ACG MAGAZINE Winter 2020
MEMBERS. MEDICINE. MEANING.
Evolution of an Idea
From Functional GI Disorders To Disorders of Gut-Brain Interaction
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WINTER 2020 // VOLUME 4, NUMBER 4
FEATURED CONTENTS COVER STORY
Evolution of an Idea: From Functional GI Disorders to Disorders of Gut-Brain Interaction Dr. Douglas Drossman reflects on the shift in approaches to functional GI disorders and the importance of considering a biopsychosocial approach
PAGE 25
LAW MIND: What Androcles and the Lion Has to Do with GI Practices During a Pandemic Ann Bittinger, Esq. on how physicians can build trust through compassion and composure during the pandemic PAGE 23
Conversations with Women In GI: Leadership for Women in GI Dr. Jill Gaidos interviews Dr. Colleen Schmitt on advice for women in GI, based on her experiences pursuing and navigating leadership roles PAGE 31
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WINTER 2020 // VOLUME 4, NUMBER 4
CONTENTS
"Improving the efficiency of our endoscopy units is one way we can attempt to recover from the events of the past year and ensure that the needs of our patients are met." —Elizabeth S. Huebner, MD, “Optimizing Endoscopy Unit Efficiency in the COVID Era,” PG 17
6 // MESSAGE FROM THE PRESIDENT Dr. David Greenwald shares his introductory message on persisting and moving forward
20 BUILDING SUCCESS Guidance on leaving your current practice with grace and success
7 // NOVEL & NOTEWORTHY
23 LAW MIND Advice on building staff and patient trust through compassion and composure
Healio Disruptive Innovators awarded at ACG 2020; 10 years of GIQuIC; working together for diversity in GI; and more
13 // PUBLIC POLICY 13 ACG AND PROJECT N95 HELP ACG MEMBERS GET ACCESS TO PPE The College meets member needs for costeffective PPE by partnering with Project N95
25 // COVER STORY EVOLUTION OF AN IDEA: FROM FGID TO DISORDERS OF GUT-BRAIN INTERACTION Dr. Lawrence Schiller interviews Dr. Douglas Drossman on the evolution of disorders of brain-gut interaction
15 GOVERNOR’S VANTAGE POINT Five questions for new ACG Board of Governors Chair Dr. Patrick Young and ViceChair Dr. Dayna Early
31 // ACG PERSPECTIVES
17 // GETTING IT RIGHT
35 // EDUCATION
17 OPTIMIZING ENDOSCOPY UNIT EFFICIENCY IN THE COVID ERA Tips on improving efficiency in the endoscopy unit during the pandemic
Photo courtesy of Dr. Elizabeth Huebner
CONVERSATIONS WITH WOMEN IN GI Dr. Jill Gaidos with Dr. Colleen Schmitt on navigating leadership roles as a woman in GI
35 PREPARING FOR GI FELLOWSHIP AND FIRST YEAR DURING THE PANDEMIC Advice for new GI fellows facing the challenges of first-year amid the pandemic
39 EDGAR ACHKAR VISITING PROFESSORSHIP EAVP reaches GI training programs by adapting to virtual visiting professorships
41 // INSIDE THE JOURNALS 42 AJG A new ACG Clinical Guideline on the Diagnosis and Management of Achalasia by Vaezi, et al. 43 ACGCRJ Gastric Electrical Stimulators Causing Erosion Through the Colonic Wall & An Odd Place for Acne: Ectopic Esophageal Sebaceous Glands 44 CTG The Gut Microbiome in Patients with Chronic Pancreatitis Is Characterized by Significant Dysbiosis and Overgrowth by Opportunistic Pathogens by Frost, et al.
45 // A LOOK BACK 25+ YEARS AGO IN AJG In a 1991 report in The American Journal of Gastroenterology, Drs. Alemayehu and Järnerot challenge prior orthodoxy that colonoscopy is contraindicated in patients with severe ulcerative colitis.
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BOARD OF TRUSTEES President: David A. Greenwald, MD, FACG President-Elect: Samir A. Shah, MD, FACG Vice President: Daniel J. Pambianco, MD, FACG Secretary: Amy S. Oxentenko, MD, FACG Treasurer: Jonathan A. Leighton, MD, FACG Immediate Past President: Mark B. Pochapin, MD, FACG
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CONTACT ACG American College of Gastroenterology 6400 Goldsboro Rd., Suite 200 Bethesda, MD 20817 (301) 263-9000 | gi.org
Past President: Sunanda V. Kane, MD, MSPH, FACG Director, ACG Institute: Neena S. Abraham, MD, MSc, FACG Co-Editors, The American Journal of Gastroenterology: Brian E. Lacy, MD, PhD, FACG
DIGITAL EDITIONS
GI.ORG/ACGMAGAZINE
Brennan M. R. Spiegel, MD, MSHS, FACG Chair, Board of Governors: Patrick E. Young, MD, FACG
ACG MAGAZINE Summer 2020
MEMBERS. MEDICINE. MEANING.
Vice Chair, Board of Governors: Dayna S. Early, MD, FACG Trustee for Administrative Affairs: Irving M. Pike, MD, FACG ACG MAGAZINE Summer 2020
MEMBERS. MEDICINE. MEANING.
TRUSTEES
Feeling fine with fear:
Mastering Risk Perception and Decision Making in Medical Practice
Feeling fine with fear:
Mastering Risk Perception and Decision Making in Medical Practice
Jean-Paul Achkar, MD, FACG William D. Chey, MD, FACG Immanuel K. H. Ho, MD, FACG Costas H. Kefalas, MD, MMM, FACG Caroll D. Koscheski, MD, 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
Mohammad Bilal, MD Dr. Bilal is an advanced endoscopist and gastroenterologist at the University of Minnesota and the Minneapolis VA Health Care System and is a member of ACG’s Professionalism and Training Committees.
Dave Limauro, MD, FACG Dr. Limauro is a gastroenterologist at Pittsburgh Gastroenterology Associates and is a member of ACG's Practice Management Committee.
Ann M. Bittinger, Esq. Ms. Bittinger is a health law expert at Bittinger Law Firm in Jacksonville, FL. She regularly contributes to ACG's publications on her areas of expertise, including legal relationships between hospital systems and physicians or physician groups. (bittingerlaw.com)
Lawrence R. Schiller, MD, MACG ACG Past President Dr. Schiller is the Program Director of the Gastroenterology Fellowship at Baylor University Medical Center and chairs ACG’s Archives Committee.
Douglas A. Drossman, MD, MACG Dr. Drossman is Professor Emeritus of Medicine and Psychiatry at UNC School of Medicine at Chapel Hill.
Dayna S. Early, MD, FACG Dr. Early is vice chair of ACG's Board of Governors and is also Professor of Medicine and Director of Endoscopy at Washington University School of Medicine in St. Louis.
Samer S. El-Dika, MD Dr. El-Dika is clinical associate professor at Stanford University School of Medicine and served on ACG's Practice Management Committee.
Jill K. J. Gaidos, MD, FACG Dr. Gaidos is associate professor at Yale School of Medicine Section of Digestive Diseases and Director of Clinical Research for the Yale IBD Program.
David A. Greenwald, MD, FACG Dr. Greenwald is the 2020-2021 ACG President and is Director of Clinical Gastroenterology and Endoscopy at Mount Sinai Hospital and Professor of Medicine at Icahn School of Medicine at Mount Sinai in New York City.
Colleen M. Schmitt, MD, MHS, FACG Dr. Schmitt is President of the Galen Medical Group, a multispecialty private practice group in Chattanooga, TN, and is a Past President of the American Society for Gastrointestinal Endoscopy.
Eric D. Shah, MD, FACG Dr. Shah is assistant professor of medicine at Dartmouth-Hitchcock Medical Center and director of the Center for Gastrointestinal Motility. He serves on ACG’s FDA-Related Matters and Practice Management Committees.
Ruchit N. Shah, DO Dr. Shah is a is a first year GI fellow in training at Geisinger Medical Center in Danville, PA.
Louis J. Wilson, MD, FACG Dr. Wilson chairs the ACG Practice Management Committee and is a gastroenterologist at Wichita Falls Gastroenterology Associates in Texas.
Patrick E. Young, MD, FACG Chair of ACG's Board of Governors, Dr. Young is the Director of the Division of Digestive Diseases at the Uniformed Services University of Health Sciences in Bethesda, MD.
Elizabeth S. Huebner, MD Dr. Huebner is clinical associate professor of medicine at Washington University School of Medicine in St. Louis and is a member of ACG's Women in GI Committee.
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MESSAGE FROM THE PRESIDEN
MOVING FORWARD FROM COVID-19 WITH HOPE FOR A BETTER YEAR AHEAD WELL, WHAT A YEAR 2020 HAS BEEN. As the calendar winds down, the COVID-19 pandemic unfortunately continues to rage, bringing horror and fear along with it, and substantial disruption to our “normal lives.” What are some of the lessons we have learned, and how will we move forward? One thing is for sure: We have learned about the power of science. Think of how little we collectively knew in early 2020, as a “novel coronavirus” made its way around the globe, to where we are now, with a substantially better understanding of how this virus is transmitted and how it causes harm. Indeed, in less than a year, through the unprecedented work and groundbreaking research of scientists and so many others worldwide, we have discovered options for therapy, and seem poised to have multiple vaccines that may limit and then eradicate the spread of SARS-CoV-2. The work of the medical community here must not be understated—a truly extraordinary effort has led to remarkable progress in a very short time. That said, we must remember those who have fallen ill and those who have died; tragically, this may include family, colleagues, friends, co-workers and patients. The suffering and grief we in the medical community have seen this past year is unparalleled and has affected us all. Isolation from each other and from the world we previously knew only amplified the tragedy that has unfolded. We watched patients gasping for their next breath and longing for support from their loved ones, and yet those most desperately ill patients often could not have their family members by their side. Masks, gowns, gloves, booties, and googles separated us, their physicians, from them—all at a time when direct personal contact would have had so much value. Yet, despite the enormous professional and economic difficulties brought on by COVID-19. I have been struck over these horrendous months by the resilience that has been so evident in the medical profession as a whole, and in the GI community in particular. Many of us were called on or volunteered to be “frontline providers,” transforming from gastroenterologists to become
6 | GI.ORG/ACGMAGAZINE
“I am confident the resiliency that has been so evident over the past year will continue, and we will find new and creative ways to solve the problems that will face our patients, our colleagues, and our profession.”
hospitalists, intensivists, or whatever was needed, to help. In many situations, it required learning a new skill set, or reactivating parts of prior training, and yes, it meant possibly putting ourselves in harm’s way. Others helped in so many different ways that it is impossible to catalog, but collectively we rose and met the challenge that presented itself and I am certain we will continue to do that as long as is needed. I am proud to say that ACG has provided support, guidance and strong leadership all the way, immediately stepping up to guide its members and the larger GI community. ACG developed webinars and printed material to help all of us understand the pandemic and how to best care for our patients and our colleagues, published a roadmap to reopen and restart our practices under the most difficult of circumstances, and provided unprecedented educational platforms to allow GI education to continue unabated during challenging times. Which brings me to you, my colleagues in gastroenterology. It is a true honor and privilege to work with such talented, resourceful and skilled individuals each day. We are healers, teachers, innovators, and all the while with a kind spirit and the greatest of compassion. Lean on each other and support each other! We should never forget the impact we can have on our patients, and especially at times when they are at their most vulnerable—a kind word, a well-timed compliment, a soothing explanation, just being a good listener can have the most profound effect on those who seek out our care. How we will move forward into 2021 is less certain, and no doubt, there remain many challenges ahead, including ones we cannot anticipate. I am confident the resiliency that has been so evident over the past year will continue, and we will find new and creative ways to solve the problems that will face our patients, our colleagues, and our profession. My simple hope as we enter 2021 is that it will be a “better year.” Yet, we can take much wisdom from 2020; the lessons have been profound and will reverberate in our GI community for many years to come.
—David A. Greenwald, MD, FACG
Note hy wor t PROFESSIONAL AWARDS AND ACCOLADES HEADLINE NOVEL & NOTEWORTHY in this issue of ACG MAGAZINE with the ACG Board of Governors awardees, winners of the Sherman Prize, and recognition for this year’s Healio “Disruptive Innovators.” Celebrating and enhancing diversity in GI and medicine has been a priority of ACG and this saw the successful launch of a new virtual 5K race as part of the College’s #DiversityinGI campaign. The 5K benefits the ACG Summer Scholars program of the Diversity, Equity & Inclusion Committee thanks to sponsors Ironwood and Sebela/Braintree. Among our noteworthy milestones, the GIQuIC endoscopic quality registry celebrated its tenth anniversary this year. This joint initiative of ACG and ASGE has seen an exponential growth in data submitted on colonoscopy and EGD, and its research dataset has powered analyses resulting in numerous abstracts and published manuscripts on endoscopic quality. Brennan M. R. Spiegel, MD, MSHS, FACG recently published an important new book, VRx: How Virtual Therapeutics Will Revolutionize Medicine.
Novel & Noteworthy | 7
// N&N [AWARDEES]
HEALIO DISRUPTIVE INNOVATOR AWARDS Clinical Innovation Award, Presented by Healio and ACG This award goes to a physician or institution that changed the face of the gastroenterology practice. The awardee is seen as an example of how patient care can be bettered through changes in administration, technique or the delivery of value-based care. Jessica R. Allegretti, MD, MPH Microbiome, of course, has been nothing short of a buzzword for years now, but few physicians have put forth the time and energy to become experts in the implementation of microbiome-based treatment. Dr. Jessica Allegretti has become a staple speaker at academic conferences when it comes to the microbiome and fecal microbiota transplantation, and Her research leads the way for treating various GI disorders with fecal microbial transplantation. Social Media Influencer Award Anita Afzali, MD, MPH, FACG Dr. Anita Afzali proves that honest engagement on tough topics has an impact on the gastroenterology community and social media. She contributes to the ongoing conversations of diversity by sharing her experiences as a woman of color in the medical community, while maintaining her status as an expert in treating women with IBD and utilizing social media to continue collaborating with experts in other specialties for better care across the board. Lifetime Disruptor Award Maria T. Abreu, MD Dr. Abreu leads the Crohn’s and colitis fields in her translational research aimed at finding a cure for these inflammatory bowel conditions. Specifically, she is bringing the genetic and environmental factors of IBD development in the Hispanic population into the mainstream conversation. 2019 brought her a Sherman Prize and 2020 started with her directing another successful Crohn’s and Colitis Congress. Rising Disruptive Innovator Elliot B. Tapper, MD Though hepatology is a seemingly smaller portion of what we discuss in GI, Dr. Elliot Tapper’s voice is heard loudly throughout. His focus on cirrhosis and hepatic
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[MILESTONE]
encephalopathy draw attention to the unmet needs for patients suffering from advanced liver disease, while his research on quality improvement decision-making and cost efficacy helps medical practitioners across specialties. We anticipate even more from Dr. Tapper in the coming years. Health Equity Award Darrell M. Gray II, MD, MPH, FACG As a champion of Black men in medicine, Dr. Darrell Gray leads by example. He uses his expertise in colorectal cancer to examine how racial and societal disparity affects people in their diagnosis and treatment. He has lifted his voice to teach others how to provide culturally competent care in our specialty. Dr. Gray pushes other physicians of color into the spotlight to present and lift them up and lift their research into discrimination and obstacles facing equity in the ivory tower of academia and medicine. Woman Disruptor of the Year Award Amy S. Oxentenko, MD, FACG Dr. Amy Oxentenko moved into multiple leadership roles in the past year, most notably taking her seat at the head of the table as Chair of Medicine for Mayo Clinic, Arizona. She previously mentored the next generation of women at Mayo through her role as Medicine Residency Director in Rochester. She has led the ACG Women in GI Committee and positively supports her colleagues across medicine. She serves on guideline committees, conducts groundbreaking research, and sets an example for how women in leadership roles can encourage one another. The Patient Voice Award Brooke Abbott Brooke Abbott is a single mom living with IBD and without her colon. In her own words, armed with a mommy bag and a new lease on life, she shares her stories, tears, triumphs, and quick tips with other mommies with autoimmune diseases via her blog “The Crazy Creole Mommy Chronicles.” Her experiences with IBD and arthritis led her to join with her friend, Amber Tresca, to create IBDMoms, a community born out of a hashtag and a bond over mothering with the chronic condition. IBDMoms hosts Twitter chats and advocates for its community on Capitol Hill.
