March 2015

gastroendonews.com

The Independent Monthly Newspaper for Gastroenterologists

Volume 66, Number 3 • March 2015

Bring on the Sticks: P4P Incentives Become Penalties in 2015

ENDOSCOPY SUITE

Case Volume Tied To Recurrence Rates After RFA for Barrett’s

S

Patients at lower-volume centers experience worse outcomes PHILADELPHIA—Recurrence rates after radiofrequency ablation (RFA) for Barrett’s esophagus are significantly higher at centers that do relatively few cases of the see RFA, page 22

Earlier Endoscopy May Benefit Patients With IBD Exacerbation

F

or patients admitted to the hospital with exacerbated inflammatory bowel disease (IBD), delaying endoscopy by more than two days may increase costs, lengthen hospital stays and increase the risk for death, according to new research.

tarting this year, the small financial incentives that had been associated with voluntary reporting of payfor-performance measures under Medicare will turn into potentially significant financial penalties for gastroenterologists who do not meet the new mandatory quality reporting requirements.

Since 2007, the Centers for Medicare & Medicaid Services (CMS) has offered physicians and other eligible professionals annual bonuses of up to 2% of their total estimated allowable charges for their billing under Medicare Part B if they voluntarily report on at least three quality measures, such as management of hepatitis C, screening for colorectal cancer and assessment of the need for reflux medications for at least half of their Medicare patients. The government’s goal was to help transform Medicare from “a passive

player to an active purchaser of higher-quality, more efficient health care,” according to CMS. These bonuses declined from a high of 2% for program years 2009 and 2010 to 0.5% for program years 2012 through 2014. Now called the Physician Quality Reporting System (PQRS), the program will start imposing a 1.5% “payment adjustment,” or see Sticks, page 19

see Earlier Scope, page 25

I N S I D E

NATIONAL COLORECTAL CANCER AWARENESS MONTH

Avoiding Surgery in Locally Advanced Rectal Cancer Evidence builds for nonsurgical treatment options SAN FRANCISCO—Many patients with locally advanced rectal cancer (stage II/III) who achieve a clinical complete response after neoadjuvant chemoradiation can skip rectal recision without negative outcomes, according to a study presented at the 2014 Gastrointestinal Cancers Symposium (abstract 509). see Nonsurgical, page 14 PRINTER-FRIENDLY VERSION AVAILABLE AT GASTROENDONEWS.COM

EDUCATIONAL REVIEW

Bowel Preparation for Colonoscopy: Assessing and Improving Quality Division of Gastroenterology

The GI Quality Improvement Consortium: Helping Practices Improve Quality and Outcomes in Endoscopy

Beth Israel Deaconess Medical Center and Harvard Medical School Boston, Massachusetts Dr. Sawhney reported no relevant financial conflicts of interest.

C

olonoscopy is the most frequently performed gastrointestinal endoscopic

procedure in the United States, with more than 3.3 million outpatient colonoscopies performed annually.1 Screening and surveillance colonoscopies account for approximately half of these procedures. The number of screening colonoscopies has increased 3-fold over the past decade, and the procedure is now the most widespread cancer screening test in the United States.2,3

See insert after page 40

Although the demand for and acceptance of colonoscopy has remained strong, competing technologies such as computed tomography colonography and fecal DNA testing have made significant progress. With the unrelenting increase in health care expenditures, there has been a renewed focus on quality and value of medical procedures. For colonoscopy to remain the dominant colon cancer screening approach, it is imperative that clinicians continually measure, report and improve its quality and value.

G AST R O E N T E R O LO GY & E N D O S CO PY N E WS • M A R C H 2 0 1 5

New Feature!

David Wild blogs on the microbiome ............. page 3 When patient care becomes irrelevant interrogations ....................................... page 6

SPECIAL REPORT

MANDEEP S. SAWHNEY, MD, MS

Bowel Preparation for Colonoscopy: Assessing and Improving Quality

MicrobEYEome

1

See insert at end of issue

Vitamin D’s link to colorectal cancer..... r page 12 Alcohol abuse common in bariatric patients.................................. page 38

3

GASTROENTEROLOGY & ENDOSCOPY NEWS • MARCH 2015

Science Should Steward Fecal Transplants

MicrobEYEome

Desperate DIYers now operating in a therapeutic Wild West

T

hey’re doing it in bathrooms and on parquet floors, in bedrooms and— shudder to think—possibly even kitchens. FDA regulations limiting use of fecal microbiota transplantation (FMT) to resistant Clostridium difficilee have pushed do-it-yourself fecal transplanters into a state of fecal lawlessness. With so many fecal slurries being kitchen-blended and

so little guidance offered to those doing the blending, perhaps the only stakeholder benefiting unequivocally from the chaos is Black & Decker.

Although the number of DIY FMTers is unknown, Catherine Duff, founder and president of The Fecal Transplant Foundation (www.thefecaltransplantfoundation.org), a patient advocacy organization,

estimates that the number of these procedures is “well over 10,000 a year.”

Individuals are selfadministering for everything from C. difff Crohn’s disease and ulcerative colitis to autism, diabetes, depression and multiple sclerosis, Ms. Duff said. Although physicians can ask the

FDA for investigational new drug approval to use FMT as part of clinical trials for non–C. diff indications, the administrative burden required to proceed down this avenue can be onerous.

Ms. Duff ’s high estimate of the number of FMTs performed in 2014 through regulated channels was roughly 1,5002,000, but that number will probably be between 2,500-5,000 in 2015, she said.

Because the safety of FMT has not been fully established, FMT anarchy is a problem from a public health perspective.

DIY instructions are available online on websites such as PoP (thepowerofpoop. ( com), but armchair practitioners still risk conducting FMT using poorly screened fecal specimens, suboptimal techniques and unhygienic equipment.

The status quo should also be disconcerting to the scientific community, which has been forced by the FDA to watch an abundance of potential DIY patient data pass by.

Given this uncertainty, it may be worthwhile to develop a network of supervised FMT clinics that bypasses regulatory requirements. Although far from being directly analogous, the concept of sites for supervised heroin injections could serve as a model for such a system.

Supervised FMT clinics could provide DIYers with educational resources and instruction on proper technique, while serving as access points through which people can obtain screened and standardized fecal specimens. Organizations such as OpenBiome (openbiome.org) have rigorous protocols for producing such specimens. (See Gastroenterology & Endoscopy News November 2014, page 1.)

Microbiome tests, which are offered

by American Gut (americangut.org) and uBiome (ubiome.com), among others, could be used to track the effects of FMT on the microbiome. Staff members of safe infusion sites might also collect patients’ demographic and clinical data.

Desperate DIYers are operating in this therapeutic Wild West despite—or because of—prohibitive regulations. The scientific establishment should step up and steward the situation as best it can.

—David Wild MicrobEYEome is a new blog on GastroEndoNews.com dedicated to news, original reporting and features related to all things microbiome.

Follow us as we keep our eye on this exciting and rapidly evolving field.

4

GASTROENTEROLOGY & ENDOSCOPY NEWS • MARCH 2015

Heard Here First

Gastro & Endo News @gastroendonews

See page 30

Follow us on Twitter The problem with so

SETs is that it is

difficult to risk-stratify them. This

results in

a lot of surgery for SETs

in the 2- to 5-cm range, the majority of which turn out to be low-risk

lesions, and an

inordinate burden of endoscopic surveillance.

So there is

motivation for

endoscopists to remove these smaller SETs by endoscopy rather

than subject

patients to laparoscopic surgery.

Vol. 66, No. 3 MEDICAL ADVISORY BOARD MANOOP S. BHUTANI, MD

GARY R. LICHTENSTEIN, MD

Houston, Texas

Philadelphia, Pennsylvania

ALAN F. CUTLER, MD

NIRMAL S. MANN, MD, PHD

Farmington Hills, Michigan

Sacramento, California

FREDRIC DAUM, MD

PETER R. MCNALLY, DO

Mineola, New York

Fort Carson, Colorado

STEVEN M. FABER, MD

TARUN MULLICK, MD

Elizabeth City, North Carolina

St. Charles, Illinois

RONNIE FASS, MD

JOEL E. RICHTER, MD

Cleveland, Ohio

Tampa, Florida

BARBARA B. FRANK, MD

DAVID ROBBINS, MD

Philadelphia, Pennsylvania

New York, New York

FRANK G. GRESS, MD

ELLEN J. SCHERL, MD

New York, New York

New York, New York

CHRISTOPHER JOLLEY, MD

PRATEEK SHARMA, MD

Gainesville, Florida

Kansas City, Kansas

MYRON LEWIS, MD

JEROME H. SIEGEL, MD

Memphis, Tennessee

New York, New York

March 2015

DAN RADEBAUGH, Director of Production and Technical Operations

EDITORIAL STAFF

SALES STAFF

ADAM MARCUS, Managing Editor, amarcus@mcmahonmed.com

BRIAN J. HIGGINSON, Publication Director, bhigginson@mcmahonmed.com

JAMES PRUDDEN, Group Editorial Director

MATTHEW SPOTO, Senior Account Manager, mspoto@mcmahonmed.com

MCMAHON PUBLISHING

CRAIG WILSON, Classified Advertising Sales, cwilson@mcmahonmed.com

VAN VELLE, President, Partner

DAVID BRONSTEIN, DONALD M. PIZZI, Editorial Directors ROBIN B. WEISBERG, Manager, Editorial Services ELIZABETH ZHONG, Associate Copy Chief

ART AND PRODUCTION STAFF MICHELE MCMAHON VELLE, Creative Director

BRANDY WILSON, Circulation Coordinator

RAYMOND E. MCMAHON, Publisher and Managing Partner

MATTHEW MCMAHON, General Manager, Partner LAUREN SMITH, MICHAEL P. MCMAHON, MICHELE MCMAHON VELLE, ROSANNE C. MCMAHON, Partners

JEANETTE MOONEY, Y Senior Art Director JAMES O’NEILL, Senior Systems Manager

Subscription to Gastroenterology & Endoscopy News Gastroenterology & Endoscopy Newss obtains its mailing list from the American Medical Association (AMA) and the American Osteopathic Association (AOA).

You do not have be a member of the AMA or AOA to receive the publication, but you do need to be correctly listed on the appropriate organization’s file, with a designated specialty of “gastroenterology,” “hepatology” or “colon and rectal surgery.” All U.S. gastroenterologists, hepatologists and colorectal surgeons should receive Gastroenterology & Endoscopy News free of charge. If you are a U.S. gastroenterologist, hepatologist or colorectal surgeon and you are not receiving Gastroenterology & Endoscopy News, or if you

are changing your name, address or professional specialty, contact the AMA at (800) 262-3211 or the AOA at (800) 621-1773 and notify them of your name, address and professional specialty.

If you are not a U.S. gastroenterologist, hepatologist or colorectal surgeon and would like to subscribe, please send a check payable to Gastroenterology & Endoscopy Newss to: Circulation Coordinator, Gastroenterology & Endoscopy News, 545 West 45th Street, 8th Floor, New York, NY 10036. Annual subscription: $70.00 (outside U.S.A., $90.00).

Single copies: $7.00 (outside U.S.A., $10.00). Please allow 8-12 weeks for delivery of the first issue.

Further questions may be addressed to the Circulation Coordinator at (212) 957-5300, ext.

362, or bwilson@mcmahonmed.com.

Educational & Commercial Reprints Reprints of articles appearing in Gastroenterology & Endoscopy Newss are available in minimum quantities of 500. Reprints can be ordered in black and white or four-color versions and are printed on 80-lb. glossy stock paper. Standard turnaround time is 4 weeks. For specific price quotes, contact Brian J. Higginson at (212) 957-5300, ext. 241, or bhigginson@mcmahonmed.com.

McMahon Publishing is a 43-year-old family-owned medical publishing and medical education company.

McMahon publishes monthly clinical newspapers, annual and semi-annual Special Editions, and continuing medical education and custom publishing pieces.

INFECTIOUS DISEASE SPECIAL EDITION

GASTROENTEROLOGY & ENDOSCOPY NEWS, the independent monthly newspaper for gastroenterologists, has been providing physicians with comprehensive and objective information since 1978. The newspaper is circulated to more than 17,500 gastroenterologists, colorectal surgeons, and hepatologists, and GI-specific physician assistants and nurse practitioners (as reported to BPA Worldwide, Publishers Audit, based on circulation data as of July 2013).

Gastroenterology & Endoscopy News (ISSN 0883-8348) is published monthly by McMahon Publishing. Periodicals postage paid at New York, NY, and at additional mailing offices. POSTMASTER: Please send address changes to Gastroenterology & Endoscopy News, 545 W. 45th Street, 8th Floor, New York, NY 10036. Copyright © 2015 by McMahon Publishing.

A new generation has arrived.

Introducing Fuse® Generation 2 FuseView™ 4K Ultra HD Viewing Experience | FuseBox® Advancements | C38s Slim Colonoscope | StrataFlex™ Technology

To schedule a Fuse demo, please email fuse@endochoice.com or call 888.682.3636 x5.

EndoChoice.com/Fuse | FuseColonoscopy.org | FuseCases.com

6

COMMENTARY

GASTROENTEROLOGY & ENDOSCOPY NEWS • MARCH 2015

Irrelevant Interrogations How the quest for patient data is gathering more and more about less and less

T

he day before I was to undergo a minor outpatient procedure, “Marie,” an employee of the surgical center, called me. The questions began and went on and on. As anyone who has ever been in that situation knows, they were intrusive and personal—the kinds of things only discussed with your doctor, not an anonymous stranger. So much for HIPAA. Following this experience, I began to pay closer attention to the datagathering system in my own workplace, a hospital-based endoscopy center where I am the primary anesthesia provider.

Once upon a time, patients were admitted to the hospital days before a procedure. The house staff, as well as the admitting physician, surgeon or endoscopist, examined them and wrote up their histories and physicals. Lab data, x-rays and other studies were performed and recorded. It was all available in a nonvirtual handwritten chart.

As the price of hospital beds accelerated to unsustainability, that system was discarded and replaced with outpatient procedures where possible, outpatient workup for all but the sickest patients and a new job description: “Marie, Collector of Information” (MCI), a secretary or an already overburdened nurse.

The flow of information from the MCI to the endoscopist, anesthesiologist or other physician involved with care is aided, abetted but unfortunately complicated by the partial introduction of electronic health records (EHRs) and the continued presence of a large pile of paper accompanying the patient.

If the MCI is able to contact the patient

on the pre-procedure day, the patient’s historical information is collected and recorded in the EHR with the blanks filled in on admission. If the patient is unavailable, the collection of information begins in the cubicle before the procedure.

And what a collection process it is.

In addition to reasonable medical information, the patient is interrogated in depth about things that are irrelevant to the procedure. None of this is the fault of an MCI or the institution that is commanded to collect this information by bureaucrats working for state and federal governments and insurance companies. Furthermore, in this era of supposed evidence-based medicine, no controlled studies definitively demonstrate the utility of these data.

Examples abound: MCI: “Do you smoke?”

Patient: “No.” MCI: “Did you ever smoke?”

Patient: “Yes.” MCI: “When did you quit?”

Patient: “35 years ago.”

MCI: “How much did you smoke 35 years ago?”

Patient: “I don’t remember.”

MCI: “You have to tell me something so I can fill in the blank on the computer.”

Patient: Blank stare.

Similar interrogations ensue about alcohol intake, religion, safety at home, measles, chickenpox and so on.

Then it’s my turn. Getting the information I need to provide a safe anesthetic can be challenging. I am mandated to not use the computer console in the patient’s room while the nurse is signed on. I can sign out the nurse and sign myself in or

go to a different screen and complete the signin process there. Both procedures take time and provide only limited information.

The papers on the patient’s bedside stand are more helpful. I used to rummage through them to locate the medication list but more recently simplifying my search, the nurses leave that list on the anesthesia record. The patient’s medicines provide a convenient launchpad into his or her medical history that I supplement by asking appropriate questions. These emphatically do not include querying the patient’s preference for microbrews or a nice Chianti for his or her bimonthly alcohol consumption. Finally, we take the patient into the procedure room and do what he or she came for.

You might ask why all this is important; why does it matter?

There are a few answers. First of all, as noted above, much of this information is unnecessarily intrusive and personal and, in the endoscopy setting, has no real bearing on patient care. The patient may feel uncomfortable revealing information to someone other than his or her personal physician (although my opinion on this may well be wrong: A large younger population cohort raised on Oprah, Dr. Phil and naturally, the social media, appears willing, and even enthusiastic, to surrender their privacy to the world).

Second, like a misdirected romantic tweet or nude selfie, this information

lives forever in the cloud, where it may be hacked or may come back to haunt the patient in ways yet unimaginable.

Third, the data-collection process is cumbersome, time-consuming and frustrating for the collectors. As pointed out by one of my colleagues Alan Weintraub, MD, creating multiple parallel lines of information rather than one continuous one written by and available to all involved parties, makes for tremendous duplication of effort.

And finally, this process puts doctors and nurses in a double bind. On one hand, we are urged and coerced to increase speed and efficiency; on the other hand, we are required to waste time collecting and documenting stacks of irrelevant interrogations.

While pondering this dilemma, the solution suddenly became obvious. I’ll contact the hospital and we’ll establish a committee! All the stakeholders—even the MCI—will be represented. We’ll have weekly meetings, think outside the box, consider robust solutions, eliminate silos, write minutes, have lunch and ...

—Steven S. Kron, MD Dr. Kron is an anesthesiologist in Hartford, Conn.

To the Editor:

I

read with interest the well-written comments of Dr. Ira Shafran and Ms. Patricia Burgunder in the October 2014 issue of Gastroenterology & Endoscopy Newss (page 6) regarding the status of our knowledge and the pyramid of care for Crohn’s disease (CD). Although it is true that we need to continue research efforts on multiple fronts, I am more a “glass is half full” fellow, in that there are modifications in our approach to the pyramid that we can and should make now, based on new knowledge that has come to clinicians over the past few years alone.

Regarding the pyramid, the principal areas of restructuring of the standard of care for moderate to severe CD are these: 1. The decision-making algorithm for care; 2. Redefining the roles for the immunomodulators;

3. More aggressive use of monitoring the levels of biologic agents; 4. Greater attention to the potential gulf between patient symptoms and the concurrent status of mucosal inflammation; and 5. Raising the bar for the remission end point.

All of these areas are interrelated and, as a whole, make up the revision of the standard of care for CD. Data from the SONIC study show that only 30% of patients achieve remission and half that many obtain mucosal healing at 26 weeks. In longer-term studies from Spain and France, immunomodulators fared no better than placebo in remission rates. Yet, the majority of practicing gastroenterologists still depend on this class of drugs for maintenance of remission. The faith seems misplaced here.

I agree fully with the authors of the letter on this point.

The use of immunomodulators in conjunction with a biologic is accepted as the standard of care. What is new is the observation that the dose to limit immunogenicity and antibodies to the biologic is much lower than the dose we may use to attempt maintenance of remission. One may choose a half-dose of 6-mercaptopurine or even 15 mg weekly of oral methotrexate for immunogenicity protection. When patients are in stable remission, one may stop the immunomodulator. If one chooses to stop the biologic, the relapse rate is 30% to 50% (Inflamm Bowel Diss 2014:20:1021-1027). On the other hand, it is reassuring to know that remission is readily achieved again with reintroduction of the biologic in these patients.

Additional revision to the CD pyramid comes from the use of drug trough and antibody levels in the

COMMENTARY

GASTROENTEROLOGY & ENDOSCOPY NEWS • MARCH 2015

7

EMRs and Smart Technology: Vectors of Infection in a Modern World Disinfecting your wired world

O

ver the past five years, there has been an explosion in the use of electronic medical records (EMRs) and personal electronic devices (PEDs) by health care workers. The use of PEDs by patients and visitors in the clinical setting is popular and common.

The recent Ebola crisis brought to light the shortcomings of control policies in modern health centers. As early as 2013, there were press reports of transmission of the virus via a cell phone in Uganda.1,2

Studies already have reported that 5% to 21% of health care workers’ mobile phones provide a reservoir of bacteria known to cause infections,3,4 but if we look at any clinical setting, we see health care workers constantly entering information through shared keyboards and constantly using the touch screens of their PEDs without thinking that such practices can spread infection to themselves and others.

I can picture a scenario in which individuals are treating a contagious patient

not stop to think that a keypad or screen was not disinfected after treating the last patient. Even in 2008, a microbiological analysis of 75 doctors’ mobile phones isolated a total of 90 bacterial pathogens5; and since this study was undertaken before the widespread use of smart screens and EMRs, the numbers can only have increased.

We must all be aware of this hidden vector of the spread of new, potentially deadly infections. A question to be asked

their PEDs and may also act as vectors by infecting large numbers of individuals who may share or use their PEDs. I recommend that health care workers and the population at large be educated with clear guidelines and advice on smart screen and PED etiquette and the proper cleaning and disinfecting of such devices.

This recent Ebola experience may be a catalyst for such education.

Starting today, we must develop preventive strategies like routine decontamination of PEDs, smart screens and keyboards with proper disinfection agents. Such agents should be part of our regular use of such devices, and manufacturers should push for their use. We should have a policy of leaving PEDs and clinical computers outside the room so as not to contaminate them. For decades, we have treated patients with virulent infections and did not bring the chart rack into the room and we did not write our notes with contaminated gloves, so why should we change that practice today?

—Peter J. Papadakos, MD Dr. Papadakos is director of critical care medicine at the University of Rochester Medical Center, in New York. He write frequently about the hazards of an overly digitized health care system.

However, few guidelines even address how shared computer keyboards and smart screens affect the spread of disease between health care workers and patients.

The way we use such devices, without thinking, as part of our daily routine, could develop into an ideal vector for such a deadly infection.

in full gown, gloves and mask coming into contact with bodily fluids and using a PED, and then using that same PED to respond to a text without gloves a few moments after removing the protective gear. In a world that is wired to respond to every alert and message, even the best-educated health professional may

in any debate on containing a virulent pathogen is the role of these new technologies that are touched by all, but cleaned by few. Thus, I believe regulatory agencies, hospitals and health care providers should address this important issue. We must also be aware that patients and their families and visitors also contaminate

6

References 1. New York Daily News. August 27, 2014.

2. Huffington Post. August 27, 2014.

3. J Hosp Infect. 2009;71:295-300.

4. Clin Microbiol Infect. 2011;17:830-835.

5. J Med Sci. 2008;8:73-76.

CORRESPONDENCE

-/," / ," " 9ÊEÊ "- "*9Ê 7-ÊUÊ" /" ,ÊÓä£{

Time To Rebuild Ancient Pyra amids To the Editor:

decision-making process when managing relapses, and also in the more proactive process of monitoring the biologic blood level at all times during the course of care.

It has taken five years, but such monitoring is clinically sensible and at some point will prove to be economically reasonable (Gastroenterologyy 2010;105:1133-1139; Gastroenterol Hepatoll 2014;10:3-5). The drug level is the strongest predictor of clinical response and costs are likely to fall soon.

One of most important decisions in the management of patients with CD relapse is the switch from an anti– tumor necrosis factor agent to the anti–alpha 4-integrin class. That decision is now much easier with the release of vedolizumab (Entyvio, Millennium Pharmaceuticals).

This drug will fully supersede its predecessor natalizumab

because of its improved gut specificity T and safety.

At the other end of the spectrum is the CD patient who has ongoing symptoms while having achieved mucosal healing. These patients are best managed by endoscopic confirmation of healing, search for opportunistic infection, continuation of the biologic and symptomatic care as a phenotype of irritable bowel syndrome.

The above revisions to the CD management pyramid can be done now and will offer an incrementally improved standard of care. The ancient Egyptians would be proud.

he classic inflammatory bowel disease (IBD) treatment pyramid presented at every professional meeting that we have attended during the past 35 years has suggested that the foundational layers of IBD management include aminosalicylates, antibiotics, steroids and immunomodulatory therapy, which have historically been the treatment substructure for Crohn’s disease and ulcerative colitis. Only after the FDA approval of infliximab in 1998 was this pyramid inverted to suggest a top-down approach, with a precarious balancing act on the tip of an otherwise stable and steady structure.

Newer, targeted biologics preventing trafficking of certain subpopulations of inflammatory T-cells, as well as targeting specific pro-inflammatory cytokines, have been tested in numerous clinical trials.

Although biological advances in treating these diseases have transformed the lives of some patients, the limited efficacy, lack of durability, unknown long-term safety issues and enormous cost constraints demand that we question how to redesign this pyramid. Should we turn it upside

down, erect a new and solid framework, or simply renovate the pyramid layers to include a customized bedrock?

It is clear in our decades of exxperience that patients with IBD need a personalized blueprint. Understanding th he pathogenesis, genetic factors and enviroonmental interactions in the early stages off this disease is fundamental in designingg specific and unique therapies for each and every patient. The idea of a customized zed plan, although idealistic, in the current fiscal environment may not be tenable.

The specific treat-to-target paradigm involves measurements of drug levels of small molecules and their antibodies, and so far has been cost-prohibitive and not of proven benefit in terms of outcomes for our patients. Most of the IBD community would agree that immunomodulatory therapy is of unproven efficacy in induction and maintenance of remission apart from steroid sparing in IBD; aminosalicylates have minimal or no value in Crohn’s induction and maintenance therapy. Steroids have induction benefits in IBD, but long-term therapy has clear safety concerns that outweigh those benefits.

An affordable method for detecting disease with simple serologic and other noninvasive measures is warranted. Controlling environmental factors, including diet, stress, smoking and narcotic dependence, with appropriate collaborative efforts in these areas, is mandatory to achieve better results. An initiative among IBD specialists, in our view, should include allocation of resources and attention—particularly research funding—to provide safer and more effective alternatives for our patients. We have an opportunity to apply unique, novel therapies using agents to repair the mucosal defect and to upregulate natural defenses and other regulators of the deranged cellular immunity.

Improving our understanding of the specific role of commensal and other potentially pathogenic microbes should also be a high priority area of exploration.

