Defining and Measuring Quality in Endoscopy

Communication from the ASGE QUALITY INDICATORS FOR Quality Assurance in Endoscopy Committee GI ENDOSCOPIC PROCEDURES

Deﬁning and measuring quality in endoscopy

Quality has been a key focus for gastroenterology, The expert panels that were convened in 2005 compiled a driven by a common desire to promote best practices list of quality indicators that were deemed, at the time, to be among gastroenterologists and to foster evidence-based both feasible to measure and associated with improved pa- care for our patients. The movement to define and then tient outcomes. Feasibility concerns precluded measures measure aspects of quality for endoscopy was sparked by that required data collection after the date of endoscopy ser- public demand arising from alarming reports about medi- vice. Accordingly, the majority of the initial indicators con- cal errors. Two landmark articles published in 2000 and sisted of process measures, often related to documentation 2001 led to a national imperative to address perceived of important parameters in the endoscopy note. The evi- areas of underperformance and variations in care across dence demonstrating a link between these indicators to many fields of medicine.1,2 Initial efforts to designate and improved outcomes was limited. In many instances, the require reporting a small number of basic outcome mea- 2005 task force relied on expert opinion. Setting perfor- sures were mandated by the Centers for Medicare & mance targets based on community benchmarks was intro- Medicaid Services, and the process to develop perfor- duced, yet there was significant uncertainty about standard mance measures for government reporting and “pay for levels of performance. Reports citing performance data often performance” programs was initiated. Since that time, ma- were derived from academic centers, expert endoscopists, jor external forces stemming from policy makers, payers, and carefully conducted, randomized, controlled studies. and ultimately patients have generated demand for a way The infrastructure for collecting community-based outcome to accurately define and measure the quality of the services data at that time was limited, and very few endoscopists endoscopists provide. were regularly recording their performance variables. The path to quality improvement naturally begins with an Despite these limitations, 5 seminal articles were pub- effort to define those aspects of care that impact the quality lished in 2006: 1 on indicators common to all gastrointes- of the patient experience. The quality goals include effective tinal endoscopy and the others on EGD, colonoscopy, care and safety and further encompass other aims such as pro- ERCP, and EUS. These publications served as the basis for fessionalism, equitable care, and increasingly, affordable care.3 the dramatic transformation that has occurred since in the To these ends, gastroenterology societies have been area of quality in endoscopy. These documents informed working to define the elements of high-quality endoscopy thinking about training and definitions of competency and and to facilitate ways to measure it. Initially, this entailed guided the evolution of electronic endoscopy reporting developing, refining, and communicating evidence-based, for documentation. Perhaps the greatest impact has been procedure-related quality indicators. This effort began in the impetus they provided and the foundation they laid 2005 with the work of the American Society for Gastroin- for the development of central data repositories to facilitate testinal Endoscopy (ASGE)/American College of Gastroen- widespread benchmarking based on these very indicators. terology (ACG) Task Force on Quality in Endoscopy. As a result of the 2006 quality indicator documents, the GI David Bjorkman, MD and John Popp, Jr, MD, then presi- Quality Improvement Consortium, Ltd (GIQuIC) estab- dents of ASGE and ACG, respectively, believed that gas- lished a data repository and benchmarking tool. This regis- troenterologists should take the lead in defining quality try, a joint initiative of the ACG and ASGE, now has an in gastroenterology practice rather than have those expanding colonoscopy database that is a resource for the outside our field define it for us. In heralding the project development of new quality measures, quality bench- and its rationale, they wrote, “The ASGE and ACG recog- marking, and clinical research. GIQuIC recently added nize that if we do not develop evidence-based quality EGD measures and is in the process of adding ERCP and measures, an administrative or governmental agency unit-based measures to the registry. Data reports from regis- without experience or insight into the practice of endos- tries are being used by endoscopists and endoscopy units in copy will define these measures for us.”4 The task force continuous quality improvement efforts, which was the pri- they established published the first set of quality indica- mary goal of the initial project to define quality indicators. tors for GI endoscopic procedures in April of 2006.5-9 Beyond this, data on variance in performance by using registries and other outcome studies have supported the adoption of GI-specific performance measures for govern- Copyright ª 2015 American Society for Gastrointestinal Endoscopy and American College of Gastroenterology ment quality reporting programs. Increasingly, govern- 0016-5107/$36.00 ment, third-party payers, and patients are requiring data http://dx.doi.org/10.1016/j.gie.2014.07.052 about the quality of the procedures we perform, and the www.giejournal.org Volume 81, No. 1 : 2015 GASTROINTESTINAL ENDOSCOPY 1 Defining and measuring quality in endoscopy quality indicators continue to evolve to meet these Prepared by: expectations. Jonathan Cohen, MD As our ability to measure actual outcomes has Irving M. Pike, MD improved and as the stakeholders begin to expect information about real outcomes rather than surrogate pro- Abbreviations: ACG, American College of Gastroenterology; ASGE, cess measures, our understanding and definition of American Society for Gastrointestinal Endoscopy; GIQuIC, Quality what constitutes quality indicators for endoscopy has Improvement Consortium, Ltd. necessarily evolved. In 2005, Bjorkman and Popp stated, This document is a product of the ASGE/ACG Task Force on Quality in “Although providing the best possible patient care is Endoscopy. This document was reviewed and approved by the our most important goal, we are poorly equipped to mea- Governing Boards of the American Society for Gastrointestinal sure our ability to achieve that goal.”4 Since that time, we Endoscopy and the American College of Gastroenterology. It appears have risen to the challenge and continue to expand the simultaneously in Gastrointestinal Endoscopy and the American Journal of Gastroenterology. menu of quality measures. The 5 articles that appear in this journal issue reflect the new body of data established since 2006 about the factors that most impact patient outcomes and address the standard level of performance achieved in the community for This document was reviewed and endorsed by the American these indicators. Some, but not all, of the feasibility chal- Gastroenterological Association Institute. lenges in measuring quality indicators have been over- come, making true outcome measurement more realistic than it was in 2006. Capturing information from days after endoscopy remains a challenge, particularly with regard to the measurement of delayed adverse events. The updated list of quality indicators contained in these articles reflects gastroenterologists’ increased ability to measure their performances as well as public and private REFERENCES payers’ desire for them to report true outcomes. New research questions focus on indicators that demonstrate 1. Kohn LT, Corrigan JM, Donaldson MS. To err is human: building a safer care that is effective, safe, equitable, and cost effective. health system. Washington (DC): National Academy Press; 2000. We anticipate that these articles will continue to guide 2. Institute of Medicine, Committee on Health Care in America. Crossing our efforts to measure and benchmark the key compo- the quality chasm: a new health system for the 21st Century. Washing- ton (DC): National Academy Press; 2001. nents of the procedures we perform. The ultimate purpose 3. Department of Health & Human Services. National Quality Strategy. of gathering data on these indicators will be to identify per- National Strategy for Quality Improvement in Health Care. March 2011. formance gaps, which will allow us to focus our improve- Available at: http://www.ahrq.gov/workingforquality/nqs/nqs2011annlrpt. ment efforts and deliver higher quality endoscopy care to htm. Accessed 8/21/2014. our patients. 4. Bjorkman DJ, Popp JW. Measuring the quality of endoscopy. Gastroint- est Endosc 2006;63(suppl):S1-2. We sincerely thank the members of the task force who 5. Faigel DO, Pike IM, Baron TH, et al. Quality indicators for gastroin- critically evaluated the literature and our endoscopic prac- testinal endoscopic procedures: an introduction. Gastrointest Endosc tice to provide these insightful reports. Their important 2006;63(suppl):S3-9. contribution has provided us with the critical tools to 6. Cohen J, Safdi MA, Deal SE, et al. Quality indicators for esophagogastro- confront a challenging future. duodenoscopy. Gastrointest Endosc 2006;63:S10-5. 7. Rex DK, Petrini JL, Baron TH, et al. Quality indicators for colonoscopy. Gastrointest Endosc 2006;63:S16-28. DISCLOSURES 8. Baron TH, Petersen BT, Mergener K, et al. Quality indicators for endoscopic retrograde cholangiopancreatography. Gastrointest Endosc 2006;63:S29-34. All authors disclosed no financial relationships rele- 9. Jacobson BC, Chak A, Hoffman B, et al. Quality indicators for endoscopic vant to this publication. ultrasonography. Gastrointest Endosc 2006;63:S35-8.

2 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 1 : 2015 www.giejournal.org Communication from the ASGE QUALITY INDICATORS FOR Quality Assurance in Endoscopy Committee GI ENDOSCOPIC PROCEDURES

Quality indicators common to all GI endoscopic procedures

Quality of care is the degree to which health services studies were identified through a computerized search for individuals and populations increase the likelihood of of Medline followed by review of the bibliographies of all desired health outcomes and are consistent with current relevant articles. When such studies were absent, indica- professional knowledge.1 The American Society for Gastro- tors were chosen by expert consensus. Although feasibility intestinal Endoscopy (ASGE), the American College of of measurement was a consideration, we hope that inclu- Gastroenterology (ACG), and the American Gastroentero- sion of highly relevant, but not yet easily measurable, indi- logical Association (AGA) have continually promoted the cators will promote their eventual adoption. Although a ideal that all patients have access to high-quality GI endos- comprehensive list of quality indicators is proposed, we copy services. A high-quality endoscopy is an examination recognize that, ultimately, only a small subset might be in which patients receive an indicated procedure, correct widely used for continuous quality improvement, bench- and relevant diagnoses are recognized or excluded, marking, or quality reporting. As in 2006, the current any therapy provided is appropriate, and all steps that task force concentrated its attention on parameters related minimize risk have been taken. solely to endoscopic procedures (Table 1). Although the The quality of health care can be measured by quality of care delivered to patients is clearly influenced comparing the performance of an individual or a group of by many factors related to the facilities in which endoscopy individuals with an ideal or benchmark.1 The particular is performed, characterization of unit-related quality indica- parameter that is being used for comparison is termed a tors was not included in the scope of this effort. quality indicator. A quality indicator is often reported as a The resultant quality indicators were graded on the ratio between the incidence of correct performance and strength of the supporting evidence (Table 2).4 Each the opportunity for correct performance or as the propor- quality indicator was classified as an outcome or a process tion of interventions that achieve a predefined goal.2 Qual- measure. Although outcome quality indicators are pre- ity indicators can be divided into three categories: (1) ferred, some can be difficult to measure in routine clinical structural measuresdthese assess characteristics of the practice, because they need analysis of large amounts of entire health care environment (eg, availability and mainte- data and long-term follow-up and may be confounded by nance of endoscopy equipment at a hospital), (2) process other factors. In such cases, the task force deemed it measuresdthese assess performance during the delivery reasonable to use process indicators as surrogate measures of care (eg, proportion of patients who undergo biopsies of high-quality endoscopy. The relative value of a process when Barrett’s Esophagus was suspected), and (3) outcome indicator hinges on the evidence that supports its associa- measuresdthese assess the results of the care that was pro- tion with a clinically relevant outcome, and such process vided (eg, proportions of patients diagnosed with colon measures were emphasized. cancer within five years of a screening colonoscopy). The quality indicators for this update were written in a manner that lends them to be developed as measures. METHODOLOGY Although they remain quality indicators and not measures, this document also contains a list of performance targets for each quality indicator. The task force selected perfor- In 2006, the ASGE/ACG Task Force on Quality in Endos- mance targets from benchmarking data in the literature copy published the first version of quality indicators com- when available. When data were unavailable to support mon to all endoscopic procedures.3 The present update establishing a performance target level, “N/A” (not available) integrates new data pertaining to previously proposed was listed. However, when expert consensus considered quality indicators and new quality indicators common to failure to perform a given quality indicator a “never event,” all endoscopic procedures. For the current report, we such as monitoring vital signs during sedation, then the per- prioritized indicators that had wide-ranging clinical applica- formance target was listed as O98%. It is important to tion, were associated with variation in practice and out- emphasize that the performance targets listed do not neces- comes, and were validated in clinical studies. Clinical sarily reflect the standard of care but rather serve as specific goals to direct quality improvement efforts (Table 3). Quality indicators were divided into 3 time periods: ª Copyright 2015 American Society for Gastrointestinal Endoscopy and preprocedure, intraprocedure, and postprocedure. For American College of Gastroenterology 0016-5107/$36.00 each category, key relevant research questions were http://dx.doi.org/10.1016/j.gie.2014.07.055 identified. www.giejournal.org Volume 81, No. 1 : 2015 GASTROINTESTINAL ENDOSCOPY 3 Quality indicators for all GI endoscopic procedures

TABLE 1. Composition of the task force

ASGE representatives ACG representatives Jonathan Cohen, MD, FASGE, FACG, co-chair Irving M. Pike, MD, FACG, FASGE, Co-chair New York University School of Medicine John Muir Health New York, New York Walnut Creek, CA

Mandeep S. Sawhney, MD, MS Maged K. Rizk, MD Beth Israel Deaconess Medical Center and Harvard Cleveland Clinic Medical School Cleveland, Ohio Boston, Massachusetts

Philip Schoenfeld, MD, MSED, MSc Douglas Rex, MD, FACG University of Michigan Indiana University Ann Arbor, Michigan Indianapolis, Indiana

Walter Park, MD Nicholas Shaheen, MD, MPH, FACG Stanford University University of North Carolina Palo Alto, California Chapel Hill, North Carolina

John Lieb II, MD Douglas G. Adler, MD, FACG, FASGE University of Pennsylvania University of Utah Philadelphia, Pennsylvania Salt Lake City, Utah

Sachin Wani, MD Michael Wallace, MD University of Colorado Mayo Clinic Denver, Colorado Jacksonville, Florida

ASGE, American Society for Gastrointestinal Endoscopy; ACG, American College of Gastroenterology.

