Quality Indicators for ERCP

ACG: American College of Gastroenterology; ASGE: American Society for Gastrointestinal Endoscopy ERCP is one of the most technically demanding and high-risk procedures performed by GI endoscopists. It requires significant focused training and experience to maximize success and to minimize poor outcomes (1, 2). ERCP has evolved from a purely diagnostic to a predominately therapeutic procedure (3). ERCP and ancillary interventions are effective in the non-surgical management of a variety of pancreaticobiliary disorders, most commonly the removal of bile duct stones and relief of malignant obstructive jaundice (4). The American Society for Gastrointestinal Endoscopy (ASGE) has published specific criteria for training and granting of clinical privileges for ERCP, which detail the many skills that must be developed to perform this procedure in clinical practice with high quality (5, 6, 7). 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 (8). The particular parameter that is being used for comparison is termed a quality indicator. A quality indicator often is 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 (9). Quality indicators can be divided into 3 categories: (1) structural measures—these assess characteristics of the entire health care environment (e.g., rates of participation by a physician or other clinician in a systematic clinical database registry that includes consensus endorsed quality measures), (2) process measures—these assess performance during the delivery of care (e.g., rate of cannulation of the desired duct), and (3) outcome measures —these assess the results of the care that was provided (e.g., rates of adverse events such as pancreatitis after ERCP). METHODOLOGY In 2006, the ASGE/American College of Gastroenterology (ACG) Task Force on Quality in Endoscopy published the first version of quality indicators common to all endoscopic procedures (10). The present update integrates new data pertaining to previously proposed quality indicators and new quality indicators common to all endo-scopic procedures. We prioritized indicators that had wide-ranging clinical application, were associated with variation in practice and outcomes, and were validated in clinical studies. Clinical studies were identified through a computerized search of Medline followed by review of the bibliographies of all relevant articles. When such studies were absent, indicators were chosen by expert consensus. Although feasibility of measurement was a consideration, we 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, we recognize that, ultimately, only a small subset might be used widely 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) (11). 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: Grades of recommendationa (12)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 no data was available 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: preprocedure, 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, evidence that performance 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 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 either move to different quality indicators if endoscopists are performing above recommended thresholds, or the employer and/or teaching center could institute corrective measures and re-measure 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 (12). The pre-procedure, intra-procedure, and post-procedure indicators common to all endoscopy are listed in Table 2. Those common factors will be discussed in this document only insofar as the discussion needs to be modified specifically to relate to ERCP.Table 2: Summary of proposed quality indicators common to all endoscopic proceduresa (12)Preprocedure quality indicators The preprocedure period includes all contact between members of the endoscopy team and the patient before the administration of sedation. Common issues for all endoscopic procedures during this period include: appropriate indication, thorough administration of informed consent, risk assessment, formulation of a sedation plan, clinical decision making with regard to prophylactic antibiotics and management of antithrombotic drugs, and timeliness of the procedure (12). Preprocedure quality indicators specific to performance of ERCP include the following: 1. Frequency with which ERCP is performed for an indication that is included in a published standard list of appropriate indications and the indication is documented (priority indicator) Level of evidence: 1C+ Performance target: >90% Type of measure: process ERCP should be performed for appropriate indications as defined in previously published guidelines (3, 4, 13). An appropriate indication should be documented for each procedure, and when it is a nonstandard indication the reasons for this should be made sufficiently clear in the documentation. Discussion: The indications for ERCP are covered in detail in separate publications (13, 14). Table 3 contains a list of the vast majority of acceptable indications for ERCP (15). Table 4 contains a list of all proposed quality indicators for ERCP. The task force selected a higher performance target for ERCP (>90%) as opposed to other endoscopic procedures (>80%) to reflect the higher incidence of serious adverse events after ERCP. Clinical settings in which ERCP is generally not indicated include the following:Table 3: Appropriate indications for ERCP (15)Table 4: Summary of proposed quality indicators for ERCPaAbdominal pain without objective evidence of pancrea-ticobiliary disease by laboratory or noninvasive imaging studies (16, 17). In this setting, the yield of ERCP is low, the risk of