Performance measures for upper gastrointestinal endoscopy: A European Society of Gastrointestinal Endoscopy quality improvement initiative

The European Society of Gastrointestinal Endoscopy (ESGE) and United European Gastroenterology (UEG) have identified quality of endoscopy as a major priority and we described our rationale for this in a first manuscript that also addressed the methodology of the quality initiative process.1 The identification of upper gastrointestinal (UGI) performance measures presents a considerable challenge, in contrast to the situation with colonoscopy for instance, where several performance measures (inspection time, adenoma detection rate, and interval cancers, among others) have been identified over the last decade.2, 3 Following the Quality in UGI Endoscopy meeting held in Lisbon in 2013, it was clear that there was a need to identify performance measures for the UGI tract, and that quality standards could be identified although there is a paucity of evidence. This lack of evidence helps however to identify research priorities for the development of clinical trials that will further validate and substantiate the implementation of performance measures. The aim therefore of the UGI working group was twofold: (a) to identify performance measures for UGI endoscopy; (b) to identify the evidence or absence of evidence that would develop the research priorities in this field. We used an innovative methodology to facilitate the quality initiative process, which combined a thorough search and standardized evaluation of the available evidence for each clinical question, followed by a Delphi process (http://is.njit.edu/pubs/delphibook/delphibook.pdf ) using an online platform.4, 5 This online platform permitted iterative rounds of modification and comment by all members of the UGI working group until agreement was reached on the performance measure. We now report these newly identified performance measures. We previously described the multistep process for the methodology to develop performance measures.1 Briefly, following the Lisbon meeting in 2013, a list of 56 possible performance measures was distributed to all of the working group members for comments, suggestions, and shortcomings in September 2014. Every participant was required to comment on all of the proposed performance measures during teleconferences that took place between 1 October–18 December 2014. All possible performance measures that were identified by this process were structured using the PICO framework (where P stands for population/patient; I for intervention/indicator; C for comparator/control; and O for outcome) to inform searches for available evidence to support the performance measures. This process resulted in 67 possible performance measures and 108 PICOs. Due to the timeframe for this first initiative and the wide range of pathology in the UGI tract, the working group had to prioritize general UGI endoscopy topics within the abundance of proposed performance measures and PICOs. As part of this prioritization, PICOs that were concerned with areas where guidelines were already available or under development were omitted. We also excluded PICOs that focused on: the assessment of effectiveness, or comparative effectiveness, of specific treatments (e.g. administration of proton pump inhibitors (PPIs) before endoscopy for acute bleeding, percentage of patients undergoing endoscopic resection in Barrett’s esophagus with high grade dysplasia (HGD) before ablation); legal or local regulation (informed consent); histopathology (e.g. the need for confirmation/revision of a diagnosis of dysplasia by an independent pathologist); and service working group issues (e.g. adequate management of anticoagulants, sedation, etc.). The initial priority list was developed during a face-to-face meeting on 14 February 2015. In total, 44 PICOs were retained as the basis for literature searches. Several disease-specific performance measures were also developed (Barrett’s esophagus, intestinal metaplasia in the stomach, and squamous cell cancer (SCC) in the esophagus). The PICOs, and the clinical statements derived from these which were organized into eight domains on the basis of their clinical applications, were adapted and/or excluded during the iterative rounds of comments and suggestions from the working group members during the Delphi process. The evolution and adaptation of the different PICOs and clinical statements during the Delphi process can be reviewed in the Supplementary Material. In total, working group members participated in four rounds of voting to agree on the performance measures in predefined domains and their respective thresholds, which are discussed below. The agreement that is given for the different statements refers to the last voting round in the Delphi process. A statement was accepted if at least 80% agreement was reached after a minimum of two voting rounds. The performance measures are displayed in boxes under the relevant domain. Each box describes the performance measure and the rationale behind its adoption, the agreement on acceptance during the modified Delphi process, and the grading of the available evidence, along with details of how the score should be measured and the desired threshold. During the Delphi process, the Quality Improvement Committee (QIC) chairs distinguished key performance measures from minor performance measures to assist service providers with decisions about the implementation of performance measures in their endoscopy services. Reasons to qualify a performance measure as minor included the measure being very disease specific (e.g. detection of neoplasia during surveillance of Barrett’s esophagus or gastric intestinal metaplasia) or that its implementation might be relatively difficult and dependent on the availability of adequate software for auditing of the performance measures. The division and allocation of performance measures to key and minor performance measures was agreed by the UGI working group in an additional face-to-face meeting in April 2016. The number of cases that need to be audited to adequately assess if the threshold for a certain performance measure is reached can be calculated by estimating the 95% confidence intervals (CIs) for a predefined threshold and variable sample size (see Appendix 1). For reasons of practicality and feasibility when implementing an audit, the working group agreed that 100 procedures (or all, if <100 procedures had been performed) should be measured to assess the performance measure. Ideally this should be done at an individual procedure level but, as this requires robust and sophisticated software, we suggest that the assessment is first performed at a service level. If problems are detected at a service level, further analysis at an individual level is then required to identify possible targets for improvement. In the first round of development, the working group accepted 11 performance measures in total, after a total of four voting rounds in the modified Delphi process. The evidence quality (assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria)6 for most of these performance measures is low; however, this does not indicate that a performance measure is not important. Taking into account both the feasibility of implementation and the possible impact on diagnostic quality and patient outcome, we identified six key and five minor performance measures (Figure 1 and Table 1 ). Nevertheless, all the performance measures were deemed valuable by the working group members and were obtained after a rigorous process, as described above. From a practical viewpoint, it may be desirable to implement the key performance measures first in those units that are not presently monitoring any performance measures. Once a culture of quality measurement is accepted and software is available, the minor performance measures may then further aid monitoring of the quality of UGI endoscopy. The domains and performance measures chosen by the working group. MAPS: management of precancerous conditions and lesions in the stomach; SCC: squamous cell carcinoma. All of the performance measures are described below, according to the domain to which they are attributed. The PICOs and statements that were used during the modified Delphi process to develop the performance measures can be found in the Supplementary Material. The statement numbers correspond to those used in Supplementary Material. Two studies were found that addressed these instructions and the duration of fasting prior to a scheduled UGI endoscopy.7, 8 In both studies, the authors mainly assessed the fasting time for liquids. The fasting time for solids was at least six hours prior to the endoscopy in both studies, with a on during endoscopy. 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