A DECADE OF GIQUIC REGISTRY The GI Quality Improvement Consortium (GIQuIC) has been making an impact on endoscopic quality for 10 years. This milestone finds the registry with more than 4,500 participants and with data on 11.8 million colonoscopies and 2.2 million EGDs. Publications based on analyses of the GIQuIC dataset have added to the literature on endoscopic quality. Learn more about how GIQuIC can help your practice improve performance to enhance patient care at giquic.org. Watch: Presentation at ACG 2020, “GIQuIC – Measuring and Improving Quality in Clinical Practice bit.ly/GIQuICExperience-2020
[AWARDEES]
ACG GOVERNOR’S AWARDS Junior Governor’s Award Anne Tuskey, MD, FACG (Virginia) Dr. Tuskey is a highly respected clinician, educator, and IBDfocused researcher at the University of Virginia. As a first term Governor, she went well above and beyond expectations, and having just been deservedly re-elected for another three-year term, the Governors are looking forward to further exceptional efforts on behalf of the College and her constituents in Virginia. Senior Governor’s Award Wilmer Rodriguez, MD, FACG (Puerto Rico) Dr. Rodriguez faithfully and ably served the gastroenterologists of Puerto Rico for six years as their governor, including during the devastation of Hurricane Maria. His steadfast, humble leadership set him apart and he will be missed. William D. Carey Award Whitfield Knapple, MD, FACG (Arkansas) Dr. Knapple tirelessly served GI patients and providers for six years as the governor for Arkansas and, more recently, as the Chair of the Legislative and Public Policy Council. His skillful diplomacy and keen insights greatly enhanced the efficacy of the Board of Governors’ advocacy efforts.
[COLLABORATION]
INTERSOCIETY GROUP ON DIVERSITY
[VIRTUAL 5K]
OVER 500 PARTICIPANTS CELEBRATE DIVERSITY IN GI IN VIRTUAL 5K RUN/WALK ACG members embraced a virtual race and over 500 participated in a 5K run/ walk celebrating the diversity of the GI profession in the weeks surrounding ACG 2020. Highlights included a barrage of inspiring social media posts, special runs organized by some of the GI training
programs, and a tremendous sense of commitment to diversity and camaraderie. CoChairs of the event, Dr. Sophie Balzora and Dr. Darrell Gray, were supported by champions from the 5K Race committee. The event raised over $30,000 thanks to generous sponsorships from Ironwood
and Braintree/Sebela and race registrations. All proceeds will benefit the ACG Summer Scholars mentorship program for medical students and residents from groups underrepresented in medicine. Learn more: bit.ly/5KACGDiversityinGI
[AWARDEES]
[VIRTUAL REALITY]
SHERMAN PRIZE AWARDS
DR. BRENNAN SPIEGEL PUBLISHES NEW BOOK ON VIRTUAL REALITY IN MEDICINE
The Bruce and Cynthia Sherman Charitable Foundation announced the 2020 Sherman Prizes for outstanding achievements in the fight to overcome Crohn’s disease and ulcerative colitis. The three recipients are: David T. Rubin, MD, FACG, is the Joseph B. Kirsner Professor of Medicine and Section Chief of Gastroenterology, Hepatology, and Nutrition at University of Chicago Medicine, where he is also Co-Director of the Digestive Diseases Center. Gary D. Wu, MD, is the Ferdinand G. Weisbrod Professor in Gastroenterology in the Perelman School of Medicine at the University of Pennsylvania. He is also Director of the Penn Center for Nutritional Science and Medicine. Jessica R. Allegretti, MD, MPH, is Associate Director of the Crohn’s and Colitis Center and Director of the Fecal Microbiota Transplant Program at Brigham and Women’s Hospital. She is also Assistant Professor of Medicine at Harvard Medical School. Dr. Allegretti received the Sherman Emerging Leader Prize.
Brennan Spiegel, MD, MSHS, FACG, Co-Editor-in-Chief of The American Journal of Gastroenterology and Professor of Medicine and Public Health at Cedars-Sinai, recently published his book VRx: How Virtual Therapeutics Will Transform Medicine. In the book, Dr. Spiegel describes how virtual reality (VR) is now being used to manage pain, improve mental health, address obesity, and enable doctors to engage more meaningfully with their patients. After years of studying the medical power of the mind, Dr. Spiegel aims to show that VR is not just for video gamers anymore; it is a new type of treatment that gastroenterologists may find useful in their clinical practice to improve patient satisfaction and clinical outcomes.
The College is honored to collaborate on the Intersociety Group on Diversity (IGD), a coalition established by AASLD, ACG, AGA, ASGE and NASPGHAN. The IGD aims to address breaking issues related to diversity, equity and inclusion collaboratively, increase diversity in gastroenterology among our societies’ members and leadership, and eradicate health disparities in the patients our members serve. One of the first joint efforts will be survey research to collect data on racial, ethnic, and gender representation in the fields of GI and hepatology in the United States. The research aims to both evaluate current perspectives, attitudes, and beliefs of GI and hepatology professionals regarding racial, ethnic, and gender diversity and to understand their perspectives regarding potential interventions to address health care inequities and workforce diversity in GI. Members of the IGD Darrell M. Gray, II, MD, MPH, FACG Co-Chair, Intersociety Group on Diversity Chair, Diversity, Equity and Inclusion Committee, ACG Rachel Issaka, MD, MAS Co-Chair, Intersociety Group on Diversity Member, Diversity Committee, AGSE Sophie M. Balzora, MD, FACG Vice Chair, Diversity, Equity and Inclusion Committee, ACG Carla W. Brady, MD, MHS, FAASLD Chair, Inclusion and Diversity Committee, AASLD Jennifer Christie, MD, AGAF, FASGE Chair, Diversity Committee, ASGE Governing Board Councilor, ASGE Byron Cryer, MD Co-Chair, Equity Project Advisory Board, AGA Lauren D. Nephew, MD, MA, MSCE Inclusion and Diversity Committee, AASLD Sandra M. Quezada, MD, MS Chair, Diversity Committee, AGA Valeria C. Cohran, MD, FAAP Co-Chair, Diversity Special Interest Group, NASPGHAN Conrad R. Cole, MD, FAAP MPH, MSc Co-Chair, Diversity Special Interest Group, NASPGHAN
Novel & Noteworthy | 9
JANUARY
30
2021 IBD SCHOOL Register: meetings.gi.org
MARCH 2021 COLORECTAL CANCER AWARENESS MONTH
FEBRUARY
26–28
MARCH 2021
2021 ACG/FGS ANNUAL SPRING SYMPOSIUM
NORTH AMERICAN INTERNATIONAL GI TRAINING GRANTS
Naples, FL
More Info: gi.org/gi-training-grants
Register: meetings.gi.org
MARCH
5–7
APRIL 2021 ACG AWARD NOMINATIONS Nominate Your Colleague Learn More: gi.org/award-nominations
2021 ACG/LGS REGIONAL POSTGRADUATE COURSE VIRTUAL Register: meetings.gi.org
APRIL
9–11 FUNCTIONAL GI DISORDERS SCHOOL & EASTERN REGIONAL
The rich array of educational content for Virtual ACG 2020 will be available on-demand through Jan 31, 2021. Register now, and get access to all of the content and earn CME and MOC.
VIRTUAL Register: meetings.gi.org
10 | GI.ORG/ACGMAGAZINE
SAVE THE DATE FOR ACG 2021
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
PUBLIC POLICY
B:11.25"B:11.25"
S:9.75" S:9.75"
T:10.75"T:10.75"
ACG and Project N95 Help ACG Members Get Access to PPE
Author: Brad Conway, Esq., Vice President, Public Policy, Coverage & Reimbursement
IN AUGUST, THE COLLEGE ANNOUNCED A COLLABORATION with Project N95 (www.projectn95. org), a nonprofit organization that helps to secure critical personal protective equipment (PPE) to frontline health care workers. Through this collaboration, ACG members had the special opportunity to purchase the following PPE at bulk pricing and in small quantities. ACG members were afforded special pricing discounts and access to N95 respirators (even in hard to find size “small”), isolation gowns, and disposable face shields.
Public Policy | 13
// PUBLIC POLICY
ACG Listening to Membership Needs In April and June 2020, Dr. Louis Wilson and the ACG Practice Management Committee surveyed ACG to assess the impact COVID-19 had on GI practices. These survey findings were presented to ACG members as part of the series of webinars and guidance from the ACG Endoscopy Resumption Task Force this spring and summer. The results showed that 25% of ACG members still had difficulty accessing PPE, even in June when access to PPE was considered more widely available in the United States. ACG’s survey results were consistent with a larger survey of health care workers concluding that there was a significant disparity in accessing PPE at the time, especially among smaller practices. In response, ACG sought opportunities to help GI practices and members across the country. The collaboration was led by the American College of Physicians, with 15 other medical specialty societies joining ACG to secure bulk volume discounts for PPE. Project N95 then worked with suppliers in getting PPE to each individual or practice. Hundreds of ACG Individual Members Buy Thousands of N95s and PPE Nearly 425 individual ACG members registered to participate in this opportunity during ACG’s “ordering window” of just 1 week. Within this week, there were 575 separate orders, or 4,600 boxes and roughly 75,000 units of PPE that were ultimately purchased and shipped to ACG members in September/ October 2020. Each morning during ACG’s window, ACG members received a “countdown” email reminding them of this opportunity, emphasizing the importance of the opportunity and ACG’s efforts to help individual GI practices. ACG will continue to strive to quickly meet membership needs.
14 | GI.ORG/ACGMAGAZINE
“According to a recent ACG survey, having an adequate supply of N95 masks remains a significant barrier to ramping up office practices and procedures. The ACG is pleased to have partnered with project N95 so that our members can now easily obtain vetted N95 masks and other PPE to ensure the safety of both our health care professionals and our patients.” —Mark B. Pochapin, MD, FACG
“ACG members repeatedly stress that having adequate PPE is critical to remaining safe while seeing patients and performing procedures. ACG is committed through participation in Project N95 to making sure that members have easy and ready access to the PPE they need.” —David A. Greenwald, MD, FACG
5
Questions
for Patrick E. Young, MD, FACG, Chair, Board of Governors & Dayna S. Early, MD, FACG, Vice Chair, Board of Governors
NEW LEADERSHIP FOR ACG’S BOARD OF GOVERNORS ACG’s Board of Governors elected Patrick E. Young, MD, FACG and Dayna S. Early, MD, FACG as Chair and as Vice Chair. The pair took the reins as Neil H. Stollman, MD, FACG stepped down. Dr. Stollman assumes a role as one of the College’s Trustees. As the state and regional elected representatives, the ACG Governors offer a a grassroots connection for ACG members to share their needs and insights for clinical matters and other issues affecting the practice of medicine. ACG MAGAZINE invited Dr. Young and Dr. Early to introduce themselves and to share their vision for the work of the Governors going forward.
// PUBLIC POLICY: GOVERNORS' VANTAGE POIJNT
Patrick E. Young, MD, FACG 1. Tell us about your practice and clinical interests and briefly about how you became involved in ACG. I am an interventional endoscopist in full time academic practice at Walter Reed National Military Medical Center and Uniformed Services University. My clinical interests include pancreaticobiliary disease, Barrett’s esophagus management, colorectal cancer prevention, and helping other endoscopists use ergonomics to prevent endoscopy related musculoskeletal injuries. 2. What’s your perspective on the role the Governors play in the life of the College? Why are the Governors relevant right now during turbulent times? The Governors serve a number of vital roles within the College. First and foremost, they are a two-way conduit between our members across the country—and in fact around the world—and the ACG leadership. Our members are the College’s raison d’etre, and understanding their challenges helps us to better care for them and helps them better care for our patients. The Governors also serve as an incredibly rich repository of insight and experience; providing a valuable resource to the College and its members on a variety of topics. To the second question: while good leadership is always important, it is particularly vital during challenging times. Imagine you are on a flight (remember those...). When all is well, you likely do not concern yourself with the pilot’s qualifications. Should an errant flock of birds suddenly take out a few engines, now you are hoping you have a “Sully”
Sullenberger at the helm! It is has never been more vital that the Governors listen well, think deeply, and act effectively. Fortunately, we have a (virtual) room full of “Sullys." 3. What is your vision for the year ahead for the Governors and some of the key priorities? While the environment may have changed, the core mission of the Governors has not. We must still advocate strongly and effectively to ensure that members are fairly reimbursed for procedures and telehealth visits, that patients can get timely access to necessary medications, and are not financially devastated by “surprise” bills. We must continue to provide timely and relevant information to our members regarding upcoming policy changes such as the 21st Century Cures Act which will give patients significantly more access to their medical information. So, the “what” has not changed, but the “how” will likely have to. The Governors, along with amazing ACG staff and the Legislative and Public Policy Council will need to be creative and flexible, but I have no doubt we can be successful and remain a beacon of best practices in this arena. 4. The Governors Washington DC Legislative Fly-In happened virtually this year. What was that like and how can the Governors and ACG members stay involved in legislative and regulatory challenges this year? Truthfully, somewhat surreal. After years of meeting with colleagues and members of Congress for a fast-paced, action-packed day of advocacy on the Hill, this year’s was much more sedate. The pandemic was in its early stages, and both the members of Congress and their staffs were chest-deep in a flood of changing information and priorities. It was difficult to be heard clearly in that environment. While much is still
Public Policy | 15
// PUBLIC POLICY: GOVERNORS' VANTAGE POIJNT
unknown, I am hopefully that we are in more stable times. As always, the ACG remains plugged into legislative affairs both locally and nationally, and regularly sends updates to our members. Moreover, I encourage each ACG members to get involved with your state GI and/or medical society and to advocate locally as well. 5. You have participated in webinars on resilience and leadership on behalf of the College during the COVID-19 pandemic. What insights and advice do you have for the Governors as they face the future, that also might benefit the College’s membership? These are tough times, without a doubt. But tough times are often when we grow the most. While I would encourage folks to view the resiliency webinar on the ACG Universe, here are a few quick tips to get you started. The good news up front—even if you do not think you are a resilient person now, you CAN become more so. First, cultivate an attitude of gratitude. Even in the most challenging times, there are things for which we can be thankful. I challenge folks to list—in writing—three specific and unique things they are thankful for each day for the next two weeks. It is transformational. Next, learn to have what psychologists call a “gain frame.” This means that you focus on what you have rather than what you don’t have — your assets rather than liabilities. Moreover, focus on what you can control, rather than what you cannot, especially your thoughts. William James wisely said, “The greatest weapon against stress is our ability to choose one thought over another.” Finally, if you need help, please get it. We will all get farther if we walk this road together.
2. How did you get involved in ACG? I attended ACG meetings early in my career and always enjoyed the focus on clinical practice and patient care. I was nominated for the Missouri Governor role in 2015, and have been active in that role as well as committee roles since then.
“The Governors also serve as an incredibly rich repository of insight and experience; providing a valuable resource to the College and its members on a variety of topics.” —Dr. Young
Dayna S. Early, MD, FACG 1. Tell us about your practice and clinical interests: I am an academic gastroenterologist at Washington University in St. Louis, where I have been on faculty since 2001. My clinical interests are endoscopic ultrasound, endoscopic eradication therapy for Barrett’s esophagus, and early stage esophageal cancer, training in EUS, endoscopic therapy of obesity, and colorectal cancer screening access and quality.
16 | GI.ORG/ACGMAGAZINE
3. You have served as Governor for Missouri. What are some of your most significant experiences and how do they shape your perspective as you assume the role of Vice Chair? One of the most impactful experiences for me have been the Washington, DC, Fly-In advocacy days with the other ACG Governors. It’s a great feeling to be in the U.S. Capitol along with other GI colleagues, taking time to communicate about the issues that affect our practices and our patients. There is always a lot of positive energy at these events, along with a sense of camaraderie and accomplishment. I also enjoy the two-way communication that being an ACG Governor allows between Missouri GI providers and the ACG Board. 4. As a clinician during the COVID-19 pandemic. What are some of the insights and challenges that will be important at the state and national level for the ACG Board of Governors? COVID has changed the way we practice gastroenterology and likely will continue to do so for the foreseeable future. The ACG responded to the pandemic with amazing support including webinars, documents, and other resources to help all of us obtain the information we needed to adapt to the “new normal.” We need to continue to be vigilant about providing timely and high quality care while maintaining a safe environment for ourselves, our staff, and our patients. 5. How can ACG members get involved in supporting the College’s public policy priorities and the work of the Board of Governors? One of the best ways for members to be involved is to partner with their Governor on local issues when they arise, and to join advocacy efforts at both the state and federal levels. The ACG has tools available to assist with these efforts. Becoming involved in committee work is another great way to support the College and its work.
