps for the day. The House of Representatives was in session so we got to see our government in action. Staff members running around, visitors in the hallways, and alarms ringing when it was time to vote—very cool stuff.

We were welcomed in each Hill office with respect and interest, legislators taking heed, staff taking notes, and us taking photos with iconic backdrops. Right now with health care being in the forefront of so much legislation, it was easy to talk about colorectal cancer screening and the cost and benefits of screening turned therapeutic colonoscopy versus managing a colon cancer diagnosis later on. Armed with data, statistics, carefully crafted talking points, and handouts to educate young Hill staffers about our priorities, we were able to personalize the conversations to local issues and each meeting was different.

Looking back at our day on the Hill, the importance of a grassroots body like the Board of Governors cannot be overstated. Perhaps I was yet another citizen traipsing through the office of my local elected official, but likely not. I believe it matters for me as a physician to meet with legislators.

While we can depend on our society staff to lobby on our behalf, until you have gone to Capitol Hill yourself, you don’t know how much of an impact you can have as an individual with clinical knowledge and experience “in the trenches.”

6 | GI.ORG/ACGMAGAZINE

“Looking back at our day on the Hill, the importance of a grassroots body like the Board of Governors cannot be overstated.”

I realize that physicians can’t be part of the problem and not be part of the solution. We must have our voices heard! Young staffers were listening just as intently as the elected officials themselves. For those of us who got to meet with our elected Representatives and Senators, that meant something as it was not just another photo op. That became clear to me when standing in line to meet Senator Amy Klobuchar from Minnesota. When Senator Klobuchar asked who we were, she stopped the line and talked with us about the importance of colorectal cancer screening­—an issue with personal resonance for her since she lost a close friend to the disease. She listened and engaged when we asked for support of the Removing Barriers to Colorectal Cancer Screening bill (S.668).

Some legislators even took advantage of our clinical knowledge for personal gastroenterology consults about their own GERD symptoms and treatment.

CULTIVATING YOUNG LEADERSHIP TALENT AND DEVELOPING ADVOCACY SKILLS This year was also different because of the presence of the Young Physician Leadership Scholars, a cohort selected by the ACG Institute to hone leadership skills and learn advocacy. As part of their day on the Hill with the Governors, they got to see how to interact with elected officials and talk about medicine as it pertains to public policy. The luncheon program at the Capitol building was definitely one of my favorite parts of the day. We met with physicians who are serving either in the Senate or the House and who described their trip from the medical office to elected office. Their choices and sacrifices to make this country great were truly inspirational.

I am so grateful that my professional life and role with ACG gave me the opportunity to do something like this and I would encourage anyone out there to step up, make an appointment with your local, state, or federal elected representatives, and make your voice heard. As physicians sworn to care for patients and committed to the health of our communities, the power of the personal lobby is one of the strongest we own.

­­—Sunanda V. Kane, MD, MSPH, FACG

Dr. Kane, Sen. Amy Klobuchar (D-MN), Dr. Prasad Iyer, Dr. Sahil Khanna

MESSAGE FROM THE PRESIDEN

GOVERNOR’S FLY-IN: MAKING OUR VOICES HEARD ON THE HILL

Note hy wor t ACG MAGAZINE seeks to strengthen readers’ connections to the College and to their GI colleagues and share stories with a focus on members, medicine and meaning. Notable College highlights include March Colorectal Cancer Awareness Month, the North American Conference of GI Fellows, and professional milestones for Dr. Eamonn Quigley, Dr. Prateek Sharma, and Dr. Bryan Green.

The College notes with great sadness the death of Dr. Barbara Frank of Philadelphia, a pioneering woman in gastroenterology and former ACG Governor.

Email your professional news and any ideas for future issues of ACG MAGAZINE to ACGMag@gi.org

Novel & Noteworthy | 7

// N&N

[COLLEGE NEWS]

INTRODUCING THE ACG INNOVATION & TECHNOLOGY COMMITTEE [AWARDEES]

Dr. Bryan Green Receives NCCRT National Achievement Award as “Physician Champion”

Dr. Bryan Green of the Digestive Disease Group in Greenwood, South Carolina was recognized by the National Colorectal Cancer Roundtable (NCCRT) for his volunteer contributions to the Colorectal Cancer Prevention Network (CCPN) at the University of South Carolina, a program which provides screening colonoscopies at no cost to uninsured and medically underserved patients. Dr. Green collaborated with the CCPN to develop

its comprehensive patient navigation model which increased participation in screening by men and African Americans, and contributed to a reduced colonoscopy no-show rate of less than 1% annually.

Significantly, Dr. Green also helped to recruit other gastroenterologists to participate and waive their professional fees.

In the last decade, the practice of gastroenterology has experienced exponential growth in innovation and new technology. Patients are aware and well-informed on these innovations and specifically request them.

To keep our members abreast of the technology and innovations in this evolving landscape, the College created a forum for members to gather information related to new ideas, innovations, and technologies in our field.

The new ACG Innovation & Technology Committee has a multi-faceted mission including generating technology assessment reports, reviews, and white papers related to new technologies and innovations, collaborating with

the ACG Hands-on Endoscopy Workshops for training and education, and liaising with industry partners to address current gaps in the device/ innovation realm.

Committee Members: Sarah M. Enslin, PA-C; Seth A. Gross, MD, FACG; Aasma Shaukat, MD, MPH, FACG; Daniel Castaneda, MD; Drew B. Schembre, MD, FACG; Laith H. Jamil, MD, FACG; Marta L. Davila, MD, FACG; Prasad G. Iyer, MD, MS, FACG; Christopher Y. Kim, MD, FACG; Vladimir M. Kushnir, MD; Amandeep K. Shergill, MD, MS; Mark B. Pochapin, MD, FACG; David T. Rubin, MD, FACG; Jay N. Yepuri, MD, MS, FACG; and Committee Chair Vivek Kaul, MD, FACG.

6 [AWARENESS]

Dr. Balzora with Fight CRC in DC

MARCH CRC AWARENESS

(2) Dr. Sophie M. Balzora, Chair of the College’s Public Relations Committee was in Washington, DC for two days in March presenting at “Call on Congress,” the annual legislative program of patient and survivor advocates from Fight Colorectal Cancer.

Tri-Society Hill CRC Event

(1)(7) ACG Trustee Dr. Renee L. Williams represented the College at a Congressional Briefing during March CRC Month with (L to R) AGA President Dr. David A. Lieberman, ASGE Councilor Dr. Jason A. Dominitz, and ASGE President Dr. Steven A. Edmundowicz.

8 | GI.ORG/ACGMAGAZINE

CRC Proclamation Nation

(3) (L to R) Dr. March E. Seabrook, Dr. John Corless, and Dr. Bryan T. Green at the South Carolina State House with a CRC Month Proclamation. (4) Dr. Whitfield L. Knapple (far left) witnesses Arkansas Governor Asa Hutchinson proclaiming March as CRC Month

with advocates from the Colon Cancer Coalition and American Cancer Society. (5) Dr. Jeremy Spector, Dr. Samir A. Shah, Dr. Abbas H. Rupawala, and Dr. Harlan Rich at the Rhode Island legislature celebrating the RI CRC Month Proclamation by wearing Blue Star pins for CRC Awareness! (6) Jean S. Wang, MD, PhD, FACG of Washington University in St. Louis (second from Right) with Missouri Governor Mike Parson and CRC advocates.



View More CRC photos: bit.ly/PhotosCRCMonth

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[EDUCATION]

FUTURE OF GI Building presentation skills and cultivating an interest in clinical research among GI fellows-in-training was the goal of the 2019 North

American Conference of Gastroenterology Fellows (NACGF) held in April in Florida.

NACGF creates opportunities for fellows to present

their research in a less pressured environment than at national meetings, interact with senior faculty, and attend excellent educational sessions.

Participants compete for a place and have the chance to network and to forge meaningful personal and professional connections. This year’s faculty included Dr. David J. Hass, Dr. Immanuel K. Ho, Dr. Jill K. Gaidos, Dr. Cynthia Levy, and Dr. Philip O. Katz.

[MILESTONES]

Prateek Sharma, MD, Named President of the International Society for Diseases of the Esophagus

Prateek Sharma, MD, FACG of The University of Kansas Cancer Center has been named President of The International Society

for Diseases of the Esophagus (ISDE).

This multidisciplinary international organization is comprised of approximately 1,000 esophageal experts.

Dr. Sharma will lead the society’s education and research activities, as well as organize its biennial World Congress on Esophageal Diseases in 2020.

[AWARDEES]

DDNC Award to Senator Wicker

Digestive Disease National Coalition (DDNC) President and ACG Treasurer Samir A. Shah, MD, FACG presents the 2019 DDNC Congressional Public Service Award to U.S. Senator Roger Wicker of Mississippi for his efforts regarding removal of barriers to colorectal cancer screening at the DDNC National Public Policy Forum in March. Pictured second from right: ACG’s Costas H. Kefalas, MD, MMM, FACG.

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Novel & Noteworthy | 9

// N&N [AWARDEES]

SCIENCE FOUNDATION IRELAND’S ST PATRICK’S DAY SCIENCE MEDAL AWARDED TO EAMONN M. M. QUIGLEY, MD, MACG

This year, Science Foundation Ireland awarded its academic medal, the St. Patrick’s Day Science Medal, to ACG Past President Eamonn M. M. Quigley, MD, MACG of Houston Methodist Hospital and Weill Cornell Medical School in Houston, Texas.

This award recognizes a distinguished Irish scientist, engineer, or technology leader living and working in the United States who is outstanding in their field of expertise and who has also demonstrably assisted researchers in Ireland in either academia or industry—via mentorship, supervision, collaboration, industrial development, entrepreneurship, or who has made significant contributions to developing the research ecosystem in Ireland.

In accepting the award, Dr. Quigley, whose long and distinguished career has included academic appointments in both the U.S. and Ireland at the University of Cork, described why he found these translocations

easy professionally: “Of course, science speaks one language, but also relevant to my own career as a clinician and clinical researcher is that the fears, hopes, and concerns of the ill are the same everywhere.

In caring for the sick, Irish graduates­—I believe—do enjoy a distinct advantage.

My generation of medical graduates may not, in the past, have been exposed to leading-edge biomedical science, but we did spend a lot of time with the sick and their families in hospitals and in general practices around Ireland. Here we learned to listen to patients, converse about their illness in a language they understood, and from these interactions, develop a plan of clinical care. In other words, the emphasis was on acquiring clinical skills and a bedside manner—characteristics that have served the Irish medical graduate well wherever he or she has practiced medicine.”

 Professor Mark Ferguson (left) formerly of the University of Manchester and now director of SFI; Minister Richard Bruton (middle), presenting Dr. Quigley with the 2019 Science Foundation Ireland St. Patrick’s Day Academic Medal.

10 | GI.ORG/ACGMAGAZINE

[IN MEMORIAM]

BARBARA B. FRANK, MD, MACG (1937-2019) The College mourns the death of Dr. Barbara Balis Frank of Philadelphia, PA on February 21, 2019 and recognizes her pioneering career and leadership.

Her family remembers Dr. Frank as a trailblazer throughout her life who excelled at everything she did, and as a loving mother and grandmother.

Dr. Frank joined the College in 1989 and was elected by her peers to serve as ACG Governor for Eastern Pennsylvania from 1992 to 1996, including a term as Regional Councilor from 1994 to 1996. She was elected for another term in 2003. In 2006, Dr. Frank received the ACG Senior Governors Award and also that year was designated a Master of the American College of Gastroenterology. She served for many years on ACG’s Women in GI Committee as well as the Educational Affairs Committee.