The bottom line is this: With all of our knowledge and advances in the treatment of patients with inflammatory bowel disease, we still need more research and discovery on causation and a cure for these patients. We need to replace the crumbling pyramid with a new edifice built with integrity, good science and novel therapies.

Ira Shafran, MD Patricia Burgunder, ARNP The authors are with the University of Central Florida College of Medicine, in Orlando.

—Nicholas V. Costrini, MD, PhD, MBA Dr. Costrini is director of gastroenterology at Kalispell Regional Medical Center, in Kalispell, Mont.

8

GASTROENTEROLOGY & ENDOSCOPY NEWS • MARCH 2015

A New Horizon for Bariatric Surgery:

Reducing Readmission Rates SAN FRANCISCO— —With the risk for death from bariatric surgery now as low as that for knee replacement surgery, the bariatric surgery community has set its sights on a new goal: reducing readmissions after bariatric surgery.

“Our next horizon is targeting readmissions, specifically, reducing readmissions within 30 days by 20% nationally,” said John Morton, MD, president of the American Society for Metabolic and Bariatric Surgery and director of bariatric surgery at Stanford University School of Medicine, in California.

In a presentation at the 2014 Clinical Congress of the American College of Surgeons (ACS), Dr. Morton reported that one in every 20 patients who undergo bariatric surgery in the United States will be readmitted to hospital within 30 days, according to an analysis of 18,296 primary bariatric procedures performed in 2012 and reported to ACS’s National Surgical Quality Improvement Program.

The analysis revealed several key risk factors associated with readmission.

Many of these factors are things that bariatric surgical teams can address pre- and postoperatively, Dr. Morton said.

“We can decrease readmissions with a lot of commonsense things that can be done at the right time for the right patient,” he said. Recommendations include dietary counseling about food and water intake and having patients fill prescriptions before discharge from the hospital.

The study comes as the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP), which establishes national standards for facilities and surgeons performing bariatric surgery, launches its first national quality improvement project, Decreasing Readmissions through Opportunities Provided, or DROP. DROP aims to reduce readmissions within 30 days of surgery by 20% at 700 accredited bariatric centers throughout the United States, which could prevent approximately 1,500 bariatric surgery readmissions and save about $525 million.

Beginning in February 2015, the program will be rolled out at about 100 randomly selected bariatric surgery centers in the United States. DROP will be implemented and evaluated over the next 12 months before a final version is extended to all MBSAQIP centers, said Stacy Brethauer, MD, associate director of Cleveland Clinic’s Bariatric and Metabolic Institute, in Ohio.

DROP was first piloted in 2008 by

Risk Factors for Readmission After Bariatric Surgery •

Body mass index >50 kg/m2

•

Longer operating time

•

Hospital length of stay >4 d

•

Preoperative diabetes diagnosis

Postoperative Risk Factors Associated With Return to Hospital •

Surgical site infections

•

Urinary tract infections

•

Deep vein thrombosis

•

Return to operating room

•

Readmissions

Stanford’s bariatric surgery department.

Over several years, Stanford reduced its bariatric surgery readmissions by 75% by implementing changes in patient education, discharge planning and preand postoperative checklists. Among the changes, staff provided patients with a help card that listed phone numbers for patients to call if they had concerns, which often saved them a trip to the emergency department. Patients were given branded water bottles to emphasize the need for proper hydration. Staff put together a detailed discharge checklist that included questions about home care, nutrition and pain. After patients were discharged, a registered nurse called each patient at home the next day to check in on them. For patients having problems, same-day appointments were made readily available. By 2012, readmissions fell to 2%, down from 8% four years earlier.

“When we drilled down into the causes, we were able to significantly decrease readmissions. We hope to pass that on to

other centers,” Dr. Morton said.

Based on Stanford’s experience, DROP organizers put together videos for patients to watch prior to surgery and set out multidisciplinary care bundles that can help manage care components such as dehydration, dietary concerns and medication issues.

In the study presented at the ACS meeting, the most common readmissions were related to gastrointestinal (45%), dietary (33.5%) and bleeding (6.57%) problems that bariatric surgical programs can target by careful discharge planning, Dr. Morton said. “That’s where you see opportunity for improvement,” he pointed out.

The study also identified patients at high risk for readmission. Patients who were readmitted to the hospital were more likely to have a body mass index greater than 50 kg/m2 (30.2% vs. 24.6% for patients who were not readmitted; P<0.001); have a longer operating time (115 vs. 132 minutes; P<0.001), have a hospital length of stay of more than four

days (9.57% vs. 3.36%; P<0.001) and have a preoperative diagnosis of diabetes (31.1% vs. 27.7%; P<0.02).

“What’s helpful about that is [that] for patients at a higher risk of readmission, we escalate coordination of care early on,” Dr. Morton said.

The study also showed that complications are the primary cause of readmission.

Postoperative factors associated with a return to hospital included surgical site infections (15.5% vs. 1.15% among patients who did not have a readmission to hospital), urinary tract infections (3.65% vs. 0.65%), deep vein thrombosis (3.58% vs. 0.13%) and, most significantly, a return to the operating room (22.6% vs.

0.92%; P<0.001 for all).

Logistic regression analysis found that readmission was significantly associated with complications, with an odds ratio of 11.3 (P<0.001).

The DROP program does not address complications, but future MBSAQIP quality initiatives will focus on complications, Dr. Brethauer noted. “One of the take-home messages from this study is that preventing complications from the primary surgery probably will go the farthest in preventing readmissions in our specialty.”

Richard D. Stahl, MD, assistant professor and medical director of bariatric surgery, University of Alabama at Birmingham, said bariatric surgery in the United States has made great strides over the past decade by paying attention to detail, learning from colleagues and never being content with the status quo.

“I think it’s in this vein that the DROP program should be viewed, and why it is so admirable,” Dr. Stahl said. “They think, and I think, we can do better and that, after all, is the mission of all dedicated bariatric surgeons. If we can make [bariatric surgery] better, then it is unacceptable not to improve.”

—Christina Frangou

CONTACT THE

EDITOR amarcus@ mcmahonmed.com

confid ™

PPrecise reccise rrotation otation with with oopen/close peen//close ffunctionality unctionallity ffor or exact exact clip cllip placement.

Save procedure time Predictable performance even in full angulation scope positions.

Reduce costs Proprietary sheath and clip design reduce the potential for channel damage.

Improve outcomes Stronger than stainless steel and tested to remain for 14 days.*

For more information on device solutions contact your Olympus sales representative or call 800-848-9024. ©2014 Olympus America Inc. Registered Trademark of Olympus or its affiliates. I www.medical.olympusamerica.com I OAIGI0814AD13722 *

FDA reviewed simulated testing on file.

NOT SEEING CLEARLY? Recover from poor bowel prep with the MEDIVATORS™ JET PREP™ Endoscopic Flushing Device. Remove stool, debris and frustration while improving colon visibility and polyp detection.

JET PREP™ Endoscopic Flushing Device in Action

Du uring Flu ush shin ing g

MEDIVATORS.COM © 2014 MEDIVATORS Inc. P/N 50098-480/A MEDIVATORS™ is a trademark of MEDIVATORS Inc. JET PREP™ is a trademark of Jet Prep Ltd.

Afte Af er Fl Flus ushi us hing hi ng

Your Best Practice is Our Promise. &/%04$01: 130$&%63& r &/%04$01: 3&130$&44*/(

CRANBERRY FLAVOR NOW AVAILABLE!

* *by

patients in clinical trials†

Split-dose Prepopik demonstrated‡: EFFECTIVE CLEANSING

PATIENT PREFERENCE †

10% difference in achieving excellent or good overall visualization (84% vs 74%)1

99% successfully completed Prepopik vs 91%1

90% achieved response in the ascending colon vs 79%1

96% would choose Prepopik again vs 55%1

92% achieved response in the transverse colon vs 86%1

3x as many patients found it very easy or easy to take (89% vs 29%)1

LOWEST VOLUME

Only 10 oz. of active prep solution with additional clear liquids of choice for hydration2

92% achieved response in the rectosigmoid colon vs 87%1

Choose Prepopik. A bowel prep that is efficacious and preferred by patients in clinical trials.‡1 †

The SEE CLEAR I study was a phase 3, randomized, multicenter, assessor-blinded, active-control, non-inferiority study in adult patients preparing for colonoscopy. The primary endpoint was overall colon cleansing using a modified version of the Aronchick scale. The secondary endpoint was the quality of cleansing of the ascending, mid (transverse and descending), and rectosigmoid segments of the colon using the Ottawa scale. Patients were also required to complete a questionnaire, which included the questions: “How easy or difficult was it to consume the study drug?” and “Would you ask your doctor for this preparation again if you needed another colonoscopy in the future?” ‡ Prepopik was studied in a head-to-head clinical trial to demonstrate non-inferiority with a split-dose regimen vs a day-before regimen of 2L PEG+E plus 2x 5 mg bisacodyl tablets.2

INDICATION AND IMPORTANT SAFETY INFORMATION Prepopik® for oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adults.

• Prepopik is contraindicated in the following conditions: patients with severely reduced renal function, gastrointestinal obstruction or ileus, bowel perforation, toxic colitis or toxic megacolon, gastric retention, or in patients with a known allergy to any of the ingredients in Prepopik. Patients should be advised on the importance of adequate hydration, and post-colonoscopy lab tests should be considered if a patient develops significant vomiting or signs of dehydration after taking Prepopik • Patients with electrolyte abnormalities should have them corrected before treatment.

Use caution when prescribing for patients who are at risk for seizures, or arrhythmias, including those patients with a history of prolonged QT, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy. Caution should also be used in patients with impaired gag reflex, regurgitation or aspiration, severe active ulcerative colitis, impaired renal function or patients taking medications that may affect renal function, electrolyte imbalance and/or water retention • Oral medication administered within one hour of the start of administration of Prepopik solution may be flushed from the GI tract and the medication may not be absorbed. Prior or concomitant use of antibiotics with Prepopik may reduce its efficacy. Tetracycline and fluoroquinolone antibiotics, iron, digoxin, chlorpromazine and penicillamine, should be

PREPOPIK® is a registered trademark of Ferring B.V. © 2014 Ferring B.V. All rights reserved. PK/1458/2014/US(1)

taken at least 2 hours before and not less than 6 hours after administration of Prepopik to avoid chelation with magnesium. Osmotic laxatives may produce colonic mucosal aphthous ulcerations and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Concurrent use of additional stimulant laxatives with Prepopik may increase this risk • Prepopik should not be used if gastrointestinal obstruction or perforation is suspected.

Prepopik is not for direct ingestion. Each packet must be dissolved in 5 ounces of cold water and administered at separate times, in addition to additional clear fluids, according to the dosing regimen. In randomized, multicenter, controlled clinical trials, nausea, headache, and vomiting were the most common treatment-emergent adverse reactions (>1%) following Prepopik administration

Please see brief summary of Prescribing Information following this advertisement.

References: 1. Rex DK, Katz PO, Bertiger G, et al. Split-dose administration of a dual-action, low-volume bowel cleanser for colonoscopy: the SEE CLEAR I study. Gastrointest Endosc.

2013;78(1):132-141. http://dx.doi.org/10.1016/ j.gie.2013.02.024. 2. Prepopik® Prescribing Information. August 2014. Ferring Pharmaceuticals Inc. Parsippany, NJ 07054, USA.

Hear what healthcare professionals are saying about Prepopik.

Visit prepopik.com/stories

12

NATIONAL COLORECTAL CANCER AWARENESS MONTH

GASTROENTEROLOGY & ENDOSCOPY NEWS • MARCH 2015

Report From the Gastrointestinal Cancers Symposium:

Study Bolsters Link Between Vitamin D Levels and CRC SAN FRANCISCO—Higher levels of vitamin D were associated with markedly improved progression-free survival and overall survival in patients receiving treatment for metastatic colorectal cancer, according to an analysis of more than 1,000 patients. The findings were presented at the recent Gastrointestinal Cancers Symposium (abstract 507).

The study’s lead investigator, Kimmie

Ng, MD, MPH, a physician at DanaFarber Cancer Institute, in Boston, said the research adds to the existing evidence that vitamin D levels have an effect on cancer. Vitamin D is known to inhibit cell proliferation and angiogenesis, induce cell differentiation and apoptosis and have anti-inflammatory effects. “Many of these processes are dysregulated in cancer, which led to the Aspiration Patients with impaired gag reÀex and patients prone to regurgitation or aspiration should be observed during the administration of PREPOPIK. Use with caution in these patients.

Not for Direct Ingestion Each packet must be dissolved in 5 ounces of cold water and administered at separate times according to the dosing regimen.

The following is a brief summary only; see full Prescribing Ingestion of additional water is important to patient tolerance. Direct Information for complete product information. ingestion of the undissolved powder may increase the risk of nausea, vomiting, dehydration, and electrolyte disturbances.

INDICATIONS AND USAGE PREPOPIK® (sodium picosulfate, magnesium oxide and anhydrous ADVERSE REACTIONS citric acid) for oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adults.

Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, CONTRAINDICATIONS adverse reaction rates observed in the clinical trials of a drug cannot PREPOPIK is contraindicated in the following conditions: be directly compared to rates in clinical trials of another drug and may • Patients with severely reduced renal function (creatinine clearance not reÀect the rates observed in practice. less than 30 mL/minute) which may result in accumulation of In randomized, multicenter, controlled clinical trials, nausea, headache, magnesium and vomiting were the most common adverse reactions (>1%) • Gastrointestinal obstruction or ileus following PREPOPIK administration. The patients were not blinded to • Bowel perforation the study drug. Since abdominal bloating, distension, pain/cramping, • Toxic colitis or toxic megacolon and watery diarrhea are known to occur in response to colon cleansing • Gastric retention preparations, these effects were documented as adverse events in • An allergy to any of the ingredients in PREPOPIK the clinical trials only if they required medical intervention (such as a change in study drug or led to study discontinuation, therapeutic or WARNINGS AND PRECAUTIONS diagnostic procedures, met the criteria for a serious adverse event), Serious Fluid and Serum Chemistry Abnormalities or showed clinically signi¿cant worsening during the study that was Advise patients to hydrate adequately before, during, and after the not in the frame of the usual clinical course, as determined by the use of PREPOPIK. Use caution in patients with congestive heart investigator. failure when replacing Àuids. If a patient develops signi¿cant vomiting PREPOPIK was compared for colon cleansing effectiveness with or signs of dehydration including signs of orthostatic hypotension a preparation containing two liters (2L) of polyethylene glycol plus after taking PREPOPIK, consider performing post-colonoscopy electrolytes solution (PEG + E) and two 5-mg bisacodyl tablets, all lab tests (electrolytes, creatinine, and BUN) and treat accordingly. administered the day before the procedure. Table 1 displays the most Approximately 20% of patients in both arms (PREPOPIK, 2L of PEG common adverse reactions in Study 1 and Study 2 for the PREPOPIK + E plus two x 5-mg bisacodyl tablets) of clinical trials of PREPOPIK Split-Dose and Day-Before dosing regimens, respectively, each as had orthostatic changes (changes in blood pressure and/or heart rate) compared to the comparator preparation. on the day of colonoscopy. In clinical trials orthostatic changes were documented out to seven days post colonoscopy.

Table 1: Treatment-Emergent Adverse Reactions observed in at Fluid and electrolyte disturbances can lead to serious adverse events Least (>1%) of Patients using the Split-Dose Regimen and Dayincluding cardiac arrhythmias or seizures and renal impairment. Fluid Before Regimen** and electrolyte abnormalities should be corrected before treatment with PREPOPIK. In addition, use caution when prescribing PREPOPIK Adverse Study 1: Split-Dose Regimen Study 2: Day-Before Regimen for patients who have conditions or who are using medications that Reaction increase the risk for Àuid and electrolyte disturbances or that may PREPOPIK 2L PEG+E* PREPOPIK 2L PEG+E* increase the risk of adverse events of seizure, arrhythmia, and renal (N=305) with 2 x 5-mg (N=296) with 2 x impairment. n (% = n/N) 5-mg n (% = n/N) bisacodyl Seizures There have been reports of generalized tonic-clonic seizures with the use of bowel preparation products in patients with no prior history of seizures. The seizure cases were associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia, hypocalcemia, and hypomagnesemia) and low serum osmolality. The neurologic abnormalities resolved with correction of Àuid and electrolyte abnormalities.

Use caution when prescribing PREPOPIK for patients with a history of seizures and in patients at risk of seizure, such as patients taking medications that lower the seizure threshold (e.g., tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, patients with known or suspected hyponatremia.

Use in Patients with Renal Impairment As in other magnesium containing bowel preparations, use caution when prescribing PREPOPIK for 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-inÀammatory drugs). These patients may be at increased risk for renal injury. Advise these patients of the importance of adequate hydration before during and after the use of PREPOPIK. Consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients. In patients with severely reduced renal function (creatinine clearance < 30 mL/min), accumulation of magnesium in plasma may occur.

tablets (N=298) n (% = n/N)

bisacodyl tablets (N=302) n (% = n/N) Nausea 8 (2.6) 11 (3.7) 9 (3.0) 13 (4.3) Headache 5 (1.6) 5 (1.7) 8 (2.7) 5 (1.7) Vomiting 3 (1.0) 10 (3.4) 4 (1.4) 6 (2.0) * 2L PEG + E = two liters polyethylene glycol plus electrolytes solution. **abdominal bloating, distension, pain/cramping, and watery diarrhea not requiring an intervention were not collected

DRUG INTERACTIONS

‘Vitamin D levels may lead to a slower-growing tumor or could enhance the effects of chemotherapy.’

—Smitha Krishnamurthi, MD

arrhythmias, and prolonged QT in the setting of Àuid and electrolyte abnormalities. This includes patients receiving drugs which may be associated with hypokalemia (such as diuretics or corticosteroids, or drugs where hypokalemia is a particular risk, such as cardiac glycosides) or hyponatremia. Use caution when PREPOPIK is used in patients on nonsteroidal anti-inÀammatory drugs (NSAIDS) or drugs known to induce Antidiuretic Hormone Secretion (SIADH), such as tricyclic antidepressants, selective serotonin re-uptake inhibitors, antipsychotic drugs and carbamazepine, as these drugs may increase the risk of water retention and/or electrolyte imbalance. Consider additional patient evaluations as appropriate.

Potential for Altered Drug Absorption Oral medication administered within one hour of the start of administration of PREPOPIK solution may be Àushed from the GI tract and the medication may not be absorbed.

Tetracycline and Àuoroquinolone antibiotics, iron, digoxin, chlorpromazine and penicillamine, should be taken at least 2 hours before and not less than 6 hours after administration of PREPOPIK to avoid chelation with magnesium.

Antibiotics Prior or concomitant use of antibiotics with PREPOPIK may reduce ef¿ f cacy of PREPOPIK as conversion of sodium picosulfate to its active metabolite BHPM is mediated by colonic bacteria.

USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category B Reproduction studies with PREPOPIK have been performed in pregnant rats at oral doses up to 2000 mg/kg/day (about 1.2 times the recommended human dose based on the body surface area), and did not reveal any evidence of impaired fertility or harm to the fetus due to PREPOPIK. The reproduction study in rabbits was not adequate, as treatment-related mortalities were observed at all doses.

A pre and postnatal development study in rats showed no evidence of any adverse effect on pre and postnatal development at oral doses up to 2000 mg/kg twice daily (about 1.2 times the recommended human dose based on the body surface area). There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, PREPOPIK should be used during pregnancy only if clearly needed.

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when PREPOPIK is administered to a nursing woman.

Pediatric Use The safety and effectiveness of PREPOPIK in pediatric patients has not been established.

Geriatric Use In controlled clinical trials of PREPOPIK, 215 of 1201 (18%) patients were 65 years of age or older. The overall incidence of treatmentemergent adverse events was similar among patients 65 years of age ( 3%) and patients <65 years of age ( 1%). Among all patients 65 years of age, the proportion of patients with successful colon cleansing Electrolyte abnormalities was greater in the PREPOPIK group (81.1%) than in the comparator In general, PREPOPIK was associated with numerically higher rates group (70.9%). of abnormal electrolyte shifts on the day of colonoscopy compared to the preparation containing 2L of PEG + E plus two x 5-mg bisacodyl Renal InsufÀ f ciency tablets. These shifts were transient in nature and numerically similar Patients with impaired renal function or patients taking concomitant between treatment arms at the Day 30 visit. medications that may affect renal function (such as diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor Postmarketing Experience blockers, or non-steroidal anti-inÀammatory drugs) may be at The following foreign spontaneous reports have been identi¿ed during increased risk for further renal injury. Advise these patients of the use of formulations similar to PREPOPIK. Because these events are importance of adequate hydration before during and after the use reported voluntarily from a population of uncertain size, it is not always of PREPOPIK. Consider performing baseline and post-colonoscopy possible to reliably estimate their frequency or establish a causal laboratory tests (electrolytes, creatinine, and BUN) in these patients. relationship to drug exposure.

In patients with severely reduced renal function (creatinine clearance < 30 mL/min), accumulation of magnesium in plasma may occur. The Allergic reactions signs and symptoms of hypermagnesemia may include, but are not Cases of hypersensitivity reactions including rash, urticaria, and limited to, diminished or absent deep tendon reÀexes, somnolence, purpura have been reported. hypocalcemia, hypotension, bradycardia, muscle, respiratory paralysis, complete heart block, and cardiac arrest.

Electrolyte abnormalities There have been reports of hypokalemia, hyponatremia and OVERDOSAGE hypermagnesemia with the use of PREPOPIK for colon preparation The patient who has taken an overdose should be monitored carefully, prior to colonoscopy. and treated symptomatically for complications.

Cardiac Arrhythmias There have been rare reports of serious arrhythmias associated with the use of ionic osmotic laxative products for bowel preparation. Use caution when prescribing PREPOPIK 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). Pre-dose and post-colonoscopy Gastrointestinal ECGs should be considered in patients at increased risk of serious Abdominal pain, diarrhea, fecal incontinence, and proctalgia have been reported with the use of PREPOPIK for colon preparation cardiac arrhythmias. prior to colonoscopy. There have been isolated reports of reversible Colonic Mucosal Ulceration, Ischemic Colitis and Ulcerative Colitis aphthoid ileal ulcers. Ischemic colitis has been reported with the use Osmotic laxatives may produce colonic mucosal aphthous ulcerations of PREPOPIK for colon preparation prior to colonoscopy. However, a and there have been reports of more serious cases of ischemic colitis causal relationship between these ischemic colitis cases and the use requiring hospitalization. Concurrent use of additional stimulant of PREPOPIK has not been established. laxatives with PREPOPIK may increase this risk. The potential for mucosal ulcerations should be considered when interpreting Neurologic colonoscopy ¿ndings in patients with known or suspected inÀammatory There have been reports of generalized tonic-clonic seizures associated with and without hyponatremia in epileptic patients. bowel disease.

Use in Patients with SigniÀcant Gastrointestinal Disease If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering PREPOPIK. Use with caution in patients with severe active ulcerative colitis.

hypothesis that perhaps vitamin D had anticancer activity,” Dr. Ng said.

Laboratory data support this hypothesis, with experiments demonstrating that administering vitamin D to mice with intestinal cancer reduces tumor burden. A previous prospective cohort study in 304 patients with colorectal cancer showed that higher blood levels of vitamin D (25-hydroxyvitamin D) were associated

Manufactured by: Ferring Pharmaceuticals (China) Co., Ltd. No. 6 HuiLing Lu (Ferring Road) National Health Technology Park Zhongshan City, Guangdong Province, CHINA Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, N.J. 07054

www.ferringusa.com 1-888-FERRING Drugs That May Increase Risks of Fluid and Electrolyte Abnormalities Use caution when prescribing PREPOPIK for patients with conditions ©2014 Ferring B.V. or who are using medications that increase the risk for Àuid and All rights reserved. Printed in USA. electrolyte disturbances or may increase the risk of seizure, PK/069/2014/US(1)

with a significant improvement in OS ((J Clin Oncoll 2008;26:2984-2991).

To shed more light on the issue, investigators analyzed pretreatment vitamin D levels and outcomes of patients with metastatic colorectal cancer in the CALGB (Cancer and Leukemia Group B)/ SWOG (Southwest Oncology Group) 80405 trial in a “preplanned, prospective, observational cohort study,” Dr. Ng said.

CALGB/SWOG 80405 compared three different first-line regimens for newly diagnosed, advanced CRC. All three regimens started with chemotherapy and added bevacizumab (Avastin, Genentech), cetuximab (Erbitux, Bristol-Myers Squibb) or both. The median vitamin D level in the 1,043 patients for whom this information was available was 17.2 ng/ mL. The recommended healthy range is greater than 20 ng/mL. The investigators organized patient data from lowest to highest levels of vitamin D, and then divided patients into five groups. They discovered that both progression-free survival and overall survival were significantly improved in patients with higher vitamin D levels (Table). The association persisted across

NATIONAL COLORECTAL CANCER AWARENESS MONTH

GASTROENTEROLOGY & ENDOSCOPY NEWS • MARCH 2015

Table. Relationship Between V Vitamin D Levels and Survival Quintile (Q)

Vitamin D Level, Range, ng/mL

Vitamin D Level, Median, ng/mL

OS, mo (log rank P=0.01)

PFS, mo (log rank P=0.02)

Q1 (n=208)

2.2-10.8

8.0

24.5

10.1

Q2 (n=209)

10.9-15.4

13.6

30.0

10.9

Q3 (n=208)

15.5-19.2

17.2

28.4

11.4

Q4 (n=201)

19.3-24.0

21.4

27.2

12.7

Q5 (n=208)

24.1-72.7

27.5

32.6

12.2

OS, overall survival; PFS, progression-free survival

levels may lead to a slower-growing tumor or could enhance the effects of chemotherapy,” Dr. Krishnamurthi said.

According to Dr. Ng, “randomized clinical trials are needed to establish causality,” and a randomized, doubleblind, Phase II trial of vitamin D in metastatic colorectal cancer is underway. The study is randomizing patients to receive FOLFOX (leucovorin, 5-FU, oxaliplatin)-bevacizumab with either 8,000 IU of vitamin D3 daily for two weeks followed by 4,000 IU of vitamin D3 daily, or 400 IU of vitamin D3

13

daily (the standard amount found in a multivitamin).