adverse events is significant, and those adverse events are disproportionately severe (18). When considered in this patient group, ERCP should be undertaken only after appropriate patient consultation and consent. If the diagnosis of sphincter of Oddi dysfunction is being considered, ERCP generally should be performed in a setting capable of performing sphincter of Oddi manometry and placing prophylactic pancreatic stents, although the efficacy of manometry in this setting has not been estab-lished (19, 20). A recent, randomized, controlled, multicenter, clinical trial (EPISOD) presented in abstract form suggested that ERCP is not likely to be efficacious in sphincter of Oddi type III in which there are no objective measures of pancreaticobiliary pathology (21). Routine ERCP before cholecystectomy. Preoperative ERCP in patients undergoing cholecystectomy should be reserved for patients with cholangitis or biliary obstruction or the presence of bile duct stones as confirmed by imaging studies or highly suspected by clinical criteria (22, 23). Relief of biliary obstruction. ERCP is not generally indicated for relief of biliary obstruction in patients with potentially resectable malignant distal bile duct obstruction in whom surgical resection will not be delayed by neoadju-vant therapy or other preoperative assessments or treatments. Preoperative biliary decompression has not been shown to improve postoperative outcomes in patients who are to proceed directly to surgery, and it may worsen outcomes according to some studies, although in current clinical practice preoperative biliary decompression is widely performed (24). Most patients with pancreatic cancer undergo preoperative biliary drainage for tissue acquisition via brushing, to relieve pruritus, to allow for neoadjuvant chemoradiation therapy, or to accommodate delays before surgery, including preoperative evaluation and optimization, and this should be considered appropriate care (25). 2. Frequency with which informed consent is obtained, including specific discussions of risks associated with ERCP, and fully documented Level of evidence: 1C Performance target: >98% Type of measure: process In addition to the risks associated with all endo-scopic procedures, the consent should address the relevant and substantial adverse events pertaining to each specific ERCP consent for ERCP should on adverse (1) (2) (3) and It is also that patients be informed of the that the procedure may not be and that procedures may be The patient should be informed that adverse events could be severe in Discussion: ERCP adverse events are from those that with standard endoscopy. A review of the adverse events specific to ERCP has been published previously The rate of pancreatitis is generally between and for most patients are in which this rate may be significantly most in patients with or suspected sphincter of Oddi events in these patients can approach to with severe pancreatitis also being likely and may the risk for pancreatitis and need to be into when endoscopists are for the procedure and informed consent. in of patients after ERCP, and to of is most commonly an adverse of endoscopic and has been reported to in to of may be or The incidence of during ERCP has been reported to be to Frequency with which appropriate antibiotics for ERCP are for settings in which they are indicated Level of evidence: Performance target: >98% Type of measure: process antibiotics for ERCP are for settings in which they are as in published guidelines Discussion: guidelines for the administration of antibiotics before ERCP been published In preprocedure antibiotics for ERCP should be considered in patients with or suspected biliary obstruction in which relief of the obstruction is not as with or in patients undergoing after patients with patients with pancreatic and in other clinical should be considered in patients who the risk of Frequency with which ERCP is performed by an who is fully and to perform ERCP Level of evidence: 3 Performance target: >98% Type of measure: process Discussion: Although all endoscopy must be performed by individuals who are and in order to and effective quality this has particular for ERCP because of the higher of the procedure and rate of severe adverse also that of and procedure outcomes with to adverse events Frequency with which the of performed is Level of evidence: 1C Performance target: >98% Type of measure: process Discussion: ERCP has been associated with in procedure success rates and adverse rates should be An group that endoscopists with had success rates and adverse events during ERCP performing higher procedure has shown that endoscopists who performed one had significantly adverse When with those who performed ERCP procedures, endoscopists who performed can be as a surrogate for performing ERCP procedures had rates of all adverse events and severe adverse events Although the procedure success rates and adverse rates are direct measures of an individual quality in ERCP, this and other ERCP benchmarking data that individual may such outcomes should be the of performance measures will based on the of For the bile duct cannulation rate may not be a for an individual who only a small number of For that it is important to of procedure to outcome Preprocedure research questions often is ERCP performed of clinical often are prophylactic antibiotics when needed for is the incidence of when antibiotics are not as many are to performance data for parameters such as rate and adverse rates training and/or procedure experience associated with current quality indicators The period for ERCP from the administration of sedation to the removal