Dr. Frank founded the CrozerChester Medical Center’s Division of Gastroenterology in 1968, served as Director of the division until 1989 and continued as an attending until 1994. For many years, Dr. Frank was Clinical Professor of Medicine in the Division of Gastroenterology and Hepatology at Hahnemann/ Medical College of Pennsylvania/ Drexel University College of Medicine in Philadelphia.

Dr. Frank was the first woman to be elected President of the American Society for Gastrointestinal Endoscopy

(1991-1992) and received the ASGE Distinguished Educator Award in 2005.

In 2006, Drexel University College of Medicine established the Barbara B. Frank, M.D. Endoscopic Learning Resource Center.

AGA honored Dr. Frank with the Outstanding Woman Scientist Award in 2008.

Dr. Frank was a member of the Bockus International Society of Gastroenterology, founded in 1959 in honor of Dr. Henry L. Bockus by his former students, residents and fellows at the School of Medicine of the University of Pennsylvania. She served as Bockus Society President from 2009 to 2011.

Her career included longtime service on two key FDA panels, the GI Devices Panel (1988–1994) and the GI Drugs Advisory Committee (1995–1999). Dr. Frank was active in Pennsylvania state and local medical societies and was elected President of the Delaware Valley Phi Beta Kappa Association, serving from 1995 to 1997.

A 1958 magna cum laude graduate of Smith College who majored in Philosophy, Dr. Frank received her M.D. in 1962 from the University of Pennsylvania. She was a resident in internal medicine at Bryn Mawr Hospital and completed her internship and fellowship in gastroenterology at the Hospital of the University of Pennsylvania.

She is survived by her husband of 61 years, Dr. Leonard A. Frank, a urologist whose career included a faculty appointment at Thomas Jefferson University; her sons, Michael Frank and Bradford Frank; as well as three grandchildren, Eliana, Adeline, and Carter Frank.

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 ECGs 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

©2018 Braintree Laboratories, Inc. All rights reserved.

HH27314B

September 2018

Novel & Noteworthy | 11

THE ORIGINAL 1 LITER PRESCRIPTION BOWEL PREP SOLUTION

1 MOST PRESCRIBED,

#

BRANDED BOWEL PREP KIT1 WITH MORE THAN 15 MILLION KITS DISPENSED SINCE 20101

A CLEAN SWEEP

EFFECTIVE RESULTS IN ALL COLON SEGMENTS2 · SUPREP® Bowel Prep Kit has been FDA-approved as a split-dose oral regimen3 · >90% of patients had no residual stool in all colon segments2* †

These cleansing results for the cecum included 91% of patients2*

†

SUPREP Bowel Prep Kit also achieved ≥64% no residual fluid in 4 out of 5 colon segments (ascending, transverse, descending, and sigmoid/rectum)2* †

Aligned with Gastrointestinal Quality Improvement Consortium (GIQuIC) performance target of ≥85% quality cleansing for outpatient colonoscopies.4

*This clinical trial was not included in the product labeling. †Based on investigator grading.

References: 1. IQVIA. National Prescription Audit Report. September 2018. 2. Rex DK, DiPalma JA, Rodriguez R, McGowan J, Cleveland M. A randomized clinical study comparing reduced-volume oral sulfate solution with standard 4-liter sulfate-free electrolyte lavage solution as preparation for colonoscopy. Gastrointest Endosc. 2010;72(2):328-336. 3. SUPREP Bowel Prep Kit [package insert].

Braintree, MA: Braintree Laboratories, Inc; 2017. 4. Rex DK, Schoenfeld PS, Cohen J, et al. Quality indicators for colonoscopy. Gastrointest Endosc. 2015;81(1):31-53.

©2018 Braintree Laboratories, Inc. All rights reserved.

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HH27314B

September 2018

7

8–9

HEPATOLOGY SCHOOL AT EASTERN REGIONAL

EASTERN REGIONAL POSTGRADUATE COURSE

 Washington, DC

 Washington, DC

Register: gi.org/regional-meetings

Register: gi.org/regional-meetings

JULY

12

YOUNG PHYSICIAN LEADERSHIP SCHOLARS PROGRAM APPLICATION DEADLINE Apply Now: gi.org/young-physicians

JULY

19

EDGAR ACHKAR VISITING PROFESSORSHIP APPLICATION DEADLINE Apply Now: gi.org/acg-institute/application

SEPTEMBER

6

FUNCTIONAL GI DISORDERS SCHOOL AT ACG/VGS/ODSGNA REGIONAL

 Williamsburg, VA IBD SCHOOL AT MIDWEST REGIONAL

AUGUST

16

AUGUST

17–18

Learn More: gi.org/regional-meetings

 Minneapolis, MN Learn More: gi.org/regional-meetings

MIDWEST REGIONAL POSTGRADUATE COURSE

 Minneapolis, MN

SEPTEMBER

7–8

ACG/VGS/ODSGNA REGIONAL POSTGRADUATE COURSE

 Williamsburg, VA Learn More: gi.org/regional-meetings

Learn More: gi.org/regional-meetings

DECEMBER

6-8

HEPATOLOGY SCHOOL & SOUTHERN REGIONAL POSTGRADUATE COURSE

 Louisville, KY

Learn More: acgmeetings.gi.org

Learn More: gi.org/regional-meetings

Novel & Noteworthy | 13

ACG CALENDAR

JUNE

JUNE

KEY PRIORITIES of the ACG From the Updated ACG

STRATEGIC PLAN

1

Satisfy the needs of our membership and profession through adherence to our mission and vision. The strength of the organization flows through the provision of services to a diverse group of clinicians who strive to provide the optimal care for their patients with digestive diseases and disorders.

2

Support members and develop leaders who embody the values of integrity, honesty, and professionalism to form the governance of the College, emulate our mission and vision, ensure social and fiscal responsibility of the affairs of the College, and represent the diverse interests and needs of the membership.

3

Create and deliver timely and relevant educational activities and academic opportunities, through a variety of innovative platforms enhancing best practices in patient care, practice management, and leadership in gastroenterology and hepatology.

4

Promote the academic achievements of our profession by providing premier journal offerings and a robust and comprehensive annual meeting at no charge to our members.

5

Support and foster a wide variety of clinical and translational research opportunities to students, trainees and researchers through increases in funding of scholarships, awards and grants, and develop resources to strengthen the understanding of clinical research methods and promote scientific collaboration and impactful discoveries.

6

Promote and emphasize the importance of quality by establishing metrics, measuring outcomes, and providing leadership to enhance and evolve systems for measuring, researching, and improving quality improvement in the field of gastroenterology.

7

Create a powerful voice in all areas of national affairs and public policy to advocate for all our members, improve the practice of medicine, and enhance the health and well-being of our patients.

8

Embrace the values of camaraderie, mutual trust, and respect within a diverse professional organization composed of voluntary executive officers, board of trustees, board of governors, administration, and our members.

9

Enhance the professional satisfaction of our members by acknowledging and attenuating the impact of burnout, and acknowledging the importance of wellness and professionalism.

10

Strengthen partnerships and alliances with national and international organizations to improve the GI health of all populations through education, research, and advocacy.

Read the ACG Strategic Plan: bit.ly/StratPlanACG19

PUBLIC

POLICY

Members of the ACG Board of Governors are joined by Young Physician Leadership Scholars on Capitol Hill, April 4, 2019.

ACG's Governors and Young Physician Leadership Scholars

// GOVERNORS' VANTAGE POINT

GIVE VOICE to GI PRIORITIES ON CAPITOL HILL // GOVERNORS' VANTAGE POINT

 THURSDAY, APRIL 4, 2019 MARKED A SIGNIFICANT ACHIEVEMENT FOR ACG’S BOARD OF GOVERNORS. On

this day, more than 100 ACG leaders arrived on Capitol Hill for the 2019 ACG Board of Governors Fly-In, constituting the largest single day of legislative meetings in College history. Attendees met with the offices of 300 legislators in the U.S. House of Representatives and U.S. Senate, shedding light on the issues impacting GI practices and patients.

The ACG Governors were joined in Washington this year by ACG officers: President Sunanda V. Kane, MD, MSPH, FACG; President-Elect Mark B. Pochapin, MD, FACG; Secretary Daniel J. Pambianco, MD, FACG; and Treasurer Samir A. Shah, MD, FACG; as well as several members of the ACG Legislative & Public Policy Council, including Chair Whitfield L. Knapple, MD, FACG.

ADVOCACY SKILLS AND MENTORING FOR ACG’S YOUNG PHYSICIAN LEADERSHIP SCHOLARS Unique to the Fly-In this year was the addition of 30 members of the Young Physician Leadership Scholars Program, shepherded by Dr. Pochapin and David J. Hass, MD, FACG. As a highlight of this year-long leadership development program sponsored by the ACG Institute for Clinical Research & Education, the cohort of ACG Young Physician Leadership Scholars joined forces with the Governors for legislative visits to sharpen their advocacy skills. They became conversant in the issues, offering a dynamic, well-rounded perspective to communicate key priorities to elected officials, ensuring that the voice for clinical gastroenterology could be heard clearly. 

Public Policy | 15

// PUBLIC POLICY: GOVERNORS' VANTAGE POINT

1 2

LEGISLATIVE PRIORITIES & KEY MESSAGES During their visits on Capitol Hill, the ACG Governors continued the College’s longstanding fight to advocate for a better future for clinical gastroenterology practices and for GI patients. The ACG leaders brought a few key messages to the table for members of Congress:

 REMOVING BARRIERS TO CRC SCREENING IN MEDICARE The main legislative focus of the Fly-In was to discuss and garner additional co-sponsors and support for the “Removing Barriers to Colorectal Cancer Screening” Acts (S.668/HR.1570). These bills seek to prohibit cost sharing for Medicare beneficiaries when a screening colonoscopy turns therapeutic.

Unanticipated costs pose a potential barrier to screening for Medicare beneficiaries, many of whom are on a fixed income, and expect that their screening colonoscopy will be covered. These cost sharing problems—also known as “the post-polypectomy surprise”—are an unintended consequence of a provision in the Affordable Care Act relating to coverage of colorectal screening. This quirk in the law must to be addressed to ensure access to potentially lifesaving colorectal screenings under Medicare.

3

4

 STEP THERAPY AND PRIOR AUTHORIZATION CHALLENGES ACG leaders also discussed other initiatives impacting the quality of patient care, including ensuring proper Medicare reimbursement for GI procedures, and issues with “Step Therapy” requirements by insurers and other prior authorizations.

The dedicated support of the more than 100 attendees at the Fly-In helped make this day a great success. All College members are encouraged to contact their respective ACG Governors regarding any important legislative issues in their area via the ACG Website at gi.org/acg-board-of-governors.



View More ACG Fly-In photos: bit.ly/Photos2019FlyIn

16 | GI.ORG/ACGMAGAZINE

5 7

6

12

10

11

9 6

8

13 (1) ACG President Dr. Sunanda V. Kane, U.S. Senator Amy Klobuchar (D-MN), Dr. Prasad Iyer, and Dr. Sahil Khanna (Minnesota). (2) Dr. Hass developed the curriculum for the YPLS program based on work he did with the Connecticut Medical Association and in collaboration with Dr. Pochapin.