“I plan to discuss our findings with patients and screen for vitamin D deficiency, since we now know that metastatic patients are frequently deficient,” said Dr. Ng. “Again, it’s too early to recommend vitamin D as a treatment, but since there are standard guidelines to replete to greater than 20 ng/mL for bone health, that is what I do with my patients.”

—Kate O’Rourke Drs. Ng and Krishnamurthi reported no relevant financial conflicts of interest.

MY KIND OF CONFERENCE

2015

‘Patients who had levels in the highest quintile had a median survival of 32.6 months compared with 24.5 months for patients with levels in the

THE ULTIMATE ENDOSCOPY EVENT

lowest quintile.’

—Kimmie Ng, MD, MPH all patient subgroups and after adjusting for multiple prognostic factors. “Patients who had levels in the highest quintile had a median survival of 32.6 months compared with 24.5 months for patients with levels in the lowest quintile,” Dr. Ng said.

Older age, black race, lower dietary and supplemental vitamin D intake, higher body mass index, worse general physical condition and lower physical activity were associated with lower vitamin D levels.

Patients whose blood specimens were drawn in the winter and spring months also had significantly lower vitamin D levels, as did patients who resided in the northern and northeastern sections of the United States and Canada. These factors have previously been linked to lower vitamin D levels. Few patients reported vitamin D supplement use.

Smitha Krishnamurthi, MD, a medical oncologist at University Hospitals Case Medical Center, in Cleveland, who was not involved with the study, said the study results will be of “great interest” to patients with colorectal cancer who frequently want to know whether there is anything in addition to chemotherapy that can be done to improve their outcomes. “Vitamin D

Join ASGE for the most anticipated endoscopy educational event of the year – EndoFest 2015 – a weekend full of endoscopyfocused, hands-on and didactic sessions highlighting the latest research, skills and technologies in the practice of endoscopy. For more information or to register, visit www.asge.org/endofest or call ASGE Customer Care at (630) 573-0600.

MY KIND OF TOWN

CHICAGO SEPTEMBER 25-27, 2015 FAI RMO NT HO TEL

EA RLY REG I STRATI O N D I SCO U N TS E N D A U G U S T 1 , 2 0 1 5 !

14

NATIONAL COLORECTAL CANCER AWARENESS MONTH

Nonsurgical continued from page 1

In a cohort of 73 such patients who were treated with a watch-and-wait strategy, 77% avoided rectal resection, and the local disease control rate, with salvage therapy, was 98%.

“For patients with complete response, nonoperative management appears to be a safe and effective treatment strategy and achieves a high rate of rectal preservation,” said lead author Philip Paty, MD, a surgical oncologist at

Memorial Sloan-Kettering Cancer Center (MSKCC), in New York City.

“Patients managed nonoperatively avoid the risks of major surgery and maintain excellent bowel function.”

Locally advanced rectal cancer is the most common presentation of the disease. For the past 10 years in the United States, standard management of this disease has been neoadjuvant chemoradiation to the pelvis, followed by rectal resection, and, in most cases, adjuvant chemotherapy. Because pathologic analyses have revealed that 12% to 38% of

GASTROENTEROLOGY & ENDOSCOPY NEWS • MARCH 2015

patients with stage II/III rectal cancer have a complete response after neoadjuvant chemoradiation, clinicians have debated whether surgery is always necessary for this subset of patients.

Angelita Habr-Gama, MD, professor of surgery at University of Sao Paulo School of Medicine, in Brazil, was the first to start evaluating nonoperative, watchand-wait management in selected rectal cancer patients. In recent years, a small number of U.S. cancer centers, including MSKCC, the University of Texas MD Anderson Cancer Center, in Houston, and

University of Rochester Medical Center, in Rochester, N.Y., have followed suit.

In the new study, investigators reviewed the records of all 442 patients with stage I/III rectal cancer who underwent neoadjuvant treatment at MSKCC between 2006 and 2013. They compared outcomes for patients who achieved clinical complete response after neoadjuvant therapy and underwent nonoperative, watch-andwait management (n=73) with outcomes of patients who underwent rectal resection and were found to have had a pathologic complete response (n=72). Most of the patients in the study had stage II/III disease. Patients undergoing the WW approach were initially followed at three- to four-month intervals by digital rectal and endoscopic examinations, and at six-month intervals by cross-sectional imaging.

The median follow-up of all patients in the study was 3.3 years, and the longest follow-up was more than eight years. In the watch-and-wait cohort, 74% experienced a durable clinical complete response and avoided rectal surgery, and 26% eventually underwent rectal surgery to treat tumor regrowth. Nineteen of the regrowths were detected by endoscopy or physical examination, and three were detected through imaging.

“Of the 19 regrowths, all were able to have surgical salvage, and in all cases, the operation was successful in removing the tumor with clear margins,” Dr. Paty said.

In 17 of the 19 cases, a full rectal resection was required, but in two of the regrowths, the tumors were small and a local excision was successful in controlling the cancer. Thus, 77% of the entire nonoperative management group had their rectal function preserved. Pelvic recurrence after salvage therapy occurred in one patient for an overall local control rate of 98.5%.

None of the patients in the cohort who had surgery up front had rectalpreserving surgery. “They either had the

GASTROENTEROLOGY & ENDOSCOPY NEWS • MARCH 2015

NATIONAL COLORECTAL CANCER AWARENESS MONTH

rate, but even larger tumors can melt away completely,” he said.

John Monson, MD, professor of surgery and oncology and chief of the Division of Colorectal Surgery at University of Rochester Medical Center, said that although momentum is building for watch-and-wait management of selected patients with rectal cancer, there are still unknowns, such as how to prove that a patient has completely responded.

“This needs to be managed in centers of excellence that have expertise in it,” Dr. Monson said. “It requires quite

rectum resected and reconnected, or rectal resection plus permanent colostomy,” Dr. Paty said. “Rectal function can be retained/restored by surgery plus reconnection, albeit [there is] poor quality in many patients. Nonoperative management preserves the rectal organ itself and preserves rectal function (normal or close to normal).”

The four-year disease-specific survival and overall survival were not significantly different between patients who had surgery up front and those in the watchand-wait group.

The study adds to evidence from international researchers showing that patients who achieve a clinical complete response after chemoradiation can safely be managed with watch-and-wait. In the most recent work from Dr. Habr-Gama’s group in Brazil, 70 patients were treated and 47 achieved clinical complete response (Dis Colon Rectum 2013;56:1109-1117). Of the 47 patients who had a clinical complete response, 72% ultimately avoided surgery and thus were able to preserve their rectum.

In the overall cohort, rectal preservation was achieved in 50%. In a 21-patient study from the Netherlands, with an average follow-up of 25 months, 20 patients remained in clinical complete response after neoadjuvant chemoradiation; one patient developed a local recurrence and was managed with salvage surgery ((J Clin Oncoll 2011;29:4633-4640). In the United Kingdom, researchers reported a series of six patients with locally advanced rectal cancer who were successfully managed without surgery (Colorectal Dis 2012;14:567-571).

Dr. Paty said that in the MSKCC series and the three international studies, patient and tumor characteristics at presentation were quite heterogeneous, with variable T stage (T1-T4), nodal stage (N0-N2) and tumor location (0-12 cm above anal opening). “Smaller tumors have a higher CR

an investment of time and effort on the part of the doctors and on the part of the patient.” Furthermore, patients being treated with this approach need to be reexamined every three months for at least the first three years, he continued.

“When Dr. Habr-Gama first started doing this, everybody thought she was crazy, although they knew she was asking a question that everybody wanted an answer to. Everybody had seen these patients,” Dr. Monson said. “Ten to 15 years later, the data became impossible to ignore and innovative centers such as

ours said, ‘what about this paper from Brazil,’ and we started evaluating it. This is definitely not ready to be standard of care, but it is ready for a serious scientific evaluation at this point.”

A prospective Phase II trial of watchand-wait management for locally advanced rectal cancer has recently begun enrolling patients at 20 institutions across the United States.

—Kate O’Rourke Drs. Paty and Monson reported no relevant financial conflicts of interest.

Over-your-counter is the new over-the-counter.

CRH Medsens Medsense se is a complete fulfillment fulfillm ment prog program gram designed to get the OTC medications you recom recommend mmend patient guesswork and improves patient adherence.

For more information about CRH Medsense call 866.433.3519 x 1002 or visit www.crhmedsense.com

It’s also now being performed by more than 1,800 physicians at 600 practices across the country.

For more information, call 866.473.3024 x 1023 or visit www.crhmedicalproducts.com

15

16

NATIONAL COLORECTAL CANCER AWARENESS MONTH

GASTROENTEROLOGY & ENDOSCOPY NEWS • MARCH 2015

For Advanced Colorectal Cancer:

TRIBE Solidifies Role for FOLFOXIRI Plus Bevacizumab SAN FRANCISCO—Updated results from the Phase III TRIBE trial provide support for the use of FOLFOXIRI plus bevacizumab as first-line therapy for patients with metastatic colorectal cancer. Compared with the standard treatment of FOLFIRI plus bevacizumab and maintenance therapy, FOLFOXIRI plus bevacizumab and maintenance therapy extended the median overall survival by roughly four months.

“The reduction in the risk of death [was] 20%,” said Chiara Cremolini, MD, a medical oncologist at the Tuscan Tumor Institute in Pisa, Italy. She presented the results of TRIBE at the Gastrointestinal Cancers Symposium (abstract 657), on behalf of the Gruppo Oncologico Nord Ovest (GONO), an Italian cooperative trials group.

Studies have shown that adding bevacizumab (Avastin, Genentech) to FOLFIRI (leucovorin, fluorouracil [5-FU],

irinotecan) and FOLFOX (leucovorin, 5-FU, oxaliplatin)—the two most widely used first-line chemotherapy regimens for metastatic colorectal cancer—increases overall survival. A previous Phase III trial, also conducted by GONO, demonstrated that FOLFOXIRI (leucovorin, 5-FU, oxaliplatin, irinotecan) alone improved survival compared with FOLFIRI alone in the first-line treatment of metastatic colorectal cancer ((J Clin Oncol 2007;25:1670-1676).

To determine if adding bevacizumab to FOLFOXIRI would add further benefit, the TRIBE investigators randomized 508 patients with unresectable metastatic colorectal cancer to receive up to 12 cycles of bevacizumab at a dose of 5 mg/kg, plus either FOLFOXIRI or FOLFIRI. Patients then received maintenance with 5-FU-leucovorin plus bevacizumab until disease progression.

The arms were well balanced in terms of

factors such as performance status and adjuvant chemotherapy.

Previously, TRIBE researchers

reported that at a median follow-up of 32.2 months, FOLFOXIRI reduced the risk for progression by 25% (median

‘Looking at the survival curve, the benefit of FOLFOXIRI plus bevacizumab increases over time.’

—Chiara Cremolini, MD

By the Numbers ■ Non-Hispanic White ■ Non-Hispanic Black

■ Asian/Pacific Islander ■ American Indian/Alaska Native

Incidence

■ Hispanic ■ All Persons

Mortality

70

70 63.8

Rate per 100,000 People

60

60 50.9

51.7

50

51.7

40.8

40

50

47.6

47.3

42.7 39.1

38.6 31.0

40

32.6 29.4

30

30

20

20

19.2 13.1

10

10

0

0

Men

Women

19.4

19.6

18.7 16.1

15.4

13.6 9.7

Men

Women

U.S. Colorectal Cancer Incidence and Mortality Rates by Race/Ethnicity and Sex, 2006-2010 Source: American Cancer Society; reprinted with permission.

13.9 10.2

NATIONAL COLORECTAL CANCER AWARENESS MONTH

GASTROENTEROLOGY & ENDOSCOPY NEWS • MARCH 2015

progression-free survival [PFS], 12.1 vs. 9.7 months; P=0.003) (N Engl J Med 2014;371:1609-1618). There also was

a trend for improved survival. At that time, the investigators reported that patients receiving FOLFOXIRI had a

‘This regimen is not for everyone, but for the right patient, this is one of the most active regimens with an impressive, almost 25%, survival rate at five years.’

—Smitha Krishnamurthi, MD

significantly higher incidence of grade 3/4 neurotoxicity, stomatitis, diarrhea and neutropenia.

In the updated results presented at the Gastrointestinal Cancers Symposium, with a median follow-up of 48.1 months, the FOLFOXIRI arm continued to show a superior PFS (median 12.3 vs. 9.7 months; hazard ratio [HR], 0.77; P=0.006), as well as a statistically signifiP cant superior OS (median 29.8 vs. 25.8 months; HR, 0.80; P=0.030).

P “Looking at the survival curve, the benefit of FOLFOXIRI plus bevacizumab increases over time,” Dr. Cremolini said.

The estimated five-year overall survival rate was 24.9% in patients receiving FOLFOXIRI plus bevacizumab compared with 12.4% in patients receiving FOLFIRI plus bevacizumab. The benefit was consistent across all subgroups, including by KRAS S or BRAF F status and performance status.

17

“This study clearly demonstrates that FOLFOXIRI and bevacizumab is a safe and effective treatment for patients with advanced colorectal cancer who can tolerate a triple chemotherapy regimen,” said Smitha Krishnamurthi, MD, a medical oncologist at University Hospitals Case Medical Center, in Cleveland, who was not involved with the study.

Pointing out that 90% of the patients in the trial were asymptomatic at the time of enrollment and patients over the age of 75 years were not eligible, Dr. Krishnamurthi said, “This regimen is not for everyone, but for the right patient, this is one of the most active regimens with an impressive, almost 25%, survival rate at five years.”

—Kate O’Rourke Dr. Cremolini reported financial relationships with Bayer and Roche.

Dr. Krishnamurthi reported no relevant financial conflicts of interest.

Two Dead After Contaminated Duodenoscopes Used at UCLA he FDA has expressed concern about the safety of reprocessed endoscopes after two patients at the Ronald Reagan UCLA Medical Center, in Los Angeles, died of infections with carbapenem-resistant Enterobacteriaceae (CRE) from contaminated duodenoscopes.

According to the medical center, another 179 individuals who underwent endoscopic retrograde cholangiopancreatography (ERCP) using contaminated duodenoscopes also may have been exposed to CRE between October 2014 and January 2015.

UCLA said the duodenoscopes were cleaned according to manufacturers’ standards, but said the medical center is now “utilizing a decontamination process that goes above and beyond manufacturer and national standards.”

The outbreak is the latest in a string involving multidrug-resistant pathogens that have been linked to contaminated duodenoscopes. Seattle, Illinois and Pennsylvania also reported similar events.

In January, the Virginia Mason Medical Center in Seattle reported that 32 patients had contracted multidrug-resistant bacteria during ERCPs that used contaminated duodenoscopes. Eleven of those patients subsequently died, but their deaths could not be definitively linked to the infection.

The FDA said it is working with other government agencies, the Centers for Disease Control and Prevention and the manufacturers of duodenoscopes used in

T

the United States “to identify the causes and risk factors for transmission of infectious agents and develop solutions to minimize patient exposure.

Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk for transmitting infection, but may not entirely eliminate it, the agency said in a statement. “[T]he complex design of ERCP endoscopes … may impede effective reprocessing.”

The FDA said institutions should follow manufacturers’ decontamination instructions as well as several additional best practices for reprocessing duodenoscopes: • Meticulously clean the elevator mechanism and the recesses surrounding the elevator mechanism by hand, even when using an automated endoscope reprocessor. Raise and lower the elevator throughout the manual cleaning process to allow brushing of both sides.

• Implement a comprehensive quality control program for reprocessing duodenoscopes. The reprocessing program should include written procedures for monitoring training and adherence to the program, and documentation of equipment tests, processes and quality monitors used during the reprocessing procedure.

—David Wild

18

GASTROENTEROLOGY & ENDOSCOPY NEWS • MARCH 2015

Taming Drug-Induced Bowel Dysfunction in the ICU PHOENIX—Prevention is the best medicine for thwarting drug-induced diarrhea (DID) and constipation—two common causes of bowel dysfunction that can complicate the care of patients in the ICU, according to two experts who detailed their management tips at the 2015 Annual Critical Care Congress.

The first step is to understand just how prevalent these adverse drug events are in the ICU. In the case of DID, “there are more than 700 drugs that cause diarrhea,” said Diana Esaian, PharmD, pharmacotherapy specialist, Critical Care Postgraduate Year 1 Pharmacy Residency program coordinator at New York University Langone Medical Center, in New York City.

Because there is little agreement on how many bowel movements in a given time frame constitutes diarrhea, the incidence of DID can be as low as 2% to as high as 95%, she noted.

But whatever the definition or frequency, DID is a potentially debilitating condition that clinicians must meet head-on. Dr. Esaian stressed that DID can lead to malnutrition; electrolyte abnormalities; metabolic acidosis; hypovolemia; increased risk for infection; and contamination of wounds and pressure ulcers. Reduced enteral drug absorption also can result from reduced mucosal contact time.

Easy Targets Although several drugs can cause diarrhea, antibiotics are the most common cause and one of the first problem areas that critical care pharmacists should review for potential interventions, Dr. Esaian noted. “Patients needing antibiotics can have diarrhea in up to 40% of cases,” she said.

Risk factors for antibiotic-associated diarrhea include the use of broad-spectrum agents, particularly those with antianaerobic and Enterobacteriaceae activity. Antibiotics that have high lumen concentrations and have a longer duration of action are also problematic, as is the use of multiple antibiotics.

Breakdown in Mucosal Defense When not used optimally, anti-infectives are uniquely suited to disrupt normal gut function. The medications cause a reduction in anaerobic flora, which lessens bacterial fermentation of carbohydrates into short-chain fatty acids (responsible for colonic health). Critically ill patients can also be deficient in these fatty acids, and there may be an impairment of the mucosal defense against bacterial adherence to colonic mucosa, Dr. Esaian explained. “Because these antibiotics decrease our normal flora, they result in the proliferation of pathogenic

microorganisms, such as Clostridium difficile,” she said. C. difficilee is responsible for more than 90% of the pseudomembranous colitis cases.

Other common organisms are C. perfringens, Staphylococcus aureus, Klebsiella oxytoca, Candidaa and Salmonellaa species.

Management Prevention is best, Dr. Esaian said. She suggested avoiding the use of therapy that is likely to cause diarrhea, avoiding liquid preparations that have a high sorbitol content, especially when using multiple liquid medications, and using antibiotics judiciously. Laxatives and stool softeners should not be on the patient’s medication list. “Sometimes, we have order sets and we don’t notice these are preselected items unless we really screen through [the patient’s] medication list,” she said.

If the diarrhea is related to enteral nutrition, she added, “slowing down the infusion rate, as well as using an infusion pump, can minimize the diarrhea.” Also, she suggested switching to a more isotonic enteral feeding formulation.

Soluble fibers can be considered; however, they should only be used in patients who are hemodynamically stable and at low risk for decreased perfusion.

First-line management should include overall supportive care, minimizing

Mechanisms and Treatments of Drug-Induced Diarrhea

Osmotic diarrhea (osmotically active solutes); laxatives

Secretory diarrhea (excess fluids and electrolytes); stimulant laxatives

Malabsorption of fat (steatorrhea); lipase inhibitors Malabsorption of carbohydrates (osmotic diarrhea); α-glucosidase inhibitors

Fat H2O

Carbohydrates

K+

Lyymphocytes C Collagen

Motility diarrhea (shortened transit time); erythromycin, cisap pride

Exudative diarrhea (protein-losing enteropathy); antineoplastics

Clostridium difficile

Source: Chassany O, et al. Drug Saf. 2000;22:53-72.

Lymphocytic or collagenous colitis; NSAIDs

Pseudomembranous colitis (bacterial proliferation); antimicrobiotics

hypovolemia and electrolyte abnormalities and ruling out infectious diarrhea as a cause. “If the diarrhea still persists or is very severe, use antidiarrheal or antispasmodic agents,” Dr. Esaian said.

Some physicians have been prescribing probiotics, which suppress pathogens by restoring the gut microecology, as a means of slowing or even preventing DID. However, safety and efficacy data on these agents have been mixed, according to Dr. Esaian. In fact, one literature review documented an increased rate of infection and mortality in patients given the supplements (Am ( J Clin Nutrr 2010;91:687-703). She therefore urged caution when prescribing probiotics, especially for the critically ill, in whom few studies on probiotics have been done.

Constipation Awareness Gap Although DID is widely recognized in the ICU, constipation is underappreciated in critically ill patients, according to Pamela L. Smithburger, PharmD, MS, associate professor at the University of Pittsburgh School of Pharmacy. “In one survey, only 52% of units recognize constipation as a problem, and very few had a protocol for diagnosis and treatment of constipation,” she said.

Yet, there also is a high incidence of drug-induced constipation in the ICU, ranging from 15% to 83% of patients, according to Dr. Smithburger. Again, the incidence is so varied because of a lack of a clear definition. Constipation has been described as a lack of bowel movement for three to nine days.

The problem is not benign. Constipation-related complications include prolonged ICU stay; delayed mechanical ventilator weaning; intestinal obstruction and perforation; and inability to receive enteral nutrition.

“Medications that reduce colonic motility are possible culprits of this druginduced condition,” Dr. Smithburger said, but the biggest culprit is high-dose opioid regimens, which decrease motility, prolong transit time and increase fluid absorption, resulting in constipation.

A variety of treatments are available.

Emollient laxatives and stool softeners are typically well tolerated but are ineffective without adequate ingested fluids, she noted. The efficacy of those treatments in reducing opioid-induced constipation is variable and not well studied.

Stimulant laxatives are significantly associated with a bowel movement.

Bulk laxatives require large volumes of water and are not always practical in the ICU, according to Dr. Smithburger, and patients tend to dislike suppositories and enemas.

19

GASTROENTEROLOGY & ENDOSCOPY NEWS • MARCH 2015

Sticks continued from page 1

penalty, this year on Medicare charges for physicians who did not report on at least three quality measures during the 2013 program year. The penalty will increase to 2% in 2016 for program year 2014, which was also the last year that PQRS bonuses were available. (CMS pays bonuses in the calendar year immediately following each program year, but will assess penalties two years afterward.)

“All this should come as no surprise for gastroenterologists,” said Carroll Koscheski, MD, chair of the National Affairs Committee of the American College of Gastroenterology (ACG). “Not a month goes by when there’s not an article about it somewhere, and it’s been a point of discussion at most professional meetings. But does this mean that everybody will be on board? Obviously it doesn’t.”

A Few Carrots, a Few Sticks Further complicating matters is the Value Modifier (VM) program, a newer system that overlaps with and expands on PQRS. The VM program is part of CMS’s

Several pharmacologic agents are promising for opioid-induced constipation.

Naloxone is a non-selective opioid receptor antagonist and the IV formulation is approved for complete or partial reversal of opioid depression. “When used orally, it may be effective in reversing opioid-induced bowel dysfunction. One of the main benefits is the limited oral bioavailability, which is important for patients to not experience opioid withdrawal when using this agent for opioid-induced constipation,” she said.

Methylnaltrexone (Relistor, Salix) is a subcutaneously administered peripheral opioid antagonist that does not cross the blood–brain barrier, thus limiting

value-based purchasing initiative, which is intended to help Medicare transition from traditional fee-for-service to reimbursement of quality-based care. In January, Sylvia Burwell, secretary of the Department of Health and Human Services, said the agency’s goal was “for virtually all Medicare fee-for-service payments to be tied to quality and value, at least 85% in 2016 and 90% in 2018.”

Whereas PQRS requires reporting on at least three quality practice measures (out of about 300 measures endorsed by the National Quality Forum) to avoid penalties, VM will require reporting on nine measures, at least one of which must be an outcome measure.

Starting in 2016, CMS will evaluate 2014 performance and impose penalties on physician groups of 10 or more members who did not report their performance last year. Those who did report on three measures will be neither penalized nor rewarded, whereas those who reported on nine measures will be eligible for bonuses under a complex formula that extracts money from those who do not report successfully.

“PQRS and the value-based purchasing modifier are two different programs in terms of their impact on

withdrawal effects. Most of the studies have been conducted on patients with noncancer pain, but there are limited data in the ICU. Alvimopan (Entereg, Cubist) is an orally administered peripheral µ-opioid receptor antagonist that also does not cross the blood–brain barrier. It is approved for postoperative ileus following partial large or small bowel resection surgery with primary anastomosis. Treatment of opioidinduced bowel dysfunction is an off-label use, Dr. Smithburger said.

“Based on the literature with these opioid antagonists, we should be aware of the possibility of withdrawal and monitor them to make sure they are not

reimbursement cuts, but PQRS participation is tied to determining the potential value-based payment modifier cut,” said Brad Conway, ACG’s vice president for public policy. There are no additional reporting requirements for VM, and CMS uses PQRS participation to determine if individual providers and group practices will automatically get an additional cut.

Recognizing that medical specialties have unique procedures and measures—and to push reporting and record keeping down to the provider level—CMS has allowed specialty organizations to formulate additional quality measures in exchange for establishing their own Qualified Clinical Data Registry (QCDR), through which individuals and physician groups can submit performance reports to avoid penalties and be eligible for bonuses.

One QCDR for gastroenterologists is the American Gastroenterological Association’s Digestive Health Recognition Program (DHRP), a quality improvement program and clinical data registry. Last year, CMS approved two DHRP modules for group reporting— the colorectal cancer screening and surveillance module and the inflammatory bowel disease module. “While the DHRP was designed to support individual participants, the DHRP can accommodate groups of physicians who wish to parrticipate in DHRP and upload their data together as a group of individuals,” the AGA said in a written stateement to Gastroenterology & Endoscopy News.

Another QCDR is the GIQuIC registry maintained by the GI Quality Improvement Consortium, a joint initiative of ACG and the American Society for Gastrointestinal Endoscopy.

E GIQuIC contains more than 80 clinically relevant data fields for more than 1 million colonooscopy cases. More than 10 quality measures are b benchmarked, including rates of cecal intubation and detection of adenomas. More than 2,000 physsicians from endoscopy centers nationwide havee registered. “GIQuIC is leading the way am mong reporting systems and helping physiciaans meet quality compliance requirements,” said d Glenn M. Eisen, MD, MPH, vice president of tthe GIQuIC board, in a statement.