In order to guide continuous quality improvement Level of evidence: 1Cþ efforts, the task force also recommended a high-priority Performance target: O80% subset of the indicators described, based on their clinical Type of measure: process relevance and importance, on evidence that performance Standard indications for endoscopy are listed in the of the indicator varies significantly in clinical practice, and ASGE Appropriate Use of GI Endoscopy guideline.5 An feasibility of measurement (a function of the number of appropriate indication should be documented for each procedures needed to obtain an accurate measurement procedure, and, when it is not a standard indication with narrow confidence intervals and the ease of mea- listed in the current ASGE Appropriate Use of GI surement). A useful approach for individual endoscopists Endoscopy guideline, it should be justified in the is to first measure their performances with regard to documentation. these priority indicators. Quality improvement efforts Discussion: In general, endoscopy is indicated when would then move to different quality indicators if endo- the information gained or the therapy provided will scopists are performing above recommended thresholds, improve patient outcomes and is not indicated when or the employer and/or teaching center could institute the risks of the procedure outweigh any possible benefit corrective measures and remeasure performance of low- to the patient. ASGE published a list of accepted indica- level performers. tions for endoscopic procedures in 2000.6 This list was determined by a review of published literature and Preprocedure quality indicators expert consensus and was updated in 2012.5 There was The preprocedure period includes all contact between little substantial change with regard to indications for members of the endoscopy team with the patient before EGD and colonoscopy in the update. Facilitation of chol- the administration of sedation or insertion of the endo- angioscopy and pancreatoscopy were added as accepted scope. Common issues for all endoscopic procedures dur- indications for ERCP. Additional EUS indications were ing this period include: appropriate indication, informed included, such as placement of fiducial markers, treat- consent, risk assessment, formulation of a sedation plan, ment of symptomatic pseudocysts, drug delivery, pro- management of prophylactic antibiotics and antithrom- vision of access to the bile or pancreatic ducts, botic drugs, and timeliness of the procedure. evaluation for chronic pancreatitis, perianal and perirec- 1. Frequency with which endoscopy is performed for an tal disease, and screening patients at increased risk indication that is included in a published standard of pancreatic cancer. Studies have shown that when list of appropriate indications, and the indication is EGD and colonoscopy are done for appropriate indica- documented (priority indicator) tions, significantly more clinically relevant diagnoses

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TABLE 2. Grades of recommendation*

Grade of Methodologic strength recommendation Clarity of benefit supporting evidence Implications 1A Clear Randomized trials without Strong recommendation; can be important limitations applied to most clinical settings

1B Clear Randomized trials with important Strong recommendation; likely to limitations (inconsistent results, apply to most practice settings nonfatal methodologic flaws)

1Cþ Clear Overwhelming evidence from Strong recommendation, can apply to most practice observational studies settings in most situations

1C Clear Observational studies Intermediate-strength recommendation, may change when stronger evidence is available

2A Unclear Randomized trials without Intermediate-strength recommendation; best action important limitations may differ depending on circumstances or patients’ or societal values

2B Unclear Randomized trials with important Weak recommendation; alternative limitations (inconsistent results, approaches may be better under nonfatal methodologic flaws) some circumstances

2C Unclear Observational studies Very weak recommendation; alternative approaches are likely to be better under some circumstances

3 Unclear Expert opinion only Weak recommendation, likely to change as data becomes available

are made.7-9,10 A quality improvement goal is to mini- privilege, waiver, or legal mandate. Consent should mize the number of procedures without appropriate include a discussion of the sedation plan and risks asso- indications. ciated with sedation, indication for the procedure, Open access endoscopy, where non-gastroenterologists description of the procedure, likely benefits, common schedule patients for endoscopy without prior consulta- adverse events, alternatives to the procedure, and pa- tion with the endoscopist is widely practiced.11 Most tient prognosis if treatment is declined. If sedation for studies have shown that open access endoscopies are the procedure is provided by an anesthesia provider, done for appropriate indications.12,13 A quality improve- then a separate consent obtained by that provider ment goal is to establish processes that allow for feedback may be appropriate. to referring physicians with regard to appropriateness of Discussion: Obtaining informed consent has several indication. Other quality improvements goals that are patient benefits. It facilitates a patient-centered process relevant to open access endoscopy include: availability of respecting patient autonomy and decision making. It al- information about the procedure to patients in advance lows the patient to receive the relevant information about of the procedure, availability of clinical information to the proposed procedure and to make an informed deci- the endoscopist in advance of the procedure, reporting sion about whether or not to proceed with the recommen- of endoscopic findings and recommendations to the ded course of action. Finally, it provides the patient the referring physician, and establishment of appropriate opportunity to ask questions, increasing patient under- follow-up. standing and confidence in the health care team. ASGE 2. Frequency with which informed consent is obtained guidelines on informed consent in endoscopy advise the and fully documented endoscopist to obtain consent personally.14 Consent may Level of evidence: 3 be supplemented by anatomic diagrams, brochures, and Performance target: O98% videos and by information provided by nurses and other Type of measure: process assistants. A consent form designed specifically for a partic- Consent should be obtained and documented for the ular procedure that contains all the essential elements of procedure, except in cases of emergency, therapeutic consent may facilitate a full discussion with the patient. www.giejournal.org Volume 81, No. 1 : 2015 GASTROINTESTINAL ENDOSCOPY 5 Quality indicators for all GI endoscopic procedures

TABLE 3. Summary of proposed quality indicators common to all endoscopic procedures*

Grade of Measure Performance Quality indicator recommendation type target (%) Preprocedure

1. Frequency with which endoscopy is performed 1Cþ Process O80 for an indication that is included in a published standard list of appropriate indications, and the indication is documented (priority indicator)

2. Frequency with which informed consent is 3 Process O98 obtained and fully documented

3. Frequency with which preprocedure history and 3 Process O98 directed physical examination are performed and documented

4. Frequency with which risk for adverse events is 3 Process O98 assessed and documented before sedation is started

5. Frequency with which prophylactic antibiotics Varies Process O98 are administered for appropriate indication (priority indicator)

6. Frequency with which a sedation plan is Varies Process O98 documented

7. Frequency with which management of 3 Process N/A antithrombotic therapy is formulated and documented before the procedure (priority indicator)

8. Frequency with which a team pause is 3 Process O98 conducted and documented

9. Frequency with which endoscopy is performed 3 Process O98 by an individual who is fully trained and credentialed to perform that particular procedure

Intraprocedure

10. Frequency with which photodocumentation is 3 Process N/A performed

11. Frequency with which patient monitoring 3 Process O98 during sedation is performed and documented

12. Frequency with which the doses and routes of 3 Process O98 administration of all medications used during the procedure are documented

13. Frequency with which use of reversal agents is 3 Process O98 documented

14. Frequency with which procedure interruption 3 Process O98 and premature termination because of sedation-related issues is documented

Postprocedure

15. Frequency with which discharge from the 3 Process O98 endoscopy unit according to predetermined discharge criteria is documented

16. Frequency with which patient instructions are 3 Process O98 provided

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TABLE 3. Continued

Grade of Measure Performance Quality indicator recommendation type target (%)

17. Frequency with which the plan for pathology 3 Process O98 follow-up is specified and documented

18. Frequency with which a complete procedure 3 Process O98 report is created

19. Frequency with which adverse events are 3 Process O98 documented

20. Frequency with which adverse events occur 3 Outcome N/A

21. Frequency with which postprocedure and late 3 Outcome N/A adverse events occur and are documented

22. Frequency with which patient satisfaction data 3 Process N/A are obtained

23. Frequency with which communication with 3 Process N/A referring providers is documented

N/A, Not available. *This list of potential quality indicators is meant to be a comprehensive list of measurable endpoints. It is not the intention of the task force that all endpoints be measures in every practice setting. In most cases, validation may be required before a given endpoint may be adopted universally.

These forms may be especially useful for high-risk and The history should include the timing and nature of complex procedures. The quality of informed consent the patient’s last oral intake. Although there are limited has been an important medicolegal issue in a majority of data on the impact of fasting on the risk of pulmonary aspi- ERCP procedures that resulted in litigation.15 The optimal ration, patients are generally required to cease oral intake af- timing and location where informed consent is obtained is ter midnight before sedation and endoscopy. According to not known. ASA practice guidelines, patients should not consume clear 3. Frequency with which preprocedure history and liquids for 2 hours, milk for 6 hours, a light meal for 6 hours, directed physical examination are performed and or a meal with fried or fatty food for 8 hours before seda- documented tion.19 Patients with gastroparesis and achalasia may require Level of evidence: 3 a longer period of fasting to minimize risk of aspiration. The Performance target: O98% quantity of food consumed should be taken into consider- Type of measure: process ation before determining actual period of fasting. Patients Before sedation, a directed preprocedure history and may take essential medications including bowel preparation physical examination should be performed and before endoscopic procedures. A recent prospective obser- documented. vational study of colonoscopy patients demonstrated that Discussion: ASGE and the American Society of Anesthesi- residual volume of liquid in the stomach was minimal (! ologists (ASA) recommend a preprocedure assessment that 25 mL) and similar whether patients split the bowel prepa- includes a health history and directed physical examination ration or consumed all of the bowel preparation on the eve- that are performed before the patient is sedated and before ning before the procedure.20 endoscopy.16-18 The Centers for Medicare & Medicaid Ser- 4. Frequency with which risk for adverse events is vices and some accrediting bodies may not allow for docu- assessed and documented before sedation is started mentation of a current patient history and physical Level of evidence: 3 examination to be solely on the endoscopy report and, Performance target: O98% therefore, separate documentation may be required. The Type of measure: process history should focus on indications for the procedure as Before sedation is begun, a risk assessment for sedation- well as conditions that may affect the performance and related adverse events is performed and documented. safety of the procedure. The history also should emphasize Stratiﬁcation of patients by established methods such sedation-related issues including (1) abnormalities of major as the ASA score emphasizes the risk of sedation- organ systems; (2) previous adverse events with sedation or related adverse events. This information should be anesthesia; (3) medication allergies, current medications, used for decision making with regard to proceeding and potential medication interactions; and (4) history of to- or deferring the procedure or modifying the procedure bacco, alcohol or substance use or abuse. and sedation plan. www.giejournal.org Volume 81, No. 1 : 2015 GASTROINTESTINAL ENDOSCOPY 7 Quality indicators for all GI endoscopic procedures

Discussion: The most commonly used scoring systems gastrostomy tube placement in all patients (grade of for stratifying risk before endoscopic procedures are the recommendation Z 1A). Antibiotics may be indicated for ASA score and the Mallampati score. The ASA score con- ERCP if patients’ clinical situations place them at higher siders comorbid conditions and ranks patients on a 1 to risk of infection (eg, immune suppression, Caroli’sdisease). 5 scale (1, normal and healthy to 5, critically ill and at sub- There are insufficient data to make recommendations stantial risk of death within 24 hours). Large studies that for antibiotic prophylaxis for patients with solid lesions used endoscopy databases have shown that ASA scores21 along the lower GI tract undergoing EUS-guided FNA. predict adverse events during endoscopy, primarily those The American Heart Association guidelines concur with that are related to sedation. The Mallampati score22 uses ASGE guidelines and, in addition, recommend prophylactic a visual analogue scale to assess the upper airway. An antibiotics for the first 6 months for patients who have un- increasing score correlates with difficulty encountered in dergone systemic vascular grafts.24 ASGE guidelines differ endotracheal intubation. This score has not been validated from the recommendations of the American Academy as a risk stratification tool for endoscopic procedures, of Orthopedic Surgeons (AAOS), which indicate that anti- but it has gained clinical relevance with widespread use biotic prophylaxis should be given to patients with pros- of deep sedation and, hence, possible need for urgent thetic joints before any invasive procedure known to airway management. cause bacteremia.25 However, the AAOS recently changed 5. Frequency with which prophylactic antibiotics are its recommendations for patients with hip and knee administered for appropriate indication (priority prosthetic joint implants undergoing dental procedures, indicator) stating that the practitioner might consider discontinuing Level of evidence: varies by individual recommendation the practice of routinely prescribing prophylactic antibi- Performance target: O98% otics.25,26 ASGE guidelines do not address patients under- Type of measure: process going peritoneal dialysis, but the International Society for Prophylactic antibiotics are administered only for Peritoneal Dialysis recommends antibiotic prophylaxis selected settings for which they are indicated. and that the abdomen be emptied of fluid before colonos- Discussion: For most endoscopic procedures, prophylac- copy with polypectomy.27 tic antibiotics are not indicated for prevention of bacterial 6. Frequency with which a sedation plan is documented endocarditis. ASGE updated its guidelines for the use of Level of evidence: varies by individual recommendation antibiotics before endoscopic procedures in 2008.23 These Performance target: O98% differ substantially from previous guidelines in that GI Type of measure: process endoscopy is no longer considered to be a significant risk Before sedation is administered, the intended level of factor for bacterial endocarditis. Therefore, antibiotics sedation is specified as no sedation, minimal sedation, to prevent bacterial endocarditis are not recommended, moderate sedation, deep sedation, or general even for patients who are at highest risk for endocarditis. anesthesia. Antibiotics are not recommended for patients having: car- Discussion: Minimal sedation (or anxiolysis) is a drug- diac conditions, synthetic vascular grafts, or other nonvalvu- induced state during which patients respond normally to lar cardiovascular devices undergoing any endoscopic verbal commands. Although cognitive function and phys- procedure (grade of recommendation Z 1Cþ); biliary ical coordination may be impaired, airway reflexes and obstruction in the absence of cholangitis undergoing ERCP ventilatory and cardiovascular functions are unaffected. with anticipated complete drainage (grade of recommenda- Moderate sedation (or conscious sedation) is a drug- tion Z 1C); solid lesions along the upper GI tract undergo- induced depression of consciousness during which pa- ing EUS-guided FNA (grade of recommendation Z 1C); tients respond purposefully to verbal commands, either and prosthetic joints undergoing any endoscopic procedure alone or accompanied by light tactile stimulation. No inter- (grade of recommendation Z 1C). ventions are required to maintain a patent airway, and Prophylactic antibiotics are recommended in the spontaneous ventilation is adequate. Cardiovascular func- following instances: (1) ERCP in patients in whom incom- tion is usually maintained. plete biliary drainage is anticipated (eg, primary sclerosing Deep sedation is a drug-induced depression of con- cholangitis) (grade of recommendation Z 2C); (2) ERCP sciousness during which patients cannot be easily aroused in patients with sterile pancreatic fluid collections that but respond purposefully after repeated or painful stimula- communicate with the pancreatic duct (eg, pseudocyst, ne- tion. The ability to independently maintain ventilatory crosis) (grade of recommendation Z 3); (3) ERCP in pa- function may be impaired. Patients may require assistance tients with posttransplant biliary strictures (grade of in maintaining a patent airway and spontaneous ventilation recommendation Z 3); (4) EUS-guided FNA in patients may be inadequate. Cardiovascular function is usually with cystic lesions along the GI tract (grade of maintained. recommendation Z 1C); (5) any endoscopic procedure General anesthesia is a drug-induced loss of conscious- in patients with cirrhosis and acute GI hemorrhage ness during which patients cannot be aroused, even by (grade of recommendation Z 1B); and (6) percutaneous painful stimulation. The ability to independently maintain