of the period includes all the of the procedure including of the and of therapeutic Common to most endo-scopic procedures is the of sedation and need for patient monitoring (12). quality indicators specific to performance of ERCP include the following: Frequency with which cannulation of the of is documented Level of evidence: 1C Performance target: >98% Type of measure: process Frequency with which cannulation of the of in patients with without is and documented (priority indicator) Level of evidence: 1C Performance target: >90% Type of measure: process Discussion: of the desired duct is the of ERCP. The of cannulation of the desired duct should be in all cannulation rates should benchmark cannulation rates for patients with similar of the duct of with a high success rate and with associated adverse rate is by in ERCP and requires training and experience in ERCP. cannulation is when the of the a is the into the desired effective of to the duct of and the of to perform diagnostic and therapeutic cannulation may the need for a ERCP or to the with resultant of from the that cannulation rates are by and rates are a goal of training in ERCP, although these data include patients who biliary and are of data that biliary success rates in patients with only is a of and the to perform ERCP after training although is an appropriate target for no consensus has yet been as to the benchmark in cannulation success rates to a quality ERCP A with a that cannulation rates in practice, may be the and also significant in cannulation rates the developed the expert consensus of the task force on this and review of the literature published before that with cannulation rates should undergoing training or their ERCP of cannulation rates for most should that because of sedation, such as and and obstruction of the and the The cannulation rate should be measured specifically in patients with rates in patients who should not be the outcome indicator for cannulation is to patients with In for all ERCP endoscopists should to the duct of in >90% of ERCP procedures of to ERCP based on In the such by may quality in ERCP patient (19, It has been suggested that ERCP endoscopists with of should not or difficult ERCP without the of a but this approach has not been validated Frequency with which time and are measured and documented Level of evidence: Performance target: >98% Type of measure: process time or should be for all Discussion: ERCP, by requires to the this should be to the to allow the procedure to be in a and manner in with the as has that endoscopists significantly when with those of endoscopists It should be that different will different amounts of and that the of the number of can significantly the which is to be a measure factors that include patient use of of patient to the and some ERCP procedures are difficult and a time and a time and are by the and can be into the ERCP procedure if available. Frequency with which common bile duct stones in patients with bile duct are and documented (priority indicator) Level of evidence: 1C Performance target: Type of measure: outcome Discussion: For of the should document is The should include stones presence of and presence of to allow in benchmarking efforts. The rate of common bile duct should be and rates should benchmark rates for patients with similar endoscopy can achieve bile duct rate for all bile duct stones in of patients includes large stones and includes use of such as or when standard It should be that ERCP endoscopists can clear the duct of small to common bile duct stones to in in >90% of by and or in patients with biliary As with cannulation outcome, this indicator is defined for stones of a particular and patients with for difficult stones stones above duct and stones in patients with should be as and benchmarking efforts should outcome similar clinical In the of difficult one for endoscopists is to a to allow for biliary and of the patient to a Frequency with which for biliary obstruction in patients with obstruction is the is and documented (priority indicator) Level of evidence: 1C Performance target: Type of measure: outcome Discussion: for of a biliary to an obstruction most commonly include or large common bile duct and Relief of obstructive jaundice from pancreatic cancer or other of biliary obstruction a common indication for ERCP. Relief of biliary obstruction is in those with cholangitis and in patient with clinical jaundice biliary has and of For of the should document or not is The should include indication, and and the presence of to allow in benchmarking efforts. in patients with obstructive the is technically to achieve in those with obstruction. ERCP should be to a biliary for relief of biliary obstruction in >90% of patients indicator is defined because of available benchmarking data for the in patients with rates for in other difficult such as and should be for benchmarking will allow specific performance targets to be for these indications in the research questions accurate is an a of the of the ERCP in success the use of associated with cannulation rates or need for procedures in clinical are the direct and to the health care for a can preprocedure imaging and the success of therapeutic is an acceptable rate of during ERCP for the indication of suspected stones in the of and there an association between success rate in the of pancreatic duct to pancreatitis or biliary cannulation and ERCP In the is the success rate for placing pancreatic duct effective are efforts by success rates or high adverse rates in ERCP, and are the most effective to address these quality indicators The period from the time the is to include to the of