Special articleA lexicon for endoscopic adverse events: report of an ASGE workshop
Section snippets
Goals of the workshop
The overall goal of the workshop was to make recommendations about the data points and menus for AEs and for risk factors that should be incorporated into endoscopy reporting systems. To do so, the group was charged to do the following:
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Provide clear definitions for AEs.
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Define levels of severity, including the minimum threshold at which an AE should be documented and thus be counted and reported.
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Consider how to deal with delayed events, in particular, the issues of timing and attribution.
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Be
What systems are now in use for documenting AEs of interventions?
Several authors have attempted to address these issues over the years. Cotton16 and Fleischer17 made general suggestions for thresholds, attribution, and severity of AEs, but these were not sufficiently specific. However, recommendations from a subsequent consensus workshop on ERCP complications have been used in many studies and publications.18 Fleischer et al19 proposed the outcome, disability, death (ODD) scoring system, for all endoscopic procedures, based on detailed documentation of 3
What defines an AE? thresholds for reporting and severity grading
Some things that happen during procedures are relatively trivial (eg, brief hypoxia, bleeding at polypectomy that is self-limited or easily treated endoscopically). Patients are unaware of such events, which do not prevent the completion of the planned procedure and have no sequelae. These incidents should be documented so that quality improvement processes can be applied and to assess whether they predict subsequent AEs. However, they are not significant enough clinically to be called AEs and
Delayed events: Timing and attribution
Dealing with delayed events is particularly challenging, both in collecting the data and interpreting them.11, 12 Studies have shown that many more AEs are found when patients are contacted at 30 days.9, 27, 28, 29 However, the longer the delay is, the greater the chance that the event is not causally connected. This is especially true after the simplest endoscopic procedures and when other procedures have occurred in the intervening period.
The simplest answer to this problem would be to mirror
Keeping track of delayed events
Recording AEs that occur after patients leave the procedure unit is a challenge. This is true particularly for referral centers whose patients often come from long distances (and it is these centers that most often publish their data). Some countries have integrated medical information systems that allow all patient encounters to be tracked, so that it is possible to link admissions to recent procedures, and thereby to produce reliable data on the more serious delayed events.31 In the United
Recommendations: Proposed data sets and definitions
Definitions and severity criteria should be generic across the different endoscopic procedures, although certain events will occur only after some of them (eg, pancreatitis after ERCP). We make a distinction between incidents and AEs.
Conclusions and next steps
This lexicon is published so that it can be tested and improved. We recommend its incorporation in endoscopy studies and reporting systems. In addition, we propose a large prospective collaborative study to evaluate the results of its use in practice and to correct any deficiencies. A variety of centers with different spectra of practice should institute these definitions and rules, and contact their patients after 21 days. This will show which delayed events occur, when (and whether any appear
Acknowledgment
The workshop was organized by the ASGE Quality Task Force, and the report is endorsed by the ASGE Governing Board.
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DISCLOSURE: The followingauthors disclosed financial relationships relevant to this publication: P.B. Cotton: Cook Endoscopy: Consultant, device royalties, CME support; Boston Scientific: fellowship, device royalties, CME support; Olympus America: consultant, Board of Charitable Foundation; CME support. Barosense USA: Advisory board, consultant. B. Peterson: Boston Scientific: Consultant and investigator; Enteromedics: consultant. Apollo Endosurgery IUSA: Consultant, equity. K. Mergener: Olympus: Consultant/speaker; Ethicon Endosurgery: Consultant; Cook Medical: Speaker. I. Pike: Olympus: Consultant. J. Romagnuolo: Olympus: Consultant; Cook Medical: lecture honoraria. J.J. Vargo: Ethicon Endosurgery: Consultant; Olympus: consultant.
Current affiliations: Digestive Disease Center (P.B.C.), Department of Gastroenterology and Hepatology (J.R.), Medical University of South Carolina, Charleston, South Carolina, Oregon Health and Science University (G.M.E.), Portland, Oregon, Rikshospitalet University Hospital (L.A.), Oslo, Norway, Divisions of Gastroenterology and Hepatology (T.H.B., B.T.P.), Mayo Clinic, Rochester, Minnesota, Massachusetts General Hospital (M.M.H.), Boston University School of Medicine (B.C.J.), Boston, Massachusetts, Digestive Health Specialists (K.M.), Tacoma, Washington, Northwestern Memorial Hospital (A.N.), Chicago, Illinois, Gastroenterology (J.L.P.), Sansum Clinic, Santa Barbara, California, Gastrointestinal and Liver Specialists of Tidewater, PLLC (I.M.P.), Virginia Beach, Virginia, University of Toronto (L.R.), Toronto, Ontario, Canada, Section of Advanced Endoscopy (J.J.V.), Department of Gastroenterology and Hepatology, Digestive Disease Institute, Cleveland Clinic Foundation, Cleveland, Ohio