ACG MAGAZINE | Vol. 6, No. 1 | Spring 2022

ACG ACG MAGAZINE MAGAZINE Spring 2022 Spring 2022

MEMBERS. MEDICINE. MEANING. MEMBERS. MEDICINE. MEANING.

Attend an upcoming

ACG POSTGRADUATE COURSE 2022 ACG/FGS Annual Spring Symposia  Hyatt Regency Coconut Point | Naples, FL  March 11–13, 2022

ACG Weekly Virtual Grand Rounds REGISTER NOW: GI.ORG/ACGVGR Plus now offering VGRs TWICE each Thursday, with a live broadcast at noon (ET) followed by an 8:00pm (ET) rebroadcast!

ACG/LGS Regional Postgraduate Course  Hilton New Orleans Riverside | New Orleans, LA  March 18–20, 2022

ACG’s Hepatology School & Eastern Regional Postgraduate Course  The Seaport Hotel | Boston, MA  April 1–3, 2022

ACG’s IBD School & Midwest Regional Postgaduate Course  JW Marriott | Indianapolis, IN  August 26–28, 2022

ACG’s Endoscopy School & ACG/VGS/ODSGNA Regional Postgraduate Course  Williamsburg Lodge | Williamsburg, VA  September 9–11, 2022

ACG 2022 Annual Scientific Meeting and Postgraduate Course  The Charlotte Convention Center | Charlotte, NC  October 21–26, 2022

ACG’s Endoscopy School & Southern Regional Postgraduate Course  Grand Hyatt | Nashville, TN  December 2–4, 2022

MORE INFO: gi.org/acg-course-calendar

SPRING 2022 // VOLUME 6, NUMBER 1

FEATURED CONTENTS Getting It Right How to prepare for and address endoscopic complications adeptly

COVER STORY

PAGE 26

ACG Perspectives Women physicians from Stony Brook University Hospital on establishing and running a holistic center for women with GI diseases and disorders PAGE 40

Dr. Frank Hamilton shares insights into his career in GI public service, fostering diversity and advancing research for more than 50 years

PAGE 28

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SPRING 2022 // VOLUME 6, NUMBER 1

CONTENTS

“I would encourage anyone considering an academic career to find mentors, both a professional and life mentor, who will provide open and honest insights on how to achieve your career goals.

Also, be open in selecting a mentor, the best mentor may not always look like you.”

—Dr. Frank Hamilton, “A Career in Medicine and Public Service,” PG 28

6 // MESSAGE FROM THE PRESIDENT

28 // COVER STORY

49 // EDUCATION EDGAR ACHKAR VISITING PROFESSORSHIP Reflecting on EAVP visits from 2021

7 // NOVEL & NOTEWORTHY

A CAREER IN MEDICINE & PUBLIC SERVICE An interview with NIDDK's Dr. Frank Hamilton, reflecting on his 50+ years of public service

Professional advancements, a landmark talk on women in GI, recognizing GI leaders recently lost & more

35 // ACG PERSPECTIVES

ACG President Dr. Samir Shah on building bridges to connect and collaborate

15 // PUBLIC POLICY

35 CULINARY CONNECTIONS ACG foodies spring into health with gutfriendly recipes for the new season

ADVOCACY & ENGAGEMENT A look into ACG’s partnership with the Digestive Disease National Coalition, advocating for patients

40 ACG PERSPECTIVES On Stony Brook University Hospital’s holistic center for women with GI diseases and disorders

21 // GETTING IT RIGHT

42 SAGE ADVICE Dr. Carol Burke recommends strategies for managing stress and ways to recharge

21 BUILDING SUCCESS How pharmaceutical device research can benefit your practice and your patients 26 PROFESSIONALISM How to prepare for and handle endoscopic complications

44 GI JANE: LIFE IN THE TRENCHES Women in GI reflect on barriers to success and offer strategies for improvement

Dr. Hamilton pictured in 2013 with ACG Past President Dr. Ronald J. Vender (2012-2013)

53 // INSIDE THE JOURNALS 54 AJG ACG Clinical Guideline for the Diagnosis and Management of Gastroesophageal Reflux Disease by Katz, et al. & The Need for Allyship in Achieving Gender Equity in Gastroenterology by Bilal, et al.

55 CTG A Coached Digital Cognitive Behavioral Intervention Reduces Anxiety and Depression in Adults with FGID by Szigethy, et al.

55 ACGCRJ Behind the Case Podcast: Infectious Abscess as Complication of Steroid Injection With Dilation of Refractory Upper Gastrointestinal Strictures

57 // A LOOK BACK 50 YEARS AGO IN AJG In 1972, Dr. Sidney Fierst and colleagues reported their experience diagnosing and treating patients with gastric cancer

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ACG MAGAZINE MAGAZINE STAFF

CONNECT WITH ACG youtube.com/ACGastroenterology

Executive Director Bradley C. Stillman, JD

facebook.com/AmCollegeGastro Editor in Chief; Vice President, Communications Anne-Louise B. Oliphant

Manager, Communications & Member Publications Becky Abel

Art Director Emily Garel

Graphic Designer Antonella Iseas

BOARD OF TRUSTEES President: Samir A. Shah, MD, FACG President-Elect: Daniel J. Pambianco, MD, FACG Vice President: Jonathan A. Leighton, MD, FACG Secretary: William D. Chey, MD, FACG Treasurer: Amy S. Oxentenko, MD, FACG Immediate Past President: David A. Greenwald, MD, FACG

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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: Mark B. Pochapin, MD, FACG Director, ACG Institute: Neena S. Abraham, MD, MSc, FACG Co-Editors, The American Journal of Gastroenterology: Jasmohan S. Bajaj, MD, MS, FACG

DIGITAL EDITIONS

GI.ORG/ACGMAGAZINE

Millie D. Long, MD, MPH, FACG Chair, Board of Governors: Patrick E. Young, MD, FACG Vice Chair, Board of Governors: Dayna S. Early, MD, FACG Trustee for Administrative Affairs: Irving M. Pike, MD, FACG

ACG MAGAZINE Spring 2021

MEMBERS. MEDICINE. MEANING.

Leading the Way in

Advancing Health Equity ACG MAGAZINE Spring 2021

MEMBERS. MEDICINE. MEANING.

Leading the Way in

Advancing Health Equity

TRUSTEES Jean-Paul Achkar, MD, FACG Seth A. Gross, MD, FACG Immanuel K. H. Ho, MD, FACG James C. Hobley, MD, MSc, FACG Costas H. Kefalas, MD, MMM, FACG Paul Y. Kwo, MD, FACG John R. Saltzman, MD, FACG Nicholas J. Shaheen, MD, MPH, MACG Neil H. Stollman, MD, FACG Renee L. Williams, MD, MHPE, FACG

4 | GI.ORG/ACGMAGAZINE

American College of Gastroenterology is an international organization with more than 16,000 clinician members representing some 86 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 Sangeeta Agrawal, MD, FACG Dr. Agrawal is Professor of Medicine, Chief of the Department of Gastroenterology, and GI Fellowship Program Director at Wright State University in Dayton, OH. She is a member of ACG’s Women in GI Committee.

Olga C. Aroniadis, MD, MSc, FACG Dr. Aroniadis is Associate Professor of Clinical Medicine at Stony Brook University Hospital and a member of ACG’s Educational Affairs Committee.

Lydia L. Aye, DO Dr. Aye is Associate Professor of Medicine and Program Director of GI Fellowship at the University of California, Irvine, and is a member of ACG’s Women in GI Committee.

Mohammad Bilal, MD Dr. Bilal is Assistant Professor of Medicine at the University of Minnesota and an advanced endoscopist and gastroenterologist at Minneapolis VA Medical Center. He is a member of ACG’s Professionalism and Training Committees.

Richard S. Bloomfeld, MD, FACG Dr. Bloomfeld is Professor of Gastroenterology and Director of the inflammatory bowel disease clinic at Wake Forest School of Medicine. He is Chair of the ACG Professionalism Committee and a member of the Credentials Committee.

Carol A. Burke, MD, FACG ACG Past President Dr. Burke is Director of the Center for Colon Polyps and Cancer Prevention and Vice Chair of the Department of Gastroenterology and Hepatology at Cleveland Clinic. She serves on ACG’s Awards Committee.

Pegah Hosseini-Carroll, MD, FACG Dr. Hosseini-Carroll is Assistant Professor of Medicine and Associate Program Director of Digestive Diseases Fellowship at the University of Mississippi Medical Center and is a member of ACG’s Women in GI Committee.

Jonathan A. Erber, MD Dr. Erber is a private practice gastroenterologist in Brooklyn, NY, with interests in endoscopy, colorectal cancer, inflammatory bowel disease, and celiac disease.

Deepinder Goyal, MD Dr. Goyal is a gastroenterologist at GastroHealth in Orlando, FL, who is board-certified in both gastroenterology and endocrinology. He is a member of ACG’s Practice Management Committee.

Frank A. Hamilton, MD, MPH, MACG Dr. Hamilton is a program director in the Division of Digestive Diseases and Nutrition at the National Institute of Diabetes, Digestive, and Kidney Diseases at the National Institutes of Health in Bethesda, MD, with a public service career of over 50 years.

Autumn Hines, DO Dr. Hines is Assistant Professor of Medicine at Emory University School of Medicine and is a member of ACG’s Women in GI Committee.

Janese S. Laster, MD Dr. Laster is a private practice gastroenterologist in Washington, DC, and is board-certified in internal medicine, gastroenterology, obesity medicine, and nutrition.

Dale Lee, MD, MSCE Dr. Lee is Medical Director of Clinical Nutrition, Director of the Celiac Disease Program, and Associate Professor at Seattle Children’s Hospital.

John G. McCarthy, MD, MAJ, MC, USA Dr. McCarthy is Associate Program Director of NCC Gastroenterology Fellowship at Walter Reed National Military Medical Center and Assistant Professor of Medicine at the Uniformed Services University of the Health Sciences.

Shajan Peter, MD, FACG Dr. Peter is Clinical Assistant Professor at the University of Alabama at Birmingham and is a member of ACG’s Practice Management Committee.

Lawrence R. Schiller, MD, MACG ACG Past President Dr. Schiller is the Program Director of the Gastroenterology Fellowship Program at Baylor University Medical Center and past chair of the ACG Archives Committee.

Samir A. Shah, MD, FACG Dr. Shah is the 2021-2022 ACG President, Clinical Professor of Medicine at Alpert Medical School at Brown University, Chief of Gastroenterology at the Miriam Hospital, and is a partner with Gastroenterology Associates, Inc. Lavanya Viswanathan, MD Dr. Viswanathan is Chief of Gastroenterology at David Grant Medical Center and Associate Professor of Medicine at the Uniformed Services University of the Health Sciences. She is a Lieutenant Colonel in the U.S. Air Force and serves on ACG’s Women in GI and Educational Affairs Committees.

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MESSAGE FROM THE PRESIDEN

BUILDING BRIDGES DEAR COLLEAGUES: We hoped the COVID-19 pandemic would be in the past by now. As I write this, Omicron is surging everywhere and no clear end is in sight. Hence, we must figure out how to continue with our lives and our profession, despite the pandemic. I want to focus on the three themes I outlined at our Annual Meeting: BOLD, BEACON and BOOM. The ACG will continue to be BOLD in its leadership in tackling the issues that face gastroenterology. The ACG will continue to be a BEACON for gastroenterology, providing our members with resources to provide the best care to the patients they serve. Finally, BOOM refers to critical mass theory (acknowledgement to Dr. Amy Oxentenko, ACG Treasurer, please see her 2021 AJG Lecture from the 2021 Annual Meeting to explore this concept: bit.ly/Oxentenko-AJG-2021).

To have these lofty goals is nice—but how do we get there?

Simple, another “B” word: BRIDGES. Bridges connect two isolated areas, fostering communication between the two previously not possible. This is more than symbolic—it is critical to progress.

For example, our ACG Governors help bridge our members to our leadership, and our website (gi.org) helps connect our members to multiple benefits, including GI OnDEMAND which bridges patients and providers to provide high level multidisciplinary care—free to all ACG members! Our ACG committee chairs meet periodically to avoid “silos” and promote collaboration across multiple committees resulting in novel approaches. Connections to our sister societies in the U.S. help us advocate with a unified, more powerful voice to influence public policy. Our International Relations Committee connects us to the WGO and GI societies in other countries, cosponsoring meetings and providing speakers. As the pandemic started spreading in early 2020, we were able to get insight about COVID-19 from colleagues in China and Italy who both helped prepare us for for that initial wave.

In 2009, ACG and ASGE forged GIQuIC to promote the highest quality of digestive health by measuring and benchmarking quality markers that matter like the adenoma detection rate (ADR). GIQuIC will be expanding to other areas beyond just endoscopy to offer participants a way to track and continuously improve quality in all aspects of GI care (shout out to Dr. Costas Kefalas and the entire GIQuIC Board!) If you are not participating in GIQuIC, consider this your personal invitation from me to participate; your practice/division and patients will be better for it!

One “bridge” that I am personally very proud of is the ACG’s relationship to the Digestive Disease National Coalition (DDNC) highlighted in this issue. Our work together led to the passage of the Removing Barriers to Colon Cancer Screening Act and today we continue to advocate together on issues like the Safe Step Therapy Act.

6 | GI.ORG/ACGMAGAZINE

“To have these lofty goals is nice – but how do we get there? Simple, another “B” word: BRIDGES. Bridges connect two isolated areas, fostering communication...”

Bridges avoid isolation, which can be detrimental in multiple ways to an individual or society. Our ability to connect with others despite the pandemic and support each other through difficult times was and is vital in mitigating stress and burnout. There was a time not too long ago in America where political parties would bridge gaps in their ideology and compromise, putting the interests of the country before partisan politics. As we witness the seemingly never-ending partisanship in our political system and in the media, we must strive to be inclusive of multiple points of view (data-driven, of course). Bridging these divides can lead to understanding of different philosophies and build mutual respect.

Finally, I can’t help but bring music into this. My favorite musician, Sting, just came out with a new album, The Bridge.

Last March, ACG member Dr. Ben Levy put together an amazing online streaming concert featuring 28 artists called “Tune It Up: A Concert to Raise Colorectal Cancer Awareness.” I can’t wait to see what he puts together this March! On February 19, ACG Governor for Northern California Dr. Ronald Hsu and colleagues hosted a concert performed by the Davis Senior High School Baroque Ensemble, directed by Angelo Moreno and Michael Sand, entitled “Bridging Medicine & Music: A Colorectal Cancer Prevention Seminar and Concert.” This was a fantastic bridge to the community involving our youth in promoting colorectal cancer screening awareness.

I hope each of you will consider which bridges are important and which bridges you/ we need to build to reach our individual and collective goals.

“Let’s build bridges, not walls.”

– Martin Luther King, Jr. “If you are good at building bridges, you will never fall into the abyss!”

– Mehmet Murat Ildan “Rather than focusing on the obstacle in your path, focus on the bridge over the obstacle.”

– Mary Lou Retton

­­—Samir A. Shah, MD, FACG

Note hy wor t OUR AIM WITH NOVEL & NOTEWORTHY IS TO CELEBRATE the accomplishments of ACG members, but sometimes we have the solemn, yet inspiring, task of sharing memorial tributes to their lives and careers. In this issue, we remember with great respect two ACG members who lived into their 90s and made important contributions to gastroenterology.

We note the passing of Dr. Burton I. Korelitz (1926–2022) ACG Past President (1980–81), and Dr. Walter R. Thayer (1929–2022) ACG Governor for Rhode Island (1996–1998), both of whom left indelible marks on the field of GI and on our world. For their many contributions to medicine, but especially for the significant ways that they taught and mentored generations of gastroenterologists and advanced the field, they will be remembered with admiration by their ACG colleagues and friends.

ACG MAGAZINE welcomes you to share your professional news or highlights from your colleagues by email at ACGMag@gi.org.

Novel & Noteworthy | 7

N&N GI EYE: ARTWORK FROM ACG MEMBERS

“FIT POSITIVE” Acrylic. 8x10 canvas board.

What inspired you to make this painting and why did you choose your subject?

As endoscopists, we shine light on parts of the human body that otherwise remain forever in darkness. We become experts at recognizing growths that are as inherently odd and fascinating as they are sinister. GI providers find them commonplace, while others are generally bewildered, repulsed, or curious…What better subject to paint than that?! Next, and in the same vein, I plan on painting colon cancer.

What captured your attention about this particular polyp?

A 45-year-old man presented for colonoscopy after a positive FIT, and I was inspired by the subsequently identified polyp. Before removing the high risk adenoma with snare cautery, I remember being impressed with the classic characteristics that implicated it as the culprit lesion. The polyp was large, surrounded by hematin, and had a classic adenomatous pit pattern. I thought the case exemplified a non-invasive test leading to a meaningful intervention. The painting hangs in my office as a nice reminder of the hidden, but incredibly rewarding, part of the job: cancer prevention.

Comment upon any technical challenges of the painting: As a new painter, it’s all challenges (mostly fun) and learning from mistakes.

These mistakes have changed how I look at everything; I now spend more time trying to understand perspective, light, and depth. I’ve learned how to better manage fast-drying acrylics. I struggled with subtleties in color selection for pink mucosa and layering. The pit pattern in the adenomatous polyp was tedious, but worth it (I think)!

When and why did you start painting?

I started painting 6 months ago and, so, very much consider myself a novice. Fueled partly by COVID-induced restriction, my

8 | GI.ORG/ACGMAGAZINE

new hobby stemmed from desperation in finding a creative outlet in an otherwise highly technical/scientific field. I was also inspired by a traveling Van Gogh exhibit — I really loved one of his remarkable sunflower paintings.

I wish I had started painting much sooner.

Have you ever taken art classes?

No. I occasionally watch online instructional videos. You can learn almost everything online these days.

What lessons or insights about yourself have you discovered as a painter?

To make something great, you have to risk ruining something good.

Knowing when to declare the painting as “done” is difficult.

What skills from medicine are transferable to painting, and vice versa?

Patience, dedication, and recognizing that fun necessitates challenge.

John G. McCarthy, MD, MAJ, MC, USA, Gastroenterology, Walter Reed National Military Medical Center; Associate Program Director, NCC Gastroenterology Fellowship; Assistant Professor of Medicine, USUHS

Novel & Noteworthy | 9

// N&N

[NEW JOB]

[CONGRATULATIONS]

[KUDOS]

NEW ROLE FOR DR. DARWIN CONWELL

DR. TAUSEEF ALI RECOGNIZED BY HOSPITAL

Darwin L. Conwell, MD, MSc, FACG, has been named Chief of Internal Medicine at the University of Kentucky School of Medicine as of April 2022. He has served as Director of the Division of Gastroenterology, Hepatology and Nutrition at The Ohio State University Wexner Medical Center since 2013. He is past president of the American Pancreatic Association, a member of the Cooperative Alliance for Pancreas Education and Research Board and a member of the National Pancreas Foundation. Congratulations, Dr. Conwell!

Tauseef Ali, MD, FACG, of Oklahoma City, OK, received the 2021 St. Luke Award. The award is given each year

by St. Anthony Hospital executives to the physician who most exemplifies the life of St. Luke, the patron saint of physicians and surgeons. Dr. Ali is the College’s Governor for Oklahoma and chairs the ACG Public Relations Committee.

ACG’S GOVERNOR FOR ONTARIO HONORED Congratulations to Nikila C. Ravindran, MD, FACG, for the Mackenzie Health Kudos President's Award for Excellence. Dr. Ravindran was recognized for her compassionate care, strong leadership, and her ability to make her patients feel heard, understood, and comfortable throughout their care journey. She serves as ACG’s Governor for Ontario. Mackenzie Health thanked Dr. Ravindran for making a positive impact on her patients and for fostering a kind and compassionate environment for them, their families, and her colleagues.

[CHIEF]

MICHIGAN GI’S NEW CHIEF: DR. BILL CHEY William D. Chey, MD, FACG, becomes the Chief of the Division of Gastroenterology and Hepatology at the University of Michigan on May 1, 2022.

He is currently the Timothy T. Nostrant Collegiate Professor in Gastroenterology and Professor of Internal Medicine, and a Professor of Nutritional Sciences. Dr. Chey has been the longstanding Director of

[BOOM]

DR. AMY OXENTENKO: THE AMERICAN JOURNAL OF GASTROENTEROLOGY LECTURE ACG Vice President Amy S. Oxentenko, MD, FACG, delivered The American Journal of Gastroenterology Lecture before a live audience of her peers at the College’s 2021 Annual Scientific Meeting in Las Vegas, “Hidden in Plain Sight: Bringing Women into the Scope of Gastroenterology.”

Dr. Oxentenko provided an elegant overview of critical mass theory as it pertains to women in both medicine and gastroenterology. In her wide ranging and illuminating talk she “brought into scope” women who have left their legacy, or are creating one, in gastroenterology, including Dr. Elizabeth Blackwell, Dr. Sarah Joran, Dr. Sadye Curry, and ACG Past President Dr. Christina Surawicz. Dr. Oxentenko also outlined a vision for ways for the GI profession can work together to further address diversity, equity, and inclusion.

Dr. Oxentenko explained that critical mass theory “requires a sufficient number in a minority group, such that once you reach

10 | GI.ORG/ACGMAGAZINE

the Michigan GI Physiology Laboratory, co-Director of the Michigan Bowel Control Program, Director of the Digestive Diseases Nutrition & Behavior Health Program, and Director of the University of Michigan Food for

that critical number, then there is a rapidly increasing acceptance of that minority viewpoint. And once you have that, the rate of adoption then self-sustains and suddenly accelerates rapidly.”

