Quality assessment of ERCP

American Society For Gastrointestinal Endoscopy

Quality assessment of ERCP BACKGROUND The ongoing interest in quality assessment affects all providers of health care from large managed care organizations down to the level of the individual physician. In the United States, gastroenterologists are being asked to provide data regarding outcomes of their endoscopic practices. Patients are likewise becoming more interested in their health care and are beginning to request information regarding their own physician’s outcomes. Unfortunately, few resources are available to enable clinicians to collect this data. The ASGE Committee on Outcomes Research was established in 1997 to address these issues. The committee includes representation by both private practice and university-based gastroenterologists, all of whom have undergone formal training and are actively involved in outcomes research. The committee’s mission has been to develop tools to assist practicing endoscopists incorporate outcomes and quality assessment activities within their daily practice. The first task was to formulate specific guidelines detailing quality indicators for EGD and colonoscopy. These indicators1 represent the first step toward minimal standards for quality assessment of endoscopic practice. With completion of this initial project, the committee has turned its attention to the more technically complex procedures. Endoscopic retrograde cholangiopancreatography (ERCP) is a technique that was first used to evaluate the biliary and pancreatic systems in the late 1960s. Its initial application was for diagnosis of biliary and pancreatic diseases, but with the advent of sphincterotomy in 1974, therapeutic biliary and more recently therapeutic pancreatic endoscopy have become widely available. The development of technical competence requires extensive additional training and experience in both diagnostic and therapeutic ERCP.2,3 Until recently, procedural outcomes have been evaluated predominantly based on their complications because ERCP is associated with significantly greater morbidity and mortality when compared with either EGD or colonoscopy. A landmark consensus conference defining ERCP complications4 has also contributed to the importance of complications as an outcomes measure. VOLUME 56, NO. 2, 2002

It is clear, however, that additional outcomes measures are necessary to provide a more complete description of the quality of ERCP. Another consensus conference was held on January 12-14, 2001, to identify additional outcomes measures that might be useful in this regard. This conference provided the foundation for selection of the quality indicators detailed below. It is the desire of the ASGE that these quality indicators provide the next step in the process of equipping practitioners with the resources to track the outcomes of their own endoscopic practices. SPECIFIC QUALITY INDICATORS The following outcomes measures have been identified as quality indicators appropriate for collection in all patients undergoing ERCP. The specific indicators can be divided into the following traditional outcomes research categories: structure, process, and outcomes. Structure measures include patient and endoscopist characteristics which allow for stratification of individual ERCPs by case-mix. Process measures are components of the encounter between patient and provider, in this case the technical aspects of the ERCP. Outcomes measures assess what happens to the patient’s health status as a result of the procedure. 1. Demographics and patient comorbidity: age, gender, and American Society of Anesthesia (ASA) classification (Table 1). The collection of demographic information permits the identification of subgroups, which can be analyzed individually. Age and gender allow for crude stratification by procedure risk. ASA classification is included because accrediting agencies already require documentation of patient risk for conscious sedation. ASA status has been shown to be an accurate predictor of complications associated with EGD and Colonoscopy,5 which consist primarily of cardiopulmonary complications, bleeding, and perforation. In contrast, ASA status and other indices of comorbid illness do not predict the risk of pancreatitis, the most common complication of ERCP, or the overall risk of complications.6 In fact, there appears to be an inverse correlation between GASTROINTESTINAL ENDOSCOPY

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Table 1. ASA classification: anesthesia risk class

Table 2. ASGE-approved indications for ERCP7

Class I Class II

A. Jaundice thought secondary to biliary obstruction B. Clinical and biochemical or imaging data suggestive of pancreatic or biliary tract disease C. Signs or symptoms suggesting pancreatic malignancy when direct imaging is equivocal or normal D. Pancreatitis of unknown etiology E. Preoperative evaluation of chronic pancreatitis or pancreatic pseudocyst F. Sphincter of Oddi manometry G. Endoscopic sphincterotomy 1. Choledocholithiasis 2. Papillary stenosis or sphincter of Oddi dysfunction causing disability 3. Facilitate biliary stent placement or balloon dilatation 4. Sump syndrome 5. Choledochocele 6. Ampullary carcinoma in poor surgical candidates 7. Access to pancreatic duct H. Stent placement across benign or malignant strictures, fistulae, postoperative bile leak, or large CBD stones I. Balloon dilatation of ductal strictures J. Nasobiliary drain placement K. Pseudocyst drainage in appropriate cases L. Tissue sampling from pancreatic or bile ducts M. Pancreatic therapeutics

Class III

Class IV

Class V

Healthy patient Mild systemic disease No functional limitations No acute problems (e.g., controlled hypertension, mild diabetes, chronic bronchitis, asthma Severe systemic disease Definite functional limitation (e.g., brittle diabetic, frequent angina, myocardial infarction) Severe systemic disease with acute, unstable symptoms (e.g., recent [3 months] myocardial infarction, congestive heart failure, acute renal failure, ketoacidosis, uncontrolled, active asthma) Severe systemic disease with imminent risk of death

