Secondary Logo

Quality Indicators for EGD

Park, Walter G, MD, MS1; Shaheen, Nicholas J, MD, MPH1; Cohen, Jonathan, MD; Pike, Irving M, MD; Adler, Douglas G, MD; Inadomi, John M, MD; Laine, Loren A, MD; Lieb, John G, MD; Rizk, Maged K, MD; Sawhney, Mandeep S, MD, MS; Wani, Sachin, MD

American Journal of Gastroenterology: January 2015 - Volume 110 - Issue 1 - p 60–71
doi: 10.1038/ajg.2014.384
QUALITY INDICATORS FOR GI ENDOSCOPIC PROCEDURES
Free
SDC

1These authors contributed equally to this work.

This document is a product of the ASGE/ACG Task Force on Quality in Endoscopy. This document was reviewed and approved by the Governing Boards of the American Society for Gastrointestinal Endoscopy and the American College of Gastroenterology. It appears simultaneously in Gastrointestinal Endoscopy and the American Journal of Gastroenterology. This document was reviewed and endorsed by the American Gastroenterological Association Institute.

Dr Inadomi served as consultant for Ethicon US LLC and received grants from Ninepoint Medical. Dr Shaheen received research grant support from Covidien Medical, CSA Medical, and Takeda Pharma&semishy;ceuticals. All other authors disclosed no financial relationships relevant to this publication.

ACG: American College of Gastroenterology; ASGE: American Society for Gastrointestinal Endoscopy; BE: Barrett’s esophagus; ESD: endoscopic submucosal dissection; PPI: proton pump inhibitor

EGD is used widely for the diagnosis and treatment of esophageal, gastric, and small-bowel disorders. When properly performed, it is generally safe and well-tolerated for the examination of the upper GI tract. Included among the many accepted indications for EGD are evaluation of dysphagia, GI bleeding, peptic ulcer disease, medically refractory GERD, esophageal strictures, celiac disease, and unexplained diarrhea. During EGD evaluation, diagnostic biopsies can be performed as well as therapies to achieve hemostasis and dilation or stenting for significant strictures. In 2009, an estimated 6.9 million EGD procedures were performed in the United States at an estimated cost of $12.3 billion dollars. From 2000 to 2010, a 50% increase in EGD utilization was observed among Medicare recipients (1).

The quality of health care can be measured by comparing the performance of an individual or a group of individuals with an ideal or benchmark (2). The particular parameter that is being used for comparison is termed a quality indicator. Quality indicators may be reported as a ratio between the incidence of correct performance and the opportunity for correct performance or as the proportion of interventions that achieve a predefined goal (3). Quality indicators can be divided into 3 categories: (1) structural measures—these assess characteristics of the entire health care environment (e.g., participation by a physician or other clinician in a systematic clinical database registry that includes consensus endorsed quality measures), (2) process mea-sures—these assess performance during the delivery of care (e.g., frequency with which appropriate prophylactic antibiotics are given before placement of a PEG tube), and (3) outcome measures—these assess the results of the care that was provided (e.g., rates of adverse events after EGD).

Back to Top | Article Outline

METHODOLOGY

In 2006, the American Society for Gastrointestinal Endoscopy (ASGE)/American College of Gastroenterology (ACG) Task Force on Quality in Endoscopy published the first version of quality indicators for EGD (4). The present update integrates new data pertaining to previously proposed quality indicators and new quality indicators for performing EGD. Indicators that had wide-ranging clinical application, were associated with variation in practice and outcomes, and were validated in clinical studies were prioritized. Clinical studies were identified through a computerized search of Medline followed by review of the biblio&semishy;graphies of all relevant articles. When such studies were absent, indicators were chosen by expert consensus. Although feasibility of measurement was a consideration, it is hoped that inclusion of highly relevant, but not yet easily measurable, indicators would promote their eventual adoption. Although a comprehensive list of quality indicators is proposed, ultimately, only a small subset might be widely used for continuous quality improvement, benchmarking, or quality reporting. As in 2006, the current task force concentrated its attention on parameters related solely to endoscopic procedures. Although the quality of care delivered to patients is clearly influenced by many factors related to the facilities in which endoscopy is performed, characterization of unit-related quality indicators was not included in the scope of this effort.

The resultant quality indicators were graded on the strength of the supporting evidence (Table 1). Each quality indicator was classified as an outcome or a process measure. Although outcome quality indicators are preferred, some can be difficult to measure in routine clinical practice, because they need analysis of large amounts of data and long-term follow-up and may be confounded by other factors. In such cases, the task force deemed it reasonable to use process indicators as surrogate measures of high-quality endoscopy. The relative value of a process indicator hinges on the evidence that supports its association with a clinically relevant outcome, and such process measures were emphasized.

Table 1

Table 1

The quality indicators for this update were written in a manner that lends them to be developed as measures. 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 performance targets from benchmarking data in the literature when available. When data were unavailable to support establishing a performance target level, “N/A” (not available) was listed. However, when expert consensus considered failure to perform a given quality indicator a “never event,” such as monitoring vital signs during sedation, then the performance target was listed as >98%. It is important to emphasize that the performance targets listed do not necessarily reflect the standard of care but rather serve as specific goals to direct quality improvement efforts.

Quality indicators were divided into 3 time periods: pre-procedure, intraprocedure, and postprocedure. For each category, key relevant research questions were identified.

In order to guide continuous quality improvement efforts, the task force also recommended a high-priority subset of the indicators described, based on their clinical relevance and importance, on evidence that performance of the indicator varies significantly in clinical practice, and feasibility of measurement (a function of the number of procedures needed to obtain an accurate measurement with narrow confidence intervals [CI] and the ease of measurement). A useful approach for individual endoscopists is to first measure their performances with regard to these priority indicators. Quality improvement efforts would then move to different quality indicators if endoscopists are performing above recommended thresholds, or the employer and/or teaching center could institute corrective measures and remeasure performance of low-level performers.