GETTING IT
GETTING it Right
Optimizing
Endoscopy Unit Efficiency in the COVID Era
By Elizabeth S. Huebner, MD, ACG Women in GI Committee
GASTROENTEROLOGY AS A SPECIALTY WAS HIT HARD BY THE COVID-19 PANDEMIC. The cancellation of elective procedures and the reluctance of many patients to seek medical care had a significant negative financial impact on practices across the country. The resulting delay in care led to a backlog of patients waiting for appointments. Even after reopening endoscopy units, implementing telemedicine, and/ or resuming in-person office visits, practices continue to feel the effects of the pandemic. Improving the efficiency of our endoscopy units is one way we can attempt to recover from the events of the past year and ensure that the needs of our patients are met. From the time the patient arrives until their departure, many individuals and multiple steps are involved, each of which can potentially affect operational flow. Given this, it can difficult to know where to focus our efforts when the process does not seem as efficient as it could be. Unfortunately, the literature on this topic is limited, with few evidence based studies available to provide guidance. Though efforts have been made to better identify quality indicators for endoscopy units,1 which metrics to monitor in terms of unit efficiency remain unclear, and needs likely vary from center to center. Given this, how do we best evaluate our units to make sure we are making the most of our work day? ď„
Getting it Right | 17
// GETTING IT RIGHT
ASSESSING EFFICIENCY Ideally, this process would start with an assessment of the current state of patient flow through your unit. “Time and motion” studies have been performed doing just that – tracking the patient from the moment they arrive until the moment they depart the unit, in hopes of identifying bottleneck areas that can serve as opportunities for improvement.2-6 Delays in patient flow processes have been shown to be a major source of endoscopy unit inefficiency.5 Doing so requires data collection. While this process can be a bit cumbersome, the electronic health record can help facilitate data collection. Flow sheets can also be used to track the patient’s progress through the unit. Start by looking at pre-procedure variables: • What time does the patient arrive in registration?
Are your patients spending longer than expected in the pre-op area?
• When are they brought back to the pre-op area, and how long does the nursing assessment take? • When is the IV placed, and what time are they evaluated by the anesthesiologist? • When is informed consent obtained, and what time do they enter the procedure room? Once in the procedure room: • What time is sedation started? • What are the “scope in” and “scope out” times, and when does the patient exit the procedure room? Following the procedure: • When has the patient recovered and met criteria for discharge? • What time does the physician meet with the patient to discuss the procedure findings and recommendations, and when does the patient actually leave the unit? After reviewing this data, it will likely become apparent which step is the most time consuming, and you can then focus your efforts on that area.
BRAINSTORMING SOLUTIONS
Do your patients tend to arrive late? If so, does your pre-procedure packet provide clear instructions for where to go, where to park and where to check in? Performing advance phone calls to patients to review driving directions and prep instructions can help reduce patient related delays, as well as cancellations, no-shows and poor preps. Prescreening patients by telephone prior to the procedure day can help identify patients that might need to be rescheduled due to COVID exposures or symptoms. COVID related protocols can be reviewed at that time, and reminders given to arrive with sufficient time to complete additional screening questions and temperature checks.
18 | GI.ORG/ACGMAGAZINE
“How do we best evaluate our units to make sure we are making the most of our work day?”
Consider staggering start times among physicians, or moving patients to the procedure room to complete pre-procedure steps. One group found that by bypassing the pre-op area for the first case of the day and by afterwards transferring patients to the procedure room to complete the check-in process as soon as it was vacated, they were able to alleviate their bottleneck in pre-op.3 Additional benefits in this study included decreased patient wait times, increased on-time starts, reduced procedure completion times and reduced operating expenses. This approach can also help facilitate social distancing in the waiting area. Patient complexity can factor into procedure preparation time as well. Having higher risk patients evaluated by anesthesiology prior to the procedure day can help eliminate surprises, avoid last minute cancellations and ensure that the procedure is performed as safely as possible.
Do procedures consistently take longer than the allotted time? Look at each physician’s average procedure times and adjust the schedule accordingly. It is important to be realistic when scheduling. While we all want to avoid unnecessary downtime, putting a physician in a position where he or she constantly feels behind can be stressful and potentially compromise quality. Patient satisfaction also often suffers as a result. Perhaps extra time can be scheduled for patients who are known to have a difficult polyp or who have had prior failed colonoscopies. Inserting breaks into the schedule can also help.
Is room turnover a problem? Several steps are involved in room turnover. While the endoscopist completes the procedure report and reviews findings with the patient, staff members have to finish any specimen handling, transfer the patient to recovery for handoff, clean the room and
Do you have ideas for how to improve your endoscopy unit, but want some idea of predicted efficacy before implementing them?
switch out the scopes, and then transfer the next patient into the procedure room. Turnover time has been shown to inversely impact productivity, with shorter turnover times predicting higher procedure volumes.7 Clear communication and role definition of team members is essential for the process to go smoothly. One group in the UK found that using a dedicated turnover nurse between cases decreased turnover time by two minutes per case, potentially leading to a 20 minute reduction in turnover time over the course of the day.8 Another group found that efficiency was improved by having dedicated personnel to obtain prior intravenous access and consent.6 Use of a two-rooms-per-endoscopist model has previously been show to improve efficiency6 and physician productivity.7 However another study found that the overall performance of the endoscopy lab was reduced with this arrangement, resulting in a prolonged patient length of stay, decreased utilization of nonphysician staff, and an increase in total facility time.9 Physician unavailability can also contribute to delays in endoscopic procedures.10 While we often find ourselves multitasking between cases, it is important to remain focused on the current patient in order to stay on schedule.
Are patients spending too much time in recovery? Patient recovery times have decreased with the use of propofol. Nonetheless, backlogs can still form in the recovery area. If staffing is the issue, consider shifting staff members between pre-op and recovery throughout the day based on demand. Cross-training staff so that they understand the entire process can also help. Using the same space for pre- and post-procedure care can reduce the need for cleaning between patients and can save time. In addition, physicians must remember to stop in the recovery between cases to discharge patients so as not to contribute to this problem.
“Improving the efficiency of our endoscopy units is one way we can attempt to recover from the events of the past year and ensure that the needs of our patients are met.”
Discrete simulation modeling can be helpful in this situation. Using software such as Microsoft Visio (Microsoft, Redmond, WA) and MedModel (ProModel Corp.), a simulation can be created to model potential solutions. For example, this process has been used to determine the ideal number of prep and recovery rooms (3.4 per procedure room for a five-procedure room unit in one study).11 It can also be used to study the effects of proposed changes in scheduling and patient arrival times prior to implementing them.
BENEFITS OF AN EFFICIENT UNIT The benefits of improved efficiency are numerous. Patient wait times can be reduced, improving patient satisfaction and potentially improving perceived quality of care. Physician productivity can be enhanced, preventing lost revenue, allowing patients to be scheduled more quickly and allowing physicians to better meet the demand for endoscopic procedures. Nursing overtime can also be reduced, minimizing overhead and potentially improving staff morale.
CONCLUSION Each endoscopy unit’s needs are unique. Patient populations differ from center to center, and despite our best efforts there will always be some level of unpredictability involved in patient care. Nonetheless by carefully evaluating throughput in your endoscopy unit, you may identify opportunities for improvement so that available resources are optimized.
REFERENCES
1. ASGE Endoscopy Unit Quality Indicator Taskforce. Quality indicators for gastrointestinal endoscopy units. VideoGIE 2017;2(6):119-140. 2. Day LW, Belson D, Dessouky M et al. Optimizing efficiency and operations at a California safety-net endoscopy center: a modeling and simulation approach. Gastrointest Endosc 2014;80(5):762-73. 3. Kaushal NK, Chang K, Lee JF et al. Using efficiency analysis and targeted intervention to improve operational performance and achieve cost savings in the endoscopy center. Gastrointest Endosc 2014;79:637-45. 4. Almeida R, Paterson WG, Craig N et al. A patient flow analysis: identification of process inefficiencies and workflow metrics at an ambulatory endoscopy unit. Can J Gastroenterol Hepatol 2016;2016:2574076. 5. Yang D, Summerlee R, Suarez AL, et al. Evaluation of interventional endoscopy unit efficiency metrics at a tertiary academic medical center. Endosc Int Open 2016;4(2):E143-8. 6. Harewood GC, Chrysostomou K, Himy N et al. A “time-and-motion” study of endoscopic practice: strategies to enhance efficiency. Gastrointest Endosc 2008;68(6):1043-50. 7. Zamir R, Rex DK. An initial investigation of efficiency in endoscopy delivery. Am J Gastroenterol 2002;97(8):1968-72. 8. Bryce K, Fearn R, Murray S. Improving endoscopy efficiency by reducing turnaround time between cases. Future Healthc J 2019;6(Suppl 1):34. 9. Rex DK, Lahue BJ, Dronzek RW et al. Impact of two procedure rooms per physician on productivity: Computer simulation examines the impact of process change in the hospital gastroenterology department [abstract. ] Gastrointest Endosc 2005;61:AB154. 10. Yong E, Zenkova O, Saibil F et al. Efficiency of an endoscopy suite in a teaching hospital: delays, prolonged procedures, and hospital waiting times. Gastrointest Endosc 2006;64(5):760-4. 11. Sauer BG, Singh KP, Wagner BL et al. Efficiency of endoscopy units can be improved with use of discrete event simulation modeling. Endosc Int Open 2016;4(11):E1140-E1145.
Elizabeth S. Huebner, MD ACG Women in GI Committee; Associate Professor, Washington University School of Medicine, GI Medical Director, Barnes-Jewish West County Hospital
Getting it Right | 19
// GETTING IT RIGHT: BUILDING SUCCESS
The Graceful Exit The Graceful Exit Building Success
By Samer El-Dika, MD, Dave Limauro, MD, FACG, Eric Shah, MD, FACG, Louis J Wilson, MD, FACG
Building Success
By Samer El-Dika, MD, Dave Limauro, MD, FACG, Eric Shah, MD, FACG, Louis J. Wilson, MD, FACG
THE CHALLENGE OF CHANGE Few things require more long-term commitment than working in a medical practice. Moving from one practice setting to another, or retirement from practice can be a daunting task. Nevertheless, such moves are a frequent occurrence. As many as 40% of newly practicing physicians choose to leave their initial practice within two years of joining. (1) Even if the move is for an exciting new opportunity or a much-needed change, leaving a medical practice is both complex and stressful. Physicians who have been colleagues and partners may find themselves forced to sit on opposite ends of a negotiating table to define exit strategy and financial terms. Achieving a “graceful exit” requires careful preparations. In this article, we will highlight important items that gastroenterologists need to consider before making a move towards retirement or practice change.
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STEP 1: PRE-ANNOUNCEMENT CONTRACTUAL REVIEWS Before announcing your intention to leave a practice, it is critical that you to review all relevant contractual arrangements. These include: your employment contract, managed care contracts, partnership agreements, operating agreements, purchase agreements, non-compete/nonsolicitation clauses, and stock-purchase agreements. It is also important to revisit practice policies as they might be set to override your current employment contract if they differ in certain aspect.(2) Review the precedents set by the departure of previous partners in the practice in order to avoid potential pitfalls. The abiding agreements, policies, and clauses must be weighed carefully into your decision to announce your departure. Carefully consider the best timing for your departure. Considerations to keep in mind are listed in Table 1.
TABLE 1. CONSIDERATIONS FOR OPTIMAL TIMING FOR DEPARTURE OR RETIREMENT 1. How will you departure affect the value of your ownership and the ownership of other partners? 2. How will purchase of your ownership interest be financed? 3. Does your departure violate any legal commitments to the practice? 4. Does your departure violate any financial obligations such as bank loans, real estate loans, or lease agreements? 5. Does the manner of the departure violate any non-compete agreements? 6. Does the practice have the capacity to assume your clinical responsibilities, or will you need to help patients find new providers?
It is also important to inquire about the type of malpractice insurance policy that you carried through your employment. If it is a “claim made” malpractice insurance policy, it means that you are insured for claims made while you are employed. In that case, you should procure a supplemental endorsement policy known as “tail coverage.” The latter usually costs 1.5 to 2 times the annual premium.(2) Once the above questions and issues are carefully evaluated, note the pros and cons of leaving with consideration of the impact of your decision on your family, finances, and career. While it is often considered prudent to keep any active job searches discreet until you are sure of your final decision, you may benefit from having an open dialogue with your current colleagues about the issues and considerations driving the change. It is best to announce retirement plans with plenty of time for your partners to make any necessary arrangements, especially if they will need financing to purchase your ownership interest.
STEP 2: ANNOUNCEMENTS When it comes to announcing your departure, your current partners should come first. It is important to have your partners notified about your intention to leave the practice before they hear it from others. It may be considered disrespectful and will likely leave a bitter taste if they learn of your plans from others. Discuss with them the “when” and “how” to announce your departure. It is essential to give plenty of notice. The required notice may also be stated in your contract. It should be enough time for you to take care of business, and for them to work on finding a replacement as well as manage any ramifications of your departure. Do not forget to show gratitude and appreciation for the opportunity to be part of the team. Acknowledge mentorships and the various support you received. Give constructive criticism while highlighting the positive impact the job had on your life and career. Next you will need to notify professional societies, specialty boards, state licensing boards, malpractice carriers, and contracted health plans. It is recommended to notify health plans at least 60–90 days from your departure to allow them to update their network.(1) If you are moving to another state, similar agencies must be contacted, and licensing and professional liability requirements must be met. After notifying your partners, you should provide enough notice to institutions or locations where you treat patients. The notification can be achieved with a telephone call followed by a confirming letter a few weeks in advance of your departure. For legal reasons, the letter should clearly state the contact information of the physician(s) picking up patients’ care.
STEP 3: THE CLINICAL EXIT Finish your assignments while gradually retreating from your responsibilities as part of a clear transition plan. Do not hesitate to recommend a qualified colleague for your replacement, offer to help recruit and or train your replacement, and check with the state authorities regarding the recommended timeline for patient notification. Many states require notifying patients when a physician is leaving the
practice. The timeline of notification can vary from one state to another. A letter formulated in conjunction with your former partners is the most commonly used notification form. In general, patient charts belong to the practice and cannot be taken by the departing physician, unless your contract and the state-mandated responsibilities regarding patient transfer and recordkeeping state otherwise. It is worth noting that most states permit patients to request that their charts be transferred to the departing physician(2).
STEP 4: THE FINANCIAL EXIT While every practice is unique, in gastroenterology there are valuable assets such as ambulatory surgical centers (ASCs), ancillary businesses, and real estate. Understanding the buy/sell agreements for these entities should begin years before you retire or depart. This may allow you to identify and make important amendments long before your departure. Consider reviewing these governing documents every few years, perhaps when new associates are joining your practice. While ownership agreements come in all shapes and sizes, it is important to review them carefully again as you plan a departure. Make sure these agreements adequately compensate you for your assets without crippling your practice financially when you do leave. One important item that must be addressed is the treatment of accounts receivable for the departing physician. Defining exactly what is owed to the departing physician, clearly stating when and how she/he will be paid. If it is not clearly stated in the practice agreement(s), an “exit agreement addendum” should be drafted to address those details. Verbiage stating that there would be access to the practice financial records granted to the retiree should also be included.(1)
VALUING YOUR PRACTICE Valuation of assets, particularly those of an ASC, equipment and real estate
are likely to be key issues in the departure of a GI physician. Decide both who will be assigned the task of determining the valuation as well as what method will be used. Reviewing historical valuations when bringing in new partners could be helpful. If a certain “multiple of EBITDA” was previously used for a buy or sell events, it may be easiest to use the same multiple again. If there is a high degree of trust for a cooperative departure, then it may be appropriate for the practice’s accountant to perform the valuation. If, however, there is a likelihood of conflict, or if you and your partners disagree about the valuation method, an independent firm should be retained. Be sure to also stipulate how these valuation-services will be paid for. We recommend an equally shared payment for this service. Methodologies for valuation of a business can be complex, but a general review is appropriate. According to Matt Sobieralski, former senior business analyst for Physicians Endoscopy, most ASCs rely on historical multiples of cash flow as a basis for valuation.(3) There are two critical components for this approach, the EBITDA and the valuation multiple. The valuation multiple would usually be clearly spelled out in the exit agreement and may be based on factors such as size, risk, liquidity and competition in the marketplace. The EBITDA stands for “earnings before interest, taxes, depreciation and amortization.” It is used as a proxy for actual cash flow and accurately captures the earning potential of the ASC or other asset that is being sold. EBITDA is generally an annual value, but carefully consider whether the EBITDA will be an average of just the immediate previous year, or of several previous years. This can have profound implications. Obviously, it is important for physicians to carefully consult with their business accountant to understand their own unique tax and debt status before and during their anticipated exit.