ASA score and pancreatitis, that is younger, healthier patients tend to be at a higher risk of developing post-ERCP pancreatitis. The ability of ASA status to predict other unplanned events associated with ERCP is still being determined, but does appear to be promising. Alternative measures such as the Charlson comorbidity index, APACHE, or POSSUM may represent more accurate predictors of unplanned events but are more laborious to compute, not widely used, and require validation of their ability to predict procedure-associated unplanned events. Likewise, further study is necessary to confirm the value of the ASA classification system among patients undergoing ERCP. 2. Endoscopists’ procedure volume: This information facilitates quantification of an endoscopist’s experience and should include the number of overall ERCPs, as well as the number of therapeutic biliary and pancreatic cases performed within the past year. The experience of the endoscopist is an important factor in procedure outcome and should influence intent of the procedure as well as the specific maneuvers attempted. For example, an endoscopist with limited experience in pancreatic therapeutics should be cautious in attempting minor papilla sphincterotomy. 3. Procedure indication and intent: Although related, these are distinct issues. The indication relates to the reason for the procedure. A list of ASGE-approved indications for ERCP are listed in Table 2.7 The intent is the goal for a specific procedure. For example, an ERCP might be indicated in a patient with obstructive jaundice, whereas the intent could be either to find the cause of jaundice (diagnostic) or relieve the jaundice (therapeutic). It is necessary to assess indication and intent prospectively because 166

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they both are integral components of determining procedure success. 4. Procedure difficulty: This is a new concept developed by Schutz and Abbott.8 The scale was developed with input from the recognized leaders in the field. Essentially, all ERCPs are classified into three levels based on the technical difficulty of each maneuver (Table 3). This score provides a simple and objective measure of the clinical complexity of an ERCP and may also provide a measure of procedure risk allowing further certification by case mix. The ability of the Schutz score to predict procedure risk requires confirmation. The difficulty of a procedure is also an important part of assessing procedure success. 5. Unplanned events (previously known as complications): The specific method of identifying and collecting unplanned events remains controversial. Certainly events such as pancreatitis or perforation are obvious and should be tracked. The significance of other events associated with the procedure remains unclear. Further research is required before the optimal method to record delayed complications can be firmly established. Nevertheless, unplanned events should be tracked for all patients undergoing ERCP. The significance of these events can be determined retrospectively. 6. Patient satisfaction: Information on patient satisfaction will be collected by using a modificaVOLUME 56, NO. 2, 2002

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Table 3. ERCP degree of difficulty grades8 Grade 1

Grade 2

Grade 3

Biliary procedures

Pancreatic procedures

Diagnostic cholangiogram Biliary cytology Standard sphincterotomy ± Removal stones <10 mm Stricture dilatation/stent/NBD for extrahepatic stricture of bile leak Diagnostic cholangiogram with BII anatomy Removal of CBD stones >10 mm Stricture dilatation/stent/NBD for hilar tumors or benign intrahepatic strictures SO manometry Cholangioscopy Any therapy with BII anatomy Removal of intrahepatic stones or any stones with lithotripsy

Diagnostic pancreatogram Pancreatic cytology

Diagnostic pancreatogram with BII anatomy Minor papilla cannulation

SO manometry Pancreatoscopy All pancreatic therapy including pseudocyst drainage

NBD, Nasobiliary drain; CBD, common bile duct; SO, sphincter of Oddi.

Table 4. ERCP specific quality indicators Demographics and patient comorbidity Age, gender, ASA status Endoscopists procedure volume Total ERCPs Therapeutic biliary and pancreatic cases Indication (Table 1) Procedure intent Either diagnostic or therapeutic Difficulty of procedure Modified Schutz score (Table 2) Unplanned events Patient satisfaction (Appendix I) Procedure success A. Technical: defined as complete success, partial success, or failed 1. Initial indicator: biliary cannulation in cases in which it was intended Success defined as satisfactory cholangiogram or deep cannulation if obstruction encountered 2. Complete indicator: technical success in all diagnostic and therapeutic maneuvers attempted Success defined as complete, partial, or failure B. Clinical: yes or no based on the following: Diagnostic intent Make or improve diagnostic certainty No additional diagnostic tests necessary Initiation of appropriate therapy

tion of the GHAA-9 Patient Satisfaction survey plus two additional questions (Appendix). This patient satisfaction survey has been in existence for nearly 20 years and has been validated in numerous patient populations. Furthermore, it is well accepted by managed care organizations, and a significant amount of reference (benchmark) data are available for comparative purposes. Research is ongoing to develop an endoscopy-specific patient satisfaction questionnaire. When this is available, it will likely supplant the current questionnaire. VOLUME 56, NO. 2, 2002

7. Technical procedure success: Technical success is probably more important for ERCP than other endoscopic procedures based on the technical difficulty of this procedure. Thus, technical success will be stratified based on technique and will be described as complete success (diagnostic and therapeutic), partial success (access to desired duct with incomplete or partial therapy), or failed (failure to access or drain the desired duct). As a starting point, a quality indicator for technical success would be deep cannulation of the bile duct, even if obstruction is identified, in GASTROINTESTINAL ENDOSCOPY