Recognizing that certain quality indicators are common to all GI endoscopic procedures, such items are presented in detail in a separate document, similar to the process in 2006 (5). The preprocedure, intraprocedure, and postpro-cedure indicators common to all endoscopy are listed in Table 2. Those common factors will be discussed only in this document insofar as the discussion needs to be modified specifically to relate to EGD.

Table 2

Table 2

Back to Top | Article Outline

Preprocedure quality indicators

The preprocedure period includes all contact between members of the endoscopy team and the patient before the administration of sedation or insertion of the endo-scope. Common issues for all endoscopic procedures during this period include: appropriate indication, informed consent, risk assessment, formulation of a sedation plan, management of prophylactic antibiotics and antithrom-botic drugs, and timeliness of the procedure (5). Preproce-dure quality indicators specific to EGD include the following:

Back to Top | Article Outline

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

Level of evidence: 1C+

Performance target: >80%

Type of measure: process

Discussion: The accepted indications for EGD are reviewed in detail in a recently updated document by the ASGE Standards of Practice Committee (Table 3) (6). The indications for EGD have expanded to include endoscopic therapy for Barrett’s esophagus (BE), intra-operative evaluation of reconstructed anatomic reconstructions typical of modern foregut surgery, and management of operative adverse events. Performing EGD for an accepted indication is associated with a statistically higher rate of clinically relevant findings (7, 8). In one study, the odds ratio (OR) for finding a clinically relevant lesion by using an appropriate indication was 1.34 (95% CI, 1.04–1.74) (7). This process measure requires documentation in the procedure report. When a procedure is performed for a reason that is not listed in Table 3, justification for the procedure should be documented.

Table 3

Table 3

Back to Top | Article Outline

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

Level of evidence: 3

Performance target: >98%

Type of measure: process

In addition to the risks associated with all endoscopic procedures, the consent should address the relevant and substantial adverse events pertaining to each specific EGD procedure.

Discussion: As with any procedure that abides by the accepted biomedical ethical principle of patient autonomy, consent must be obtained from the patient or guardian before EGD on the same day as the procedure (or as required by local law or institutional policy). Adequate time must be allotted to discuss the risks, benefits, and alternatives to the procedure for the patient to voluntarily make a fully informed decision. In rare exceptions, such as in a life-threatening emergency, informed consent can be abridged or omitted. Further guidance on informed consent can be found in a position statement by the ASGE Standards of Practice of Committee (9). The particular risks associated with EGD include bleeding, perforation, infection, cardiopulmonary adverse events, missed diagnosis, missed lesions, intravenous site adverse events, chest pain, sore throat, aspiration, and reaction to local anesthetic spray (10, 11, 12). As a quality indicator, informed consent is a process measure based on expert opinion and supported by principles of biomedical ethics. A clinical study that correlates the presence or absence of informed consent with clinical outcomes has not been, and is not likely to be, performed.

Back to Top | Article Outline

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

Level of evidence: 1B

Performance target: >98%

Type of measure: process

Discussion: A Cochrane systematic review of 12 studies showed a relative risk (RR) reduction of death (RR 0.79; 95% CI, 0.63–0.98), bacterial infections (RR 0.36; 95% CI, 0.27–0.49), and rebleeding (RR 0.53; 95% CI, 0.38–0.74) with antibiotic prophylaxis for patients with cirrhosis and acute upper GI bleeding (13). Independent of performing EGD, antibiotic prophylaxis should be administered in this population (14). Oral fluoroquino-lones can be recommended safely for most patients, but intravenous ceftriaxone may be preferred in advanced cirrhosis and in areas of high fluoroquino-lone resistance (15, 16, 17). Antibiotic selection may change over time as new agents become available and drug resistance patterns change. This is a process measure for which an evidence-based correlation of a clinically beneficial outcome exists.

Back to Top | Article Outline

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

Level of evidence: 1A

Performance target: >98%

Type of measure: process

Discussion: A Cochrane systematic review incorporating over 1000 patients in 10 clinical trials showed a decreased peristomal infection rate with antibiotic pro-phylaxis (18). Antibiotics that cover cutaneous sources of bacterial infection such as intravenous cefazolin should be administered 30 min before the procedure (19). Where methicillin-resistant Staphylococcus aureus is highly prevalent, screening with decontamination should be performed (20).

Back to Top | Article Outline

5. Frequency with which a proton pump inhibitor (PPI) is used for suspected peptic ulcer bleeding (priority indicator)

Level of evidence: 1B

Performance target: >98%

Type of measure: process

Discussion: When possible, the intravenous PPI should be started on presentation with bleeding and before EGD. Intravenous PPI treatment before EGD reduces the proportion of high-risk stigmata seen at index endoscopy (OR 0.67; 95% CI, 0.54–0.84) and need for endo-scopic therapy (OR 0.68; 95% CI, 0.50–0.93) when compared with controls. In a Cochrane review of 6 randomized clinical trials, however, no statistically significant difference in mortality (OR 1.12; 95% CI, 0.72–1.73) between PPI and control treatment was observed (21).

Back to Top | Article Outline

6. Frequency with which vasoactive drugs are initiated before EGD for suspected variceal bleeding

Level of evidence: 1B

Performance target: >98%

Type of measure: process

Discussion: In a meta-analysis of 30 clinical trials involving over 3000 patients, the use of vasoactive medications and their analogues, such as terlipressin and oc-treotide, was associated with a lower risk of 7-day mortality (RR 0.74; 95% CI, 0.57–0.95) and a significant improvement in hemostasis (RR 1.21; 95% CI, 1.13–1.30) (22). There was no difference in efficacy among the different vasoactive medications.

Back to Top | Article Outline

Preprocedure research questions

1.What is the optimal antithrombotic management before therapeutic EGD procedures?

2.What are the adverse event rates of physicians relative to recently updated antibiotic prophylaxis recommendations for cardiac conditions, synthetic vascular grafts, nonvalvular cardiac devices, and orthopedic prostheses?

3.Is there sufficient interoperator and intraoperator variabi&semishy;lity in risk stratification to explain sedation-related adverse events?