In her lecture she applied critical mass theory to women in GI and medicine: “When you look at gender diversity in the boardroom, what constitutes critical mass? Well, what you see is that once you reach 20 to 30 percent women on boards, the profitability of that company increases significantly. I don't know a whole lot about history, but I do love science, so this definition really spoke to me: Critical mass has its root in physics. It's the amount of material needed to sustain a nuclear explosion. Accumulate enough, set it off, and there's no other outcome but, “boom!” Look at the data from AAMC: It was in the year 1980 where suddenly we reached that critical mass in medical school faculty and students, finally reaching 30% of faculty that were women and 30% of medical students that were women at that time. And that really was the pivotal point where we started to see changes in medical school matriculation.”  WATCH: bit.ly/Oxentenko-AJG-2021

Life Kitchen. He is a former CoEditor-in-Chief of The American Journal of Gastroenterology (2009-2015), has been a member of the ACG Board of Trustees since 2015, and currently serves as the College’s Secretary.

Top: Amy S. Oxentenko, MD, FACG delivers The American Journal of Gastroenterology Lecture, October 25, 2021. Former AJG Co-Editors in Chief, Brian E. Lacy, MD, PhD, FACG (left) and Brennan M. R. Spiegel, MD, MSHS, FACG (right) recognize Dr. Oxentenko, the 2021 AJG Lecturer.

[IN MEMORIAM]

[IN MEMORIAM]

WALTER R. THAYER, MD, FACG (1929-2022)

BURTON I. KORELITZ, MD, MACG (1926-2022)

The College notes with sadness the passing of Walter R. Thayer Jr., MD, FACG, who died in January 2022. Dr. Thayer was an expert in Crohn’s disease and a distinguished leader in gastroenterology from Rhode Island, where he was elected as ACG’s Governor for 1996 to 1998.

A lifelong resident of Rhode Island and 1954 graduate of Tufts University Medical School, Dr. Thayer served as chief of gastroenterology at Brown Medical School and of the gastroenterology division at Rhode Island Hospital, where he started a Gastrointestinal Residency Program, in partnership with Brown. He held these positions for 30 years and was a beloved and respected professor at the Brown Alpert Medical School.

Upon his retirement in 2004, he proudly cut the ribbon at the Walter R. Thayer Inflammatory Bowel Disease Laboratory at Rhode Island Hospital.

Following his retirement, Dr. Thayer remained committed to patient care and preparing the next generation of gastroenterologists. He volunteered at the Providence Veterans Affairs Medical Center and as a teacher at the medical school, where he was recognized as Teacher of the Year in 2016. He also volunteered at the Rhode Island Hospital clinic and mentored Brown medical students.

His colleagues at Brown remember Dr. Thayer for his welldeserved reputation as a caring and empathetic doctor to the thousands of patients he treated. ACG President Samir A. Shah, MD, FACG, remembers, “Dr. Thayer was universally beloved by his patients and was considered the authority on IBD in Rhode Island for many decades and to whom colleagues would refer their most challenging cases. He was recognized by the New England Chapter of the Crohn’s and Colitis Foundation with the Humanitarian Award in 2001. Besides his dedication to patient care, he was instrumental in training gastroenterologists in RI and was an exemplary mentor/ teacher for GI fellows and young faculty. Even after his retirement, he was a regular at our GI Grand Rounds at Rhode Island Hospital, asking probing questions of the presenter and providing historical perspective on all things GI. He was ahead of his time, speculating on the role of mycobacteria and the microbiome in Crohn’s disease. His positive impact on gastroenterology and medical care regionally was profound and will continue for decades to come.”

“Dr. Thayer proudly trained hundreds of young doctors to excel in the field of gastroenterology with a particular emphasis on the recruitment and support of doctors of color, understanding that the expansion of diversity in this vital field could have a great impact on the treatment of patients across all cultural and ethnic communities,” wrote Jack A. Elias, MD, Senior Vice President for Health Affairs, Dean of Medicine and Biological Sciences, Brown University Alpert Medical School.

His obituary in the Providence Journal noted, “Dr. Thayer’s extraordinary professional reputation was, perhaps, eclipsed by his adventurous spirit and it is said that he spent each and every one of his 92 years seeking new ways to test his fortitude … and courage.” The obituary recounted several of his many adventures in the great outdoors, as well as his love of hiking, swimming, cycling, and mountain climbing. He had a passionate interest in wildflowers and later in life received a degree in Botany from the University of Rhode Island. Dr. Thayer is survived by his sister, three children, and numerous grandchildren and great-grandchildren.

The College has the sad duty to report that ACG Past President and pioneering expert in inflammatory bowel disease Dr. Burton I. Korelitz died suddenly at age 95 on January 8, 2022. He served as ACG President in 1980-1981 and up until the very end of his life remained a strong supporter, actively engaged with the College. In 2016, Dr. Korelitz was recognized for outstanding career service to ACG with the College’s highest honor, the Samuel Weiss Award.

He was born in Boston and grew up in Lawrence, Massachusetts.

He attended Duke University, but left for the Army in 1944 during World War II and then returned to graduate in 1947. At graduation from Boston University School of Medicine (AOA) in 1951, he received the Weinstein/Keefer Award for Internal Medicine.

Dr. Korelitz interned at Mt. Sinai Hospital, New York, during which time he met his future wife, Ann. He returned to Boston for residency at the “new” Boston VA hospital, and became the first fellow in gastroenterology at the Beth Israel Hospital under Dr. Benjamin Banks and Dr. Louis Zetzel, where he did research in IBD. He then returned to Mt. Sinai to become Chief Medical Resident, a Rosenstock Fellow, and later became an attending physician. In later years, he was honored with the Jacobi Medallion by the Mt. Sinai Alumni for achievement.

In the 1960s, he joined the medical staff at Lenox Hill Hospital, New York and became the Chief of Gastroenterology for the next 28 years. There, he had the opportunity to teach hundreds of fellows in gastroenterology and medical residents. Dr. Korelitz also served as Chairman of the Scientific Advisory Board of the Crohn’s and Colitis Foundation where he is remembered for his dedication to patient care and his instrumental research on therapies for IBD. “Dr. Korelitz was a consummate physician scientist who left an enduring legacy of expert and compassionate patient care, groundbreaking clinical research, and inspired teaching over a 60-year career. His discovery and advocacy of immunomodulating therapy for inflammatory bowel disease has immeasurably altered and advanced the progress of medical science worldwide,” reflected David B. Sachar, MD, MACG, Clinical Professor of Medicine and Emeritus Chief of Gastroenterology, Icahn School of Medicine at Mount Sinai.

In a remembrance of Dr. Korelitz, Keith Sultan, MD, FACG; Ramona Rajapakse, MD, FACG; and the GI fellows of Lenox Hill Hospital shared: “Whatever else we may become, we will always be Dr. Burton Korelitz’s fellows. Though his legacy as a leader in the field of inflammatory bowel disease research and treatment is secured and widely known, we also wish to honor the impact he made on a generation of gastroenterology fellows during his many years as Chief at Lenox Hill Hospital. We did not merely train with Dr. Korelitz, but were mentored by him in every sense of the word. His devotion to us was sincere, and his interest in our professional and personal development never waned with the passing years. When meeting him face-to-face, most of us continued addressing him as Dr. Korelitz out of respect and habit. Amongst ourselves however, we speak only of ‘Burt,’ out of love.”

ACG Past President Seymour Katz, MD, MACG, (1995-1996) remembers his friend: “It is indeed an honor to speak of Burt’s iconic role in American gastroenterology. He was the consummate physician with coupling of skill and kindness in the compassionate care of his patients, yet never lessening his immersion in clinical research. Burt’s legacy lives on in all who knew him as the ideal physician-role model.”

Novel & Noteworthy | 11

MARCH

MARCH 2022

18–20

COLORECTAL CANCER AWARENESS MONTH

2022 ACG/LGS REGIONAL POSTGRADUATE COURSE

 New Orleans, LA Register: meetings.gi.org

MARCH 31

MARCH 14

NORTH AMERICAN INTERNATIONAL GI TRAINING GRANTS More Info:

gi.org/gi-training-grants

ACG 2022 CALL FOR ABSTRACTS SUBMISSION SITE OPENS Learn More: conferenceabstracts.com/acg2022.html

APRIL

1–3 2022 ACG HEPATOLOGY SCHOOL & EASTERN REGIONAL POSTGRADUATE COURSE  Boston, MA Register: meetings.gi.org

APRIL 15 ACG AWARD NOMINATIONS Nominate Your Colleague

AUGUST

Learn More: gi.org/award-nominations

26–28

MAY

31

ENTER TO WIN A SCOPY Submit your Entry: gi.org/scopy

OCTOBER 21-26, 2022 Charlotte Convention Center Charlotte, NC

CALL for abstracts  SUBMISSION DATES: MARCH 14-JUNE 20, 2022  conferenceabstracts.com/acg2022.html

12 | GI.ORG/ACGMAGAZINE

2022 IBD SCHOOL & MIDWEST REGIONAL POSTGRADUATE COURSE  Indianapolis, IN Register: meetings.gi.org

BRIEF SUMMARY: Before prescribing, please see Full Prescribing Information and Medication Guide for SUTAB® (sodium sulfate, magnesium sulfate, potassium chloride) tablets for oral use.

INDICATIONS AND USAGE: An osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults.

DOSAGE AND ADMINSTRATION: Split Dose (2-Day) Regimen: Dose 1 – On the day prior to colonoscopy: A low residue breakfast may be Packaging and consumed. After breakfast, only clear liquids may be consumed until after the tablets not shown colonoscopy. Early in the evening prior to colonoscopy, open one bottle of actual size.

12 tablets. Fill the provided container with 16 ounces of water (up to the fill line).

Swallow each tablet with a sip of water and drink the entire amount over 15 to 20 minutes. Approximately one hour after the last tablet is ingested, fill the provided container a second time with 16 ounces of water (up to the fill line) and drink the entire amount over 30 minutes. Approximately 30 minutes after finishing the second container of water, fill the provided container with 16 ounces of water (up to the fill line) and drink the entire amount over 30 minutes. Dose 2 - Day of colonoscopy: Continue to consume only clear liquids until after the colonoscopy. The morning of colonoscopy (5 to 8 hours prior to the colonoscopy and no sooner than 4 hours from starting Dose 1), open the second bottle of 12 tablets. Fill the provided container with 16 ounces of water (up to the fill line). Swallow each tablet with a sip of water and drink the entire amount over 15 to 20 minutes. Approximately one hour after the last tablet is ingested, fill the provided container a second time with 16 ounces of water (up to the fill line) and drink the entire amount over 30 minutes.

Approximately 30 minutes after finishing the second container of water, fill the provided container with 16 ounces of water (up to the fill line) and drink the entire amount over 30 minutes. Complete all SUTAB tablets and required water at least 2 hours before colonoscopy.

CONTRAINDICATIONS: Use is contraindicated in the following conditions: gastrointestinal obstruction or ileus, bowel perforation, toxic colitis or toxic megacolon, gastric retention. WARNINGS AND PRECAUTIONS: Serious Fluid and Electrolyte Abnormalities: Advise all patients to hydrate adequately before, during, and after the use of SUTAB. If a patient develops significant vomiting or signs of dehydration after taking SUTAB, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN). Fluid and electrolyte disturbances can lead to serious adverse events including cardiac arrhythmias, seizures and renal impairment. Correct fluid and electrolyte abnormalities before treatment with SUTAB. Use SUTAB with caution in patients with conditions, or who are using medications, that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and renal impairment; Cardiac arrhythmias: Use caution when prescribing SUTAB for patients at increased risk of arrhythmias (e.g., patients with a history of prolonged QT, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy). Consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias; Seizures: Use caution when prescribing SUTAB for patients with a history of seizures and in patients at increased risk of seizure, such as patients taking medications that lower the seizure threshold (e.g., tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia; Use in Patients with Risk of Renal Injury: Use SUTAB with caution in patients with impaired renal function or patients taking concomitant medications that may affect renal function (such as diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or non-steroidal anti-inflammatory drugs). These patients may be at risk for renal injury.

Advise these patients of the importance of adequate hydration with SUTAB and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients; Colonic Mucosal Ulcerations and Ischemic Colitis: Osmotic laxative products may produce colonic mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Concurrent use of stimulant laxatives and SUTAB may increase these risks. Consider the potential for mucosal ulcerations resulting from the bowel preparation when interpreting colonoscopy findings in patients with known or suspect inflammatory bowel disease (IBD); Use in Patients with Significant Gastrointestinal Disease: If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering SUTAB. Use with caution in patients with severe active ulcerative colitis. ADVERSE REACTIONS: Most common gastrointestinal adverse reactions are: nausea, abdominal distension, vomiting and upper abdominal pain. POTENTIAL FOR DRUG ABSORPTION: SUTAB can reduce the absorption of other co-administered drugs. Administer oral medications at least one hour before starting each dose of SUTAB. Administer tetracycline and fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, and penicillamine at least 2 hours before and not less than 6 hours after administration of each dose of SUTAB to avoid chelation with magnesium. Pregnancy: There are no available data on SUTAB use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. No reproduction or developmental studies in animals have been conducted with sodium sulfate, magnesium sulfate, and potassium chloride (SUTAB). Lactation: There are no available data on the presence of SUTAB in human or animal milk, the effects on the breastfed child, or the effects on milk production.

Pediatric Use: Safety and effectiveness in pediatric patients has not been established. Geriatric Use: Of the 471 patients who received SUTAB in pivotal clinical trials, 150 (32%) were 65 years of age or older, and 25 (5%) were 75 years of age or older. No differences in safety or effectiveness of SUTAB were observed between geriatric patients and younger patients. Elderly patients are more likely to have decreased hepatic, renal or cardiac function and may be more susceptible to adverse reactions resulting from fluid and electrolyte abnormalities. STORAGE: Store at 20º to 25°C (68º to 77°F). Excursions permitted between 15º to 30°C (59º to 86°F). See USP controlled room temperature. Rx only. Manufactured by Braintree Laboratories, Inc. Braintree, MA 02185 See Full Prescribing Information and Medication Guide at SUTAB.com.

References: 1. SUTAB® [package insert]. Braintree, MA; 2020. 2. Di Palma JA, Bhandari R, Cleveland M, et al. A safety and efficacy comparison of a new sulfate-based tablet bowel preparation versus a PEG and ascorbate comparator in adult subjects undergoing colonoscopy. Am J Gastroenterol. Published online November 6, 2020. doi: 10.14309/ajg.0000000000001020 3. Rex DK, Johnson DA, Anderson JC, Schoenfeld PS, Burke CA, Inadomi JM; ACG. American College of Gastroenterology guidelines for colorectal cancer screening 2009 [corrected]. Am J Gastroenterol. 2009;104(3):739-750. 4. IQVIA. National Prescription Audit Report. November 2020.

For additional information, please call 1-800-874-6756 ©2021 Braintree Laboratories, Inc.

All rights reserved.

201-133-v1-A January 2021

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!

W! E NEW N

A NEW TABLET CHOICE A BOWEL NEW TABLET CHOICE IN PREPARATION IN BOWEL PREPARATION

• NO SODIUM PHOSPHATE1

• SAFE AND EFFECTIVE1,2 1 • NO SODIUM PHOSPHATE • ACG-RECOMMENDED1,2 SPLIT-DOSE REGIMEN3 • SAFE AND EFFECTIVE 1 – Two SUTAB doses are required for a complete preparation

Dose 1 consists of 12 tablets and 16 oz of water REGIMEN3 • ACG-RECOMMENDED SPLIT-DOSE Dose 2 consists of 12 tablets and 16 oz of water 1 – Two are required for a complete preparation EachSUTAB dose isdoses followed by two additional 16 oz of water Dose 1 consists of 12 tablets and 16 oz of water Dose 2 consists of 12 tablets and 16 oz of water Packaging and tablets not shown size.

Each dose is followed by actual two additional 16 oz of water

92% OF PATIENTS IN TWO PIVOTAL TRIALS ACHIEVED SUCCESSFUL BOWEL CLEANSING WITH SUTAB1,2* 91% OF PATIENTS IN ONE PIVOTAL TRIAL RATED SUTAB AS TOLERABLE TO VERY EASY TO CONSUME2† 1,2 ® 1,2‡ 92% OF PATIENTS IN TWO PIVOTAL TRIALSreported ACHIEVED SUCCESSFUL CLEANSING SUTAB * • 52% of all SUTAB and MoviPrep patients at least one selectedBOWEL gastrointestinal adverseWITH reaction • More SUTAB patients reported experiencing nausea and vomiting than competitor, with ≤1%TO of these reports2† 91% OF PATIENTS IN ONE PIVOTAL TRIAL RATED SUTAB AS TOLERABLE TO VERY EASY CONSUME 2‡ Packaging and tablets not shown actual size.

considered severeand MoviPrep® patients reported at least one selected gastrointestinal adverse reaction1,2‡ • 52% of all SUTAB

2† 78% OF PATIENTS ONE reported PIVOTALexperiencing TRIAL WOULD REQUEST SUTAB AGAIN FOR A FUTURE • More SUTAB IN patients nausea and vomiting than competitor, with ≤1% ofCOLONOSCOPY these reports

considered severe * Success was primary endpoint and was defined in noninferiority trials as an overall cleaning assessment of 3 (good) or 4 (excellent) by the blinded endoscopist; scores were assigned on withdrawal of colonoscope.

OF PATIENTS IN ONE PIVOTAL TRIAL WOULD REQUEST SUTAB AGAIN FOR A FUTURE COLONOSCOPY2† † Patients completed preference questionnaire following completion of study drug to capture the subject’s perceptions of the preparation experience. This * questionnaire has not undergone formal validation.

Success was primary endpoint and was defined in noninferiority trials as an overall cleaning assessment of 3 (good) or 4 (excellent) by the blinded endoscopist; ‡ scores were assigned on withdrawal of colonoscope.

Patients were queried for selected gastrointestinal adverse reactions of upper abdominal pain, abdominal distension, nausea, and vomiting following completion †of study drug, rating the intensity as mild, moderate, or severe.

Patients completed preference questionnaire following completion of study drug to capture the subject’s perceptions of the preparation experience. This questionnaire has not undergone formal validation.

ACG=American College of Gastroenterology ‡ ® Patients were queried for selected gastrointestinal adverse reactions of upper abdominal pain, abdominal distension, nausea, and vomiting following completion is a registered trademark of Velinor AG. MoviPrep of study drug, rating the intensity as mild, moderate, or severe.

ACG=American College of Gastroenterology MoviPrep® is a registered trademark of Velinor AG. IMPORTANT SAFETY INFORMATION 2‡

78%

SUTAB® (sodium sulfate, magnesium sulfate, potassium chloride) tablets for oral use is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults. DOSAGE AND ADMINSTRATION: A low residue breakfast may be consumed. After IMPORTANT SAFETY INFORMATION breakfast, only clear liquids may be consumed until after the colonoscopy. Administration of two doses of SUTAB (24 tablets) are required ® SUTAB (sodium sulfate, magnesium sulfate, potassium chloride) tablets for oral use is an osmotic laxative indicated for cleansing of the for a complete preparation for colonoscopy. Twelve (12) tablets are equivalent to one dose. Water must be consumed with each dose colon in preparation for colonoscopy in adults. DOSAGE AND ADMINSTRATION: A low residue breakfast may be consumed. After of SUTAB and additional water must be consumed after each dose. Complete all SUTAB tablets and required water at least 2 hours breakfast, only clear liquids may be consumed until after the colonoscopy. Administration of two doses of SUTAB (24 tablets) are required before colonoscopy. CONTRAINDICATIONS: Use is contraindicated in the following conditions: gastrointestinal obstruction or ileus, for a complete preparation for colonoscopy. Twelve (12) tablets are equivalent to one dose. Water must be consumed with each dose bowel perforation, toxic colitis or toxic megacolon, gastric retention. WARNINGS AND PRECAUTIONS: Risk of fluid and electrolyte of SUTAB and additional water must be consumed after each dose. Complete all SUTAB tablets and required water at least 2 hours abnormalities: Encourage adequate hydration, assess concurrent medications and consider laboratory assessments prior to and after each before colonoscopy. CONTRAINDICATIONS: Use is contraindicated in the following conditions: gastrointestinal obstruction or ileus, use; Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk; Seizures: Use caution in patients bowel perforation, toxic colitis or toxic megacolon, gastric retention. WARNINGS AND PRECAUTIONS: Risk of fluid and electrolyte with a history of seizures and patients at increased risk of seizures, including medications that lower the seizure threshold; Patients with abnormalities: Encourage adequate hydration, assess concurrent medications and consider laboratory assessments prior to and after each renal impairment or taking concomitant medications that affect renal function: Use caution, ensure adequate hydration and consider use; Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk; Seizures: Use caution in patients laboratory testing; Suspected GI obstruction or perforation: Rule out the diagnosis before administration. ADVERSE REACTIONS: with a history of seizures and patients at increased risk of seizures, including medications that lower the seizure threshold; Patients with Most common gastrointestinal adverse reactions are: nausea, abdominal distension, vomiting and upper abdominal pain. DRUG renal impairment or taking concomitant medications that affect renal function: Use caution, ensure adequate hydration and consider INTERACTIONS: Drugs that increase risk of fluid and electrolyte imbalance. laboratory testing; Suspected GI obstruction or perforation: Rule out the diagnosis before administration. ADVERSE REACTIONS: Please see Brief Summary of Prescribing Information on reverse side. See Full Prescribing Information and Medication Guide at Most common gastrointestinal adverse reactions are: nausea, abdominal distension, vomiting and upper abdominal pain. DRUG SUTAB.com.

INTERACTIONS: Drugs that increase risk of fluid and electrolyte imbalance.

Please see Brief Summary of Prescribing Information on reverse side. See Full Prescribing Information and Medication Guide at SUTAB.com.