(3) U.S. Senator William Cassidy (R-LA) is a gastroenterologist and hepatologist and ACG member who addressed ACG’s Young Physician Leadership Scholars. (4) Dr. James Hobley (Louisiana) and Dr. Michael Bay (New Mexico) on their way to the Capitol. (5) Dr. Elizabeth Paine, Sen. Cindy HydeSmith (R-MS), and Dr. Stephen Amann (Mississippi). (6) Dr. Yasmin Hernandez-Barco with House Ways & Means Chair, Congressman Richard Neal (D-MA) and Dr. Anthony Lembo (Massachusetts).

(7) Dr. Kane shares insights at the YPLS lunch. (8) ACG Young Physician Leadership Scholars at the United States Capitol with Dr. David Hass (front row second from left), ACG President Dr. Sunanda Kane, and Dr. Mark Pochapin. Dr. Hass and Dr. Pochapin are the program directors for the YPLS program. (9) Dr. Mark Pochapin introduces Congressman Brad Wenstrup (R-OH) at the YPLS lunch at the U.S. Capitol. (10) Dr. David Beswick (Delaware). (11) Dr. Patrick Young (Vice Chair, Board of Governors), Dr. Joseph Cheatham (Military Governor) and Dr. James Hobley. (12) Dr. Tauseef Ali and Dr. Pooja Singhal (Oklahoma). (13) U.S. Representative Kim Schrier (D-WA). Dr. Schrier, a pediatrician, is the only female physician in the House of Representatives, and offered inspiring comments to the Young Physician Leadership Scholars.

Public Policy | 17

Accessible. Relevant. Practical.

The information you need to improve your practice.

The ACG Practice Management Committee’s mission is to equip College members with accessible tools to overcome management challenges, improve operations, enhance productivity, and support physician leadership in their private and physician-lead clinical practices.

Learn from practicing colleagues through monthly articles on topics important to you. Articles include a topic overview, suggestions, examples, and a list of resources or references.

Explore the 2019

PRACTICE MANAGEMENT TOOLBOX and LAW MIND insights!

Download the e-Book: bit.ly/PM19EBOOK

ACG PRACTICE MANAGEM Toolbox High ENT

lights

Brought

you by the ACG PracticetoMa nagement Commit tee

"Pressures are high as gastroenterologists make important management decisions that profoundly affect their business future, their private lives, and their ability to provide care to patients." —Louis J. Wilson, MD, FACG

Start Building Success Today.

GI.ORG/TOOLBOX

GETTING IT

GETTING it Right Reviewing and U pdating the // BUILDING

SUCCESS

INFORMED CONSENT iPnrYoocuerss PRACTICE This artic le is part of a serie the ACG s sponso Practice red by Managem ent Com m ittee.

See more : gi.org/to olbox Stephen T. Am ann, MD, FA CG, Partner, Dige stive Health Specialists, PA , Tupelo, MS Brian B. Bagg ott, MD, Sect ion Head, Gene ral Ga Director of Am stroenterology, bulatory GI Operations M ain Campus, Cleveland Cl inic, Clevelan d, OH

 BEYOND ITS OBVIOUS MEDICAL-LEGAL RAMIFICATIONS, INFORMED CONSENT (IC) IS A CRITICAL PART OF GOOD PATIENT COMMUNICATION AND DOCUMENTATION. The principles of IC can be applied to procedures, treatments and the prescription of high-risk medications. It is also more than a document.

Informed consent is a process by which patients can accept or reject “health care treatments” in an informed and voluntary manner. Practices should periodically review the processes and the documents related to informed consent.

This toolbox provides a useful framework to accomplish this important project.

OVERVIEW

Obtaining IC is a process that allows the provider to discuss risks and benefits of the proposed treatment. The “IC form” documents that discussion. As a rule, the consent process should not be delegated, and the performing provider should take full responsibility to provide the necessary information to the consenting patient. Simple and appropriate language is key. The provider should use words the patient understands to review the intervention being proposed, the indications for it, expected outcomes (including the possibility of incomplete or failed procedures), known risks and complications, and any additional risks specific to that patient. Alternative treatments should also be reviewed, especially if the patient declines consent. Consent for procedures should include discussions of the risks of sedation or additional interventions being provided. In all of this, a two-way conversation is optimal, always allowing time to hear and respond to questions from the patient and family. The documentation of the discussion should become a permanent part of the medical record. 

Getting it Right | 19

// GETTING IT RIGHT: BUILDING SUCCESS

INFORMED CONSENT REQUIREMENTS Informed consent documents are typically developed in response to state and local regulatory requirements. In addition, CMS CoPs (conditions of participation for ASC) and hospitals have their own requirements. We recommend against the use of consent forms provided by pharmaceutical companies or device manufacturers.

Significant state to state variations in the informed consent process exist. There are also institutional interpretations of those laws that need to be considered. Consult your legal team and malpractice provider to assist you in including all the required elements pertinent to your state. If handouts or videos are used in the process, one should document in the patient’s chart that the patient viewed/received them. Using a common format, develop a form for each procedure incorporating large font and simple language. The provider performing the test and the patient (or appropriate designee) should sign and date the form.

SPECIFIC ELEMENTS OF INFORMED CONSENT FOR GI PRACTICE: 1. What interventions should be consented?  Operative or invasive procedures  Percutaneous procedures

traversing into an organ  High risk (risks that the

patient would consider important) diagnostic or therapeutic interventions  Intravascular insertion

of instruments (excluding peripheral IVs)  General, deep, or

moderate sedation  Receipt of blood or

blood products

3. Who must give consent?  Any person 18 years or older who

is mentally competent  If a person is judged to be

incompetent (unable to understand the risks, benefits, and alternatives to the proposed health care treatment), consent can be obtained from the following: a. Court appointed guardian b. Spouse c. Adult Child d. Parent e. Adult Sibling f. Next closest relative by blood or adoption  Utilize the services of an

interpreter if the patient does not speak English and family member or friend accompanying the patient does not speak English and follow local policies and guidelines, regarding interpreters  In case of an emergency, and

if none of the above persons is available, emergent consent may be obtained from two physicians, but this may vary from state to state and hospital/facility/ health care system, depending on specific laws and regulations

 Drugs with black box

warnings from the FDA (e.g., metoclopramide, obeticholic acid) or drugs with mandated consents (isotretinoin)  Drugs with potentially serious

side effects (i.e., biologics)

20 | GI.ORG/ACGMAGAZINE

1. Remember simple and appropriate language a. Simple and clear wording is crucial. b. Use 12-point font or larger c. Use bullet points instead of paragraphs d. Place development date on your forms and review intermittently to keep up to date 2. Use educational language and keep legal jargon to minimum 3. Review all consents you are using now and update to include information and ideas in this kit 4. If trainees are performing the procedure, this should be included in the discussion and document 5. For medications, consider a modified consent as all elements will not be needed. Consider using the FDA medication guides and document they were given to the patient. (www.fda.gov/drugs/ drugsafety/ucm594941.htm) 6. If treatment or procedure is not accepted, document refusal and discussion of alternatives and prognosis

3. Who can obtain informed consent?  The provider who is supervising

or performing the Health Care Treatment  Physicians can obtain consent

for all treatments requiring IC for which they are credentialed  APPs may obtain IC for

procedures in which they have been trained and for which they are credentialed 4. What key elements are included in the consent?  The intervention or treatment

being proposed  The expected outcomes

2. What treatments or medications should be considered for a modified consent?

KEY CONCEPTS

(including incomplete or failed procedure if possible)  The known risks, benefits,

standard alternatives, and risks specific to the patient  The type and options of

sedation provided

RESOURCES 1. Websites: CMS.gov: [CMS Conditions of Participation for Hospitals: 42C>F>R> 482.24.C(2)(v).482.51(b) (2),482.13(B)(2)] Your state Dept. of Health website FDA: fda.gov/drugs/drugsafety/ ucm594941.htm 2. Organizations: Your state Department of Health Your malpractice carrier: [for Mississippi we use Medical Assurance Company of Mississippi (MACM)] 3. The Joint Commission Accreditation Hospital Standards: RI.01.03.01 The honors the patient’s right to give or withhold informed consent, Elements of Performance 1-7,9,11- 12 4. Informed consent for GI Endoscopy. Gastrointest Endosc 2007; 66(2): 213-17.

8 MILLION CASES

AND GROWING

GI Quality Improvement Consortium, Ltd.

Setting the standard in quality improvement initiatives in GI. Improving clinical practice and patient outcomes.

Providing real-time peer-based performance evaluation.

Upload data directly from a number of endowriters—saving staff time.

Generate reports in real-time, at the physician and facility level.

Submit GI-specific measures to MIPS via the GIQuIC registry.

Join the 4,500 U.S. gastroenterologists who have made GIQuIC their quality improvement benchmarking registry.

To contact GIQuIC, email info@giquic.org

Visit giquic.org for more info

GIQuIC is a joint initiative of ACG and ASGE

Getting it Right | 21

// GETTING IT RIGHT: LAW MIND

Your practice was likely first involved in research when a pharmaceutical company or other company—called a Sponsor in the research field—asked one of your physicians to be a principal or sub investigator. You may be asked to participate in a pre-study site visit (PSSV), in which the sponsor or a contractor interviews you and assesses your site.

MODELS FOR RESEARCH IN PRIVATE GI PRACTICES

TRIALS WITHOUT TRIBULATIONS // LAW MIND

Pursuing Clinical Research for Ancillary Income

By Ann M. Bittinger, Esq., a health care attorney with physician group clients across the country.

Questions? Email ann@bittingerlaw.com

 IT’S QUITE COMMON FOR GASTROENTEROLOGY GROUPS TO PURSUE CLINICAL RESEARCH TRIALS not only to generate ancillary income for their practices but also to stay abreast of new developments in the specialty.

Research offers patients state-ofthe-art treatment approaches that might not otherwise be available.

And sponsors generally pay well for participation.

Scientific inquiry can be professionally fulfilling. But physicians should not perform trials without understanding the associated tribulations.

I have represented a few highlyregarded physicians who hired me after their state licensing boards 22 | GI.ORG/ACGMAGAZINE

received word that they failed to conduct research properly. Physicians jeopardize their ability to maintain a clear license and their general practice of medicine if things go awry in their clinical trials.

LOOK BEFORE YOU LEAP Physicians should not leap into research without looking at clinical research laws. Clinical trials are governed by complex and layered federal law, with different agencies in the Department of Health & Human Services (HHS) regulating the research dependent on its subject matter. If your trial involves a pharmaceutical, the U.S. Food and Drug Administration rules apply. The HHS Office of Human Research Protections oversees all research involving human subjects under what is generally referred to as the Common Rule. The Office of Research Integrity and Office of Inspector General may also be involved.

Generally speaking, there are two business models for research in private practices: original research and contract research.

Original research is organic from the physicians in the practice. They develop the protocols.

Contract research involves agreeing to be a principal or sub investigator in a trial that was developed by a third party (usually forprofit) company, such as a pharmaceutical company. Most research in private GI practices is contract research.

Within the contract research model, you can take one of two routes. The first is to deal directly with the sponsor and to retain your own staff to handle the administrative portion. Practices are increasingly following the second route though, by contracting with a Contract Research Organization (“CRO”). They feed studies to practices and help practices with compliance and data management. They are a middle man, so to speak, between the sponsors and the investigators and most provide assistance to the investigators.

TIPS IF YOU GO IT ALONE • Don’t sign a principal investigator agreement without implementing some level of a Research Compliance Plan in your office and retaining someone to oversee it on site for you.

• Take it upon yourself to attend a seminar in basic research administration requirements.

Remember that your site, as principal investigator, will be ultimately responsible for the research it performs and for data and adverse incident reporting. You can’t supervise what you don’t understand.