8 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 1 : 2015 www.giejournal.org Quality indicators for all GI endoscopic procedures ventilatory function is often impaired. Patients often Type of measure: process require assistance in maintaining a patent airway, and pos- Before administration of sedation or insertion of the endo- itive pressure ventilation may be required because of scope, the endoscopy team pauses to confirm patient depressed spontaneous ventilation or drug-induced identity and type of procedure. This should be recorded. depression of neuromuscular function. Cardiovascular Discussion: A team pause (also referred to as time-out) function may be impaired. before initiating any procedure requiring sedation or anes- The ASA recommends that because sedation is a contin- thesia is now mandated nationally by the Centers for Medi- uum, it may not be possible to predict how an individual care & Medicaid Services and several accrediting patient will respond. Hence, physicians intending to pro- organizations. The purpose of this pause is to verify that duce a given level of sedation should be able to rescue pa- the correct patient is undergoing the desired procedure. tients whose level of sedation becomes deeper than If necessary, the pause may allow for reassessment of any initially intended. Individuals administering moderate history, laboratory test, or radiologic data that may affect sedation should be able to rescue patients who enter a the performance or safety of the endoscopic procedure. state of deep sedation, whereas those administering It also may provide an opportunity for the endoscopist deep sedation should be able to rescue patients who enter to inform team members of the planned procedure and a state of general anesthesia.28 the potential for interventions or deviations from usual 7. Frequency with which management of antithrombotic practice that would require special equipment. therapy is formulated and documented before the 9. Frequency with which endoscopy is performed by an procedure (priority indicator) individual who is fully trained and credentialed to Level of evidence: 3 perform that particular procedure Performance target: N/A Level of evidence: 3 Type of measure: process Performance Target: O98% Antithrombotic medication use by the patient is re- Type of measure: process corded, and a plan regarding periprocedural manage- A quality endoscopy procedure is one performed by an ment of antithrombotic medications is documented endoscopist who has met objective measures for and communicated to the patient and health care team. competency. Discussion: ASGE guidelines regarding the management Discussion: Achieving the desired objectives and mini- of patients taking antithrombotic agents undergoing mizing adverse events ultimately define the quality of an endoscopy were updated in 2009.29 In general, diagnostic endoscopic procedure. There is evidence that colonoscopy endoscopic procedures are considered low risk for performed by a low-procedure–volume endoscopist is asso- causing procedure-related bleeding and do not require ciated with an increased risk of perforation and bleeding.30 cessation of antithrombotic agents. Some therapeutic endo- The ASGE has published training and credentialing guide- scopic procedures are considered high risk for causing lines31-35 that establish basic principles of competency, procedure-related bleeding and require cessation of some and these should be applied to the credentialing process antithrombotic agents. Patients at high risk for thromboem- wherever GI endoscopy is performed. Several important bolic adverse events may require bridge therapy, deferment themes in this regard deserve emphasis: (1) objective mea- of endoscopy, or consultation with a cardiologist. These sures of performance and not simply number of procedures high-risk conditions include atrial fibrillation associated performed in training should be used to define compe- with other cardiac conditions or a history of thromboembo- tency; (2) measures of competence, especially when well- lism, mechanical mitral valve, coronary artery stent placed established benchmarks are available, should be universal within a year, acute coronary syndrome, or non-stented and not vary by specialty; (3) competency in one procedure percutaneous coronary intervention after myocardial infarc- should not necessarily imply competency in another; and tion. Most endoscopic procedures can be performed safely (4) competency in a given endoscopic procedure should without discontinuing aspirin. In the majority of nonthera- require that the endoscopist be able to perform minimum peutic procedures, antithrombotic medications may be therapeutic maneuvers specific to that procedure (eg, stan- resumed immediately. In patients who have received endo- dard polypectomy in colonoscopy and stent placement for scopic therapy, the timing of resumption needs to be indi- distal biliary obstruction in ERCP).32,36 vidualized, taking into account the type of endoscopic therapy performed and the risk of thromboembolism. A Preprocedure research questions quality improvement goal is to formulate and document a 1. How often are procedures performed for inappropriate coordinated plan to manage antithrombotic medications indications in clinical practice? What is the reason for for all patients taking these medications. performance of such procedures? Are there strategies 8. Frequency with which a team pause is conducted and that can minimize such procedures? documented 2. Do supplements such as pamphlets, videos, or interac- Level of evidence: 3 tive computer programs enhance patient understanding Performance target: O98% of the procedure during the consent process? www.giejournal.org Volume 81, No. 1 : 2015 GASTROINTESTINAL ENDOSCOPY 9 Quality indicators for all GI endoscopic procedures

3. Do new preprocedure risk stratification tools that are strap fold and the cecum with ileocecal valve be photo- specific for GI endoscopy need to be developed and graphed. Alternative images include the ileocecal valve validated? orifice or the terminal ileum showing the presence of ter- 4. Are referring physicians and endoscopists knowledge- minal ileal villi, circular valvulae conniventes, or lymphoid able about new antibiotic prophylaxis guidelines? hyperplasia.41 Photodocumentation of anatomic landmarks 5. What is the optimal and most cost-effective use of for other endoscopic procedures are not as well standard- monitored anesthesia sedation for GI endoscopy? ized but are encouraged. Does monitored anesthesia sedation influence endo- 11. Frequency with which patient monitoring during scopists performance, endoscopy outcomes, or patient sedation is performed and documented satisfaction? Level of evidence: 3 6. What are the risks of stopping antithrombotic medica- Performance target: O98% tions for endoscopy? Type of measure: process 7. Can small colon polyps be removed in patients taking During sedated endoscopic procedures the following antithrombotic medications? parameters are monitored: oxygen saturation with 8. What are the optimal components of a team pause for pulse oximetry, pulse rate, and blood pressure. Blood endoscopy? pressure and pulse rate should be recorded at intervals 9. How prevalent is the use of recently proposed no greater than 5 minutes. endoscopy-specific checklists, and does this process Discussion: It is generally accepted that patient improve patient outcomes? monitoring improves safety, even though none of the proposed monitoring parameters have been shown to Intraprocedure quality indicators improve outcome in well-designed studies. Patient moni- The intraprocedure period extends from the administra- toring recommendations for oximetry, pulse rate, and tion of sedation, or insertion of the endoscope when blood pressure are included in guidelines published no sedation is given, until the endoscope is removed. by ASGE and ASA17,42 and provide a means to detect This period includes all the technical aspects of the proce- potentially dangerous changes in a patient’s cardiopulmo- dure including completion of the examination and of nary status during sedation.43 Although capnography moni- therapeutic maneuvers. Common to most endoscopic pro- toring has been shown to be associated with reduced cedures is the provision of sedation and need for patient hypoxemia in patients undergoing endoscopy under monitoring. deep sedation with propofol there are no data yet to sup- 10. Frequency with which photodocumentation is port the use of capnography monitoring in moderate performed sedation.44 Level of evidence: 3 12. Frequency with which the doses and routes of admin- Performance target: N/A istration of all medications used during the proce- Type of measure: process dure are documented Photodocumentation of important anatomic land- Level of evidence: 3 marks and pathology should be performed. Performance target: O98% Discussion: Although the effectiveness of endoscopic Type of measure: process photography is unlikely to be proven in clinical studies, 13. Frequency with which use of reversal agents is its use reflects current best practice and should be encour- documented aged. Photographs of pathology may enhance patient un- Level of evidence: 3 derstanding of the disease process, facilitate consultation Performance target: O98% with other physicians, and allow for precise comparisons Type of measure: process during repeat procedures. This also may provide valuable The use of reversal agents (eg, flumazenil, naloxone) information about the quality and completeness of prior should be recorded. This should be reported as the evaluation when patients present at a later date with GI percentage of such events of all procedures using the symptoms. same sedation agent (eg, the percent of time flumaze- Cecal intubation rates of R95% are achievable in nil was used for excessive sedation when midazolam healthy adults.37-39 Photodocumentation of the cecum is was used as a sedative). an integral part of the cecal intubation rate quality indicator Discussion: As a surrogate to measuring airway manage- and is included in the Physician Consortium for Perfor- ment, some health care institutions have chosen to use the mance Improvement/AGA/ASGE 2008 Endoscopy and administration of reversal agents for an adverse event or Polyp Surveillance Measure Set. Photodocumentation of unsafe procedure. The use of this indicator must be judi- the cecum is the simplest and most practical method of cious because it may penalize physicians for use of these verifying that a complete colonoscopy has been potentially life-saving medications. The task force strongly achieved.40 It is recommended that key anatomical fea- recommends that any use of this endpoint be accom- tures like the appendiceal orifice with surrounding cecal plished in a nonpunitive manner so as not to discourage

10 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 1 : 2015 www.giejournal.org Quality indicators for all GI endoscopic procedures the use of reversal agents. Although documentation of Measure type: process reversal agents used should be standard and such events Documentation is required that the patient has met scrutinized, it should be considered within the context predetermined discharge criteria before discharge of process improvement and not as an indirect measure from the endoscopy unit. of outcome. Discussion: Every endoscopy unit should have a written 14. Frequency with which procedure interruption and policy regarding criteria the patient must meet before premature termination because of sedation-related discharge from the unit.43 Documentation that the patient issues is documented has achieved these criteria should be made. Level of evidence: 3 16. Frequency with which patient instructions are Performance target: O98% provided Measure type: process Level of evidence: 3 Any sedation-related event including airway manage- Performance target: O98% ment that requires interruption and premature termi- Measure type: process nation of the procedure should be documented. Written discharge instruction should be provided in Discussion: Clinical decision making in which the physi- compliance with ASGE guidelines.43 cian is constantly weighing the risks and benefits of the Discussion: Clear written instructions should be pro- endoscopic procedure are the hallmark of good clinical vided to the patient before discharge. These instructions care and are to be encouraged. Therefore, an aborted should include: diet restrictions, resumption or change in endoscopic procedure should not automatically be consid- medications including antithrombotic agents, prescription ered an adverse event. Such events should be scrutinized of medications, return to activities such as driving, and in a nonpunitive manner within the context of continuous contact information should an adverse event, question or quality improvement. When the cause of procedure inter- emergency arise.44 Patients should be informed of signs ruption is related to oversedation or poor airway manage- and symptoms of delayed adverse events potentially ment, this should be recorded. As more sedation-related relating to the procedure performed that should prompt outcomes are studied, benchmarks for the outcome mea- a call to the physician. Patients should be told how they sure in the future may vary by procedure type, ASA classi- will be informed of relevant biopsy results. Information fication, and type of sedation used. concerning necessary follow-up appointments or lack of need for such should be included. Intraprocedure research questions 17. Frequency with which the plan for pathology follow- 1. Do monitoring techniques, such as capnography, during up is specified and documented routine endoscopic procedures under moderate and Level of evidence: 3 deep sedation improve detection of sedation-related Performance target: O98% adverse events with any impact on patient outcomes? Measure type: process 2. What is the optimal training requirement for gastro- When biopsy specimens have been obtained, the man- enterologists with regard to airway management and agement plan for the patient and notification of this sedation? plan to the referring physician should be documented. 3. What is the optimal sedation protocol for the following Discussion: The pathology results frequently alter or groups of patients: the obese, patients with sleep apnea, determine subsequent management plans (eg, timing of and patients classified as ASA class III or higher? surveillance colonoscopy, need for Helicobacter pylori 4. Does monitoring reversal agent administration as a qual- treatment). Integration of pathology results into the ity indicator discourage their use and adversely affect care plan requires that the patient and the referring patient outcomes? physician be notified of these findings and their implications. Patients may be notified by letter, electronically, by Postprocedure quality indicators telephone call, or during a subsequent follow-up visit The postprocedure period extends from the time the (with the endoscopist or other provider). Similarly, refer- endoscope is removed to subsequent follow-up. Postpro- ring physicians should be notified of pathology results. cedure activities include providing instructions to the pa- The frequency with which patient and referring physi- tient, documentation of the procedure, recognition and cians actually receive pathology results and that these documentation of adverse events, pathology follow-up, were integrated into a care plan is a more meaningful communication with referring physicians, and assessing quality indicator than simple documentation of a notifica- patient satisfaction. tion plan. With increasing use and integration of elec- 15. Frequency with which discharge from the endoscopy tronic medical records, measurement of such more unit according to predetermined discharge criteria meaningful indicators may be readily possible in the is documented future. Level of evidence: 3 18. Frequency with which a complete procedure report is Performance target: O98% created www.giejournal.org Volume 81, No. 1 : 2015 GASTROINTESTINAL ENDOSCOPY 11 Quality indicators for all GI endoscopic procedures

Level of evidence: 3 19. Recommendations for subsequent care Performance target: O98% 19. Frequency with which adverse events are Measure type: process documented Procedure reports are required for every endoscopic Level of evidence: 3 procedure and should be accurate, succinct, and Performance target: O98% completed in a timely manner. Measure type: process Discussion: Accurate and timely documentation of Adverse events should be classified according to their endoscopic findings and recommendations enhances timing, level of certainty of attribution to the endo- patient care.40 The task force emphasizes that the proce- scopic procedure, and degree of consequent distur- dure report be detailed, yet succinct. Requiring the inclu- bance to the patient, and this should be documented. sion of unnecessary details (eg, amount of blood loss Discussion: Improving the safety of endoscopy is a during screening colonoscopy) distracts from relevant major goal of the ASGE, ACG, and AGA and is consistent findings. Standardization of the language and structure of with efforts spearheaded by the Institute of Medicine.46 endoscopic reports may improve communication between There is evidence suggesting that adverse event rates physicians, enhance performance improvement activities, may be 2 to 3 times higher than previously documented advance research activities, and foster international collab- and reported.47 An ASGE task force proposed definitions oration. Electronic medical records and computerized and classification of endoscopy-related adverse events in endoscopic report generating systems may greatly aid an attempt to standardize data collection and reporting.48 in this task. Quality assessment and “pay for performance” An adverse event is one that prevents completion of the programs that depend on the collection of reliable, repro- planned procedure or results in admission to the hospital, ducible data benefit from such standardization. One prolongation of existing hospital stay, another procedure such scheme is the Minimal standard terminology for (needing sedation and/or anesthesia), or subsequent gastrointestinal endoscopydMST 3.0. proposed by the medical consultation. Adverse events can be subdivided World Organization of Digestive Endoscopy.45 This docu- based on timing as preprocedure, intraprocedure (from ment forms the basis for computer software by offering the administration of sedation, or insertion of the endo- standard lists of terms to be used in the structured docu- scope when no sedation is given, until the endoscope is mentation of endoscopic findings. The Quality Assurance removed), postprocedure (up to 14 days), and late (any Task Group of the National Colorectal Cancer Roundtable time after 14 days). A level of certainty of attribution to also has developed a reporting and data system that is the endoscopic procedure as definite, probable, possible, specific for colonoscopy.40 The goal of this tool is to pro- or unlikely should be recorded. Severity of adverse vide endoscopists with a quality improvement instrument events should be graded by the degree of consequent and to provide referring physicians with a colonoscopy disturbance to the patient and any changes in the plan report that uses standard terms and provides evidence- of care as mild, moderate, severe, or fatal. Preprocedure based follow-up recommendations. and intraprocedure adverse events that are evident on The following are the minimal elements of an completion of endoscopy should be recorded in the endoscopy.40 endoscopy report. Adverse events that are recognized 1. Date of procedure later also should be recorded. Ideally, this documentation 2. Patient identification data should be linked to the original endoscopy report as an 3. Endoscopist(s) addendum. 4. Assistant(s) and trainee participation in procedure 20. Frequency with which adverse events occur 5. Documentation of relevant patient history and physical Level of evidence: 3 examination (if not separately documented) Performance target: N/A 6. Confirmation of informed consent Measure type: outcome 7. Endoscopic procedure (both planned and performed Discussion: Periprocedural adverse events vary from are required) mild postprocedure bloating to cardiopulmonary arrest. 8. Indication(s) The rate of cardiopulmonary adverse events in large, na- 9. Type of endoscopic instrument tional studies is between 0.01% and 0.6%.49-52 Patient- 10. Medication (anesthesia, analgesia, sedation) related risk factors for cardiopulmonary adverse events 11. Anatomic extent of examination include preexisting cardiopulmonary disease, advanced 12. Limitation(s) of examination age, ASA class III or higher, and an increased modified 13. Tissue or fluid samples obtained Goldman score.53 Prospective, multicenter registries 14. Findings report perforation rates of 0.01% to 0.04% for upper endos- 15. Diagnostic impression copies, whereas the rate of perforation during colonoscopy 16. Results of therapeutic intervention (if any) is generally less than 0.1%.54-57 In general, perforation rates 17. Adverse events (if any) O0.1% during screening colonoscopies or 0.2% for all co- 18. Disposition lonoscopies should raise concerns as to whether