From the makers of SUPREP® Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Solution for adults—

THE #1 MOST PRESCRIBED, BRANDED BOWEL PREP KIT4

From the makers of SUPREP® Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Solution for adults—

THE #1 MOST PRESCRIBED, BRANDED BOWEL PREP KIT4

PUBLIC POLICY

B:11.25"B:11.25"

ACG’s Work with the Digestive Disease National Coalition

T:10.75"T:10.75"

S:9.75" S:9.75"

Advocacy & Engagement:

INTRODUCTION TO THE DIGESTIVE DISEASE NATIONAL COALITION – 40 YEARS OF ADVOCACY FOR PATIENTS WITH DIGESTIVE DISEASES For more than 40 years, the Digestive Disease National Coalition (DDNC) has advocated for federal policies and legislation benefiting patients with digestive diseases and the clinicians who support them.

At the conclusion of the original late1970s National Commission on Digestive Disease Research, representatives from the professional GI societies and the digestive disease patient community, several of whom served as commissioners, decided that it would take a collaborative effort of all stakeholders to convince Congress to implement the structural changes to

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the NIH digestive disease research program recommended by the National Commission.

This decision to establish a coalition to speak with one voice in support of the recommendations of the National Commission was the birth of the DDNC. Congress responded to the DDNC’s advocacy to enhance the Division of Digestive Disease Research at the then National Institute of Arthritis and Diabetes and Digestive and Kidney Diseases (NIADDK, now NIDDK), and also added other important elements to the digestive disease division, giving it more authority to support a comprehensive research program—including the current NIDDK Silvio O. Conte Digestive Diseases Research Core Centers program.

In the late 1990s, the DDNC worked alongside the professional GI societies to advocate for legislation providing for the establishment of a Medicare benefit for colon cancer screening and was also the driving force behind the establishment of the Centers for Disease Control and Prevention’s (CDC) Colorectal Cancer Control Program which works with state, local, and academic partners to implement evidence-based interventions known to be effective in increasing colorectal cancer screening. More recently, the DDNC partnered with the American Cancer Society and the professional GI societies to pass legislation to solve the “polyp penalty”—the Removing Barriers to Colorectal Cancer Screening Act, which waives Medicare coinsurance requirements with respect to colorectal cancer screening tests.

To this day, the hallmark of the DDNC continues to be the collaboration among patient and provider organizations to speak with one voice to legislators and

federal government officials. The DDNC works closely with all federal health agencies and helped write the national hepatitis screening program for HHS, ran webinars for the FDA regarding its new food safety division, and helped compose the 10-year federal plan for gastrointestinal disease.

Decision-makers in Washington respond well when patients and providers visit their offices together and are on the same page in their legislative and policy recommendations. The DDNC’s 32nd annual Public Policy Forum is scheduled for March 6th and 7th, 2022. Patients and health care professionals from around the country will receive briefings on key legislative topics and throughout the week will join each other to visit legislators in support of the DDNC Public Policy Agenda.

In the second session of the 117th Congress, DDNC will advocate for its traditional federal research and public health funding priorities and urge Congress to pass the Safe Step Act, federal legislation establishing common sense guardrails and a swift appeals process on the practice of step therapy—a costshifting tactic utilized by third party payors to require a patient to fail first on their preferred treatment before being allowed to receive the treatment recommended by their doctor. The bipartisan Safe Step Act is gaining steam in the House and Senate and is being supported by over 200 national patient and provider organizations.

The DDNC welcomes the participation of all patient organizations and national and state-based provider organizations.

Visit the DDNC website (www.ddnc.org) or contact Dale Dirks, Lesia Griffin, and Jackson Rau at 202-544-7497. – Dale Dirks

Patient, physician, and nurse representatives present the DDNC’s Public Policy Leadership Award to Senator Roger Wicker (R-MS) for his support of colon cancer screening legislation.

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and Jordan Rau, DDNC Staff, Health and Medical Counsel of Washington

ACG & DDNC “The DDNC is an umbrella organization encompassing patient advocacy groups, professional organizations, and industry partners. The DDNC’s mission is to advocate for patients with digestive diseases and, hence, it is vital for ACG to be involved with DDNC in relation to its own public policy priorities. I served as ACG representative to the DDNC starting in 2021, and as its President from 20182020, where I worked with dedicated volunteers on its executive committee and staff. Other ACG members, including Dr. Costas Kefalas and Dr. Ralph McKibbin, served not only as ACG representatives to DDNC but also as very effective DDNC Presidents. Currently, the College is fortunate to have Dr. Caroll Koscheski, a past ACG Trustee, and Dr. Aline Charabaty, ACG Governor for the District of Columbia, as the ACG representatives to DDNC along with ACG member Dr. Bryan Green serving as DDNC President, continuing the tradition of ACG involvement with the DDNC.” —Samir A. Shah, ACG President, Past President DDNC

PERSPECTIVES FROM ACG LEADERS Samir A. Shah, MD, FACG, ACG President and DDNC Past President

Q1. SHAH Why did you get involved with the DDNC? I have to credit the ACG leadership who asked me to serve as one of the ACG representatives to the DDNC in 2010. I was fortunate that the other ACG representative, Dr. Costas Kefalas, took me under his wing and brought me up to speed on the DDNC's patient-centered approach to lobbying for digestive health.

Q2. SHAH Why does the DDNC matter to the GI community? The DDNC should matter to anyone involved in digestive disorders — whether a patient, provider, researcher or company — because of its

longstanding reputation as patient-centered.

Thanks to its global approach to unifying patient groups, professional groups and pharma, the DDNC has earned a powerful, respected voice in Washington. Congressional representatives and their staff know and trust the information provided by the DDNC. Because their team approach to lobbying includes constituents who bring a face to real life consequences of the legislation or issue at stake, the DDNC is more effective at lobbying than other organizations. The DDNC, ACG, sister GI organizations, the American Cancer Society, and patients’ groups worked hard for years to get the Removing Barriers to Colorectal Cancer Screening Act passed last year.

Q3. SHAH What are the issues that the DDNC tackles that most resonate with you, and why?

Step therapy is the current focus of the DDNC and many partner organizations. My patients face this all the time and things are getting worse. Access to the best therapeutic option is delayed, resulting in unnecessary suffering by the patient and frustration and increased time spent by physicians/staff to fight for the appropriate therapy at the right dosage to be used first line, rather than waiting for lesser options to fail.

It seems ludicrous that an insurance company or pharmacy benefits manager is dictating the course of treatment for a complicated disease like Crohn's, rather than allowing shared decision making by the expert physician and patient with the patient's clinical issues and life circumstances in deciding the best course of treatment.

Hopefully, with passage of the Safe Step Therapy Act, control will return to where it should be: with the patients and their doctors.

Ralph McKibbin, MD, FACG, DDNC Past President

Q1. MCKIBBIN Why did you get involved with the DDNC? Years ago, as a new member of my hospital medical staff, I was appointed to our cancer committee and became the Cancer Liaison Physician to the Commission on Cancer.

This made me responsible for improving all cancer care in our cancer center. With time, I learned that the best pathway for change is influencing influencers. Change is hastened by personally interacting with outside groups both to get new ideas and to assess the true impact of change. We now use the term stakeholder engagement. Through the Pennsylvania Society

of Gastroenterology, I became the representative to the DDNC so that we could share our views directly with our federal representatives and to receive input on topics from the many patient care organizations and other stakeholders. This has made our state society more relevant and greatly strengthened our ability to impact policy on the state and federal levels and to challenge insurance carrier restrictions.

“With time, I learned that the best pathway for change is influencing influencers. Change is hastened by personally interacting with outside groups both to get new ideas and to assess the true impact of change.”

—Ralph McKibbin, MD, FACG

Q2. MCKIBBIN Why does the DDNC matter to the GI community? The DDNC was conceived as a stakeholder group. Each member association has its own best interests at heart but by getting us together to discuss the impact of proposed legislative and policy changes, we can arrive at a consensus position that is best for all patients with gastrointestinal diseases. This is a powerful thing when we advocate with policymakers, and they take notice. DDNC’s success in advocating for change is very well respected. On a personal level, DDNC representatives will interact with peers from state and national GI societies as well as leaders from national patient groups and industry, which gives us a broader perspective.

This type of networking is a valuable resource for the member groups and can grow and strengthen our physician leadership.

Q3. MCKIBBIN What are the issues that the DDNC tackles that most resonate with you, and why? Access to care is probably the one area of advocacy that is dear to my heart. As an actively practicing physician, I see many inflammatory bowel disease patients, as well as others with chronic diseases, and non-medical switching is a very important problem impacting our patients.

Changing medications in stable patients based solely on price is proven to lead to nonadherence, poorer clinical outcomes, and higher patient and system costs. The DDNC has been instrumental in organizing efforts to level the playing field and regulate issues such as this.

Caroll Koscheski, MD, FACG, DDNC Member-at-Large and Past ACG Trustee

Working with the DDNC has provided a pivotal outlook on the importance and effectiveness of advocacy work. I initially was urged to attend the DDNC Public Policy Forum as the North Carolina representative. I had attended the ACG legislative fly-in to Washington, DC, prior to this,

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but I truly realized the importance of the patient’s presence in working with members of Congress. Once the patient discusses the hardships and challenges in some of their problems, the whole visit takes an entirely new meaning to the staff members. You are no longer talking about a patient in the third person but actually have a patient with you in person to frame your discussion. It is a huge boost into why our advocacy work is so important.

send information and updates to each of the member organizations who, in turn, pass that along to individual members. And once again, the advocacy efforts of the DDNC are unmatched, in terms of the scope and depth of the team approach, most importantly with the inclusion of patient advocates.

Costas H. Kefalas, MD, MMM, FACG, DDNC Past President, GIQuIC President, ACG Trustee

Q1. KEFALAS Why did you get involved with the DDNC? My involvement with the DDNC began when we co-founded the Ohio Gastroenterology Society (OGS) in 2009.

We reached out to the DDNC because of the work they were doing, with respect to advocacy at the federal level, but also at the state level. There were a number of prominent state GI societies that were members (FL, PA, NY, TX, etc.). What was intriguing to our OGS board at that time was the fact that the DDNC advocated in teams of physicians, nurses, industry representatives, and, most importantly, patients. The patient advocates are the most effective advocates on Capitol Hill, because their stories matter more than any policy or numbers that the rest of the DDNC advocacy team discusses. Subsequent to this, I was asked to serve as the ACG representative to the DDNC, when Dr. Peter Banks stepped down from this position after many years of dedicated service.

Q2. KEFALAS Why does the DDNC matter to the GI community? The DDNC fulfills a critical mission in the GI community. Being based in Washington, DC, and led by the professional staff of the Health and Medicine Counsel of Washington, the DDNC includes numerous national GI societies, state GI societies, pharma, and patient advocate groups covering a multitude of GI diseases and conditions. This unified voice is extremely powerful not only on Capitol Hill, but also at various federal agencies that oversee funding for research and care of patients with digestive diseases, such as the NIH and FDA, to name only two. DDNC staff

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“This unified voice is extremely powerful not only on Capitol Hill, but also at various federal agencies that oversee funding for research and care of patients with digestive disease.”

—Costas H. Kefalas, MD, MMM, FACG

Q3. KEFALAS What are the issues that the DDNC tackles that most resonate with you, and why? Over the years, there have been many specific issues with which the DDNC has been successfully involved. Colorectal cancer screening access and insurance coverage has been foremost in my mind over the years, given the effectiveness of colorectal cancer screening in general and via colonoscopy in particular. But there are so many others, including access for testing and treatment of viral hepatitis, access to treatment considered experimental for end stage GI cancer or disease, the annual push for NIH research funding and protection against decreases to the same, and promotion of reasonable drug costs. These issues affect most of our patients, and I cannot be grateful enough to the DDNC for what they have done and continue to do for our patients, year in and year out, since 1978 when the DDNC was founded. It was a privilege for me to represent the ACG at the DDNC for a decade and to see firsthand the critical work that the DDNC undertakes.

Bryan Green, MD, FACG, DDNC President

Q1. GREEN Why did you get involved with the DDNC? I became involved with the DDNC while I was serving as the President of the South Carolina Gastroenterology Association (SCGA). In this position I had championed digestive health issues at the state level, especially funding for our statewide Colon Cancer Prevention Network (CCPN) that provides free screening colonoscopies to uninsured South Carolinians. I realized that many of largest issues of digestive health are shared by patients throughout the country and can be best addressed at the federal level.

Q2. GREEN Why does the DDNC matter to the GI community? By partnering with

patient-centered organizations, the physicians involved in the DDNC can send a more compelling and heartfelt message to legislators. For instance, when I advocate for increased coverage of colon cancer prevention with a spouse of colon cancer victim who put off getting a colonoscopy due to the fear of a large coinsurance bill, it sends a far more poignant message to the legislator. While we as physicians are scientific, most legislators are not. The combination of the scientific viewpoint and the passion of a patient is far more cogent than either alone.

Q3. GREEN What are the issues that the DDNC tackles that most resonate with you, and why? We were very proud to get the “polyp penalty” removed that turned a 100% covered screening colonoscopy into a diagnostic one and left patients with a bill. Currently non-medical switching where an insurance company requires a patient to change from an effective medication or try several ineffective ones first has become commonplace.

Additionally, the advent of Pharmacy Benefit Managers (PBMs) in the last several years restrict patient access to affordable medications. While PBMs were touted as a way to lower drug costs, they have simply shifted more of the cost to patients. The DDNC is working hard to educate legislators on these dangerous trends that deny patients the affordable care they need and deserve.

Aline Charabaty, MD, FACG, ACG Governor for the District of Columbia and DDNC Representative

Q1. CHARABATY Why did you get involved with the DDNC? As a gastroenterologist working in DC and as the ACG Governor for Washington, DC, I have been advocating for access to quality care for our patients and for our profession with the ACG and with patient organizations such as

the Crohn’s and Colitis Foundation for many years. So, it was only natural for me to get involved with the DDNC; their values and their mission aligns with those of the ACG community: increase funds for research in GI disorders, promote research for the diagnosis and therapy of GI illnesses, and address the many barriers to care our patients face.

Q2. CHARABATY Why does the DDNC matter to the GI community?

Like we often say, we are stronger together and we can achieve our goals better and faster by working together. When professional societies and patient groups work together and when our needs, values, and asks as a GI community are aligned, our voices and advocacy actions are amplified in Congress. ACG has been a leader in advocating for improved access to care to patients and in addressing health disparities and inequities in our communities, and as a professional society, the ACG has been a strong and effective supporter of gastroenterologists of all career paths (private practice, academics, and researchers). So it is absolutely key for us to partner with the DDNC to advance our dual mission: provide excellent care to patient and protect our profession.

Q3. CHARABATY What are the issues that the DDNC tackles that most resonate with you, and why? The main struggles I have in my IBD and GI practice (and that I share with many of my colleagues in DC and in the nation) have been the burden of the obscure process of prior authorization and the step therapy process imposed by payors. These two processes have been absolutely detrimental to our patient care and health and add extreme financial burden to GI practices. Because these issues deeply affect both our patients and our profession, these are the kind of issues that we are tackling with the DDNC.

James C. Hobley, MD, FACG, DDNC Vice President, ACG Trustee

Q1. HOBLEY Why did you get involved with the DDNC? I became involved with the DDNC due to a significant and undeniable desire to be an advocate for the patients whom I serve. This desire began at fellowship where I embarked on a masters degree in health evaluation sciences with the thesis of my studies involving health care disparities in colorectal cancer screening. The DDNC was my first involvement with physician advocacy. It was here where I began to engage with members of Congress, both nationally and locally, to fight for digestive disease issues at a high-level.

It was amazing to be engaged with other physicians and community leaders who came together along with patients themselves to advocate for digestive disease issues at our nation's capital.

Q2. HOBLEY Why does the DDNC matter to the GI community? It became inherently obvious to me that policy changes do not occur overnight. It takes an incredible concentration of effort from those who fight for these changes to coincide with members of Congress who are willing to listen to and act on the desires of their constituents. When faced with an organization that boasts more than 85 affiliations, spanning from physician-centered organizations down to patients themselves, this creates a significant force that is hard to ignore.

Watching this organization, along with other GI-predominant organizations such as our own American College of Gastroenterology, demonstrates to me how there is truth to the statement that there is strength in numbers. I don’t believe one should rest on numbers alone, but there’s also strength in perspective.

Having the perspective of patients, along with patient-centered support organizations, as well as physician organizations, creates a significant force whose voice will continue to be well heard.

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Q3. HOBLEY What are the issues that the DDNC tackles that most resonate with you, and why? The DDNC tackles issues that are primarily patientcentered. Many concurrent agenda items that groups such as the ACG are adamant about often overlap with the DDNC‘s purpose and plans. The patient-centered nature of the DDNC resonates most with me because, at the end of the day, this is who we serve. Our patients mean everything to our work as physicians. Without them, there is no role for us. To have an organization that centers around patients is key. While we are blessed to be fortunate members of such a great organization such as the American College Gastroenterology, the DDNC provides patients with a beacon of light to fight for them in a direct way that they also can be involved with.

PERSPECTIVES FROM DDNC LEADERS James DeGerome, MD, FACP, FACG, Florida Gastroenterological Society (FGS) Representative to DDNC, Past President FGS, Past President DDNC, and current DDNC Director of Development

The Digestive Disease National Coalition is a highly respected voice on Capitol Hill, advocating for over 40 constituent gastrointestinal disease organizations, all the national GI societies, and many state GI societies. The basic aim of the DDNC is to fight for ’patient access to quality care.’ In addition to lobbying Congress, each year, the DDNC meets with its institutional partners from pharmaceutical and medical device companies to learn of, and possibly promote, cutting-edge treatment advances. The DDNC receives input from ACG and other GI societies to aid in the selection of its yearly legislative agenda which they then promote. The DDNC could not carry out its mission without the aid of the ACG and is very grateful for ACG’s steadfast and loyal support all these years. I am very grateful to the DDNC for the opportunity it has

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afforded me to ‘give back’ a bit these past 20 years.

Ceciel T. Rooker, DDNC Chairperson, and President IFFGD

Q1. ROOKER Why did you get involved with the DDNC? I first got involved with the DDNC while working at the Rome Foundation. I was asked to attend a Public Policy Forum on behalf of the Rome Foundation, and I had no idea what I was signing up for! I was thrilled to meet others in the gastrointestinal illness community and learn how I can add my voice to help inform congressional offices about our needs. I continued attending the annual spring Public Policy Forum each year and was honored to have been asked to serve on the Executive Committee in 2017 and then as Chairwoman this past year.

Q2. ROOKER Why does the DDNC matter to the GI community? The DDNC is a collection of all stakeholders in the gastroenterology therapeutic area. It brings together a united front of patients, healthcare providers, and industry to Capitol Hill. This type of collaboration shows lawmakers that we are united in our concerns and needs. But, most importantly, the DDNC gives patients a voice — allows them to be heard personally — by the people in Washington that represent them. It highlights each individual voice among the many who suffer with gastrointestinal disorders.

Q3. ROOKER What are the issues that the DDNC tackles that most resonate with you, and why? The DDNC places a high priority on patient access to care issues, such as step therapy and non-medical switching. So many who suffer with illnesses, not just gastrointestinal illness, are unable to afford the cost of their care.

They are unable to manage the financial burden and, thus, are unable to live full normal lives. This an issue that needs to be addressed and the DDNC is leading efforts to do so.

DDNC PUBLIC POLICY FORUM: PRIORITIES AND PARTNERSHIPS ACG will participate in the 32nd DDNC Annual Policy Forum in March, bringing together patient advocacy groups, professional specialty societies, and industry representatives for meetings with Congress.

Each group provides a unique perspective for policymakers and staff. The DDNC has supported prior authorization and step therapy reforms, reducing barriers to colorectal cancer screening and other GI services, as well as increasing research funds for the National Institutes of Health (NIH).

–Brad Conway, Esq., ACG Vice President of Public Policy & Reimbursement

DDNC MISSION AND WEBSITE About The Coalition: The Digestive Disease National Coalition (DDNC) is an advocacy organization comprised of the major national voluntary and professional societies concerned with digestive diseases.

The DDNC focuses on improving public policy and increasing public awareness with respect to diseases of the digestive system.

DDNC Mission: The DDNC’s mission is to work cooperatively to improve access to and the quality of digestive disease health care in order to promote the best possible medical outcome and quality of life for current and future patients.  Learn More: ddnc.org

GETTING IT ACG Practice Management Toolbox

Pharmaceutical and Device

Research: A Win-Win for Your Patients and Your Practice

By Deepinder Goyal, MD, MSCR, and Shajan Peter, MD, FACG

 TRADITIONALLY, PHYSICIANS HAVE FOCUSED ON EITHER RESEARCH OR CLINICAL PRACTICE AS THEIR CAREER PATHS. However, pharmaceutical and endoscopy/device research provides a unique opportunity to allow these two paths to meet. Both community-based and academic physicians involved in patient care can participate in healthcare industrysponsored research. Furthermore, it allows an increased volume of patients of diverse demographics to participate in clinical studies. Pharmaceutical and endoscopy/ device research has several benefits, as well as barriers, for both participating

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// GETTING IT RIGHT

physicians and patients that should be thoughtfully considered while integrating clinical research into your practice. The concern for patient safety is paramount in all clinical research and therefore all participants must keep this in mind when diligently working towards fulfilling the objectives. We review these aspects below to consider conceptually adding clinical research into your practice. To fully integrate clinical research in your practice, it will take a deeper dive into a number of these.

BENEFITS TO PRACTICES AND PHYSICIANS •

•

•

•

•

•

Attracts patients and allows growth in practice by increasing reputation and stands out by providing research offerings.

Improves care of existing patients by providing access to newer therapies, higher patient engagement, and improved patient compliance, providing access to medications and devices under development or in pipeline.

Provides valuable clinical experience to providers with newer diagnostic/ prognostic laboratory methodologies. It leads to academic growth, advancement of knowledge, and intellectual stimulation of participating physicians. It also allows non-participating providers of the practice to stay up to date with the latest and best in the field.