4.What is the optimal sedation regimen and setting for EGD in patients with obesity and sleep apnea?

5.What are barriers to wider use of EGD without patient sedation?

6.How often do endoscopists in the community comply with surveillance guidelines for nondysplastic BE?

7.How often is endoscopy performed for other than an appropriate indication in the community, and what are the barriers to wider adherence to recommendations regarding indications?

Back to Top | Article Outline

Intraprocedure quality indicators

The intraprocedure period extends from the administration of sedation, or insertion of the endoscope when no sedation is given, to the removal of the endoscope. This period includes all the technical aspects of the procedure including completion of the examination and therapeutic maneuvers. Common to most endoscopic procedures is the provision of sedation and need for patient monitoring (23). Intraprocedure quality indicators specific to performance of EGD include the following:

Back to Top | Article Outline

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

Level of evidence: 3

Performance target: >98%

Type of measure: process

Discussion: Except in cases of esophageal or gastric outlet obstruction, every EGD should include complete visualization of all the organs of interest from the upper esophageal sphincter to the second portion of the duodenum. Complete examination may require efforts to clear material from the stomach or esophagus, as in assessment for the source of upper GI hemorrhage. Written documentation should confirm the extent of the examination. If a clinically significant abnormality is encountered, photodocumentation is indicated. In studies of the learning curve of EGD, over 90% of trainees successfully perform technically complete EGD after 100 cases, and technical proficiency may be accelerated through the use of simulators (24, 25). It is reasonable to expect that any practicing endoscopist be capable of visualizing the organs of interest with rare exception. Given the recent increase in gastric cardia cancers, this should include retroflexion in the stomach in all cases (26).

Back to Top | Article Outline

8. Among those with nonbleeding gastric ulcers, frequency with which gastric biopsy specimens are taken to exclude malignancy

Level of evidence: 2C

Performance target: >80%

Type of measure: process

Discussion: Careful attention to the presence of mucosal abnormalities during EGD is crucial. The acquisition of adequate and appropriate samples demonstrates an understanding of the importance of a complete and thorough examination. Biopsy specimens from gastric ulcers are required to assess for the possibility of malignancy. The optimal number and type (maximum-capacity vs. standard) has not been determined; however, a single biopsy may not detect malignancy in as many as 30% of those with gastric cancer. Four or more biopsies detect >95% of malignancies (27). In the setting of acute GI bleeding, the endoscopist may choose to defer biopsy of the ulcer, provided that a subsequent endoscopy is planned.

Back to Top | Article Outline

9. Frequency with which BE is appropriately measured when present

Level of evidence: 2C

Performance target: >98%

Type of measure: process

Discussion: BE may be present in up to 5 to 15% of high-risk patients (e.g., older white men with GERD symptoms) undergoing upper endoscopy (28). The risk of progression to dysplasia or cancer may be related to the length of Barrett’s epithelium (29, 30). In addition, in patients eventually needing endoscopic therapy for BE, the amount of involved tissue may influence both the endo-scopic approach and the choice of sedation modality. Therefore, it is important to characterize and document the length and location of the salmon-colored mucosa during EGD. Although a single measurement may describe the total length of the BE in the tubular esophagus, the Prague classification is a validated, widely used, more descriptive system that describes both the circumferential and maximal extent of the BE (31, 32). This system defines the distance from the top of the gastric folds to the most proximal extent of the BE as the maximal (M) extent of the BE. The distance from the top of the gastric folds to the most proximal extent of the circumferential involvement of the BE is the circumferential (C) measurement. Assessment of the endo-scopic involvement of columnar tissue is essential because intestinal metaplasia of the Z line may occur in up to 18% of individuals with GERD symptoms and does not, without accompanying endoscopic findings, constitute BE (33). Intestinal metaplasia of the Z line is not known to carry sufficient cancer risk to warrant surveillance programs when this is diagnosed. Accordingly, it is important that when the presence of BE tissue is suspected, these landmarks are clearly documented.

Back to Top | Article Outline

10. Frequency with which biopsy specimens are obtained in cases of suspected BE

Level of evidence: 2C

Performance target: >90%

Type of measure: process

Discussion: Criteria for the diagnosis of BE are debated. Although some professional societies in other countries consider any columnar epithelium in the tubular esophagus consistent with the diagnosis of BE (34), professional societies in the United States have traditionally required specialized or intestinal epithelium with goblet cells to fulfill the diagnosis (35, 36), and only such patients to be candidates for surveillance protocols. Recent data suggest that patients with intestinalized metaplasia of the esophagus are at 5-fold increased risk of progression to high-grade dysplasia or cancer compared with those with columnar-lined esophagus without goblet cells (37). Although the endoscopic appearance may suggest BE, a definitive diagnosis cannot be made without pathology confirmation. For patients with known BE undergoing EGD with no contraindication to endoscopic biopsy, an adequate number of biopsy specimens should be obtained to exclude dys-plasia. Although the optimal number of biopsy specimens has not been defined, 4-quadrant biopsies every 1 to 2 centimeters throughout the length of the BE tissue are recommended (28, 36). Acquisition of fewer biopsy specimens than those suggested by this protocol is associated with a reduced likelihood of detecting dysplasia, after controlling for segment length (38).

Recent evidence has suggested that the time that the endoscopist spends inspecting the BE may be an important determinant of the yield of an endoscopic surveillance examination (39). Longer inspection times may be associated with increased detection of either high-grade dysplasia or the detection of suspicious lesions. Confirmation of this finding and prospective validation that increased inspection time leads to the identification of lesions (and not that the identification of lesions leads to longer inspection) may allow the future use of this metric as a quality indicator.

Most advanced neoplasia found on endoscopic examinations is found not on random biopsy but on targeted biopsy of lesions that are suspicious for neoplasia, because of nodularity, ulceration, depression, changes in vascularity, or other findings. Previous work suggests that use of advanced imaging modalities, such as narrowband imaging, might allow for identification of areas suspicious for neoplasia. This would lead to a decreased number of esophageal biopsies necessary to survey the patient (40). If so, this quality metric may require future alteration to reflect best practices.