Getting it Right | 21
// GETTING IT RIGHT: BUILDING SUCCESS
SUCCESSION PLANNING: THE BENEFITS OF A PRE-DETERMINED EXIT PATHWAY Succession planning is best done in an open, proactive, and transparent way. Important questions such as whether the retiring physician may continue to work part-time may also be addressed long before a retirement event begins. As an example, does the practice allow the retiring physician to cut back hours or stop taking call, but remain in the practice? Does your group allow you to do this and also take your exit-distribution? Some agreements state that a physician must die, be disabled, or exit completely to take any final distribution. This creates a counterincentive to a smooth and mutually beneficial succession. A clearly defined process for a smooth departure is critical for medical practices seeking to recruit new members. A professional services agreement (PSA) for partners approaching retirement can be an excellent option for practices seeking to ease the transition both clinically and financially.(4) A PSA should include a formula for compensation for the semi-retiring physician based on collections, minus the overhead rate of the practice and the expenses allocable to the “contractor.� Other items to clearly define include the treatment of compensation and expenses, malpractice insurance requirements, duration of the agreement, terms for renewal, and provisions for early termination.
Samer El-Dika, MD, Stanford University, Redwood City, CA
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A GRACEFUL EXIT FOR A BRIGHTER FUTURE Change is part of every career and cannot be avoided. Likewise, physician retirement/exit is an inevitable event and is part of the normal career cycle of every gastroenterologist. Achieving a graceful exit requires open communication, careful planning, and consideration of important details that can save you and your former partner(s) preventable legal headaches and financial losses. Leaving properly helps ensure a positive outcome for the departing physician and the long-term success of the practice.
REFERENCES: 1. https://www.nejmcareercenter.org/article. Moving on issues to consider when making a career move. 2. A Must Do List for the Departing Physician. James D. Wall, Esq, Family Practice Management. www.aafp.or/fpm/Octover 2005. 3. Retirement Ahead. TJ Berdzik. Endoeconomics. Winter 2019, p. 6-7. Understanding Business Valuation. Matt Sobieralski. Endoeconomics. Winter 2016. P. 11-12. 4. Alignment but not Employment: Professional Service Agreement with a Hospital System. Stephen T. Amann, James C. Dilorenzo. ACG GI Practice Toolbox.
Dave Limauro, MD, FACG, Pittsburg Gastroenterology Associates, Pittsburg, PA
Eric Shah, MD, FACG, Dartmouth-Hitchcock Medical Center, Hanover, NH
Louis J. Wilson, MD, FACG, Wichita Falls Gastroenterology Associates, Wichita Falls, TX
// GETTING IT RIGHT: LAW MIND
What Androcles and the Lion has to do with GI Practices During a Pandemic By Ann Bittinger, Esquire
IN TODAY’S CLIMATE OF UNCERTAINTY, legal protections and considerations relating to ensuring that physicians, health care workers, and patients are safe while operations remain solvent are critical. Physicians have been facing extraordinary challenges while evolving their GI practices with agility. Continuing to address unique legal liabilities of operating a medical practice in the pandemic is of upmost importance. But in doing so, physicians may be best served by reflecting on the folk tale of Androcles and the Lion. In that story, Androcles, a shepherd, follows his flock into a high mountain forest. As it grows dark, he seeks refuge in a cave. As he lights his lantern, he sees that the cave is also inhabited by a
lion in obvious distress. As scared Androcles tries to maintain his composure and decide whether to fight or flee, he sees that the source of the lion’s distress is a massive thorn in his paw. With utmost bravery and compassion, Androcles removes the thorn from the paw. Years later, Androcles is imprisoned, taken to the Colosseum in Rome and thrown before a lion for the pleasure of the audience. But the lion was the one from the cave. When he saw Androcles, he bowed his head in gratitude. While it goes without saying that the healthcare delivery system—and society as a whole—will be fundamentally changed long term by the pandemic, some things will return to normal. Your colleagues and patients will remember those who—even while maintaining legal protections—acted with compassion and composure.
HOW YOU PAY YOUR PHYSICIANS. Lockdowns followed by patient fear have resulted in decreased volume in many practices, resulting in lower revenue and, therefore, decreased pay. In “eat what you kill” models, in which physician pay is tied to their collections minus their expenses, collections may have dropped below expenses for many months now, triggering obligations of employed physicians to repay the difference to their employer. I’ve even heard of this happening in health systems that received hundreds of thousands of dollars in paycheck protection program loans—they are keeping the government-sponsored PPP money but still holding employed physicians to their contractual obligations to repay the employer if their expenses exceed their collections. Sure, that’s legal, and it’s what the contract says, but is it the right thing to do? Employers may be able to forgive the debt or collaborate with the employee to develop a compromise or longer-term plan for repayment. Perhaps there are other ways that a physician can contribute to the practice to make up for the loss that does not involve writing a check to the employer. After all, the pandemic is not your employed physician’s fault. For example, could the physician use the time due to the decreased patient volume to help implement the telemedicine or remote patient monitoring program? Could the practice help the physician organize Zoom calls with patients to promote trust in returning to the practice? There are legal steps that can be taken that protect the practice while showing compassion to the physician employee in the “eat what you kill” compensation model. A simple internet search allows people to see who received CARES Act and Paycheck Protection Plan money, and the amount received. The hypocrisy of taking the money while holding employed physicians to their contracts will be apparent.
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// GETTING IT RIGHT: LAW MIND
WHAT IF A COLLEAGUE GETS COVID-19? One of my consultations recently involved a situation in which one of the practice’s physician owners has been in the ICU with COVID for the last month. If the practice applied its shareholders agreement’s disability provision to the situation, right around Christmas they would be able to terminate the physician’s employment and ownership in the company, as he would be “disabled” according to the shareholders agreement for the requisite contractual period. Is that the right thing to do? Just end his employment and buy back his shares, sending the payments to the physician’s husband at home with their kids while the former partner battles for his life in the ICU? Perhaps, instead, the other partners could agree to an amendment to the shareholders agreement to address this situation in a way that reflects the fact that the physician is not generating revenue for the group but that provides the support that he needs. After all, the pandemic is not that sick physician’s fault. There are legal steps that can be taken that protect the practice while showing compassion to the sick physician. One of my first COVID-related consultations this spring (during the “all hands on deck” phase of the early outbreak) was with an asthmatic physician employed in one of the hospitals in the epicenter of the outbreak. In a high risk group as an asthmatic, she ended up quitting because the system would not or could not find a place for her to provide services to the employer that did not potentially expose her to the virus. She had to choose between sacrificing her health or sacrificing her job. PATIENT TRUST. One principle of basic risk management is that the best approach to reducing legal risk is to promote patient trust and communication. Physician practices would be well served by implementing robust cleaning, screening and testing programs and explaining them in detail to their patients and the public. Of course, subject to the severity of
24 | GI.ORG/ACGMAGAZINE
the outbreaks in your area, consider taking everyone’s temperature and having them complete a screening questionnaire before they enter the office. Make family members wait in the car during patient visits but give them a “curb side” service. Get drivers’ phone numbers so you can text them when the patient is done and ready to be assisted into the car after a procedure. Limit the number of people in your office (pharma reps, vendors, etc.) Increase use of disposables and tailor your procedure “kits” to include everything you need per procedure in one disposable kit. Check the disinfectant aerosols and whether they are activated in 5 or 15 minutes—that matters as you revolve patients in and out of the endoscopy center procedure bays. Limit the number of people allowed to scrub in. And let your patients and the public know what you are doing. Put it on your website. Not only does that promote trust in your clients, it documents your risk management efforts so that if you are ever questioned about them, you can easily show what you were doing to protect patients and staff. This will also produce the benefit of increased trust from staff, many of whom are also scared of infection. It is neither difficult nor horribly expensive for an employer to contract with a lab that can send a phlebotomist to the workplace each day to swab staff for COVID and run tests that are turned around same day or within 48 hours. Fortune 500 companies are doing it for their CEOs, executives and board members so as to promote continuity and avoid disruption of the company if a key employee gets sick. Tulane University is testing students daily in two of their dorms where there has been an outbreak, at no cost to the students. I speculate that in the new presidential administration that we
will see an increased importance placed on rapid COVID testing, and perhaps some government subsidies for those. A prudent practice will be ahead of the curve in implementing testing of its team members, and maybe even use that program to get better rates as it negotiates with its health and other insurance companies. We clearly have a long winter ahead of us, but this too shall come to pass. Will your practice be eaten by the lion in the cave or in the Colosseum, or will the lion bow its head in gratitude, loyalty and respect?
Ann Bittinger, Esq., is the owner of The Bittinger Law Firm, dedicated solely to advising physicians, physician groups and healthcare entities on their compliance and legal challenges and opportunities. Questions? Email ann@bittingerlaw.com
// COVER STORY: THE DISCOVERERS
Evolution of an Idea From Functional GI Disorders To Disorders of Gut-Brain Interaction
An Interview in the “Discoverers” Series with Douglas A. Drossman, MD, MACG By Lawrence R. Schiller, MD, MACG
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// COVER STORY: THE DISCOVERERS
D
Dr. Doug Drossman has been instrumental in developing the current conceptual basis of what used to be called “functional bowel disorders,” now known as “disorders of gut-brain interaction” (DGBI). This interview in the ACG MAGAZINE “Discoverers” Series tracks his intellectual journey from just trying to understand his patients’ complaints to the development of a criteria-based diagnosis system which has led to a flowering of our understanding and ability to treat these disorders. – Dr. Lawrence Schiller Q1. Thanks for agreeing to reminisce about your career and the development of ideas that we now take for granted. How did you get interested in gastroenterology as a career choice?
I chose gastroenterology because it met my need to combine medicine's technical aspects with a strong focus on the patient. It is a blending of science and art. In that regard, it is different from other medical subspecialties. For example, with cardiology, pulmonary disease, and nephrology, clinicians can rely on cardiac catheterization, lung physiology, or kidney function tests to understand how well the specific organs function, which determines how the patient is doing and the management. But those techniques almost exclude any interaction with the patient in decision making. 26 | GI.ORG/ACGMAGAZINE
In contrast, GI illnesses and diseases are more complex; there are no numbers or calculations of organ function to explain why the patient has abdominal pain or nausea. So, traditional physician and patient expectations to test, diagnose, and treat aren’t always successful. Gastroenterology looks at the person and his or her symptoms in the context of daily functioning, life stress, quality of life, and coping style. Optimal patient diagnosis and management require human interaction through history, physical examination, and a patient-centered care model. Of course, we also need imaging methods and endoscopy for many of our patients, but it all comes back to the patient and patient communication. Furthermore, gastroenterology science involves gut-brain interactions, and that has always appealed to me. We need to understand how serotonin, norepinephrine, or endorphins/ opioids neurotransmitters and their receptors and inflammatory mediators affect gastrointestinal and brain function. Particularly for the DGBI (formerly functional GI disorders), all GI symptoms are a derivative of brain and gut interactions, and it is their dysregulation that leads to these disorders. So, this also met my need to address gut-brain interactions and the biopsychosocial aspects of GI illness. How endoscopic, pathological, or physiological (motility) findings affect GI function and symptoms also appealed to me. People may not be aware that I was an interventional endoscopist until the last decade and I edited a GI procedure manual. I thought it fascinating to learn to what extent observable diseasespecific, structural abnormalities related to patient illness, and ill health experience. Correlations between structure and even GI physiological disturbances and symptoms are far lower than many realize. Patients with active ulcerative colitis or Crohn’s disease may have severe disease on endoscopy yet have minimal GI symptoms. Conversely, patients with
“Gastroenterology looks at the person and his or her symptoms in the context of daily functioning, life stress, quality of life, and coping style. Optimal patient diagnosis and management require human interaction through history, physical examination, and a patientcentered care model. Of course, we also need imaging methods and endoscopy for many of our patients, but it all comes back to the patient and patient communication.”
IBD may have minimal mucosal disease after treatment yet have continuing severe pain and diarrhea; we now call that IBD-IBS. Even the relation between physiological testing such as delayed gastric emptying or colonic motility and GI symptoms is low. These discrepancies posed a challenge to me and eventually led me to focus on the biopsychosocial aspects of GI illness and disease. Q2. What led you to seek additional training in the biopsychosocial aspects of medicine at the University of Rochester?
When I was in medical school, I wasn’t sure if I wanted to go into medicine or psychiatry. I enjoyed learning about human behavior and the role of psychosocial factors in GI illness. I chose a medical residency because my priority was to take care of patients as a medical doctor. When I was a medical resident at the University of North Carolina and later an internist at an Air Force hospital during the Vietnam era, I learned that many of the medical symptoms that patients described were unrelated to the X-rays and laboratory findings. I believed that something was missing in understanding and treating patients and considered integrating psychosocial learning into GI practice. I heard about George Engel in Rochester, NY, who soon became my mentor, and joined his program as a fellow before going into gastroenterology. Dr. Engel coined the term Biopsychosocial Model which became the driving force of my career. He was an internist and psychoanalyst who set up a training program to teach what was then called psychosomatic medicine. My growing concern about the disconnect between symptoms and medical findings drew me to his program. Also, he was considered a master medical interviewer. I recall him diagnosing what was later confirmed to be a thalamic tumor of the brain based on the quality of the pain that the patient-reported; I guess he preceded by decades the TV doctor “House.” My learning with him allowed me to develop and expand my interview skills to improve my ability to acquire even subtle medical and biopsychosocial data. It also helped me to understand the patient’s inner world and illness experience entirely
differently. I believed that this training would add a unique perspective to my training in gastroenterology. Q3. What did physicians use to make a diagnosis of IBS before the Manning Criteria were published in 1978?
The simple answer is that there was no unified approach to making a diagnosis of IBS other than to exclude other diseases and rely on the physician's experience. To fully answer this question, let me bring in a bit of history about how IBS and the other functional GI disorders evolved. At the turn of the 19thcentury, abdominal pain, diarrhea, nausea, or vomiting were considered merely collections of symptoms. From the 1950s well into the 1980s, gastroenterology was dominated by attention to structural disorders, like peptic ulcers, GI tumors, diverticulitis, pancreatic disease, and inflammatory bowel disease. They were easy to diagnose using imaging methods like X-rays and, later, endoscopies. Yet these structural diagnoses applied to only about half of the patients seen in GI clinics. The other half having symptoms not diagnosed by imaging studies were called "functional." These functional symptoms were attributed to the GI tract's abnormal movements and were considered motility disorders. Motility testing helped diagnose motility disorders such as gastroparesis, achalasia, sphincter of Oddi dysfunction, dyssynergic defecation, etc. However, motility testing did not diagnose the common GI symptoms like pain, bloating, or nausea and, furthermore, this type of testing was not readily available in clinical practice. So, before 1978, a diagnosis of IBS was made by exclusion of other problems. But diagnosing by exclusion was not cost-effective because there were no guidelines to help decide what studies to do, and there was no limit to the number of tests that could be ordered. The Manning study was a breakthrough because it opened the door to making a positive diagnosis. The authors tested whether collections
of GI symptoms might distinguish patients with IBS from organic disease (e.g., IBD, diverticular disease, etc.). Their findings showed that clusters of symptoms could lead to a diagnosis when physiological testing or endoscopy was negative. This study was a precursor to the Rome criteria. Q4. How did the initial Rome criteria for IBS and other functional GI diagnoses come to be?
In the late 1970’s and early 1980’s, I was part of a small group of gastroenterologists and scientists including W. Grant Thompson, MD (Canada), William Whitehead, Ph.D. (USA), Nicholas Talley, MD, MPH, (Australia), Ken Heaton, MD (UK), and Enrico Corazziari, MD (Italy), who believed that the disorders called “functional” were not wellunderstood nor well-conceptualized. As a result, they were treated as “second class” to the structurallybased GI diagnoses. We believed that creating a classification system for the functional GI disorders would “put them on the map,” so to speak. Then patients could be identified and studied scientifically—and, in the process, be legitimized. At the time, we were all conducting clinical and epidemiological research to characterize GI symptoms and see if they had diagnostic value. The Manning Criteria was the first of several publications we did that followed into the 1980s. In 1987, Dr. Aldo Torsoli, of the International Congress of Gastroenterology (Roma '88), created a working team of five GI experts researching this area. We worked by a Delphi approach: a consensus of experts made clinical recommendations for diagnosis and treatment when there was inadequate scientific evidence. The team included W. Grant Thompson (Canada, chair), myself (USA), Wofgang Kruis (Germany), Ken Heaton (UK), and Gerhard Dotevall (Sweden). This team created the first consensus document that established diagnostic criteria for IBS. The work was presented at Roma '88 and published in 1989 (Thompson,
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// COVER STORY: THE DISCOVERERS
“
“...the disorders called “functional” were not
well-understood nor well-conceptualized.