Allows for development of centers of excellence in non-academic settings. It leads to development of professional relationships with colleagues and pharmaceutical and endoscopy/device industries at both regional and national levels. This also helps recruit new physicians with research interests into private practice settings.

Builds a data repository, which can be used for internal review, quality control, improved patient outcomes, or publications.

Serves as an additional direct source of revenue to practice and providers. It helps diversify revenue streams for the practice.

There is further financial incentive from value-based patients’ contracts for improving patient outcomes and cost of care.

•

•

“Both community-

•

based and

•

academic physicians

•

•

involved in patient care can participate

BARRIERS FOR PRACTICES AND PHYSICIANS •

in healthcare industrysponsored

•

research.”

•

BENEFITS TO PATIENTS •

•

Access to experimental therapies/devices for patients who have failed available standard of care medical interventions.

Access to expensive medications and interventions through research grant funds for patients who are uninsured or underinsured.

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Reduced travel requirements to receive study-related and advanced care options by accessing new and emerging medical interventions locally with physician teams already involved in their care.

Increased attention and oversight of clinical care as study patients benefit by being seen by research staff for study-related visits in addition to routine standard of care clinical visits.

Patients can also expect state-of-theart clinical care as physician teams and sites selected for clinical research are generally scrutinized and expected to deliver evidence-based standard of care.

Increased patient understanding of their disease process in turn helps improve their personal disease outcomes.

Allows patients to contribute to advancement in the medical field.

Minimal time commitment, risks, and involvement are required in observational studies.

Involvement of community-based private practices in clinical research allows diverse patient populations, including minorities, to gain access to the studyrelated drug and other interventions, as well as help provide real-world outcomes data.

•

•

Research infrastructure, which requires time, effort, upfront and recurring costs, and appropriate training for staff members. There are challenges for non-academic practices due to lack of experience, training, resources, and contacts with pharmaceutical industry.

In addition, there may be local internal review board (IRB) barriers.

Research budgeting process, direct and indirect costs of services provided by the practice, and calculation of appropriate overhead to determine financial viability of individual studies.

Knowledge of practice patient profiles (i.e., what type and volume of patients) to determine realistic recruitment goals.

Compliance with regulatory paperwork including informed consents, adverse events reporting, and periodic reviews by your data management team.

Maintaining data safety and HIPPA compliance

• • •

Medical malpractice coverage for research-related clinical care Time commitment Disruption in the routine practice flow

CONCERNS FOR PATIENTS • •

•

• •

•

Physical harm from experimental dugs and devices Costs related to management of long-term adverse events after study termination Time commitment for participation and travel requirements Concern for safety of personal data May require temporary interruption of medical care by their regular doctors to participate in clinical trials Extensive medico-legal paperwork for obtaining informed consent, which may be confusing and time consuming

KEY POINT: Clinical research has potential benefits, primarily to the advantage of patients as well as the practice; however, it has to be implemented with balancing thought of understanding the pros and cons prior to initiation.

Is pharmaceutical or device research right for my practice?

As clinical research has become a sophisticated process, each physician or clinical practice should consider going through a checklist of personal and organizational criteria before assuming the dual roles of physician and researcher.

Goals of Physicians and Practices Overarching professional goals of clinicians and practices should be reviewed internally. Unlike academic programs, community-based clinical practices may not have research programs built in as a part of their mission. After reviewing the benefits and barriers mentioned above, if pharmaceutical research participation meets individual and organizational goals, it needs to be discussed formally with physician leaders and administrative staff in terms of feasibility, time commitment, travel and training needs, and collective interest of the group.

CHOICE OF THE FIELD AND TYPE OF RESEARCH Most industry-sponsored research protocols are Phase III (compares new to existing treatment), or Phase IV studies (evaluates long-term benefits and side effects). Once a decision has been made to proceed with industryfunded research, the choice of the type(s) of study often depends upon a number of factors. These include the local expertise, sub-specialty interests, disease-specific patient base of the practice, type, and the level of clinical and research infrastructure in place, available resources, practice compensation model, and availability of studies open for enrollment.

KEY POINT: A knowledge of the practice’s patients and clinical conditions in aggregate will help

Table 1: Key concepts and checklist to consider for participation in pharmaceutical research  Establish goals of practice and determine administrative, financial, time commitment  Isolate several potential fields and types of studies  Organize and train a local clinical research team and define their individual roles  Contact industry sponsors to obtain access to the trials  Consider joining a research organization  Fulfill regulatory obligations during patient enrollment and monitoring  Predetermine dissemination of results, authorship, and revenue at study closeouts

navigate which studies you can realistically acquire patients and the number of patients you can provide. For instance, a busy practice taking care of inflammatory bowel disease patients could be an ideal platform to establish research relevant to IBD based therapies.

REQUIREMENTS OF A CLINICAL RESEARCH PROGRAM One of the most challenging aspects of clinical research for non-academic community-based practices is the need to navigate through a potential myriad of daunting administrative and regulatory requirements. While academic settings typically have a pre-existing sophisticated research infrastructure and leadership, many community settings can generally be lacking in this regard. A clear understanding of these needs is critical.

KEY POINT: While understanding the process for clinical research, charting out individual goals, such as choice of research and basic requirements, are prime to gain ground for successful implementation.

ORGANIZING AN INTEGRATED CLINICAL RESEARCH PROGRAM Obtaining institutional/practice commitment to provide resources, administrative support, and protected time is important for development of a clinical research organization or team. An effective research organization includes study site management staff, study investigators, and clinical research coordinators. Study staff need to acquire basic or advanced clinical research orientation and training by taking either online or live courses.

Certified Clinical Research Professionals (CCRP) designation can be obtained through programs offered by the Society of Clinical Research Associates (SOCRA).

It is an internationally accepted standard in the clinical research community. Other training resources include the Association of Clinical Research Professionals (ACRP) and the Certified Clinical Research Professionals Society (CCRPS). This training is a big step towards a safe and reliable program.

Ideally, protected time will need to be carved out of the busy clinical schedule to allow focus on the research study.

Specialized software programs may need

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to be acquired for data collection, maintenance, and submission. In addition, development and maintenance of a research program requires fiscal planning, much like any clinical practice. A sample of simple broad budgetary considerations is shown below.

to, patient recruitment, ensuring compliance with regulatory bodies, maintaining study data, and adverse event reporting. However, it is important to note that clinical investigators remain responsible for their regulatory obligations. SMOs can be quite helpful to your program.

Table 2: Budgetary Considerations for Clinical Research Category

Types of Costs

Labor costs

Physician honoraria, Research coordinator salary, Biostats fees

Site Overhead

Building rent and utilities

Participant costs

Recruitment and travel stipend

Clinical care

Office visits, Procedures, Labs, Imaging

research

Material costs

Drugs, Equipment, Test kits, Shipping, Storage of samples

program

Data Management

Data capture and storage software

has different

Miscellaneous

Advertising, Travel, Meetings

For industry-sponsored multi-institutional studies, approval of study protocol, informed consents, budget, and use of local or central IRB application is usually assisted by the principal investigator (PI) in coordination with study sponsors. However, it’s important to note that it is the responsibility of the individual site to adhere to good clinical practice (GCP)1, NIH HIPPA guidelines2 and FDA regulations3. All clinical staff involved in research need to be trained in GCP. This can be obtained relatively easily through the NIH (grants.NIH.gov) or CITI program about. citiprogram.org). The clinical investigator at the study site has the primary responsibility to ensure patient safety and protect their rights and welfare.

Contract Research Organizations (CROs) and Site Management Organizations (SMOs) are major players in today’s clinical research environment.

A CRO is an entity/business that assumes one or more obligations typical of the study sponsor (pharmaceutical or device corporation) by establishing an independent legal contract and relationship with them to assume those duties.

More relevant to the clinical practice research team, an SMO is an independent contractor and team that assumes a number of the roles and duties required of clinical investigation at the practice’s research site. An SMO provides research-related services including, but not limited

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“Organizing a successful clinical

facets that must integrate the investigator, research sponsor, and other supporting groups.”

KEY POINT: Organizing a successful clinical research program has different facets that must integrate the investigator, research sponsor, and other supporting groups.

TYPICAL CHALLENGES ENCOUNTERED IN THE IMPLEMENTATION OF CLINICAL RESEARCH Identifying a Healthcare Industry Sponsor Active trials in your local area fitting the interests, timeline, and requirements of the practice can be found on the FDA website (ClinicalTrials.gov). Networking with other clinical research sites helps to gain access to these studies. Interacting with fellow physicians and pharmaceutical and device companies at regional and national conferences allows you to develop such contacts. Pharmaceutical studies can also be accessed through direct or indirect contacts with medical scientific liaisons of the companies. Pharmaceutical and device sales representatives can be approached to build relationships and liaise with their clinical research teams. Alternatively, you can reach out to third-party clinical research companies, which work with various stakeholders in healthcare, to bring opportunities to participate in clinical research. Occasionally, such organizations contact clinical practices for their interest and availability based upon study inclusion criteria. It always helps to get your practice enlisted in a Clinical Research Organization database such as Quintiles. It goes without saying that personal effort and time commitment is needed to communicate with the sponsor, CRO, and to review/sign contracts. Of note, at the start of a research program, less desirable studies (for example, studies that are difficult to recruit or laborintensive) may have to be performed to gain experience and a record of accomplishment.

PATIENT ENROLLMENT AND MONITORING Identifying patients with predetermined eligibility criteria for the study and getting them to participate in pharmaceutical and device studies can be challenging. It

CONCLUSION Increasing participation of clinicians in pharmaceutical and device research enhances engagement of both physicians and patients, thereby advancing medical research and improving patient care. It further provides mutual benefits in terms of cost and quality of care to both patients and their treating physicians; a win-win for all. It will require dedicated time for physician investigators, new staff with clinical coordinator(s), and continued training in GCP, but can open the door for new care for your patients, physician well-being and satisfaction, and can be financially sustainable. Although this will take time and effort, it can be quite rewarding. Please see the resources below for more detailed information to dive into for your clinical research program.

REFERENCES: 1. Clinical Trials and Human Subject Protection: https://www. fda.gov/science-research/science-and-research-specialtopics/clinical-trials-and-human-subject-protection

often requires a great degree of trust between the patient and provider.

Financial disclosure is needed, and careful navigation is required to avoid potential conflicts of interest. It further requires extensive patient education in the form of both counseling and easy-to-understand handouts of study-related information.

After enrollment, follow-up and monitoring of patients on study protocol requires additional commitment by study-related clinical staff.

STUDY CLOSEOUT The dissemination of study results to participating patients and providers and authorship on any resulting publication should be agreed upon at the time of the initial contract agreement. This is generally clear in the contracts for the studies.

Understand that some studies will hold back revenue until the study is closed.

For your site, an important goal is to limit those holdbacks to be related only to your site and not all sites, as you cannot control other site quality or data acquisition.

CONSIDER JOINING WITH A RESEARCH ORGANIZATION This can be done to help a practice navigate the aforementioned considerations of training, expertise, trial evaluations and acquisition, compliance and regulation control, and overall guidance. This can be especially helpful if undergoing an FDA audit related to clinical research and building a team to help navigate that process. In addition, after you have considered all of the above considerations, an SMO can help you navigate quickly into research or help a robust program become bigger and more efficient.

Deepinder Goyal, MD, MSCR, Gastro Health, Orlando, FL

2. Clinical Research and the HIPAA Privacy Rule: https:// privacyruleandresearch.nih.gov/pdf/clin_research.pdf 3. FDA Regulations: https://www.fda.gov/science-research/ clinical-trials-and-human-subject-protection/regulationsgood-clinical-practice-and-clinical-trials 4. https://www.clinicaltrials.gov/ 5. Search Query for Clinical Trials: https://www.fda.gov/ patients/clinical-trials-what-patients-need-know 6. FDA Clinical Trial Guidance Documents: https://www. fda.gov/regulatory-information/search-fda-guidancedocuments/clinical-trials-guidance-documents 7. Guide to Clinical Trials. Spilker, B. Lippincott-Raven Press, (1991,1993) 8. Basics About Clinical Trials: https://www.fda.gov/patients/ clinical-trials-what-patients-need-know/basics-aboutclinical-trials 9. Guide for Medical Device Investigations, IDE Institutional Review Boards (IRB): https://www.fda.gov/medical-devices/ investigational-device-exemption-ide/ide-institutionalreview-boards-irb

Shajan Peter, MD, FACG, Division of Gastroenterology and Hepatology, University of Alabama, Birmingham, AL

Getting it Right | 25

Complication – Now What?

I Had a

 While a majority of the gastrointestinal (GI) endoscopic procedures are considered low-risk, complications or adverse events will still occur, even in the hands of the most experienced endoscopist. The key to management of an endoscopic adverse event (AE) is early recognition and intervention. While there is adequate training and discussion regarding the technical and medical management of GI endoscopic AEs, the non-technical aspects of conduct after an AE are discussed less often.

ALL ENDOSCOPISTS WILL EXPERIENCE COMPLICATIONS It is important to recognize that once we choose a procedural specialty such as gastroenterology, an AE is going to occur at some point in our careers.

AEs can be minor or major, and can be procedurerelated or sedation-related. All physicians go into medicine to help patients and a complication can seem to be a failure of this aim. Therefore, in addition to consequences to the patient, these AEs can cause significant emotional strain on the endoscopist.

INFORMED CONSENT Informed consent is an important process. While the specifically designed consent forms typically satisfy legal and institutional requirements of documenting informed consent, this does not always translate to patient-centered high quality decision making. It is important to ensure that the process of procedural informed consent

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By Mohammad Bilal, MD, Member, ACG Professionalism Committee & Richard Bloomfeld, MD, FACG, Chair, ACG Professionalism Committee

“It is important to recognize that once we choose a procedural specialty such as gastroenterology, an adverse event is going to occur at some point in our careers.”

includes shared decision-making where the patient understands the possibility of AEs and what that might entail (e.g., surgery, prolonged hospitalization, dietary modifications, etc.), and alternative options should be discussed. In the era of open-access endoscopy, this short but important time spent during informed consent can be pivotal for patientphysician rapport.

COMMUNICATION When an AE occurs, open and honest communication with the patient and family members is a vital component of managing the AE. The goal is to maintain the trust of the patient, established during the informed consent process.

DISCLOSURE The first step after an AE has occurred is to disclose it to the patient and family members. This usually sets the stage for how the physician-patient/family relationship will build. Patient/family members might be understanding of the AE or be upset or angry about it.

One should be prepared for any of these reactions. The patient reaction might also depend on the length and nature of the patient-physician relationship that has been established.

While breaking the news of the AE, it is advisable to follow the general principles of having difficult conversations. This includes using non-verbal cues, finding a quiet place, taking a seat, showing empathy, listening intently, and honestly disclosing all the facts related to the AE. For severe AEs, it may be a good idea to have a chaperone present at the time of the conversation (for instance, another colleague, fellow, or nurse).

with the involved services. It can go a long way in strengthening the patient-physician relationship.

INVOLVEMENT IN CARE At times, an AE can leave the endoscopist emotionally distraught and it can be challenging to be objective. Therefore, it is reasonable to transfer care to a trusted colleague if necessary. This decision should be made on a personal level on a case-bycase basis. This should also be done if the patient or family request it.

APOLOGY While complications and adverse events are usually not caused by negligence or error during the procedure (e.g., splenic injury can occur with an appropriately performed colonoscopy), the adverse event causes harm to the patient. As a physician, one of the more challenging parts of our job is knowing that something we did with good intention ended up causing harm to a patient.

This applies to medication side effects as well. An apology can be an important aspect to managing an AE. It shows empathy and compassion and has important implications for the relationship with the patient, but it can have legal implications as well.

Wording of the apology should be, “I am sorry that this happened to you,” rather than apologizing that you caused this adverse event.

COORDINATING CARE It is crucial that the endoscopist takes ownership of coordinating the care of the patient after an AE. Even if the treatment for the AE is not endoscopic, and whether the patient needs surgery, hospitalization, or conservative management, the endoscopist should arrange consultations as needed with colleagues that they trust. It is important to be explicit to the patient and family, that even though your role in the management of the complication might not be primary, you will coordinate the care and next steps needed in the treatment of the complication. If the management of an AE is conservative, the endoscopist should still arrange visits to see the patient and stay in communication

DOCUMENTATION Documentation regarding the AE and all relevant communication with the patient/ family and any consulting services should be timely documented in the medical record. This documentation must be done contemporaneously and prior documentation should not be altered.

POST-ADVERSE EVENT FOLLOW-UP Following major endoscopic AEs, most patients will be hospitalized for a period of time. While the primary endoscopist or a trusted colleague should visit the patient frequently during the acute episode, after the patient is discharged, it is good practice to follow-up with a patient. A phone call or an office visit a few days after discharge can help foster a better physician-patient relationship.

COPING WITH ADVERSE EVENTS AEs are most difficult for the patient, but can also be challenging for the endoscopist; feelings of guilt can occur.

It is important to have a support group of trusted colleagues and peers where these feelings can be discussed in a safe environment. Practices and institutions should have quality improvement initiatives to discuss complications in a constructive manner without casting blame. The goal of these discussions should be to generate ideas for process improvement. Practices and institutions should also be open and accepting to formal counseling if emotional effects on the endoscopist are significant.

early. Experts advise talking to your lawyer, even if just for a consultation.

Endoscopists should be aware that discussions with risk management and hospital peer review committees are not discoverable, but that other discussions outside of these venues might be discoverable in the event of legal action.

FINAL THOUGHTS Adverse events and complications will occur in gastrointestinal endoscopy.

How an endoscopist conducts themself coordinating the care of the patient and keeping the patient and family informed will usually determine the lasting impact that an AE will have on the physician-patient relationship.

We as a community of GI endoscopists must be there to support our colleagues when they are involved in a serious adverse event since it can cause an emotional burden on the endoscopist. We must create a culture where everyone feels empowered to share the technical and non-technical challenges that stem from a complication and use these as opportunities to improve.

REFERENCES FOR FURTHER READING

1. Kothari ST, Huang RJ, Shaukat A, et al. ASGE review of adverse events in colonoscopy. Gastrointest Endosc 2019;90:863-876.e33.

2. Richter JM, Kelsey PB, Campbell EJ. Adverse Event and Complication Management in Gastrointestinal Endoscopy. Am J Gastroenterol 2016;111:348-52.

3. Zuckerman MJ, Shen B, Harrison ME, 3rd, et al.

Informed consent for GI endoscopy. Gastrointest Endosc 2007;66:213-8.

4. Adler DG. Consent, common adverse events, and post-adverse event actions in endoscopy. Gastrointest Endosc Clin N Am 2015;25:1-8.

5. Cotton PB, Eisen GM, Aabakken L, et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc 2010;71:446-54.

6. Feld AD, Moses RE. Most doctors win: what to do if sued for medical malpractice. Am J Gastroenterol 2009;104:1346-51.

7. Feld KA, Feld AD. Time to Put Managing Endoscopic Complications Into the Curriculum. Am J Gastroenterol 2016;111:353-4.

Mohammad Bilal, MD, Member, ACG Professionalism Committee

LEGAL ASPECTS If there is any concern about a complication leading to potential legal action, then the physician should involve the institution’s risk management team

Richard Bloomfeld, MD, FACG, Chair, ACG Professionalism Committee

Getting it Right | 27

1 | GI.ORG/ACGMAGAZINE

Cover Story | 2

// COVER STORY

D

DR. FRANK HAMILTON serves as the director of the gastrointestinal (GI) program within the Division of Digestive Diseases and Nutrition (DDN) at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) in Bethesda, MD. Dr. Hamilton received his medical degree from

Howard University and pursued a combined internal medicine residency/preventive medicine program through a U.S. Public Health Service (USPHS) training program. He subsequently received his master’s degree in Public Health from the Bloomberg School of Health at Johns Hopkins University. He completed his gastroenterology fellowship at the University of Maryland and then served as a faculty member at the USPHS Hospital in Baltimore, the University of Maryland, and the Baltimore Veterans Administration Hospital.

Dr. Hamilton then served in the Office of the Surgeon General, USPHS, where he worked on the landmark U.S. Department of Health and Human Services Task Force on Black and Minority Health. In late 1987, he joined the extramural program at NIH/ NIDDK as Program Director in the DDN, where he has been instrumental in fostering basic and clinical research in gastroenterology. Dr. Hamilton has been active in promoting diversity in the gastroenterology workforce and in eliminating health disparities in patients with gastroenterological disorders.

His research interests include motility disorders, serving as project scientist for the NIDDK Gastroparesis Consortium; functional bowel disorders, where he is involved with the Irritable Bowel Diseases Consortium; fecal incontinence, for which he has organized clinical trials; and inflammatory bowel diseases, where he has supported many basic, translational and clinical trials. His portfolio at NIH also includes oversight of research training programs that have supported many of the current leaders of gastroenterology early in their careers.

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In 2013, Dr. Hamilton was recognized by the College for his leadership and accomplishments with the Minority Digestive Health Care Award by then ACG President Dr. Ronald Vender.

This achievement award recognizes an ACG member or fellow whose work in the areas of clinical investigation or clinical practice has improved the digestive health of minorities or other underserved populations of the United States.

“...Dr. Hildrus Poindexter encouraged me to apply for to the USPHS Commissioned Corps to fulfill my military obligation in 1970. Dr. Poindexter was the first African American physician in USPHS and practiced tropical medicine in the late 1940 to 1960s. He stressed to me and other students in public health that we could make a difference in health care by working within the USPHS. ”

An Interview with Frank Hamilton, MD, MPH, MACG

by Lawrence R. Schiller, MD, MACG DR. SCHILLER: Dr. Hamilton, thank you very much for agreeing to talk with ACG MAGAZINE about your career in medicine and public service. Let me start off by asking what factors led to your deciding on pursuing a career in public health and gastroenterology?