Back to Top | Article Outline

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

Level of evidence: 3

Performance target: >80%

Type of measure: process

Back to Top | Article Outline

12. Frequency with which, during EGD examination 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

Level of evidence: 1A

Performance target: >98%

Type of measure: process

Back to Top | Article Outline

13. Frequency with which, unless contraindicated, endo-scopic treatment is given for ulcers with active bleeding or with nonbleeding visible vessels (priority indicator)

Level of evidence: 1A

Performance target: >98%

Type of measure: process

Discussion: The completion of therapeutic procedures is a logical and obvious target for quality metrics in upper endoscopy. It is impossible prospectively to define and create metrics for all potential therapeutic maneuvers in upper endoscopy for the purpose of quality monitoring. Nonetheless, given the clinical importance and commonplace nature of the management of GI bleeding, monitoring processes and outcomes related to these conditions will likely reflect the quality of overall clinical care. Practitioners performing EGD in the setting of upper GI bleeding should be trained, equipped, and prepared to therapeutically manage the bleeding source when found.

The first task of the therapeutic endoscopist is to find and define the location of the bleeding site. In the majority of patients, a bleeding site can be determined after careful examination (41, 42, 43). However, because of impaired visualization because of blood, or occasionally because of intermittent bleeding from a lesion without obvious endoscopic stigmata, such as a Dieula-foy’s lesion, the cause of bleeding may not be identified. For situations in which a bleeding site is not initially identified because of copious amounts of blood, the use of intravenous erythromycin or meto-clopramide, as well as repositioning the patient, may aid in identification of a site (44, 45). The bleeding site’s description should be detailed enough to allow a subsequent endoscopist to find the site. A detailed description of the lesion also is necessary, including documentation of stigmata associated with different risks of rebleeding (46).

Ulcers should be classified as actively bleeding (with spurting lesions having a more ominous prognosis than oozing lesions), nonbleeding visible vessel, adherent clot, flat spot, and clean-based ulcer. These stigmata provide prognostic information on rebleeding rates and need for subsequent intervention. They dictate management strategies including level of care and need for endoscopic therapy. In general, endo-scopic attempts at hemostasis should be performed in those with spurting or oozing ulcers as well as in those with nonbleeding visible vessels. In patients with adherent clots, vigorous irrigation with or without suctioning may allow identification of underlying stigmata of hemorrhage. If irrigation does not dislodge the clots, these lesions should be considered for endo-scopic therapy. Meta-analysis of multiple trials demonstrates that endoscopic therapy markedly decreases the risk of further bleeding and also decreases the need for surgery (47). Appropriate risk stratification in peptic ulcer bleeding requires knowledge of not only the stigmata but also of their different rates of rebleed-ing in various clinical scenarios. For practices with a low volume of EGD for bleeding, it may be appropriate to measure on a unit basis rather than per endoscopist.

Back to Top | Article Outline

14. Frequency with which achievement of primary hemo-stasis in cases of attempted hemostasis of upper GI bleeding lesions is documented

Level of evidence: 3

Performance target: >98%

Type of measure: process

Discussion: Prognosis in the patient with active GI bleeding depends in part on the success of initial intervention. Patients in whom hemostasis is not achieved are more likely to require subsequent interventional radiology or surgery and are at increased risk of mortality compared with those undergoing successful inter-vention (48, 49, 50). In many prospective series evaluating various modalities for managing actively bleeding upper GI lesions, primary hemostasis rates from 90 to 100% have been achieved (46). In order to gauge and track successful hemostasis, it will be necessary for endoscopists to clearly record whether or not their efforts to achieve primary hemostasis in high-risk endoscopic stigmata are successful. At present, there are no currently accepted standards of hemostasis attainment in community practice from which to assign an evidenced-based performance target. However, by tracking the rate of primary hemostasis and comparing to benchmark data, endoscopists will be able to engage in quality improvement in the area of GI bleeding management.

Back to Top | Article Outline

15. Frequency with which a second treatment modality is used (e.g., coagulation or clipping) when epinephrine injection is used to treat actively bleeding or nonbleeding visible vessels in patients with bleedingpeptic ulcers

Level of evidence: 1A

Performance target: >98%

Type of measure: process

Discussion: Multiple modalities may be used in the treatment of peptic ulcer bleeding. Current practices include the use of injection in conjunction with a second modality, such as multipolar coagulation, heater probe thermal coagulation, endoscopic clipping, argon plasma coagulation, or various other therapies (46). The success or failure of such treatments should be documented when practical and clearly described. Epineph-rine injection alone should not be considered adequate because multiple studies have documented the superiority of combined modality therapy over epinephrine alone (51, 52).

Treating peptic ulcers with active bleeding or non-bleeding visible vessels is associated with significantly reduced rebleeding rates and should therefore be attempted in most instances. Additionally, there are supportive data for the endoscopic removal of adherent clots and subsequent treatment of underlying stig-mata,(53, 54, 55) and this practice should be considered for all patients with adherent clots.

Back to Top | Article Outline

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

Level of evidence: 1A

Performance target: >98%

Type of measure: process

Discussion: In bleeding from esophageal varices, banding is preferred over sclerotherapy for safety and efficacy (56, 57). Octreotide infusion should be instituted in patients with acute variceal bleeding who do not have a contraindication to the medication (58, 59). After the initial treatment, follow-up plans should include repeat endoscopy with repeat treatment until varices are eradicated. Postprocedure plans also should include some recommendation concerning the use of beta blockers for prevention of recurrent bleeding or a statement about why they are contraindicated (60, 61).