As a result, they were
treated as “second class” to the structurallybased GI diagnoses. We believed that creating a classification system for the functional GI disorders would “put them on the map,” so to speak. Then patients could be identified and studied scientifically— and, in the process, be legitimized.”
(Drossman (ed) et al. The Functional Gastrointestinal Disorders: Diagnosis, Pathophysiology, and Treatment. 1994; Little Brown and Company, Boston) is considered to be Rome I.
WG, et al., Irritable Bowel Syndrome: Guidelines for the diagnosis. Gastroenterology International 1989; 2:92-95). Many publications on other functional GI disorders like functional dyspepsia, functional heartburn, or post-cholecystectomy biliary pain were starting to appear during this time. However, there was no viable way to characterize and diagnose these disorders systematically. The next step was to bring our group together to establish guidelines for diagnosing all these disorders. To this end, we convened another working team and created 23 diagnoses that were categorized by location or domain: esophageal, gastroduodenal, bowel, biliary, and anorectal. Within each domain, there were several diagnoses. Each had a definition and diagnostic assessment, including the new symptom-based criteria (Drossman, DA, et al., Identification of Sub-groups of Functional Gastrointestinal Disorders. Gastroenterology International 1990;3:159-172). We used this publication as a template to expand upon the knowledge by creating additional working teams for each domain and published the findings over the next several years. We also created a working team to make recommendations on designing treatment trials. Finally, we used all the criteria to publish the first nationwide epidemiological study of 10,000 US Householders (Drossman, DA, et al., US Householder Survey of Functional Gastrointestinal Disorders. Dig Dis Sci 1993;38:1560-1580). We then compiled these documents into a book (Drossman (ed) et al., The Functional Gastrointestinal Disorders: Diagnosis, Pathophysiology, and Treatment. 1994; Little Brown and Company, Boston, pp. 1-370), which, retrospectively, is considered to be Rome I. This was the beginning of the Rome Foundation WATCH: romedross.video/origins
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Q5. What was the impact of the initial Rome criteria on research in IBS?
The use of symptom-based diagnostic criteria changed the way doctors diagnosed these patients, and investigators incorporated these criteria into epidemiological and clinical studies. Symptom-based criteria offered a new conceptual framework to study disorders not related to structural or motility disturbances (see Figure 1). It also legitimized these disorders and created a framework for clinical and biopsychosocial research; this countered dualistic thinking which ineffectively categorized all disorders as being “organic” or “psychosomatic.” Initially, however, and into the early 1990s the Rome classification system and its criteria were not well accepted by investigators. Understandably, this new classification was based on empiric wisdom, not scientific validation studies. Many thought that there was a lack of evidence to support the criteria because there were no structural or physiological correlations or measurement methods to legitimize them. Then the Food and Drug Administration (FDA) and other regulatory agencies saw the value of these criteria and recommended their use for clinical research on patients. The criteria were then adopted by pharmaceutical companies to use in clinical trials. Subsequently, more and more studies were done, and this established a database of patients to use in future validation studies for the criteria, which ensued in the coming years. Q6. How have the subsequent revisions of the Rome criteria improved their utility?
The criteria were never mean to be “etched in stone.” The Rome Foundation Board believed that the diagnostic criteria would change as new scientific data emerged. The revisions of the criteria occurred with subsequent publications from Rome I (1994) to Rome II (2000), Rome III (2006), Rome IV (2016), and may occur for Rome V scheduled for 2026. Surprisingly, the criteria
Organic Disorder
Motility Gut-Brain
DGBI (Functional GI)
Primary Domain
Organic morphology
Organ function
Illness experience
Criterion
Pathology (disease)
Altered Motility
Symptoms
Measurements
• Histology • Pathology • Endoscopy • Radiology
• Motility • Visceral sensitivity
• Motility • Visceral sensitivity • Symptom criteria (Rome) • Psychosocial
• Medications • Surgery • Ther. endoscopy
• Pro / anti-kinetics • Surgery • Pacing / Stimulator
• Pro / anti-kinetics • Antinociceptives • Antidepressants • Behavioral
Treatment Options
Examples
• Esophagitis • Peptic Ulcer • IBD • Colon Cancer
• Diffuse esophageal spasm • Gastroparesis • Pseudo-obstruction • Colonic inertia
• Esophageal chest pain • Functional dyspepsia • IBS • Functional abdominal pain
Figure 1.
have not changed very much over the years, but when criteria are changed, scientific data is required to justify the change. While the Rome I criteria were developed by consensus, each subsequent Rome iteration became more evidence-based. The utility of the criteria also has increased through their globalization. Over the years, the Rome books and criteria were translated into Spanish, Portuguese, Italian, and Chinese. This increases the opportunity to study these disorders from a cross-cultural basis. Under the direction of Dr. Ami Sperber, the Rome IV criteria were used to study the prevalence and phenotypic features for the DGBIs in over 70,000 subjects in 33 countries (Sperber A, et al., Worldwide Prevalence and Burden of FGIDs, Results of the Rome Foundation Global Study. Gastroenterology 2020 romedross. video/GlobalStudy). The utility of the criteria has also increased through the Rome Foundation’s educational efforts in publishing diagnostic algorithms and the development of the Multi-Dimensional Clinical Program (MDCP) to standardize treatment approaches. There is also an intelligent software program incorporating the diagnostic algorithms and MDCP called the GI Genius (romeonline.org).
Q7. How should clinicians utilize the Rome criteria in their practices?
It may come as a surprise to many that the Rome criteria were designed for clinical trials, not for clinical practice. As a result, the criteria's preciseness can lead to discrepancies when experienced clinicians diagnose these disorders and find they do not meet the Rome criteria exactly. This is best highlighted for IBS when comparing Rome III to Rome IV criteria. Epidemiological studies show that the frequency of IBS using Rome IV is about half that of Rome III. What has changed, though, is not the true prevalence, but the number of patients meeting the more stringent criteria. Rome III requires the frequency of symptoms to be at least three times a month, and Rome IV requires symptoms to be present at least once a week, which explains the discrepancy. It turns out that Rome IV identifies a more severe population that may be more amenable to clinical trials. However, clinicians will diagnose patients who don’t meet frequency criteria, but clinically still have this diagnosis qualitatively. In other words, the pattern of abdominal pain relieved or made worse with defection and associated with diarrhea or constipation symptoms still clinically support the diagnosis. So, in clinical practice, the criteria can be used as a guide to making a diagnosis. Milder cases may not meet the research criteria, but these patients can still
be given a “form fruste” diagnosis and be treated appropriately. While it is too early to say with certainty, I believe that we may develop both clinical and research criteria for Rome V. Q8. Recently, “Functional Bowel Disorders” have been relabeled as “Disorders of Gut-Brain Interaction.” How does that alter our conception of these disorders?
In the 1980’s, I surveyed the AGA membership and asked the definition of a functional bowel disorder. The most common response was that there was “nothing found,” and of course, this often prompted doctors to do more tests. The second most common response was that it was a psychiatric disorder. Only about 5% thought that the definition meant a disorder of the functioning of the GI tract. While this last definition could be considered acceptable, the other two were not helpful to patients or doctors. Moreover, the term can be regarded as stigmatizing. After much discussion, the Rome Foundation Board and Rome IV Chapter Committee chairs decided to change the name to Disorders of Gut-Brain Interaction because it eliminates the stigma and is scientifically based. We understand these disorders as related to dysregulation of the gut-brain axis manifest by any combination of 1) motility disturbance, 2) visceral hypersensitivity, 3) altered mucosal and immune function, 4) altered microbiota, and 5) altered CNS processing. The Rome Foundation has increased the use of this term in our publications and educational programs, and we see it being used more and more in research papers and teaching. We know that patients find it more acceptable, and doctors are beginning to feel more comfortable using it. Q9. How should we explain these disorders to our patients?
I believe that the change in terminology to DGBI makes it easier to explain these disorders. No other organ system is as hardwired to the brain
Getting it Right | 29
curate information from ical interview to make a iagnosis
ommunication skills to nnect with your patients
Part 1 offers a conceptual understanding of the DGBIs and the biopsychosocial model Part 2 is a compendium of all 33 DGBIs and includes pathophysiology, diagnosis, and treatment Part 3 teaches methods for doctors and patients to improve communication Part 4 is a guide for doctors to optimize the patient-doctor relationship by implementing shared responsibility. Both authors hope that this book will help make the patient-doctor relationship more meaningful for both parties.
GUT FEELINGS
Disorders of Gut-Brai n Interaction and the Patient-Doctor Rela tionship A GUIDE FOR PATIE
NTS AND DOCTORS
DGBI and the Patient -Doctor Relationship
to: he pathophysiology, is, and treatment of all rs of Gut-Brain Interactio n
(drossmancare.com/gut-feelings-book).
GUT FEELINGS
doctor, it will help you
Ms. Johannah Ruddy and Dr. Drossman have now co-authored a book: “Gut Feelings: Disorders of Gut-Brain Interaction and the Patient-Doctor Relationship. A Guide for Patients and Doctors” that promotes a model where patients and doctors collaborate
DROSS MAN & RUDDY
their doctors ist and patient advocat e. agnosis, and treatme nt of all ed Functional GI Disorder s) t-doctor relationship.
// COVER STORY: THE DISCOVERERS
— COLOR EDITION
—
Douglas A. Drossm an, MD Johannah Ruddy, MEd
Johannah Ruddy, M.Ed., and Douglas A. Drossman, MD, MACG
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as the gut; this is the gut-brain axis. In the embryo, nerve cells from the developing brain send down nerves to populate the GI tract to become the enteric nervous system. We can tell our patients that the GI symptoms are a product of nerve signals generated in the gut that go to the brain and the brain signals' reciprocal effects going to the gut to regulate them. The gutbrain axis is usually in harmony, but with the DGBIs, symptom-perception or gut function may be dysregulated. So, for example, abdominal pain could be due to dysmotility or visceral hypersensitivity, but there may also be a failure of the brain to downregulate these signals and this can be enabled by stress. Dysregulation of the gut-brain axis can apply not only to pain but to other GI symptoms, including nausea, vomiting, diarrhea, etc. The Rome Foundation has produced a card to demonstrate this concept to patients. It contains an image of the gut-brain axis with a written explanation and a video for a demonstration: https://romedross. video/B-GAxisCard. There is also a series of brief video discussions on the pathophysiology, diagnosis, and treatments of the DGBIs on the Rome website: https://theromefoundation. org/patient-educational-q-a/ Q10. One of the new initiatives for you and the Rome Foundation is to teach ways to improve the patientdoctor relationship. What made you decide to do this, and how are you doing it?
During my fellowship with George Engel, I became trained in advanced interview and communication techniques. I learned of its value to make a better diagnosis and solidify the patient-doctor relationship. I also learned from the teachings of Carl Rogers, and a group called the American Academy of Physician and Patient (now called the Academy of Communication in Healthcare) about patient-centered care. This concept was later promoted in 2001 by the Institute of Medicine. Subsequently, I started teaching these methods when I lectured at GI and medical programs.
This led to the founding of the Center for Education and Practice of Biopsychosocial Care (DrossmanCare). We created videos on communication skills teaching and did workshops and symposia at national and international programs. Two years ago, I started collaborating with a patient advocate, Johannah Ruddy, M.Ed., who is also the Executive Director of the Rome Foundation. She joined me in our educational programs, bringing in the patient’s perspective which was enlightening for the attendees. We then created a collaboration between DrossmanCare and the Rome Foundation and created a multimodal curriculum to teach communication skills to optimize the patient-doctor relationship. Since then, we have successfully produced educational lectures and workshops at GI and medical programs, workshops, symposia, Train the Trainer programs, visiting scholars programs, and several peer-reviewed publications: https:// romedross.video/2kfU3Dd. The ACG has used these services at its FGID School where I have run workshops at several of the meetings.
Conversations with Women in GI Dr. Jill Gaidos talks to Dr. Colleen Schmitt on “Leadership for Women in GI”
I HAD THE OPPORTUNITY TO MEET DR. COLLEEN SCHMITT at the ACG “Bridging the Leadership Gap in GI” conference in January 2020. Dr. Schmitt was one of our amazing faculty members for the conference and presented a talk on “Developing Your 5-Year Plan in Academics and Private Practice.” We had planned to meet up at the next GI society meeting for her interview, however, due to COVID, the interview was postponed. We were finally able to catch up this summer and talk about her experience being a leader in GI. You were previously the Chief of the Gastroenterology division and the Director of Clinical Research at the University of Tennessee College of Medicine Chattanooga Unit. You are now the President of the Galen Medical Group which is a multi-specialty private practice group in Chattanooga, Tennessee. You have leadership experience in both academic and private practice settings. What lead to you to transition from academics to private practice? My first academic position was at Duke after finishing my fellowships. The move to Chattanooga was a deeply personal decision. My husband and I wanted our children to grow up near their grandparents, as we are both originally from this area. We both looked at a lot of opportunities. Clint is a musician and I’m in medicine. We looked at both academic and private practice positions in different cities that we had enjoyed and loved living in, like Boston and Durham as well. But what took us back home, if you will, was this personal decision. And we both had to give up something to do that, but in the end that was the wisest, best decision I think we could have made for ourselves and our family.
ACG Perspectives | 31
// PERSPECTIVES
You know, you don’t have a perfect crystal ball, but my career has been very satisfying and enriching. The nice thing about the move to Chattanooga was that I was able to take on a hybrid position, where our group straddled both private practice and academics. For individuals who still want to have an opportunity to teach while working out of a private practice setting, those opportunities do exist. Our group eventually had to leave the teaching hospital behind due to system changes, so we made the decision to give up our faculty positions there. The decision to close that door was a decision I made jointly with the rest of my partners. You also have quite extensive research experience. You were the Director of Clinical Research at the University of Tennessee College of Medicine Chattanooga Unit and then the founding Medical Director for Chattanooga’s first multispecialty clinical trials unit. So, this is one of those situations where you just take what you have and use it and see what kind of doors and opportunities will open for you. When I was at Duke, my mentors there, Scott Brazer, and Jack Feussner, who was the chief at the Durham VA, encouraged me to do a joint fellowship in health services research. During that experience, I had accumulated enough academic hours to complete a Master’s degree in Biometry and Informatics. So, when I came to Chattanooga, there were a couple of single-specialty clinical trials groups. I became friends with them, and with folks in industry and asked about starting to do clinical trials. I went to my partners and asked if they had interest in doing clinical trials I believe this is a kind of situation where if you enjoy the work, you can make what you want to out of the job. It’s been a job that has allowed us to continue to be cutting edge, has crossed several different clinical areas, has been tremendously rewarding, and really just plain fun. With all of your leadership experience, did you ever have any formal leadership training through leadership conferences or classes? Never. It was a real eye opener to me. I can tell you exactly how and when it happened. I remember when Sheryl Sandberg’s book Lean In was published, and there was a lot of pushback against that book. I don’t know if you remember it. But I thought, “I’m going to read this just because she’s gotten so much flack. Judge for yourself about who she is as a person or her personal wealth, whatever you want, but I want to know what this says so I can be part of that conversation.” At the same time, I read a book called Women Don’t Ask by Linda Babcock. I think I read them both the same month. I found Linda Babcock’s research to be so compelling and then juxtaposed that with the personal experience and observations
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“What we have seen happen over the last few years is considerable education and thought around how to develop professional leadership skills. We have had to borrow from the business community, to do that effectively because they were so far ahead of academia in terms of what kind of resources brought to bear on this problem.”