“B Bottom line, it’s not a perfect scenario that all physiicians are happy with,” Dr. Koscheski said. “If you are not a member of one of the GI groups, you need to be eengaged and pay attention to what they are talking abou ut because they are trying to get everybody ready for alll these coming changes.”

—Ted Agres

withdrawing from the opioids we are giving them for their pain,” she said.

Dr. Smithburger stressed that opioids are not the only drugs that can cause constipation. “If your patient is suffering from drug-induced constipation and is not taking opioids, it would be worthwhile to review medications to see if any have anticholinergic properties.” Other causes of constipation, she added, include shock, inadequate oral fluid intake and electrolyte disturbances.

Importance of Prevention The constipation protocol should include risk assessment and dietary intervention; correction of fluid and

electrolyte abnormalities; and minimizing drugs known to slow gastric motility. Dr. Smithburger also recommended reducing patients’ use of opioids and getting them out of bed. It’s also important “to be accountable for discussing the presence or absence of bowel movements” and thus to ensure that bowel movements are charted.

To ensure success, Dr. Smithburger recommended having a standardized protocol in place for managing constipation in the ICU: “How can we correct something if we don’t know that it is happening?”

—Marie Rosenthal The sources reported no relevant financial conflicts of interest.

22 00

GASTROENTEROLOGY & ENDOSCOPY NEWS • MARCH 2015

ENDOSCOPY SUITE

Propofol for Colonoscopy: Are Some Patients Being Oversedated?

NEW ORLEANS— —The The depth of sedation provided by propofol during colonoscopy may be greater than necessary, according to researchers who objectively monitored it in their patients.

The study was prompted by a recent populationbased analysis ((JAMA JAMA Intern Medd 2013;173:551-556) suggesting that complications—especially aspiration pneumonia—are increased during cases with anesthesia assistance.

“No studies have measured the depth of sedation in patients receiving propofol for colonoscopy,” said Basavana Goudra, MD, of the University of Pennsylvania, in Philadelphia.

Dr. Goudra and his colleagues compared the depth of sedation between propofol and non–propofol-based sedation during colonoscopy, as measured by an electroencephalogram-based monitor, SEDline (Masimo), which displays the patient state index (PSI). Dose and timing of administered sedatives were independent of PSI values.

Of the 87 patients studied, 44 received endoscopistguided sedation without propofol (midazolam/fentanyl with or without diphenhydramine) and the remaining patients received propofol administered by a nurse anesthetist. Demographic variables, including mean age, sex and weight, were comparable in both groups. The gastroenterologist and nurse anesthetist were blinded to PSI values.

Drexel University, in Philadelphia, who presented the findings at the 2014 annual meeting of the American Society of Anesthesiologists (abstract 1230). “In colonoscopy, we are aiming for mild to moderate sedation.”

Sedation Much Deeper With Propofol “We found that patients who received propofol were much more deeply sedated,” Mr. Carlin said. Although this is no surprise, he said it is important to objectively quantify the effect.

Dosing of sedatives in all patients was guided by clinical responsiveness and aimed at achieving minimum patient movement. SEDline scores at scope insertion were significantly lower in the patients who received propofol: 52 versus 73 for those given midazolam/fentanyl ((P P=0.004). SEDline scores when patients became

‘Patients receiving propofol were much more deeply sedated, and most patients were in the range of general anesthesia, whereas those with IV conscious sedation were mostly in the moderately sedated range.’

—Augustus Carlin

Propofol-based sedation

to removal of the colonoscope: 24 versus 17 minutes (P=0.007).

Dr. Goudra added that no aspirations occurred in these patients, for whom the risk is low: approximately one patient per 2,000 to 3,000 receiving propofol. Nevertheless, he added, “We know that patients receiving propofol are much more deeply sedated, which means a higher aspiration risk. We believe that, with appropriate titration, all the benefits of propofol sedation can be realized, with a possible reduction in risk.”

Use of a monitor such as the SEDline could optimize the titration of propofol, but whether it is cost-effective in practice is another issue, Dr. Goudra acknowledged.

Anesthesiologists should understand more about depth of sedation, he said, and monitors such as SEDline would help them be more accurate.

Safe in Anesthesiologists’ Hands Jeffrey Jacobs, MD, president of the Florida Society of Anesthesiologists, said the risks associated with propofol have been “exaggerated,” and the drug has “a long track record of safety when administered by an anesthesia professional.”

The Centers for Medicare & Medicaid Services recently indicated that because cost should not be a barrier to screening colonoscopy, it will reimburse for anesthesiologist-led sedation, Dr. Jacobs added.

6.34%

6.06%

Non n–Propofol-based sedation 19.24%

46.34%

28.87%

28.36%

64.78%

■ SEDline score 0-25 ■ SEDline score 25-50 ■ SEDline score 50-75 ■ SEDline score 75-100

Figure. Patients receiving propofol spent a much greater percentage of time in the deepest phases of sedation.

A dedicated research assistant watched the SEDline monitor and noted the PSI scores at baseline, at the time of unresponsiveness (coinciding with insertion of the colonoscope), on removal of the scope and when the patient was appropriately responsive. The researchers also determined the time spent in the various levels, or spectra, of sedation. These spectra—PSI scores of 0 to 25, 25 to 50, 50 to 75 and 75 to 100—indicate deep general anesthesia; general anesthesia/deep sedation; and mild to moderate sedation, respectively.

“While awake, the typical patient has a PSI of 90 to 100, which drops into the 80s, 70s and so forth with titration,” said Augustus Carlin, a medical student at

responsive to verbal commands were also significantly lower with propofol sedation: 62 versus 79 ((P P<0.001), the researchers reported. Patients receiving propofol spent a much greater percentage of time in the deepest phases of sedation (Figure).

“Patients receiving propofol were much more deeply sedated, and most patients were in the range of general anesthesia [PSI, 25-50], whereas those with IV conscious sedation were mostly in the moderately sedated range [PSI, 50-75],” Mr. Carlin said.

The mean total duration of sedation was significantly longer in the propofol group, 34 versus 24 minutes ((P P=0.003), as was the time interval from insertion

“Everything carries a risk, but we attempt to identify patients who are most likely to aspirate, such as those with diabetes-related gastroparesis,” Dr. Jacobs said.

“Maybe there are subsets of patients, like them, who could benefit from depth-of-sedation monitoring, as was done in this study. Of course, if there’s an opportunity to use less propofol, that’s always great; but in our experience, gastroenterologists and patients prefer the deeper sedation.”

—Caroline Helwick The SEDline and the sensors were provided free of charge from the manufacturer. Dr. Goudra, Mr. Carlin and Dr. Jacobs reported no other relevant financial conflicts of interest.

ScopeGuide Real-time, 3D visualization of the scope configuration

Physicians: Identify and mitigate loops.

Nurses: Document precise locations for biopsies.

Assistants: Apply abdominal pressure to the correct location.

Patients: Experience a more comfortable colonoscopy.

Watch Video or visit www.medical.olympusamerica.com/scopeguide/gen Contact a sales representative at 800-848-9024 Š2014 Olympus America Inc. Registered Trademark of Olympus or its afďŹ liates. I www.medical.olympusamerica.com/scopeguide/gen I OAIGI0813AD11548

22 22

GASTROENTEROLOGY & ENDOSCOPY NEWS • MARCH 2015

ENDOSCOPY SUITE

RFA continued from page 1

procedure than at facilities that do them frequently, researchers have found.

The data suggest that it may be necessary to perform 30 or more RFA procedures each year to achieve rates of recurrence that are as low as those achieved at the highest-volume centers, according to the study, which used the US RFA Registry.

After three years of follow-up, the

recurrence rate at low-volume centers was about 20% greater than that for high-volume centers, according to the researchers, from the University of North Carolina (UNC) at Chapel Hill. Nicholas Shaheen, MD, chief of the Division of Gastroenterology and Hepatology at UNC, said the differences were both clinically and statistically significant.

Cary Cotton, a medical student working under Dr. Shaheen, presented the findings at the 2014 annual meeting of the American College of Gastroenterology (abstract 38).

Mr. Cotton and his colleagues stratified the 148 centers participating in the US RFA Registry into five groups by volume. The first quintile consisted of centers enrolling seven or fewer RFA

Figure. Application of a focal ablation device.

Advances in Probiotic Therapy For Diarrhea-Associated Illness To participate in this FREE CME activity, log on to

www.CMEZone.com

Release Date: February 10, 2014

Expiration Date: August 11, 2015

Chair

Statement of Need

Intended Audience

William D. Chey, MD

Probiotics can be powerful tools in managing a number of medical conditions. However, efficacy may be suboptimal if these agents are not used appropriately. As public interest in the benefits of probiotics increases, so does the need for clinical education.

Many physicians and patients are unfamiliar with the nuances of probiotic pharmacology, or—with many probiotics available for over-the-counter purchase— may not be aware that their patients are selecting ineffective therapies. Thus, it is important for health care professionals to familiarize themselves with the latest research data on probiotic use.

Gastroenterologists, primary care physicians, nurse practitioners, nurses, physician assistants, pharmacists, and other health care professionals involved in the care of patients who may benefit from the use of probiotic therapy.

Professor of Internal Medicine Director, Gastrointestinal Physiology Laboratory Co-Director, Michigan Bowel Control Program H. Marvin Pollard Institute Scholar Division of Gastroenterology University of Michigan Health System Ann Arbor, Michigan

Faculty Brooks Cash, MD Professor of Medicine Division of Gastroenterology University of South Alabama Mobile, Alabama

Shanti Eswaran, MD Clinical Assistant Professor Division of Gastroenterology University of Michigan Health System Ann Arbor, Michigan

Goal The goal of this educational activity is to provide clinicians with current evidence and strategies for effective probiotic therapy in a variety of disease states.

Learning Objectives Upon completion of this activity, the participant will be better prepared to do the following: 1 Review key differentiating characteristics of various probiotic therapies, including mechanism of action.

2 Describe the importance of strain specificity in the clinical applicability of probiotic therapies.

Estimated Time for Completion 1 hour

Course Format Monograph

Accreditation Statement This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of AKH Inc., Advancing Knowledge in Healthcare, and Applied Clinical Education. AKH Inc. is accredited by the ACCME to provide continuing medical education for physicians.

Credit Designation AKH Inc. designates this activity for a maximum of 1.0 AMA PRA Category 1 Credit™. t Physicians should claim only the credit commensurate with the extent of their participation in the activity.

3 Discuss the role of probiotic therapy in clinical digestive ailments.

4 Review strategies for appropriate patient selection and education in the use of probiotic therapies.

Jointly sponsored by AKH Inc. and Applied Clinical Education

Supported via an educational grant from Procter & Gamble

Distributed via CMEZone and Gastroenterology and Endoscopy News

patients per year in the registry. In the fifth quintile, the centers were enrolling 56 or more patients per year. Centers that had not been performing RFA for at least one year were excluded from the analysis, which involved 5,521 patients.

The hazard ratio for intestinal metaplasia (IM) recurrence was adjusted for such potential confounders as initial histology, academic or community center, race, length of Barrett’s esophagus and age.

Recurrence of IM fell with increasing patient volume. The difference in the relative risk for recurrence remained large between the third quintile, which represented an annual case rate of 17 to 29 patients, and the fourth, which represented an annual case rate of 30 to 55 patients. The difference was not significant between the fourth and fifth quintiles.

“The data suggest that RFA should be confined when possible to centers where at least 30 cases are performed per year,” Mr. Cotton reported. Although the authors maintained that an increased risk for recurrence should not preclude performance of this procedure when a high-volume center is not available, the data are consistent with some previously published studies suggesting that optimal performance of RFA involves a learning curve.

A large proportion of patients in the study underwent RFA for nondysplastic Barrett’s, which is not clearly an indication for use of the procedure.

Although the authors noted that the registry was created before current indications were established, almost half of patients in the low-volume centers had low-grade or no dysplasia at the time of their ablation.

RFA has been widely adopted as the treatment of choice at a growing number of centers for dysplastic Barrett’s esophagus, according to the UNC team. Although the US RFA registry data suggest that efficacy in practice

GASTROENTEROLOGY & ENDOSCOPY NEWS • MARCH 2015

22 33

ENDOSCOPY SUITE

Metal Stents Boost Success Rates in Pseudocyst Management PHILADELPHIA—Most pancreatic fluid collections are asymptomatic and will resolve spontaneously, but situations in which the patient becomes symptomatic or the pseudocysts grow in size may require drainage, which typically has involved the placement of multiple plastic stents.

In recent years, fully covered selfexpanding metal stents have gained favor with clinicians, and new research shows they are at least as effective as double pigtail plastic stents but have fewer complications.

“Traditionally, [ultrasound-guided] translumenal drainage of pancreatic pseudocycsts is performed using plastic stents, but metal stents are easier to deploy and eliminate the need for multiple plastic stent placements,” said Reem Z. Sharaiha, MD, an advanced endoscopy attending physician at Weill Cornell Medical Center, in New York City, who presented the study at the 2014 annual meeting of the American College of Gastroenterology (abstract 2).

“Drainage of pseudocysts using metal stents results in better outcomes and fewer adverse events compared with

is comparable to that achieved in the clinical trials that led to adoption of the approach, they also indicate that experience affects a patient’s risk for recurrence—a measure of successful and sustained therapy.

The results were not surprising to Prateek Sharma, MD, professor in the Division of Gastroenterology, Hepatology, and Motility at the University of Kansas Medical Center, in Kansas City.

Endoscopic treatment of neoplastic Barrett’s esophagus “is a complex issue requiring a multidisciplinary approach,” Dr. Sharma said. Centers with a focus on RFA offer more than just experience.

“Such treatment should be provided in centers of excellence that take such a multidisciplinary approach,” Dr. Sharma said. These centers “not only reduce the risk of recurrence as shown in this study,” but are more likely to offer other aspects of care, such as close follow-up and patient education, that increase the likelihood of a good outcome.

—Ted Bosworth Mr. Cotton reported no relevant financial conflicts of interest. Dr. Sharma has received research grants from Cook Medical and Olympus. Dr. Shaheen has received research grants or has other financial relationships with Covidien, CSA Medical, Diagnovus, Gi Dynamics NeoGenomics, Oncoscope, Shire and Takeda. Dr. Sharma is on the editorial board of Gastroenterology & Endoscopy News.

plastic. We speculate [the use of ] metal stents may improve success of [pseudocyst] drainage and reduce the number of adverse events,” Dr. Sharaiha said.

Dr. Sharaiha and his colleagues, including researchers at Jefferson University Hospital, in Philadelphia, retrospectively evaluated 230 patients who underwent stent placement for pancreatic pseudocysts between October 2010 and May 2014. Of those, 112 received metal

a

stents. The most common cause of pancreatitis was gallstones (50%) followed by alcoholism (31%). Mean patient age was 52.6 years; about 63% were men; and the mean cyst size was 98 mm (39-250 mm).

The mean number of endoscopy sessions performed was 1.5 (70% of patients had one session, 20% had two) with no difference between the two groups. There was also no difference between the type of stent used and the drainage site. The

median follow-up was 16 months, ranging from just over a year to 27 months.

The two groups were matched in terms of age, sex, cause of pancreatitis, and size and location of the pseudocyst. Successful stent placement was achieved in 98% of patients who received metal devices and 92% of those given plastic stents, a difference that was not statistically significant.

Complete resolution, however, defined as see Stents, page 24

ADD REVENUE TO YOUR PRACTICE WITH ANORECTAL MANOMETRY

Ask about our new biofeedback software

“mcompass is a real game changer, it really brings testing within reach of the private practice market. But hospitals can benefit from it too.”

-Dr. Keith Munson, MD

I t ’s A b o u t Ti m e . . . D i a g n o s t i c Confidence...and Expanding

N E W O P T I O N F O R PAT I E N T S S U F F E R I N G FROM FECAL INCONTIENCE OR C H R O N I C C O N S T I PAT I O N 1 in 3 women will suffer from fecal

The mcompass is the only manometry

incontinence/chronic constipation in their

device optimized exclusively for anorectal

lifetime. Anorectal manometry is a

applications, and for the first time ever,

diagnostic test that can give physicians an

makes in-office manometry and sensation

understanding of why the patient is

testing practical and profitable.

suffering from these debilitating issues.

The mcompass simplifies this procedure

Medspira along with the Mayo Clinic

while still maintaining all of the industry

have created the mcompass to bring

standards of testing/accuracy. As a result,

- Disposable Catheter with easy insertion

anorectal manometry to offices who may

the mcompass system is being utilized by

tip for fast and convenient patient care

have been concerned about cost, time

colorectal surgeons, gastroenterologists,

constraints, space, etc.

URO/GYNs, OB/GYNs and physical

Patient Care - Complete exams in as little as 15 minutes - Portable, wireless system eliminating the need for a cart and dedicated room - Cost efficient mobile technology enables testing in any office setting

- Easy emailing using built-in WiFi - Developed by the Mayo Clinic

2718 Summer Street NE Minneapolis, MN 55413

therapists worldwide.

Contact sales@medspira.com and mention “GE01” and receive 5% savings

Tel 800.345.4502

Fax 612.789.2708

WWW.MEDSPIRA.COM/MCOMPASS

22 44

GASTROENTEROLOGY & ENDOSCOPY NEWS • MARCH 2015

ENDOSCOPY SUITE

Stents continued from page 23

a resolution of the pancreatic connection at 12 months, was significantly higher in the metal-stent group, occurring in 110 (98%) compared with 106 (89%) in the plastic-stent group (P=0.01).

P “When controlled for age, sex, size of pseudocyst and number of sessions, metal stents were roughly five times more likely to achieve successful drainage,” Dr. Sharaiha said.

“

Adverse events—perforations, bleeding, infection, and migration or occlusion of the stent—occurred in 16% of patients given metal stents and 31% of those who received plastic devices, which was statistically significant (P=0.008). On multivariate analysis, patients with plastic stents were 2.5 times more likely than those with metal stents to experience an adverse event, Dr. Sharaiha said.

There was no difference in the rates of pseudocyst recurrence between the two groups.

The findings make intuitive sense, “since the opening of the lumen of the metal stent is significantly larger and would allow drainage over a longer period of time without occluding,” William Silverman, MD, clinical professor in the Department of Internal Medicine at the

AAAHC accreditation is testimony for your patients of your facility’s total commitment to quality care.

Lawrence S. Kim, MD Gastroenterologist AAAHC Board Member

”

‘Drainage of pseudocysts using metal stents results in better outcomes and fewer adverse events compared with plastic.’

—Reem Z. Sharaiha, MD

Choose the leeader eader in Outpatient Surgery Accrreditation.

We accredit more e than 6,000 facilities because our surveyors are you ur peers. The collaborative AAAHC approach is designed to identify and enhance the best in your organization. Our Standards are nationally-recogn nized and annually updated.

When you’re AAA AHC accredited you join the rankss of the very best.

For more information, Contact us: 847-853-6060 By email: info@aaahc.org Log on: www.aaahc.org

Improving Health Care Quality through Accreditation

University of Iowa Hospitals and Clinics, in Iowa City, told Gastroenterology & Endoscopy News.

However, Dr. Silverman said the retrospective nature of the study was a significant limitation for two reasons.

The first is that the researchers had no information about the status of patients’ pancreatic ducts; those with destroyed pancreatic ducts would be more likely to experience a recurrence, Dr. Silverman explained. The second limitation is that there is no information on the number of stents placed in those who received plastic devices. It is common practice to place multiple plastic stents because their lumen is narrow, “but that’s not defined here,” he said.

“So there are two significant pieces of missing information, but in general this abstract confirms that metal stents are likely better than plastic stents,” Dr. Silverman said. “I would add that they are usually easier to place. The downside is that they are more expensive, but probably a small part of the overall cost of managing these patients.”

—Monica J. Smith

GASTROENTEROLOGY & ENDOSCOPY NEWS • MARCH 2015

Earlier Scope continued from page 1

“This is so far the first evidence to demonstrate that an early procedure will have a significant impact on quality of care and costs for inpatient IBD,” said Cheng Zhang, MD, PhD, assistant professor of gastroenterology, hepatology and nutrition at The Ohio State University, in Columbus.

Dr. Zhang suggested that the findings, which he and his colleagues presented recently at the 2014 annual meeting of the Advances in Inflammatory Bowel Diseases (abstract P-25), have come as a surprise to some physicians.

“In my medical center, about half of the physicians follow recommendations from experts to perform a sigmoidoscopy or colonoscopy early, and about half do not,” said Dr. Zhang, referring to advice published in Gut (2011;60:571-607) and the American Journal of Gastroenterology (2012;107:179-194). “We still do not have a standard of care.”

The lack of consensus among clinicians, Dr. Zhang added, has been driven by a dearth of evidence. He and his colleagues looked to fill that deficit with data from the National Inpatient Sample, the largest publicly available all-payor inpatient health care database in the United States. The investigators compiled information on 96,080 IBD patients—all at least 19 years old. They excluded Crohn’s patients with isolated small bowel disease, elective admissions and hospital transfers, as well as those who had been diagnosed with both Crohn’s and ulcerative colitis.

Most of the study patients underwent endoscopy within two days of hospital admission (62%). Compared with this group, the researchers found that the average IBD patient who underwent a procedure three or more days after admission had nearly triple the risk for in-hospital death (odds ratio [OR], 2.71; 95% confidence interval, 1.79-4.11), stayed in the hospital four or five days longer (4.46 days; P<0.0001) and was charged an additional $22,065. Patients whose procedures were delayed also were more likely to require surgery and experienced more postsurgical complications.

“These are staggering numbers,” said Ellen Scherl, MD, director of the Jill Roberts Center for Inflammatory Bowel Disease at Weill Cornell Medical College, in New York City. “It’s a pivotal finding not only for disease management and clinical outcomes and effectiveness, but also for insurance companies.”

When Dr. Scherl admits a patient with ulcerative colitis to her hospital, she performs an unprepped flexible sigmoidoscopy “as quickly as possible,” generally within 24 hours. To avoid perforation bleeding in

22 55

ENDOSCOPY SUITE

cases of severe disease, she inserts the scope a minimal distance—less than 20 cm—and takes a single biopsy. She recommends the same strategy to other clinicians: “Get in, take a look and get out.”

Fear of perforating an inflamed colon, added Dr. Scherl, is likely a factor dissuading some doctors from performing endoscopies on IBD patients, despite the procedure’s benefits for assessing disease severity and differentiating an infectious colitis caused by Clostridium difficilee or cytomegalovirus, or another source of

disease exacerbation. Guidelines about performing the procedure in cases of severe IBD, she said, may be warranted.

Gary Lichtenstein, MD, director of the IBD program at the Hospital of the University of Pennsylvania, in Philadelphia, emphasized that more research, including an analysis broken down by differences in patients’ conditions at presentation, is also warranted.

“We can’t say this is cause and effect,” he said, noting that sicker patients in the study population may have simply been

Skills Training Assessment Reinforcement

less likely to receive early endoscopies.

Dr. Zhang hopes the prospective study that his team has planned for next year will strengthen the evidence and clarify the reasons for the improved outcomes.

Until then, he advises his colleagues to at least “seriously consider” performing an early procedure.

—Lynne Peeples Drs. Zhang, Lichtenstein and Scherl reported no relevant financial conflicts of interest.

Drs. Scherl and Lichtenstein are on the editorial board of Gastroenterology & Endoscopy News.

ASGE

STAR

ASGE EMR STAR Certificate Program An Assessment-Based Curriculum

Certi Certificate Program EMR

Expand your endoscopic skills to meet the need for EMR in your practice

Acquire the knowledge and skill you need to confidently perform this advanced technique Demonstrate your qualifications and proficiency in performing EMR Receive a transcript detailing the completed curriculum, earned

CME and assessment of performance in EMR skills

Offer better patient care

Skills to be covered

EMR has eemerged as one of the most im mportan ant advancements in GI over the last 10 years. For established d endosccopists, p , there have been no pathways p to developing skills in n this com mplex technique, until now.

The ASGE EMR STAR Certificaate Program m preparess endoscopists endoscop pists to overcom me challenges, gain confidencce and dem monstrate their “readinesss” to perform EMR to medical colleague es.

Endoscopic mucosal resection (EMR) is defined as the use of various snares, cautery and injection/lifting technique in the resection of large, complex or high risk colonic polyps.

LOWER GI EMR

UPPER GI EMR

★ ★ ★

★ ★

Lesion Recognition Submucosal Injection Techniques Piecemeal and Snare Resection Piecemeal Resection of Flat Lesions

★ ★

Polyp Retrieval Polypectomy Site Treatment Band Ligator and Cap Assisted Lesion Resection

★ ★

Tattooing Clipping /EMR Closure

The EMR STAR S Certificate Prog gram inclu udes two modules: 1) Lower GI and an 2) Upper GI. The Loweer GI Certifi ficate is a prerequisitte for participa ipation in the Upper GI module.

Perforation & Complication Management

★

Course and Assessment

The ASGE EMR Star Certificate of Completion is earned d by completing several components sequentially over the specified time period.

★

Perforation Management Communication Skills

The EMR Program ram is designed to specificcally teach core know wledge and motor skills in n EMR E throug gh case-based video sessions an nd intensive, standardized d hands-on ha training g. Immediaately follow wing the live components, all participan ipants ant will com mplete a po ost-test, as well as a one-on-one assessment of a standardiz stand zed checklist of skills. CME credit can be earned for both online ne and live componen nts.

The American Society for Gastrointestinal Endoscopy certifies that

Online program

March–June, 2015

Course/Assessment

June 27-28, 2015

Module 2: Upper GI EMR (Completion of Module 1 prerequisite)

Online program

May–August, 2015

Course/Assessment

August 22-23, 2015

Your registration includes the opportunity to bring one nurse or one technician to the live course at no additional charge.

Participation is limited to the first 40 physician registrants. Register today to secure your spot!