Back to Top | Article Outline

17. Frequency with which at least 4 intestinal biopsy specimens are taken from patients in whom celiac disease is suspected

Level of evidence: 1C

Performance target: >90%

Type of measure: process

Discussion: In patients with clinical signs, symptoms, and suspected celiac disease, small-intestine biopsies often are instrumental in ascertaining the diagnosis. Similarly, biopsies may help elucidate the response to therapy. Because of the potentially patchy nature of the disease, in patients in whom celiac disease is suspected, at least 4 biopsy specimens should be taken to maximize accuracy of diagnosis, and some should include the duodenal bulb (62). Biopsies of the duodenal bulb may improve diagnostic yield by detecting the most severe villous atrophy within the duodenum (63).

Back to Top | Article Outline

Intraprocedure research questions

1.The structures of the oropharynx can be observed during EGD, and examination of this area may be of particular importance in patients at high risk for squamous cell cancers of the esophagus and head and neck (64). Should complete visualization of a routine EGD include the oropharynx?

2.Do patients with endoscopic stigmata of BE, but no specialized metaplasia on biopsy, suffer from an increased risk of neoplasia, and if so, what is the magnitude of that risk?

3.Which patients with BE benefit from endoscopic ablative therapies?

4.Does increasing the time duration of the inspection of BE result in an improvement in the yield of BE surveillance examinations, and if so, what is the minimum inspection time necessary for optimal diagnostic yield?

5.What are the most effective therapies for patients with recurrent strictures or those resistant to therapy?

6.What is the rate of successful primary hemostasis for major stigmata of nonvariceal bleeding in community practice? What is the utility of newer endoscopic modalities in treating acute upper GI bleeding?

7.What are the variations in practice in the community with regard to performance of duodenal biopsies to rule out celiac disease and from what sites in the duodenum?

8.How often is dual therapy used when epinephrine is used? Is there variation in rates of surgery among community endoscopists?

9.Does case volume affect primary hemostasis or delayed rebleeding rates? Is there variation in rates of interventional radiology and surgery use among community endoscopists?

10.How often is surveillance recommended among patients with abnormalities confined to the Z line?

11.Are recommendations to measure and perform biopsies in suspected BE followed in clinical practice?

Back to Top | Article Outline

Postprocedure quality indicators

The postprocedure period extends from the time the endoscope is removed to subsequent follow-up. Postprocedure activities include providing instructions to the patient, documentation of the procedure, recognition and documentation of adverse events, pathology follow-up, communication with referring physicians, and assessing patient satisfaction (23). Postprocedure quality indicators specific to performance of EGD include the following:

Back to Top | Article Outline

18. Frequency with which PPI therapy is recommended for patients who underwent dilation for peptic esoph-ageal strictures

Level of evidence: 1A

Performance target: >98%

Type of measure: process

Back to Top | Article Outline

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

Level of evidence: 1A

Performance target: >98%

Type of measure: process

Discussion: PPIs, when used in patients who have had peptic strictures, reduce the need for future dilations (65, 66). Treatment with antisecretory therapy is indicated for patients with newly identified gastric or duodenalulcers (67, 68).

Back to Top | Article Outline

20. Frequency with which plans to test for Helicobacter pylori infection for patients diagnosed with gastric or duodenal ulcers are documented (priority indicator)

Level of evidence: 1A

Performance target: >98%

Type of measure: process

Discussion: H pylori is a common cause of gastric and duodenal ulcer disease. Successful eradication of this organism results in dramatically reduced rates of ulcer recurrence (69). ASGE guidelines pertaining to the role of endoscopy for peptic ulcer disease recommends that all patients with gastric or duodenal ulcers should be assessed for this infection (70).

Back to Top | Article Outline

21. Frequency with which patients with evidence of recurrent bleeding from peptic ulcer disease after endoscopic treatment undergo repeat upper endoscopy

Level of evidence: 1B

Performance target: >98%

Type of measure: process

Discussion: Despite adequate endoscopic therapy for a bleeding peptic ulcer, rebleeding can occur in up to one third of patients. Repeat endoscopy for recurrent bleeding is effective and should be done unless contra-indicated (71, 72). This should be documented and communicated with the primary providers. Routine second-look endoscopy in the absence of rebleeding is not recommended (26, 72, 73).

Back to Top | Article Outline

22. Frequency that patients are contacted to document the occurrence of adverse events after EGD

Level of evidence: 3

Performance target: N/A

Type of measure: process

Discussion: As more therapeutic EGD procedures occur (EMR, endoscopic submucosal dissection [ESD]), endo-scopists should develop a mechanism to capture and track not only immediate but also delayed endoscopic adverse events (from 14 days to 1 month). Such a practice would promote patient safety—a principle supported by the ASGE, ACG, American Gastroentero-logical Association, and the Institute of Medicine (11, 74, 75). Tracked adverse events should include cardiopulmo-nary events, infections, perforation, bleeding, and abdominal pain requiring medical attention or intervention. In the future, individual adverse events could be developed into separate quality indicators once further data are obtained for benchmarking. For EGD, these might include specific adverse event rates such as skin infections after PEG tube placement, aspiration pneumonia after EGD with hemostasis, and stricture formation after esophageal mucosal resection or ablation.

Back to Top | Article Outline

Postprocedure research questions

1.What is the long-term outcome from following surveillance recommendations for BE, and how will targeted biopsy techniques that use new technology affect the yield and efficacy of surveillance?

2.Are there variations in rebleeding rates from peptic ulcer disease after endoscopic therapy, and can this be used to identify high performers of quality upper endoscopy?

3.What are the sources of variability in adverse event rates after endoscopic intervention for upper GI bleeding, and how can they be diminished?

4.What is the optimal management of anticoagulation regimens in patients undergoing EGD with hemostasis of upper GI bleeding requiring chronic anticoagulation in the periprocedure and postprocedure bleeding periods?

5.What is the incidence of incomplete mucosal resection by using advanced imaging techniques to identify margins?

6.What are the best strategies to minimize adverse events after EMR and ESD?

7.What are the rates in the community of aspiration pneumonia after endoscopic hemostasis of acute upper GI bleeding, stricture formation after esophageal ablation or mucosal resection, and post-PEG wound infections?