• The main component of research compliance is administration of the informed consent to patients. The content of the informed consent document and the process for obtaining

signatures and retaining the signed forms is important for compliance with federal law.

Who in your office is going to be trained to carry this out?

• The FDA requires the disclosure of certain financial information—potential conflicts of interest—relating to studies.

• Institutional Review Boards (IRBs) must approve the protocols and research methods.

• In addition to compliance with the above, you need to make sure you don’t bill payers—particularly Medicare­­— inappropriately for your research patients. Data management and reporting requirements within the protocol requirements are substantial. A physician can’t do it alone.

• Monitors will visit your site and audit the research.

• Have a clinical trials health law specialist develop a Research Compliance Program for you—and implement it.

TIPS IF YOU CONTRACT WITH A CRO • If you lack the magnitude of trials or the time and resources to develop your own Compliance Plan and train your own clinical trials director, contract with a third-party research management company or CRO. They usually take a portion of the payments from the sponsor to the researcher in exchange for performing compliance activities.

• Have a lawyer with specialized training in clinical trials review the contract and interpret for you what exactly your expectations should be about what the CRO will do for you. A lot of times, CRO contracts say they will assist with compliance and reporting, but they don’t take responsibility for taking the initiative and completing the proper documents.

CULTIVATING LONG-TERM RELATIONSHIPS WITH RESEARCH SPONSORS Once you have the compliance infrastructure in place, how do you grow this service line? Make your practice attractive to sponsors. Here’s how to cultivate a long-term relationship with sponsors: • When you enter into principal investigator agreements, meet your enrollment quotas.

Enroll patients in the study. Believe it or not, this is one of the major challenges for sponsors—to hit proper enrollment

numbers so that data is statistically reliable. Your research contract will likely include the number of subjects that you are expected to enroll as well as the timeline for enrollment. You will be asked to participate in more studies if you hit enrollment numbers.

• Hiring an experienced coordinator to serve as a liaison with the sponsors is important not only for compliance and management purposes, but for marketing purposes as well.

• Invest in your infrastructure. Physicians get in trouble when they think they can make six figures being a principal investigator and doing very little work by simply hiring a few nurses and a coordinator to do the research. And you will burn bridges with the sponsors if you fail to meet contractual requirements or breach the law due to your failure to invest in staff and other infrastructure.

STRUCTURING YOUR PRACTICE FOR CLINICAL RESEARCH ANCILLARY SERVICES I am often asked if practices should form a separate research company to perform research initially or later spin-off the research component from their practices into a separate company. Certainly, normal asset protection and personal liability analysis should be performed by a health law specialist on your specific situation. To protect the practice from regulatory fines (and perhaps malpractice claims) from the research operations, the two service lines (clinical practice and research) would have to be in separate companies; however, if the patient is a normal practice patient (as most are), it may be difficult in a malpractice claim to separate what was done in the research company versus what was done in the practice.

Generally speaking, two companies are safer than one if the scale is appropriate.

Separate companies need to be truly separate though, with appropriate documentation and reporting. A medical assistant who works for both the research and practice service lines would have to become a part-time employee of both companies instead of a full-time practice employee. The research company would have to file employment taxes, pay rent, and so forth. This may be more trouble than it is worth. And in a group practice, issues of which physician practice shareholders also

become shareholders of the research company, and how they make decisions and earn profit distributions, can be difficult to address.

Like any business, your research component is perhaps best grown if you start out small as a sub investigator or principal investigator, work out the kinks, and see if the research work complements your practice. As things grow, consider setting up your own separate, legal research clinic company.

Be mindful of the need to keep EMR and other data separate also.

Another issue is physical space.

Should the research service line have its own dedicated space? It’s a good idea to maintain research records separate from general practice records. Having a separate room where research contracts and data are analyzed and stored is important. Dedicated administrative space for the principal investigator is important. You may want to dedicate a separate exam room within your normal practice just for research patients. The coordinator likely needs an office space.

Monitors will visit and it’s good to have a guest office in which you can meet with them and they can perform their work without seeing practice data or other study data.

Following these steps should help you avoid tribulations. Don’t let your excitement about contributing to science and adding ancillary income jeopardize your medical license and existing livelihood.

HOW TO GROW YOUR CLINICAL RESEARCH SERVICE LINE • Start small and grow with expert guidance • Invest in infrastructure: implement a business plan and don’t be cheap with coordinators • Educate yourself on clinical research compliance—attend a seminar • Implement a Research Compliance Plan • Make your practice attractive to sponsors by implementing effective enrollment processes • Reward practice physicians (legally) who meet enrollment quotas and comply with the Research Compliance Plan Getting it Right | 23

// COVER STORY

Food

FOR

THOUGHT

24 | GI.ORG/ACGMAGAZINE

low FODMAP diet The

how this came to be

By Peter Gibson, MD and the FODMAP team Monash University and Alfred Health

JOHN, A 28-YEAR-OLD MEDICAL PRACTITIONER, STRUGGLED THROUGHOUT HIS UNDERGRADUATE AND POSTGRADUATE YEARS WITH ALMOST DAILY ABDOMINAL PAIN, ASSOCIATED WITH BLOATING AND ERRATIC BOWEL HABITS.

When he sought medical advice as an undergraduate, there were no alarm symptoms, screening blood tests were negative, and upper and lower gastrointestinal endoscopy excluded celiac disease and IBD. A diagnosis of IBS-M was made. John had altered his fibre intake and tried multiple medications with minimal benefit and/or side effects (e.g., a tricyclic antidepressant caused “brain fog” the next day, impairing his ability to study). His symptoms are now disrupting preparations for his Internal Medicine Specialty examinations and he is taking more time off work. He seeks your advice.

This common scenario was frustrating to me as a gastroenterologist—the diagnosis was easy, but the therapy was disappointingly ineffective or carried sometimes intolerable side effects. In 2002, I set up the first Functional Gut Service in Melbourne, Australia, with a key aim of improving management.

I focused on diet therapy, as my research background involved dietary carbohydrates, gut fermentation and epithelial biology. I recruited Jane Muir, a dietitian-scientist who had done seminal work in resistant starch and non-starch polysaccharides, and Susan Shepherd, a dietitian known for her clinical prowess in celiac disease, but also with a passion about fructose malabsorption and gut symptoms. This meeting of complementary expertise led to the development of the “new” FODMAP concept.

We proposed that because all slowlyabsorbed or non-digestible short-chain carbohydrates could induce IBS-like symptoms (by similar mechanisms of water retention in the small intestine and fermentation in the colon), restricting them simultaneously would more reliably reduce IBS symptoms than restricting one alone. Common FODMAPs in the diet include fructose (in excess of glucose), lactose (in the presence of hypolactasia), sugar alcohols or polyols (such as sorbitol and mannitol) and non-digestible oligosaccharides (especially fructans and galacto-oligosaccharides). We

Cover Story | 25

// COVER STORY

UNIVERSITY OF MICHIGAN FOOD FOR LIFE KITCHEN

needed to change our colleagues’ perspectives from considering each sugar in isolation (like lactose) to considering these sugars collectively. In 2004, a departmental competition was launched and the term, “FODMAP” won. The next challenge was to introduce this term into the published literature and, in 2005, the “FODMAP” hypothesis for the pathogenesis of Crohn’s disease was published.

With our “FODMAP concept” in hand, Jane Muir convinced us of the need for comprehensive FODMAP data regarding the FODMAP content of food, and our program of measuring hundreds of foods using validated techniques began. These data allowed us to design nutritionally adequate low and high FODMAP diets. Susan Shepherd then provided evidence in a blinded re-challenge study that fructose and fructans were additive triggers in patients previously responding to their specific restriction, and mechanistic studies by Jane Muir and Jacqueline Barrett showed that our diet reduced both small intestinal water content and colonic gas production.

In clinical practice, the diet was highly successful, but the question remained: how much was related to our “enthusiasm” in generating strong placebo responses, and how much related to the diet? We needed quality evidence of efficacy and chose the gold standard method of providing all food to blinded participants, then crossing them over to a standard diet (and vice versa). We had a window of opportunity to do this while the dietary therapy was generally unknown—subjects

26 | GI.ORG/ACGMAGAZINE

“We proposed that because all slowly-absorbed or non-digestible short-chain carbohydrates could induce IBSlike symptoms... ...restricting them simultaneously would more reliably reduce IBS symptoms than restricting one alone.”

—Professor Peter Gibson

Michigan Medicine’s Division of Gastroenterology and Hepatology founded its “Food for Life Kitchen” as a dedicated learning space to serve as a hub for a number of programs where food and health intersect. The kitchen is the centerpiece of Michigan Medicine’s budding culinary medicine program directed by ACG Trustee William D. Chey, MD, FACG. This growing field explores the links between food and health. At Michigan, a multidisciplinary partnership is working to advance knowledge of the medical consequences of what, when, and how much we eat, and offers practical advice and experiences to help patients develop smart, sensible, sustainable food strategies.

The kitchen is used to host a culinary medicine elective for medical students, and offers cooking classes on topics such as “The Mediterranean Diet for Fatty Liver Disease” and “Reducing Fat and Fiber for Gastroparesis.” Michigan also offers CE courses for GI dietitians entitled, “Food: The Main Course to Gut Health and Disease.” The course aims to meet the needs of dietitians with interest and training in GI and helps them to stay up-to-date and expand their body of knowledge. This year's course is September 20 to 22, 2019.

 Learn More: bit.ly/UMichKitchen

R

GOLDRING CENTER FOR CULINARY MEDICINE AT TULANE Bringing basic science curriculum together with clinical education, the Goldring Center for Culinary Medicine at Tulane offers a more complete view of how future physicians can incorporate dietary intervention strategies into their practice of medicine. Through handson cooking classes, medical students and physicians learn the practical aspects of lifestyle change necessary to help them guide their patients to healthier choices.

Tulane’s Culinary Medicine program offers an innovative, integrated approach to nutrition education for medical students and community members, and the medical school has implemented a fully integrated, comprehensive curriculum for doctors, medical students, chefs, and community members focused on the significant role that food choices and nutrition play in preventing and managing obesity and associated diseases in America. Tulane offers a designation “Certified Culinary Medicine Specialist” to Physicians, Physician Assistants, Pharmacists, Registered Dietitians and Nurse Practitioners. Their “Health Meets Food” courseware (healthmeetsfood.com) has been adopted by over 55 medical schools, residency programs, and nursing schools across the United States and the United Kingdom.

The Executive Director of the Goldring Center is Timothy S. Harlan, MD, FACP, CCMS, aka “Dr. Gourmet.”

 Learn More:

DR. JEFF SCOTT’S HAPPY COLON FOODS ACG member Dr. Jeff D. Scott of Oklahoma City, OK saw the need for a new colon prep regimen that addresses some of patients’ common objections to improve colonoscopy utilization. In March of 2016, Dr. Scott and his wife and partner, Marisa, began working with a food scientist and food manufacturers to produce Happy Colon Foods for patient use.

They developed a standardized solid food kit which is combined with a physician-prescribed prep regimen. Patients eat solid food and have a minimally disruptive day. The goal is for patients to have a better overall prep experience.

According to Dr. Scott, “Patients who have utilized Happy Colon Foods have reported the prep experience is far more pleasant, allowing many to even work while they are prepping.” Patient feedback was tremendous, as were procedural results, eventually culminating in publication of an observational study by Dr. Scott, Marisa Scott, and co-author Paul Feuerstadt, MD, FACG in December 2017 (Scott, JD, et al.