The above-named participant has successfully demonstrated acquisition of knowledge and s kills in EMR: Lower GI including • Lesion Recognition • Submucosal Injection Techniques • Piecemeal and Snare Resection • Clipping /EMR Closure • Tattooing • Perforation Management • Communication Skills

Visit www.asge.org/star for details.

ASGE

STAR

C i Cert Certificate Program EMR

ASGE President The American Society for Gastrointestinal Endoscopy (ASGE) is dedicated to advancing patient care and digestive health by promoting excellence and innovation in gastrointestinal endoscopy. ASGE promotes the highest standards for endoscopic training and practice, fosters endoscopic research, recognizes distinguished contributions to endoscopy, and is the foremost resource for endoscopic education.

★ ★

Module 1: Lower GI EMR

John Doe, MD, FASGE Has successfully completed the training and assessment in Endoscopic Mucosal Resection (EMR): Lower GI as outlined in the ASGE EMR STAR Certificate Program

★

2015 EMR STAR Certificate – Program Schedule

Skills • Training • Assessment • Reinforcement

ASGE EMR STAR Certificate Program – Lower GI

★

Earn 20 ABIM MOC Points!

22 66

GASTROENTEROLOGY & ENDOSCOPY NEWS • MARCH 2015

ENDOSCOPY SUITE

Taking NOTES? GIs Finding Success With New Endoscopic Procedures

T

wo approaches to performing natural orifice translumenal endoscopic surgery to remove deepseated subepithelial tumors (SETs) appear to be safe and effective, provided physicians can acquire the training necessary to become proficient in the novel techniques.

Endoscopic full-thickness resection (EFTR) and submucosal tunnel endoscopic resection (STER) may be challenging to learn, but they offer a promising alternative to the current standards of care for SETs surgery and surveillance.

“The problem with SETs is that it is so difficult to risk-stratify them,” said Stavros N. Stavropoulos, MD, chief of endoscopy at Winthrop-University Hospital, in Mineola, N.Y. Given the uncertainty about which SETs are potentially malignant, guidelines recommend surgically removing those that are 2 to 5 cm and conducting follow-up endoscopy every one or two years in patients with tumors less than 2 cm in diameter.

“This results in a lot of surgery for SETs in the 2- to 5-cm range, the majority of which turn out to be low-risk lesions, and an inordinate burden of endoscopic surveillance. So there is motivation for endoscopists to remove these smaller SETs by endoscopy rather than subject patients to laparoscopic surgery,” Dr. Stavropoulos told Gastroenterology & Endoscopy News.

Asia Leading the Way Finding a better way to deal with SETs has prompted endoscopists, mainly in Asia, to investigate EFTR and STER. “In EFTR, you resect the tumor with the muscle, leaving a hole, and then use endoscopic clips to close the fullthickness defect,” Dr. Stavropoulos said.

“In STER, you make a tunnel in the

Table. Tumor Types GISTs

18

Leiomyomas

8

Pancreatic rests

3

Schwannoma

1

Leiomyosarcoma

1

Carcinoid

1

Low-grade adenocarcinoma

1

Benign lesions

6

GIST, gastrointestinal stromal tumor

submucosal plane starting a few millimeters upstream from the tumor. Once you encounter the tumor, you cut it out with the attached muscle, again leaving a hole in the muscle of the esophagus, and then remove the tumor by mouth.”

The resulting orifice, deep within this submucosal tunnel, is closed using three or four clips.

Dr. Stavropoulos began performing STERs and EFTRs at his institution in 2012, and presented the case series at the 2014 annual meeting of the American College of Gastroenterology. Most of the patients (30 of 38) underwent EFTR (Table).

The SETs had a mean size of 22 mm (10-55 mm). In the early part of the study, Dr. Stavropoulos used endoclips to close the defects, but switched to endoscopic suturing once this technology became available. Mean procedure time was 72 minutes (21-220 minutes), and mean length of stay in the hospital was 1.6 days.

Dr. Stavropoulos was able to resect all but three of the tumors in a single piece; one, although excised in one piece, was too large to remove through the patient’s mouth and needed to be cut into pieces while in the stomach; the other two were too difficult to resect en bloc. “But we

had 89% en bloc removal, with negative margins, which is a very high efficacy,” he said.

There were some mild complications, including bleeding that required prolonged endoscopic hemostasis in three patients, two of whom needed transfusion. No complications required surgical intervention, although one patient was converted to laparoscopic surgery after the tumor was discovered to be perilously close to the left gastric artery.

“As endoscopists, we don’t have the tools yet to deal with large arteries,” Dr. Stavropoulos said.

Only two patients had tumors with high-risk potential. One was referred for definitive surgery; the other was advised to undergo gastrointestinal stromal tumor–specific chemotherapy.

Given the efficacy and safety of these procedures, Dr. Stavropoulos has begun offering them selectively to patients with SETs smaller than 2 cm.

“In those patients, surveillance is recommended every one to two years, but in a younger patient looking at 40 or 50 years of endoscopy with ultrasound, endoscopic resection may be preferable,” he said. With smaller SETs, “resection is even easier and faster; we can essentially

offer them a 50-minute procedure, they go home in 24 hours, and if it’s benign we can spare them lifelong endoscopic surveillance.”

John R. Saltzman, MD, director of endoscopy at Brigham and Women’s Hospital, and associate professor of medicine at Harvard Medical School, both in Boston, praised the study.

“Dr. Stavropoulos was able to do something for which we’ve needed surgery and an incision for in the past,” he said. “But this does require a special skill set. Endoscopists would need proper training: observing experts, practicing the technique in animal labs and using proper back-up with their first human cases, hopefully under the supervision of someone like Dr. Stavropoulos.”

One problem the study highlighted to Dr. Saltzman is that uncertainty remains over which SETs require removal. “Even in this series, not all of the lesions would have needed to be removed if we knew the final pathology. We need to do better at selecting patients for surgery or these aggressive endoscopic techniques. There are advances in this area, and I think we will be better able to identify these patients in the future.”

—Monica J. Smith

Length of BE Segments Appears Not To Change After Diagnosis y the time a patient is diagnosed with Barrett’s esophagus, the affected segment likely has reached its maximum length, researchers have found.

In a study of more than 3,600 patients, researchers determined that Barrett’s esophagus does not change significantly in size from the time it is first detected to the last assessment.

The study also found that age does not seem to be related to the length of an affected segment.

The researchers assessed the length of the Barrett’s segments for the patients, 88% of whom were men, at diagnosis and at the final

B

examination. Mean length of the segment was 3.5 cm at initial endoscopy, and grew by an average of 0.9 cm. The researchers also divided the study population into seven groups based on age at diagnosis. However, age did not affect the results, as younger patients (under age 30 years) were no more likely to experience lengthening of the affected segment than older patients (over age 80; P=0.47).

One group, patients with benign Barrett’s esophagus experienced a significant shrinkage in the length of the segment, a change that varied depending on age ((P=0.03).

Prateek Sharma, MD, professor of gastroenterology, hepatology and motility at the University of Kansas, in Kansas City, and last author of the study, said the findings will not alter treatment decisions. However, they do “support the fact that [Barrett’s esophagus] does not ‘form’ over time but rather early on, because the length is the same by age and in a given patient does not change over time.”

Dr. Sharma and his colleagues published their findings in Gutt (published online Feb 4, 2015.

Doi: 10.1136/gutjnl-2014-308552).

—GEN Staff

H E M OS TA S I S

Case closed.

To complete any endoscopic clipping procedure, you need a clip with a tight grip that won’t buckle under pressure. You need Instinct. Its distinctive anchoring tips improve your tissue grasping capability while the ed jaws give you added extra-thick, nitinol reinforced stability. This is the kind of strength and security that leads to the outcomes you expect. hanced patient care.

Trust your instincts for enhanced

Instinct

™

ENDOSCOPIC HEMOCLIP

www.cookmedical.com

Image courtesy of Shou Jiang Tang, MD, University of Mississippi Medical Center, Jackson, MS.

© COOK 2015 ESC-WADV-INSTINCT-GEN-201502

22 88

GASTROENTEROLOGY & ENDOSCOPY NEWS • MARCH 2015

ENDOSCOPY SUITE

Endoscopy Turns Eye To Fixing Problems After Weight Loss Surgery PHILADELPHIA— —The number of people undergoing bariatric surgery continues to climb, and although expertise and refinement in the procedures may lead to less postoperative morbidity, the overall population of patients with complications is not small.

Once the realm of surgery, endoscopy is becoming a first-line approach to managing these complications and many, such as leaks and fistulas, can be repaired using skills common to all physicians trained in interventional gastroenterology.

“Most of us would agree that endoscopic management is reasonable to consider in early postoperative care; we want to avoid reoperating on these patients if possible,” said Steven Edmundowicz, MD, professor of medicine and chief of endoscopy at Washington University Hospital, in St. Louis. Dr. Edmundowicz discussed the role of endoscopy in post-bariatric surgery complications at the 2014 annual meeting of the American College of Gastroenterology.

endoscopic suturing are much more useful; they allow you to close the defect with a submucosal or muscular propria layer closure,” Dr. Edmundowicz said.

of the laparoscopic band. “There is an epidemic of this complication because a great number of bands have been placed and a significant number of them will

Early Complications Leaks occur in as many as about 8% of bariatric surgery patients, Dr. Edmundowicz said, and present fairly early on—within one to two days for those caused by a mechanical disruption, five to seven days for those caused by tissue ischemia. Like any other approach in this situation, endoscopic intervention has a failure rate, “but it can be very effective and patients can recover rapidly and resume oral nutrition,” he said.

Management of leaks begins with detection, usually with computed tomography (CT) imaging and oral contrast.

“You can certainly perform an upper GI [gastrointestinal] contrast study or CT scan and identify large leaks. Smaller leaks are subtle and can be found with endoscopy, sometimes with the help of a bubble test,” Dr. Edmundowicz said.

Closure is obtained using standard or over-the-scope clips, as well as suturing and stents—although no stent is explicitly labeled for this use. “We use fully covered esophageal stents in an off-label indication,” Dr. Edmundowicz said.

Stent migration is an issue, but using multiple stents, endoscopic suturing or over-the-scope clips to fix the stent in place can mitigate this problem.

Through-the-scope clips can be used to manage smaller leaks, but these should be limited to mucosal and submucosal closure, Dr. Edmundowicz said. “For larger defects, over-the-scope clips and

‘There is an epidemic of this complication because a great number of bands have been placed and a significant number of them will eventually erode into the stomach.

Fortunately, the bands tend to be well encapsulated, so there is usually limited or no danger of creating a perforation when they erode and while removing them.’

—Steven Edmundowicz, MD

Endoscopic suturing also has become an option for repairing lesions in the proximal GI tract, allowing the endoscopist to close more significant defects. “There are significant challenges in terms of device size, field of view and maneuverability,” Dr. Edmundowicz said. “But we can usually visualize lesions in the gastric pouch and esophagus quite well. There has been very positive anecdotal and series experience, and many of us are gaining experience closing defects with these devices.”

To achieve the best outcomes as rapidly as possible, Dr. Edmundowicz recommended a combination of closure and stenting. “If you’re going to make the effort to treat a patient with an acute postoperative injury, you’ll probably want to close [the defect] as well as stent it,” he said.

Later Complications Another problem endoscopists are increasingly encountering is the erosion

eventually erode into the stomach,” Dr. Edmundowicz said. “Fortunately, the bands tend to be well encapsulated, so there is usually limited or no danger of creating a perforation when they erode and while removing them.”

One technique for doing so involves passing a 0.35-inch guidewire endoscopically through the band, grasping it with a snare and pulling the entire wire out of the patient’s mouth, thereby creating a loop around the band.

“Once that’s accomplished, we can position the wire and use the handle and sheath from a salvage mechanical lithotripter system to engage the wire and use it as a cutting device to break through the band,” Dr. Edmundowicz said.

After the band is cut, the endoscopist uses the snare and grasping forceps to pull the band into the stomach, where it can be grasped and extracted from the patient, Dr. Edmundowicz explained. The port will need to be removed by a surgeon.

Endoscopists also may play a role in anastomotic reduction in situations in which patients who have undergone Roux-en-Y gastric bypass experience weight gain resulting from dilation of the gastrojejunostomy. “With dilation, the restrictive component of the operation is defeated,” Dr. Edmundowicz said. “If we can narrow the anastomosis, we can usually get some improvement in these patients.”

Chemically narrowing the anastomosis by applying the sclerosing agent morrhuate sodium has been effective (Gastrointest Endoscc 2007;66:240-245), and endoscopic techniques and devices in this area have advanced. One large multicenter trial investigating narrowing of the anastomosis using an endosuturing device found significant improvement in weight loss after the procedure.

“The clinical improvement we saw with our patients in this trial was not quite as dramatic, but I think with the newer devices available, we should be able to get more robust closure of the anastomosis,” Dr. Edmundowicz said.

Some techniques used in the management of complications after bariatric surgery, such as endoscopic suturing, are quite advanced and would require special training. “These are things not everyone is doing and not everyone will be doing in the future,” said David Greenwald, MD, GI fellowship program director at Montefiore Medical Center, in New York City.

But the evolution of devices may make it easier for endoscopists who want to extend their armamentarium of services.

“The devices keep getting better and better,” Dr. Greenwald said. “With each passing year endoscopic suturing devices, for example, seem to be easier to use and to require fewer special skills, more in the realm of something a generally trained endoscopist would know how to do.”

Even so, many complications can be managed using skills familiar to most endoscopists. “Identifying and treating an ulcer is a common skill, or dealing with strictures that occur at the site of anastomosis—all gastroenterologists are trained in the dilation used to treat these,” Dr. Greenwald explained.

“It’s a bit more complicated because you have to understand the altered anatomy and what the surgeon has done, but it’s clearly within the realm of all gastroenterologists.”

—Monica J. Smith

OPT IN to receive your free e-newsletter from the best-read gastroenterology publication in the country www.gastroendonews.com/renew

Articles from the current monthâ&#x20AC;&#x2122;s issue Articles ahead of print Web-exclusive content

33 00

GASTROENTEROLOGY & ENDOSCOPY NEWS • MARCH 2015

ENDOSCOPY SUITE

Small GIST Lesions Increasingly Amenable To Endoscopic Resection SAN FRANCISCO—Recent advancements in technology and techniques—flexible endoscopy, endoscopic resections and hybrid approaches—are allowing endoscopists to play an increasing role in the management of small gastrointestinal stromal tumors (GISTs).

Endoscopists benefit by having a role in cancer care, as do patients, whose tumors in the past were treated by open gastrectomy—a more morbid procedure.

At the 2014 Clinical Congress of the American College of Surgeons, a panel of experts discussed the growing role of endoscopy, and areas for improvement, in managing GISTs. Panel member David A. Kooby, MD, professor of surgery at Emory University School of Medicine, in Atlanta, called the minimally invasive approaches to GIST “really innovative, really wonderful stuff.

“Where we are now, and where we will be in five to 10 years, are very different. The use of endoscopy for lowerrisk tumors would be a great advantage over our standard approach, which is to remove a big portion of the stomach. If we can do this minimally invasively ... and adhere to oncologic principles, this will really optimize treatment.”

“Flexible endoscopy is proving to be a critical surgical tool in GI surgery, and this will only increase with time,” said panelist Lee L. Swanstrom, MD, clinical professor of surgery at Oregon Health & Science University, and director of GI and minimally invasive surgery for Legacy Health System, both in Portland.

“We are seeing more small GISTs due to increased screening, and these will be amenable to hybrid [endoscopy/laparoscopy] or pure endoscopic resection,” Dr. Swanstrom said. “Endoscopic resection is demanding but it has been shown to be safe and feasible for the right indications.

Improvements in flexible endoscopic tools will make such resections quicker and easier in the near future.”

Which GISTs Should Be Resected?

Chandrajit P. Raut, MD, associate professor of surgery at Harvard Medical School, in Boston, noted that GISTs are “exceedingly common, but most are clinically irrelevant.” In one study, submucosal, microscopic GISTs, those smaller than 0.5 cm, were identified in more than 35% of gastrectomy specimens, he said.

“Certainly, these don’t all require surgery,” Dr. Raut said. For GISTs larger than 2 cm, resection is recommended for

‘The use of endoscopy for lower-risk tumors would be a great advantage over our standard approach, which is to remove a big portion of the stomach. If we can do this minimally invasively ... and adhere to oncologic principles, this will really optimize treatment.’

—David A. Kooby, MD

lesions that are symptomatic, ulcerated and enlarging. For smaller tumors without high risk features—irregular borders, cystic spaces, ulceration, echogenic foci and heterogeneity—endoscopic surveillance at six- to 12-month intervals can be considered, according to the guidelines of the National Comprehensive Cancer Network (NCCN).

Field F. Willingham, MD, MPH, director of endoscopy and assistant professor of medicine at Emory University, agreed that surveillance is appropriate for a patient with a submucosal mass smaller than 2 cm and no suspicious features on endoscopic ultrasound. “The NCCN has adopted this, and we think it’s a reasonable way to go for these small lesions,” he said.

Dr. Raut said that surgery is indicated when GISTs increase in size or become symptomatic. There is a need for a better way to identify aggressive lesions smaller than 2 cm, but current radiology, endoscopy, histopathology and molecular diagnostics fall short of being able to do so, he added.

“Endoscopic biopsy using standard biopsy forceps is not usually helpful for submucosal tumors. Mitotic count can help identify which to resect but cannot be accurately assessed on endoscopic ultrasound-guided fine-needle aspiration specimens. Tumors less than 2 cm versus those greater than 2 cm have an excess of wild type cases, versus known mutations,

so they appear to be a different subpopulation with less proliferation potential,” Dr. Raut said.

Methods of Endoscopic Resection Endoscopic resection methods— which are still novel approaches in North America—were described by Drs. Swanstrom and Willingham.

Dr. Willingham described a hybrid approach that pairs endoscopic and laparoscopic techniques for resection, as he and his Emory colleagues reported in 2012 (Gastrointest Endoscc 2012;75:905912). He said the approach grew out of their efforts to offer less invasive treatments to GIST patients.

“To resect lesions at the [gastroesophageal] junction and in the proximal cardia surgically may require a total gastrectomy, so that is a particularly difficult area, especially for small non-aggressive tumors. This led us to think of ways we could work together [with surgeons] to offer less invasive therapy in this area,” Dr. Willingham said.

“We developed a technique, as an extension of our hybrid work, to address the deep margins of the tumors,” he said.

Dr. Willingham’s group has dubbed the technique “push-pull endoscopic and laparoscopic full-thickness resection,” and they reported their results at Digestive Disease Week 2014 (abstract Su1847).

Their series included four patients with challenging tumors: near the GE

junction, endophytic, and/or difficult to identify laparoscopically. The hybrid procedure was successful, without complications or conversions to open resection.

Mean operative time was 162 minutes.

“The advantages of this technique are that it is minimally invasive, does not require major organ resection, and provides a full-thickness resection of the involved deep margin,” Dr. Willingham explained.

Endoscopic submucosal dissection (ESD) is another emerging approach to GIST. Although ESD is used mainly for resecting mucosal-based lesions, ESD techniques can be extended in the submucosal plane, Dr. Swanstrom said.

“With the addition of newer technologies from the NOTES [natural orifice transluminal endoscopic surgery] toolbox, it is becoming increasingly feasible to go beyond mucosal resection,” he said.

ESD is still relatively uncommon in the United States, but it is widespread in Asia, where more than 50% of foregut digestive cancers are treated using flexible endoscopy rather than surgical resection, according to Dr. Swanstrom.

Dr. Swanstrom cautioned that endoscopic resection of GISTs is limited to lesions that are smaller than 5 cm, located in the esophagus or stomach, and that demonstrate low-risk characteristics.

Performing ESD for GISTs requires fullthickness resection, but this can be done, he added.

“As our instrumentation in flexible endoscopy becomes more sophisticated, with better ways to control energy, and with oncologic tools such as specimen retrieval sacs, we will see an expansion of ESD,” Dr. Swanstrom predicted. “We no longer fear doing full-thickness resections in the gut as we once did.”

Dr. Raut also added a note of caution: “Ultimately, GIST is a cancer, and oncologic principles trump whatever observational or operative approach we use.

We need to do what’s most appropriate oncologically.”

He does not advocate for a pure endoscopic excision, and this is not performed at his institution. Instead, he favors a laparoscopic or combined laparoendoscopic approach that allows for the removal of the tumor with a margin of normal tissue.

—Caroline Helwick Dr. Swanstrom receives research and education support from and/or consults for Apollo, Aponos Medical, Boston Scientific, Cardica, Covidien, Endogastric Solutions, Fractyl Laboratories, Olympus, Stryker and Titan.

Drs. Willingham, Raut and Kooby reported no relevant financial conflicts of interest.

º 0 1 2

cm W Polyps Hide. ™ RetroView Seeks.

With a 25% smaller retroflex radius and 210 degree retroflex angulation, the EC-3490TLi Video Colonoscope (RetroView™ ) is designed to help you go the extra measure. When incorporating retroflex visualization into colonoscopy withdrawal, physicians using RetroView™ have indicated it has the potential to help detect more polyps.* In addition, its remarkable geometry allows for better scope positioning for access and removal of challenging polyps. To learn more, visit RetroViewSeeks.com

*Data on file ©2014 PENTAX America, Inc. All Rights Reserved. All company and product names and marks contained within are federally registered trademarks, trademarks or service marks of PENTAX of America, Inc. MK-608 Rev: A

m c 0 .

0 7 1 g n e L ki 210˚

ONE SHE’S BEEN WAITING FOR IS HERE

HARVONI, the HARVONI logo, GILEAD and the GILEAD logo are trademarks of Gilead Sciences, Inc., or its related companies. ©2014 Gilead Sciences, Inc. All rights reserved. GILP0374 10/14

One tablet contains ledipasvir and sofosbuvir

34

GASTROENTEROLOGY & ENDOSCOPY NEWS • MARCH 2015

Study Supports Link Between Bariatric Surgery And Alcohol Use Disorder BOSTON— —About 17% of patients who undergo Roux-en-Y gastric bypass (RYGB) have an alcohol use disorder three years after their surgery, new research shows.

This rate is approximately 10% higher than what is seen in the general population, as found in data from the National Institutes of Health (NIH).

The study suggests that all patients undergoing RYGB need to be cautioned regarding alcohol use, and routinely asked about such problems during follow-up visits, said James Mitchell, MD, chairman of the Department of Psychiatry and Behavioral Science at the University of North Dakota School of Medicine and Health Sciences, in Grand Forks, who presented the findings at Obesity Week 2014 (abstract 201).

The study included 201 RYGB patients in the Longitudinal Assessment of Bariatric Surgery (LABS), an NIHfunded consortium of six clinical centers and a data-coordinating center that works with NIH staff to conduct research involving bariatric surgery.

Patients were interviewed three years after surgery, using the Structured Clinical Interview for DSM Disorders (SCID-DSM)-IV, and accessory impulse control disorders criteria. SCID criteria for alcohol use disorder require a positive response to ingestion of five or more drinks on one occasion as a screening question, which based on pharmacokinetic research in RYGB patients, is excessive. The researchers also evaluated patients with the Alcohol Use Disorders Identification Test (AUDIT), which assigns a score based on answers to a series of questions, such as how often during the past year the respondent failed to do what was normally expected because of drinking. Alcohol use disorder symptoms were defined as an AUDIT score greater than 8, or a positive response to symptoms of alcohol dependence or alcohol-related harm. The median age of patients in the study was 48 years, and 81% were women.

The investigators found that 16.9% of patients had an alcohol use disorder three years after RYGB, with 41.2% of them being a de novo problem (Table 1).

Patients with a history of alcohol abuse were at highest risk, but some reported that cases were new. Conversely, 26.9% had a history of alcohol use disorder before surgery by SCID and/or AUDIT definition, but did not report symptoms of an alcohol use problem within the three years after surgery. The investigators also identified fluctuations in other addictive disorders, such as impulsive-compulsive buying and Internet use (Table 2).

The study adds to the growing body of evidence showing an association between weight loss surgery and alcohol abuse.

“There is definitely enough convincing evidence that some patients are at risk for problems with alcohol after [weight loss] surgery,” said Stephanie Sogg, PhD, staff psychologist at Massachusetts General Hospital, and assistant professor at Harvard Medical School, in Boston.

Dr. Sogg, who gave an overview of the evidence at Obesity Week, pointed out that numerous studies have been published about alcohol use after bariatric surgery, but many have small sample sizes and/or low response rates, and almost all are retrospective. The studies also use a wide range of assessment methods (i.e., questionnaires and interviews) and different definitions of alcohol use, misuse and abuse, which makes comparison across studies difficult.

“Some studies merely look at alcohol use. Others look at high-risk, hazardous or problem drinking, and some studies look at whether patients have symptoms of or meet the criteria for alcohol abuse or dependence,” Dr. Sogg said.

Many studies also don’t make a distinction between three different subgroups: individuals who have alcohol problems at the time of surgery and continue to have problems afterward, recovered substance abusers who relapse after surgery and individuals who develop new-onset alcohol problems after surgery. “These are three very clinically distinct subgroups and many studies lump them all together,” she said.

Dr. Sogg pointed out that overall, studies have shown that after weight loss surgery, there is an increase in alcohol use, with a higher percentage of patients reporting any alcohol use as well as increased quantities and/or frequencies of alcohol consumption among those who use it.

A previous study using data from LABS showed that the risk for developing an alcohol use disorder was greater in the second year after surgery than the first ((JAMA A 2012;307:2516-2525). The Swedish Obese Subjects Study found that the rate of self-reported alcohol problems continued to increase for 10 years (Obesityy 2013;21:2444-2451).

“Across all of the studies, the prevalence of alcohol problems after surgery ranges from 4% to 28%, with about 10% meeting criteria for abuse/dependence; this includes patients who previously had these problems,” Dr. Sogg said. “What is strikingly consistent is that across all studies, if you look at all of the people who develop problems with alcohol after surgery, about 60% of those cases are new-onset cases.”