8.Is actively tracking patients for the occurrence of adverse events after endoscopy cost effective?

Back to Top | Article Outline

Priority indicators for EGD

A summary of discussed quality indicators for EGD is listed in Table 4. Among these for EGD, recommended priority indicators are (1) frequency with which, unless contraindicated, ulcers with active bleeding or with non-bleeding visible vessels are treated endoscopically, (2) frequency with which plans for assessing H pylori infection for patients diagnosed with gastric or duo&semishy;denal ulcers are documented, (3) frequency with which appropriate prophylactic antibiotics are given in patients with cirrhosis with acute upper GI bleeding before EGD, and (4) frequency with which a PPI is used for suspected peptic ulcer bleeding (Table 5). Among all indicators, these were chosen based on combined availability of strength of supporting evidence, measurement feasibility, and evidence of substantial variation in performance (76, 77, 78). There are very limited data on practice variation for the majority of these EGD indicators, representing an important research area.

Table 4

Table 4

Table 5

Table 5

Simple educational and corrective measures can improve performance. The primary purpose of measuring quality indicators is to improve patient care by identifying poor performers and retraining them or removing privileges to perform EGD if performance cannot be improved.

Back to Top | Article Outline

Conclusion

This update on quality indicators for EGD incorporates new information to provide a relevant list for endoscopists who want to perform high-quality upper endoscopy. Similar to those from the original version published in 2006, the indicators are classified as preprocedure, intra-procedure, and postprocedure indicators, and this is summarized in Table 4. The proposed indicators vary in the level of supporting evidence, and several are based solely on expert opinion. For practical and ethical reasons, some indicators may be impossible to validate, such as performing and documenting informed consent and patient monitoring during moderate sedation. The absence of evidence does not equate to evidence of no benefit.

For EGD, the proposed quality measures are predominantly process measures. Many of these process measures are good surrogates of outcomes, based on evidence that links them to clinically recognized outcomes. The future direction of quality indicator development will include relevant outcome measures and a more robust evidence base to support proposed performance targets. The proposed research questions address this deficit of evidence.