that Sheryl Sandberg made. We knew then how many women were going into our field and yet really were not rising to the level of leadership positions that you would naturally think that they would be getting to by that point. And this is 20 years into women going into GI as a specialty. It’s not an original observation, by any means, but I think all of our societies were looking internally at ourselves and wondering what is going on and what can we do to change it. I believe what differentiated the experience of someone my age or anyone around the time we trained is that we felt very fortunate to actually be in an era where there was a serious focus on the development of clinical research skills in training. And what we have seen happen over the last few years is considerable education and thought around how to develop professional leadership skills. We have had to borrow from the business community, to do that effectively because they were so far ahead of academia in terms of what kind of resources brought to bear on this problem. So, that is what we did. I was very lucky. I don’t think it would have happened, Jill, if I didn’t have a Board who all had daughters in the 18–25-year old range and women leadership in the society administrative staff who were completely behind at the idea. They all arrived at the same conclusion I did. So, no, no formal training. I went through the Leadership, Education and Development (LEAD) program with the LEAD classes for the first three years. I actually attended all of those. The hard part is that our GI societies seem so siloed. I have met with women on different committees or task forces for various GI societies and all the women are saying, “We need leadership training.” That is one of the reasons that Dr. Amy Oxentenko and I worked so hard to develop the “Bridging the Leadership Gap in GI” conference — because of this need for leadership training for women in GI. Do you see any way we can expand these training opportunities? First of all, it was a really good course. My observation is that it’s an expensive endeavor. The people who really teach well these topics teach it professionally at places like the Kellogg School of Business or Stanford and they are expensive. The other thing that I believe is very different is, in medicine in particular, we are taught to learn in bitesize lectures. In fact, that has gotten more obvious over time. When was the last time you sat through a 45-minute lecture at the postgraduate course? They are usually 15 or 20 minutes with Q & A, at most. Leadership training can’t be taught in bite-size snippets. These are deep dives. So you have to be invested for coming in for more than a day and be willing to spend two days with a speaker and come out on the other side of that tangibly and functionally changed. Minimum for some of these lectures is going
to be four hours. And there are so many nuances to what we are talking about that are still going to be impactful for the development of one skill set. We learned that before we launched LEAD at ASGE, and incorporated that model into the development program. Pooled resources and opportunities to share that kind of substantive content would be of benefit to women in all of these groups. When we were developing the curriculum for the conference, I had several conversations about this with Jean Gasen, the executive leadership coach who gave the keynote speech at the conference. She looked at the agenda and said, “How can you process this information in 20 minutes? When do you reflect on what you’ve learned?” But when you look at a business school leadership course, these topics are covered over hours, not minutes. Yes, and there is a lot of role playing that occurs and the commitment to developing these skills is time consuming. You have to allow time for introspection and feedback. Any of us are smart enough to go sit and learn something about a biopsy protocol or diagnostic criteria for certain disorders. That’s memorization work and something you can write down and put in your back pocket. But practicing, I’ll pull this out, practicing an elevator speech is not something that comes naturally to us, by any means, much less the opportunity to use it. It’s important to really be still, and sit, and think. I think my talk at your course was developing your career path. To really have time to ponder that, and then think about where your gaps are, and where you want to invest time and learning—this is not a 20-minute thought process by any stretch. Right! Back to your talk at the ACG “Bridging the Leadership Gap in GI” conference, you spoke on developing a 5-year career plan to identify steps to take to develop and achieve future career plans. Throughout your career, did you have a career plan? Do you encourage others that you mentor to create a plan? Yes, although I did not have the pointby-point plan that I outlined in my talk. I don’t know if that was even a thing back then. I’m not sure if you remember, but one of the points I made for me personally was that mine was more of
a crooked path and part of that was because there were two people to think about—I believe that’s true for many women. We did not set out for our family to say, “Okay, we’re going to take turns,” but that’s basically what we did. One would make a decision to help put the other one forward for education or for whatever purpose and then the other person would put that person forward. It’s easier to see that in retrospect, but in real life if you’re not willing to do that, I don’t think the end result is going to be happy. I believe, first of all, leadership is about creating opportunity for other people. Truly, that has been the best part of any leadership position I’ve been in. Of course, the downstream benefit of that is that I get to surround myself with people who are extremely talented and gifted. I would say that our career plan was maximum 5 years. When we came to Chattanooga, it was not my career plan to be a division chief or lead a clinical trials group. I kind of looked around and thought, “You know, there is an opportunity to do this and I’ve got this person who works with me that would be really good at this,” and we would explore that and more opportunities would come from that. I hate to tell you that’s what I did, but in truth it is. So, if my partners read this article and saw anything else, they’d start laughing. (Laughing). In reality, I don’t think I’ve ever made a 5-year career plan. I hadn’t ever really considered it until I listened to your talk. It’s funny because I’ve just moved to Yale University for the Director of Clinical Research in IBD position and my husband asked me, “So, is this it or are we going to be moving again for a Chair position?” And I said, “You know what, I haven’t even thought about that.” I think that’s an honest question and an honest answer.
Colleen M. Schmitt, MD, MHS, FACG Galen Medical Group Chattanooga, TN
It’s certainly not in the 5-year plan. I would be interested to hear what your 5-year plan is. I’ll let you know when I come up with it. (Laughing) (Laughing) Oh, that’s funny! I think the next most important point from my talk is for folks not just to “give and get” but the “try, rinse, and repeat.” Understanding that the trajectory is not going to be just a straight arrow. It’s going to wind, it’s going to curve and may require iterations of your plan. Honestly, it’s taking advantage of those curves, taking advantage of those unexpected opportunities, that’s where the magic happens. And I’m sure the same thing is true for people who do research primarily. It’s the accidental discoveries. It’s not just the deliberate, intentional discoveries, it’s the ones that you take advantage of that you didn’t expect are really the amazing part of that. That’s something that is hard for women to do. I listen to a podcast called, “The Brave Enough Show” (www. becomebraveenough.com/podcast) by Dr. Sasha Shillcutt. On the podcast she talks about how women get on these trajectories and we continue to do what we are good at, but not necessarily what we love. And it becomes hard to switch from the things that we are good at to the things that we love but we may not be as good at yet. That takes courage and it also takes a significant amount of insight. That is the big decision maker for someone who is leaving one type of position and going to another type of position, like leaving academics. You are taught certain things about what that means, but for everyone in a position like yours where you have to juggle or balance the administrative responsibilities, which, let’s face it, some people love, and the research responsibilities, teaching and clinical responsibilities, it may even be a moving target. You may love the clinical part of it for a period of time or the research part and want to maximize something else. There may be no door that you want to close. But if you do have the insight and then the courage to say, “Okay, I’m committed to this path,” you do realize that you may close doors. It’s not a small decision.
Jill K. J. Gaidos, MD, FACG Yale School of Medicine New Haven, CT
ACG Perspectives | 33
SUBMIT YOUR APPLICATION for the ACG
2021 International GI Training Grant Awards
The International Relations Commi ee of the American College of Gastroenterology is now accepting applications for the 2021 International GI Training Grants. Each training grant will award one fellowship, with a maximum of $10,000, during 2021. 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, 2021, and June 30, 2022.
‚ƒ‚„
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.
‚ƒ‚„
SUBMISSION DEADLINE March 31, 2021 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.
34 | GI.ORG/ACGMAGAZINE
SUBMISSION DEADLINE March 31, 2021 APPLY HERE gi.org/gi-training-grants
EDUCATION
Navigating the Start of GI fellowship During the COVID-19 Pandemic:
s k c i r T & s Tip By Mohammad Bilal, MD and Ruchit N. Shah, DO
STARTING GASTROENTEROLOGY AND HEPATOLOGY FELLOWSHIP IS AN EXCITING—YET NERVOUS—TIME. Most fellows have dreamed of it for years, and now finally they can answer their pages as “GI.” Starting fellowship brings with it the apprehensions of getting used to the role of a consultant and learning endoscopy, while studying for medicine boards. Further, if fellowship involved a move to a different program or city, it could include learning the new city and maybe a new electronic medical record system. Now, in 2020, add to this list the unprecedented challenges presented by the COVID-19 pandemic. Before we go any further, to the GI fellows-in-training starting their fellowship in July 2020 – you all deserve special recognition. We cannot even imagine the challenges that you all are facing. In this Q & A, we discuss some tips and tricks for preparing for GI fellowship and our personal experiences that we hope will be helpful to new fellows.
Education | 35
// EDUCATION
DR. RUCHIT SHAH’S QUESTIONS TO DR. MOHAMMAD BILAL As GI fellows, we are developing into roles of a consultant. What do you believe makes for a good consultant? The old saying goes, “a good consultant is a good internist.” However, as fellow, it is also important to understand what being a consultant means. First and foremost, you are now considered an expert in the field (as a first year fellow, I remember many times not feeling that way), so every consult or question that comes to you is a call for help. While, as a busy internal medicine resident, a night without pages or admissions is a pleasant break, to build your reputation as a consultant, you have to get into a mindset of being available and ready to help. If a consult seems too simple to you, take it as a compliment for your skillset and knowledge, and use as an opportunity to educate and teach the consulting teams. The other goal is to aim to “answer the question you have been asked.” While, as an internal medicine resident, your goal is to manage everything, as a consultant your main focus should be to provide expertise in the area where you have been asked for help. This means that your notes should outline a clear plan of action for the referring physicians and primary services. Residents should feel welcomed to call you and reach out to you for your expertise and help. Developing these skills during fellowship will also help in building a great practice whether you choose to stay in academia or go into private practice. Endoscopic training is an integral part of GI fellowship. Endoscopic skills cannot be taught via books or words, but by actions. For endoscopic training, what are some pearls of wisdom you have for new fellows? Well, truly, endoscopy is a combination of both technical and non-technical skills. I am sure we have all heard as fellows, “don’t worry, eventually you will learn endoscopy.” Yet, every fellow (including me during my fellowship) worries about learning endoscopic skills. Remember, that the goal is to have fellows proficient in endoscopic skills over the course of three years. Every fellow has a unique learning curve, and one should only compare their growth to themselves. I always tell my junior fellows that every time you feel like you are not learning endoscopy fast enough, think about the procedural skills you are competent in today as compared to July of your first year (remember the first time navigating the
36 | GI.ORG/ACGMAGAZINE
sigmoid or even those mid esophageal biopsies). So never proceed with a procedural step that you don’t feel comfortable with—it’s always better to err on the side of caution and NEVER be afraid to ask for help. Meanwhile, focus on learning non-technical skills. Mastering the principles of informed consent, procedural indications, and even understanding the concepts of some endoscopic skills is helpful. For instance, while you might struggle with performing polypectomy in a difficult location, understanding how to do a proper polypectomy can still be achieved. Lastly, you don’t only learn from your attendings, but also from experienced endoscopy technicians and nurses whose insights can be so helpful as you learn the equipment, sizes of snares, basics of electrocautery, etc.
“The beauty of fellowship is that you get to work with several different faculty members, each with a different path, interest and style. You can learn something from everyone.”
How has COVID-19 affected GI fellowship? What suggestions do you have for GI fellows in navigating GI fellowship through the pandemic? I can’t even imagine how challenging it is to start GI fellowship during the SARS-CoV-2 pandemic. Fellowship presents so many new changes in the day-to-day work and life, and pandemic adds a whole new set of challenges. I guess most first year fellows will not even know how it was to do endoscopy without an N95 mask (used in most places currently). It certainly affects in-room communication and education. I believe it is also up to the trainers to be mindful of the new realities of doing procedures during a pandemic, set expectations with fellows ahead of time, and be clear during the procedure. Many experts have predicted that there will be a “new normal” after the pandemic, and there are several aspects of medicine and GI training that we have adopted during the pandemic such as telemedicine or virtual conferences that will be here to stay. I would urge fellows to use a systematic approach to your learning. There is an ocean of virtual learning opportunities available, which is great, but also can be overwhelming. The ACG Virtual GI Grand Rounds are great and cover basic topics (gi.org/ACGVGR). Also, if you have resources and your endoscopy volumes are low due to the pandemic, using endoscopy simulators and working with your fellowship program to incorporate other validated tools that improve non-technical skills will be important parts of your training. There are several resources such as the ACG Education Universe, ASGE Video Tip of the Week library, and YouTube channels of master endoscopists which provide excellent knowledge and endoscopy education. Social media has also emerged as a great tool for medical education.
Many GI-focused chats such as @MondayNightIBD, @ScopingSundays, @GIjournal and @LiverFellows have emerged as popular tools for both GI/ Liver and endoscopy education. Lastly, fellowship training can be stressful, and certainly COVID-19 can create even more apprehension, but it is important that we have a support system. While COVID-19 does not allow for wellness events or gatherings, fellows should consider doing virtual happy hours since no one understands your day-to-day challenges better than your peers. How can fellows develop themselves as healers, leaders, and educators? That is a loaded question, if I may say. I will say that, most importantly, there is no one recipe or one path to success. The beauty of fellowship is that you get to work with several different faculty members, each with a different path, interest and style. You can learn something from everyone. Eventually, the most important part of our job as physicians is to be good doctors and give the best clinical care to our patients, so the most important thing from my perspective is to keep working on yourself to be better in all aspects. Being a great physician means knowing when to ask for help, when to refer a patient to a colleague, and also when to be there for a colleague. Being a physician, we are always leading. It’s important to know that you don’t need a position or title to lead. As a GI fellow, medical residents and students are looking up to you. You lead your team during rounds, and even during an endoscopy procedure, you are the leader for all team members involved in the procedure. You may also have leadership roles in the fellowship program (as chief fellow) or regional and national committees. While some leadership traits might be inherent, I believe many of these skills can be acquired. Engaging with national organizations such as the ACG is a great way to develop leadership skills. ACG offers great programs for GI fellows including a mentoring program (I was fortunate to have Dr. Amy Oxentenko as my mentor and that opened several opportunities for me.) Other opportunities include the option to publish
in the ACG Case Reports Journal, and trainees are usually welcome to apply for ACG committee appointments. In addition, there is a GI fellows research meeting (North American Conference of GI Fellows “NACGF”) and an ACG Second Year Fellows course which are all opportunities to engage with leaders in the field and develop leadership skills. As far as being educators, I believe as fellows we have the constant opportunity to educate and teach. Every single consult and note are an opportunity to teach, so use these. You will be surprised at the compliments you will get—“great note” or “that was a helpful reference you shared.” How did you manage to be so productive, prolific, and positive throughout fellowship? You are a role model, mentor, and friend to so many of us. What’s the secret? Thank you, Ruchit—you are too kind. I believe the most important part of fellowship is to try to develop the skill set needed to be an excellent gastroenterologist who can provide the best possible care to patients. As far as being productive during fellowship, I believe it is important to remember that it’s not only research, but also scholarly work. I try to make scholarship out of my daily work. What does that mean? Each experience teaches you something— so if you see an interesting case—try to convert it into a case report or image of the month. If you see an area of improvement in your division/ department, think of a quality improvement project. If you discuss an article in a journal club where you have some questions, think about a letter to the editor. Remember that each of us have our unique skills sets. You might be prolific in statistics, while another cofellow might have better writing skills. One person cannot do everything, so build a team, and collaborate. I also encourage fellows to leverage social media (especially Twitter) to collaborate with likeminded trainees and trainers around the world to
enhance your scholarly work. Find good mentors for projects, such as retrospective studies and meta-analysis, but also become a mentor yourself to residents and medical students. This allows you to delegate tasks that they need to learn while you learn new skill sets. This way both you and your mentee grow together. I was fortunate to work with exceptional residents and medical students who pushed me to be more productive. Again, while inperson meetings and conferences are cancelled for now, social media allows for opportunity to network with GI fellows across the country, share ideas and challenges, and learn from each other’s experiences. I predict you will be surprised at how you will find great peer mentors (I certainly did).
DR. MOHAMMAD BILAL’S QUESTIONS TO DR. RUCHIT SHAH Congratulations, Ruchit, on starting GI fellowship! You should be so proud of yourself. What do you think have been the biggest challenges as you started your first year of GI fellowship? Thank you so much, Bilal! You have played a great role in getting me here with your constant support, advice, and mentorship. I think early on in fellowship, one of the bigger challenges was finding the time to study for my IM boards while learning new GI material. Fortunately, I started out on my procedure rotation, so the schedule permitted me to still go home and study. Another challenge for me earlier was being on call. I have some great co-fellows and senior fellows who have always been available to help—even in the middle of the night. However, nothing in medical school or residency prepares you for your first call as a GI fellow. I remember going into the hospital for everything! Triaging, answering calls, staffing with the attendings, picking the right scope and equipment, communicating with the primary teams, cramming in some sleep—it’s been a great learning experience.
Education | 37
// EDUCATION
Learning endoscopy is always a big focus for GI fellows. There are several articles from trainers on how to train in endoscopy, but as an early fellow, what feedback do you have for us (trainers), on what have you found the most helpful in your trainers in terms of learning endoscopy? As one of my mentors said during my first day in the endoscopy unit as a fellow, endoscopy cannot be read, but must be demonstrated. I think there are four components to teaching endoscopy: 1. Discuss a brief plan of action before starting (scope type, screen positioning, ergonomics, equipment, etc.). 2. Give advice, constructive criticism, and positive feedback as the fellow is scoping, live. I think giving pep talks or comments while the fellow is scoping is helpful because it enables us to learn, make changes, and hone our skills in real time. 3. If the fellow is struggling, for instance to reduce the scope after passing the sigmoid, demonstrate how to troubleshoot, and then let the fellow re-do their moves. This helps me a lot because I not only see what the endoscopist did, but also get to physically do it myself right after. 4. Go over the good and the bad, after the procedure is over and what the fellow can improve on for the next one. The COVID-19 pandemic has presented all of us with unprecedented challenges. But I can’t even imagine how challenging it could be to start GI fellowship in the midst of the pandemic. What do you think has been the biggest challenge in navigating the start of GI fellowship through the pandemic? As someone who ended residency and started fellowship with the COVID-19 pandemic being a part and parcel of daily life, the biggest challenge for me was not actually the disease itself, but the aftermath it had on medical education. Didactics, conferences, and networking is a huge part of the GI world. With changes in our in-person didactic schedule, and cancellation of many conferences, many of us first year fellows felt like we missed out on meeting other first year fellows
from around the country. That being said, platforms such as Twitter have brought a lot of us together and closer. We have learned so much from each other via informational tweets, surveys, polls, etc. Moreover, ACG has paved the way for virtual education with their Virtual Grand Rounds and course. There is indeed a silver lining!