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cases where biliary pathology is suspected (Table 4). More specific parameters of success that would subsequently be applied to all levels of ERCP difficulty including pancreatic therapy would cover particular components of the diagnostic and therapeutic maneuvers. It is important to include measures of therapeutic technical success so that simple cannulation is not sufficient to represent success in cases where basic therapeutic measures are necessary. 8. Clinical procedural success: As with other endoscopic procedures, this is the most difficult area to define objectively. The main goal of this quality indicator is to determine whether the procedure actually benefited the patient. An example of this might be the patient with pancreas divisum and recurrent pancreatitis who undergoes a successful minor papilla sphincterotomy but continues to have attacks of pancreatitis. Clinical success often includes more factors than the procedure itself, potentially confounding the determination of what actually contributed to the clinical improvement. Nevertheless, meaningful assessment of clinical success requires structured, long-term follow-up, in addition to clearly defined and validated outcomes measures in order to be valid. By using the core set of quality indicators listed above, specific indicators were selected for ERCP (Table 4). RECOMMENDATIONS It is recommended that these quality indicators be tracked routinely on all patients undergoing ERCP. For some parameters, only a random sample of patients may need to be surveyed. For example, patient satisfaction may require sampling of patients on an intermittent basis to provide sufficient quality data. For other areas such as demographics, indications and intent, unplanned events, and technical success, all patients undergoing ERCP should be tracked. This is particularly true for unplanned events because their occurrence can be so variable. The task of tracking these quality indicators is made considerably easier by implementing an endoscopic data base program. CONCLUSIONS ERCP is one of the most technically complex endoscopic procedures. It is also associated with the

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greatest risk for procedure-related morbidity and mortality. Although the clinical benefits of ERCP have been firmly established, its effectiveness in routine clinical practice has only recently been addressed.6,9 The burgeoning interest in outcomes and quality assessment by both payers and patients indicates that the time has come to begin applying these methods to ERCP. The quality indicators outlined above represent the starting point in the quality assessment process, the ultimate goal of which is to improve patient care. REFERENCES 1. ASGE Ad Hoc Committee on Outcomes Research. Quality and outcomes assessment in gastrointestinal endoscopy. Gastrointest Endosc 2000;52:827-30. 2. ASGE. Principles of training in gastrointestinal endoscopy. Gastrointest Endosc 199;38:743-6. 3. Jowell PS, Baillie J, Branch S, Affronti J, Browning CL, Bute BP. Quantitative assessment of procedural competence: a prospective study of training in endoscopic retrograde cholangiopancreatography. Ann Intern Med 1996;125:983-9. 4. Cotton PB, Lehman G, Vennes JA, Geenen JE, Russell RC, Meyers WC, et al. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc 1991;37:383-93. 5. Eisen GM, deGarmo P, Brodner R, Lieberman DA. Can the ASA grade predict the risk of endoscopic complications? [abstract]. Gastrointest Endosc 2000;51:AB142. 6. Freeman ML, Nelson DB, Sherman S, Haber GB, Herman ME, Dorsher PJ, et al. Complications of endoscopic biliary sphincterotomy. N Engl J Med 1996;335:909-18. 7. ASGE. Appropriate use of gastrointestinal endoscopy. Gastrointest Endosc 2000;52:831-7. 8. Schutz SM, Abbott RM. Grading ERCPs by degree of difficulty: a new concept to produce more meaningful outcome data. Gastrointest Endosc 2000;51:535-9. 9. Freeman ML, Nelson DB, Eisen GM, DiSario JA, Snady HW, Overby CS, et al. Failures and complications of attempted therapeutic ERCP: impact on outcomes and costs [abstract]. Gastrointest Endosc 1998;47:AB114.

Prepared by: Ad Hoc Committee on Outcomes Research Committee Members: John F. Johanson, MD, MS, Chairman Greg Cooper, MD Glenn M. Eisen, MD, MPH Martin Freeman, MD Jay L. Goldstein, MD Dennis M. Jensen, MD Anand Sahai, MD, MS Colleen M. Schmitt, MD, MHS Philip Schoenfeld, MD, MS

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Appendix Patient satisfaction questions—modified from the GHAA 9 A number of questions are listed below regarding the visit you just made. In terms of your satisfaction, how would you rate each of the following: 1. How long you waited to get an appointment Excellent

Very good

Good

Fair

Poor

Fair

Poor

2. Length of time spent waiting at the office for the procedure Excellent

Very good

Good

3. The personal manner (courtesy, respect, sensitivity, friendliness) of the physician who performed your procedure Excellent

Very good

Good

Fair

Poor

4. The technical skills (thoroughness, carefulness, competence) of the physician who performed your procedure Excellent

Very good

Good

Fair

Poor

5. The personal manner (courtesy, respect, sensitivity, friendliness) of the nurses and other support staff Excellent

Very good

Good

Fair

Poor

6. Adequacy of explanation of what was done for you—all your questions answered Excellent

Very good

Good

Fair

Poor

Very good

Good

Fair

Poor

7. Overall rating of the visit Excellent

8. Would you have the procedure done again by this physician? Yes

No

9. Would you consider having this procedure done again at this facility? Yes

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No

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