“PEG-3350, Senna and Solid Food Based Bowel Preparation for Colonoscopy Appears Safe, Effective and Well Tolerated”. EC Gastroenterology and Digestive System 4.5 2017: 142-151).

 LEARN MORE: bit.ly/HappyColonFoods

culinarymedicine.org

Cover Story | 27

// COVER STORY

would be unable to recognise what diet they were on. So we undertook a major study, led by Emma Halmos, that fed low and standard Australian FODMAP diets to over 40 subjects for three weeks. With the infrastructure to do this, our team (including a research chef) prepared, packaged and delivered over 5,000 complete meals to subjects! The 2014 results clearly demonstrated benefit of the low FODMAP diet in about 70% of patients with IBS and reflected our clinical experience.

Randomised controlled trials in the UK, US, and Canada have since demonstrated benefit of a dietitian-delivered, low FODMAP diet over various diets (including a true placebo diet). The support and drive of insightful physicians and dietitians in the US and Canada including Bruno Chumpitazi, William Chey, Stephen Vanner, Patsy Catsos and Kate Scarlata have greatly facilitated North American implementation of the diet.

With comprehensive FODMAP composition data, our new challenge was one of translation— how to deliver these data to patients making food choices.

While low and high FODMAP food lists had sprung up, many were grossly inaccurate. This is where digital technology stepped in and the “Monash University FODMAP Diet App” was released in 2011. Our app allowed us to deliver up-to-date and easy to interpret FODMAP composition data to users at the point-of-need (e.g., in the supermarket). It also provided the unique opportunity for patients to interact with scientists, and to gather feedback on missing foods. The success of the app (sold in more than 120 countries and achieving #1 medical app in many) was reflected in app sales—income that is reinvested in the research program, and permits ongoing laboratory analysis

28 | GI.ORG/ACGMAGAZINE

PHASE 1 High FODMAP foods are swapped for low FODMAP alternatives.

PHASE 2 FODMAPs are systematically challenged to determine which ones trigger symptoms and which ones are tolerated.

PHASE 3 "Personalised” FODMAP diet is constructed.

Well-tolerated foods and FODMAPs are included, and only restricts poorly tolerated FODMAPs to a necessary level.

of food, app development, and new FODMAP research.

While a highly restrictive FODMAP diet was initially devised to alleviate symptoms, clinical experience, and to a lesser extent, research, showed that most “responders” would tolerate a less restrictive FODMAP diet long-term, and a three-phased diet has evolved. In Phase 1 (the subject of multiple RCTs), high FODMAP foods are swapped for low FODMAP alternatives. In Phase 2, FODMAPs are systematically challenged to determine which trigger symptoms and which are tolerated. In Phase 3, a “personalised” FODMAP diet is constructed that includes welltolerated foods and FODMAPs, and only restricts poorly tolerated FODMAPs to a necessary level.

In our clinic, the FODMAP diet is our first-line approach for the majority of patients with IBS who require intervention for their symptoms. Integral to the success of this approach is our team of highly skilled dietitians who see patients two to three times. Adherence is high and the effects appear durable.

This “real world” experience is reflected in clinical guidelines and multiple publications on clinical experience from the Americas, Asia and Europe.

John experienced a considerable symptom improvement on the Phase 1 diet and discovered during Phase 2 (FODMAP re-introduction), that fructans were his major trigger. He remains well and states that he no longer follows the FODMAP diet, although he chooses foods wisely (i.e., he follows the “personalised FODMAP diet”). For example, he uses filters on the Monash App to identify foods that are low in fructans (e.g., a low FODMAP sourdough spelt bread in place of wheat breads, while limiting garlic and avoiding onions). If his symptoms flare, he usually recognizes the food source and does not worry. At stressful times, he often reduces his FODMAP intake to avoid symptoms. He also tries foods not previously tolerated to ensure he is not over-restricting. John passed his examinations, completed his specialty training and is now an oncologist with a good quality of life!

Undertaking the FODMAP program requires engagement and motivation on the part of patients, but while the diet looks daunting, it is not difficult and three-quarters of patients find it easy to incorporate into their lifestyle. It is a fact that most doctors have neither the time nor dietetic training to implement the diet themselves. We suggest three ways forward. The first is for doctors to recruit and/or train dietitians in their practices.

In 2017, our team, led by Jane Varney, developed an accredited 10-module online course for

dietitians for this very purpose.

The second is for doctors to train and utilise assistant physicians or practice nurses to deliver the diet. The third is for doctors to up-skill and deliver the diet themselves. Our team has created a range of tools to support the implementation of this diet including our app, instruction sheets, booklets and patient videos.

The FODMAP diet has gained traction worldwide.

This is unsurprising given the diet is based upon sound dietary and biological principles and backed by comprehensive food composition data. Most importantly, it empowers patients to self-manage their symptoms.

Investment in this therapeutic strategy improves the quality of life of patients and doctors alike!

Cover Story | 29

// COVER STORY

Learning to eat

By Patricia L. Raymond, MD, FACG, a gastroenterologist with Gastroenterology Consultants, a division of Gastrointestinal and Liver Specialists of Tidewater PLLC in Virginia Beach, VA and an Assistant Professor of Clinical Internal Medicine at Eastern Virginia Medical School in Norfolk, VA.

Conference on Nutrition in Medicine, hosted by the PCRM up the road in Washington, DC. I was free, it was inexpensive, and offered CME; let's go!

People are fed by the food industry, which pays no attention to health, and are treated by the health industry, which pays no attention to food. ~Wendell Berry

Learning to eat was about learning to live—and deciding to live; and it is one of the most radical things I’ve ever done. ~Anne Lamott, from Traveling Mercies

IF YOU'RE EXPECTING A MILITANT VEGAN TO CHASTISE YOU THAT 'YOUR FOOD HAS A FACE', I'M NOT HER. I regard

myself as Whole Food Plant Based (WFPB) in my 'real' life, but I am also an opportunistic carnivore—that opportunism occurring with frequency at drug rep dinners and friends' supper parties. Should you invite me into your home, I won't angst over your lack of Tofurky—Mom raised me right.

However, I believe that you should also embrace WFPB, and encourage your patients to do so. Here I share my personal voyage to Beanville.

Like so many in medicine, I began reasonably lean after college, then began packing on the pounds with unwise food choices, stressors, and frequent free food opportunities.

I ballooned up, and as I reached menopause, I was a hundred pounds overweight with bad knees. Being a good scientist, I researched my options.

After a partially successful several-year stint at Weight Watchers, a patient introduced me to a notable no sugar/ flour plan called "Bright Line Eating."

Some of my BLE Facebook friends were also doing WFPB, and I was intrigued. I played at increasing my bean intake and dropping animal protein and fat. In a burst of cosmic synchronicity, my CNA shared a flyer for the upcoming International

30 | GI.ORG/ACGMAGAZINE

“As masters of the alimentary canal, we in gastroenterology should own both these diseases and our expanding obesity epidemic.

Who else?”

—Dr. Patricia Raymond

There, my brain exploded. (When was the last time you attended a medical conference and suffered a cranial combustion?) Why did I, as a healthcare provider, not know this information? Was it perhaps because 'Big Broccoli' doesn't sponsor office lunches? I learned many chronic American diseases could be reversed by pursuing a WFPB diet—that is vegan, low fat, no processed food. I heard data on coronary artery disease, type 2 diabetes, obesity, multiple sclerosis, Alzheimer's, arthritis, migraines, and yes—colorectal cancer.

And I was appalled that many of us, the arbitrators of the digestive tract, do not know and do not teach the role of diet in disease. As masters of the alimentary canal, we in gastroenterology should own both these diseases and our expanding obesity epidemic. Who else?

Let's look at some of the things I've learned:

 Processed meat is classified as carcinogenic to humans (Group 1), based on sufficient evidence in humans that the consumption of processed meat causes colorectal cancer.

Daily consumption of 50 grams of processed meat increases the risk of colorectal cancer by 18%. Red meat is in Group 2A (probably carcinogenic to humans). https://www.iarc. fr/wp-content/uploads/2018/07/pr240_E.pdf  When your post-polypectomy FHCC patient inquires what they can do to reduce their CRC risk, are you discussing specifics of processed and unprocessed red meat consumption? Dr. Stephen Devries' 2017 study of cardiologists reveals them to be woefully undertrained in nutrition, despite Dr. Ornish demonstrating CAD reversal by diet in the 1970s. (A Deficiency of Nutrition Education and Practice in Cardiology Am J Med(2017) 130, 1298-1305) https://amjmed.org/a-deficiency-ofnutrition-education-and-practice-in-cardiology. Among cardiologists, 90% reported receiving no or minimal nutrition education during fellowship, 8% self-described as having “expert” nutrition knowledge, 95% believe that their role includes personally providing patients with at least basic nutrition information. Only 20% of cardiologists ate five vegetable/fruit servings daily. Do we expect that gastroenterology results would differ?

Where am I now?

I am starting my next phase in my gastroenterology career, advocating for a WFPB diet for all. My website www.EatWell.MD will burst with tasty vegan recipes, humor, and links to peerreviewed journal articles supporting diet to eliminate or prevent disease. I will produce targeted cookbooks and videos for spectacular (yes, spectacular) bean recipes, and compose digestive ditties about the vegan life (www.ButtMeddler.com). And I will continue living my healthiest life ever. I'm sad that it took me 30 years of not being at my peak to choose to embrace WFPB.

ACG ACG MOBILE MOBILE

ACCESS KEY RESOURCES ACCESS at KEY theRESOURCES point of care at the point of care

Americans will eat garbage, provided you sprinkle it liberally with ketchup. ~Henry Miller

I challenge you to research WFPB and disease for yourself and your patients. Consider joining the PCRM (www.PCRM.org), download their comprehensive app (https://nutritionguide.pcrm. org/nutritionguide), take free nutrition CME courses (www. nutritioncme.org), and send your patients who are veg-curious to download a free 21-Day Kickstart Program at www.kickstart. pcrm.org.

We are physicians. We must teach our patients to heal themselves.

STAY ON-THE-GO

Let food be thy medicine and medicine be thy food. ~ Hippocrates

STAY ON-THE-GO with ACG’S MOBILE APP with ACG’S MOBILE APP An exclusive ACG Member benefit that provides access toMember valuable benefi resources An exclusive ACG t that for your practice and your patients, all provides access to valuable resources from your mobile device. for your practice and your patients, all

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Cover Story | 31

Diet for IRRITABLE BOWEL SYNDROMEWhat S hould I Eat? Irritable Bowel Syndrome (IBS) is a common problem, affecting up to 15 percent of people in the world.

Common IBS symptoms:

Fermentable

 Bloating

Oligosaccharides

 Diarrhea

Disaccharides

 Constipation

Monosaccharides And

 Abdominal cramping

 The role of diet in IBS is still being explored, but many patients say that certain foods can make symptoms worse.

Polyols

 “FODMAPs” are the initials for a group of carbohydrates that are not well absorbed in the gut by many IBS patients, and can trigger IBS symptoms.

 Many diets have been explored for IBS, but the low FODMAP diet has the most evidence. It was developed by the team at Monash University in Australia.

 FODMAPs are found naturally in many foods and food additives.  The best way to start this diet is with the help of a dietitian.