You opted for a combined internal medicine/preventive medicine residency after finishing your medical school training at Howard University.

What led to that choice?

DR. HAMILTON: During my senior year of medical school at Howard University, the late Dr. Hildrus Poindexter encouraged me to apply for to the USPHS Commissioned Corps to fulfill my military obligation in 1970. Dr. Poindexter was the first African American physician in USPHS and practiced tropical medicine in the late 1940 to 1960s. He stressed to me and other students in public health that we could make a difference in health care by working within the USPHS. What attracted you to a career in gastroenterology?

It is a personal story. My maternal grandmother, who lived in a rural community, died during my PGY-1 year of far advanced colon cancer due to poor care and late diagnosis. Somewhat confused, I asked myself in what way could I help others avoid this fate and I decided to apply preventive medicine, internal medicine, and gastroenterology to underserved communities.

“

“... it’s important that all major GI societies and other medical professionals work to together to strengthen national efforts to improve diversity, equity, and inclusion in health care delivery in the United States. Furthermore, as our population becomes more diverse, it is critical that educational institutions and academic medical centers develop strategies to increase the diversity of health professionals and promote more culturally-sensitive health professional education.”

L-R: Dr. Costas Kefalas, Dr. Hamilton and Dr. Samir Shah in Washington, DC for a meeting of the Digestive Disease National Coalition when Dr. Hamilton was honored in March, 2020.

During your time at the Office of the Surgeon General, the U.S. Department of Health and Human Services established a Task Force on Black and Minority Health which published the Heckler Report in October 1985 and which led to development of the HHS Office of Minority Health. Thirty-five years later, we are still facing substantial health disparities in our country. Why do you think that this has been such a recalcitrant problem?

When I was one of the staff physicians on Secretary Heckler’s HHS Task Force on Black and Minority Health, I think that there was general concern about health disparities, but at that time the federal departments and agencies did not display the robust and firm commitment and determination that I now see in the area of health equity and health disparities.

How can we address health care disparities better?

I believe ACG and other medical societies can do a better job addressing health disparities and focusing on improving the quality of health care by introducing culturally sensitive educational modules into training, and by making high-quality medical care broadly available to all diverse populations. Also, it’s important that all major GI societies and other medical professionals work together to strengthen national efforts to improve diversity, equity, and inclusion in health care delivery in the United States. Furthermore, as our population becomes more diverse, it is critical that educational institutions and academic medical centers develop strategies to increase the diversity of health professionals and promote more culturally-sensitive health professional education.

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In gastroenterology, one of the leading health care disparities has to do with colon cancer and screening. How do you think that we can narrow the gap?

Over the last 15 years, through the efforts of ACG and its colorectal cancer awareness programs and those of other medical societies, the rate of colorectal cancer screening has improved significantly. When the ACG Minority Affairs and Cultural Diversity Committee was charged by then ACG President Dr. Douglas Rex to do a comprehensive analysis of screening for colorectal cancer in African Americans, little did the committee expect to discover such dramatic disparities. The committee published its landmark paper on Colorectal Cancer Screening in African Americans in 2005 [Agrawal S, Bhupinderjit A, Bhutani MS, Boardman L, Nguyen C, Romero Y, Srinivasan R. Colorectal Cancer in African Americans. Am J Gastroenterol.

2005;100:515–523].

At that time, the screening rate for colorectal cancer among African Americans was about 32 percent and now it is about 60.3 percent. This marked improvement in colorectal cancer screening rates can be attributed to well-designed and targeted public awareness campaigns and the efforts of all the GI societies and the American Cancer Society. Although this is an improved outcome, there is still room for improvement with more concerted efforts using culturally sensitive materials to reach underserved communities. Several medical centers have incorporated patient navigators in their colorectal cancer prevention programs; this approach has greatly increased screening rates in minority populations.

In 2012, Dr. Hamilton presented to students at Rancho High School in Las Vegas, NV for ACG’s “Prescriptions for Success” program and shared his personal reflections on his career path in medicine along with members of the ACG Committee on Minority Affairs & Cultural Diversity on which he served from 2003 to 2010, from 2003 to 2007 as Chair.

Over the years, NIDDK has endeavored to increase the diversity of researchers that it has supported. For example, it has supported the Network of Minority Health Research Investigators, which encourages mutual support among researchers interested in diseases affecting underrepresented groups, including investigators from those groups.

How do you think that we can encourage more participation in both research and clinical gastroenterology by members of underrepresented groups?

The Network of Minority Health Research Investigators (NMRI) has been very effective in developing a venue for diverse academic researchers to develop and improve their research skills. It has been most effective in promoting mentoring of new investigators in how to be successful in the research enterprise. The NIDDK currently is undergoing an evaluation process to assess the effectiveness of this program in achieving its goals of recruiting and retaining minority academic investigators.

In 2013, Dr. Hamilton [center rear] again was part of a group from the ACG Committee on Minority Affairs who presented at San Diego High School for the “Prescriptions for Success” program.

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For many years the Diversity, Equity and Inclusion Committee of the American College of Gastroenterology has visited high schools with large numbers of minority students to encourage these students to consider careers in medicine, especially gastroenterology. What advice would you give the College to encourage minority students to pursue medicine as a career so that we have a physician workforce more representative of our population?

Dating back to 1990 when I joined ACG, the American College of Gastroenterology has—in my opinion—always been at the forefront of increasing diversity and inclusion in gastroenterology. While serving as Chair of the Minority Affairs Committee at the invitation of Dr. Christina Surawicz, former ACG President, in 1999 our committee launched an outreach program for high schools students attending culturally diverse schools to trigger their interest in medicine and gastroenterology. This program is still a yearly program held during the ACG Annual Scientific Meeeting. The ACG committee members who were speakers at these events, stress to the students that— because of their unique racial and ethnic backgrounds—they could make a difference in health care in their communities. This message continues to resonate at each yearly visit.

“I would encourage anyone considering an academic career to find mentors, both a professional and life mentor, who will provide open and

In 2020, Dr. Hamilton received the Lifetime Achievement Award from the Digestive Disease National Coalition.

honest insights on how to achieve your career goals. Also, be open in selecting a mentor; the best mentor may not always look like you. If someone is willing to help, take advantage of the helping hand because it makes a big difference in your career path.”

Your main area of research— gastrointestinal motility problems, such as gastroparesis and irritable bowel syndrome—has grown dramatically during the last 30 years, with more focused definitions, better diagnostic tests, and innovative treatments. How do you assess the role of NIDDK in promoting these developments?

Through the efforts of researchers with an interest in these areas and advocacy groups, NIDDK has become increasingly more aware of the burden of illness of these conditions.

Through many workshops involving the GI community, we have used the recommendations to develop, foster, and initiate programs in these areas.

The main challenge with IBS and gastroparesis is that there have been no biomarkers for disease activity.

However, in the last decade, NIDDKsupported investigators have been able to identify particular signals which may provide insights into the pathogenesis of these disorders. NIDDK is very proud of the fact that it has sponsored creation of the largest cohort of welldescribed patients with gastroparesis as part of the Gastroparesis Clinical Research Consortium. Research conducted by this consortium has enhanced our clinical knowledge, and is beginning to identify cellular and molecular signals in stomach biopsies which may advance our understanding of the fundamental pathogenesis of gastroparesis.

What advice do you have for young physicians interested in pursuing a career in clinical research?

I would encourage any young physician considering clinical research to take courses in clinical research or pursue an advanced degree involving clinical research. This skill set will make one more competitive when applying for federal, industry, or foundation support. In addition, I would encourage anyone considering an academic career to find mentors, both a professional and life mentor, who will provide open and honest insights on how to achieve your career goals. Also, be open in selecting a mentor; the best mentor may not always look like you. If someone is willing to help, take advantage of the helping hand because it makes a big difference in your career path.

In 2013, Dr. Hamilton made a strong impression in the classroom addressing high school biology students at San Diego High School for the “Prescriptions for Success” program.

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You have served our nation for over 50 years. What has excited you about government service and makes you eager to go to work each day?

I think that the greatest opportunity that I have had is to be involved in federal committees looking at GI disorders and being able to work very closely with research and other committees of the GI societies. In addition, being a federal employee, I have had the opportunity to serve as planning Chairperson on NIH Consensus Conferences on therapeutic endoscopy for bleeding ulcer, the importance of Helicobacter in peptic ulcer disease, celiac disease, the role of ERCP in pancreatic disease, and the prevention of fecal and urinary incontinence. My participation in these conferences has allowed me to be involved with the GI communities in developing guidelines that improve patient care outcomes.

In 2020, Dr. Hamilton addresses the Digestive Disease National Coalition at their Washington, DC event.

Faculty from ACG High School Event, “Prescription for Success: Careers in Medicine and Science” in 2006 at Rancho High School in Las Vegas, NV.

Thank you, Dr. Hamilton, for all that you have done for our profession and our country.

L-R: Dr. Lawrence Agodoa (NIDDK), Dr. Janine Austin Clayton (Director, NIH Office of Research on Women’s Health), Dr. Vivian Pinn (1st Director of ORWH), Dr. Frank Hamilton, Dr. Griffin Rodgers (Director, NIDDK)

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Culinary Connections:

Spring Into Health

AS THE WINTER HOLIDAYS HAVE COME AND GONE, we now begin anew; refreshed, reinvigorated, and reconnected.

As the world thaws from the snow and ice, here is some inspiration to help us "spring into health.” We start in Alabama, travel the aisles of a supermarket in Madrid, and end in New York.

Through these globetrotting stories you will hear some common threads, mainly of love for family, for friends, and for food.

We hope you enjoy and feel inspired to share your own culinary journeys with us. ­—Dr. Alexander Perelman for the #ACGFoodies (Dr. Christina Tennyson and Dr. Vani Paleti) Reach out by email to Dr. Perelman, Dr. Tennyson, and Dr. Paleti if you want your culinary creations featured in the pages of ACG MAGAZINE using acgmag@gi.org.

ACG Perspectives | 35

// PERSPECTIVES

DALE LEE, MD, MSCE

Seattle Children's Hospital, University of Washington, Seattle, WA

Growing up, food and health were forefront in many family conversations. Early in my pediatric gastroenterology fellowship, I distinctly remember my first encounter with the power of food in the form of exclusive enteral nutrition therapy (EEN).

I observed a hospitalized patient with Crohn’s disease and malnutrition improve steadily on EEN with improvement in symptoms, objective markers of inflammation, and weight gain trajectory. I now primarily care for children and adolescents with inflammatory bowel disease and celiac disease.

For IBD, immunosuppressive medications are the primary focus, and the role of food has been rising in prominence. For celiac disease, the converse is true with a gluten-free diet recognized as the only effective therapy, but with much momentum increasing for drug therapies.

Food is always on my mind—in my professional and personal life. I am the medical director of clinical nutrition at Seattle Children’s Hospital and director of the Celiac Disease Program. Following my pediatric GI fellowship, I did a fellowship in nutrition and had the opportunity during this time to form relationships with food scientists at Penn State University. There, I began to learn about the science behind designing and producing foods—something clinicians generally do

“As GI clinicians and scientists, we play a unique role in guiding patients and shaping the landscape of dietary recommendations. On a personal level, I want to know what I am eating and how it impacts me, and this is a question that is important to our society.”

—Dale Lee, MD, MSCE

FAVORITE EASY CHOPPED SALAD  Ingredients • 4 Persian cucumbers, cut

lengthwise, then sliced into semicircles • 1 red bell pepper, cut into ½ inch pieces • 1 yellow bell pepper, cut into ½ inch pieces • 1 cup grape tomatoes, halved • ½ orange, cut into ½ inch pieces • ½ pear, cut into ½ inch pieces • 1 medium avocado, cubed • 2 hard-boiled eggs (exactly 8 minutes boiled), peeled and sliced • Balsamic vinegar, to taste

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 Steps

1. Wash then cut all produce into approximately ½ inch size pieces/cubes 2. Add all vegetables to a bowl

3. Bring water to a boil in a small pot, and gently add eggs (using a spoon) • Remove eggs after 8 minutes, then transfer to cold water (this will provide a hard-boiled white with a slightly creamy yolk) 4. Add orange, pear, avocado, and egg to bowl 5. Pour a small amount of balsamic vinegar to lightly coat the salad

not learn about in their training. This has helped form my appreciation for food and an awareness of the strong science guiding food production.

I do not have any dietary restrictions, but I try to minimize refined sugars and highly processed foods. Though I’m familiar with recommendations for macro and micronutrient intake, I believe that food goes beyond its constituent nutrients. Processed food and the “Western diet” has been implicated in numerous disease processes, including IBD, but food processing is challenging to define and has become ubiquitous in our food supply. Though valuable in preserving food and maintaining shelf stability, numerous untoward effects are likely.

My research on food additives and the intake of processed foods has led to more questions than answers and has demonstrated the complexity of studying diet and food. Preclinical models have suggested that specific food additives may be harmful to the gut epithelium and predispose to intestinal inflammation, but much work remains to be done to better understand the exposures and effect of foods in humans.

As GI clinicians and scientists, we play a unique role in guiding patients and shaping the landscape of dietary recommendations.

On a personal level, I want to know what I am eating and how it impacts me, and this is a question that is important to our society. I live in a busy household, and we value food that is delicious and quick to prepare. One of my goto dishes is a chopped salad that can adapt to both winter and summer produce. In the winter, citrus fruit and pears provide tang and sweetness while in the summertime berries can be incorporated. The produce, together with precisely boiled eggs and the simple splash of a good balsamic vinegar, brings the dish together.

JANESE S. LASTER, MD

“As I share with my patients, plant-based meals can be cool too!”

—Janese S. Laster, MD

Washington, DC

I grew up in Birmingham, Alabama, with a huge family, so every event was centered around food with each family member bringing their best dish. Food was used as a show of love! And I wanted in and couldn’t

wait to be old enough to help my mom, aunts, and grandmother in the kitchen. It was definitely a rite of passage to finally make a dish that got the familial stamp of approval. For me, this then led to experimenting with flavor, texture, and implementing additional cultures into dishes as well.

Throughout my life my parents both instilled eating whole foods with very little processed foods being available in our home, much to my chagrin. I joke with them now about the distress this caused in not being one of the cool kids with the famed Lunchables for field trips. They also loved gardening and gifting excess fruits and vegetables before it was cool. I found them a little embarrassing to say the least.

Fast forward 20 years and I’m a plant-based gastroenterologist specializing in nutrition, obesity medicine, and bariatric endoscopy. I have found common correlations in many gastrointestinal complaints, excess weight, and metabolic syndrome with excess processed foods, which I counsel patients to modify. Since I live in the city with little outdoor space, I even have a hydroponic indoor garden to grow greens, herbs, fruits, and vegetables…Can we say full circle? I guess they rubbed off on me a bit.

During my bariatric endoscopy training in Madrid, I fell in love with roaming the aisles of the beautiful fresh food markets and enjoying all of the traditional dishes. One common dish is jamón (ham), which I

ARROZ AL HORNO  Ingredients • 1 ½ cups jasmine rice

• ¾ cup chopped mushrooms • ¾ cup finely diced green, red, oran ge bell peppers • ¼ cup finely diced yellow onion • 2 whole bulbs of garlic • 1 large tomato, cut into ½ inch slices • 1 cup of chickpeas • 1 large potato, peeled and cut into ½ inch slices • Extra virgin olive oil • 1 ½ cups vegetable broth • Sea salt, black pepper, cumin (garl ic and onion powder optional)

 Steps 1. Preheat oven to 400˚F.

2. Warm casserole dish in the oven, then set aside.

3. Sauté mushrooms, bell peppers, onions, and 4 cloves of minced garlic with 2 Tbsp of olive oil.

4. Cook chickpeas (soak overnight for dried chickpeas or use low-sodium canned chickpeas ) on the stovetop and add sea salt, black pepp er, and cumin to taste.

5. Remove sautéed vegetables and place potatoes in the same oil and leftover seasoning in the pan. Add a pinch of sea salt and black pepper to taste. Fry on both sides until soft and golden, then remove.

6. Add rice to the same pan and fry for 5-10 mins in the same seasoning and oil. Make sure it is coated or add 1-2 additional Tbsp of olive oil, if needed.

7. Combine sauteed vegetables and drained chickpeas in a bowl.

8. Add fried rice to the casserole dish, then the chickpea and vegetable mixture, distr ibuting evenly, 9. Layer potato slices, then sliced toma toes on top.

10. Pour vegetable broth over the dish, making sure the rice is covered.

11. Place a whole garlic clove in the center.

12. Place in the oven and bake for abou

t 20-30 mins or until the broth has evaporate d. Taste a few grains of rice, as they should be soft.

13. Remove from the oven, let sit for 5-10 mins, then enjoy!

ACG Perspectives | 37

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don’t eat and was often met with concern and confusion when I didn’t partake. But my colleague and mentor, Dra. Inmaculada Bautisa Castaño, hosted a cooking lesson and dinner for us to learn to make Tortilla de Patatas and Arroz al Horno. Weeks later, COVID hit, and we were placed on a strict lockdown. Needless to say, we all had to get creative in our meals and I decided to put my vegetarian spin on Arroz al Horno and got photographic approval from the master herself!

Arroz al Horno translates to “baked rice” and is typically made in a casserole with stock left over from the pork for flavoring. It is also beautifully garnished with a garlic in the middle. However, in lieu of pork, I transitioned the recipe to a plant-based alternative and used onions, garlic, bell peppers, and mushrooms as the base stock for added flavor. As I share with my patients, plantbased meals can be cool too!

I hope you’ll enjoy the Spanish aromas coming from your oven!

“I have always loved to prepare some of my dishes for holidays and special occasions, so I seized the opportunity and challenge of making healthy recipes that look as good as they taste.”

—Jonathan A. Erber, MD

JONATHAN A. ERBER, MD

Brooklyn, NY

As a busy practicing gastroenterologist, I don’t often find myself with too much time to spend in the kitchen. However, when time permits, I enjoy preparing some of my “favorites” for family and friend get-togethers, holiday celebrations and, of course, sporting events I love to watch—Michigan football (for all you Georgia Dogs out there, yes, we did get crushed by you in that Orange Bowl!).

These past few years, with COVID looming over us, I found myself with more spare time on my hands. One silver lining of COVID was that I got to spend some more of that time with my family doing things we all love: spending quality time together, cooking, and of course, watching Michigan football. Game day meal prep has become one of my new favorite Fall Saturday traditions. I have always loved to prepare some of my dishes for holidays and special occasions, so I seized the opportunity and challenge of making healthy recipes that look as good as they taste.

BUFFALO TOFU WINGS  Ingredients • 1 16-oz pack super firm tofu

iry milk • 1 cup unsweetened non-da bs • 1 cup panko breadcrum (gluten-free) ioca flour • ½ cup cornstarch or tap • 2 tsp Italian seasoning • 1 tsp garlic powder • 1 tsp onion powder • ½ tsp black pepper ce (or • 1 cup Frank’s Red Hot Sau

any of your favorites)

 Tips

won’t it have to press water out of include • Non-dairy milk options , or any soy , oat t, onu almond, coc milk. iry -da non ed ferr pre r of you l wel k • Panko breadcrumbs wor when not cooking with oil.

• Super firm tofu best, as you

38 | GI.ORG/ACGMAGAZINE

 Steps and 1. Preheat oven to 420˚F

line baking sheet or dish with parchment paper al 2. Slice the tofu into 6 equ

h width slabs, then slice eac ise of those pieces lengthw into 3 slices (18 tofu sticks)

ls: In the

3. Set out three separate bow

ch, garlic first bowl add the corn star black and der, pow n onio powder, milk into the the r Pou . mix and per pep third small second small bowl. In the rumbs and adc bre ko pan bowl, add the . mix and ing son Italian sea and coat in 4. Take each tofu “wing” milk, and n the flour mixture, the the adcrumbs. bre ko pan the finally coat in k onto the stic tofu d ade bre h Place eac prepared baking sheet. e for 25 5. Place in the oven and bak brown. en gold t ligh minutes until add them and gs win tofu the 6. Remove the buffalo r to a large mixing bowl. Pou gs and win tofu sauce over the baked gs are win tofu the all il gently toss unt o the ont k bac tofu the e Plac . covered and n, ove baking sheet, return to the s. ute min bake for another 20

ry sticks and

7. Serve with carrots or cele

g. ranch or blue cheese dressin

My son Dylan has celiac disease. Since we both enjoy eating “gastropub” food together like wings, fries, chips, and dips, we worked hard to perfect a menu that encompassed quality, healthy ingredients without compromising flavor. We did all of this by adapting recipes that work with a gluten-free diet.

We also concluded that these “gastropub” foods don’t have to be laden with fat, meat-centric, or fried. With a few simple ingredient substitutions, it was easy to prepare and enjoy a more plant-based and gluten-free diet.

These meals tasted GOOD as we watched the game while also being GREAT for the Gut! My favorite dishes listed below are quick and easy to prepare.

They require minimal prep and cooking time with ingredients that are easy to find in your local market. Three of my favorites to prepare and eat while watching the big game at home are Buffalo Tofu Wings, Stuffed Dates (aka Devils on Horseback), and Mediterranean 7-Layer Dip.



We would love to hear from you if you have personal connections with GI and gastronomy. Contact ACG MAGAZINE staff at acgmag@gi.org to share your story with the ACG community. You can also tweet using #ACGfoodies to connect with the community.

Wishing you all good health and great meals from our culinary connections #ACGfoodies team.