Back to Top | Article Outline

REFERENCES

1. Peery AF, Dellon ES, Lund J et al. Burden of gastrointestinal disease in the United States: 2012 update. Gastroenterology 2012;143:1179–1187 e1-3.
2. Chassin MR, Galvin RW. The urgent need to improve health care quality. Institute of Medicine National Roundtable on Health Care Quality. JAMA 1998;280:1000–1005.
3. Petersen BT. Quality assurance for endoscopists. Best Pract Res Clin Gastroenterol 2011;25:349–360.
4. Cohen J, Safdi MA, Deal SE et al. Quality indicators for esophagogas-troduodenoscopy. Am J Gastroenterol 2006;101:886–891.
5. Faigel DO, Pike IM, Baron TH et al. Quality indicators for gastrointestinal endoscopic procedures: an introduction. Am J Gastroenterol 2006;101:866–872.
6. Early DS, Ben-Menachem T, Decker GA et al. Appropriate use of GI endoscopy. Gastrointest Endosc 2012;75:1127–1131.
7. Froehlich F, Repond C, Mullhaupt B et al. Is the diagnostic yield of upper GI endoscopy improved by the use of explicit panel-based appropriateness criteria? Gastrointest Endosc 2000;52:333–341.
8. Charles RJ, Chak A, Cooper GS et al. Use of open access in GI endos-copy at an academic medical center. Gastrointest Endosc 1999;50:480–485.
9. Zuckerman MJ, Shen B, Harrison ME 3rd et al. Informed consent for GI endoscopy. Gastrointest Endosc 2007;66:213–218.
10. Ginzburg L, Greenwald D, Cohen J. Complications of endoscopy. Gastro&semishy;intest Endosc Clin N Am 2007;17:405–432.
11. Ben-Menachem T, Decker GA, Early DS et al. Adverse events of upper GI endoscopy. Gastrointest Endosc 2012;76:707–718.
12. Eisen GM, Baron TH, Dominitz JA et al. Complications of upper GI endo&semishy;scopy. Gastrointest Endosc 2002;55:784–793.
13. Chavez-Tapia NC, Barrientos-Gutierrez T, Tellez-Avila FI et al. Antibiotic prophylaxis for cirrhotic patients with upper gastrointestinal bleeding. Cochrane Database Syst Rev 2010, CD002907.
14. Garcia-Tsao G, Sanyal AJ, Grace ND et al. Prevention and management of gastroesophageal varices and variceal hemorrhage in cirrhosis. Hepatology 2007;46:922–938.
15. Banerjee S, Shen B, Baron TH et al. Antibiotic prophylaxis for GI endoscopy. Gastrointest Endosc 2008;67:791–798.
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;131:1049–1056 quiz 1285.
17. de Franchis R, Baveno VF. Revising consensus in portal hypertension: report of the Baveno V consensus workshop on methodology of diagnosis and therapy in portal hypertension. J Hepatol 2010;53:762–768.
18. Lipp A, Lusardi G. Systemic antimicrobial prophylaxis for percutaneous endoscopic gastrostomy. Cochrane Database Syst Rev 2006, CD005571.
19. Jain NK, Larson DE, Schroeder KW et al. Antibiotic prophylaxis for percutaneous endoscopic gastrostomy: a prospective, randomized, double-blind clinical trial. Ann Intern Med 1987;107:824–828.
20. Thomas S, Cantrill S, Waghorn DJ et al. The role of screening and antibiotic prophylaxis in the prevention of percutaneous gastrostomy site infection caused by methicillin-resistant Staphylococcus aureus. Aliment Pharmacol Ther 2007;25:593–597.
21. Sreedharan A, Martin J, Leontiadis GI et al. Proton pump inhibitor treatment initiated prior to endoscopic diagnosis in upper gastrointestinal bleeding. Cochrane Database Syst Rev 2010, CD005415.
22. Wells M, Chande N, Adams P et al. Meta-analysis: vasoactive medications for the management of acute variceal bleeds. Aliment Pharmacol Ther 2012;35:1267–1278.
23. Rizk MK, Sawhney MS, Cohen J et al. Quality indicators common to all GI endoscopic procedures. Gastrointest Endosc 2015 (in press).
24. Cass OW, Freeman ML, Peine CJ et al. Objective evaluation of endoscopy skills during training. Ann Intern Med 1993;118:40–44.
25. Ferlitsch A, Schoefl R, Puespoek A et al. Effect of virtual endoscopy simulator training on performance of upper gastrointestinal endoscopy in patients: a randomized controlled trial. Endoscopy 2010;42:1049–1056.
26. Jeon J, Luebeck EG, Moolgavkar SH. Age effects and temporal trends in adenocarcinoma of the esophagus and gastric cardia (United States). Cancer Causes Control 2006;17:971–981.
27. Graham DY, Schwartz JT, Cain GD et al. Prospective evaluation of biopsy number in the diagnosis of esophageal and gastric carcinoma. Gastroenterology 1982;82:228–231.
28. Spechler SJ, Sharma P, Souza RF et al. American Gastroenterological Association technical review on the management of Barrett’s esophagus. Gastroenterology 2011;140:e18–e52 quiz e13.
29. Rugge M, Zaninotto G, Parente P et al. Barrett’s esophagus and adeno-carcinoma risk: the experience of the North-Eastern Italian Registry (EBRA). Ann Surg 2012;256:788–794.
30. Sikkema M, Looman CW, Steyerberg EW et al. Predictors for neoplastic progression in patients with Barrett’s esophagus: a prospective cohort study. Am J Gastroenterol 2011;106:1231–1238.
31. Vahabzadeh B, Seetharam AB, Cook MB et al. Validation of the Prague C & M criteria for the endoscopic grading of Barrett’s esophagus by gastro&semishy;enterology trainees: a multicenter study. Gastrointest Endosc 2012;75:236–241.
32. Sharma P, Dent J, Armstrong D et al. The development and validation of an endoscopic grading system for Barrett’s esophagus: the Prague C & M criteria. Gastroenterology 2006;131:1392–1399.
33. Spechler SJ, Zeroogian JM, Antonioli DA et al. Prevalence of metaplasia at the gastro-oesophageal junction. Lancet 1994;344:1533–1536.
34. Playford RJ. New British Society of Gastroenterology (BSG) guidelines for the diagnosis and management of Barrett’s oesophagus. Gut 2006;55:442.
35. American Gastroenterological AssociationSpechler SJ, Sharma P, Souza RF et al. American Gastroenterological Association medical position statement on the management of Barrett’s esophagus. Gastroenterology 2011;140:1084–1091.
36. Wang KK, Sampliner RE, Practice Parameters Committee of the American College of Gastroenterology. Updated guidelines 2008 for the diagnosis, surveillance and therapy of Barrett’s esophagus. Am J Gastroenterol 2008 103:788–797.
37. Bhat S, Coleman HG, Yousef F et al. Risk of malignant progression in Barrett’s esophagus patients: results from a large population-based study. J Natl Cancer Inst 2011;103:1049–1057.
38. Abrams JA, Kapel RC, Lindberg GM et al. Adherence to biopsy guidelines for Barrett’s esophagus surveillance in the community setting in the United States. Clin Gastroenterol Hepatol 2009;7:736–742 quiz 710.
39. Gupta N, Gaddam S, Wani SB et al. Longer inspection time is associated with increased detection of high-grade dysplasia and esophageal adenocarcinoma in Barrett’s esophagus. Gastrointest Endosc 2012;76:531–538.
40. Sharma P, Hawes RH, Bansal A et al. Standard endoscopy with random biopsies versus narrow band imaging targeted biopsies in Barrett’s oesophagus: a prospective, international, randomised controlled trial. Gut 2013;62:15–21.
41. Villanueva C, Colomo A, Bosch A et al. Transfusion strategies for acute upper gastrointestinal bleeding. N Engl J Med 2013;368:11–21.