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TABLE 4. Priority quality indicators common to all GI endoscopic procedures*

Frequency with which endoscopy is performed for an indication that is included in a published standard list of appropriate indications, and the indication is documented

Frequency with which prophylactic antibiotics are administered for appropriate indication

Frequency with which management of antithrombotic therapy is formulated and documented before the procedure *See text for specific targets and discussion. inappropriate practices are the cause of the perforations.58 event is confirmed by direct patient contact, such informa- Perforation rates with ERCP range from 0.1% to 0.6%.59-61 tion should be added.45,48 We anticipate that adherence to Early identification and expeditious management of a this quality indicator will become more easily accomplished perforation have been shown to decrease associated with future integration of interoperable electronic health morbidity and mortality.54,56,61,62 Although perforation records, practice management systems, and endoscopy often requires surgery, endoscopic repair may be appro- report writers, which will allow searchable data warehouses priate in select individuals.63 to identify delayed adverse events. Hemorrhage is most often associated with polypectomy 22. Frequency with which patient satisfaction data are but can happen after ERCP with or without sphincterot- obtained omy, mucosal resection, gastrostomy placement, stent Level of evidence: 3 placement, or dilation.49,51,52 When associated with poly- Performance target: N/A pectomy, hemorrhage may occur immediately or can be Measure type: process delayed for several weeks after the procedure.64 A number Information on patient satisfaction is collected by use of large studies have reported hemorrhage rates of 0.1% of a validated and standardized questionnaire. to 0.6% after colonoscopy.56 For routine clinical practice, Discussion: ASGE, in its publications “Quality and out- bleeding rates for polypectomy should be !1%.58 A comes assessment in gastrointestinal endoscopy,” recom- study analyzing over 50,000 colonoscopies by using Me- mends the use of a validated questionnaire of patient dicare claims found that the rate of GI hemorrhage satisfaction (GHAA 9) modified for use after endoscopic pro- was significantly different with or without polypectomy: cedures.46,68,69 For smaller practices, it may be reasonable to 2.1 per 1000 procedures coded as screening without poly- offer surveys to all patients, whereas, in other settings, a pectomy and 3.7 per 1000 for procedures coded as diag- random sample may be appropriate. It is anticipated that nostic without polypectomy, compared with 8.7 per 1000 these survey results will be reviewed within a continuous for any procedures with polypectomy.65 quality improvement process. As greater percentages of pa- 21. Frequency with which postprocedure and late tients provide satisfaction feedback and as benchmarks for adverse events occur and are documented patient satisfaction surveys are defined, true outcome indica- Level of evidence: 3 tors of patient satisfaction may become feasible. Performance target: N/A 23. Frequency with which communication with referring Measure type: outcome providers is documented Attempts should be made to contact patients about 14 Level of evidence: 3 days after endoscopy to determine whether any Performance target: N/A adverse events had occurred after discharge from the Measure type: process endoscopy unit and whether these were attributable The results of the endoscopic procedure and follow-up to the procedure. recommendations must be communicated to the refer- Discussion: The task force recognizes the challenges ring provider or primary care physician, and this of collecting complete and reliable data on postprocedure communication should be documented. and late adverse events resulting from endoscopy. To Discussion: Lack of communication of endoscopic results emphasize the importance of collecting and recording post- with other care providers may result in patient mismanage- procedure and late adverse events, this is stated as a sepa- ment. It is the responsibility of the endoscopist to provide rate quality indicator. The significant added cost and use of results and recommendations regarding therapy, further human resources necessary to perform 14-day follow-up diagnostic testing, and follow-up to the referring physician, remain an obstacle. Voluntary reporting of adverse events primary provider, or other relevant health care providers. alone is neither ideal nor sufficient because 15% to 45% This may be done by letter, facsimile, telephone call, secure of adverse events go unrecognized or unreported.57,66,67 e-mail, or forwarded electronic medical record communica- This task force also recommends that endoscopy report tion. In particular, patients with confirmed or suspected generators allow these data to be included as an addendum malignancies need documentation of plans for further to the endoscopy report. When absence of any adverse follow-up, staging, and treatment. www.giejournal.org Volume 81, No. 1 : 2015 GASTROINTESTINAL ENDOSCOPY 13 Quality indicators for all GI endoscopic procedures

Postprocedure research questions already are being met, then another set of indicators should 1. How often do patients comply with instructions on be chosen to further the process of continuous quality resumption of driving after sedation? Can patients improvement. If performance falls below the benchmarks, drive after being given propofol sedation? then remediation programs should be developed and im- 2. Does giving a copy of the procedure report directly to plemented. Indicators should be remeasured periodically the patient affect patient satisfaction or compliance to determine the effectiveness of such programs. with follow-up recommendations? 3. Does the use of standardized terminology improve communication and compliance with postprocedure recommendations? DISCLOSURES 4. Would the practice of using required ﬁelds to report quality indicators improve the reliability of data ob- Dr Shaheen received research grant support from tained from the computerized reports for benchmarking Covidien Medical, CSA Medical, and Takeda Pharmaceu- and quality reporting? ticals. All other authors disclosed no ﬁnancial relation- 5. What factors improve patient satisfaction with endoscopy? ships relevant to this publication. Prepared by: Priority quality indicators Maged K. Rizk, MD* The recommended priority indicators that are common Mandeep S. Sawhney, MD, MS* to all endoscopic procedures are (1) appropriate indication Jonathan Cohen, MD dendoscopy performed for an appropriate indication, (2) Irving M. Pike, MD prophylactic antibioticsdprophylactic antibiotics adminis- Douglas G. Adler, MD tered only for selected settings in which they are indicated, Jason A. Dominitz, MD, MHS and (3) antithrombotic therapydantithrombotic medica- John G. Lieb II, MD tion use by the patient recorded and a plan regarding man- David A. Lieberman, MD agement of antithrombotic medications in place (Table 4). Walter G. Park, MD, MS For each of these indicators, reaching the recommended Nicholas J. Shaheen, MD, MPH performance target is considered strongly associated with Sachin Wani, MD important clinical outcomes. These indicators can be measured readily in a manageable number of examinations. *Drs Rizk and Sawhney contributed equally to this work.

Conclusions Abbreviations: AAOS, American Academy of Orthopedic Surgeons; ACG, American College of Gastroenterology; AGA, American Gastroenterological Quality assurance and pay-for-performance programs Association; ASA, American Society of Anesthesiologists; ASGE, American are increasingly playing a vital role in health care policy. Society for Gastrointestinal Endoscopy. By providing incentives to good clinical practices and by penalizing unnecessary and suboptimal care, policymakers This document is a product of the ASGE/ACG Task Force on Quality in rationalize that clinical outcomes will improve while Endoscopy. This document was reviewed and approved by the Governing Boards of the American Society for Gastrointestinal Endoscopy and the reducing health care spending. For practitioners to differ- American College of Gastroenterology. It appears simultaneously in entiate between good and suboptimal clinical care, these Gastrointestinal Endoscopy and the American Journal of Gastroenterology. programs require need-validated and robust quality indicators. These programs now inﬂuence practice patterns and reimbursement. The law of unintended consequences applies to measurement of quality, therefore, it is para- mount that endoscopists and their representative organiza- This document was reviewed and endorsed by the American tions remain intimately involved in the development of Gastroenterological Association Institute. these quality indicators. Our goal is to develop a rational and evidence-based system of benchmarks for every quality indicator. The benchmark will be set such that every well- trained endoscopist committed to patient care will be able to meet them without undue burden. However, the benchmarks will need to be set high enough to identify REFERENCES underperforming providers who may beneﬁt from remediation. It is anticipated that endoscopy units will select a sub- 1. Chassin MR, Galvin RW. The urgent need to improve health care quality. Institute of Medicine National Roundtable on Health Care Quality. set of these indicators most appropriate for their needs. JAMA 1998;280:1000-5. These indicators should then be measured and reported. 2. Petersen BT. Quality assurance for endoscopists. Best Pract Res Clin If the benchmarks associated with these indicators Gastroenterol 2011;25:349-60.

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Lieberman D, Nadel M, Smith RA, et al. Standardized colonoscopy 21. Enestvedt BK, Eisen GM, Holub J, et al. Is the American Society of An- reporting and data system: report of the Quality Assurance Task Group esthesiologists classification useful in risk stratification for endoscopic of the National Colorectal Cancer Roundtable. Gastrointest Endosc procedures? Gastrointest Endosc 2013;77:464-71. 2007;65:757-66. 22. Charles RJ, Chak A, Cooper GS, et al. Use of open access in GI endos- 41. Hewett DG, Rex DK. Improving colonoscopy quality through health- copy at an academic medical center. Gastrointest Endosc 1999;50: care payment reform. Am J Gastroenterol 2010;105:1925-33. 480-5. 42. American Society of Anesthesiologists Task Force on Sedation and 23. ASGE Standards of Practice Committee; Banerjee S, Shen B, Baron TH, Analgesia by Non-Anesthesiologists. Practice guidelines for sedation et al. Antibiotic prophylaxis for GI endoscopy. Gastrointest Endosc and analgesia by non-anesthesiologists. Anesthesiology 2002;96:1004-17. 2008;67:791-8. 43. Waring JP, Baron TH, Hirota WK, et al. Quality indicators for conscious 24. Wilson W, Taubert KA, Gewitz M, et al. Prevention of infective endocar- sedation and monitoring during gastrointestinal endoscopy. Gastroint- ditis: guidelines from the American Heart Association: a guideline from est Endosc 2003;58:317-22. www.giejournal.org Volume 81, No. 1 : 2015 GASTROINTESTINAL ENDOSCOPY 15 Quality indicators for all GI endoscopic procedures

44. ASGE Ensuring Safety in the Gastrointestinal Endoscopy Unit Task 57. Zubarik R, Fleischer DE, Mastropietro C, et al. Prospective analysis of Force; Calderwood AH, Chapman FJ, Cohen J, et al. Quality indica- complications 30 days after outpatient colonoscopy. Gastrointest tors for safety in the gastrointestinal endoscopy unit. Gastrointest Endosc 1999;50:322-8. Endosc 2014;79:363-72. 58. Rex DK, Schoenfeld PS, Cohen J, et al. Quality indicators for colonos- 45. Aabakken L, Barkun AN, Cotton PB, et al. Standardized endoscopic copy. Gastrointest Endosc 2015;81:31-53. reporting. J Gastroenterol Hepatol 2014;29:234-40. 59. Johanson JF, Cooper G, Eisen GM, et al. Quality assessment of ERCP. 46. Institute of Medicine, Committee on Quality of Healthcare in America. Endoscopic retrograde cholangiopancreatography. Gastrointest En- Crossing the quality chasm: a new health system for the 21st century. dosc 2002;56:165-9. Washington DC: National Academy Press; 2001. 60. Lai CH, Lau WY. Management of endoscopic retrograde 47. Leffler DA, Kheraj R, Garud S, et al. The incidence and cost of unex- cholangiopancreatography-related perforation. Surgeon 2008;6:45-8. pected hospital use after scheduled outpatient endoscopy. Arch Intern 61. Masci E, Toti G, Mariani A, et al. Complications of diagnostic and ther- Med 2010;170:1752-7. apeutic ERCP: a prospective multicenter study. Am J Gastroenterol 48. Cotton PB, Eisen GM, Aabakken L, et al. A lexicon for endoscopic 2001;96:417-23. adverse events: report of an ASGE workshop. Gastrointest Endosc 62. Loperfido S, Angelini G, Benedetti G, et al. Major early complications 2010;71:446-54. from diagnostic and therapeutic ERCP: a prospective multicenter 49. ASGE Standards of Practice Committee; Anderson MA, Fisher L, Jain R, study. Gastrointest Endosc 1998;48:1-10. et al. Complications of ERCP. Gastrointest Endosc 2012;75:467-73. 63. Trecca A, Gaj F, Gagliardi G. Our experience with endoscopic repair 50. Freeman ML, Nelson DB, Sherman S, et al. Complications of endo- of large colonoscopic perforations and review of the literature. Tech scopic biliary sphincterotomy. N Engl J Med 1996;335:909-18. Coloproctol 2008;12:315; 21, discussion 322. 51. ASGE Standards of Practice Committee; Ben-Menachem T, Decker GA, 64. Singaram C, Torbey CF, Jacoby RF. Delayed postpolypectomy bleeding. Early DS, et al. Adverse events of upper GI endoscopy. Gastrointest Am J Gastroenterol 1995;90:146-7. Endosc 2012;76:707-18. 65. Warren JL, Klabunde CN, Mariotto AB, et al. Adverse events after 52. ASGE Standards of Practice Committee; Fisher DA, Maple JT, Ben-Men- outpatient colonoscopy in the Medicare population. Ann Intern Med achem T, et al. Complications of colonoscopy. Gastrointest Endosc 2009;150:849; 57, W152. 2011;74:745-52. 66. Dreisler E, Schou L, Adamsen S. Completeness and accuracy of volun- 53. Sharma VK, Nguyen CC, Crowell MD, et al. A national study of cardio- tary reporting to a national case registry of laparoscopic cholecystec- pulmonary unplanned events after GI endoscopy. Gastrointest Endosc tomy. Int J Qual Health Care 2001;13:51-5. 2007;66:27-34. 67. Bruce J, Russell EM, Mollison J, et al. The quality of measurement of 54. Quine MA, Bell GD, McCloy RF, et al. Prospective audit of perforation surgical wound infection as the basis for monitoring: a systematic re- rates following upper gastrointestinal endoscopy in two regions of view. J Hosp Infect 2001;49:99-108. England. Br J Surg 1995;82:530-3. 68. Johanson JF, Schmitt CM, Deas TM Jr, et al. Quality and outcomes 55. Rabeneck L, Rumble RB, Axler J, et al. Cancer Care Ontario colonoscopy assessment in Gastrointestinal Endoscopy. Gastrointest Endosc standards: standards and evidentiary base. Can J Gastroenterol 2000;52:827-30. 2007;21(suppl D):5-24D. 69. Brotman M, Allen JI, Bickston SJ, et al. AGA Task Force on Quality in 56. Ko CW, Dominitz JA. Complications of colonoscopy: magnitude and Practice: a national overview and implications for GI practice. Gastro- management. Gastrointest Endosc Clin N Am 2010;20:659-71. enterology 2005;129:361-9.