The FODMAP diet has three main phases:

1

2

3

Cutting high FODMAP foods from your diet

Re-introducing these foods in a step-wise way

Finding your own personal FODMAP diet, because not everyone has the same food triggers

Learn more about the FODMAP diet and access resources: MonashFODMAP.com

Download a mobile app to learn about the low FODMAP diet: bit.ly/FODMAPApp

Courtesy of Dr. Michael Bass, ACG Patient Care Committee | More Info: patients.gi.org

32 | GI.ORG/ACGMAGAZINE

Patient Perspective: Collaborative Doctor-Patient Relationship Key to Dietary Management of Eosinophilic Esophagitis

By Jacqueline Gaulin

NOT MANY PEOPLE WOULD BELIEVE THAT LORI EATON, A PERSONAL CHEF AND CERTIFIED HEALTH AND NUTRITION COACH,

cannot eat (or even taste) most of the delicious food she prepares for her clients, who have included Dwayne "The Rock" Johnson, Jeff Bridges, and the cast and crew of many TV shows and movies. But for Lori, who was diagnosed with eosinophilic esophagitis (EoE) in 2007, just taking a bite of a dish containing such common ingredients as rice, gluten, soy, corn, dairy, wheat, pork, or fish will trigger any number of GI and other symptoms that will wreak havoc on her body, including swallowing difficulties or a food impaction.

Lori has faced these challenges related to food by learning all she can about EoE and the role diet and nutrition plays in her disease, and by steadfast selfadvocacy that has made her a “model” empowered patient, according to her doctor, a leading expert and researcher in EoE, Evan Dellon, MD, MPH, FACG. Dr. Dellon is Professor of Medicine in the Division of Gastroenterology and Hepatology at the Center for Esophageal Diseases and Swallowing at the University of North Carolina at Chapel Hill. Lori’s strong collaborative relationship with Dr. Dellon has been key to her finding effective dietary management of her EoE and achieving remission. 

ACG Perspectives | 33

// ACG PERSPECTIVES

Research shows that dietary treatment is effective for patients with EoE, but Dr. Dellon notes that an elimination diet is not for every patient, “Elimination diets may not be the best approach for college students who have to eat in the school cafeteria or people who travel a lot, for instance."

Dr. Dellon says that some patients just cannot tolerate the restrictions, or do not have the discipline, time, insurance coverage or resources to commit to a sometimes expensive and logistically difficult diet, or to attend follow-up appointments and endoscopies, which are an integral part of the process. EoE patients and their physicians should consider these factors when deciding between swallowed steroids and dietary therapy.

AN AVID TRAVELER ON A CHALLENGING JOURNEY WITH EOE An avid traveler, Lori admits it’s “very challenging” to stay on an elimination diet. “That’s why Dr. Dellon and I have worked out a way for me to have my cake and eat it too,” she says.

“I take budesonide when I go on vacation. It’s a short-term steroid treatment which allows me to eat anything I want while I’m on vacation. It helps keep me sane. It helps keep me on my eliminations the other days of the year. I also look forward to vacations because I get to eat like a normal person again.”

She praises Dr. Dellon’s expertise in EoE and his willingness to listen, answer her questions, and embrace her as an educated partner in her healthcare. She credits this as the reason she can enjoy life and trips abroad without worrying about what she can eat. But Lori’s journey to Dr. Dellon wasn’t easy.

Like many patients who suffer for months and even years before seeing a doctor or getting an accurate diagnosis, it took Lori years before she was finally diagnosed with EoE. But she had struggled with a variety of GI issues, such as acid reflux, constipation, and abdominal pain since 1997. These symptoms worsened and proton pump inhibitors (PPIs) only caused unpleasant side effects.

Even after her EoE diagnosis, Lori felt dismissed and unheard. After more failed medications and side effects, she researched the role of diet in GI health and tried to manage her symptoms by eliminating various foods and keeping a food journal.

Over time, her symptoms worsened and by the spring of 2010 her dysphagia was so extreme she was having trouble swallowing applesauce and yogurt. That’s when she sought a referral.

“I’m so glad I stood up for myself and asked for a referral because that’s how I came to know Dr. Evan Dellon. It took several months to get in to see Dr. Dellon, but he was worth the wait. Dr. Dellon gave me a clear and accurate explanation of EoE and the different therapies. Finally, I found a doctor who could help me understand my disease and treatment options! He has been my doctor ever since.”

Lori drives over 300 miles round trip for each appointment with Dr. Dellon. “I haven’t found a doctor in my city with the expertise and understanding Dr. Dellon has. I’ve also never worked with a doctor who is responsive to my questions and open to my ideas. He has a wonderful bedside manner.”

34 | GI.ORG/ACGMAGAZINE

“She’s incredibly motivated and knowledgeable as a chef, so she knows how to work within the very strict eliminations to make her food both nutritious and enjoyable, so she is better able to stick to the diet, something not every patient is able to do.”

—Dr. Evan Dellon

INGREDIENT FOR SUCCESS: A STRONG PARTNERSHIP WITH CLINICIANS Dr. Dellon is equally impressed with Lori. “She’s incredibly motivated and knowledgeable as a chef, so she knows how to work within the very strict eliminations to make her food both nutritious and enjoyable, so she is better able to stick to the diet, something not every patient is able to do.” He urges that EoE patients who undergo an elimination diet work closely with a registered dietitian or nutritionist to make sure they are getting adequate nutrition and support. “This is crucial for success,” he says.

Dr. Dellon recommends that patients fully understand the process and requirements of an elimination diet and be honest with themselves and their doctors about their willingness and ability to follow it. He suggests clinicians also understand that an elimination diet is not a “one-sizefits-all” treatment option, and that each patient should be evaluated for suitability for treatment type based on their individual circumstances.

Photos courtesy of Lori Eaton.

THE INSIDE SCOOP: ELIMINATION DIET FOR EOE AND TIPS FOR SUCCESS A Q&A WITH LORI EATON HOW DID YOU APPROACH DR. DELLON ABOUT TRYING AN ELIMINATION DIET? Elimination diets were part of the discussion from the beginning of my treatment with Dr. Dellon. Since EoE is triggered differently in each person, it can take a long time to discover a person’s triggers. I wanted to try and figure out what my triggers are versus taking medication.

At the time I started treatment with Dr. Dellon in 2011, there were studies/trials being done on elimination diet and medications.

I know I did a budesonide study, and I was on steroids on and off from 2011 to 2013.

My insurance company notified me in 2013 that budesonide was no longer covered, so I became focused on elimination diet therapy as my sole treatment.

I told Dr. Dellon that from 2013 to 2016, I had tried various forms of eliminations (gluten, dairy, soy, nuts/seeds, eggs, fish/shellfish) and I was frustrated that I couldn’t get into remission. In early 2016, I came up with my own mega-elimination diet, and Dr. Dellon approved. (Note: Dr. Dellon emphasized that this approach was specifically tailored to Lori given her prior history of treatments, and is not representative of a starting point for most people who go on an elimination diet.)

For eight weeks, I ate only organic chicken, blackberries, sweet potatoes, and nonnightshade vegetables. I used olive oil, avocado oil, and basic seasonings on those items. I only drank water and herbal teas like ginger and peppermint. I kept a food diary and I did not eat anything else outside of this diet, except for one cheat night halfway through the eliminations. It was a challenge, but my mind was made up about achieving remission.

Dr. Dellon performed my endoscopy at the end of the eight weeks, and the result was zero eosinophils! I did it! It was exciting to finally reach remission, but then began the arduous task of reintroduction, and that was immediately humbling.

WHAT WERE THE RESULTS OF YOUR REINTRODUCTION? My first re-introduction was fish and shellfish. I passed and remained in remission. I was really excited to be getting results and making progress. Then I failed my rice trial and then failed pork. When a food is a trigger, the eosinophils come back into the esophagus, and in order to move forward with trialing a new food, you must first clear out the eosinophils. This means a reset of eliminations for at least four weeks before trialing the next food.

To me, it’s the worst part of the process because it felt like time was being wasted, but it is ACG Perspectives | 35

necessary to clear out the eosinophils so the next food trialed gets an accurate result.

I continued to trial dairy, eggs, turkey, beef, corn, nightshades, etc. and I will continue to trial more foods in the future. In 2018, I suspended my food trials due to other health issues, travel, and my work schedule, but my plan is to begin food trials again in 2019.

WHAT ARE YOUR TIPS FOR PATIENTS WHO WANT TO TRY A DIETARY INTERVENTION FOR EOE? Anyone with EoE could try diet therapy, however, a few people with EoE have environmental triggers. If someone’s EoE is triggered by dust, mold, pollen, dander, etc., those triggers would have to be eliminated before food trials could begin. Dr. Dellon discussed elimination therapy from the beginning of my treatment, but not all doctors support that. I would say for anyone who wants to try to discover their triggers with eliminations and reintroductions, you may need to find a new doctor if your current one isn’t open to the idea. You need to have a doctor work with you in order to test for eosinophils. Only an endoscopy with pathology will be able to show how many eosinophils are in your esophagus when you trial each new food.

I think my success with my elimination diet was due to having a plan. I kept a food diary, counted down the days until my endoscopy, and encouraged myself to stick with it because I could possibly be in remission. Patients need to know going in that it’s not easy. I did not eat a single meal in eight weeks that was not prepared by me. I was afraid of food contamination so I made all of my meals to ensure I was eating safe food. Not everyone can do that, not without a lot of planning and determination.

36 | GI.ORG/ACGMAGAZINE

WHAT DO GI PHYSICIANS NEED TO KNOW ABOUT DIETARY INTERVENTION FOR THEIR EOE PATIENTS? A disease like EoE should teach doctors that it is time to look at nutrition as a tool for healing. I do not need steroids or PPIs if I do not eat my trigger foods. Many GI patients would prefer to avoid taking medications, as we often have side effects which are as bad or worse than the disease.

When I take steroids long-term, I develop oral thrush, restless legs, headaches, sinusitis, rashes, and achy joints. I would rather avoid foods than deal with all of those side effects.

There have been moments over the past decade when I have simply stopped eating because of fear of impaction. There are times I feel socially isolated because I can’t eat what everyone is eating around me. I have felt depressed, resentful, and anxious over food for many years now. I have gone without eating for several meals because there is no food available to meet my elimination diet criteria. Some days are easier than others. I suggest that physicians stress to any patient trying eliminations to take it day by day.

RESOURCES  Clinical Guidance and Research • ACG Clinical Guideline: Evidence Based Approach to the Diagnosis and Management of Esophageal Eosinophilia and Eosinophilic Esophagitis (EoE). Evan S. Dellon, MD, MPH, et al. Am J Gastroenterol 2013; 108:679–692; doi:10.1038/ajg.2013.71; published online 9 April 2013.

• Elimination Diet Effectively Treats Eosinophilic Esophagitis in Adults; Food Reintroduction Identifies Causative Factors. Gonsalves N, Yang GY, Doerfler B, et al. Gastroenterology. 2012;142(7):1451-9.e1.

• Dietary Therapy and Nutrition Management of Eosinophilic Esophagitis: A Work Group Report of the American Academy of Allergy, Asthma, and Immunology. J Allergy Clin Immunol Pract. 2017 Mar Apr;5(2):312-324.e29. doi: 10.1016/j.jaip.2016.12.026.

• Six-Food Elimination Diet and Topical Steroids are Effective for Eosinophilic Esophagitis: A MetaRegression. Cotton CC, Eluri S, Wolf WA, et al. Dig Dis Sci (2017) 62: 2408. https://doi.org/10.1007/s10620-0174642-7 • The Six-Food Elimination Diet for Eosinophilic Esophagitis Increases Grocery Shopping Cost and Complexity. Asher Wolf W, Huang KZ, Durban R, et al.