42. Hearnshaw SA, Logan RF, Lowe D et al. Acute upper gastrointestinal bleeding in the UK: patient characteristics, diagnoses and outcomes in the 2007 UK audit. Gut 2011;60:1327–1335.
43. Barkun A, Sabbah S, Enns R et al. The Canadian Registry on Nonvariceal Upper Gastrointestinal Bleeding and Endoscopy (RUGBE): Endoscopic hemostasis and proton pump inhibition are associated with improved outcomes in a real-life setting. Am J Gastroenterol 2004;99:1238–1246.
44. Szary NM, Gupta R, Choudhary A et al. Erythromycin prior to endoscopy in acute upper gastrointestinal bleeding: a meta-analysis. Scand J Gastroenterol 2011;46:920–924.
45. Barkun AN, Bardou M, Martel M et al. Prokinetics in acute upper GI bleeding: a meta-analysis. Gastrointest Endosc 2010;72:1138–1145.
46. Laine L, Jensen DM. Management of patients with ulcer bleeding. Am J Gastroenterol 2012;107:345–360 quiz 361.
47. Laine L, McQuaid KR. Endoscopic therapy for bleeding ulcers: an evidence-based approach based on meta-analyses of randomized controlled trials. Clin Gastroenterol Hepatol 2009;7:33–47.
48. Garcia-Iglesias P, Villoria A, Suarez D et al. Meta-analysis: predictors of rebleeding after endoscopic treatment for bleeding peptic ulcer. Aliment Pharmacol Ther 2011;34:888–900.
49. Marmo R, Koch M, Cipolletta L et al. Predicting mortality in non-variceal upper gastrointestinal bleeders: validation of the Italian PNED score and prospective comparison with the Rockall score. Am J Gastroenterol 2010;105:1284–1291.
50. Chiu PW, Ng EK, Cheung FK et al. Predicting mortality in patients with bleeding peptic ulcers after therapeutic endoscopy. Clin Gastroenterol Hepatol 2009;7:311–316 quiz 253.
51. Marmo R, Rotondano G, Piscopo R et al. Dual therapy versus mono-therapy in the endoscopic treatment of high-risk bleeding ulcers: a meta-analysis of controlled trials. Am J Gastroenterol 2007;102:279–289 quiz 469.
52. Gralnek IM, Barkun AN, Bardou M. Management of acute bleeding from a peptic ulcer. N Engl J Med 2008;359:928–937.
53. Kahi CJ, Jensen DM, Sung JJ et al. Endoscopic therapy versus medical therapy for bleeding peptic ulcer with adherent clot: a meta-analysis. Gastroenterology 2005;129:855–862.
54. Bleau BL, Gostout CJ, Sherman KE et al. Recurrent bleeding from peptic ulcer associated with adherent clot: a randomized study comparing endoscopic treatment with medical therapy. Gastrointest Endosc 2002;56:1–6.
55. Bini EJ, Cohen J. Endoscopic treatment compared with medical therapy for the prevention of recurrent ulcer hemorrhage in patients with adherent clots. Gastrointest Endosc 2003;58:707–714.
56. Villanueva C, Piqueras M, Aracil C et al. A randomized controlled trial comparing ligation and sclerotherapy as emergency endoscopic treatment added to somatostatin in acute variceal bleeding. J Hepatol 2006;45:560–567.
57. Zargar SA, Javid G, Khan BA et al. Endoscopic ligation compared with sclerotherapy for bleeding esophageal varices in children with extra-hepatic portal venous obstruction. Hepatology 2002;36:666–672.
58. Garcia-Tsao G, Lim JK, Members of Veterans Affairs Hepatitis CRCP. Management and treatment of patients with cirrhosis and portal hypertension: recommendations from the Department of Veterans Affairs Hepatitis C Resource Center Program and the National Hepatitis C Program. Am J Gastroenterol 2009;104:1802–1829.
59. D’Amico G, Politi F, Morabito A et al. Octreotide compared with placebo in a treatment strategy for early rebleeding in cirrhosis: a double blind, randomized pragmatic trial. Hepatology 1998;28:1206–1214.
60. D’Amico G, Pagliaro L, Bosch J. Pharmacological treatment of portal hypertension: an evidence-based approach. Semin Liver Dis 1999;19:475–505.
61. Sarin SK, Gupta N, Jha SK et al. Equal efficacy of endoscopic variceal liga-tion and propranolol in preventing variceal bleeding in patients with noncirrhotic portal hypertension. Gastroenterology 2010;139:1238–1245.
62. Pais WP, Duerksen DR, Pettigrew NM et al. How many duodenal biopsy specimens are required to make a diagnosis of celiac disease? Gastrointest Endosc 2008;67:1082–1087.
63. Kurien M, Evans KE, Hopper AD et al. Duodenal bulb biopsies for diagnosing adult celiac disease: Is there an optimal biopsy site? Gastroint-est Endosc 2012;75:1190–1196.
64. Emura F, Baron TH, Gralnek IM. The pharynx: examination of an area too often ignored during upper endoscopy. Gastrointest Endosc 2013;78:143–149.
65. Silvis SE, Farahmand M, Johnson JA et al. A randomized blinded comparison of omeprazole and ranitidine in the treatment of chronic esophageal stricture secondary to acid peptic esophagitis. Gastrointest Endosc 1996;43:216–221.
66. Jaspersen D, Schwacha H, Schorr W et al. Omeprazole in the treatment of patients with complicated gastro-oesophageal reflux disease. J Gastro&semishy;enterol Hepatol 1996;11:900–902.
67. Lauritsen K, Rune SJ, Bytzer P et al. Effect of omeprazole and cimeti-dine on duodenal ulcer: a double-blind comparative trial. N Engl J Med 1985;312:958–961.
68. Lauritsen K, Rune SJ, Wulff HR et al. Effect of omeprazole and cimeti-dine on prepyloric gastric ulcer: double blind comparative trial. Gut 1988;29:249–253.
69. Ford AC, Delaney BC, Forman D et al. Eradication therapy for peptic ulcer disease in Helicobacter pylori positive patients. Cochrane Database Syst Rev 2006, CD003840.
70. Banerjee S, Cash BD, Dominitz JA et al. The role of endoscopy in the management of patients with peptic ulcer disease. Gastrointest En-dosc 2010;71:663–668.
71. Lau JY, Sung JJ, Lam YH et al. Endoscopic retreatment compared with surgery in patients with recurrent bleeding after initial endoscopic control of bleeding ulcers. N Engl J Med 1999;340:751–756.
72. Barkun AN, Bardou M, Kuipers EJ et al. International consensus recommendations on the management of patients with nonvariceal upper gastrointestinal bleeding. Ann Intern Med 2010;152:101–113.
73. El Ouali S, Barkun AN, Wyse J et al. Is routine second-look endoscopy effective after endoscopic hemostasis in acute peptic ulcer bleeding? A meta-analysis. Gastrointest Endosc 2012;76:283–292.
74. Quality improvement of gastrointestinal endoscopy: guidelines for clinical application. From the ASGE. American Society for Gastrointestinal Endo&semishy;scopy. Gastrointest Endosc 1999;49:842–844.
75. Committee on Quality of Health Care in America IoM. To err is human; building a safer health system. National Academies Press: Washington, DC. 2000.
76. Lanas A, Aabakken L, Fonseca J et al. Variability in the management of nonvariceal upper gastrointestinal bleeding in Europe: an observational study. Adv Ther 2012;29:1026–1036.
77. Xu HW, Wang JH, Tsai MS et al. The effects of cefazolin on cirrhotic patients with acute variceal hemorrhage after endoscopic interventions. Surg Endosc 2011;25:2911–2918.
78. Brown MR, Jones G, Nash KL et al. Antibiotic prophylaxis in variceal hemorrhage: timing, effectiveness and Clostridium difficile rates. World J Gastroenterol. 2010;16:5317–5323.
© The American College of Gastroenterology 2015. All Rights Reserved.