“With changes in our in-person didactic schedule, and cancellation of many conferences, many of us first year fellows felt like we missed out on meeting other first year fellows from around the country. That being said, platforms such as Twitter have brought a lot of us together and closer.”
Mohammad Bilal, MD is a gastroenterologist at the Veterans Administration Medical Center Minneapolis, MN, and as Assistant Professor of Medicine at the University of Minnesota. He completed an Advanced Endoscopy fellowship at Beth Israel Deaconess Medical Center/Harvard Medical School and his GI fellowship training at the University of Texas Medical Branch Hospitals. His residency in internal medicine was at Allegheny Health Network in Pittsburgh, PA. Follow Dr. Bilal on Twitter @BilalMohammadMD.
How do you feel about virtual learning with most educational conferences being run virtually? What do you think is the role of social media based educational platforms? Virtual learning has been a great asset for us. Speaking to some senior fellows, I believe this is the first year where the concept of virtual learning has taken off. An example of this is ACG Virtual Grand Rounds. This is such an incredible initiative. Social media has also played a massive role in bring us together as a GI community. From virtual journal clubs to live tweetorials, social media continues to remain one of the most important learning tools for me. What has been the best thing regarding starting GI fellowship so far? This is such as tough question! Everything, all of it. I often get asked by my colleagues how fellowship has been going. My answer has always been that I am literally living my dream. I feel so fortunate to be able to become a part of this wonderful GI community. Waking up every morning (or sometimes, even in the middle of the night), I never feel like I am going to “work.” Getting to joke around with my co-fellows, learning from some awesome GI and hepatology attendings, and being able to live and learn all things GI has been incredible. But, if forced to pick one best thing, I think it would be being able learn about a field of medicine that resonates with your interests and passions. After all these years of schooling and training, finally being able to call myself a gastroenterology fellow feels amazing. I am very excited for the journey ahead, learning from an ambassador in the field like yourself.
Ruchit N. Shah, DO is a first year GI fellow in training at Geisinger Medical Center in Danville, PA where he completed his residency in internal medicine. He is a Social Media Ambassador for the Pennsylvania Society of Gastroenterology. Follow Dr. Shah on Twitter @RuchitShahDO.
Dr. Ruchit Shah and Dr. Mohammad Bilal offered to share insights on starting GI fellowship in 2020 during an extraordinary time. Their perspectives and experiences offer an enlightening snapshot of training at a critical moment in medicine.
38 | GI.ORG/ACGMAGAZINE
ACG Edgar Achkar
By Muku Mugwagwa
Visiting Professorship Program transitions to a virtual format for 2020 THE EDGAR ACHKAR VISITING PROFESSORSHIP PROGRAM TRANSITIONED TO A VIRTUAL FORMAT IN THE SUMMER OF 2020. This change, like so many other adjustments that have occurred as a result of COVID-19, offered new opportunities to connect, while at the same time presenting unique challenges. Delivering the strengths and sense of connection, which are so essential to these EAVP visits with expert faculty, while socially distant meant converting to virtual grand rounds and lectures, as well as organizing one-on-one time for faculty and trainees to connect via Zoom. ACG Past President Dr. Stephen Hanauer was the Edgar Achkar Virtual Visiting Professor in August 2020 at Geisinger Health in Pennsylvania. The visit included case presentations by the fellows to Dr. Hanauer and concluded with a grand rounds presentation, “Best Practices in IBD.” The Geisinger fellows expressed how appreciative they were to have Dr. Hanauer’s expertise on the complex IBD issues they presented. In September, Ascension Providence-Providence Park Hospital held a hybrid visit with Dr. John Pandolfino hosted by Dr. Isaam Turk. Dr. Pandolfino presented to
Education | 39
0 2 0 2
// EDUCATION
a small audience
ACG EDGAR ACHKAR VISITING PROFESSORSHIPS
on “GERD and Everything Esophagus.” Dr. Turk orchestrated a visit that allowed
ROY SOETIKNO, MD, FACG University of North Carolina at Chapel Hill JANUARY 9-11
attendees to be split up in groups of fifteen, in separate auditoriums, as well as to broadcast
STEPHEN B. HANAUER, MD, FACG Geisinger AUGUST 7 (VIRTUAL)
virtually to Zoom attendees. Dr. Turk’s enthusiasm about the hybrid live-virtual visit could serve
JOHN E. PANDOLFINO, MD, MSCI, FACG Providence-Providence Park Hospital SEPTEMBER 9-10
as an template for success for future EAVP programs.
PAUL Y. KWO, MD, FACG UC Irvine SEPTEMBER 16 (VIRTUAL)
Dr. Paul Kwo was a virtual visiting professor at University of California, Irvine. Dr.
DAVID A. JOHNSON, MD, MACG Rutgers Robert Wood Johnson School of Medicine NOVEMBER 13 (VIRTUAL)
Kwo presented on a number of hepatology topics ranging from NAFLD to hepatitis
MILLIE D. LONG, MD, MPH, FACG Tufts Medical Center POSTPONED
C. As moderator and host, Dr. Kenneth Chang was able to
BRUCE E. SANDS, MD, MS, FACG University of Kansas Medical Center POSTPONED
lead a discussion on challenging cases and facilitate fellows sharing different patient presentations. Outgoing ACG Institute Director Dr. Nicholas Shaheen remarked, “Of all of the new programs initiated during my tenure as Director of the Institute, the Edgar Achkar Visiting Professorship (EAVP) holds a special place in my heart. First and foremost, it is a terrific example of how the College listens to the needs of its members and designs programs to meet these needs. In the years prior to the initiation of this program, a recurrent theme from all the training program directors in the U.S. was that money was drying up for facilitating the exposure of their trainees to the people in clinical GI who were leading the field. Money
undergo frequent review to assure that they are effective in accomplishing
BRIAN E. LACY, MD, PHD, FACG Allegheny General Hospital POSTPONED
their goals.” “Making the Edgar Achkar Visiting Professorships ‘virtual’ actually opened up new possibilities for learning, including live case presentations, one-on-one or one-on-few learning, and remote attendance for providers from throughout the country. While COVID-19 has certainly provided plentiful challenges for this program, I am confident that we have learned
DAVID T. RUBIN, MD, FACG Methodist Dallas Medical Center POSTPONED CAROL A. BURKE, MD, FACG Atrium Health in Charlotte, North Carolina POSTPONED CHRISTINA HA, MD University of New Mexico POSTPONED
lessons of great utility, and that some of the practices borne of these times will persist after the pandemic ends,” commented Dr. Shaheen.
for visiting professorships at the institutional level was becoming more and more scarce. This program was designed to specifically fill this need. All of the programs run by the Institute
40 | GI.ORG/ACGMAGAZINE
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.
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
A NEW CLINICAL TREATMENT GUIDELINE on achalasia by Vaezi, et al., includes a diagnostic and treatment algorithm and offers a comparative effectiveness assessment of therapeutic modalities. The authors assess current treatment options including pharmacologic, endoscopic and surgical options. To accompany the guideline, The American Journal of Gastroenterology produced a podcast with Dr. Rena Yadlapati, one of the authors. Researchers in Germany published results of their analysis of changes in the composition of the gut microbiota in patients with chronic pancreatitis in Clinical and Translational Gastroenterology. They found marked dysbiosis, reduced diversity in the gut microbiome, and increased abundance of opportunistic pathogens that could increase complications from pancreatitis. Highlights of two recent cases are showcased in ACG MAGAZINE reflecting the ongoing work by the editorial team of ACG Case Reports Journal to provide GI fellows, private practice clinicians, and other members of the health care team an opportunity to share interesting case reports with their peers.
Inside the Journals | 41
// INSIDE THE JOURNALS
INSIDE THE JOURNALS [THE AMERICAN JOURNAL OF GASTROENTEROLOGY]
ACG Clinical Guideline: Diagnosis and Management of Achalasia Michael F. Vaezi, MD, PhD, MSc, FACG; John E. Pandolfino, MD, MS, FACG; Rena H. Yadlapati, MD, MHS (GRADE Methodologist); Katarina B. Greer, MD, MS; and Robert T. Kavitt, MD, MPH
ď‚Š ACHALASIA IS AN ESOPHAGEAL MOTILITY DISORDER characterized by aberrant peristalsis and insufficient relaxation of the lower esophageal sphincter. Patients most commonly present with dysphagia to solids and liquids, regurgitation, and occasional chest pain with or without weight loss. High-resolution manometry has identified 3 subtypes of achalasia distinguished by pressurization and contraction patterns. Endoscopic findings of retained saliva with puckering of the gastroesophageal junction or esophagram findings of a dilated esophagus with bird
beaking are important diagnostic clues. In this American College of Gastroenterology guideline published in September, the authors used the Grading of Recommendations Assessment, Development and Evaluation process to provide clinical guidance on how best to diagnose and treat patients with achalasia. TREATMENT ALGORITHM A reasonable tailored treatment algorithm for patients with achalasia and no previous therapy is outlined in Figure 8. Symptomatic patients with suspected achalasia should undergo upper endoscopy to ensure no other pathology
and to rule out pseudoachalasia. HRM and timed barium swallow should be used to confirm the diagnosis. The choice between the therapeutic modalities depends on manometric subtypes of achalasia, patient preference, and institutional expertise. PD, HM, and POEM are good choices in those with types I and II achalasia. PD should be performed in a graded fashion starting with the smallest balloon (3.0 cm) except in younger men (less than age 45 years) who may benefit with the initial balloon size of 3.5 cm or surgical myotomy. In patients unresponsive to PD, surgical myotomy should be performed. In patients with type III achalasia tailored HM or POEM may be used. If patients are unfit to undergo definitive therapy because of comorbidities, then therapy with botulinum toxin and smooth muscle relaxants should be offered. To maximize patient outcomes, all definitive therapies should be Clinical Guidelineswith 1407 offered inACG centers of excellence
FIGURE 8
Figure 8. Diagnostic and treatment algorithm for patients with suspected achalasia. FLIP, functional lumen imaging probe; GERD, gastroesophageal reflux disease; HRM, high resolution manometry; PPI, proton pump inhibitor.
failed endoscopic dilations showed signiďŹ cant symptom and objective improvements in esophageal parameters after POEM (145).
42 | GI.ORG/ACGMAGAZINE
100,000 patient years at risk for adenocarcinoma (148). There is evidence that the risk of esophageal adenocarcinoma is also increased in achalasia; however, this is substantially lower than the
recovered without complications. Chronic suppressive antibiotics were discontinued.
cutaneous pocket in the abdominal wall where t resides. Less common is the erosion of the abdo the stimulator, stimulation of abdominal rec penetration of the leads through gastric mucos wires in the generator pocket and formation of a DISCUSSION [ACG CASE REPORTS JOURNAL] adequate volume and expertise. development of volvulus around the wires.12,13,1 involves 4 Journal modes (ACGCRJ) of treatment: Postintervention patients should Management of gastroparesis ACG Case Reports is a peer-reviewed, open-access analysis, the infectionpublication rate is about 1%–2% and nutrition, glycemic control in diabetics, pharmacologic, andclinicians, be followed for symptom 10of the health that provides GI fellows, private practice and other members perforation rate 0.8%. In considering GES, risk invasive treatment (ie, GES and surgery). Dietary modifications recurrence and complications care team an opportunity to share interesting should case reports with theirdepending peers and with be weighed on a patient’s pr are small meals that are low in fat and fiber. When dietary leaders in the field. The journal is edited by a team of GIquality fellowsof under from GERD. TBE and endoscopy current life. the leadership changes are ineffective, prokinetics are indicated, including of Co-Editors-in-Chief Ahmad Bazarbashi, MD and Isabel Hujoel, MD. can be complementary in metoclopramide, macrolide antibiotics, and domperidone, The first sign of erosion is an infection of the subc assessing for recurrent disease supplemented with symptomatic treatment for nausea and or failure of the device’s intended purpose. It is vs reflux-related inflammation or pain. In refractory patients, GES is considered as a next step. inflammation or erosion of gastric mucosa in There is no guideline for the appropriate time to consider GES, stricturing. 8,9 electrode impedance.14 This can occur anytime but patients should have failed noninvasive methods. Efficacy Repeat PD, HM, or POEM likely in the immediate postoperative period. In has been variable: In one cohort study of 151 patients, 75% had may be performed in those occurred about 7 weeks after his most recent s symptom improvement. A meta-analysis of 13 studies, 12 of with recurrent disease and placement. He presented with worsening gastrop which were uncontrolled, with Sallyshowed Condon, MD;overall Aniruddhimprovement Patel, MD; Nihar Shah,MD; and other parts of the in areported presentati acid-suppressive therapy toms, consistent withbowel 2 other GES. Among the 5 studies reporting gastric emptying, sigAbigail Stocker, MD;on Michael Hughes, MD; Russell Farmer, 59-year-old patient with gastroparesis should be offered to those MD; Thomas Abell, MD, University of Louisville, KY electrical stimulator erosion, which penetrated th nificant improvement at 2 and 4 hours were 23% and 12.6%, a history of multiple with GERD-induced symptoms. respectively. Seventy-eight percent of patients requiring par- and cosa. Interestingly, thesehardware 2 cases had no changes i infections with device exchanges. trical stimulator settings on interrogation.15 Previo Esophagectomy may be needed enteral and enteral feeding was no longer dependent. The total Condon, et al. report on a rare but infection is a major risk factor because both ca showed significant, although variable, in those with a dilated esophagus symptom severity score important complication of gastric erosion presented in Liu et al had hardware infect randomized, controlled study improvement.10 In one electrical (larger than 8 cm) with poor stimulators, erosion of of 55 11 Our Readpatient the Case: hadbit.ly/ACGCRJmultiple device exchanges rela patients, weekly vomiting decreased 67% at 1 year. electrodes through the gastricmucosa response to an initial myotomy.
Gastric Electrical Stimulators Causing Erosion Through the Colonic Wall
1396
Vaezi et al.
Condon-GES
Table 3. Key concept statements Statement Timed barium esophagram showing retained barium and bird beaking in the appropriate clinical presentation may be diagnostic of achalasia. Endoscopic signs of dilated esophagus with retained saliva and food with puckered and tight gastroesophageal junction to the passage of endoscope should raise clinical suspicion for achalasia. FLIP can be complementary in the evaluation of patients with achalasia before and after treatment. Pharmacologic therapy in achalasia should be reserved for those who cannot undergo definitive therapy and have failed botulinum toxin injection.
READ bit.ly/ACG-Guideline-
Serial pneumatic dilation is the most effective non-surgical treatment option for patients with achalasia. Recommendations
In young male patients with achalasia, PD with larger balloon sizes (3.5 cm then 4 cm) or myotomy or POEM may be more effective than initial PD with the 3 cm balloon size.