YER DIP MEDITERRANEAN 7-LA  Ingredients

oz., mmus (about 16 • Container of hu nts to other ingredie or proportional ) er lay to er you use and the contain d pe se, chop • 1 cup feta chee ped tomatoes, chop ry er ch or e • Grap tional to other (amount propor can eyeball this) u yo ingredients; ped d cucumber, chop • 1 medium-size d pe op • ¼ red onion, ch redded sh ts, rro ca 1-2 • , chopped • 1-2 celery stalks olives, chopped a at lam Ka • ½ cup sh dill, chopped • Handful of fre ips, • Bag of pita ch

 Steps

d mus into a roun 1. Spread hum all gh for dish, deep enou er. lay to s nt die re ing cheese over a fet ad re Sp 2. hummus. layer all other 3. Continue to e order ingredients in th olives e above, up to th er. ov all l 4. Sprinkle dil mperature. te om ro 5. Serve at

fresh pita, or u anything else yo dip to e sir de

STUFFED DATES  Ingredients • 24 Medjool dates

• 4 oz. goat chee se • 3 Tbsp pistachio s • Smoked paprika • Sea salt and fre sh ground black pepper • Honey (option al)

 Tips • If you can, buy pitted

dates to avoid pitting them your self • Use room temp goat cheese or warm with your hands • The smoked pa prika

flavor of bacon

simulates the

 Steps 1. Use a knife to

split the date lengthwise. Remo ve pit, if using unpitted dates. Us e a spoon or your hands to fill with goat cheese.

2. Crush the pis tachios with a rolling pin (or my way: put into ziploc bag and cru sh with mallet or back of a spoo n).

3. Sprinkle each date with black pepper, sea salt, and small amount of smok ed paprika and pistachio dust.

4. Optional: add a tiny drizzle of honey to the top.

5. Serve at room temp or yo

u can warm for a few m inutes in oven or toaster at very low heat.

ACG Perspectives | 39

// PERSPECTIVES

their GI symptoms were intertwined with their mental health and nutritional habits.

Furthermore, they expressed difficulties engaging a mental health provider and registered dietitian who truly understood the relationship between their gut and their mental and nutritional health.

I began to recognize the need for a multidisciplinary center that offered women the opportunity to receive holistic care from a gastroenterologist, mental health provider and registered dietitian in a coordinated clinical setting.

A Holistic, Multidisciplinary Approach to Treating Women

with GI Diseases and Disorders

By Olga C. Aroniadis, MD, MSc, FACG

“Women who are seen in our clinic are

STUDIES HAVE SHOWN that women with certain gastrointestinal diseases and disorders are significantly more likely to experience both mental health conditions, such as depression and anxiety, and unhealthful eating habits. Moreover, coping with debilitating and complex GI symptoms can also affect mental health, wellness and nutritional habits. We believe that successful treatment of women with GI problems, concurrent mental health conditions and unhealthful eating habits requires a multidisciplinary approach that involves gastroenterologists, mental health providers, and registered dietitians. However, there is a paucity of true multidisciplinary centers in the United States that focus on such a holistic approach for treating women with GI disorders.

When I started on staff at Stony Brook University Hospital, I focused my GI clinical practice on the treatment of women. Not uncommon to most gastroenterologists, I saw many women with complex GI symptoms who had tried multiple medications and remedies and were frustrated by their lack of relief. Many also reported that

40 | GI.ORG/ACGMAGAZINE

typically referred by gastroenterologists who are unable to manage their patients’ complex symptoms. Our patients have a GI disease or disorder that is either exacerbated by or has resulted in a concurrent mental health condition and unhealthful eating pattern.”

Our Clinical Champions With support from our Division Chief, Dr. Jonathan Buscaglia, I approached two of my female GI colleagues: Dr. Alexandra Guillaume, the Director of the Motility Center; and Dr. Farah Monzur, the Director of the Center for Inflammatory Bowel Diseases; and engaged them in partnering with me to create a holistic Center for Women with Gastroenterological Diseases and Disorders at Stony Brook. We then involved both the Department of Psychiatry and Division of Nutrition at Stony Brook.

Dr. Brittain Mahaffey, an Assistant Professor and psychologist whose practice focuses on stress and anxiety in women, had already pioneered the creation of other integrated care models; she has played an integral role in the development of our coordinated care model as well.

Together, we identified two clinical champions; Dr. Veronique DeutschAnzalone, a clinical psychologist with expertise in cognitive behavioral therapy (CBT) and mindfulness-based treatments for mood and anxiety disorders among women; and Dr. Melissa Rossi, a psychiatrist who focuses on the integration and collaboration of interdisciplinary teams of clinicians in the delivery of care to women.

We also engaged another clinical champion: Dr. Josephine Connolly-Schoonen, a registered dietitian with specific expertise in the treatment of women with various GI disorders.

The Logistics As a GI division at Stony Brook, we are fortunate to have a designated clinical building with nursing, clerical and administrative staff who are solely dedicated to the care of patients with GI disorders. With the support of the

Chairman of Medicine and Division Chief, we identified a recurring monthly time block when our GI clinical suite and staff were available to support our new clinic. Our clinical partners in psychiatry and nutrition also identified a staff member within their individual departments who could provide additional administrative support. This level of interdepartmental administrative support ensures that each clinical provider can bill for services rendered during our clinic.

Our Collaborative Care Model Although it has taken time and considerable effort, it is incredibly rewarding that we can offer women holistic care in a coordinated clinical setting. Women who are seen in our clinic are typically referred by gastroenterologists who are unable to manage their patients’ complex symptoms.

Our patients have a GI disease or disorder that is either exacerbated by or has resulted in a concurrent mental health condition and unhealthful eating pattern. Each patient referral is discussed by our clinical team to best match patients with individual providers. Our patients also complete a comprehensive survey on GI symptoms, anxiety, depression and nutritional habits prior to their office visit. Patients are seen by a gastroenterologist, mental health provider and registered dietitian during our clinic. Immediately following each session, our clinical team discusses each patient.

Through this collaborative care model, we obtain insight into the complex relationships among their patient’s GI symptoms, mental health and nutritional habits. In addition, we begin to craft a holistic approach to each patient’s care that not only includes common GI medications, but also may involve initiation of psychiatric medications, behavioral interventions, supplements, dietary modifications and nutrition plans.

referral to our clinic. Our providers treated the underlying anxiety with initiation of duloxetine, mirtazapine and weekly CBT and time-limited CBT focused on behavioral goal setting and anxiety coping skills. Additionally, a comprehensive and tailored nutrition plan was developed to reduce nausea.

The collaborative discussion among providers led to these combined interventions, which resulted in a considerable decrease in GI symptoms, marked reduction in anxiety, a more healthful lifestyle and an improvement in quality of life.

A 31-year-old woman with history of hidradenitis suppurativa, asthma and moderately severe ulcerative proctosigmoiditis diagnosed 1 year ago. The patient was initially started on a 5-ASA but continued to have symptoms of bloody diarrhea. She expressed considerable anxiety related to both her new diagnosis of ulcerative colitis and inability to tolerate various foods. The patient was recently referred to our clinic by her GI provider.

She was started on vedolizumab for control of her diarrhea by our providers. Our cognitive behavioral therapist diagnosed her with persistent adjustment disorder with mixed anxiety and depression and the patient began to receive weekly cognitive behavioral therapy. Our registered dietitian created a nutrition plan that included avoidance of pro-inflammatory foods and started the patient on a probiotic and vitamin/mineral supplements specifically designed for patients with inflammatory bowel diseases (i.e., fat soluble vitamins are in water miscible forms).

Lessons Learned The concept of a multidisciplinary center for the treatment of women with GI diseases and disorders is not innovative. However, our holistic model for the treatment of women with complex gastrointestinal symptoms is not commonly available in the United States. Moreover, our GI referral base is unique. We have found our model to be extremely helpful because it facilitates communication between gastroenterologists, mental health providers and registered dietitians to improve the care of women with complex GI symptoms. Although we have been fortunate to offer this collaborative care model to our patients, we recognize that this may not be possible in most clinical settings. This emphasizes the need for gastroenterologists to assess their patients for concurrent mental health disorders and unhealthful eating habits and refer to mental health providers and registered dietitians, when appropriate.

Moreover, once referred, it is critical to maintain open lines of communication between providers.

The feedback we have received thus far from our clinic is quite positive; our patients have reported that our collaborative care model has resulted in effective management strategies that are truly holistic. I hope that we see similar collaborative care models in the future. We are a group of women who have come together with the goal of helping other women build happier and healthier lives for themselves.

Our Patient Experience Examples of patients who have benefited from our multidisciplinary approach: A 30-year-old woman with cyclical vomiting syndrome. The patient reported frequent bouts of severe nausea and vomiting since 2017 that were debilitating and exacerbated by stress, anxiety and poor eating habits. A prior extensive GI work-up was unremarkable. Nortriptyline initially alleviated her GI symptoms, but symptoms recurred, prompting

ACG Perspectives | 41

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Sage Advice from a Seasoned Clinician

Roadmap for Recharging in 2022

By Carol A. Burke, MD, FACG, Past ACG President

THERE IS NO NEED TO RECOUNT the significant and myriad ways the COVID-19 pandemic has impacted every aspect of our lives and sensibilities. Who would have imagined two years ago that, in 2022, our day-to-day activities would continue to be fraught with the uncertainty, vagaries and vulnerability related to the pandemic?

The chronic and sustained pandemic-associated stress, due in part to requisite social distancing, self-isolation, long work hours often requiring N95 respirators, redeployment, health risk and worry, have led to physician fatigue, feelings of futility, anxiety, post-traumatic stress disorder, depression, sleep disturbances, maladaptive behaviors, and emotional exhaustion (EE), particularly in health care workers (HCW). A study in Australia uncovered 26% of frontline HCWs increased their alcohol consumption as a

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coping strategy, which was associated with worsened mental health symptoms.

Suicidal ideation has risen in HCWs with a study from the United Kingdom reporting that 13% of intensive care unit HCWs experienced thoughts of self-harm.

A systematic review and meta-analysis confirmed 50% of HCWs during the pandemic met the criteria for burnout as measured by EE, a key measure of burnout.

Faced with these sobering facts, what can be done to mitigate burnout? One large study demonstrated that surgeons who utilized the following wellness strategies were less likely to experience burnout: finding meaning in their work; maintaining a positive outlook; engaging in recreation such as vacation, exercise, and hobbies; spending time with family; creating work-life balance; and focusing on the meaning of life. Other data identified gratitude as a positive coping disposition, which significantly predicted lower psychological stress among nurses and

acted independently to protect against stress among emergency service personnel. Gratitude is related to optimism, and optimism to well-being.

Additionally, grateful people more often sought social support, utilized approaching rather than avoidant coping strategies, and may be more resilient following traumatic events.

One study suggests that gratitude helped nurses cope with stress and protected against COVID-19-specific trauma by decreasing depressive symptoms and self-criticism while enhancing self-reassurance.

Four Steps on the Road to Health and Wellness Here are 4 steps that can help maintain you on the road to health and wellness.

1. Follow the CDC guidelines for physical activity: >150 minutes of moderate aerobic activity or >75 minutes of vigorous activity,

or a combination of both, plus strength training, >2 days/week.

While many of us are avoiding gyms, evidence demonstrates that exercise in nature, especially green spaces and waterscapes, decreases stress and depression.

One study reporting 10 studies from the United Kingdom, involving 1,252 participants, demonstrated acute short-term exposures to facilitated green space exercise improves selfesteem and mood, regardless of duration, intensity, location (e.g., urban green space, woodlands, countryside), gender, age, and health status. The presence of water generated greater effects and the greatest effects were noted from just 5 minutes of activity, with lower effects for 10-60 min and half-day exposure, and a rise again after exposure for the whole day.

2. Follow the CDC guidelines for sleep: >7 hours for adults 18 years and older.

SLEEP STRATEGIES  Consistent sleep/wake schedule  Before bedtime avoid: • Caffeine for 7 hrs • ETOH for 3 hrs • Nicotine for 4 hrs • Exposure to blue light from devices after 9pm • Suppresses melatonin  Napping for 20 mins leads to meaningful restoration • Improves quality of work, speeds cognition, decreases errors, increases sustained attention to difficult tasks later in day  Impact may be with only 8 minutes per day

3. Do not smoke, and maintain a healthy diet according to the CDC recommendations.

HEALTHY DIET STRATEGIES FROM CDC 1. Meet your food group needs with nutrient-dense foods and beverages: • Vegetables of all types—dark green; red and orange; beans, peas, and lentils • Fruits, especially whole fruit • Grains, at least half of which are whole grain • Dairy, including fat-free or low-fat milk, yogurt, and cheese, and/or lactose-free versions and fortified soy beverages and yogurt as alternatives • Protein foods, including lean meats, poultry, and eggs; seafood; beans, peas, and lentils; and nuts, seeds, and soy products • Oils, including vegetable oils and oils in food, such as seafood and nuts 2. Stay within calorie limits 3. Limit alcoholic beverages, (<2 drink/ day for men and <1 drink/day for women) 4. Decrease foods and beverages higher in added sugars (to <10% calories/ day), saturated fat (to <10% calories/ day), and sodium (to <2.3 g/day)

4. Meditation, mindfulness and gratitude. Mindfulness is a form of meditation that is associated with a decrease in burnout, particularly in EE, in HCWs. Mindfulness is a practice which cultivates an awareness of our thoughts, feelings, bodily sensations, and surrounding environment in the present moment through non-judgment and acceptance.

A recent study of HCWs participating in a Transcendental Meditation intervention during the COVID-19 pandemic demonstrated significant reductions in burnout and symptoms of depression, anxiety, stress, and sleep disturbance. There are a plethora of online resources and apps that can assist in developing a practice in mindfulness and meditation.

Gratitude, being aware of and reflecting on things to be thankful for, is associated with many health and wellness benefits including positive emotions, better sleep, greater compassion and kindness, and stronger immune function.

Some approaches to building gratitude include writing down things you are grateful for in a gratitude journal and actively acknowledging those you are grateful for.

Conclusion We cannot change the reality of the COVID-19 pandemic, but we certainly can work toward self-healing through a prescription of 4 simple steps.

Carol A. Burke, MD, FACG, Past ACG President Director, Center for Colon Polyps and Cancer Prevention; Vice Chair, Department of Gastroenterology and Hepatology, Cleveland Clinic Foundation

ACG Perspectives | 43

// PERSPECTIVES

GI Jane: Life in the Trenches ACG Women in GI Committee Reflects on Barriers to Success for Female Gastroenterologists and Offers Strategies for Change

INTRODUCTION This is an exceptional time of change and progress for women in all spheres of medicine, but especially in the field of gastroenterology. Although more than 50% of medical students are women, only 25-30% of GI fellows are women. This is an improvement since 2016, when it was reported that only 15% of GI fellows were women. The reasons are multifactorial, but even amongst those women who choose to pursue a career in GI, many of us face significant barriers to success throughout the years. We discuss our experiences in private, amongst our friends and trusted colleagues.

Members of the ACG Women in GI Committee believe, however, that these experiences may be more commonplace than previously thought. Discussing some of these experiences and offering advice as colleagues who have “been there” may provide validation to many of our members as well as equip our fellow gastroenterologists to deal with these

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issues constructively. As part of the work of the ACG Women in GI Committee, we collected examples of experiences reported by female colleagues (who remain anonymous in this article), and we offer commentary and strategies for constructive action, as well as references.

We hope you enjoy our spotlight on some of the challenges of “life in the trenches” as a woman in GI and that these reflections spark further conversations about solutions. —Lavanya Viswanathan, MD, MS

LET'S STICK TO THE CV

By Pegah Hosseini-Carroll, MD, FACG A woman in gastroenterology recalled: “One of my earliest fellowship interviews started out benign enough. We initially engaged in some introductory small talk followed by the obligatory, 'Why GI?' question. I waited for at least one question about any number of my publications, research projects, or health policy advocacy initiatives. Instead, he asked me if I had a family, to which I

replied, 'No.' The PD gave a perfunctory nod and the APD squirmed in his seat, understanding that his colleague had just broken the law. I decided that I had no interest in the program by that point, so I said, 'I guess that's why I had so much time to publish and engage in research, as I'm sure you might have noted from my CV.' Both men laughed nervously while I wondered why I had bothered blocking off a day for this. I attended a different training program, where my educators saw me as a person, not a 'female fellow'. They took interest in my career goals, rather than my reproductive ones. I gained important insight from that interview: to make sure to go where I am valued and respected.”

Dr. Hosseini-Carroll: There are state and federal laws designed to protect against discrimination related to marital status, sexual orientation, and whether you have or plan to have children.

Unfortunately, questions related to these areas are frequently still asked in interviews. The author did not have to answer the question and could have declined. However, declining to answer during an interview for a highly competitive fellowship would have been tremendously difficult.

The program director asked a loaded question designed to extrapolate whether this applicant may have competing priorities, less time to dedicate to the program, and the likelihood of whether she would become pregnant. The United States consistently lags behind other nations regarding support for family-friendly leave and work policies. Positive steps have been taken in the world of graduate medical education for parental leave recently, but we have a long way to go. In general, there remains a significant gender gap which has persisted over decades.

Women are paid less than men, promoted less than men, and hold fewer leadership positions, despite their growing representation. Women who choose to have children are especially at a disadvantage when it comes to career advancement. The disadvantages continue even during

// PERSPECTIVES

lactation due to poor support and lack of recognition that milk expression is a biological need and the sustenance of a child, the future of society.

I applaud the author for choosing a program where she felt valued and respected. I also hope that she provided feedback and education to the offending program so that they may recognize the issue and remedy it in the future.

References 1.

Rabinowitz L, Anandasabapathy S, Sethi A, Siddiqui U, Wallace M, Kim M. Addressing Gender in Gastroenterology: Opportunities for Change.

Gastrointest Endosc. 2020;91 (1):155-161.

2. Gerson L, Twomey K, Hecht G, Lee L, McQuaid K, Pizarro T, Street S, Yoshida C, Early D. Does Gender Affect Career Satisfaction and Advancement in Gastroenterology? Results of an AGA InstituteSponsored Study. Gastroenterology. 2017;132:1598-1606.

3. Wehner M, Nead K, Linos K Linos E. Plenty of Moustaches But Not Enough Women: Cross Sectional Study of Medical Leaders. BMJ. 2015;351:h62311.

4. Tomer G, Xanthakos S, Kin S, Rao M, Book L, Litman H, Fishman, L. Perceptions of Gender Equality in Work-life Balance, Salary, Promotion, and Harassment: Results of the NASPGHAN Task Force Survey. JPGN. 2015;60:481-485.

5. Singh A, Burke C, Larive B, Sastri S. Do Gender Disparities Persist in Gastroenterology After 10 Years of Practice? Am J Gastroenterol. 2008;103:1589-1595.

About: Dr. Hosseini-Carroll is Assistant Professor of Medicine and Associate Program Director of Digestive Diseases Fellowship at the University of Mississippi Medical Center, Jackson, MS.

“I’M NOT LOST, I’M THE DOCTOR”

By Autumn Hines, DO A female colleague reported: “I was 7.5 months pregnant and recently had joined the staff of a hospital, so was not well-known around there yet. One day, I was called to urgently help in an emergency C-section because there was concern for a bowel injury. As I walked around the OR suite in scrubs, with badge, asking where Dr. X was, a staff member approached me to let me know I was in the wrong place. 'Ma’am, this is not where you check in for Labor and Delivery!' I had to obviously point out that I was not a patient trying to find L&D but instead the surgeon called to assist the OB/GYN for a bowel injury.”

Dr. Hines: What they don’t teach you in medical school is that you most likely will be treated differently as a female physician at some point in your career. This can be rooted in implicit and, at times, explicit bias.

The first time I experienced the effects of gender bias, I was surprised and caught off guard. No part of the medical hierarchy is immune. It can be experienced at any time, as a medical student and as an attending.

Ask any female physician about a time she was treated differently, or questioned, because of her gender and she will give you a list of examples.

The physician in this vignette cites an example of when she was assumed to be a patient, instead of a physician, despite wearing appropriate attire and identification. This assumption was likely rooted in the fact that she was a pregnant female. I agree with the physician’s approach of immediately correcting the staff member. With her direct approach, she was able to establish her position and hopefully prevent future occurrences.

In my experience, a direct approach is necessary if you want to see change.

Asserting yourself, and your role, doesn’t have to be done in an accusatory (or lighthearted) way; instead it should be said in a matter-of-fact manner.

Unfortunately, this situation is not uncommon in my experience, and points to a broader issue of gender inequality in the medical field. Disparities between genders are seen in multiple areas, including in pay, representation in academic promotion, publications, as well as leadership roles.¹’² Implicit gender bias is one of the components that contributes to this. Multiple factors are needed to change our biases and our culture to be more inclusive and equitable, ranging from targeted training courses to onthe-ground intervention². This story is a perfect example of where an opportunity for intervention can occur.

Diversity and equality should be part of our everyday lives, but it will take an active role on our part to get there, through education, training, and evaluation of our own biases. As I look down at my 3-month-old son, I am reminded that we are not born with these biases. This is what makes me hopeful for the future.

References 1.

Spector ND, Overholser B. Examining Gender Disparity in Medicine and Setting a Course Forward.

JAMA Netw Open. 2019;2(6):e196484. doi:10.1001/ jamanetworkopen.2019.6484

2. Chadwick AJ, Baruah R. Gender disparity and implicit gender bias amongst doctors in intensive care medicine: A 'disease' we need to recognise and treat. J Intensive Care Soc. 2020;21(1):12-17. doi:10.1177/1751143719870469

About: Dr. Hines is Assistant Professor of Medicine, Division of Digestive Diseases at Emory University School of Medicine, Atlanta, GA.

“DOES YOUR MOM KNOW WHAT YOU DO?”

By Lavanya Viswanathan, MD, MS A recollection from fellowship training by a woman in GI: “Throughout my fellowship, an older male surgeon would ask me this question any time he saw me passing through the OR. I usually would smile and go on about my busy day, even though I had a feeling there was an insinuation in that question that I wouldn’t like. One day, I finally asked him to clarify his statement after advising that, 'Yes, of course my mom knows what I was doing and that she is very proud of me.' Upon confronting him, he stated, 'I thought you had some type of fetish' because of me being a 'female in GI.' By directly questioning him (and being in a public space!) his demeanor changed and he appeared ashamed. We discussed how this was inappropriate before he apologized and walked away.