16 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 1 : 2015 www.giejournal.org Communication from the ASGE QUALITY INDICATORS FOR Quality Assurance in Endoscopy Committee GI ENDOSCOPIC PROCEDURES

Quality indicators for EGD

EGD is used widely for the diagnosis and treatment ical studies were identified through a computerized search of esophageal, gastric, and small-bowel disorders. When of Medline followed by review of the bibliographies of all properly performed, it is generally safe and well-tolerated relevant articles. When such studies were absent, indica- for the examination of the upper GI tract. Included among tors were chosen by expert consensus. Although feasibility the many accepted indications for EGD are evaluation of of measurement was a consideration, it is hoped that inclu- dysphagia, GI bleeding, peptic ulcer disease, medically sion of highly relevant, but not yet easily measurable, indi- refractory GERD, esophageal strictures, celiac disease, cators would promote their eventual adoption. Although and unexplained diarrhea. During EGD evaluation, diag- a comprehensive list of quality indicators is proposed, nostic biopsies can be performed as well as therapies to ultimately, only a small subset might be widely used for achieve hemostasis and dilation or stenting for significant continuous quality improvement, benchmarking, or quality strictures. In 2009, an estimated 6.9 million EGD proce- reporting. As in 2006, the current task force concentrated dures were performed in the United States at an estimated its attention on parameters related solely to endoscopic cost of $12.3 billion dollars. From 2000 to 2010, a 50% in- procedures. Although the quality of care delivered to pa- crease in EGD utilization was observed among Medicare tients is clearly influenced by many factors related to the recipients.1 facilities in which endoscopy is performed, characteriza- The quality of health care can be measured by tion of unit-related quality indicators was not included in comparing the performance of an individual or a group of the scope of this effort. individuals with an ideal or benchmark.2 The particular The resultant quality indicators were graded on the parameter that is being used for comparison is termed a strength of the supporting evidence (Table 1). Each quality in- quality indicator. Quality indicators may be reported as a ra- dicator was classified as an outcome or a process measure. tio between the incidence of correct performance and the Although outcome quality indicators are preferred, some opportunity for correct performance or as the proportion can be difficult to measure in routine clinical practice, because of interventions that achieve a predefined goal.3 Quality in- they need analysis of large amounts of data and long-term dicators can be divided into 3 categories: (1) structural mea- follow-up and may be confounded by other factors. In such suresdthese assess characteristics of the entire health care cases, the task force deemed it reasonable to use process in- environment (eg, participation by a physician or other clini- dicators as surrogate measures of high-quality endoscopy. cian in a systematic clinical database registry that includes The relative value of a process indicator hinges on the evi- consensus endorsed quality measures), (2) process mea- dence that supports its association with a clinically relevant suresdthese assess performance during the delivery of outcome, and such process measures were emphasized. care (eg, frequency with which appropriate prophylactic an- The quality indicators for this update were written in tibiotics are given before placement of a PEG tube), and (3) a manner that lends them to be developed as measures. outcome measuresdthese assess the results of the care Although they remain quality indicators and not measures, that was provided (eg, rates of adverse events after EGD). this document also contains a list of performance targets for each quality indicator. The task force selected perfor- METHODOLOGY mance targets from benchmarking data in the literature when available. When data were unavailable to support establishing a performance target level, “N/A” (not available) In 2006, the American Society for Gastrointestinal was listed. However, when expert consensus considered fail- Endoscopy (ASGE)/American College of Gastroenterology ure to perform a given quality indicator a “never event,” such (ACG) Task Force on Quality in Endoscopy published the 4 as monitoring vital signs during sedation, then the perfor- first version of quality indicators for EGD. The present up- mance target was listed as O98%. It is important to empha- date integrates new data pertaining to previously proposed size that the performance targets listed do not necessarily quality indicators and new quality indicators for performing reflect the standard of care but rather serve as specific goals EGD. Indicators that had wide-ranging clinical application, to direct quality improvement efforts. were associated with variation in practice and outcomes, Quality indicators were divided into 3 time periods: pre- and were validated in clinical studies were prioritized. Clin- procedure, intraprocedure, and postprocedure. For each Copyright ª 2015 American Society for Gastrointestinal Endoscopy and category, key relevant research questions were identified. American College of Gastroenterology In order to guide continuous quality improvement efforts, 0016-5107/$36.00 http://dx.doi.org/10.1016/j.gie.2014.07.057 the task force also recommended a high-priority subset of the www.giejournal.org Volume 81, No. 1 : 2015 GASTROINTESTINAL ENDOSCOPY 17 Quality indicators for EGD

TABLE 1. Grades of recommendation*

Grade of Clarity of Methodologic strength recommendation benefit supporting evidence Implications 1A Clear Randomized trials without Strong recommendation; can be important limitations applied to most clinical settings

1B Clear Randomized trials with important Strong recommendation, likely to limitations (inconsistent results, apply to most practice settings nonfatal methodologic flaws)

1Cþ Clear Overwhelming evidence from Strong recommendation; can apply to observational studies most practice settings in most situations

1C Clear Observational studies Intermediate-strength recommendation; may change when stronger evidence is available

2A Unclear Randomized trials without Intermediate-strength recommendation; important limitations best action may differ depending on circumstances or patients’ or societal values

2B Unclear Randomized trials with important Weak recommendation; alternative limitations (inconsistent results, approaches may be better under some nonfatal methodologic flaws) circumstances

2C Unclear Observational studies Very weak recommendation; alternative approaches likely to be better under some circumstances

3 Unclear Expert opinion only Weak recommendation, likely to change as data become available

*Adapted from Guyatt G, Sinclair J, Cook D, et al. Moving from evidence to action. Grading recommendationsda qualitative approach. In: Guyatt G, Rennie D, editors. Users’ guides to the medical literature. Chicago: AMA Press; 2002. p. 599-608. indicators described, based on their clinical relevance and the administration of sedation or insertion of the endo- importance, on evidence that performance of the indicator scope. Common issues for all endoscopic procedures dur- varies significantly in clinical practice, and feasibility of mea- ing this period include: appropriate indication, informed surement (a function of the number of procedures needed consent, risk assessment, formulation of a sedation plan, to obtain an accurate measurement with narrow confidence management of prophylactic antibiotics and antithrom- intervals [CI] and the ease of measurement). A useful botic drugs, and timeliness of the procedure.5 Preproce- approach for individual endoscopists is to first measure their dure quality indicators specific to EGD include the performances with regard to these priority indicators. Quality following: improvement efforts would then move to different quality indicators if endoscopists are performing above recommended 1. Frequency with which EGD is performed for an indi- thresholds, or the employer and/or teaching center could cation that is included in a published standard list institute corrective measures and remeasure performance of appropriate indications, and the indication is of low-level performers. documented Level of evidence: 1Cþ Recognizing that certain quality indicators are common O to all GI endoscopic procedures, such items are presented Performance target: 80% in detail in a separate document, similar to the process Type of measure: process in 2006.5 The preprocedure, intraprocedure, and postpro- Discussion: The accepted indications for EGD are reviewed in detail in a recently updated document by cedure indicators common to all endoscopy are listed in 6 Table 2. Those common factors will be discussed only the ASGE Standards of Practice Committee (Table 3). The indications for EGD have expanded to include in this document insofar as the discussion needs to be ’ modified specifically to relate to EGD. endoscopic therapy for Barrett s esophagus (BE), intraoperative evaluation of reconstructed anatomic reconstructions typical of modern foregut surgery, and Preprocedure quality indicators management of operative adverse events. Performing The preprocedure period includes all contact between EGD for an accepted indication is associated with a statis- members of the endoscopy team and the patient before tically higher rate of clinically relevant findings.7,8 In one

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TABLE 2. Summary of proposed quality indicators common to all endoscopic procedures*,23

Grade of Performance Quality indicator recommendation Measure type target (%) Preprocedure

2. Frequency with which informed consent is 3 Process O98 obtained and fully documented

3. Frequency with which preprocedure history and 3 Process O98 directed physical examination are performed and documented

4. Frequency with which risk for adverse events is 3 Process O98 assessed and documented before sedation is started

5. Frequency with which prophylactic antibiotics are Varies Process O98 administered only for selected settings in which they are indicated (priority indicator)

6. Frequency with which a sedation plan is Varies Process O98 documented

7. Frequency with which management of 3 Process N/A antithrombotic therapy is formulated and documented before the procedure (priority indicator)

8. Frequency with which a team pause is conducted 3 Process O98 and documented

9. Frequency with which endoscopy is performed 3 Process O98 by an individual who is fully trained and credentialed to perform that particular procedure

Intraprocedure

10. Frequency with which photodocumentation is 3 Process N/A performed

11. Frequency with which patient monitoring 3 Process O98 among patients receiving sedation is performed and documented

12. Frequency with which the doses and routes of 3 Process O98 administration of all medications used during the procedure are documented

13. Frequency with which use of reversal agents is 3 Process O98 documented

14. Frequency with which procedure interruption 3 Process O98 and premature termination because of oversedation or airway management issues is documented

Postprocedure

15. Frequency with which discharge from the 3 Process O98 endoscopy unit according to predetermined discharge criteria is documented

16. Frequency with which patient instructions are 3 Process O98 provided

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TABLE 2. Continued

Grade of Performance Quality indicator recommendation Measure type target (%)

17. Frequency with which the plan for pathology 3 Process O98 follow-up is specified and documented

18. Frequency with which a complete procedure 3 Process O98 report is created

19. Frequency with which immediate adverse 3 Process O98 events requiring interventions are documented

20. Frequency with which immediate adverse 3 Outcome N/A events requiring interventions including hospitalization occur

21. Frequency with which delayed adverse events 3 Outcome N/A leading to hospitalization or additional procedures or medical interventions occur within 14 days

22. Frequency with which patient satisfaction data 3 Process N/A are obtained

23. Frequency with which communication with 3 Process N/A referring providers is documented

study, the odds ratio (OR) for finding a clinically relevant nary adverse events, missed diagnosis, missed lesions, lesion by using an appropriate indication was 1.34 (95% intravenous site adverse events, chest pain, sore throat, CI, 1.04-1.74).7 This process measure requires documen- aspiration, and reaction to local anesthetic spray.10-12 As tation in the procedure report. When a procedure is per- a quality indicator, informed consent is a process measure formed for a reason that is not listed in Table 3, based on expert opinion and supported by principles of justification for the procedure should be documented. biomedical ethics. A clinical study that correlates the pres- 2. Frequency with which informed consent is obtained, ence or absence of informed consent with clinical out- including specific discussions of risks associated with comes has not been, and is not likely to be, performed. EGD, and fully documented 3. Frequency with which appropriate prophylactic antibi- Level of evidence: 3 otics are given in patients with cirrhosis with acute up- Performance target: O98% per GI bleeding before EGD (priority indicator) Type of measure: process Level of evidence: 1B In addition to the risks associated with all endoscopic Performance target: O98% procedures, the consent should address the relevant Type of measure: process and substantial adverse events pertaining to each spe- Discussion: A Cochrane systematic review of 12 studies cific EGD procedure. showed a relative risk (RR) reduction of death (RR Discussion: As with any procedure that abides by the 0.79; 95% CI, 0.63-0.98), bacterial infections (RR 0.36; accepted biomedical ethical principle of patient auton- 95% CI, 0.27-0.49), and rebleeding (RR 0.53; 95% CI, omy, consent must be obtained from the patient or 0.38-0.74) with antibiotic prophylaxis for patients guardian before EGD on the same day as the procedure with cirrhosis and acute upper GI bleeding.13 Indepen- (or as required by local law or institutional policy). dent of performing EGD, antibiotic prophylaxis should Adequate time must be allotted to discuss the risks, be administered in this population.14 Oral fluoroquino- benefits, and alternatives to the procedure for the pa- lones can be recommended safely for most patients, tient to voluntarily make a fully informed decision. In but intravenous ceftriaxone may be preferred in rare exceptions, such as in a life-threatening emergency, advanced cirrhosis and in areas of high fluoroquino- informed consent can be abridged or omitted. Further lone resistance.15-17 Antibiotic selection may change guidance on informed consent can be found in a over time as new agents become available and drug position statement by the ASGE Standards of Practice of resistance patterns change. This is a process measure Committee.9 The particular risks associated with EGD for which an evidence-based correlation of a clinically include bleeding, perforation, infection, cardiopulmo- beneficial outcome exists.

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TABLE 3. Indications and contraindications for EGD6

1. EGD is generally indicated A. Upper abdominal symptoms, which persist despite an appropriate trial of therapy for evaluating: B. Upper abdominal symptoms associated with other symptoms or signs suggesting serious organic disease (eg, anorexia and weight loss) or in patients aged O45 years C. Dysphagia or odynophagia D. Esophageal reflux symptoms, which are persistent or recurrent despite appropriate therapy E. Persistent vomiting of unknown cause F. Other diseases in which the presence of upper GI pathology might modify other planned management. Examples include patients who have a history of ulcer or GI bleeding who are scheduled for organ transplantation, long-term anticoagulation, or chronic nonsteroidal anti-inflammatory drug therapy for arthritis and those with cancer of the head and neck G. Familial adenomatous polyposis syndromes H. For confirmation and specific histologic diagnosis of radiologically demonstrated lesions: 1. Suspected neoplastic lesion 2. Gastric or esophageal ulcer 3. Upper tract stricture or obstruction I. GI bleeding: 1. In patients with active or recent bleeding 2. For presumed chronic blood loss and for iron deficiency anemia when the clinical situation suggests an upper GI source or when colonoscopy result is negative J. When sampling of tissue or fluid is indicated K. In patients with suspected portal hypertension to document or treat esophageal varices L. To assess acute injury after caustic ingestion M. Treatment of bleeding lesions such as ulcers, tumors, vascular abnormalities (eg, electrocoagulation, heater probe, laser photocoagulation, or injection therapy) N. Banding or sclerotherapy of varices O. Removal of foreign bodies P. Removal of selected polypoid lesions Q. Placement of feeding or drainage tubes (peroral, PEG, or percutaneous endoscopic jejunostomy) R. Dilation of stenotic lesions (eg, with transendoscopic balloon dilators or dilation systems by using guidewires) S. Management of achalasia (eg, botulinum toxin, balloon dilation) T. Palliative treatment of stenosing neoplasms (eg, laser, multipolar electrocoagulation, stent placement) U. Endoscopic therapy for intestinal metaplasia V. Intraoperative evaluation of anatomic reconstructions typical of modern foregut surgery (eg, evaluation of anastomotic leak and patency, fundoplication formation, pouch configuration during bariatric surgery) W. Management of operative adverse events (eg, dilation of anastomotic strictures, stenting of anastomotic disruption, fistula, or leak in selected circumstances) 2. EGD is generally not indicated A. Symptoms that are considered functional in origin (there are exceptions in which an for evaluating: endoscopic examination may be done once to rule out organic disease, especially if symptoms are unresponsive to therapy) B. Metastatic adenocarcinoma of unknown primary site when the results will not alter management C. Radiographic findings of: 1. Asymptomatic or uncomplicated sliding hiatal hernia 2. Uncomplicated duodenal ulcer that has responded to therapy 3. Deformed duodenal bulb when symptoms are absent or respond adequately to ulcer therapy 3. Sequential or periodic EGD may A. Surveillance for malignancy in patients with premalignant conditions (ie, Barrett’s be indicated: esophagus)

4. Sequential or periodic EGD is A. Surveillance for malignancy in patients with gastric atrophy, pernicious anemia, or generally not indicated for: prior gastric operations for benign disease B. Surveillance of healed benign disease such as esophagitis or gastric or duodenal ulcer C. Surveillance during repeated dilations of benign strictures unless there is a change in status