Achalasia
Patients with suspected achalasia based on clinical presentation should always undergo upper endoscopy to rule-out pseudoachalasia from an obstructing mass. FLIP, functional lumen imaging probe; PD, pneumatic dilation.
excluding pseudoachalasia or other mechanical obstruction that may result in symptoms similar to achalasia. A significant shortterm weight loss in elderly patients with suspected achalasia should alert providers to the possibility of pseudoachalasia. In such cases, cross-sectional imaging and/or endoscopic ultrasound may be used for establishing the correct diagnosis. Endoscopy is useful in patients after therapy who have recurrence of symptoms to assess for reflux and possible reflux-related stricturing vs recurrence of achalasia. Barium esophagram can be complementary in patients whose manometric findings are equivocal or not classic. Timed barium esophagram (discussed in the “Post-Therapy Assessment” section) was developed to guide providers not only in suspecting the diagnosis of achalasia but also to help guide post-therapy success. Barium column height at 1-, 2-, and 5-minutes after ingestion of a large barium bolus determines the retention of barium and rate of emptying. Thus, in the appropriate clinical setting, achalasia can be diagnosed with esophagram findings of retained barium and bird beaking and/or endoscopic signs of a dilated esophagus with retained saliva and food with a puckered and tight esophagogastric junction (EGJ). The diagnosis of achalasia is confirmed with high-resolution manometry (HRM), which is the current gold standard test (8). HRM leverages improved space-time resolution and a more
intuitive description of contractile and pressure patterns to refine
the classification of motor dysfunction that was originally de LISTEN: bit.ly/Yadlapatiscribed using conventional low-resolution pressure tracing ma-
Achalasia-2020
nometry. The main benefits of this classification are an improved accuracy, an ability to distinguish clinically relevant subtypes, and a higher level of reproducibility. The achalasia subtypes represent the foundation of the Chicago Classification, and this approach advanced our understanding of achalasia as a heterogeneous disease with distinct patterns of pressurization and contraction in the body of the esophagus (9). Achalasia is now recognized to present with 3 distinct manometric subtypes (Figure 2). All 3 subtypes have impaired EGJ relaxation, but the distinguishing features are the pattern of esophageal pressurization and contraction. Achalasia type I (second most common; 20%–40% of cases) is characterized by 100% failed peristalsis (aperistalsis) with the absence of panesophageal pressurization to more than 30 mm Hg, achalasia type II (most common; 50%–70% of cases) is characterized by 100% failed peristalsis (aperistalsis) with panesophageal pressurization to greater than 30 mm Hg, and achalasia type III (least common; 5% of cases) is characterized by spastic contractions because of abnormal lumen obliterating contractions with or without periods of panesophageal pressurization (9).
Dr. Rena Yadlapati in conversation with Dr. Brian Lacy, AJG Co-Editor-in-Chief
ACG CASE REPORTS JOURNAL IMAGE | ESOPHAGUS
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An Odd Place for Acne: Ectopic Esophageal Sebaceous Glands Ross J. Humes, MD1,2, Brett W. Sadowksi, MD, FACP1,2, James O. Long, MD3,4, and Mark N. Damiano, MD, FACP1,2 Department of Medicine, Uniformed Services University, Bethesda, MD Division of Gastroenterology, Walter Reed National Military Medical Center, Bethesda, MD Department of Pathology, Uniformed Services University, Bethesda, MD 4 Department of Pathology, Walter Reed National Military Medical Center, Bethesda, MD 1 2 3
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Figure 1. (a) Endoscopic appearance of foam and saliva in the esophagus in achalasia. (b) Puckering of gastroesophageal junction requiring more than usual pressure to traverse in achalasia. (c) Barium swallow showing dilated esophagus with retained barium and “bird beaking.”
CASE REPORT
1397 A 63-year-old man was seen in a gastroenterology clinic for evaluation of chronic cough and globus sensation. An esophagogastroduodenoscopy displayed yellow, plaque-like material extending from the proximal to distal esophagus (Figure 1). These lesions could not be removed with lavage and were subsequently biopsied.showing The biopsy 2 demonstrated a collection round cohesiveseen cells with Figure 1. (A–D) Endoscopic images from colonoscopy wires from gastricofstimulator piercing the distal transver cleared out cytoplasm and small centrally located nuclei arranged in an acinar configuration, consistent with ectopic sebaceous 60 cm from the anus, with a disk-like structure attached to the distal part of the wire. glands. These glands are located within the lamina propria underlying a normal-appearing stratified squamous cell epithelium (Figure 2). The patient also had esophageal pH testing showing a normal DeMeester score. The patient was treated with nasal fluticasone with improvement his presenting symptoms. Therefore, symptoms were attributed to postnasal drip, rather than 1,2 Ross7 J.inHumes, MD1,2; Brett W. Sadowksi, MD,the FACP ; ACG Case Reports Journal / Volume acgc globus sensation. An EGD displayed the ectopic sebaceous glands. 3,4 1,2
ACG Clinical Guidelines
VOLUME 115 | SEPTEMBER 2020 www.amjgastro.com
The American Journal of GASTROENTEROLOGY
Copyright © 2020 by The American College of Gastroenterology. Unauthorized reproduction of this article is prohibited.
An Odd Place for Acne: Ectopic Esophageal Sebaceous Glands James O. Long, MD ; Mark N. Damiano, MD, FACP ;
Correct diagnosis, treatment, and management of patients with achalasia is crucial to ensure optimal patient outcome. In a blinded multicenter study by Carlson et al. (10) esophageal pressure topography was shown to have superior inter-rater agreement and diagnostic accuracy compared with conventional manometry. The total agreement in the study was moderate for esophageal pressure topography (k 5 0.57; 95% confidence interval [CI]: 0.56–0.59) and fair for conventional manometry (k 5 0.32; 0.30–0.33), and the odds for an incorrect diagnosis was 3.4 times higher with conventional manometry. In addition, Roman et al. (11) performed a randomized trial in which 124 patients underwent conventional manometry and 123 patients underwent esophageal pressure topography to determine diagnostic accuracy in unexplained dysphagia. This study reported a higher yield of making the diagnosis of achalasia (26% vs 12%) and a higher degree of diagnostic confirmation on follow-up (89% vs 81%) with esophageal pressure topography compared with conventional manometry, respectively. Similarly, additional studies have supported high rates of inter- and intra-rater agreement for achalasia (12–14). Recommendation 2. Based on the inherent benefit of improved detail in describing esophageal pressurization and contractile patterns using esophageal pressure topography and superior accuracy and reproducibility in diagnosing achalasia in both randomized controlled and blinded comparison studies, we recommend using esophageal pressure topography over conventional line tracing for the diagnosis of achalasia.
In the era before HRM and esophageal pressure topography, patients with achalasia were grouped as a single disease and were offered various treatment modalities focused on disrupting the LES via dilation or myotomy. The treatment decision was not tailored based on physiology or anatomy and was primarily driven by the expertise of the treating physician and the patient’s preference. Although most studies suggest very good outcomes over a short duration, treatment failures over the first 1–5 years could be as high as 10%–20%. The achalasia subtypes in the Chicago Classification were created to subtype vigorous achalasia and variants into a more uniform scheme to determine whether these subtypes had different pathogenic features and response to therapy (9). The achalasia subtypes were found to differ in prevalence, degree of esophageal dilatation, and underlying opioid utilization, and there was also observational evidence of patients progressing across the subtypes typically starting with © 2020 by The American College of Gastroenterology
yellow, plaque-like material extending
Department Medicine, Uniformed University, Ectopic esophageal sebaceous glandsofare a rare finding with Services an incidence near 0.005%.1 The origins of esophageal sebaceous the proximal to distal glands are unknown, but 2 proposed explanations exist. First, sebaceous could develop in the esophagus fromesophagus, a Bethesda, MD; 2Division of Gastroenterology, Walter glands from 2 type III and moving to type II (9). This signature was consistent Second, they could form changes in patients with gastrocongenital anomaly or Reed heterotopic histogenesis. National Military Medical Center, Bethesda, MD; as metaplastic with the typical description of the progression of disease because a rarebut and benign finding of ectopic 2 it relates to dilatation as type I patients were typically more dilated At present, there is not a clear answer to this question, case reports following patients esophageal reflux disease (GERD). 3 than type II patients. These initial findings led to multiple studies Department of Pathology, Uniformed Services University,3 that assessed treatment outcomes, and a consistent pattern is no known correlation with other with this finding have shown no attributable symptoms or malignant potential. There sebaceous glands located within the emerged where type II patients seemed to have the best outcome, MD; 4Department of Pathology, Walter esophageal conditions Bethesda, such as dysphagia or dysmotility. In our case, theReed patient underwent gastroenterology evaluation to whereas type III patients tended to do poorly with treatments that lamina propria. were confined to the LES or short myotomies (15–20). Two recent National Military Medical Center, Bethesda, MD determine if GERD was causing his cough and globus sensation. His normal pH testing off proton pump inhibitor and meta-analyses also support that achalasia subtypes defined in the Chicago Classification have prognostic value and varying outresolution of symptoms with treatment of postnasal drip are not consistent with GERD as the causative etiology for the comes across therapies (21,22). More recently, there have been additional studiessebaceous focused on glands. Although rare and benign, endoscopists should have a familiarity with the appearance of ectopic esophageal single therapies (Heller myotomy, POEM) and the achalasia subtypes. Three studies assessing the effect of Heller myotomy sebaceous glands to distinguish them from other, nonbenign lesions (such as squamous cell carcinoma) and potentially avoid Humes et al. report a case in a 63-yearacross the achalasia subtypes suggested only mild differences or unnecessary biopsies or other invasive testing. similar outcomes (23,24). These findings are in line with the Humes et al Read the Case: bit.ly/ACGCRJ-Humes1
Figure 2. High resolution manometry of achalasia phenotypes: type I-absent pressurization (left), type II-pan pressurization (middle), and type III-spastic contractions (right). Lower esophageal sphincter relaxation is impaired for all subtypes.
old evaluated for chronic cough and
previous findings supporting better outcomes with surgery for type I and type III based on a more robust disruption and a longer myotomy. Even better results have been found with POEM across the subtypes (25,26), and one study actually found that type III patients performed better with POEM (98% response) vs Heller myotomy (80%) (27). This also suggests that the longer myotomy may be an important component of treatment for type III achalasia. Tailored POEM, which typically extends the myotomy further than Heller myotomy, seems to be even more effective in this subtype, (27) and thus, identifying type III achalasia has implications in treatment decisions. Recommendation
Es-Sebaceous
Financial disclo
Informed cons
Received May 1
3. Based on these observations, we suggest that classifying achalasia subtypes by the Chicago Classification may help inform both prognosis and treatment choice because type II patients have very good outcomes, regardless of which therapy is selected, and type III patients require a more extensive myotomy.
REFERENCE 1. 2.
The functional lumen imaging probe (FLIP) is a highresolution impedance system that is approved by the U.S. Food and Drug Administration to study the pressure geometry relationship and motor function of the esophagus (28). Its role in the diagnosis of achalasia and post-therapy assessment of patients is evolving. By assessing simultaneous cross-sectional area and pressure (distensibility), the FLIP device can depict Figure the pressure1. geometry relationship in a simulated 3D model, and this approach is useful in assessing the EGJ opening dynamics in
ACG Case The American Journal of GASTROENTEROLOGY
3.
Chiu KW, Wu ceous gland m 311–5. Montalvo N sebaceous gla agnosis: A cas 5(2):89–92. Fukuchi M, Ts esophagus: En 2012;6(1):217–
Figureto 2. distal The ectopic sebaceous glands located within the lamina (A and B) Esophagogastroduodenoscopy showing yellow, plaque-like material extending from the proximal esophagus.
Rep J 2020;7:e00465. doi:10.14309/crj.0000000000000465. Published online: November 6, 2020
Copyright © 2020 by The American College of Gastroenterology. Unauthorized reproduction of this article is prohibited. Correspondence: Ross J. Humes, MD (Ross.humes@gmail.com).
propria underlying a normal-appearing stratified squamous cell epithelium.
DISCLOSURES Inside
the Journals | 43
Author contributions: All authors contributed equally to this
Written work prepare duties is, under the U which copyright prot such, copyright doe Government.
// INSIDE THE JOURNALS [CLINICAL & TRANSLATIONAL GASTROENTEROLOGY]
The Gut Microbiome in Patients with Chronic Pancreatitis Is Characterized by Significant Dysbiosis and Overgrowth by Opportunistic Pathogens Fabian Frost, MD; Frank U. Weiss, PhD; Matthias Sendler, PhD; Tim Kacprowski, PhD; Malte Rühlemann, PhD; Corinna Bang, PhD; Andre Franke, PhD; Uwe Völker, PhD; Henry Völzke, MD; Georg Lamprecht, MD; Julia Mayerle, MD; Ali A. Aghdassi, MD; Georg Homuth, PhD; Markus M. Lerch, MD
EXOCRINE PANCREATIC FUNCTION IS A CRITICAL HOST FACTOR in determining the intestinal microbiota composition. Diseases affecting the exocrine pancreas could therefore influence the gut microbiome. We investigated the changes in gut microbiota of patients with chronic pancreatitis (CP). METHODS: Patients with clinical and imaging evidence of CP (n 5 51) were prospectively recruited and compared with twice the number of nonpancreatic disease controls matched for distribution in age, sex, body mass index, smoking, diabetes mellitus, and exocrine pancreatic function (stool elastase). From stool samples of these 153 subjects, DNA was extracted, and intestinal microbiota composition was determined by bacterial 16S ribosomal RNA gene sequencing. CONCLUSIONS: We have studied the intestinal microbiota composition and diversity in patients with chronic pancreatitis and found a significant microbiota dysbiosis, overgrowth by opportunistic, facultative pathogens such as Enterococcus, and depletion of short-chain fatty acid and lactate producers
WHAT IS KNOWN • CP severely affects patients’ quality of life and survival • Exocrine pancreatic function is one of the most important host regulators of intestinal microbiome composition in adults
WHAT IS NEW HERE • CP is associated with a high degree of gut microbial dysbiosis, the degree of which is independent of exocrine pancreatic insufficiency • Abundance of epithelialprotective short-chain fatty acid and lactate producers is reduced in CP • Opportunistic pathogens, previously identified in infected pancreatic necrosis, such as Enterococcus are greatly increased
TRANSLATIONAL IMPACT • Gut microbiota changes in CP may, if and when pancreatitis recurs with an acute episode, facilitate the translocation of pathogens into necrotic collections or, when it remains chronic, permit the development of small intestinal bacterial overgrowth
such as Faecalibacterium or Fusicatenibacter. These changes can facilitate the translocation of pathogens into areas of necrosis, if and when chronic pancreatitis recurs with an acute episode, or allow the development of small intestinal bacterial overgrowth when pancreatitis remains chronic. Certain antibiotic regimens such as the combination of ceftriaxone and metronidazole may further amplify the unfavorable microbiota composition of patients with chronic pancreatitis. CLINICAL IMPLICATIONS This is the first study to identify spectral traits of the esophageal samples related to EoE activity and tissue pathology and to profile tissue-level biochemical composition associated with pediatric EoE. Future research to determine the role of these biochemical alterations in development and clinical course of EoE can advance our understanding of EoE pathobiology.
READ: bit.ly/CTG-Frost
Gut Microbiota Dysbiosis in Chronic Pancreatitis Healthy pancreas
Chronic pancreatitis Various triggers/risk factors Chronic inflammation Acute pancreatitis episodes
Intact gut microbiome regulation Few facultative pathogenic bacteria Diverse microbiome Visual Abstract Frost, et al.
Frost et al. Clin Trans Gastroenterol. [Month Year]. [doi] All icons were created in PowerPoint.
44 | GI.ORG/ACGMAGAZINE
Impaired gut microbiome regulation Facultative pathogenic bacteria Microbial diversity
25+ YEARS AGO... from the pages
of The American Journal of Gastroenterology By Lawrence R. Schiller, MD, MACG for the ACG Archives Committee
N
ot so long ago, colonoscopy was regarded as contraindicated in patients with severe ulcerative colitis for fear of causing perforation. Dr. Alemayehu and Dr. Järnerot from Örebro, Sweden challenged this orthodoxy in an article published in The American Journal of Gastroenterology over 25 years ago.1 They reported a case series of 34 patients with severe ulcerative colitis at risk for surgery who had colonoscopy during the attack. Actionable information was obtained in most,
and no complications occurred. A more recent review of colonoscopic perforation in inflammatory bowel disease by Dr. Makkar and Dr. Shen suggests that the risk of perforation in IBD patients is marginally higher than that in the general population, and that colonoscopy in severe colitis may add some additional risk.2 Nevertheless, the information to be gained often warrants the extra risk since treatment decisions are guided by the extent and severity of inflammatory changes, as outlined in the recent ACG Clinical Guideline for Ulcerative Colitis
in Adults.3 Colonoscopists must be careful with the preparation, insufflation and intubation of the colon in patients with IBD, especially when clinically severe, but need not eschew the procedure when indicated. References: 1. Alemayehu G, Järnerot G. Colonoscopy during an attack of severe ulcerative colitis is a safe procedure and of great value in clinical decision making. Am J Gastroenterol. 1991 Feb;86(2):187-90. 2. Makkar R, Shen B. Colonoscopic perforation in inflammatory bowel disease. Gastroenterol Hepatol (N Y). 2013 Sep;9(9):573-83. 3. Rubin DT, Ananthakrishnan AN, Siegel CA, Sauer BG, Long MD. ACG Clinical Guideline: Ulcerative Colitis in Adults. Am J Gastroenterol. 2019 Mar;114(3):384-413. doi: 10.14309/ ajg.0000000000000152.
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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