the procedure, and of adverse of results to the follow-up of and patient (12). quality indicators specific to the performance of ERCP include the following: Frequency with which a ERCP that the specific performed, particular and all outcomes is Level of evidence: 3 Performance target: >98% Type of process ERCP should document cannulation if of key of the procedure should be or not the goal of the procedure was also should be The should clearly the events and outcome of the Discussion: The ERCP procedure should document cannulation of the desired duct was and type of was used to or should be included in the if the although this may not be the in all of identified is considered by the task with and endoscopic is the ideal to objective evidence of was performed during the Frequency of cannulation and of the pancreatic duct also should be in the procedure other of a procedure are discussed in the document quality indicators common to all GI endoscopic procedures (12). of these who are directly with patient care to appropriate on patient Frequency with which adverse events and are documented Level of evidence: 3 Performance target: >98% Type of measure: process adverse events are reported in the procedure with the management Discussion: adverse events should be and pancreatitis are the outcomes of of pancreatitis (priority indicator) Level of evidence: 1C Performance target: Type of measure: outcome The incidence of pancreatitis should be and Discussion: pancreatitis rates are on the type of ERCP who perform sphincter of Oddi manometry are likely to higher rates of pancreatitis with those of who do The current rate of pancreatitis in clinical practice is and by and experience as as the type of ERCP procedures being for that it is difficult to a performance target for all for this indicator. pancreatitis is defined as pain after ERCP with with a and of the of rates of pancreatitis are commonly to certain high-risk patient such as those with or suspected sphincter of Oddi dysfunction and those undergoing pancreatic who may for pancreatitis including pancreatic or prophylactic use of (16, It should be that the value of this in patients with sphincter of Oddi function is not if the use of should be It is this time should be used in all or selected and type of Level of evidence: Performance target: Type of measure: outcome The rate of should be and Discussion: during ERCP with a between and of the and can be with management by duct or pancreatic duct although can be via and although may if endoscopic is not small of the can be if they are which can be will surgical risk factors for during ERCP include or sphincter of Oddi biliary and procedures In patients undergoing ERCP who the rate is may from of the or from from or of or from other therapeutic procedures. may be or the of performed to individual rates is and may be of clinically significant after or in patients undergoing ERCP Level of evidence: 1C Performance target: Type of measure: outcome The rate of should be and Discussion: has been shown via to in of cases, with most can be or and many to achieve endoscopic for identified rates are in patients who are data to on rates in patients some of the may be used in patients undergoing ERCP Most is related to or the use of generally is defined as endoscopic or other or delayed by clinical evidence as with a in or need for after ERCP The rate of can be as high as factors that the risk of include therapy 3 after the procedure, and However, the risk of is higher when other therapeutic are performed, such as and drainage The risk of from a diagnostic ERCP or therapeutic ERCP without or (e.g., is in patients who are Frequency with which patients are or to and the of delayed adverse events after ERCP Level of evidence: 3 Performance target: >90% Type of process to contact patients should adverse events and will with data Discussion: Most a for with and these often or other often routine follow-up to patients to after endoscopy. may to review pathology results and to or to follow-up on adverse events identified in the routine follow-up to and improve the of delayed data on adverse events should outcome data for this procedure in the efforts to patients may the of the research questions are the rates of and in the procedure indication and of adverse routine use of the of adverse it the success rate of the are the rates of delayed adverse events patients therapy after and is the most effective to and post-procedure adverse indicators for ERCP For ERCP, the recommended priority indicators are appropriate indication, cannulation success success and of pancreatitis (Table For each of these the recommended performance target is associated with important clinical indicators can be measured in a number of and for each there is evidence of substantial variation in performance quality indicators for individuals who are made of procedure outcomes, and corrective measures can improve The of quality indicators is to improve patient care by poor who then might be given an opportunity for training or to perform ERCP if performance be The task force has to a comprehensive list of quality indicators for ERCP. We recognize that not indicator is to practice We that endoscopists who perform ERCP on quality indicators most related to outcomes or on the outcomes such as rate of success rates of and and rates of such as the rates of ERCP, and also should be if The task force that the quality indicators be in continuous quality improvement of performance can be used to endoscopists and/or for training and monitoring can be undertaken to document improvement in task force to a in which quality improvement in ERCP will be