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4. Frequency with which appropriate prophylactic antibi- 5. What are barriers to wider use of EGD without patient otics are given before placement of a PEG tube sedation? Level of evidence: 1A 6. How often do endoscopists in the community comply Performance target: O98% with surveillance guidelines for nondysplastic BE? Type of measure: process 7. How often is endoscopy performed for other than an Discussion: A Cochrane systematic review incorporat- appropriate indication in the community, and what are ing over 1000 patients in 10 clinical trials showed a the barriers to wider adherence to recommendations decreased peristomal infection rate with antibiotic pro- regarding indications? phylaxis.18 Antibiotics that cover cutaneous sources of bacterial infection such as intravenous cefazolin should Intraprocedure quality indicators be administered 30 minutes before the procedure.19 The intraprocedure period extends from the administra- Where methicillin-resistant Staphylococcus aureus is tion of sedation, or insertion of the endoscope when no highly prevalent, screening with decontamination sedation is given, to the removal of the endoscope. This should be performed.20 period includes all the technical aspects of the procedure 5. Frequency with which a proton pump inhibitor (PPI) including completion of the examination and therapeutic is used for suspected peptic ulcer bleeding (priority maneuvers. Common to most endoscopic procedures is indicator) the provision of sedation and need for patient monitoring.23 Level of evidence: 1B Intraprocedure quality indicators specific to performance of Performance target: O98% EGD include the following: Type of measure: process 7. Frequency with which a complete examination of the Discussion: When possible, the intravenous PPI should esophagus, stomach, and duodenum, including retro- be started on presentation with bleeding and before flexion in the stomach, is conducted and documented EGD. Intravenous PPI treatment before EGD reduces Level of evidence: 3 the proportion of high-risk stigmata seen at index endos- Performance target: O98% copy (OR 0.67; 95% CI, 0.54-0.84) and need for endo- Type of measure: process scopic therapy (OR 0.68; 95% CI, 0.50-0.93) when Discussion: Except in cases of esophageal or gastric compared with controls. In a Cochrane review of 6 ran- outlet obstruction, every EGD should include complete domized clinical trials, however, no statistically significant visualization of all the organs of interest from the upper difference in mortality (OR 1.12; 95% CI, 0.72-1.73) be- esophageal sphincter to the second portion of the duo- tween PPI and control treatment was observed.21 denum. Complete examination may require efforts to 6. Frequency with which vasoactive drugs are initiated clear material from the stomach or esophagus, as in before EGD for suspected variceal bleeding assessment for the source of upper GI hemorrhage. Writ- Level of evidence: 1B ten documentation should confirm the extent of the ex- Performance target: O98% amination. If a clinically significant abnormality is Type of measure: process encountered, photodocumentation is indicated. In Discussion: In a meta-analysis of 30 clinical trials studies of the learning curve of EGD, over 90% of trainees involving over 3000 patients, the use of vasoactive med- successfully perform technically complete EGD after 100 ications and their analogues, such as terlipressin and oc- cases, and technical proficiency may be accelerated treotide, was associated with a lower risk of 7-day through the use of simulators.24,25 It is reasonable to mortality (RR 0.74; 95% CI, 0.57-0.95) and a significant expect that any practicing endoscopist be capable of visu- improvement in hemostasis (RR 1.21; 95% CI, 1.13- alizing the organs of interest with rare exception. Given 1.30).22 There was no difference in efficacy among the the recent increase in gastric cardia cancers, this should different vasoactive medications. include retroflexion in the stomach in all cases.26 8. Among those with nonbleeding gastric ulcers, fre- Preprocedure research questions quency with which gastric biopsy specimens are taken 1. What is the optimal antithrombotic management before to exclude malignancy therapeutic EGD procedures? Level of evidence: 2C 2. What are the adverse event rates of physicians relative to Performance target: O80% recently updated antibiotic prophylaxis recommenda- Type of measure: process tions for cardiac conditions, synthetic vascular grafts, Discussion: Careful attention to the presence of nonvalvular cardiac devices, and orthopedic prostheses? mucosal abnormalities during EGD is crucial. The acqui- 3. Is there sufficient interoperator and intraoperator vari- sition of adequate and appropriate samples demon- ability in risk stratification to explain sedation-related strates an understanding of the importance of a adverse events? complete and thorough examination. Biopsy specimens 4. What is the optimal sedation regimen and setting for from gastric ulcers are required to assess for the possi- EGD in patients with obesity and sleep apnea? bility of malignancy. The optimal number and type

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(maximum-capacity vs standard) has not been deter- nalized metaplasia of the esophagus are at 5-fold mined; however, a single biopsy may not detect malig- increased risk of progression to high-grade dysplasia or nancy in as many as 30% of those with gastric cancer. cancer compared with those with columnar-lined esoph- Four or more biopsies detect O95% of malignancies.27 agus without goblet cells.37 Although the endoscopic In the setting of acute GI bleeding, the endoscopist may appearance may suggest BE, a definitive diagnosis choose to defer biopsy of the ulcer, provided that a sub- cannot be made without pathology confirmation. For sequent endoscopy is planned. patients with known BE undergoing EGD with no contra- 9. Frequency with which BE is appropriately measured indication to endoscopic biopsy, an adequate number of when present biopsy specimens should be obtained to exclude dys- Level of evidence: 2C plasia. Although the optimal number of biopsy speci- Performance target: O98% mens has not been defined, 4-quadrant biopsies every Type of measure: process 1 to 2 centimeters throughout the length of the BE tissue Discussion: BE may be present in up to 5% to 15% are recommended.28,36 Acquisition of fewer biopsy spec- of high-risk patients (eg, older white men with GERD imens than those suggested by this protocol is associ- symptoms) undergoing upper endoscopy.28 The risk of ated with a reduced likelihood of detecting dysplasia, progression to dysplasia or cancer may be related to the after controlling for segment length.38 length of Barrett’s epithelium.29,30 In addition, in patients Recent evidence has suggested that the time that the eventually needing endoscopic therapy for BE, the endoscopist spends inspecting the BE may be an amount of involved tissue may influence both the endo- important determinant of the yield of an endoscopic scopic approach and the choice of sedation modality. surveillance examination.39 Longer inspection times Therefore, it is important to characterize and document may be associated with increased detection of either the length and location of the salmon-colored mucosa high-grade dysplasia or the detection of suspicious le- during EGD. Although a single measurement may sions. Confirmation of this finding and prospective vali- describe the total length of the BE in the tubular esoph- dation that increased inspection time leads to the agus, the Prague classification is a validated, widely identification of lesions (and not that the identification used, more descriptive system that describes both the of lesions leads to longer inspection) may allow the circumferential and maximal extent of the BE.31,32 This future use of this metric as a quality indicator. system defines the distance from the top of the gastric Most advanced neoplasia found on endoscopic examina- folds to the most proximal extent of the BE as the tions is found not on random biopsy but on targeted maximal (M) extent of the BE. The distance from the biopsy of lesions that are suspicious for neoplasia, top of the gastric folds to the most proximal extent of because of nodularity, ulceration, depression, changes the circumferential involvement of the BE is the circum- in vascularity, or other findings. Previous work suggests ferential (C) measurement. Assessment of the endo- that use of advanced imaging modalities, such as narrow- scopic involvement of columnar tissue is essential band imaging, might allow for identification of areas sus- because intestinal metaplasia of the Z line may occur in picious for neoplasia. This would lead to a decreased up to 18% of individuals with GERD symptoms and number of esophageal biopsies necessary to survey the does not, without accompanying endoscopic findings, patient.40 If so, this quality metric may require future constitute BE.33 Intestinal metaplasia of the Z line is not alteration to reflect best practices. known to carry sufficient cancer risk to warrant surveil- 11. Frequency with which the type of upper GI bleeding lance programs when this is diagnosed. Accordingly, it lesion is described, and the location is documented is important that when the presence of BE tissue is sus- Level of evidence: 3 pected, these landmarks are clearly documented. Performance target: O80% 10. Frequency with which biopsy specimens are obtained Type of measure: process in cases of suspected BE 12. Frequency with which, during EGD examination Level of evidence: 2C revealing peptic ulcers, at least one of the following Performance target: O90% stigmata is noted: active bleeding, nonbleeding visible Type of measure: process vessels (pigmented protuberance), adherent clot, flat Discussion: Criteria for the diagnosis of BE are spot, and clean-based debated. Although some professional societies in other Level of evidence: 1A countries consider any columnar epithelium in the Performance target: O98% tubular esophagus consistent with the diagnosis of Type of measure: process BE,34 professional societies in the United States have 13. Frequency with which, unless contraindicated, endo- traditionally required specialized or intestinal epithe- scopic treatment is given for ulcers with active bleeding lium with goblet cells to fulfill the diagnosis,35,36 or with nonbleeding visible vessels (priority indicator) and only such patients to be candidates for surveillance Level of evidence: 1A protocols. Recent data suggest that patients with intesti- Performance target: O98% www.giejournal.org Volume 81, No. 1 : 2015 GASTROINTESTINAL ENDOSCOPY 23 Quality indicators for EGD

Type of measure: process 14. Frequency with which achievement of primary hemo- Discussion: The completion of therapeutic procedures stasis in cases of attempted hemostasis of upper GI is a logical and obvious target for quality metrics in bleeding lesions is documented upper endoscopy. It is impossible prospectively to Level of evidence: 3 define and create metrics for all potential therapeutic Performance target: O98% maneuvers in upper endoscopy for the purpose of qual- Type of measure: process ity monitoring. Nonetheless, given the clinical impor- Discussion: Prognosis in the patient with active GI tance and commonplace nature of the management of bleeding depends in part on the success of initial inter- GI bleeding, monitoring processes and outcomes vention. Patients in whom hemostasis is not achieved related to these conditions will likely reflect the quality are more likely to require subsequent interventional of overall clinical care. Practitioners performing EGD in radiology or surgery and are at increased risk of mortal- the setting of upper GI bleeding should be trained, ity compared with those undergoing successful inter- equipped, and prepared to therapeutically manage the vention.48-50 In many prospective series evaluating bleeding source when found. various modalities for managing actively bleeding upper The first task of the therapeutic endoscopist is to GI lesions, primary hemostasis rates from 90% to 100% find and define the location of the bleeding site. In have been achieved.46 In order to gauge and track suc- the majority of patients, a bleeding site can be deter- cessful hemostasis, it will be necessary for endoscopists mined after careful examination.41-43 However, because to clearly record whether or not their efforts to achieve of impaired visualization because of blood, or occasion- primary hemostasis in high-risk endoscopic stigmata are ally because of intermittent bleeding from a lesion successful. At present, there are no currently accepted without obvious endoscopic stigmata, such as a Dieula- standards of hemostasis attainment in community prac- foy’s lesion, the cause of bleeding may not be identi- tice from which to assign an evidenced-based perfor- fied. For situations in which a bleeding site is not mance target. However, by tracking the rate of initially identified because of copious amounts of primary hemostasis and comparing to benchmark blood, the use of intravenous erythromycin or meto- data, endoscopists will be able to engage in quality clopramide, as well as repositioning the patient, may improvement in the area of GI bleeding management. aid in identification of a site.44,45 The bleeding site’s 15. Frequency with which a second treatment modality is description should be detailed enough to allow a sub- used (eg, coagulation or clipping) when epinephrine sequent endoscopist to find the site. A detailed injection is used to treat actively bleeding or nonbleed- description of the lesion also is necessary, including ing visible vessels in patients with bleeding peptic ulcers documentation of stigmata associated with different Level of evidence: 1A risks of rebleeding.46 Performance target: O98% Ulcers should be classified as actively bleeding (with Type of measure: process spurting lesions having a more ominous prognosis Discussion: Multiple modalities may be used in the than oozing lesions), nonbleeding visible vessel, treatment of peptic ulcer bleeding. Current practices adherent clot, flat spot, and clean-based ulcer. These include the use of injection in conjunction with a sec- stigmata provide prognostic information on rebleeding ond modality, such as multipolar coagulation, heater rates and need for subsequent intervention. They probe thermal coagulation, endoscopic clipping, argon dictate management strategies including level of care plasma coagulation, or various other therapies.46 The and need for endoscopic therapy. In general, endo- success or failure of such treatments should be docu- scopic attempts at hemostasis should be performed mented when practical and clearly described. Epineph- in those with spurting or oozing ulcers as well as in rine injection alone should not be considered those with nonbleeding visible vessels. In patients adequate because multiple studies have documented with adherent clots, vigorous irrigation with or without the superiority of combined modality therapy over suctioning may allow identification of underlying stig- epinephrine alone.51,52 mata of hemorrhage. If irrigation does not dislodge Treating peptic ulcers with active bleeding or non- the clots, these lesions should be considered for endo- bleeding visible vessels is associated with significantly scopic therapy. Meta-analysis of multiple trials demon- reduced rebleeding rates and should therefore be at- strates that endoscopic therapy markedly decreases tempted in most instances. Additionally, there are sup- the risk of further bleeding and also decreases the portive data for the endoscopic removal of adherent need for surgery.47 Appropriate risk stratification in clots and subsequent treatment of underlying stig- peptic ulcer bleeding requires knowledge of not only mata,53-55 and this practice should be considered for the stigmata but also of their different rates of rebleed- all patients with adherent clots. ing in various clinical scenarios. For practices with a 16. Frequency with which variceal ligation is used as the low volume of EGD for bleeding, it may be appropriate first modality of treatment for the endoscopic treat- to measure on a unit basis rather than per endoscopist. ment of esophageal varices