Table 1. Characterization of Patients With an Alcohol Use Disorder After Bariatric Surgery Alcohol Use Category

Patients, Definition %

Continued alcohol use disorder

20.6

Positive on the AUDIT the year before surgery, and continues to meet SCID-IV and/or AUDIT criteria after surgery

Recurrent alcohol use disorder

38.2

Negative on the AUDIT in the year before surgery, but positive for lifetime presurgery (SCID) and postsurgery (SCID and/or AUDIT)

New alcohol use disorder

41.2

No history of alcohol use disorder before surgery (SCID or AUDIT) but positive for the disorder after surgery (SCID and/or AUDIT)

AUDIT, Alcohol Use Disorders Identification Test; SCID, Structured Clinical Interview for DSM Disorders-IV

Table 2. Prevalence of Non–Drug-Related Compulsive Disorders Pre-Op, %

Pre-Op and Post-Op, %

Post-Op, %

Overall non–drug-related addictive behavior disorders

5

6.5

3

Impulsive-compulsive buying

3

5.5

1.5

Impulsive-compulsive Internet use

0.5

0

2

In contrast, some individuals reduce alcohol intake after weight loss surgery. “Anywhere between 17% and 59% of patients who had problem drinking before surgery reported being free of such problems when they were assessed at some point after surgery,” Dr. Sogg noted. Weight loss surgery may have opposite effects on drinking patterns, depending on an individual’s genotype or phenotype. Studies in rats have revealed that RYGB increases alcohol consumption in wild-type rats (who ordinarily do not like alcohol) and decreases consumption in genetically “alcohol-preferring” rats (Obes Surgg 2013;23:920-930; Biol Psychiatryy 2012;72:354-360).

RYGB in particular can change the sensitivity to or the pharmacodynamics of alcohol after weight loss surgery. After RYGB, patients who drink alcohol reach

a higher peak blood alcohol level more quickly, and a longer time is required for alcohol to clear out of their system (Surg Obes Relat Dis 2007;3:543-548; Obes Surgg 2010;20:744-748).

“These changes become more pronounced as time goes on after surgery, not less pronounced,” Dr. Sogg said.

These pharmacodynamic changes may be linked to the onset of alcohol problems after RYGB. “People who have alcohol problems after surgery are much more likely to have undergone a bypass, and that makes us suspect that there is some anatomic and metabolic basis for this.”

Research findings on whether similar pharmacodynamic changes occur in patients who had a sleeve gastrectomy are mixed; such changes were found in one study but not in others,

35

GASTROENTEROLOGY & ENDOSCOPY NEWS • MARCH 2015

Gastric Surgery for Diabetes Deemed Safe BOSTON— —An analysis of a national surgical database has concluded that laparoscopic Roux-en-Y gastric bypass (LRYGB) surgery for type 2 diabetes has a complication and mortality rate comparable to some of the safest and most commonly performed surgeries in the United States, such as cholecystectomy, hysterectomy and total knee replacement.

The study was reported at Obesity Week (abstract A701) with simultaneous publication in Diabetes, Obesity, and Metabolism (2014 Oct 29. [Epub ahead of print]).

“The risk-to-benefit ratio of gastric bypass for diabetes and obesity is very favorable. There’s significant

and no studies have yet examined the prevalence of alcohol problems among patients who have had a sleeve gastrectomy, a procedure that only recently has been performed in large numbers.

Factors common to both the gastric bypass and sleeve gastrectomy that could lead to higher and more rapid blood alcohol concentrations include less alcohol dehydrogenase in the stomach, faster gastric emptying, shorter transit time in the intestines to break down the alcohol, lower body weight and less food in the stomach when alcohol is consumed.

“We tell our bariatric surgery patients not to eat and drink at the same time. If you drink on an empty stomach, you are definitely going to feel more intoxicated,” Dr. Sogg said.

She said it is important for clinicians to ensure that all patients undergoing weight loss surgery be screened for alcohol use problems before surgery and be educated about the risk for postoperative problems.

Dr. Sogg counsels patients to be watchful for early warning signs of increased alcohol consumption, and not to drink at all after surgery if they are going to drive.

“It is also important for surgery practices to identify the appropriate referral resources to use when they do encounter patients who have this kind of problem,” Dr. Sogg said. However, she also noted, “It is not yet clear whether a patient who has alcohol problems after surgery will respond to traditional addiction treatment approaches or if they need specifically tailored care.”

Dr. Mitchell also believes that all patients should be cautioned and monitored, and that a history of a substance use disorder should not rule out a patient for bariatric surgery. “The monitoring can be done by carefully and nonjudgmentally asking about such problems during follow-up visits,” Dr. Mitchell said. “If there is a suspicion of such problems, but the patient denies it, I would ask for permission to talk with another family member.”

—Kate O’Rourke Drs. Mitchell and Sogg reported no relevant financial conflicts of interest.

weight loss, diabetes improvement or remission and a relatively low complication and mortality rate,” said lead investigator Ali Aminian, MD, a bariatric surgeon from the Cleveland Clinic, in Ohio.

According to Dr. Aminian, at least five randomized controlled trials have demonstrated that bariatric surgery has a striking impact on type 2 diabetes, with respect to glycemic control, cardiovascular risk factor modification and, possibly, long-term, complete remission of progressive disease. However, the safety of metabolic/diabetes surgery has been debated; the surgical risk has not been well characterized.

In the new study, investigators used the American College of Surgeons’ National Surgical Quality Improvement Program (ACS-NSQIP) database. ACS-NSQIP collects data on more than 150 variables, including 30-day postoperative morbidity and mortality outcomes for patients undergoing major surgical procedures in the United States.

The researchers collected data for patients with diabetes undergoing LRYGB (CPT codes 43644 and 43645) between January 2007 and December 2012. For the same period, the researchers also collected data on see Diabetes, page 39

for iPad! Download the e app p from the best-read st-rea ad gastroenterology logy publication in n the United States s

Read the #1 gastroenterology publication.

Anytime. Anywhere.

36

GASTROENTEROLOGY & ENDOSCOPY NEWS • MARCH 2015

Study Finds Limited Role for Analgesic Pumps In Lap Sleeve Gastrectomy Benefits of open procedures not shared in laparoscopic cases BOSTON—A double-blind, randomized controlled trial has concluded that in patients undergoing laparoscopic sleeve gastrectomy, a continuous infusion of local anesthetic via an anterior abdominal wall catheter does not improve pain control and does not reduce the use of narcotics, the use of antiemetics or length of stay in the hospital.

“Our study does not support the increased cost of using the continuous infusion [analgesic] catheters,” said Elaine Cleveland, MD, a general surgeon at William Beaumont Army Medical Center, in El Paso, Texas. She presented the study at Obesity Week 2014 (abstract A102).

The proposed benefits of continuous analgesic infusion catheters include better pain control in the perioperative setting, which can reduce the use of narcotics and their associated side effects. “This can lead to a more comfortable recovery with faster return to normal activity, decreased length of stay and possibly decreased costs,” Dr. Cleveland said.

These benefits have been shown in several studies. In a randomized, placebo-controlled study involving 70 patients, a continuous analgesia infusion pump of 0.5% bupivacaine after midline laparotomy reduced average daily patient-controlled analgesia (PCA) morphine by 25 mg (33.7 vs. 60 mg; P P=0.03) (J Am Coll Surg 2006;202:297-305). In a 21-patient, placebo-controlled study, continuous administration of 0.2% ropivacaine for 48 hours after open colorectal resection for cancer reduced average daily morphine by 36 mg and decreased hospital stays, pain scores and antiemetic use ((Anesthesiologyy 2007;107:461-468).

Studies evaluating the use of these pumps in laparoscopic procedures, however, have provided mixed results (Table 1), and to date, no studies have evaluated their use in laparoscopic surgery. To fill this knowledge gap, surgeons at William Beaumont Army Medical Center randomized patients undergoing laparoscopic sleeve gastrectomy to receive either 0.2% ropivacaine or 0.9% normal saline via an intraoperatively placed continuous pain catheter. Dr. Cleveland said the pumps cost $710 and are placed either in the preperitoneal space or in subcutaneous tissue.

Postoperatively, catheter rates were set at 7 mL per hour and patients received PCA with hydromorphone plus IV antiemetics. On the morning of postoperative day 1, patients were started on oral nausea and pain medications, and the catheter infusion rates were decreased to 4 mL per hour. Patients were discharged when they were ambulatory and oral medications could control their pain and nausea. After discharge, clinicians recorded total narcotic use, total antiemetic use, pain scores, duration of hospitalization and adverse events.

To be enrolled in the study, patients were required to have a body mass index (BMI) greater than 40 kg/m2 or a BMI greater than 35 with comorbidities. Patients were excluded if they had revision surgery, single-port surgery or an allergy to local anesthetic. Only 7% of patients in the study were male; the average age was about 35 years.

The study was halted early after an interim analysis showed that an additional 20 patients would not change the outcomes.

Table 1. Sample of Trials Testing Continuous-Analgesia Pumps Patient Population

Trial Design

Outcome

Patients undergoing laparoscopic ventral hernia repair (N=73)

Continuous 0.5% bupivacaine vs. placebo

No difference in postoperative pain scores, narcotic use, time to return of bowel function or length of hospital stay

Patients undergoing Continuous 0.375% bupilaparoscopic adjustable vacaine vs. placebo gastric banding (N=30)

No difference in shoulder pain, morphine requirements or antiemetic requirements, but improvements were seen in subjective reports of pain by visual analog scale scores (1.8 vs. 3.5; P<0.046)

Patients undergoing laparoscopic Rouxen-Y gastric bypass surgery (N=45)

Continuous 0.2% ropivacaine vs. placebo

No significant difference in pain scores, morphine requirement or length of stay between the two groups, but patients in the ropivacaine group were able to sit up half a day sooner

Patients undergoing laparoscopic Rouxen-Y gastric bypass surgery (N=40)

Bupivacaine pain pump vs. meperidine patient-controlled analgesia initiated in the postanesthesia care unit and discontinued at 06:00 h the next morning

No significant differences between the groups in pain scores, nausea scores, gas pain scores, antiemetic use throughout their stay, or opioid use in the postanesthesia care unit.

Patients receiving bupivacaine had a dramatic decrease in opioid use over the time interval from leaving the postanesthesia care unit to 06:00 h (average meperidine by patient-controlled analgesia, 217 vs.

129 mg meperidine equivalents; P=0.008).

Sources: Surg Endosc 2009;23:2637-2643; Obes Surg 2008;18:1581-1586; Surg Obes Relat Dis 2010;6:181-184; Obes Surg 2007;17:595-600.

Table 2. Comparison of Outcomes Between Patients Receiving Ropivacaine and Placebo Ropivacaine

Placebo

P Value

Total narcotic, morphine equivalents

51.8

55.17

0.63

Patient-controlled analgesia attempts

61.95

73.74

0.59

Ondansetron, mg

10.6

10.6

0.98

Promethazine, mg

11.7

6.83

0.10

Hospital time, h

37.45

38.19

0.77

The investigators identified no benefit of catheter use.

“The continuous-infusion catheter provided no benefit regarding narcotic usage, pain scores, PCA attempts, antiemetic usage or hospital stay in the setting of laparoscopic sleeve gastrectomy,” Dr. Cleveland said (Table 2).

Adverse events were minimal, with no hypoxia or ileus in either group; urinary retention was identified in three patients, two in the ropivacaine group. Dr. Cleveland said the study was limited in that it was performed at a single institution and most of the patients were young females, which may not represent the typical bariatric population.

So, why are analgesia pumps beneficial in open but not laparoscopic procedures?

“In open surgeries, the catheters are placed directly in the incision, delivering local anesthetic into the operative site. In laparoscopic surgeries, the catheters are placed near the incisions, but may not directly

deliver anesthetic to these small trocar sites,” Dr. Cleveland said. “Additionally, open surgeries tend to have increased pain compared to laparoscopic surgeries, and with that, local anesthetic can have a greater impact in reducing pain.”

Kelvin Higa, MD, director of minimally invasive and bariatric surgery at Fresno Heart and Surgical Hospital, in Fresno, Calif., said the study was important in an era when emphasis is placed on value-based care.

“Today, the environment in which we practice is changing. As surgeons, we were only taught to think about quality at any cost, and now we are charged with talking about value … and cost-effectiveness. This research is something that any of us can do on a local level and can make a significant impact on the care of our patients.”

—Kate O’Rourke

ClassiďŹ eds GASTROENTEROLOGY & ENDOSCOPY NEWS â&#x20AC;˘ MARCH 2015

Gastroenterologist Opportunity Geisinger Health System (GHS), a national leader in quality and integrated healthcare is seeking a BC/BE Gastroenterologist with an interest in ERCP, motility or IBD to join its innovative practice at Geisinger Medical Center in Danville, PA. Ability to perform ERCP will be supported in a new state-of-the-art endoscopy suite with 3 dedicated advanced procedure rooms. Become part of a closely integrated department comprised of more than 23 gastroenterologists, 3 hepatologists and 10 fellows with some of the best resources available for academic and clinical practice. Call is equally shared and is no more than 5 to 6 weeks per year. Transplant Hepatology, and our Gastroenterology and Advanced Endoscopy fellowship programs are located at Geisinger Medical Center.

As a part of Geisingerâ&#x20AC;&#x2122;s team, you will work in an academic environment, backed by the resources of one of the nationâ&#x20AC;&#x2122;s most progressive integrated health systems. Enjoy the balance of a favorable call

schedule with the collegiality of a unique practice and surrounding community that offers a low cost of living, superb public schools, numerous outdoor and cultural activities, and easy access to major metropolitan areas including New York City, Baltimore, Philadelphia and Washington, D.C. Geisinger Health System serves nearly 3 million people in Northeastern and Central Pennsylvania and has been nationally recognized for innovative practices. A mature electronic health record connects a comprehensive network of 9 hospital campuses, 43 community practice sites and more than 1,200 Geisinger primary and specialty care physicians.

Discover for yourself the Geisinger difference.

For more information visit geisinger.org/careers or contact: Mathew McKinney, &GRCTVOGPV QH 2TQHGUUKQPCN 5VCHĆ&#x201A;PI CV QT OYOEMKPPG["IGKUKPIGT GFW

PRESBYTERIAN PRESBYTERIAN HEALTHCARE SERVICES Albuquerque, NM Presbyterian Healthcare Services is seeking Board CertiďŹ ed Gastroenterology trained physicians to join our established practice of 11 physicians, 2 Gastroenterology Hospitalists and 7 advanced practitioners. Our medical group employs more than 600 primary care and specialty providers and is the fastest growing employed physician group in New Mexico. Presbyterian Healthcare Services is a locally owned, not-for-proďŹ t organization based in Albuquerque. Our integrated healthcare system includes eight hospitals in seven New Mexico cities, a medical group, multispecialty clinics and a health plan (over 400,000 members).

We have been proudly providing care to New Mexicans for 105 years.

In addition to a guaranteed base salary we also offer a sign on bonus, incentive bonus, malpractice, relocation, house hunting trip, health, dental, vision, 403(b) w/ contribution from PHS 457(b), short & long term disability, CME allowance, etc.

Albuquerque thrives as New Mexicoâ&#x20AC;&#x2122;s largest metropolitan center with a population of 700,000. Albuquerque has been listed as one of the best places to live in the United States by Newsweek, U.S. News & World Report, Money and Entrepreneur Magazines! Albuquerque is considered a destination city for most types of outdoor activities with 310 days of sunshine. A truly diverse and multicultural city, Albuquerque offers you and your family a great variety of activities and entertainment including national theater productions, sporting events, golf courses ranked among the best in the country, the largest hot air balloon festival in the US, American Indian Cultural activities and much more.

For more information, e-mail Kelly Herrera at kherrera@phs.org or call 505-923-5662.

Visit our website at www.phs.org EOE

For classiďŹ ed advertising, contact Craig Wilson 212-957-5300 x235 cwilson@mcmahonmed.com

Career Opportunities Education Financial & Legal Services Medical Equipment

37

37

McMahon Group Acknowledges Exemplary Staff Every year the entire McMahon Group staff takes a moment to review the past year and celebrate the achievements of its various departments and the company overall.

McMahon Group’s print and digital properties enjoyed significant successes during 2014, often advancing in both readership and revenues.

2014

The following employees were singled out as exemplary at this year’s annual celebration.

We thank them, and we thank our readers for their continued enthusiasm for our medical journalism, which has made many of our publications the best read in their specialty.

SUPPORT/ART/PRODUCTION/IT/FINANCE

SUPPORT/ART/PRODUCTION/IT/FINANCE

This award is for a commingled group of several vital departments within the company, without any one of which the company would not thrive, and as such there are two recipients of this award.

MARTIN BARBIERI is the production manager for several of the company’s newsmagazines—a complicated task, which he accomplishes seamlessly month after month.

KWANGHEE CHUNG is senior lead developer in the IT Department, having input in all things digital, including our various websites, internal content management systems, and apps, to name a few.

EDITOR OF THE YEAR

SALES ACHIEVEMENT AWARD

This award is for the outstanding editor among the publication, copy and projects editorial staffs.

KEVIN HORTY Y won for his editorial direction of General Surgery News, the best-read publication in general surgery. His contributions have included an important effort to enhance our Web-based video offerings.

MATTHEW SPOTO is senior account manager for Gastroenterology & Endoscopy News, the best-read publication in gastroenterology. This award celebrates creative thinking to enhance sales and customer service.

SALESPERSON OF THE YEAR

THE MCMAHON GROUP PARTNERS’ AWARD

RICHARD TUORTO, the senior group publication director for Anesthesiology News and Pain Medicine News, both of which are the best-read publications in their fields, earned this award for the ninth year in a row for generating the most revenue in the calendar year.

ROSANNE MCMAHON is a partner and co-founder of the company and the wife of CEO Ray McMahon. For many years she was personally involved in financial oversight, but nowadays she continues to do what she has done expertly from the very beginning: supporting the CEO and family members working at the company!

THE MCMAHON GROUP PERSON OF THE YEAR RICHARD TUORTO, this year’s Salesperson of the Year, was voted Person of the Year by McMahon Group employees for his longstanding excellence in both sales and publication management.

39

GASTROENTEROLOGY & ENDOSCOPY NEWS • MARCH 2015

Diabetes continued from page 35

patients with diabetes undergoing seven other surgeries: coronary artery bypass graft, infrainguinal peripheral vascular revascularization, various laparoscopic procedures (partial colectomy, cholecystectomy, appendectomy and hysterectomy) and total knee arthroplasty.

Overall, 66,678 patients with diabetes were included in the study, 16,509 of whom underwent LRYGB (Table 1). The 30-day postoperative composite complication was defined as the presence of any of nine serious adverse events: pneumonia, acute renal failure, myocardial infarction, deep vein thrombosis, sepsis, pulmonary embolism, septic shock, stroke and need for transfusion. In patients undergoing LRYGB, the composite complication rate was 3.43%, with some patients having more than one complication (Table 2); the mortality rate was 0.30%; the average operating time was 137 minutes; and the average hospital length of stay (LOS) was

Table 1.

Baseline Characteristics of Patients Undergoing Laparoscopic Roux-en-Y Gastric Bypass Female, %

71.5

Average age, y

50

Average body mass index, kg/m2

46.5

Insulin use, %

37.4

Hypertension, %

79

Average American Society of Anesthesiologists score

2.9

Table 2.

Complications of Laparoscopic Roux-en-Y Gastric Bypass Outcome

Rate, %

Transfusion

1.22

Sepsis

0.81

Pneumonia

0.66

Deep vein thrombosis

0.36

Septic shock

0.30

Acute renal failure

0.22

Pulmonary embolism

0.22

Myocardial infarction

0.16

Stroke

0.05

2.57 days. The 30-day readmission and reoperation rate after LRYGB was 6.72% and 2.46%, respectively.

The LRYGB composite complication rate was similar to the rate seen in laparoscopic cholecystectomy and hysterectomy procedures. Mortality rates from gastric bypass and knee arthroplasty were comparable. Patients undergoing LRYGB and laparoscopic appendectomy had similar length of stay in the hospital and readmission rates. Gastric bypass patients had significantly better short-term outcomes in all examined variables compared with

coronary artery bypass graft, infrainguinal revascularization and laparoscopic colectomy.

“The findings of this study indicate that the 30-day mortality risk for LRYGB is one-tenth that of cardiovascular surgery,” Dr. Aminian said. “Earlier intervention with metabolic/diabetes surgery to treat diabetes and metabolic syndrome may eliminate the need for some later higher-risk procedures to treat cardiovascular complications of diabetes.”

Other clinicians were impressed with the study. “One of the biases against

bariatric surgery is that there is a high complication and mortality [rate], and this study proves that is not true, at least in the month after surgery,” said Ricardo Cohen, MD, of Oswaldo Cruz Hospital and Marcia Maria Braido Hospital, in São Paulo, Brazil.

Bipan Chand, MD, director of metabolic and bariatric surgery at the Stritch School of Medicine of Loyola University, in Chicago, said he “hoped the study would alert physicians to the safety of current bariatric procedures.”

—Kate O’Rourke

OPT IN to receive your free e-newsletter from the best-read gastroenterology publication in the country www.gastroendonews.com/renew

Articles from the current month’s issue Articles ahead of print Web-exclusive content

The #1 best-read gastroenterology publication in the USA. Anytime. Anywhere. gastroendonews.com

The Independent Monthly Newspaper for Gastroenterologists

Real-World Data Mimic Trial Findings For HCV Treatment BOSTON—Drugs often fall short of the expectations set in clinical trials, because the trials often exclude patients with various comorbidities and the sickest of the sick.

This does not seem to be the case with the latest generation of medications to treat hepatitis C virus (HCV) infection, which so far are meeting the high bar they set in pre-approval trials. see Real World, page 28

‘Normal’ Stomach On Endoscopy May Be Anything But Precautionary biopsies make sense PHILADELPHIA A—Nearly 30% of stomachs that appear to be normal during endoscopy in fact may have significant gastric pathology, according to a new study, which suggests that endoscopists may want to consider taking more biopsies as a precaution. see Biopsy, page 38

Falling Through the Cracks: Mothers With Hepatitis B Receive Inadequate Treatment, Follow-up

M

ore than on ne-third of women with the hepatitis B virus (HBV) are initially diagnoosed with the infection at their first prenatal care visit, but they do not receive follow-up care for the infection after their pregnaancy, researchers have found.

The retrospective stud dy examined the medical records of 243 women with HBV who receiveed prenatal care at facilities under th he umbrella of Massachusetts Gen neral Hospital (MGH).

“It’s clear from the data that these women are getting lostt to followup or not getting ap ppropriate care to begin with,” saaid Ruma Rajbhandari, MD, MPH, a gastroenterology and hepatology fellow at MGH H, in Boston, who led the sttudy.

“It’s a real shame. It is siimilar to getting diagnosed with HIV and not receiviing any follow-up care for it.”

The researchers presented theeir findings at the 2014 Liver Meetin ng of the American Association for th he Study of Liver Diseases (AAS SLD), in Boston (abstract 1552).

In 1990, the Centers for Disease Control and Prevention created the U.S. Perinatal Hep patitis B Prevention Program (P PHBPP) in an effort too reduce perinatal trransmission of the disease.

Under the P PHBPP, pregnantt women are rroutinely screened for H HBV and their inffants are treated an nd monitored approopriately.

The prograam has resulted in a sharp reduction of p perinatal infections with HBV. see Hep B, page 36

I N S I D E

Are We There Yet? Women still feel gender disparities in pediatric gastroenterology

W

hen it comes to compensation, mentoring and promotions, women in pediatric gastroenterology believe they continue to lag behind their male peers, a new survey has found. see Disparities, page 24

-/Ê" Ê ÊÓä£{\Ê* ,/ÊÓ 8* ,/-½Ê* -Ê More of the Best of the American College of Gastroenterology annual meeting.................... «>}iÊ£{

Gary Lichtenstein, MD

*iÌiÀÊ }} Ã] MD

Rajiv Chhabra, MD

PRINTER-FRIENDLY VERSION A AVAILABLE A AT GASTROENDONEWS.COM

Now available! À> `Ê iÜÊ *>`Ê ««

OPT IN

EDUCATIONAL REVIEW

Hemorrhoids: Evaluation and Management for the Office-based Clinician ERIC FONTENOT, MD

to receive your free monthly e-Newsletter at www.gastroendonews.com

see insert at page 20

STEPHEN W. LANDRENEAU, MD

Louisiana State University School of Medicine Department of Medicine Section of Gastroenterology New Orleans, Louisiana

Louisiana State University School of Medicine Department of Medicine Section of Gastroenterology New Orleans, Louisiana

The authors report no relevant financial conflicts of interest.

T

he medical literature on hemorrhoidal disease dates back at least as far

Hemorrhoids: Evaluation and Management for the Office-based Clinician

as Hippocrates, who described techniques that will be familiar to practitioners even today. This article will cover the epidemiology,

Internal hemorrhoidal plexus

normal anatomy and physiology, pathophysiology, and classification of

Dentate line

hemorrhoids, with a particular focus

External hemorrhoidal plexus

on the office-based physician.

Epidemiology Hemorrhoids are a common problem, estimated in a large epidemiologic study to have an overall prevalence of as much as 4.4% in the United States.1 Both sexes demonstrate a peak prevalence in the age range of 45 to 65 years, with increased rates associated with higher socioeconomic status.1 However, the true prevalence of hemorrhoidal disease may be underestimated because many patients do not seek medical attention, or overestimated because some patients erroneously attribute any anorectal problem to “hemorrhoids.”2

Anatomy The anal canal (Figure 1) consists of the approximately 4 cm between the distal rectum and the anal verge. In the approximate midpoint of the canal is the dentate line, an important anatomic landmark in the

Figure 1. Normal anorectal anatomy.

Courtesy of Iain Cleator MD, Vancouver, BC, Canada

evaluation and treatment of hemorrhoidal disease.

The dentate line represents the junction between the embryologic endoderm and ectoderm and is the point that the mucosa of the anal canal changes from the insensitive columnar epithelium of the rectum to the highly sensitive squamous epithelium of the anoderm.