Dysphagia. 2016 Dec;31(6):765-770. Epub 2016 Aug 9.

• Cost Utility Analysis of Topical Steroids Compared With Dietary Elimination for Treatment of Eosinophilic Esophagitis. Cotton CC, Erim D, Eluri S, et al. Clin Gastroenterol Hepatol. 2017 Jun;15(6):841-849.e1. doi: 10.1016/j.cgh.2016.11.032. Epub 2016 Dec 7.

 Patient Resources • American Partnership for Eosinophilic Disorders (APFED) • Campaign for Urging Research in Eosinophilic Disorders (CURED) • Carolinas EoE Collaborative (CEoEC) • The Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR) • Current Clinical Trials in EoE at UNC • National Organization for Rare Disorders

 How do I find a good dietitian?

1. Ask your colleagues or health system for a referral to a registered dietitian.

2. Visit the Academy of Nutrition and Dietetics website to find an expert. Refine your search to locate an RD with specific digestive health expertise.

3. Contact Gastro Girl: info@gastrogirl.com

EDUCATION “Dr. Eamonn Quigley's lecture was a fascinating navigation through the history of the gut biome. He provided us with enthusiasm and insight into clinical applications today, and eager anticipation of future practice implications. His talk opened our eyes to impacts of the microbiome beyond gastrointestinal illnesses.” —Dr. Hershman of Mount Sinai on Dr. Quigley's visit

THE ACG EDGAR ACHKAR VISITING PROFESSORSHIP Providing Noteworthy Speakers for Training in Your Communities

Photo Top: Dr. Eamonn Quigley visits with GI fellows at Mt. Sinai Beth Israel.

A SIGNATURE STRENGTH OF THE EDGAR ACHKAR VISITING PROFESSOR PROGRAM is the opportunity

for prominent leaders in GI and hepatology to engage with fellows-in-training and local ACG members for an unforgettable learning experience. By dissecting clinical scenarios and presenting their clinical reasoning, the visiting faculty help shape the way fellows critically assess evidencebased approaches to diagnosis and management of patients with GI and liver diseases.

Recently, ACG Past President Eamonn M. M. Quigley, MD, MACG, visited the Division of Gastroenterology and Hepatology

at Mount Sinai Beth Israel. His Grand Rounds presentation on the gut microbiome was broadcast to participants at both Mount Sinai St. Luke's and Mount Sinai West, extending the reach of his visit.

ACG Trustee Amy Oxentenko, MD, FACG represented ACG at NYU Langone Health where she met with GI faculty, fellows, and staff. The evening before her Grand Rounds talk, "Celiac Mimickers: A Wolf in Sheep's Clothing, or a Sheep in Wolf 's Clothing," NYU put together a Women in GI reception in honor of Dr. Oxentenko’s visit.

Lehigh Valley Health Network in Allentown, Pennsylvania,

hosted ACG Past President Stephen B. Hanauer, MD, FACG who gave case presentations on a complicated IBD patient and gave a Grand Rounds presentation, “Fake News Regarding Personalized Medicine in IBD.” Dr. Hanauer met with the IBD attendings and all three years of fellows for a lengthy journal club session that included case questions and interval didactics on subjects such as therapeutic drug monitoring, pharmacology of thiopurines, IBD and pregnancy, monitoring for adverse events, discussions regarding steroids, and newer agents such as tofacitinib.

Education | 37

// EDUCATION

“Groups are incredibly grateful for the opportunity to host ACG visiting professors. It is a wonderful experience for the presenters who are truly embraced by the host program. Unlike many other visiting professorships, the ACG imprimatur greatly enhanced the participation, credibility, and perceived value.”

—Stephen B. Hanauer, MD, FACG, on his visit to Lehigh Valley Health Network

38 | GI.ORG/ACGMAGAZINE

2019

ACG EDGAR ACHKAR VISITING PROFESSORSHIPS

EAMONN M. M. QUIGLEY, MD, MACG Mount Sinai Beth Israel, St. Luke and West FEBRUARY 26–27 AMY S. OXENTENKO, MD, FACG NYU School of Medicine APRIL 2 STEPHEN B. HANAUER, MD, FACG Lehigh Valley Health Network APRIL 3–4 DAVID T. RUBIN, MD, FACG Brown University MAY 8–9 BRIAN E. LACY, MD, PHD, FACG New York Presbyterian/Weill Cornell MAY 9

“The entire visit had great impact! The NYU GI faculty, fellows and staff were incredibly welcoming, and the spirit of camaraderie in the division is so evident...This initiative is such a wonderful opportunity to allow faculty to go to such highly regarded institutions and interact with trainees and faculty on a personal level. It was fantastic that the visit was customized to things that were so valuable to me (women in GI reception, the one on one meetings, the fellow get-together).”­­

NICHOLAS J. SHAHEEN, MD, MPH, FACG Wayne State University/ Detroit Medical Center MAY 9–10 WILLIAM D. CHEY, MD, FACG University of Colorado JUNE 6–7 ASHWANI K. SINGAL, MD, MS, FACG University of Iowa Hospitals & Clinics JULY 25 SUNANDA V. KANE, MD, MSPH, FACG Washington University in St. Louis School of Medicine SEPTEMBER 18–19 EDWARD V. LOFTUS JR., MD, FACG University of California, Davis SEPTEMBER 19 COREY A. SIEGEL, MD, MS Creighton University SEPTEMBER 25

—Amy S. Oxentenko, MD, FACG, on her visit to NYU School of Medicine

Education | 39

CALLING ALL

BACK BY POPULAR DEMAND!

NEGATIVE STUDIES If you have been holding on to a GREAT NEGATIVE STUDY that has NEVER BEEN PUBLISHED, then this announcement is for you.

Journals are great at publishing studies about what we should do to patients, but are generally less willing to publish high quality research about what we shouldn’t do in clinical practice. The biomedical literature is full of positive studies; this trend can lead to a “publication bias” by systematically failing to disseminate important yet negative studies.

The American Journal of Gastroenterology wants to help correct this shortsightedness by dedicating a special issue to negative results.

WE CALL IT THE NEGATIVE ISSUE The Co-Editors are particularly interested in high quality manuscripts that provide scientific information applicable to clinical practice. We want to know what medicines don’t work, what diets miss the mark, what risk factors are irrelevant, what supplements are no better than placebo, what diagnostic tests are unrevealing, unhelpful, or even harmful, and anything else that may be terrifically non-contributory in gastroenterology and liver diseases.

Please clearly state in your cover letter that your manuscript is intended for the special Negative Issue of AJG. Depending upon the response to this request, some accepted manuscripts may be published in other upcoming issues of AJG.

Please address questions to Lindsey Topp, Managing Editor: ltopp@gi.org

DEADLINE: AUGUST 1, 2019 Submit manuscripts to

www.editorialmanager.com/ajg www.amjgastro.com 40 | GI.ORG/ACGMAGAZINE

Inside the

JOURNALS

G

AC RTS EPO CASE RO J URN L G OM I.OR TS.C TS.G POR POR ERE ERE CAS CAS ACG ACG

VOLUME 6

ed by orts edit e Rep ed by nal of CasRep orts edit ne Jour ows An Onli nal of Case atology Fell ne Jour ows An Onli ology & Hep atology Fell Gastroenter ology & Hep Gastroenter

AUTHOR INSIGHT: ACG’S UPDATED UC GUIDELINE ACG MAGAZINE invited authors David T. Rubin, MD, FACG and Millie D. Long, MD, FACG, to share insights and clinical pearls from the long-awaited update to ACG’s Clinical Guideline on Ulcerative Colitis in Adults.

The Red Journal’s strong offering of guidelines is a testament to the productivity of the ACG Practice Parameters Committee under the leadership of Chair David W. Wan, MD, 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 NEW PUBLISHER, NEW JOURNAL WEBSITES ACG’s publishing partnership with Wolters Kluwer launched successfully in January 2019. New websites for all ACG’s journals mean that exploring clinical GI and hepatology research and fascinating cases is even easier. Sign up for e-TOC and RSS feeds to have the latest GI research and fascinating cases delivered to your inbox.  The American Journal of Gastroenterology: amjgastro.com  Clinical and Translational Gastroenterology: clintranslgastro.com  ACG Case Reports Journal: acgcasereports.com

Inside the Journals | 41

// INSIDE THE JOURNALS

INSIDE THE JOURNALS [THE AMERICAN JOURNAL OF GASTROENTEROLOGY]

Why It Is Time for New Practice Guidelines for Ulcerative Colitis Millie D. Long, MD, MPH, FACG, ACG Research Committee Chair and David T. Rubin, MD, FACG, ACG Trustee

 THE PREVIOUS AMERICAN COLLEGE OF GASTROENTEROLOGY ULCERATIVE COLITIS (UC) PRACTICE GUIDELINE was published in 2010.1 Over the course of the last ten years, a great deal has changed in the diagnosis and management of adults with UC. The new ACG clinical guideline on the management of UC in adults was released in March 2019 and is a substantial update from the prior publication. This new document provides an evidence-based framework to care for patients with UC throughout the entire course of their disease. The guideline includes the management of patients with all ranges of UC severity—from the outpatient with mildly active disease to the hospitalized patient with acute severe UC.

The priorities for developing this new set of guidelines included incorporating more objective endpoints as goals of management, updating the positioning and utilization therapies, and integrating therapeutic drug monitoring and fecal calprotectin testing in precision assessment of patients. In addition, these guidelines address the changing approach to colorectal cancer prevention.

Some highlights from the guideline that clinicians will find particularly useful include a new ACG Disease Activity Index, updated treatment goals that include mucosal healing, a review and recommendations for the new biological and small molecule therapies, and medical and surgical recommendations on the management of the hospitalized patient with severe UC.

ACG UC Guideline in the Context of Other New ACG Guidelines in IBD Over the course of the past two years, the ACG has released new clinical practice guidelines on preventive care in inflammatory bowel disease (IBD),2 Crohn’s disease,3 and now UC.4 Taken together, these evidence-based guidelines provide a comprehensive overview of the increasingly complicated and rapidly changing landscape of IBD management. We anticipate that this new guideline will advance the state of UC care and help our clinician colleagues and their patients.

References

1. Kornbluth A, Sachar DB. Ulcerative colitis practice guidelines in adults: American College of Gastroenterology, Practice Parameters Committee.

Am J Gastroenterol 2010;105:501-23; quiz 524.

2. Farraye FA, Melmed GY, Lichtenstein GR, et al. ACG Clinical Guideline: Preventive Care in Inflammatory Bowel Disease. Am J Gastroenterol 2017;112:241-258.

3. Lichtenstein GR, Loftus EV, Isaacs KL, et al. ACG Clinical Guideline: Management of Crohn's Disease in Adults. Am J Gastroenterol 2018;113:481-517.

4. Rubin DT, Ananthakrishnan AN, Siegel CA, Sauer BG, Long MD. ACG Clinical Guideline: Ulcerative Colitis in Adults. Am J Gastroenterol 2019.

TAKEAWAYS FOR CLINICIANS The following are examples of takeaways from the UC guideline that clinicians may immediately incorporate into their practices:

 Treatment decisions should no longer be based only on symptoms at a single point in time (disease activity).

Instead, definitions of disease severity (prognosis) should drive treatment paradigms. The new ACG definition of disease severity includes: • patient-reported outcomes of bleeding and bowel habits; • inflammatory burden (e.g., endoscopic severity of inflammation); • disease course (need for hospitalization, steroids, failure to respond to medications); and • disease impact (functionality and quality of life).