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Level of evidence: 1A practice? What is the utility of newer endoscopic mo- Performance target: O98% dalities in treating acute upper GI bleeding? Type of measure: process 7. What are the variations in practice in the community with Discussion: In bleeding from esophageal varices, regard to performance of duodenal biopsies to rule out banding is preferred over sclerotherapy for safety celiac disease and from what sites in the duodenum? and efficacy.56,57 Octreotide infusion should be insti- 8. How often is dual therapy used when epinephrine is tuted in patients with acute variceal bleeding who used? Is there variation in rates of surgery among com- do not have a contraindication to the medication.58,59 munity endoscopists? After the initial treatment, follow-up plans should 9. Does case volume affect primary hemostasis or de- include repeat endoscopy with repeat treatment until layed rebleeding rates? Is there variation in rates of varices are eradicated. Postprocedure plans also interventional radiology and surgery use among com- should include some recommendation concerning munity endoscopists? the use of beta blockers for prevention of recurrent 10. How often is surveillance recommended among pa- bleeding or a statement about why they are tients with abnormalities confined to the Z line? contraindicated.60,61 11. Are recommendations to measure and perform bi- 17. Frequency with which at least 4 intestinal biopsy spec- opsies in suspected BE followed in clinical practice? imens are taken from patients in whom celiac disease is suspected Postprocedure quality indicators Level of evidence: 1C The postprocedure period extends from the time the Performance target: O90% endoscope is removed to subsequent follow-up. Postpro- Type of measure: process cedure activities include providing instructions to the pa- Discussion: In patients with clinical signs, symptoms, tient, documentation of the procedure, recognition and and suspected celiac disease, small-intestine biopsies documentation of adverse events, pathology follow-up, often are instrumental in ascertaining the diagnosis. communication with referring physicians, and assessing Similarly, biopsies may help elucidate the response patient satisfaction.23 Postprocedure quality indicators to therapy. Because of the potentially patchy nature specific to performance of EGD include the following: of the disease, in patients in whom celiac disease is 18. Frequency with which PPI therapy is recommended suspected, at least 4 biopsy specimens should be for patients who underwent dilation for peptic esoph- taken to maximize accuracy of diagnosis, and some ageal strictures should include the duodenal bulb.62 Biopsies of the Level of evidence: 1A duodenal bulb may improve diagnostic yield by detect- Performance target: O98% ing the most severe villous atrophy within the Type of measure: process duodenum.63 19. Frequency with which patients diagnosed with gastric or duodenal ulcers are instructed to take PPI medica- Intraprocedure research questions tion or an H2 antagonist 1. The structures of the oropharynx can be observed dur- Level of evidence: 1A ing EGD, and examination of this area may be of partic- Performance target: O98% ular importance in patients at high risk for squamous Type of measure: process cell cancers of the esophagus and head and neck.64 Discussion: PPIs, when used in patients who have had Should complete visualization of a routine EGD peptic strictures, reduce the need for future dilations.65,66 include the oropharynx? Treatment with antisecretory therapy is indicated for pa- 2. Do patients with endoscopic stigmata of BE, but tients with newly identified gastric or duodenal no specialized metaplasia on biopsy, suffer from an ulcers.67,68 increased risk of neoplasia, and if so, what is the 20. Frequency with which plans to test for Helicobacter magnitude of that risk? pylori infection for patients diagnosed with gastric or 3. Which patients with BE benefit from endoscopic abla- duodenal ulcers are documented (priority indicator) tive therapies? Level of evidence: 1A 4. Does increasing the time duration of the inspection Performance target: O98% of BE result in an improvement in the yield of BE Type of measure: process surveillance examinations, and if so, what is the mini- Discussion: H pylori is a common cause of gastric mum inspection time necessary for optimal diagnostic and duodenal ulcer disease. Successful eradication of yield? this organism results in dramatically reduced rates of 5. What are the most effective therapies for patients with ulcer recurrence.69 ASGE guidelines pertaining to the recurrent strictures or those resistant to therapy? role of endoscopy for peptic ulcer disease recom- 6. What is the rate of successful primary hemostasis for mends that all patients with gastric or duodenal ulcers major stigmata of nonvariceal bleeding in community should be assessed for this infection.70 www.giejournal.org Volume 81, No. 1 : 2015 GASTROINTESTINAL ENDOSCOPY 25 Quality indicators for EGD

TABLE 4. Summary of proposed quality indicators for EGD*

Grade of Performance Quality indicator recommendation Type of measure target (%) Preprocedure

1. Frequency with which EGD is performed for an 1Cþ Process O80 indication that is included in a published standard list of appropriate indications, and the indication is documented

2. Frequency with which informed consent is 3 Process O98 obtained, including specific discussions of risks associated with EGD, and fully documented

3. Frequency with which appropriate prophylactic 1B Process O98 antibiotics are given in patients with cirrhosis with acute upper GI bleeding before EGD (priority indicator)

4. Frequency with which appropriate prophylactic 1A Process O98 antibiotics are given before placement of a PEG tube

5. Frequency with which a PPI is used for suspected 1B Process O98 peptic ulcer bleeding (priority indicator)

6. Frequency with which vasoactive drugs are 1B Process O98 initiated before EGD for suspected variceal bleeding

Intraprocedure

7. Frequency with which a complete examination of 3 Process O98 the esophagus, stomach, and duodenum, including retroflexion in the stomach, is conducted and documented

8. Among those with nonbleeding gastric ulcers, 2C Process O80 frequency with which gastric biopsies are done to exclude malignancy

9. Frequency with which Barrett’s esophagus is 2C Process O98 appropriately measured when present

10. Frequency with which biopsies are obtained in 2C Process O90 cases of suspected Barrett’s esophagus

11. Frequency with which type of upper GI bleeding 3 Process O80 lesion is described, and the location is documented

12. Frequency with which, during EGD examination 1A Process O98 revealing peptic ulcers, at least one of the following stigmata is noted: active bleeding, nonbleeding visible vessels (pigmented protuberance), adherent clot, flat spot, and clean-based

13. Frequency with which, unless contraindicated, 1A Process O98 endoscopic treatment is given to ulcers with active bleeding or with nonbleeding visible vessels (priority indicator)

14. Frequency with which achievement of primary 3 Process O98 hemostasis in cases of attempted hemostasis of upper GI bleeding lesions is documented

15. Frequency with which a second treatment 1A Process O98 modality is used (eg, coagulation or clipping) when epinephrine injection is used to treat actively bleeding or nonbleeding visible vessels in patients with bleeding peptic ulcers

26 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 1 : 2015 www.giejournal.org Quality indicators for EGD

TABLE 4. Continued

Grade of Performance Quality indicator recommendation Type of measure target (%)

16. Frequency with which variceal ligation is used as 1A Process O98 the first modality of treatment for the endoscopic treatment of esophageal varices

17. Frequency with which at least 4 intestinal 1C Process O90 biopsies are done from patients in whom celiac disease is suspected

Postprocedure

18. Frequency with which PPI therapy is 1A Process O98 recommended for patients who underwent dilation for peptic esophageal strictures

19. Frequency with which patients diagnosed with 1A Process O98 gastric or duodenal ulcers are instructed to take PPI medication or an H2 antagonist

20. Frequency with which plans to test for H pylori 1A Process O98 infection are documented for patients diagnosed with gastric or duodenal ulcers (priority indicator)

21. Frequency with which patients with evidence of 1B Process O98 rebleeding from peptic ulcer disease after endoscopic treatment undergo repeat upper endoscopy

22. Frequency with which patients are contacted to 3 Process N/A document the occurrence of adverse events after EGD PPI, Proton pump inhibitor. *This list of potential quality indicators was meant to be a comprehensive listing of measurable endpoints. It is not the intention of the task force that all endpoints be measured in every practice setting. In most cases, validation may be required before a given endpoint may be universally adopted.

21. Frequency with which patients with evidence of adverse events (from 14 days to 1 month). Such a prac- recurrent bleeding from peptic ulcer disease after tice would promote patient safetyda principle endoscopic treatment undergo repeat upper supported by the ASGE, ACG, American Gastroentero- endoscopy logical Association, and the Institute of Medicine.11,74,75 Level of evidence: 1B Tracked adverse events should include cardiopulmo- Performance target: O98% nary events, infections, perforation, bleeding, and Type of measure: process abdominal pain requiring medical attention or interven- Discussion: Despite adequate endoscopic therapy for a tion. In the future, individual adverse events could be bleeding peptic ulcer, rebleeding can occur in up to one developed into separate quality indicators once further third of patients. Repeat endoscopy for recurrent data are obtained for benchmarking. For EGD, these bleeding is effective and should be done unless contra- might include speciﬁc adverse event rates such as skin indicated.71,72 This should be documented and commu- infections after PEG tube placement, aspiration pneu- nicated with the primary providers. Routine second-look monia after EGD with hemostasis, and stricture forma- endoscopy in the absence of rebleeding is not tion after esophageal mucosal resection or ablation. recommended.26,72,73 22. Frequency that patients are contacted to document Postprocedure research questions the occurrence of adverse events after EGD 1. What is the long-term outcome from following surveil- Level of evidence: 3 lance recommendations for BE, and how will targeted Performance target: N/A biopsy techniques that use new technology affect the Type of measure: process yield and efﬁcacy of surveillance? Discussion: As more therapeutic EGD procedures occur 2. Are there variations in rebleeding rates from peptic ul- (EMR, endoscopic submucosal dissection [ESD]), endo- cer disease after endoscopic therapy, and can this be scopists should develop a mechanism to capture and used to identify high performers of quality upper track not only immediate but also delayed endoscopic endoscopy? www.giejournal.org Volume 81, No. 1 : 2015 GASTROINTESTINAL ENDOSCOPY 27 Quality indicators for EGD

TABLE 5. Priority quality indicators for EGD*

Frequency with which, unless contraindicated, endoscopic treatment is performed for ulcers with active bleeding or with nonbleeding visible vessels

Frequency with which plans to test for Helicobacter pylori infection are documented for patients diagnosed with gastric or duodenal ulcers

Frequency with which appropriate prophylactic antibiotics are given in patients with cirrhosis with acute upper GI bleeding who undergo EGD

Frequency with which a proton pump inhibitor is used for suspected peptic ulcer bleeding

*See text for specific targets and discussion.

3. What are the sources of variability in adverse event rates poor performers and retraining them or removing privi- after endoscopic intervention for upper GI bleeding, leges to perform EGD if performance cannot be improved. and how can they be diminished? 4. What is the optimal management of anticoagulation Conclusion regimens in patients undergoing EGD with hemostasis This update on quality indicators for EGD incorporates of upper GI bleeding requiring chronic anticoagulation new information to provide a relevant list for endoscopists in the periprocedure and postprocedure bleeding who want to perform high-quality upper endoscopy. periods? Similar to those from the original version published in 5. What is the incidence of incomplete mucosal resection 2006, the indicators are classified as preprocedure, intra- by using advanced imaging techniques to identify procedure, and postprocedure indicators, and this is sum- margins? marized in Table 4. The proposed indicators vary in the 6. What are the best strategies to minimize adverse events level of supporting evidence, and several are based solely after EMR and ESD? on expert opinion. For practical and ethical reasons, 7. What are the rates in the community of aspiration pneu- some indicators may be impossible to validate, such as per- monia after endoscopic hemostasis of acute upper GI forming and documenting informed consent and patient bleeding, stricture formation after esophageal ablation monitoring during moderate sedation. The absence of or mucosal resection, and post-PEG wound infections? evidence does not equate to evidence of no benefit. 8. Is actively tracking patients for the occurrence of For EGD, the proposed quality measures are predomi- adverse events after endoscopy cost effective? nantly process measures. Many of these process measures are good surrogates of outcomes, based on evidence that Priority indicators for EGD links them to clinically recognized outcomes. The future A summary of discussed quality indicators for EGD direction of quality indicator development will include rele- is listed in Table 4. Among these for EGD, recommended vant outcome measures and a more robust evidence base priority indicators are (1) frequency with which, unless to support proposed performance targets. The proposed contraindicated, ulcers with active bleeding or with non- research questions address this deficit of evidence. bleeding visible vessels are treated endoscopically, (2) frequency with which plans for assessing H pylori infection for patients diagnosed with gastric or duodenal ulcers are DISCLOSURES documented, (3) frequency with which appropriate prophylactic antibiotics are given in patients with cirrhosis Dr Inadomi served as consultant for Ethicon US LLC with acute upper GI bleeding before EGD, and (4) fre- and received grants from Ninepoint Medical. Dr Shaheen quency with which a PPI is used for suspected peptic ulcer received research grant support from Covidien Medical, bleeding (Table 5). Among all indicators, these were cho- CSA Medical, and Takeda Pharmaceuticals. All other au- sen based on combined availability of strength of support- thors disclosed no financial relationships relevant to this ing evidence, measurement feasibility, and evidence of publication. substantial variation in performance.76-78 There are very limited data on practice variation for the majority of Prepared by: these EGD indicators, representing an important research Walter G. Park, MD, MS* area. Nicholas J. Shaheen, MD, MPH* Simple educational and corrective measures can Jonathan Cohen, MD improve performance. The primary purpose of measuring Irving M. Pike, MD quality indicators is to improve patient care by identifying Douglas G. Adler, MD

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John M. Inadomi, MD 13. Chavez-Tapia NC, Barrientos-Gutierrez T, Tellez-Avila FI, et al. Antibiotic Loren A. Laine, MD prophylaxis for cirrhotic patients with upper gastrointestinal bleeding. John G. Lieb II, MD Cochrane Database Syst Rev 2010:CD002907. 14. Garcia-Tsao G, Sanyal AJ, Grace ND, et al. Prevention and management Maged K. Rizk, MD of gastroesophageal varices and variceal hemorrhage in cirrhosis. Mandeep S. Sawhney, MD, MS Hepatology 2007;46:922-38. Sachin Wani, MD 15. Banerjee S, Shen B, Baron TH, et al. Antibiotic prophylaxis for GI endoscopy. Gastrointest Endosc 2008;67:791-8. *Drs Park and Shaheen contributed equally to this work. 16. Fernandez J, Ruiz del Arbol L, Gomez C, et al. Norfloxacin vs ceftriaxone in the prophylaxis of infections in patients with advanced cirrhosis and hemorrhage. Gastroenterology 2006;131:1049-56; quiz 1285. Abbreviations: ACG, American College of Gastroenterology; ASGE, 17. de Franchis R, Baveno VF. Revising consensus in portal hypertension: American Society for Gastrointestinal Endoscopy; BE, Barrett’s report of the Baveno V consensus workshop on methodology of diag- esophagus; ESD, endoscopic submucosal dissection; PPI, proton pump nosis and therapy in portal hypertension. J Hepatol 2010;53:762-8. inhibitor. 18. Lipp A, Lusardi G. Systemic antimicrobial prophylaxis for percutaneous endoscopic gastrostomy. Cochrane Database Syst Rev 2006:CD005571. This document is a product of the ASGE/ACG Task Force on Quality in 19. Jain NK, Larson DE, Schroeder KW, et al. Antibiotic prophylaxis for Endoscopy. This document was reviewed and approved by the percutaneous endoscopic gastrostomy: a prospective, randomized, Governing Boards of the American Society for Gastrointestinal double-blind clinical trial. Ann Intern Med 1987;107:824-8. Endoscopy and the American College of Gastroenterology. It appears 20. Thomas S, Cantrill S, Waghorn DJ, et al. 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Effect of omeprazole and cimeti- evidence-based approach based on meta-analyses of randomized dine on duodenal ulcer: a double-blind comparative trial. N Engl J controlled trials. Clin Gastroenterol Hepatol 2009;7:33-47; quiz 1-2. Med 1985;312:958-61. 48. Garcia-Iglesias P, Villoria A, Suarez D, et al. Meta-analysis: predictors of 68. Lauritsen K, Rune SJ, Wulff HR, et al. Effect of omeprazole and cimeti- rebleeding after endoscopic treatment for bleeding peptic ulcer. dine on prepyloric gastric ulcer: double blind comparative trial. Gut Aliment Pharmacol Ther 2011;34:888-900. 1988;29:249-53. 49. Marmo R, Koch M, Cipolletta L, et al. Predicting mortality in non- 69. Ford AC, Delaney BC, Forman D, et al. Eradication therapy for peptic variceal upper gastrointestinal bleeders: validation of the Italian ulcer disease in Helicobacter pylori positive patients. Cochrane Data- PNED score and prospective comparison with the Rockall score. Am base Syst Rev 2006:CD003840. J Gastroenterol 2010;105:1284-91. 70. Banerjee S, Cash BD, Dominitz JA, et al. The role of endoscopy in the 50. Chiu PW, Ng EK, Cheung FK, et al. Predicting mortality in patients with management of patients with peptic ulcer disease. Gastrointest En- bleeding peptic ulcers after therapeutic endoscopy. Clin Gastroenterol dosc 2010;71:663-8. Hepatol 2009;7:311-6; quiz 253. 71. Lau JY, Sung JJ, Lam YH, et al. Endoscopic retreatment compared with 51. Marmo R, Rotondano G, Piscopo R, et al. Dual therapy versus mono- surgery in patients with recurrent bleeding after initial endoscopic therapy in the endoscopic treatment of high-risk bleeding ulcers: a control of bleeding ulcers. N Engl J Med 1999;340:751-6. meta-analysis of controlled trials. Am J Gastroenterol 2007;102: 72. Barkun AN, Bardou M, Kuipers EJ, et al. International consensus recom- 279-89; quiz 469. mendations on the management of patients with nonvariceal upper 52. Gralnek IM, Barkun AN, Bardou M. Management of acute bleeding gastrointestinal bleeding. Ann Intern Med 2010;152:101-13. from a peptic ulcer. N Engl J Med 2008;359:928-37. 73. El Ouali S, Barkun AN, Wyse J, et al. Is routine second-look endoscopy 53. Kahi CJ, Jensen DM, Sung JJ, et al. Endoscopic therapy versus medical effective after endoscopic hemostasis in acute peptic ulcer bleeding? therapy for bleeding peptic ulcer with adherent clot: a meta-analysis. A meta-analysis. Gastrointest Endosc 2012;76:283-92. Gastroenterology 2005;129:855-62. 74. Quality improvement of gastrointestinal endoscopy: guidelines for 54. Bleau BL, Gostout CJ, Sherman KE, et al. Recurrent bleeding from clinical application. From the ASGE. American Society for Gastrointes- peptic ulcer associated with adherent clot: a randomized study tinal Endoscopy. Gastrointest Endosc 1999;49:842-4. comparing endoscopic treatment with medical therapy. Gastrointest 75. Committee on Quality of Health Care in America IoM. To err is human; Endosc 2002;56:1-6. building a safer health system. Washington, DC: National Academies 55. Bini EJ, Cohen J. Endoscopic treatment compared with medical ther- Press; 2000. apy for the prevention of recurrent ulcer hemorrhage in patients 76. Lanas A, Aabakken L, Fonseca J, et al. Variability in the management of with adherent clots. Gastrointest Endosc 2003;58:707-14. nonvariceal upper gastrointestinal bleeding in Europe: an observa- 56. Villanueva C, Piqueras M, Aracil C, et al. A randomized controlled trial tional study. Adv Ther 2012;29:1026-36. comparing ligation and sclerotherapy as emergency endoscopic treat- 77. Xu HW, Wang JH, Tsai MS, et al. The effects of cefazolin on cirrhotic ment added to somatostatin in acute variceal bleeding. J Hepatol patients with acute variceal hemorrhage after endoscopic interven- 2006;45:560-7. tions. Surg Endosc 2011;25:2911-8. 57. Zargar SA, Javid G, Khan BA, et al. Endoscopic ligation compared with 78. Brown MR, Jones G, Nash KL, et al. Antibiotic prophylaxis in variceal sclerotherapy for bleeding esophageal varices in children with extra- hemorrhage: timing, effectiveness and Clostridium difficile rates. World hepatic portal venous obstruction. Hepatology 2002;36:666-72. J Gastroenterol 2010;16:5317-23.