Although he never spoke to me again, the more I thought about it, I realized that even the hallways of the OR weren’t safe from ’catcalls.’”

Dr. Viswanthan: I applaud this physician for her bravery and assertiveness! As physicians, we face microaggressions from patients and staff, and it can be daunting to walk the fine line of assertiveness. Microaggressions include being asked by the patient, “When is the doctor going to come and see me?” when you enter the room or a colleague addressing you professionally as “Miss” or by your first name instead of “Doctor.” Historically, I have found it easier to just ignore such statements entirely, mostly because it made me

ACG Perspectives | 45

feel uncomfortable and also because I was never quite sure whether it would be appropriate to correct a patient or, at times, a colleague. But it does happen far too often and it leads to resentment and burnout. It also sends a negative message to the rest of the care team that stoicism is more valuable than setting boundaries and remaining assertive. Just because we take care of others, does not mean we should endure disrespect.

Over the years, I have learned there are several ways to deal with these types of inappropriate and at times, hurtful, behaviors. One is by leaving the room in order to gather your thoughts and digest what has happened. If one of the members of your team has been targeted by a patient, it may be appropriate to take the team out of the room and address them separately. You can always tell a patient that you will be stepping out of the room for a few minutes in order to take back control of the situation or if you feel unsafe or threatened in that situation.

Perhaps with age and experience, I have recently gathered the courage to address some of these microaggressions directly with statements such as, “I’m surprised you thought that was appropriate to say to your doctor,” or, “Your medical team is comprised of several highly trained professionals whom I respect. I request that you do the same.” I have found that when the inappropriate statement is directly confronted, most people feel badly that they were perceived as rude or hurtful, and they usually apologize and try to be more respectful, as the surgeon did in this vignette. It can be tricky to confront a colleague who is harassing you, especially publicly. One does not need to be rude at all, but a simple, “What do you mean by that?” or, “I find your comments to be unprofessional. Please stop,” can be highly effective.

In the case of complicated patient interactions, it is also important to speak with the care team after such an encounter and discuss what went wrong and how this situation could be handled better. While most medical professionals will be quick to minimize any perceived slight and rationalize it

46 | GI.ORG/ACGMAGAZINE

by saying, “He’s just very old and doesn’t know what he’s saying,” the team should be told that they are allowed to feel upset and hurt, because we are all human, after all. Most importantly, people on your team should feel valued and safe in order to foster a professional learning environment.

It is important for us as physicians to set the tone of respect and decorum during a patient encounter and even more important to model this for the next generation of doctors. In fact, we should encourage our colleagues to be allies and help to protect one another from verbal and, at times, even physical abuse. Sometimes, the easiest thing to say to a patient is, “Let’s just keep this professional and focus on your health issues.” Hats off to this physician for modeling this behavior perfectly and for teaching her colleague that all doctors, even women, deserve respect.

Reference 1.

Shankar, Megha, et al. Approaches for Residents to Address Problematic Patient Behavior: Before, During, and After the Clinical Encounter. J Grad Med Educ (2019) 11 (4): 371–374.

About: Dr. Viswanathan is Associate Professor of Medicine, USUHS and UC Davis, and serves as Chief, Department of Gastroenterology and Hepatology at David Grant Medical Center, Travis Air Force Base, CA.

GASLIGHTING IN MEDICINE

By Lydia Aye, DO The experience of a female endoscopist: “As a junior attending, I had a particularly difficult procedure. This colonoscopy required repositioning and various maneuvers in order to complete the procedure. The male endoscopy tech in the room displayed a disrespectful attitude and voiced his displeasure at how long the procedure was going. He commented that the patient was not cooperating and that the procedure was taking too long. He made comments that other attendings would not take as long and would be ’more efficient.’

The tech left the room prior to finishing the procedure and did not return. After the colonoscopy, I reported his behavior to his supervisor. The nurse manager called me later that day to discuss the event. She told me that I had misperceived his behavior and that no wrongdoing had occurred.”

Dr. Aye: This situation demonstrates two microaggressions, underestimating the ability of a female physician and gaslighting by management. Many times in medicine, women are told to “avoid rocking the boat.” However, it is important to address unprofessional behavior, especially if it affects the integrity of the clinical team. I would have directly addressed the tech after the procedure to discuss his behavior and how unprofessional his behavior was. This would allow for direct communication with the tech, to clarify the situation and potentially discuss how future interactions should proceed. After the discussion with the tech, I would have then approached his manager to discuss the situation and inform the manager that I had already spoken to the tech directly.

This would give me the advantage of controlling the narrative when speaking to the manager. It does not allow the manager to dictate the direction of the conversation.

In this case, the individual technician’s behavior should be addressed, but his outlook may not change unless his leadership reflects those same values. Periyakoil, et al., discussed that “passive bystanders should be trained to identify microaggressions and become active upstanders (someone who recognizes when something is wrong and acts to make it right) in providing realtime support to those subjected to microaggressions.” Addressing microaggressions in medicine is not just addressing specific situations but training people at all levels (including management, administrators, and division chiefs) to identify and eliminate microaggressions.

Reference 1.

Periyakoil V, Chaudron L, Emorica V, Pellegrini V, Neri E, Kraemer H. Common Types of GenderBased Microaggressions in Medicine. Academic Medicine(2020) 95 (3): 450-457.

About: Dr. Aye is Associate Professor of Medicine and Program Director, Gastroenterology Fellowship at University of California, Irvine, Irvine, CA.

// PERSPECTIVES

THE HIGH EMOTIONAL COST OF FITTING IN

By Sangeeta Agrawal, MD, FACG A female gastroenterologists reports: “I was the first female GI fellow in the program in 10 years. The guys didn’t know how to behave around me — especially the attendings. It was always very awkward until another female fellow joined the program. When I got pregnant in my second year, I wanted to prove to “the boys” that pregnancy didn’t make me handicapped, or less capable to perform well in fellowship. I was moving patients around, a patient who was coming off sedation punched me, and I went into premature labor after a two-hour ERCP, all because I didn’t want to be perceived as weak.

This way of thinking cost me greatly: a premature child who was later diagnosed with autism. Whether or not there was any causative correlation with her diagnosis, I will never know.

What is certain is the guilt I carry about trying to be superwoman, trying to prove something to the less important people in my life at the time. They did not deserve all my efforts. My child deserved me being more conscientious about her health than bowing down to the system.”

Dr. Agrawal: Pregnant professional women tend to hold themselves to a very high standard. Very early in life, women learn that they must prove themselves to be better than men to be taken seriously and that crawls into their subconscious and settles down there. Professional women do not want to be perceived as the weaker sex and therefore during pregnancy, instead of taking on less work, women tend to go above and beyond just to prove a point. With increasing numbers of women entering medicine, pregnancy during residency and fellowship is very common. We need a supportive work culture where women can celebrate their pregnancy rather than try to hide it. At the same time, we also need to change our mindset, as this physician has herself pointed out — we owe it to ourselves and our children.

In this situation, the physician should have stayed away from too much manual labor like moving patients around, especially during her last trimester of pregnancy. Standing for two hours during an ERCP wearing lead is also very physically demanding during the last trimester. So it is better to have an honest discussion with your attending prior to the procedures and set expectations so that he/she is not taken by surprise when you ask to be excused from the procedure. If the colleagues and attendings are male, as was in this case scenario, we cannot expect them to automatically understand our situation. Therefore, I would recommend open communication and discussion and that is fair for both parties involved.

You would be surprised by how much cooperation and understanding you can get from your colleagues once that happens.

An article published in 1988, “Pregnancy Complications of Physicians" addressed these issues (1). According to this article, “The emotional and physiologic stresses of medicine are incomparable to other occupations and add particular hazards to pregnancy. Physician’s work is both strenuous and stressful and leads to prematurity, low birth weight, and placental abruption. Call for reduced work hours, changes in night call schedules, and lengthened maternity leave are all justified and appropriate but the culture in medicine does not allow these necessities.”

Another study in 2014 showed that there was a direct correlation between the number of hours worked and pregnancyrelated complications like premature birth and threatened abortion (2). A recent national survey published in JAMA Surgery in July 2021 highlighted increased medical risks of infertility and pregnancy complications among female surgeons (3).

Our medical culture needs to change to eliminate this conscious or subconscious bias. Hospitals and training programs need to prioritize the physical and mental health of all physicians, but especially women physicians as they face unique challenges during their training periods, like pregnancy.

Women physicians should not be forced to carry this guilt of “not working enough” either at work or at home.

References 1.

Katz VL, Miller NH, Bowes WA Jr. Pregnancy complications of physicians. West J Med. 1988;149(6):704-707.

2. Takeuchi, M., Rahman, M., Ishiguro, A. et al. Long working hours and pregnancy complications: women physicians survey in Japan. BMC Pregnancy Childbirth 14, 245 (2014). https://doi.org/10.1186/1471-2393-14-245 3. Rangel EL, Castillo-Angeles M, Easter SR, et al.

Incidence of Infertility and Pregnancy Complications in US Female Surgeons. JAMA Surg. Published online July 28, 2021. doi:10.1001/jamasurg.2021.3301

About: Dr. Agrawal is Professor of Medicine, Chief, Department of Gastroenterology, and GI Fellowship Program Director at Wright State University, Dayton, OH.

CONCLUSIONS AND CALL-TOACTION Dr. Viswanathan: While these anecdotes are specific to the experience of women in medicine, they are relevant to all members of our profession. Women come to work every day against the backdrop of sexual harassment, and face both gender discrimination including unequal pay and various implicit biases held by colleagues, as well as patients. We have to accept that the infrastructure put in place several generations ago must be updated to reflect the richness of diversity of our current demographic makeup. But in order to enact meaningful change, we must first understand the problem and engage in open and honest dialogue. We hope that sharing these experiences will shed light on some of the harsher realities faced by some women in GI and may provide context for our colleagues, regardless of gender. Let’s all be better allies to one another and strive for equity in our field.

ACG Perspectives | 47

New Book Reflects on

(History of Medicine) from the Pages of The American Journal of Gastroenterology

T

he latest book by Robert E. Kravetz, MD, MACG, “A Look Back – Reflections on Medical History & Artifacts from the Pages of The American Journal of Gastroenterology” is available for purchase at a special rate of $25 for College members.

With a keen eye for fascinating images and a gift for vivid and erudite descriptions, Dr. Robert Kravetz reflects on artifacts and trends in the evolution of modern medicine and finds lessons and insights from medical antiques that remain fascinating and relevant today. His appreciation for the past and his curiosity are both evident in each essay in “A Look Back: Reflections on Medical History & Artifacts from the Pages of The American Journal of Gastroenterology.”

learn from the mistakes, sacrifices and advances of bygone eras. “ We History also teaches us to pay homage to our predecessors in the medical profession who paved the way for us. ” – Dr. Kravetz Dr. Kravetz is a healer and historian whose humanistic sensibility shines through in this elegant volume. Illustrated with vivid color photographs and short reflections by Dr. Kravetz, this curated selection of medical antiquities and rare objects, many from his personal collection, comes to life. As a champion of medical history, an avid collector of medical antiques and artifacts, and a consummate educator, Dr. Kravetz shares his passion with readers interested in gastroenterology and medicine.

Order Online ( (members.gi.org/store The book has a retail value of $60 and is available for purchase through the ACG website to current ACG members at the special price of $25.

This cost covers shipments to addresses in the United States only.

For information on ordering outside the U.S., please contact info@gi.org.

48 | GI.ORG/ACGMAGAZINE

EDUCATION Edgar Achkar Visiting Professorship Staying connected, INSPIRING GI TRAINEES THE 2021 EAVP EXPERIENCE: COVID-19 COULD NOT STOP THE LEARNING The Edgar Achkar Visiting Professorships (EAVP) were reimagined during the pandemic without sacrificing quality.

GI training programs hosted virtual EAVP visits that featured educational lectures, trainee mentoring, and community partnership. The ACG Institute learned to adapt this popular

program using technology, which opens new possibilities for expansion beyond the constraints of in-person travel.

The purpose of these visits is to reach a diverse number of programs while aiming to maximize the impact of each visit by targeting GI training programs which could also leverage an additional community event with local ACG member physicians. This program offers expertise for a specific area of need at each institution.

The ACG Institute is grateful to all the GI training programs that hosted visiting professors in

2021 and recognizes with great thanks the faculty featured in this issue of ACG MAGAZINE. Visiting professorships at the end of 2021 included: Dr. John E. Pandolfino, who visited Virginia Tech Carilion School of Medicine; Dr. Aline Charabaty who visited VA Caribbean Health System; Dr. Edward V. Loftus who visited Brooke Army Medical Center; Dr. Sunanda V. Kane who visited St. Luke’s University Hospital; Dr. Millie D. Long who visited University of Texas Southwestern; and Dr. Christina Ha who visited University of New Mexico.

Eduation | 49

// EDUCATION

"In spite of COVID pandemic travel bans and in spite of our geographic location, we were able at VA Caribbean Healthcare System in Puerto Rico to get the benefit of an IBD expert such as Dr. Charabaty presenting a Grand Rounds, 'Update on the Managemaent of Ulcerative Colitis.' Afterwards in the case presentation, fellows were able to have the input of a national/ international IBD expert in a one-to-one interaction with her on their complex IBD patients."

—Dr. Jaime Martinez-Souss, of VA Caribbean Health System on Dr. Aline Charabaty’s visit

"I enjoyed working with Dr. Edgar Achkar when we were both associate editors of The American Journal of Gastroenterology in the 2000’s, and I was honored to be a visiting professor in his name. I think being able to interact with junior faculty and fellows on a daily basis is what keeps me going and so I was delighted to participate in this endeavor."

—Dr. Edward V. Loftus, on his visit to Brooke Army Medical Center

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“The best part was having a lecturer at the caliber of Dr. Kane giving us a personal lecture for our GI fellows and attendings and drawing on her expertise to teach us locally. I am so thankful to ACG for giving for us this opportunity. For a new program, it’s just great.”

—Dr. Kimberly Chaput of St. Luke’s University Hospital on Dr. Sunanda Kane’s Pregnancy in IBD talk

“The Edgar Achkar Visiting Professor program is a testament to the educational mission of the ACG and allows for outstanding access to experts in GI subspecialties and networking opportunities for all program participants.

It is a true honor to be a part of this program.”

“I especially enjoyed the interactive case presentations. As a fellow, this was an invaluable learning experience; it solidified my knowledge on IBD patient management.”

—Dr. Zorisadday Gonzalez on Dr. Christina Ha’s presentation at University of New Mexico

—Dr. Millie D. Long on her experience presenting to trainees and faculty at UT Southwestern

2021

ACG EDGAR ACHKAR VISITING PROFESSORSHIPS CAROL A. BURKE, MD, FACG* Atrium Health MARCH 11, 2021 MOHAMED O. OTHMAN, MD University of Miami ON MARCH 24, 2021 SATISH S.C. RAO, MD, PHD, FACG University of Rochester Medical Center APRIL 27-28, 2021 DOUGLAS K. REX, MD, PHD, MACG Westchester Medical Center MAY 19, 2021 BRIAN E. LACY, MD, PHD, FACG Allegheny General Hospital MAY 27, 2021 COREY A. SIEGEL, MD, MS William Beaumont Hospital JUNE 2 AND JULY 20, 2021 JOHN E. PANDOLFINO, MD, MSCI, FACG Virginia Tech Carilion School of Medicine AUGUST 19-20, 2021

"I would strongly encourage other programs to take advantage of this wonderful opportunity provided by the ACG. This really energizes the fellows and faculty alike, giving them a very fresh and different perspective towards approaching clinical issues." —Dr. Vikas Chitnavis on Dr. John Pandolfino’s visit to Virginia Tech Carilion School of Medicine

ALINE CHARABATY, MD, FACG VA Caribbean Healthcare System SEPTEMBER 22, 2021 EDWARD V. LOFTUS, JR., MD, FACG* Brooke Army Medical Center OCTOBER 14, 2021 SUNANDA V. KANE, MD, MSPH, FACG at St. Luke’s University Hospital NOVEMBER 2, 2021 MILLIE D. LONG MD, MPH, FACG UT Southwestern NOVEMBER 10, 2021 CHRISTINA Y. HA, MD, FACG* University of New Mexico NOVEMBER 18, 2021 *Received funding in 2019, visit scheduled in 2020 **Received funding in 2020, visit scheduled in 2021

The Edgar Achkar Visiting Professorship program is a project of the ACG Institute and is supported by charitable contributions to the G.U.T. Fund.

Eduation | 51

EVIDENCE-BASED GI JOURNAL REVIEW Clinical take-aways and evidence-based summaries of articles in GI, Hepatology & Endoscopy.

ACG PUBLICATION EVIDENCE--BASED GI (EBGI) evaluates new research articles published across GI and Hepatology journals using evidence-based criteria.

ACG Editors identify the highest quality studies published on important topics and create structured abstracts summarizing the study for quick reference and provide commentary on how the data is applicable to clinical practice.

Editors record audio summaries for easy listening on the go.

Listen to individual article summaries or stream the entire issue all at once.

Member benefit!

Watch for the eTOC delivered in your inbox monthly!



Full issue download available as PDF: gi.org/ebgi

52 | 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

AN IMPORTANT CONTRIBUTION TO CLINICAL GI practice was published in The American Journal of Gastroenterology with the update of ACG Guidelines on the Diagnosis and Management of GERD by Katz, et al. in the January 2022 issue. “A lot has changed, much remains the same,” write the authors, who provide a comprehensive evidence-based update to ACG’s 2013 guidelines.

Clinical and Translational Gastroenterology, under the editorial leadership of EIC Dr. Brian Jacobson, continues to publish findings from research at the intersection of bench and bedside, including studies exploring new technologies with the potential to shift paradigms of patient care. Work by Szigethy, et al., at the University of Pittsburgh on a novel app that delivers digital cognitive behavioral interventions to patients with disorders of gut-brain interaction is featured here, Inside the Journals.

Inside the Journals | 53

// INSIDE THE JOURNALS [THE AMERICAN JOURNAL OF GASTROENTEROLOGY]

ACG Clinical Guidelines: Guidelines for the Diagnosis and Management of Gastroesophageal Reflux Disease Philip O. Katz, MD, MACG; Kerry B. Dunbar, MD, PhD; Felice H. Schnoll-Sussman, MD, FACG; Katarina B. Greer, MD, MS, FACG; Rena Yadlapati, MD, MSHS; and Stuart Jon Spechler, MD, FACG, The American Journal of Gastroenterology: January 2022 - Volume 117 - Issue 1.

 OVERVIEW: “Gastroesophageal reflux disease

(GERD) continues to be among the most common diseases seen by gastroenterologists, surgeons, and primary care physicians. Our understanding of the varied presentations of GERD, enhancements in diagnostic testing, and approach to patient management have evolved. During this time, scrutiny of proton pump inhibitors (PPIs) has increased considerably. Although PPIs remain the medical treatment of choice for GERD, multiple publications have raised questions about adverse events, raising doubts about the safety of long-term use and increasing concern about overprescribing of PPIs. New data regarding the potential for surgical and endoscopic interventions have emerged. In this new document, we provide updated, evidence-based recommendations, and practical guidance for the evaluation and management of GERD, including pharmacologic, lifestyle, surgical, and endoscopic management.”

Presence of extraesophageal GERD symptoms

• Detailed medical history to identify other potential causes • Refer to other specialists for evaluation if history suggests non-GERD cause is likely

Typical GERD + Extraesophageal symptoms

PPI Trial BID up to 12 weeks

Extraesophageal symptoms

Extraesophageal symptoms

Improve

No improvement

Treat as GERD

Reflux monitoring off PPI

Abnormal

Treat as GERD Diagnostic algorithm for extraesophageal GERD symptoms.

 READ bit.ly/ACG-GERD-Guidelines-2022

Normal Consider pH-impedance monitoring

 LISTEN AJG Podcast Conversation with Dr. Katz: bit.ly/ajg-podcast-katz

AJG: In the Red Section The Need for Allyship in Achieving Gender Equity in Gastroenterology Mohammad Bilal, MD; Sophie M. Balzora, MD, FACG; Mark B. Pochapin, MD, FACG; Amy S. Oxentenko, MD, FACG, The American Journal of Gastroenterology: December 2021 – Volume 116 – Issue 12.

 “DESPITE A RISE IN U.S. MEDICAL STUDENTS self-

identifying as women, challenges persist for women physicians, particularly those in male-predominant subspecialties, such as gastroenterology (GI). Not only is there underrepresentation of women in leadership, but women are more likely to face discrimination and harassment, which may be more profound for women with intersectional identities. Campaigns such as '#BeEthical,' '#HerTimeIsNow,' '#HeforShe,' and '#DiversityinGI' have brought necessary awareness of gender inequity in health care of the work required from gatekeepers to foster a more inclusive environment.

Obstacles endured by women in GI need to be addressed collectively. When there are injustices,

54 | GI.ORG/ACGMAGAZINE

we should not ask those who face such injustices to be responsible to address the issues alone—this is where allyship is essential. Allyship refers to support for and practice of promoting rights, representation, and inclusion by members of an advantaged group to advance the

underrepresented or marginalized.