42 | GI.ORG/ACGMAGAZINE

 Mucosal healing (improvement or resolution of inflammatory changes) is a treatment goal for all patients with UC.  Fecal calprotectin may be used as a surrogate for endoscopy when endoscopy is not feasible or available to assess for mucosal healing. It is anticipated that this recommendation will enable insurance coverage of this diagnostic test.  For individuals who have previously failed 5-aminosalicylate (5-ASA) therapy and are now receiving an anti-tumor necrosis factor alpha (anti-TNF) agent, we recommend against continuation of the 5-ASA therapy to maintain remission.

 Other specific treatment recommendations are categorized by disease severity in the guideline statement. We provide recommendations on the use of oral and rectal 5-ASA agents, immunomodulators, anti-TNF agents, anti-integrin therapy, and the novel small molecules.  In the hospitalized patient with severe UC failing to respond to intravenous corticosteroids by day 3 to 5, we recommend either infliximab or cyclosporine to induce remission.  When using high-definition colonoscopes for dysplasia surveillance, both white light endoscopy with narrow band imaging or dye-spray chromoendoscopy are appropriate.

[THE AMERICAN JOURNAL OF GASTROENTEROLOGY]

AJG "How I Approach It" Low FODMAP Diet: What Your Patients Need to Know By: Kathryn Scarlata, RDN

 FOOD INTOLERANCE IS REPORTED IN ABOUT TWOTHIRDS OF INDIVIDUALS WITH IRRITABLE BOWEL SYNDROME (IBS).[1] The majority of IBS patients are interested in holistic approaches to treatment such as nutritional interventions, probiotic supplements, and hypnotherapy.[2] One such therapy that is gaining traction in the IBS community is the low FODMAP diet. The low fermentable oligo-saccharides, di-saccharides, monosaccharides, and polyols (FODMAP) diet is a novel threephase nutritional approach shown to be effective in managing symptoms in 50 to 70 percent of IBS patients.[3,4] FODMAP carbohydrates are abundant in many everyday foods.

Food-related fears are exhibited in the IBS population. A GI dietitian can help patients sort through the hype versus the science and deliver individualized nutrition guidance to enhance food-related quality of life. Given the restrictive nature of the low FODMAP diet, it is important to select patients for this intervention that are most likely to benefit.

TABLE 2: Checklist to Help Identify Appropriate Low FODMAP Diet Candidates ❒ No evidence or history of eating disorder, maladaptive eating, or extreme food fears

❒ Diet recall reveals foods high in FODMAP content

“The end goal of this nutritional approach is to consume as liberal a diet as possible to meet nutrient needs, maintain quality of life, and adequately manage digestive symptoms.”

The low FODMAP diet has three discrete phases, which are elimination, reintroduction, and personalization. This “learning diet” is utilized to help identify personal food triggers. The end goal of this nutritional approach is to consume as liberal a diet as possible to meet nutrient needs, maintain quality of life, and adequately manage digestive symptoms.

❒ IBS diagnosis is present ❒ Nutritional approach treatment is desired ❒ Celiac serology testing has been completed with adequate gluten intake

The diet is not suitable for those with an active eating disorder; simply handing every patient with IBS a one-sheet low FODMAP diet handout may do more harm than good. Referring patients with IBS for nutritional guidance to a GI dietitian is recommended.

Myths about the low FODMAP diet abound.

The low FODMAP diet is not gluten-, dairy-, or wheat-free. Low lactose dairy such as hard and semi-soft cheeses, butter, lactose-free milk, lactose-free yogurt, and lactose-free cottage cheese are acceptable on the diet. These dairy foods can help meet daily calcium needs.

The low FODMAP diet does reduce the protein, gluten—as it minimizes fermentable carbohydrates found in wheat, barley, and rye (gluten sources). Small amounts of wheat, however, in traditional soy sauce or in a handful (portion size matters) of many wheat-based crackers or pretzels are typically low enough in FODMAP carbohydrates.  READ the article: bit.ly/ScarlataAJG

References

1. Simrén M, Månsson A, Langkilde AM, et al. Food-related gastrointestinal symptoms in the irritable bowel syndrome.

Digestion.

2001;63:108–15.

❒ Eating exacerbates symptoms

2. Otten MH, Holierhoek Y, Stellingwerf F, et al. Reduce IBS project: Multiple therapy choices and shareddecision making gives IBS patients self-management and better quality of life. Digestive Disease Week, abstract 164. 2017.

3. Eswaran S, Chey WD, Han-Markey T, et al. A randomized controlled trial comparing the low FODMAP diet vs. modified NICE guidelines in US adults with IBS-D. Am J Gastroenterol.

2016;111:1824–32.

4. Halmos EP, Power VA, Shepherd SJ, et al. A diet low in FODMAPs reduces symptoms of irritable bowel syndrome.

Gastroenterology.

2014;146:67–75.

TABLE 1: Sample of high FODMAP food sources Lactose

Excess Fructose

Fructans

GOS

Polyols

• Milk • Custard • Cottage Cheese • Ice Cream • Ricotta Cheese • Yogurt

• Agave • Apples • Asparagus • Figs • High Fructose Corn Syrup • Honey • Mango • Pears • Sugar Snap Peas • Watermelon

• Garlic • Onion • Wheat, Barley, Rye • Artichoke • Chicory Root Extract • Dried Fruit • Inulin Additives • Watermelon

• Legumes • Pistachios • Cashews

• Apples • Apricots • Blackberries • Nectarine • Peach • Pears • Cauliflower • Mushrooms • Sugar Alchohol Additives: Isomalt, Mannitol, Sorbitol, Maltitol

Inside the Journals | 43

Your Journals,

REINVENTED

ACG’s Journals Are Now Published by Wolters Kluwer ACG

CASE REPORTS JOURN L ACGCASEREPORTS.GI.ORG ACGCASEREPORTS.COM

VOLUME 6

An Online Journal of Case Reports edited by An Online Journal of Case Reports edited by Gastroenterology & Hepatology Fellows Gastroenterology & Hepatology Fellows

acgcasereports.com clintranslgastro.com amjgastro.com

44 | GI.ORG/ACGMAGAZINE

// INSIDE THE JOURNALS [ACG CASE REPORTS JOURNAL]

Pumpkin Seed Bezoar Causing Lower Gastrointestinal Bleeding Fredy Nehme, MD; Kyle Rowe, MD; Imad Nassif, MD Kansas University School of Medicine, Wichita, KS

A 38-year-old woman with no significant past medical history presented to the emergency department with a one-day history of diffuse abdominal pain. She reported normal bowel movements up to one day prior and was unable to pass anything rectally since. Laboratory evaluation was unremarkable, and a computed tomography scan of the abdomen and pelvis showed fecal impaction without evidence of obstruction. Colonoscopy revealed a pumpkin seed bezoar impacted at the distal rectum.

Removal of the phytobezoar was accomplished with multiple washings and digital removal under general anesthesia.

[CLINICAL & TRANSLATIONAL GASTROENTEROLOGY]

Home Blenderized Tube Feeding: A Practical Guide for Clinical Practice Caroline Weeks, RDN, LD, Blank Children's Hospital Pediatric Gastroenterology Clinic, Des Moines, Iowa, and Mayo Clinic Children's Center, Rochester, MN

 BLENDERIZED TUBE FEEDING (BTF) REGIMEN MODELS HAVE GARNERED INTEREST and have started to permeate gastroenterology and nutrition practices as patients and caregivers seek to provide a more natural source of nourishment in the setting of chronic illness. BTF is proving to be a popular alternative to standard enteral formulas as constructed recipes are rich in phytonutrients, contain less added sugar, and can yield improvements in both GI symptoms and feeding relationships. Although this method is more involved and requires collaboration between the gastroenterologist, registered dietitian, and caregiver, these challenges can be mitigated by careful planning and appropriate follow-up. Further research is needed to examine the performance of BTF regimens compared to traditional formulas

in different disease outcomes and evaluate the safety profiles and risks of infection when such regimens are applied.  READ the full article: bit.ly/WeeksCTG

 Caroline Weeks via Instagram: @theclinicdietitian

 READ the full case: bit.ly/ACGCRJPumpkinSeeds

Inside the Journals | 45

M CECUM THE CECU HING THE REACHING REAC

By Robert E. Kravetz, MD, MACG Phoenix, AZ

A LOOK BACK

MEDICATED PRUNES This archival reflection originally appeared in The American Journal of Gastroenterology in November, 2002.

C

onstipation has plagued mankind even before recorded history. Bleed, blister, and purge was the motto of early medicine, and every conceivable type of laxative, enemas, and alternative remedies were prescribed for the treatment of constipation.

Hippocrates said: “Let food be your medicine.”

Indeed, for over 2,000 years, various foods and diets have played a major role in treating a variety of diseases and symptoms. Prunes have proven to be very effective in relieving constipation because of their fiber content and the laxative effect of an active principle similar to dihydroxyphenyl isatin.

46 | GI.ORG/ACGMAGAZINE

This handsomely preserved jar of medicated prunes was touted to relieve not only constipation but also bilious disorders, which referred to bloating, flatulence, heartburn, and dyspepsia. There was no indication on the label regarding the contained medication.

Preparations of this type, which date from 1878, usually contained unspecified herbs that had a proven laxative benefit. It probably was quite effective.

Constipation continues to be a symptom of modern civilization, and laxatives are some of the most frequently used over-the-counter medications. High fiber diets are helping to change this, and prunes still have their therapeutic place today.

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 ECGs 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

©2018 Braintree Laboratories, Inc. All rights reserved.

HH27314A

September 2018

THE ORIGINAL 1 LITER PRESCRIPTION BOWEL PREP SOLUTION

1 MOST PRESCRIBED,

#

BRANDED BOWEL PREP KIT1 WITH MORE THAN 15 MILLION KITS DISPENSED SINCE 20101 2

FIVE-STAR EFF1CACY WITH SUPREP ® Distinctive results in all colon segments • SUPREP Bowel Prep Kit has been FDA-approved as a split-dose oral regimen3 • 98% of patients receiving SUPREP Bowel Prep Kit had “good” or “excellent” bowel cleansing2* †

• >90% of patients had no residual stool in all colon segments2*

†

These cleansing results for the cecum included 91% of patients2*

†

Aligned with Gastrointestinal Quality Improvement Consortium (GIQuIC) performance target of ≥85% quality cleansing for outpatient colonoscopies.4 *This clinical trial was not included in the product labeling. †Based on investigator grading.

References: 1. IQVIA. National Prescription Audit Report. September 2018. 2. Rex DK, DiPalma JA, Rodriguez R, McGowan J, Cleveland M. A randomized clinical study comparing reduced-volume oral sulfate solution with standard 4-liter sulfate-free electrolyte lavage solution as preparation for colonoscopy. Gastrointest Endosc.

2010;72(2):328-336. 3. SUPREP Bowel Prep Kit [package insert]. Braintree, MA: Braintree Laboratories, Inc; 2017. 4. Rex DK, Schoenfeld PS, Cohen J, et al.

Quality indicators for colonoscopy. Gastrointest Endosc. 2015;81(1):31-53.

©2018 Braintree Laboratories, Inc. All rights reserved.

HH27314A

September 2018

ACG MAGAZINE ARCHIVE 2019 ACG MAGAZINE Spring 2019

MEMBERS. MEDICINE. MEANING.

Profiles in Courage IN The Fight Against Colorectal Cancer

Vol. 3 No. 1 // Spring 2019

2018 ACG MAGAZINE Fall 2018

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