30 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 1 : 2015 www.giejournal.org Communication from the ASGE QUALITY INDICATORS FOR Quality Assurance in Endoscopy Committee GI ENDOSCOPIC PROCEDURES

Quality indicators for colonoscopy

Colonoscopy is widely used for the diagnosis and treat- lesions that are endoscopically subtle or difficult to re- ment of colon disorders. Properly performed, colonos- move, such as sessile serrated polyps and flat and/or copy is generally safe, accurate, and well-tolerated. depressed adenomas, and differences in tumorigenesis Visualization of the mucosa of the entire large intestine between right-sided and left-sided cancers. Improving and distal terminal ileum usually is possible during colo- prevention of right-sided colon cancer is a major goal noscopy. Polyps can be removed during colonoscopy, of colonoscopy quality programs. thereby reducing the risk of colon cancer. Colonoscopy Five studies have established that gastroenterologists is the preferred method to evaluate the colon in most are more effective than surgeons or primary care physi- adult patients with large-bowel symptoms, iron deficiency cians at preventing CRC by colonoscopy.27,29-32 This most anemia, abnormal results on radiographic studies of the likely reflects higher rates of complete examinations (ie, colon, positive results on colorectal cancer (CRC) cecal intubation)30 and higher rates of adenoma detection screening tests, post-polypectomy and post-cancer resec- among gastroenterologists.33,34 All endoscopists perform- tion surveillance, and diagnosis and surveillance in inflam- ing colonoscopy should measure the quality of their colo- matory bowel disease. In addition, colonoscopy is the noscopy. Institutions where endoscopists from multiple most commonly used CRC screening test in the United specialties are practicing should reasonably expect all en- States.1 Based on 2010 data, over 3.3 million outpatient doscopists to participate in the program and achieve rec- colonoscopies are performed annually in the United ommended quality benchmarks. States, with screening and polyp surveillance accounting The quality of health care can be measured by for half of indications.2 comparing the performance of an individual or a group Optimal effectiveness of colonoscopy depends on patient of individuals with an ideal or benchmark.35 The particular acceptance of the procedure, which depends mostly on parameter that is being used for comparison is termed a acceptance of the bowel preparation.3 Preparation quality af- quality indicator. A quality indicator often is reported as a fects the completeness of examination, procedure duration, ratio between the incidence of correct performance and and the need to cancel or repeat procedures at earlier dates the opportunity for correct performance4 or as the propor- than would otherwise be needed.4,5 Ineffective preparation tion of interventions that achieve a predefined goal.35 is a major contributor to costs.6 Meticulous inspection7,8 and Quality indicators can be divided into 3 categories: (1) longer withdrawal times9-14 are associated with higher ade- structural measuresdthese assess characteristics of the noma detection rates (ADR). A high ADR is essential to entire health care environment (eg, participation by a rendering recommended intervals15 between screening physician or other clinician in systematic clinical database and surveillance examinations safe.16,17 Optimal technique registry that includes consensus endorsed quality mea- is needed to ensure a high probability of detecting dysplasia sures), (2) process measuresdthese assess performance when present in inflammatory bowel disease.17-21 Finally, during the delivery of care (eg, ADR and adequate biopsy technical expertise and experience will help prevent adverse sampling during colonoscopy for chronic ulcerative coli- events that might offset the benefits of removing neoplastic tis), (3) outcome measuresdthese assess the results of lesions.22 the care that was provided (eg, the prevention of cancer Recent studies report that colonoscopy is less effective by colonoscopy and reduction in the incidence of colono- in preventing proximal colon cancer and cancer scopic perforation). deaths (ie, colon cancer proximal to the splenic flexure) compared with distal cancer (ie, colon cancer at or distal to the splenic flexure).23-28 Decreased protection METHODOLOGY against right-sided CRC is likely due to multiple factors. These include missed adenomas or incompletely resected In 2006, the American Society for Gastrointestinal adenomas; suboptimal bowel preparation; precancerous Endoscopy (ASGE)/American College of Gastroenterology (ACG) Task Force on Quality in Endoscopy published their first version of quality indicators for colonoscopy.36 The present update integrates new data pertaining to pre- Copyright ª 2015 American Society for Gastrointestinal Endoscopy and American College of Gastroenterology viously proposed quality indicators and new quality indi- 36 0016-5107/$36.00 cators for performing colonoscopy. Indicators that had http://dx.doi.org/10.1016/j.gie.2014.07.058 wide-ranging clinical application, were associated with www.giejournal.org Volume 81, No. 1 : 2015 GASTROINTESTINAL ENDOSCOPY 31 Quality indicators for colonoscopy

TABLE 1. Grades of recommendation*

Grade of Clarity of Methodologic strength recommendation benefit supporting evidence Implications 1A Clear Randomized trials without important Strong recommendation, can be applied to limitations most clinical settings

1B Clear Randomized trials with important Strong recommendation, likely to apply to limitations (inconsistent results, most practice settings nonfatal methodologic flaws)

1Cþ Clear Overwhelming evidence from Strong recommendation, can apply to most observational studies practice settings in most situations

1C Clear Observational studies Intermediate-strength recommendation, may change when stronger evidence is available

2A Unclear Randomized trials without important Intermediate-strength recommendation, best limitations action may differ depending on circumstances or patients’ or societal values

2B Unclear Randomized trials with important Weak recommendation, alternative approaches limitations (inconsistent results, may be better under some circumstances nonfatal methodologic flaws)

2C Unclear Observational studies Very weak recommendation, alternative approaches likely to be better under some circumstances

3 Unclear Expert opinion only Weak recommendation, likely to change as data become available

variation in practice and outcomes, and were validated in factors. In such cases, the task force deemed it reasonable clinical studies were prioritized. Clinical studies were iden- to use process indicators as surrogate measures of high- tified through a computerized search of Medline followed quality endoscopy. The relative value of a process indicator by review of the bibliographies of all relevant articles. hinges on the evidence that supports its association with When such studies were absent, indicators were chosen a clinically relevant outcome, and such process measures by expert consensus. Although feasibility of measurement were emphasized. was a consideration, it is hoped that inclusion of highly The quality indicators for this update were written in a relevant, but not yet easily measurable indicators, would manner that lends them to be developed as measures. promote their eventual adoption. Although a comprehen- Although they remain quality indicators and not measures, sive list of quality indicators is proposed, it is recognized this document also contains a list of performance targets that, ultimately, only a small subset might be widely used for each quality indicator. The task force selected perfor- for continuous quality improvement, benchmarking, or mance targets from benchmarking data in the literature quality reporting. As in 2006, the current task force concen- when available. When no data were available to support es- trated its attention on parameters related to endoscopic tablishing a performance target level, “N/A” (not available) procedures; whereas the quality of care delivered to pa- was listed. However, when expert consensus considered tients is clearly influenced by many factors related to the failure to perform a given quality indicator a “never event” facilities in which endoscopy is performed, characteriza- such as monitoring vital signs during sedation, then the tion of unit-related quality indicators was not included in performance target was listed as O98%. It is important the scope of this effort. to emphasize that the performance targets listed do not The resultant quality indicators were graded on the necessarily reflect the standard of care but rather serve strength of the supporting evidence (Table 1). Each quality as specific goals to direct quality improvement efforts. indicator was classified as an outcome or a process mea- Quality indicators were divided into 3 time periods: pre- sure. Although outcome quality indicators are preferred, procedure, intraprocedure, and postprocedure. For each some can be difficult to measure in routine clinical prac- category, key relevant research questions were identified. tice, because they need analysis of large amounts of data In order to guide continuous quality improvement and long-term follow-up and may be confounded by other efforts, the task force also recommended a high-priority

32 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 1 : 2015 www.giejournal.org Quality indicators for colonoscopy subset of the indicators described, based on their clinical clinically relevant diagnoses are made.40-42 In these relevance and importance, evidence that performance studies, which divided indications into appropriate, varies significantly in clinical practice, and feasibility of uncertain, and inappropriate and looked at high- measurement (a function of the number of procedures volume European centers, 21% to 39% were classified needed to obtain an accurate measurement with narrow as inappropriate. It is likely that this can be improved confidence intervals and the ease of measurement). A use- to a !20% inappropriate rate.43 The European Panel ful approach for an individual endoscopist is to first mea- on the Appropriateness of Gastrointestinal Endoscopy sure their performances with regard to these priority Internet guideline is a useful decision support tool for indicators. Quality improvement efforts would move to determining the appropriateness of colonoscopy.43 different quality indicators if the endoscopists are perform- The goal is to minimize the number of inappropriate ing above recommended thresholds, or the employer and/ procedures.44-46 or teaching center could institute corrective measures and 2. Frequency with which informed consent is obtained, remeasure performance of low-level performers. including specific discussions of risks associated with Recognizing that certain quality indicators are common colonoscopy, and fully documented to all GI endoscopic procedures, such items are presented Level of evidence: 1C in detail in a separate document, similar to the process in Performance target: O98% 2006.37,38 The preprocedure, intraprocedure, and postpro- Type of measure: process cedure indicators common to all endoscopy are listed in In addition to the risks associated with all endoscopic Table 2. Those common factors will be discussed in this procedures, the consent should address the relevant document only insofar as the discussion needs to be modi- and substantial adverse events pertaining to each spe- fied specifically to relate to colonoscopy. cific colonoscopy procedure. Discussion: As with all other endoscopic procedures, Preprocedure quality indicators consent must be obtained before the procedure from The preprocedure period includes all contacts between the patient or guardian (or as required by local law members of the endoscopy team and the patient before or per policy of the institution). It must include a the administration of sedation or insertion of the endo- discussion of the risks, benefits, and alternatives to scope. Common issues for all endoscopic procedures the procedure. The most common risks of colonoscopy during this period include: appropriate indication, include bleeding, perforation, infection, sedation- informed consent, risk assessment, formulation of a seda- related adverse events, missed lesions, and intravenous tion plan, management of prophylactic antibiotics and an- site adverse events. tithrombotic drugs, and timeliness of the procedure.38 3. Frequency with which colonoscopies follow recommen- Preprocedure quality indicators specific to performance ded post-polypectomy and post-cancer resection sur- of colonoscopy include the following: veillance intervals and 10-year intervals between 1. Frequency with which colonoscopy is performed for screening colonoscopies in average-risk patients who an indication that is included in a published standard have negative examination results and adequate bowel list of appropriate indications, and the indication is cleansing (priority indicator) documented Level of evidence: 1A Level of evidence: 1Cþ Performance target: R90% Performance target: O80% Type of measure: process Type of measure: process Discussion: For colonoscopy to be both effective The ASGE has published appropriate indications for and cost-effective and to minimize risk, the intervals colonoscopy (Table 3).39 An appropriate indication between examinations should be optimized. Intervals should be documented for each procedure, and when between examinations can be effective in prevention it is a nonstandard indication, it should be justified in of incident CRC only when the colon is effectively the documentation. When performing colonoscopy for cleared of neoplasia. Therefore, detailed and effective average-risk CRC screening or colon polyp surveillance, examination of the colon, as discussed in the following, endoscopists should specifically document whether the is critical to the effectiveness and safety of recommen- patient had a colonoscopy previously, date of the last ded intervals between colonoscopy. The recommended colonoscopy (or document that the date of that proce- intervals assume cecal intubation, adequate bowel prep- dure is not available), and any histologic findings from aration, and careful examination. polyps removed during that colonoscopy. In the average-risk population (persons aged R50 years Discussion: In 2012, the ASGE updated its indications without other risk factors for CRC or who have only for endoscopic procedures.39 This list was determined one first-degree relative with CRC and that cancer was by a review of published literature and expert diagnosed at age O60 years), colonoscopic screening consensus. Studies have shown that when colonoscopy is recommended in all past and current guidelines at is done for appropriate reasons, significantly more 10-year intervals.15,47,48 A German case-control study www.giejournal.org Volume 81, No. 1 : 2015 GASTROINTESTINAL ENDOSCOPY 33 Quality indicators for colonoscopy

TABLE 2. Summary of proposed quality indicators common to all endoscopic procedures38,*

Quality indicator Grade of recommendation Measure type Performance target (%) Preprocedure