We aim to review how allyship for women can advance the GI field.”  READ: bit.ly/AJG-Allyship

[CLINICAL & TRANSLATIONAL GASTROENTEROLOGY]

A Coached Digital Cognitive Behavioral Intervention Reduces Anxiety and Depression in Adults with Functional Gastrointestinal Disorders Eva Szigethy, MD, PhD; Aylin Tansel, MD, MPH; Alexa N. Pavlick, BA; Maria A. Marroquin, BA; Catherine D. Serio, PhD; Valerie Silfee, BA, Meredith L. Wallace, PhD; Michael J. Kingsley, MD; and David J. Levinthal, MD, PhD, Clinical and Translational Gastroenterology: December 2021 - Volume 12 - Issue 12

Disorder-7) and depression (Personal Health Questionniare Depression Scale) measures through the app. Our primary study outcome was the change in General Anxiety Disorder-7 and Personal Health Questionniare Depression Scale scores.

 TOPLINE FINDINGS: “A coached digital cognitive behavioral intervention can be feasibly and effectively incorporated into routine medical care for patients with disorders of gut-brain interaction and is associated with improvements in anxiety and depressive symptom severity. Our preliminary observations also suggest that our intervention was associated with reduced emergency department utilization.”

BACKGROUND: Traditional cognitive behavioral interventions (CBIs) improve mood and gastrointestinal symptom severity in patients with functional gastrointestinal disorders (FGIDs) but face substantial barriers to implementation. Integrating behavioral health technology into medical clinic workflows could overcome these barriers.

Szigethy, et al., evaluated the feasibility and impact of a coached digital CBI (dCBI) as a first-line intervention in a prospective cohort of emotionally distressed patients with FGID. METHODS: Patients with anxiety and/or depressive symptoms were offered a dCBI (an app called RxWell) during routine clinic visits. RxWell provides cognitive behavioral techniques enhanced by within-app text messaging with a health coach. Both gastroenterology and behavioral health-care providers electronically prescribed RxWell. We tracked patient interactions with RxWell, and patients completed anxiety (General Anxiety

[ACG CASE REPORTS JOURNAL]

Infectious Abscess as Complication of Steroid Injection With Dilation of Refractory Upper Gastrointestinal Strictures Rebecca S. Voaklander, MD & John C. Fang, MD

RESULTS: Of 364 patients with FGID (mean age 43 years [SD 16 years]; 73.1% women) prescribed the dCBI, 48.4% enrolled (median use, 3 techniques [interquartile range 1–14]). About half

of RxWell enrollees communicated with health coaches. The mean baseline anxiety score was 11.4 (SD 5.5), and the depression score was 11.5 (SD 6.1).

RxWell users experienced improvements in anxiety (mean change 2.71 [t = 3.7, df = 58; P < 0.001]) and depression (mean change 2.9 [t = 4.2, df = 45; P < 0.001]) at 4 months.

DISCUSSION: Patients with FGIDs and moderately severe anxiety and depressive symptoms are willing to use dCBI tools recommended by their providers. Our pilot data demonstrate that dCBI usage is associated with clinically and statistically significant mood symptom reductions.

 READ: bit.ly/ctg-szigethy-cbt

Figure 1. Screenshots of the RxWell app: (a) RxWell home page, (b) task selection interface, (c) platform for health coach interactions.

 IN THIS BEHIND THE CASE podcast episode, co-author Dr. John Fang discusses how to treat upper gastrointestinal strictures using dilation combined with intralesional steroid injection with CRJ Co-Editor-in-Chief Dr. Judy Trieu.

Listen: bit.ly/CRJ-Podcast-Fang-UGI-Strictures

Read: bit.ly/CRJ-Voaklander-UGI-Strictures

Inside the Journals | 55

// INSIDE THE JOURNALS

SUBMIT YOUR APPLICATION for the ACG

2022 International GI Training Grant Awards The International Relations Commi ee of the American College of Gastroenterology is now accepting applications for the 2022 International GI Training Grants. Each training grant will award one fellowship, with a maximum of $10,000, during 2022. Grants are to be used for travel to and from the training center and to the ACG Annual Meeting, as well as for incidental expenses related to the training. The training must take place between July 1, 2023, and June 30, 2023.

INTERNATIONAL GI TRAINING GRANT

This grant provides partial financial support to physicians outside the United States and Canada to receive clinical or clinical research training or education in Gastroenterology and Hepatology in selected medical training centers in North America.

WHO IS ELIGIBLE? Physicians who are not citizens or residents of the United States or Canada, and who are working in gastroenterology or related areas, are eligible to apply together with their training institution.

SUBMISSION DEADLINE March 31, 2022 APPLY HERE gi.org/gi-training-grants

NORTH AMERICAN INTERNATIONAL GI TRAINING GRANT

This grant provides partial financial support to United States and Canadian GI Fellows in training, or GI Physicians who have completed their training within the last five years, to receive clinical or clinical research training or education in Gastroenterology and Hepatology outside of North America.

WHO IS ELIGIBLE? GI Fellows in training who are enrolled in an accredited gastroenterology fellowship program, or GI Physicians who completed their training within the last five years, and are citizens of the United States or Canada, are eligible to apply together with their training institution.

56 | GI.ORG/ACGMAGAZINE

SUBMISSION DEADLINE March 31, 2022 APPLY HERE gi.org/gi-training-grants

A Look Back

50 YEARS AGO... from the pages

of The American Journal of Gastroenterology

By Lawrence R. Schiller, MD, MACG for the ACG Archives Committee

G

astric cancer was the leading cause of cancer deaths among American men until 1950, but has declined dramatically since then, falling out of the top ten causes for cancer deaths for both men and women.

This change was not due to improved treatments, but rather a substantial decrease in the overall incidence of gastric cancer.1 One curiosity of this change in epidemiology was the observation that whereas cancers in the body and antrum (“non-junctional cancers”) had the greatest decline, cancers of the cardia and fundus (“junctional cancers”) actually increased. Junctional cancers went from 10% of all gastric cancers in 1975 to 27% in 2012.1 Fifty years ago, Sidney M. Fierst, MD, MS, MACG, then at Downstate Medical Center and the Brooklyn VA Hospital, reported his experiences with 48 patients with carcinomas of the cardia and fundus of the stomach in the pages of The American Journal

of Gastroenterology.2 Patients had been seen from 1956 to 1969.

There were four times as many men as women, patients averaged 63 years of age, and dysphagia and weight loss were the most common presenting symptoms.

Nowadays, men still outnumber women with junctional carcinoma, and all patients are slightly older, on average.

Radiology was the most commonly used diagnostic method 50 years ago (see Figure), but the first examination was correct in only 75%. Endoscopy was not as common in that era as today, and fiberoptic endoscopes were first being used instead of rigid endoscopy at that time. When endoscopy was used in this cohort of patients, it proved to be 90% correct, presaging its prominence as the diagnostic tool of choice.

In 1972, surgery was the only therapy with a chance of cure for junctional gastric cancer, but the chance was small; of 43 patients who underwent exploration, curative excision was attempted in only 12, with an operative

mortality of 17% and only two patients who survived more than 5 years. In the decades since then, surgeons have improved the anatomic classification of junctional cancers and used that to decide on an appropriate surgical approach.3 Outcomes with surgery alone remain poor, with 2050% survival at 5 years because of the high frequency of local and distant metastasis by the time that surgical resection is attempted.1 Adjuvant chemoradiation is often used nowadays to try to optimize survival.

Dr. Fierst went on to complete a long and productive career in Brooklyn, New York, as Director of the Division of Gastroenterology at Brookdale University Hospital and Medical Center. His obituary in the New York Times (March 28, 2000) memorialized him as “Pioneer and world renowned in the field of gastroenterology during his affiliations with Maimonides, Brooklyn and Brookdale Hospitals.

Professor of Medicine at Downstate Medical School. Beloved by his students and patients for his teaching and diagnostic abilities and respect for the dignity of life.”

References: 1. Quante M, Bornschein J. Adenocarcinoma of the Stomach and Other Gastric Tumors. Chapter 54, in Sleisenger and Fordtran’s Gastrointestinal and Liver Disease. Pathophysiology, Diagnosis, Management; Feldman M, Friedman LS, Brandt LJ, Chung RT, Rubin DT, Wilcox CM, eds. Philadelphia, Elsevier, 2021. P.820-841.

2. Fierst SM. Carcinoma of the cardia and fundus of the stomach. Am J Gastroenterol 1972;57(5):403-409.

3. Berith F, Hoelscher AH. History of esophagogastric junction cancer treatment and current surgical management in western countries. J Gastric Cancer 2019;19(2):139-147.

Inside the Journals | 57

ACG PRACTICE MANAGEMENT

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ACG’S

ACG members and GI practices continue to face mounting financial and reimbursement pressures. Complex coding and documentation requirements only add to these

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burdens. The ACG Practice Management Committee is pleased to announce the new member benefit: professional coding and documentation assistance for ACG members, tailored to your individual practice’s questions and needs.

HAVE A QUESTION? Email coding@gi.org

Arlene Morrow, CPC, CMM, CMSCS, is now available to answer your questions!

ACG members will receive an answer and guidance within a few business days.

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58 | GI.ORG/ACGMAGAZINE

BRIEF SUMMARY: Before prescribing, please see Full Prescribing Information and Medication Guide for SUTAB® (sodium sulfate, magnesium sulfate, potassium chloride) tablets for oral use.

INDICATIONS AND USAGE: An osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults.

DOSAGE AND ADMINSTRATION: Split Dose (2-Day) Regimen: Dose 1 – On the day prior to colonoscopy: A low residue breakfast may be Packaging and consumed. After breakfast, only clear liquids may be consumed until after the tablets not shown colonoscopy. Early in the evening prior to colonoscopy, open one bottle of actual size.

12 tablets. Fill the provided container with 16 ounces of water (up to the fill line).

Swallow each tablet with a sip of water and drink the entire amount over 15 to 20 minutes. Approximately one hour after the last tablet is ingested, fill the provided container a second time with 16 ounces of water (up to the fill line) and drink the entire amount over 30 minutes. Approximately 30 minutes after finishing the second container of water, fill the provided container with 16 ounces of water (up to the fill line) and drink the entire amount over 30 minutes. Dose 2 - Day of colonoscopy: Continue to consume only clear liquids until after the colonoscopy. The morning of colonoscopy (5 to 8 hours prior to the colonoscopy and no sooner than 4 hours from starting Dose 1), open the second bottle of 12 tablets. Fill the provided container with 16 ounces of water (up to the fill line). Swallow each tablet with a sip of water and drink the entire amount over 15 to 20 minutes. Approximately one hour after the last tablet is ingested, fill the provided container a second time with 16 ounces of water (up to the fill line) and drink the entire amount over 30 minutes.

Approximately 30 minutes after finishing the second container of water, fill the provided container with 16 ounces of water (up to the fill line) and drink the entire amount over 30 minutes. Complete all SUTAB tablets and required water at least 2 hours before colonoscopy.

CONTRAINDICATIONS: Use is contraindicated in the following conditions: gastrointestinal obstruction or ileus, bowel perforation, toxic colitis or toxic megacolon, gastric retention. WARNINGS AND PRECAUTIONS: Serious Fluid and Electrolyte Abnormalities: Advise all patients to hydrate adequately before, during, and after the use of SUTAB. If a patient develops significant vomiting or signs of dehydration after taking SUTAB, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN). Fluid and electrolyte disturbances can lead to serious adverse events including cardiac arrhythmias, seizures and renal impairment. Correct fluid and electrolyte abnormalities before treatment with SUTAB. Use SUTAB with caution in patients with conditions, or who are using medications, that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and renal impairment; Cardiac arrhythmias: Use caution when prescribing SUTAB for patients at increased risk of arrhythmias (e.g., patients with a history of prolonged QT, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy). Consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias; Seizures: Use caution when prescribing SUTAB for patients with a history of seizures and in patients at increased risk of seizure, such as patients taking medications that lower the seizure threshold (e.g., tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia; Use in Patients with Risk of Renal Injury: Use SUTAB with caution in patients with impaired renal function or patients taking concomitant medications that may affect renal function (such as diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or non-steroidal anti-inflammatory drugs). These patients may be at risk for renal injury.

Advise these patients of the importance of adequate hydration with SUTAB and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients; Colonic Mucosal Ulcerations and Ischemic Colitis: Osmotic laxative products may produce colonic mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Concurrent use of stimulant laxatives and SUTAB may increase these risks. Consider the potential for mucosal ulcerations resulting from the bowel preparation when interpreting colonoscopy findings in patients with known or suspect inflammatory bowel disease (IBD); Use in Patients with Significant Gastrointestinal Disease: If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering SUTAB. Use with caution in patients with severe active ulcerative colitis. ADVERSE REACTIONS: Most common gastrointestinal adverse reactions are: nausea, abdominal distension, vomiting and upper abdominal pain. POTENTIAL FOR DRUG ABSORPTION: SUTAB can reduce the absorption of other co-administered drugs. Administer oral medications at least one hour before starting each dose of SUTAB. Administer tetracycline and fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, and penicillamine at least 2 hours before and not less than 6 hours after administration of each dose of SUTAB to avoid chelation with magnesium. Pregnancy: There are no available data on SUTAB use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. No reproduction or developmental studies in animals have been conducted with sodium sulfate, magnesium sulfate, and potassium chloride (SUTAB). Lactation: There are no available data on the presence of SUTAB in human or animal milk, the effects on the breastfed child, or the effects on milk production.

Pediatric Use: Safety and effectiveness in pediatric patients has not been established. Geriatric Use: Of the 471 patients who received SUTAB in pivotal clinical trials, 150 (32%) were 65 years of age or older, and 25 (5%) were 75 years of age or older. No differences in safety or effectiveness of SUTAB were observed between geriatric patients and younger patients. Elderly patients are more likely to have decreased hepatic, renal or cardiac function and may be more susceptible to adverse reactions resulting from fluid and electrolyte abnormalities. STORAGE: Store at 20º to 25°C (68º to 77°F). Excursions permitted between 15º to 30°C (59º to 86°F). See USP controlled room temperature. Rx only. Manufactured by Braintree Laboratories, Inc. Braintree, MA 02185 See Full Prescribing Information and Medication Guide at SUTAB.com.

References: 1. SUTAB® [package insert]. Braintree, MA; 2020. 2. Di Palma JA, Bhandari R, Cleveland M, et al. A safety and efficacy comparison of a new sulfate-based tablet bowel preparation versus a PEG and ascorbate comparator in adult subjects undergoing colonoscopy. Am J Gastroenterol. Published online November 6, 2020. doi: 10.14309/ajg.0000000000001020 3. Rex DK, Johnson DA, Anderson JC, Schoenfeld PS, Burke CA, Inadomi JM; ACG. American College of Gastroenterology guidelines for colorectal cancer screening 2009 [corrected]. Am J Gastroenterol. 2009;104(3):739-750. 4. IQVIA. National Prescription Audit Report. November 2020.

For additional information, please call 1-800-874-6756 ©2021 Braintree Laboratories, Inc.

All rights reserved.

201-133-v1-A January 2021

!

W! E NEW N

A NEW TABLET CHOICE A BOWEL NEW TABLET CHOICE IN PREPARATION IN BOWEL PREPARATION

• NO SODIUM PHOSPHATE1

• SAFE AND EFFECTIVE1,2 1 • NO SODIUM PHOSPHATE • ACG-RECOMMENDED1,2 SPLIT-DOSE REGIMEN3 • SAFE AND EFFECTIVE 1 – Two SUTAB doses are required for a complete preparation

Dose 1 consists of 12 tablets and 16 oz of water REGIMEN3 • ACG-RECOMMENDED SPLIT-DOSE Dose 2 consists of 12 tablets and 16 oz of water 1 – Two are required for a complete preparation EachSUTAB dose isdoses followed by two additional 16 oz of water Dose 1 consists of 12 tablets and 16 oz of water Dose 2 consists of 12 tablets and 16 oz of water Packaging and tablets not shown size.

Each dose is followed by actual two additional 16 oz of water

92% OF PATIENTS IN TWO PIVOTAL TRIALS ACHIEVED SUCCESSFUL BOWEL CLEANSING WITH SUTAB1,2* 91% OF PATIENTS IN ONE PIVOTAL TRIAL RATED SUTAB AS TOLERABLE TO VERY EASY TO CONSUME2† 1,2 ® 1,2‡ 92% OF PATIENTS IN TWO PIVOTAL TRIALSreported ACHIEVED SUCCESSFUL CLEANSING SUTAB * • 52% of all SUTAB and MoviPrep patients at least one selectedBOWEL gastrointestinal adverseWITH reaction • More SUTAB patients reported experiencing nausea and vomiting than competitor, with ≤1%TO of these reports2† 91% OF PATIENTS IN ONE PIVOTAL TRIAL RATED SUTAB AS TOLERABLE TO VERY EASY CONSUME 2‡ Packaging and tablets not shown actual size.

considered severeand MoviPrep® patients reported at least one selected gastrointestinal adverse reaction1,2‡ • 52% of all SUTAB

2† 78% OF PATIENTS ONE reported PIVOTALexperiencing TRIAL WOULD REQUEST SUTAB AGAIN FOR A FUTURE • More SUTAB IN patients nausea and vomiting than competitor, with ≤1% ofCOLONOSCOPY these reports

considered severe * Success was primary endpoint and was defined in noninferiority trials as an overall cleaning assessment of 3 (good) or 4 (excellent) by the blinded endoscopist; scores were assigned on withdrawal of colonoscope.

OF PATIENTS IN ONE PIVOTAL TRIAL WOULD REQUEST SUTAB AGAIN FOR A FUTURE COLONOSCOPY2† † Patients completed preference questionnaire following completion of study drug to capture the subject’s perceptions of the preparation experience. This * questionnaire has not undergone formal validation.

Success was primary endpoint and was defined in noninferiority trials as an overall cleaning assessment of 3 (good) or 4 (excellent) by the blinded endoscopist; ‡ scores were assigned on withdrawal of colonoscope.

Patients were queried for selected gastrointestinal adverse reactions of upper abdominal pain, abdominal distension, nausea, and vomiting following completion †of study drug, rating the intensity as mild, moderate, or severe.

Patients completed preference questionnaire following completion of study drug to capture the subject’s perceptions of the preparation experience. This questionnaire has not undergone formal validation.

ACG=American College of Gastroenterology ‡ ® Patients were queried for selected gastrointestinal adverse reactions of upper abdominal pain, abdominal distension, nausea, and vomiting following completion is a registered trademark of Velinor AG. MoviPrep of study drug, rating the intensity as mild, moderate, or severe.

ACG=American College of Gastroenterology MoviPrep® is a registered trademark of Velinor AG. IMPORTANT SAFETY INFORMATION 2‡

78%

SUTAB® (sodium sulfate, magnesium sulfate, potassium chloride) tablets for oral use is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults. DOSAGE AND ADMINSTRATION: A low residue breakfast may be consumed. After IMPORTANT SAFETY INFORMATION breakfast, only clear liquids may be consumed until after the colonoscopy. Administration of two doses of SUTAB (24 tablets) are required ® SUTAB (sodium sulfate, magnesium sulfate, potassium chloride) tablets for oral use is an osmotic laxative indicated for cleansing of the for a complete preparation for colonoscopy. Twelve (12) tablets are equivalent to one dose. Water must be consumed with each dose colon in preparation for colonoscopy in adults. DOSAGE AND ADMINSTRATION: A low residue breakfast may be consumed. After of SUTAB and additional water must be consumed after each dose. Complete all SUTAB tablets and required water at least 2 hours breakfast, only clear liquids may be consumed until after the colonoscopy. Administration of two doses of SUTAB (24 tablets) are required before colonoscopy. CONTRAINDICATIONS: Use is contraindicated in the following conditions: gastrointestinal obstruction or ileus, for a complete preparation for colonoscopy. Twelve (12) tablets are equivalent to one dose. Water must be consumed with each dose bowel perforation, toxic colitis or toxic megacolon, gastric retention. WARNINGS AND PRECAUTIONS: Risk of fluid and electrolyte of SUTAB and additional water must be consumed after each dose. Complete all SUTAB tablets and required water at least 2 hours abnormalities: Encourage adequate hydration, assess concurrent medications and consider laboratory assessments prior to and after each before colonoscopy. CONTRAINDICATIONS: Use is contraindicated in the following conditions: gastrointestinal obstruction or ileus, use; Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk; Seizures: Use caution in patients bowel perforation, toxic colitis or toxic megacolon, gastric retention. WARNINGS AND PRECAUTIONS: Risk of fluid and electrolyte with a history of seizures and patients at increased risk of seizures, including medications that lower the seizure threshold; Patients with abnormalities: Encourage adequate hydration, assess concurrent medications and consider laboratory assessments prior to and after each renal impairment or taking concomitant medications that affect renal function: Use caution, ensure adequate hydration and consider use; Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk; Seizures: Use caution in patients laboratory testing; Suspected GI obstruction or perforation: Rule out the diagnosis before administration. ADVERSE REACTIONS: with a history of seizures and patients at increased risk of seizures, including medications that lower the seizure threshold; Patients with Most common gastrointestinal adverse reactions are: nausea, abdominal distension, vomiting and upper abdominal pain. DRUG renal impairment or taking concomitant medications that affect renal function: Use caution, ensure adequate hydration and consider INTERACTIONS: Drugs that increase risk of fluid and electrolyte imbalance. laboratory testing; Suspected GI obstruction or perforation: Rule out the diagnosis before administration. ADVERSE REACTIONS: Please see Brief Summary of Prescribing Information on reverse side. See Full Prescribing Information and Medication Guide at Most common gastrointestinal adverse reactions are: nausea, abdominal distension, vomiting and upper abdominal pain. DRUG SUTAB.com.

INTERACTIONS: Drugs that increase risk of fluid and electrolyte imbalance.

Please see Brief Summary of Prescribing Information on reverse side. See Full Prescribing Information and Medication Guide at SUTAB.com.

From the makers of SUPREP® Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Solution for adults—

THE #1 MOST PRESCRIBED, BRANDED BOWEL PREP KIT4

From the makers of SUPREP® Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Solution for adults—

THE #1 MOST PRESCRIBED, BRANDED BOWEL PREP KIT4