Found proximally to the dentate line, the internal hemorrhoids are a specialized collection of 3 fibrovascular “cushions” arranged in a left lateral, right anterior, and right posterior configuration.3 They are composed of an arteriovenous plexus where branches of the superior, middle, and, to a lesser extent, inferior hemorrhoidal

G AST R O E N T E R O LO GY & E N D O S CO PY N E WS • JA N UA RY 2 0 1 5

For iPad

1

PRINTER-FRIENDLY VERSION AVAILABLE AT GASTROENDONEWS.COM

Bowel Preparation for Colonoscopy: Assessing and Improving Quality MANDEEP S. SAWHNEY, MD, MS Division of Gastroenterology Beth Israel Deaconess Medical Center and Harvard Medical School Boston, Massachusetts Dr. Sawhney reported no relevant financial conflicts of interest.

C

olonoscopy is the most frequently performed opic gastrointestinal endoscopic

procedure in the United States, atient with more than 3.3 million outpatient ally.1 colonoscopies performed annually. onoscopies account Screening and surveillance colonoscopies for approximately half of these procedures. The number of screening colonoscopies has increased 3-fold over the past decade, and the procedure is now the most widespread cancer screening test in the United States.2,3

Although the demand for and acceptance of colonoscopy has remained strong, competing technologies such as computed tomography colonography and fecal DNA testing have made significant progress. With the unrelenting increase in health care expenditures, there has been a renewed focus on quality and value of medical procedures. For colonoscopy to remain the dominant colon cancer screening approach, it is imperative that clinicians continually measure, report and improve its quality and value.

G AST R O E N T E R O LO GY & E N D O S CO PY N E WS â&#x20AC;˘ M A R C H 2 0 1 5

1

Figure 1. Adherent stool. This can be washed off the colon wall using a water jet.

Effect of Bowel Preparation On Colonoscopy Outcomes Bowel preparation in an integral part of colonoscopy and significantly affects the quality and value of the examination (Figures 1-8). In a systematic review of 56 studies assessing barriers to colonoscopy, McLachlan et al found that patients perceived the bowel preparation as the most burdensome aspect of colonoscopy.4 The quality of preparation significantly affects the ability of clinicians to detect polyps. In a study of 133 patients with initially suboptimal bowel preparation who underwent a repeat colonoscopy, 33.8% had at least 1 adenoma detected, and 18% had high-risk lesions detected.5 A recent study found that an “excellent” bowel preparation was superior to a “good” one with regard to the ability to detect sessile serrated adenomas (inter-rater reliability [IRR], 1.66; P=0.008) and advanced adenomas (IRR, 1.37; P=0.007).6 Inadequate bowel preparation also reduces the value of colonoscopy, as value equals health care outcome per dollar spent on health care. Poor bowel preparation can increase the cost of colonoscopy by up to 22% because of prolonged procedures and the need for shorter surveillance intervals.7

Measuring Quality Terms that often are used to characterize bowel preparation in clinical practice include excellent, good, fair, and poor. These terms do not have standardized

2

G AST R O E N D O N E WS .CO M

Figure 2 and 3. Semi-solid stool.

Particulate matter in the stool often obstructs the colonoscope channel; suctioning this is often impossible.

definitions, and therefore cannot be used to monitor or improve the quality of bowel preparation.

One option is to use the terms adequate and inadequate to describe bowel preparation, where an adequate bowel preparation is defined by the criteria that it allows for the detection of polyps greater than 5 mm.8 Another option is to use a validated scoring system, such as the Boston Bowel Preparation Scale (BBPS) or the Ottawa Bowel Preparation Scale (OBPS). The BBPS was designed for colonoscopy-oriented research, but

Table. Commonly Used Purgatives for Colonoscopy Preparation Class Polyethylene glycol 4-L PEG-ELS

Product

Recommended Usea

GoLYTELY (Braintree)

240 mL (8 oz) every 10 min beginning at 5 to 6 PM the evening before colonoscopy (total, 3 L); remaining 1 L 10 to 12 h later (at least 3 h before procedure) Same as above

Colyte (Schwarz Pharma) 4-L SF-PEG 2-L PEG-ELS and bisacodyl delayed-release tablets

2-L PEG and bisacodyl delayed-release tablets 2-L PEG with ascorbate

Sodium phosphate Tablet

NuLYTELY (Braintree) TriLyte (Schwarz Pharma) HalfLytely (Braintree)

MiraLax (Schering-Plough)

Same as above Same as above 2 bisacodyl delayed-release tablets at noon the day before colonoscopy; 240 mL (8 oz) every 10 min beginning at 5 to 6 PM (total, 1 L); repeat 240 mL (8 oz) every 10 min beginning 3 to 4 h before procedure (total, 1 L) Same as above

MoviPrep (Salix)

240 mL (8 oz) every 15 min beginning at 5 to 6 PM the evening before colonoscopy (total, 1 L), followed by at least 16 oz of fluid; 240 mL (8 oz) every 15 min at least 3 to 4 h before procedure (total, 1 L), followed by 16 oz of fluid

OsmoPrep (Salix)b

20 tablets (4 tablets every 15 min) at 5 to 6 PM the evening before colonoscopy; repeat with 12 tablets 10 to 12 h later (at least 3 h before procedure)

Sodium picosulfate/magnesium citrate Prepopik (Ferring Pharmaceuticals, Inc.)

Step 1: Dissolve 1 packet in 5 oz of liquid and consume, followed by 5, 8-oz glasses of clear liquid at 4 to 6 PM Step 2: Repeat step 1, followed by 3, 8-oz glasses of clear liquid (later the same evening, or 4 to 6 h before the procedure)

Suprep (Braintree)

6-oz bottle diluted with 16 oz of water followed by 32 oz water over the next hour; take the evening before colonoscopy and repeat the morning of examination

Sodium sulfate

ELS, electrolyte lavage solution; PEG, polyethylene glycol; SF, sulfate-free a

In some cases, these recommendations do not correspond with the FDA-approved dosage.

b

There have been rare reports of serious acute phosphate nephropathy in patients who received oral sodium phosphate products for colon cleansing prior to colonoscopy. Some cases have resulted in permanent impairment of renal function and some patients required long-term dialysis.

studies have found that it also is a valid and reliable instrument in routine clinical practice.9 The BBPS is applied during the withdrawal phase of colonoscopy, after the endoscopist has performed all washing, suctioning, and other cleaning maneuvers. The colon is divided into 3 segments: right, including the cecum and ascending colon; transverse, including the hepatic and splenic flexures; and left, including the descending colon, sigmoid, and rectum. Each segment is then scored on a scale from 0 to 3. An unprepared colon segment with mucosa not seen because of solid stool that cannot be cleared receives a score of 0; a score of 1 means a portion of mucosa of the colon segment is seen, but other areas of the colon segment are obscured by staining, residual stool, and/or opaque liquid; a score of 2 indicates the presence of minor residual staining, small fragments of stool, and/or opaque

liquid, but mucosa of the colon segment are seen well; and a score of 3 means the entire mucosa of the colon segment can be seen well with no residual staining, small fragments of stool, or opaque liquid. The 3 segment scores are then summed for a total score of 0, an unprepared colon, to 9, an entirely clean colon. If an endoscopist aborts a procedure because of inadequate preparation, any nonvisualized proximal segments are assigned a score of 0. In an observational study that included endoscopists in a variety of clinical settings, Calderwood et al found that the BBPS demonstrated high interobserver and intraobserver reliability.10 Furthermore, polyp detection was greater in segments with scores of 2 or 3 than segments with scores of 0 or 1. Endoscopists from a variety of settings worldwide found the scale easy to implement and applicable to their patient population.

G AST R O E N T E R O LO GY & E N D O S CO PY N E WS â&#x20AC;˘ M A R C H 2 0 1 5

3

Figure 6. Clear fluid.

Figure 4 and 5. Turbid and opaque fluid.

The OBPS uses 2 measurement parameters: fluid and residual stool in the colon.11 The fluid quantity is a global value given for the entire colon and is scored from 0 (no fluid) to 2 (substantial amounts of fluid). For assessment of residual stool, the colon is divided into 3 segments: right colon, mid-colon, and rectosigmoid colon.

Each segment is scored individually on residual stool.

A residual stool score of 0 indicates no residual stool; 1 indicates mild yellow staining but mucosal detail can be clearly seen; 2 reflects liquid stool but suction can provide a clear view; 3 indicates stool residue that requires both washing and suctioning to obtain a clear view; and

4

G AST R O E N D O N E WS .CO M

4 means stool that cannot be removed despite washing and suctioning. The fluid and stool scores are then added to yield an overall score ranging from 0, a totally clean colon, to 14, a completely unprepared colon. For example, if at colonoscopy, the right colon has stool residue that requires washing and suctioning (3), the midcolon contains liquid stool with suction alone needed to obtain a clear view (2), the rectosigmoid colon has mild yellow staining but mucosal detail can be clearly seen (1), and there is a moderate volume of fluid overall in the colon (1), the overall quality score is 7.

The OBPS is more appropriate for comparing the quality of cleanliness between different laxatives.

The score is applied to the condition of the colon as it was found by the endoscopist—that is, before any attempt is made to clean the colon. This scale, therefore, reflects the efficacy of the bowel preparation regimen. The BBPS, in contrast, is applied to the colon only after all cleaning maneuvers have been performed by the endoscopist. This score, therefore, may be better suited to assess the quality of the withdrawal examination and may better assess the influence of bowel preparation on the ability to detect polyps and other lesions.

Quality Indicators Quality measures are tools that are used as guides to monitor, evaluate, and improve the quality of patient care.12 These may be used to compare the performance of an individual health care provider or a group of such individuals with an ideal or a “benchmark.”13 The specific parameter that is being used for comparison is termed a quality indicator. A quality indicator is often reported as

Figure 7. Bubbles. These can easily be removed using water containing simethicone.

Figure 8. Excellent bowel preparation.

a ratio between the incidence of correct performance and the opportunity for correct performance, or as the proportion of interventions that achieve a predefined goal.14 Quality indicators can be divided into 3 categories: Structural measures assess characteristics of the entire health care environment, such as the proportion of eligible patients who received automated computerbased reminders to schedule a screening colonoscopy; process measures assess performance during the delivery of care, such as the proportion of patients undergoing screening colonoscopy for whom the surveillance interval was shortened because of suboptimal bowel preparation; and outcome measures assess the results of the care that was provided, including the proportion of patients diagnosed with colon cancer within 5 years of a screening colonoscopy.

The Taskforce on Quality in Endoscopy of the American Society for Gastrointestinal Endoscopy and the American College of Gastroenterology (ASGE/AGA) recently published updated quality indicators for colonoscopy.15 Of the 23 quality indicators that were proposed, 2 are pertinent to the issue of bowel preparation and are discussed below.

1. FREQUENCY

WITH WHICH THE PROCEDURE NOTE DOCU-

MENTS THE QUALITY OF PREPARATION N.

• Level of evidence to support this quality indicator: expert opinion.

• Type of measure: process measure.

• Performance target set by the taskforce: >98%.

The taskforce recommends that endoscopists should document the quality of the bowel preparation for every colonoscopy. The examination can be considered adequate if it allows detection of polyps greater than 5 mm.

Endoscopists are encouraged to use a validated scoring system to document the quality of bowel preparation; however, the taskforce recommends that this be done after retained fluid or stool have been suctioned to improve the ability to identify polyps. If bowel cleansing is inadequate to identify polyps greater than 5 mm, and the procedure is being performed for screening or surveillance, then the procedure should be repeated within 1 year. Adequate preparation carries the implication that the recommended interval before the next colonoscopy will be consistent with guidelines.16

2. FREQUENCY

IN WHICH THE BOWEL PREPARATION IS ADE-

QUATE TO ALLOW THE USE OF RECOMMENDED SURVEILLANCE OR SCREENING INTERVALS S.

• Level of evidence to support this quality indicator: expert opinion.

• Type of measure: process measure.

• Performance target set by the taskforce: ≥85% of outpatient examinations.

The taskforce recommends that the percentage of outpatient examinations with inadequate bowel preparation that require repeat colonoscopy within 1 year should not exceed 15%. Recent clinical trials suggest that such a target should be readily achievable in

G AST R O E N T E R O LO GY & E N D O S CO PY N E WS • M A R C H 2 0 1 5

5

Key Points The quality of bowel preparation significantly affects the ability to detect polyps and the costs associated with colonoscopy.

• Splitting the laxative dose between the day before and the day of colonoscopy significantly improves quality of bowel preparation.

• The quality of bowel preparation should be recorded for every colonoscopy, preferably using a validated scale.

• For split-dose bowel preparation, the second laxative dose should be started 4 to 5 hours before the proposed start time of the procedure. To minimize the risk for aspiration, patients should complete ingestion of the laxative at least 2 hours before colonoscopy. For early morning colonoscopies, patients may begin ingestion of the second half of the laxative late in the evening before (after 11 PM).

• The percentage of outpatient colonoscopies with inadequate bowel preparation that require repeat colonoscopy within 1 year should not exceed 15%.

• For screening and surveillance colonoscopies, if bowel preparation is inadequate to identify polyps greater than 5 mm, the procedure should be repeated within 1 year.

outpatients.17 Individual endoscopists should measure the proportion of their colonoscopies that require repetition because of inadequate bowel preparation. Endoscopists who have more than 15% of examinations with inadequate bowel preparation should re-examine their bowel preparation protocols, including patient education, choice of purgative, and protocol for administering the purgative.

Improving the Quality of Bowel Preparation Endoscopists should be aware of factors that are associated with poor bowel preparation. Studies have found that diabetes, poor patient motivation, later colonoscopy starting time, a reported failure to follow preparation instructions, inpatient status, constipation, presence of comorbidities, older age, and lower socioeconomic status are predictors of an inadequate bowel preparation.18-20 A quality improvement program may be able to target resources to patients who are at increased risk for suboptimal bowel preparation.

The recognition that splitting the laxative dose between the day before and the day of the colonoscopy improves quality of bowel preparation is a significant advance in colonoscopy. A meta-analysis found that split-dose polyethylene glycol (PEG) was superior to full dose with regard to the number of satisfactory bowel preparations (odds ratio [OR], 3.70; P<0.01), willingness to repeat the same preparation (OR, 1.76; P=0.03), decreased number of preparation discontinuations (OR, 0.53; P=0.04), and nausea (OR, 0.55; P<0.01).21 Another meta-analysis found that 4 L splitdose PEG was superior to other bowel preparations, suggesting that this may be considered the preferred bowel preparation option for most patients.22 Based on the recognition that the quality of bowel preparation diminishes as the interval between intake of the laxative and performance of colonoscopy increases, the ASGE/AGA taskforce recommends that all patients

6

G AST R O E N D O N E WS .CO M

be prescribed split-dosing of bowel preparations. Half the preparation should be taken on the day of the examination. The second dose should be started 4 to 5 hours before the scheduled colonoscopy start time. To minimize the risk for aspiration, patients should complete ingestion of their bowel preparation at least 2 hours before the administration of sedation for colonoscopy.

Patients who are scheduled for colonoscopy early in the morning and who do not want to take laxatives 4 to 5 hours before the scheduled colonoscopy time may begin ingestion of the second half of the preparation late in the evening before (after 11 PM). Patients scheduled for afternoon colonoscopies may also consider taking the entire bowel preparation on the day of the procedure.23 Split-dose bowel preparation constitutes a significant improvement, but it has limitations. Menees et al found that 15.4% of patients were unable to comply with this laxative regimen.24 Several other strategies have been proposed to enhance patient experience and compliance with bowel preparation. Brahmania et al showed that a low-volume preparation (2 L of PEG and 15 mg of bisacodyl tablet) was better tolerated than the standard split-dose 4 L regimen, without compromising the quality of cleansing.1 Sipe at el found that allowing a low-residue diet the day before colonoscopy did not impair the quality of bowel preparation while significantly improving patient satisfaction and reducing the rate of procedure cancellation.25

Conclusion Bowel preparation is an integral part of colonoscopy, as it influences all aspects of the procedure. It is perceived by patients as the single most onerous part of the procedure. Other colon cancer screening options that do not require bowel preparation will routinely become available to patients in the future. Therefore, for colonoscopy-based colon cancer screening to remain viable, urgent innovation in this area is needed.

References 1.

Brahmania M, Ou G, Bressler B, et al. 2 L versus 4 L of PEG3350 + electrolytes for outpatient colonic preparation: a randomized, controlled trial. Gastrointest Endosc. 2014;79(3):408-416.

2. Lieberman DA, Williams JL, Holub JL, et al. Colonoscopy utilization and outcomes 2000 to 2011. Gastrointest Endosc.

2014;80(1):133-143.

4. McLachlan SA, Clements A, Austoker J. Patients’ experiences and reported barriers to colonoscopy in the screening context—a systematic review of the literature. Patient Educ Couns.

2012;86(2):137-146.

17. Rex DK, Katz PO, Bertiger G, et al. Split-dose administration of a dual-action, low-volume bowel cleanser for colonoscopy: the SEE CLEAR I study. Gastrointest Endosc. 2013;78(1):132-141.

5. Chokshi RV, Hovis CE, Hollander T, et al. Prevalence of missed adenomas in patients with inadequate bowel preparation on screening colonoscopy. Gastrointest Endosc. 2012;75(6):1197-1203.

6. Tholey DM, Shelton CE, Francis G, et al. Adenoma detection in excellent versus good bowel preparation for colonoscopy. J Clin Gastroenterol. 2014 Dec 9. [Epub ahead of print]

8. Rex DK, Bond JH, Winawer S, et al. Quality in the technical performance of colonoscopy and the continuous quality improvement process for colonoscopy: recommendations of the U.S. MultiSociety Task Force on Colorectal Cancer. Am J Gastroenterol.

2002;97(6):1296-1308.

9. Lai EJ, Calderwood AH, Doros G, et al. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009;69(3 Pt 2):620-625.

12. Mainz J. Defining and classifying clinical indicators for quality improvement. Int J Qual Health Care. 2003;15(6):523-530.

13. Chassin MR, Galvin RW. The urgent need to improve health care quality. Institute of Medicine National Roundtable on Health Care Quality. JAMA. 1998;280(11):1000-1005.

18. Serper M, Gawron AJ, Smith SG, et al. Patient factors that affect quality of colonoscopy preparation. Clin Gastroenterol Hepatol.

2014;12(3):451-457.

19. Ness RM, Manam R, Hoen H, et al. Predictors of inadequate bowel preparation for colonoscopy. Am J Gastroenterol.

2001;96(6):1797-1802.

20. Lebwohl B, Wang TC, Neugut AI. Socioeconomic and other predictors of colonoscopy preparation quality. Dig Dis Sci. 2010;55(7):2014-2020.

7. Rex DK, Imperiale TF, Latinovich DR, et al. Impact of bowel preparation on efficiency and cost of colonoscopy. Am J Gastroenterol.

2002;97(7):1696-1700.

11. Rostom A, Jolicoeur E. Validation of a new scale for the assessment of bowel preparation quality. Gastrointest Endosc.

2004;59(4):482-486.

15. Rex DK, Schoenfeld PS, Cohen J, et al. Quality indicators for colonoscopy. Gastrointest Endosc. 2015;81(1):31-53.

16. Lieberman DA, Rex DK, Winawer SJ, et al. Guidelines for colonoscopy surveillance after screening and polypectomy: a consensus update by the US Multi-Society Task Force on Colorectal Cancer.

Gastroenterology. 2012;143(3):844-857.

3. Vital signs: colorectal cancer screening test use—United States, 2012. MMWR Morb Mortal Wkly Rep. 2013;62(44):881-888.

10. Calderwood AH, Jacobson BC. Comprehensive validation of the Boston Bowel Preparation Scale. Gastrointest Endosc.

2010;72(4):686-692.

14. Petersen BT. Quality assurance for endoscopists. Best Pract Res Clin Gastroenterol. 2011;25(3):349-360.

21. Kilgore TW, Abdinoor AA, Szary NM, et al. Bowel preparation with split-dose polyethylene glycol before colonoscopy: a metaanalysis of randomized controlled trials. Gastrointest Endosc.

2011;73(6):1240-1245.

22. Enestvedt BK, Tofani C, Laine LA, et al. 4-Liter split-dose polyethylene glycol is superior to other bowel preparations, based on systematic review and meta-analysis. Clin Gastroenterol Hepatol.

2012;10(11):1225-1231.

23. Varughese S, Kumar AR, George A, et al. Morning-only one-gallon polyethylene glycol improves bowel cleansing for afternoon colonoscopies: a randomized endoscopist-blinded prospective study.

Am J Gastroenterol. 2010;105(11):2368–2374.

24. Menees SB, Kim HM, Wren P, et al. Patient compliance and suboptimal bowel preparation with split-dose bowel regimen in average-risk screening colonoscopy. Gastrointest Endosc.

2014;79(5):811-820.

25. Sipe BW, Fischer M, Baluyut AR, et al. A low-residue diet improved patient satisfaction with split-dose oral sulfate solution without impairing colonic preparation. Gastrointest Endosc.

2013;77(6):932-936.

G AST R O E N T E R O LO GY & E N D O S CO PY N E WS • M A R C H 2 0 1 5

7

1978

â&#x20AC;&#x201D;

37th Anniversary â&#x20AC;&#x201D; 2 0 1 5

2015 2014

Th Independ The Independent Monthly Newspaper for Gastroenterologists

For almost four decades, Gastroenterology & Endoscopy News has been providing gastroenterology health care professionals with specialty-specific news and reviews, offering comprehensive and objective information for the practicing clinician.

We are proud to be the best-read gastroenterology publication in the marketplace, and we look forward to continuing to be your #1 source for gastroenterology news in decades to come.

gastroendonews.com

Brought g to You by y

MARCH MARCH 2015 2015

REPORT The GI Quality Improvement Consortium: Helping Practices Improve Quality and Outcomes in Endoscopy

T

he gastroenterology practice is increasingly focused on the documentation of quality. Accreditation of endoscopy centers and Medicare reimbursements depend on evidence of high-quality gastrointestinal (GI) care. Referring physicians and patients seek quality data, such as a physicianâ&#x20AC;&#x2122;s adenoma detection rate (ADR) on colonoscopy. Above all, gastroenterologists continually strive to improve efficiency and outcomes, especially in their use of endoscopic technologies.

The measurement and documentation of quality, once a time-consuming process, has been streamlined by the GI Quality Improvement Consortium (GIQuIC), a quality benchmarking registry that enables practices to

track their performance on quality indicators for colonoscopy and esophagogastroduodenoscopy (EGD), and compare it within the practice for individual physician performance and with other practices in a national database. The registry is a nonprofit collaboration of the American College of Gastroenterology (ACG) and the American Society for Gastrointestinal Endoscopy (ASGE), and is designed to offer GI practices distinct clinical, organizational, and economic benefits. These benefits include improvements in care, ease of quality reporting to Medicare, an enhanced ability to negotiate with payors and to market endoscopy services, and opportunities to use the database for research.

Faculty Irving M. Pike, MD, FACG, FASGE

Bergein F. Overholt, MD, FACG, FACP, MACG

Director and President, GIQuIC Chief Medical Officer John Muir Health Walnut Creek, California

Gastrointestinal Associates Knoxville, Tennessee

Thomas Deas, MD, FACG, FASGE

Karen Reynolds, LPN

Kim West, RN, CGRN THR Regional Quality Coordinator Quality Coordinator/Data Manager Fort Worth Endoscopy/Southwest Fort Worth Endoscopy Centers Fort Worth, Texas

Utilization Review Coordinator Gastrointestinal Associates Knoxville, Tennessee

Director, Physician Development North Texas Specialty Physicians Fort Worth, Texas

Supported by

REPORT Overview of GIQuIC

Uploading procedure records to the registry is simplified by a built-in interface between GIQuIC and 10 electronic endowriters (Table 2).6 Physicians conduct and report each endoscopy as they normally would on their endowriter system, and data from the report can be automatically populated into a GIQuIC data set during the upload process. A nurse or allied professional who serves as a data manager for the practice can check the data set and upload it to GIQuIC according to the practice’s time settings (eg, weekly, monthly). For those practices that do not use an endowriter, endoscopy data can be entered manually on the GIQuIC website.

Quality measure reports are then generated in a realtime manner by the participating facility. These reports allow each physician and the practice as a whole to compare performance with results from the entire GIQuIC registry.

Figure 1 shows a summary chart for an endoscopy site as a whole compared with all data in the registry for the quality indicator of ADR. GIQuIC allows members to select time frames for reporting (eg, quarterly) and apply filters and display options to the data set (eg, display 95% confidence intervals with data).5

GIQuIC is the result of a 3-year collaboration of clinicians, endowriter software developers, and Sentara Healthcare, a Virginia-based health system. From 2006 to 2009, the partnership, spearheaded by Irving M. Pike, MD, FACG, FASGE, completed a pilot project in which physicians from across the country submitted colonoscopy quality-indicator data to a central repository using diverse methods of submission.1,2 In 2009, ACG and ASGE adopted the project and rolled it out nationally as GIQuIC.1 In 2014, GIQuIC achieved 2 milestones: the national database surpassed 1 million colonoscopy cases and the Centers for Medicare & Medicaid Services (CMS) approved the GIQuIC registry as a Qualified Clinical Data Registry (QCDR), a new reporting mechanism for the Physician Quality Reporting System (PQRS).3,4 More than 335 practices, representing in excess of 2,800 physicians, have enrolled in GIQuIC.5 Membership in GIQuIC is open to GI offices, endoscopy units, ambulatory surgery centers, and hospitals of all sizes.6 Registration for GIQuIC can be accomplished via a form available at the website, www.giquic.org.

The GIQuIC registry is based on an electronic exchange of information between member facilities and the central registry. Participating facilities submit data fields from endoscopic procedure reports or manually into the registry. In turn, the GIQuIC registry provides the participating facility real-time, ondemand reports that show each physician’s performance and overall practice performance across multiple quality indicators (Table 1).6 Additionally, performance data from the entire database also is reported, allowing facilities to compare their performance to that of nationwide peers.

Derivation and Evolution of Quality Indicators The GIQuIC quality measures were derived from the quality indicators for GI endoscopy established by the ACG and ASGE Task Force on Quality in Endoscopy in 2006.2,7-11 These quality measures had a transformative effect on endoscopic practice, training, and documentation, and have raised the bar for endoscopic competency across the specialty.12

Table 1. GIQuIC Current Quality Indicators 14 Colonoscopy Measures

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

14.

A. Female B. Male Adequacy of bowel prep Adverse events—immediate Age-appropriate screening colonoscopy Appropriate follow-up interval for normal colonoscopy in average-risk patients ASA category documentation Cecal intubation rate with photo documentation A. All colonoscopies—screening, surveillance, and diagnostic B. Screening Colonoscopy interval for patients with a history of adenomatous polyps - avoidance of inappropriate use History and physical documentation Indication documentation Informed consent documentation Repeat colonoscopy recommended due to poor bowel preparation Withdrawal time Written discharge instructions—outpatient

12 EGD Measures 1.

2.

3.

4.

Adverse events—immediate Appropriate antibiotic prophylaxis Appropriate anticoagulation management Appropriate endoscopic therapy for stigmata of peptic ulcer disease bleeding 5. Appropriate management of new diagnoses of bleeding esophageal varices 6. Appropriate specimen acquisition in Barrett’s esophagus 7. ASA category documentation 8. Helicobacter pylorii status 9. History and physical documentation 10. Indication documentation 11. Informed consent documentation 12. Written discharge instructions—outpatient

ASA, American Society of Anesthesiologists; EGD, esophagogastroduodenoscopy Based on reference 6.

2

REPORT

Patients,

%

The central goal of the Task Force was to improve endoscopic care by promulgating quality indicators backed by clinical evidence and expert consensus.7 A procedural goal was to adopt quality indicators that, in the majority of cases, could be extracted from the endoscopy report or documentation7; this goal ensured the utility of indicators in clinical practice, and paved the way for GIQuIC’s streamlined interface with endoscopy reporting.

The Task Force developed quality indicators for the 4 major GI endoscopic procedures: colonoscopy, EGD, endoscopic retrograde cholangiopancreatography (ERCP), and endoscopic ultrasonography (EUS).2,7-12 Although GIQuIC currently includes quality measures only for colonoscopy and EGD, the registry is in the process of considering measures for other procedures.12 GIQuIC working groups also are exploring unit-based quality measures,12 which address the organized delivery of care in the endoscopy unit, and disease management–related quality measures in inflammatory bowel disease and hepatitis C. Quality indicators created by the Task Force fall into 3 groups: pre-procedure, intra-procedure, and post-procedure.7,11 For example, a pre-procedural quality indicator in colonoscopy mandates that, in every case, quality of bowel preparation should be noted in the report.2 This indicator is backed by evidence that inadequate preparation unnecessarily extends cecal intubation and withdrawal time and reduces detection of polyps,13,14 increasing the likelihood that the colonoscopy will need to be repeated with a shorter interval than normally recommended.2 A decade ago, about one-fourth of colonoscopies performed had inadequate bowel prep,13 indicating a significant need for quality improvement in this area.

100 90 80 70 60 50 40 30 20 10 0

Table 2. Endowriters Certified for Use With GIQuIC Amkai CORI eMerge Health Solutions EndoSoft gMed MD-Reports Olympus (version 7.4) Pentax (endoPRO iQ 7.5) ProVation (version 5.0)

Summit Imaging Based on reference 6.

This quality indicator is reflected in the quality metric of adequate bowel prep in GIQuIC (Table 1).6 Examples of intra-procedural quality indicators include cecal intubation rates of at least 90% in all cases (≥95% in screening of a healthy adult); an ADR of at least 25% in men and at least 15% in women over age 50 years in screening colonoscopy, and an average withdrawal time of at least 6 minutes in colonoscopies with normal results performed in patients with

Male goal: 30% Female goal: 20%

Adenoma Detection Male goal: 30%, Female goal: 20% Benchmark Group

Numerator

Denominator Patients, %

95% Confidence Interval, low

95% Confidence Interval, high

Endoscopy Site

1,442

3,690

39.1

37.5

40.7

Entire Registry

162,104

474,013

34.2

34.1

34.4

Figure 1. GIQuIC quality indicator sample report.

Percentage of patients age 50 years or over undergoing screening colonoscopy with a finding of at least 1 adenomatous polyp from June 1, 2011 through February 10, 2015.

ADR, males and females combined, for an endoscopy site (red) compared with all of the data in the entire registry at the time of the report (blue). Horizontal lines show the goal ADR rates for males and females.

ADR, adenoma detection rate

3

REPORT intact colons.2,15 Intubating the cecum is important because a substantial proportion of colorectal cancers are located in the proximal colon, including the cecum.2,16 During screening colonoscopy, ADR has historically been variable among endoscopists, increasing the risk that a missed adenoma will develop into an interval cancer between screenings.2 Longer withdrawal times (â&#x2030;Ľ6 minutes) have been associated with increased detection of adenomas.2 Post-procedural quality indicators include documentation and management of perforation and post-polypectomy bleeding.8 GIQuIC covers these quality indicators under the broader metric of adverse events.

Endoscopy quality indicators continue to be refined. In December 2014, the ASGE/ACG Task Force published updated quality indicators for colonoscopy, EGD, ERCP, and EUS.12,17-21 These updated indicators reflect data accrued on the factors that most affect outcomes since 2006.12 Some measure targets or goals within GIQuIC will be updated to reflect the changes in these revision documents.

For example, updated colonoscopy indicators include additional data in support of the metric of at least 90% compliance with recommended post-polypectomy and post-cancer resection surveillance intervals and 10-year intervals between screening colonoscopies in average-risk patients who have negative examination results and adequate bowel cleansing.18 These newer data include a 2011 study showing that patients with a previously negative colonoscopy have a low risk for colorectal cancer 10 years after screening and beyond.22 Another update in colonoscopy is an elevation in ADR performance targets for men and women from 25% and 15% (2006) to 30% and 20% (2014), respectively.2,18 The evidence in ADR

has expanded with new data, notably a 2014 publication demonstrating an inverse correlation between ADR and the risk for interval cancers, including advanced and fatal interval cancers, based on more than 314,872 colonoscopies performed by 136 endoscopists (Figure 2).23

GIQuIC in Practice GIQuIC has an ever-evolving range of applications that include facility-wide quality improvement; simplification of quality reporting to Medicare; novel opportunities to negotiate favorably with third-party payors; enhanced ability to market the practice; performance of quality assurance projects for units; completion of a Practice Improvement Module (PIM) for Maintenance of Certification (MOC); and utility of the GIQuIC database for research (see The User Experience).

Facility-Wide Quality Improvement Before GIQuIC, gastroenterologists had no objective measure of their performance. Using GIQuIC data, they are able to obtain quality benchmarks relative to their in-practice and national peers for an accurate assessment.

Clinicians who meet benchmarks work to surpass them, whereas clinicians who fall short of benchmarks strive to equal or outdo their peers. Throughout this process, medical executive committees and individual physicians often seek the advice of those endoscopists in the facility who consistently exceed expectations on GIQuIC metrics.

For example, a clinician who wants to boost his or her percentage of patients with adequate bowel prep may ask another clinician with very high compliance on this measure for advice on patient counseling and information on pre-procedures. In

Interval Colorectal Cancer Cases per 10,000 person-years, n

12 10

9.8 (HR: 1)

8.6 (HR: 0.93)

8

8 (HR: 0.85)

7 (0.70) 4.8 (0.52)

6 4 2 0

7.35-19.05

19.06-23.85

23.86-28.40

28.41-33.50

33.51-52.51

ADR, %

Figure 2. Unadjusted risk for interval colorectal cancers as a function of ADR in a study of 314,872 colonoscopies.

ADR, adenoma detection rate; HR, hazard ratio Based on reference 23.

4

REPORT some facilities, physicians and data managers organize specific quality initiatives that are monitored and validated using GIQuIC data (see Case Study). y Physicians are able to employ GIQuIC data to complete the American Board of Internal Medicine’s (ABIM’s) Self-Directed PIM by demonstrating personal quality improvement. In doing so, they will earn points in the MOC program.

Medicare Quality Reporting Under the Affordable Care Act, Medicare payments are tied to PQRS quality reporting. Physicians and groups that successfully report data on PQRS quality measures may qualify to receive upward payment adjustments. 24,25 However, there are penalties for not reporting to PQRS, and these penalties increase over time depending on the practice size. Physicians and groups that do not successfully report are subject to a cut by PQRS that is compounded by downward payment adjustments through the Value-Based Payment Modifier program that is tied to PQRS reporting.

For example, for the 2017 payment year, physician groups and solo practitioners who do not report PQRS quality measures in 2015 will receive a negative payment adjustment of 2%, which will be compounded with a downward payment adjustment via the value modifier. Physician groups of 2 to 9 as well as solo practitioners who do not successfully report PQRS quality measures in 2015 will be subjected to an automatic downward adjustment of –2% value modifier adjustment, while groups of 10 or more physicians will incur a –4% value modifier adjustment in 2017.26 Enrollment in GIQuIC enables practices to address these federal mandates more easily. In May 2014, GIQuIC became a QCDR, allowing eligible professionals to use the registry for reporting quality measures to CMS in order to participate in PQRS.27,28 A webinar on GIQuIC as a QCDR for PQRS is available on the GIQuIC website, www.giquic.org.

Negotiating With Private Payors Evidence of practice quality in GIQuIC may facilitate

favorable reimbursement negotiations with insurers. For example, a facility that consistently surpasses benchmarks on key quality indicators may negotiate incentive reimbursement within a framework of value-based benefit design.

GIQuIC also can be used for documentation of high-quality, affordable care within a commercial or Medicare-based accountable care organization (ACO); in the case of ACOs organized under the Medicare Shared Savings Program,29,30 demonstration of good-quality, appropriate care can result in reimbursement of cost savings attributed to quality.

Marketing of the Facility/Practice GIQuIC can be a tool for Web-based and in-person marketing to referring physicians and the larger community. Tangible proof of quality, supplied by GIQuIC data, encourages clinicians to refer their patients for endoscopy. Patients with high health literacy may ask about ADRs; GIQuIC provides an unequivocal answer to such questions. Once a facility registers for GIQuIC, it receives marketing materials that explain the meaning of participation in GIQuIC and a public relations/media toolkit to help publicize the facility’s involvement with the registry.6

Research Given its vast database, GIQuIC can be employed for clinical research. The number of procedures and data fields in the registry can be analyzed to identify which behaviors are associated with an outcome indicator such as high ADR in colonoscopy. Practice-level, case-based research also can be facilitated by GIQuIC data.

Conclusion Endoscopy quality is the focus of professional associations, government agencies, private payors, referring physicians, and patients. Moreover, procedure quality is the chief concern of every endoscopist. GIQuIC provides a comprehensive program to meet the continuing demand for quality improvement and reporting. The result is improved quality, greater practice efficiency, and better outcomes for patients.

The User Experience The following Q & A provides insight on the utility of GIQuIC from registered users.

Q.

Has GIQuIC improved endoscopy quality for you and your colleagues?

Dr. Deas: GIQuIC can have an amazing effect on your practice. Without it, you’re like a guy who runs track, but doesn’t measure his times. He thinks he’s good, but he really doesn’t know. Likewise, we think we’re good endoscopists, but without GIQuIC, we have no objective data on whether we’re worse than, equal to, or better than our colleagues or quality benchmarks. We all strive to improve, and GIQuIC is the tool we need to continue to get better.

Dr. Overholt: Previously, our practice did not do the best job on endoscopic quality measurements and reporting. Our

measures were self-reported and not validated. With GIQuIC, validation is national and the performance data are shifted back to the practice to use. When you show physicians their performance measured against their peers nationally, they will improve their performance.

Physicians are competitive people, and they will try to beat averages. This was true for our practice. Since implementing GIQuIC, we’ve seen improvements across the board. Physicians who were already better than their peers wanted to stay there.

Those with lower numbers worked to surpass the benchmarks.

Dr. Pike: One way GIQuIC works is via the Hawthorne effect: People improve what is measured. Knowing that your performance is being measured and routinely checking your results motivates improvement.

5

REPORT

Q.

Is GIQuIC easy to use?

Dr. Overholt: One of the great things about GIQuIC is that the format is fully compatible with the endowriters we all use to create our endoscopy reports (Table 2). At the end of your report, you click on a drop-down menu for GIQuIC. A lot of the GIQuIC information is already populated from the report you’ve just completed—you only have to enter a little additional information. Then, you just click to upload to the GIQuIC database.

Ms. West: The interface between GIQuIC and our endowriter is seamless. Physicians need some training on the program, but the learning curve is very short. Training mainly involves how best to enter data in the endoscopy report so that it is picked up by GIQuIC. A lot of that depends on the endowriter you use, but typically it involves entering less in free text and more on specific menus. For instance, in our practice, some physicians used to input the time since last colonoscopy in free text; we’ve shown them how to input that information on a specific menu item so that it shows up readily in GIQuIC.

Q.

Does GIQuIC change practice management?

Dr. Overholt: We have used GIQuIC in negotiations with a large third-party insurance carrier: We get incentive reimbursement if we perform above the national level on 4 benchmarks measured by GIQuIC—ADR, cecal intubation rate, recommended 10-year follow-up for normal-risk colonoscopy, and recommended 5-year follow-up for prior screenings with less than 3 non–high-risk adenomas. Part of the negotiation was to show that extra reimbursement, to help defray the cost of GIQuIC, would result in overall better value for the payor.

Dr. Deas: Before GIQuIC, our 17-physician practice tried to track quality. It was laborious, and as a result we would look at a quality indicator for a few months, then stop. GIQuIC lets us accomplish the same goal with less work and more consistency. For about 5 years now, we’ve gotten quality reports every quarter that are shared with our medical executive committee and each physician.

Ms. Reynolds: There’s an aspect of day-to-day practice that GIQuIC makes much easier: handling controversial issues. GIQuIC reports have a lot of credibility with physicians and nurses. There are times when clinicians use a method or approach to endoscopy that isn’t helping them do their best work. If you say this without tangible support, it can cause conflict. But when you have the support of a credible data registry like GIQuIC, you’re just presenting facts, not criticizing. It’s a really good way to enhance accountability.

Q.

Is GIQuIC assisting you with reporting to CMS and other health agencies?

Dr. Pike: I’m happy to say that, in May 2014, Medicare, via CMS, began accepting our quality indicators. GIQuIC is now a QCDR, a qualified clinical data registry, which means that practices can use it to participate in the PQRS. CMS uses GIQuIC as a source of 13 GI-centered quality metrics.

6

Before this, gastroenterologists were reporting to PQRS— and so gaining eligibility for incentive payments and protection from losing reimbursement—based on a set of PQRS metrics that were not GI-specific. You could get credit for being a quality GI provider if you provided smoking cessation, diabetes care, and other non-GI services. By accepting quality reporting from GIQuIC, CMS is looking at measures relevant to the work we’re actually doing.

Dr. Overholt: In 2014, Medicare required practices to input a minimum of 3 and as many as 9 approved quality measures.

GIQuIC serves as an intermediary to PQRS. By using it, our providers will report 9 quality metrics to PQRS. So we can expect to obtain the 0.5% bonus Medicare reimbursement in 2014, and we will also prevent the Medicare payment reductions slated for 2016.

Ms. West: Reporting of all kinds is very difficult and laborintensive when you have to do it all yourself. With GIQuIC, I can complete in 30 minutes what would take days without the program.

Q.

What advice would you give to practices that are considering membership in GIQuIC?

Dr. Overholt: Do it yesterday! There is simply no way we can keep up with the demands and requirements of federal agencies and private insurers, unless we have this kind of electronic reporting. GIQuIC is also a great marketing tool for your practice; we provide our GIQuIC data under a “Quality” button on the website, so that patients and referring physicians can see our performance.

Ms. West: Think about what a GI practice is all about. We are all in the business of saving lives by early detection of precancerous polyps. That’s what we do. We all really want to reduce the incidence of colon cancers. Tracking our ADR rate through GIQuIC is a very efficient tool to help us do just that.

Ms. Reynolds: There is a lot to be said for the timely reports we get from GIQuIC. If needed, you can get a report the next day on procedures done as late as the day before.

It’s nearly live data. That’s become very important to our physicians, who are always asking to see their GIQuIC numbers.

With GIQuIC, our endoscopists have been pleased to find out that they are very good relative to their peers.

Dr. Deas: My advice is this: We have an obligation to our patients to be sure we provide high-quality care; but to know whether you are actually meeting that obligation, you need data. I would hate to see that my colonoscopy ADR rate was only 12% and that, as a result, my patients were at greater risk for getting colon cancer. I would want to know that, so I could improve.

Dr. Pike: GIQuIC has helped gastroenterologists achieve multiple goals over time. It started out as a grassroots effort.

Then, once the program rolled out, it began to help the membership of ACG and ASGE improve the quality of their work.

In 2014, the registry became a QCDR, making it easier for the GI practice to report quality measures to Medicare. GIQuIC can also be used to apply for points in maintenance of certification. The GIQuIC database is now large enough to be a clinical research tool, and the program has continued to offer more and more to its members.

REPORT

Getting Started With GIQuIC sive additional text materials and webinars. A drop-down

To participate in GIQuIC, facilities pay an annual site license feea per the number of physicians at the site:

menu allows access to the “Register” page to obtain

•

1-5 physicians:

a registration form. For more information, contact the

•

6-10 physicians: $5,400

GIQuIC staff at (301) 263-9000 or info@giquic.org.

•

11-15 physicians: $9,400

•

16-20 physicians: $10,800

The GIQuIC website (http://giquic.gi.org) provides exten-

$4,000

For facilities with more than 20 physicians, please contact GIQuIC. a

Participants in ASGE’s Endoscopy Unit Recognition Program qualify for discounted GIQuIC rates.

Case Study 30

Fort Worth and Southwest Fort Worth Endoscopy Centers

Withdrawal time <6 minutes

25

F

Withdrawal time ≥6 minutes

20

Percent

ort Worth Endoscopy wanted to improve ADR to reduce the risk for interval cancers. 23 GIQuIC reports indicated that 3 physicians were not consistently meeting the 25% benchmark for ADR. Based on research published in 2005 linking higher ADR with longer (≥6 minutes) scope withdrawal times (Figure 3),8,31 the practice embarked on a quality improvement initiative: Increase withdrawal times to increase ADR. “We used our GIQuIC data to start tracking whether if physicians increased their withdrawal times, would their ADRs go up as well,” said Ms. West.

That hypothesis proved correct. In response to the initiative—which included regular comparative charts created from GIQuIC—physicians as a group increased average withdrawal times from a minimum of 6 minutes to 8 minutes or greater over 6 months. During the same period, 17 of 18 physicians attained a consistent ADR of 25%.

“It’s simple, when you see the data, it changes your behavior—that’s how GIQuIC works in a very tangible way,” said Dr. Deas.

Fort Worth Endoscopy Center will be presenting its data at the 2015 Annual Course of the Society of Gastroenterology Nurses and Associates (SGNA).

28.3

15

11.8 10

6.4 5

2.6

0

ADR, %

Advanced neoplasia detection rate, %

Figure 3. ADR and advanced neoplasia detection rate as a function of withdrawal time in colonoscopy.

ADR, adenoma detection rate Based on reference 31.

7

REPORT References 1. GIQuIC: History. http://giquic.gi.org/what-is-giquic.asp#history.

Accessed January 8, 2015.

2. Rex DK, Petrini JL, Baron TH, et al. Quality indicators for colonoscopy. Am J Gastroenterol. 2006;101(1):873-885.

3. GIQuIC colonoscopy quality registry surpasses 1 million colonoscopy cases milestone underscores value of clinical benchmarking tool for gastroenterology practices. Bethesda, MD: GIQuIC. November 5, 2014. http://giquic.gi.org/docs/GIQuIC_one_million_colonoscopies_FINAL_110514.pdf. Accessed January 8, 2015.

4. CMS approves GIQuIC as a PQRS Qualified Clinical Data Registry.

Bethesda, MD: GIQuIC. June 2, 2014. http://giquic.gi.org/docs/ GIQuIC_QCDR_Media_Advisory_6-2-14.pdf. Accessed January 8, 2015.

17. Rizk MK, Sawhney MS, Cohen J, et al. Quality indicators common to all GI endoscopic procedures. Am J Gastroenterol.

2015;81(1):3-16.

18. Rex DK, Schoenfeld PS, Cohen J, et al. Quality indicators for colonoscopy. Am J Gastroenterol. 2015;81(1):31-53.

19. Park WG, Shaheen NJ, Cohen J, et al. Quality indicators for EGD. Am J Gastroenterol. 2015;81(1):17-30.

20. Adler DG, Lieb JG, Cohen J, et al. Quality indicators for ERCP. Am J Gastroenterol. 2015;110(1):91-101.

21. Wani S, Wallace MB, Cohen J, et al. Quality indicators for EUS. Am J Gastroenterol. 2015;110(1):102-113.

5. Pike IM. GIQuIC: A powerful tool for benchmarking GI endoscopy, June 22, 2010. http://giquic.gi.org/benchmarking.asp. Accessed January 8, 2015.

22. Brenner H, Chang-Claude J, Seiler CM, et al. Long-term risk of colorectal cancer after negative colonoscopy. J Clin Oncol. 2011;29(28): 3761-3767.

6. GI Quality Improvement Consortium, Ltd. GIQuIC. Bethesda, MD: American College of Gastroenterology/American Society for Gastrointestinal Endoscopy. 2014.

23. Corley DA, Jensen CD, Marks AR, et al. Adenoma detection rate and risk of colorectal cancer and death. N Engl J Med. 2014;370(26): 1298-1306.

7. Faigel DO, Pike IM, Baron TH, et al. Quality indicators for gastrointestinal endoscopic procedures: an introduction. Am J Gastroenterol.

2006;101(4):866-872.

24. Centers for Medicare & Medicaid Services. PQRSâ&#x20AC;&#x201D;Analysis and Payment. http://www.cms.gov/Medicare/Quality-InitiativesPatient-Assessment-Instruments/PQRS/AnalysisAndPayment.html.

Accessed January 8, 2015.

8. Cohen J, Safdi MA, Deal SE, et al. Quality indicators for esophagogastroduodenoscopy. Am J Gastroenterol. 2006;101(4):886-891.

9. Baron TH, Petersen BT, Mergener K, et al; ASGE/ACG Taskforce on Quality in Endoscopy. Quality indicators for endoscopic retrograde cholangiopancreatography. Am J Gastroenterol. 2006;101(4): 892-897.

10. Jacobsen BC, Chak A, Hoffman B, et al; ASGE/ACG Taskforce on Quality in Endoscopy. Quality indicators for endoscopic ultrasonography. Am J Gastroenterol. 2006;101(4):898-901.

11. Faigel DO, Pike IM, Baron TH, et al. Quality indicators for gastrointestinal endoscopic procedures: an introduction. Gastrointest Endosc.

2006;63(4 suppl):S3-S9.

12. Cohen J, Pike IM. Defining and measuring quality in endoscopy.

Am J Gastroenterol. 2015;81(1):1-2.

13. Harewood GC, Sharma VK, de Garmo P. Impact of colonoscopy preparation quality of detection of suspected colonic neoplasia.

Gastrointest Endosc. 2003;58(1):76-79.

14. Froelich F, Wietlisbach V, Gonvers JJ, et al. Impact of colonic cleansing on quality and diagnostic yield of colonoscopy: the European Panel of Appropriateness of Gastrointestinal Endoscopy European Multicenter Study. Gastrointest Endosc. 2005;61(3):378-384.

25. Centers for Medicare & Medicaid Services. Physician Quality Reporting System. http://www.cms.gov/Medicare/Quality-InitiativesPatient-Assessment-Instruments/PQRS/index.html?redirect=/PQRS. Accessed January 8, 2015.

26. Medicare Learning Network. 2015 Medicare Physician Fee Schedule Final Rule. December 2, 2014.

27. GIQuIC. PQRS/QCDR/Meaningful use. Report on file, 2014.

28. Centers for Medicare & Medicaid Services. Qualified Clinical Data Registry reporting. https://www.cms.gov/Medicare/Quality-InitiativesPatient-Assessment-Instruments/PQRS/Qualified-Clinical-DataRegistry-Reporting.html. Accessed January 8, 2015.

29. Centers for Medicare & Medicaid Services. Accountable Care Organization 2014 program analysis quality performance standards narrative measure specifications. http://www.cms.gov/Medicare/ Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/ACO-NarrativeMeasures-Specs.pdf. Accessed January 8, 2015.

15. Calderwood AH, Jacobson BC. Colonoscopy quality: metrics and implementation. Gastroenterol Clin North Am. 2013;42(3):599-618.

30. Centers for Medicare & Medicaid Services. Methodology for Determining Shared Savings and Losses under the Medicare Shared Savings Program. http://www.cms.gov/Medicare/Medicare-Fee-forService-Payment/sharedsavingsprogram/Downloads/ACO_Methodology_Factsheet_ICN907405.pdf. Accessed January 8, 2015.

16. Rabeneck L, Souchek J, El-Serag HB. Survival of colorectal cancer patients hospitalized in the Veterans Affairs Health Care System.

Am J Gastroenterol. 2003;98(5):1186-1192.

31. Barclay RL, Vicari JJ, Doughty AS, et al. Colonoscopic withdrawal times and adenoma detection during screening colonoscopy. N Engl J Med. 2006;355(24):2533-2541.

Copyright Š 2015, McMahon Publishing, 545 West 45th Street, New York, NY 10036. Printed in the USA. All rights reserved, including the right of reproduction, in whole or in part, in any form.

8

SR159

Disclaimer: This monograph is designed to be a summary of information. While it is detailed, it is not an exhaustive clinical review. McMahon Publishing, GIQuIC, Braintree Laboratories, and the authors neither affirm nor deny the accuracy of the information contained herein. No liability will be assumed for the use of this monograph, and the absence of typographical errors is not guaranteed. Readers are strongly urged to consult any relevant primary literature.