SPECIAL ARTICLE A lexicon for endoscopic adverse events: report of an ASGE workshop Peter B. Cotton, MD, FRCP, FRCS, Glenn M. Eisen, MD, MPH, Lars Aabakken, MD, Todd H. Baron, MD, Matt M. Hutter, MD, Brian C. Jacobson, MD, MPH, Klaus Mergener, MD, PhD, CPE, Albert Nemcek Jr, MD, Bret T. Petersen, MD, John L. Petrini, MD, Irving M. Pike, MD, Linda Rabeneck, MD, MPH, FRCPC, Joseph Romagnuolo, MD, MScEpid, FRCPC, John J. Vargo, MD, MPH Charleston, South Carolina, Portland, Oregon, Oslo, Norway, Rochester, Minnesota, Boston, Massachusetts, Tacoma, Washington, Chicago, Illinois, Santa Barbara, California, Virginia Beach, Virginia, Cleveland, Ohio, USA, Toronto, Ontario, Canada Patients and practitioners expect that their endoscopy procedures will go smoothly and according to plan. There are several reasons why they may be disappointed. The procedure may fail technically (eg, incomplete colono- scopy, failed biliary cannulation). It may seem to be suc- cessful technically but turn out to be clinically unhelpful (eg, a diagnosis missed, an unsuccessful treatment), or there may be an early relapse (eg, stent dysfunction). In addition, some patients and relatives may be disappointed by a lack of courtesy and poor communication, even when everything otherwise works well. The most feared negative outcome is when something ‘‘goes wrong’’ and the patient experiences a ‘‘complica- tion.’’ This term has unfortunate medicolegal connota- tions and is perhaps better avoided. Describing these deviations from the plan as ‘‘unplanned events’’ fits nicely with the principles of informed consent, but the term ad- verse events (AEs) is in common parlance. AEs can occur before the endoscope is introduced (eg, a reaction to prophylactic antibiotics or the bowel cleans- ing preparation), during the procedure (eg, hypoxia), im- mediately afterward (eg, pain caused by perforation), a few hours later (eg, pancreatitis after ERCP), or can be delayed for several days or weeks (eg, aspiration pneumo- nia, delayed bleeding). Some events (eg, viral transmis- sion) may be so far delayed that the connection is difficult to make or is missed completely. There is substantial literature describing individual AEs and many large collected series. 1-11 What is lacking is a standardized nomenclature and agreed-on definitions for AEs. For example, what is meant by hypoxia or bleed- ing or infection? At what level do they become significant enough to be counted? Another major issue is how to clas- sify and report delayed events, which may or may not be attributable to the procedure. This lack of standardization has many consequences. 12 It hampers the comparison of data from different research and quality improvement studies. It makes individual stud- ies suspect because practitioners may not be consistent in their own perceptions and definitions. Furthermore, it makes it impossible to compare endoscopic outcomes with those from other disciplines such as surgery. The need for standardized nomenclature has come into closer focus recently with the increasing use of electronic report writers, which demand a lexicon. In pursuing quality outcomes, it would also be helpful to document the factors that may increase the risk of en- doscopic procedures. Many of these risk factors are known, 11 but there is no consensus on a data set with which to describe them and no link to those used in other disciplines. The American Society for Gastrointestinal Endoscopy (ASGE) has played a leadership role in enhancing the quality of endoscopic practice and has made numerous recommendations about the metrics of quality and how Abbreviations: AE, adverse event; ASA, American Society of Anesthesiol- ogists; ASGE, American Society for Gastrointestinal Endoscopy; CNS, central nervous system; CTCAE, Common Terminology Criteria for Adverse Events; HI-IQ, Health & Inventory Information for Quality; MST, minimum standard terminology; NIH, National Institutes of Health; NSQIP, National Surgical Quality Improvement Program; ODD, outcome, disability, death; OMED, World Organisation of Digestive Endoscopy; SNOMED CT, Systematized Nomenclature of Medicine–Clinical Terminology. DISCLOSURE: The following authors 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. Copyright ª 2010 by the American Society for Gastrointestinal Endoscopy 0016-5107/$36.00 doi:10.1016/j.gie.2009.10.027 446 GASTROINTESTINAL ENDOSCOPY Volume 71, No. 3 : 2010 www.giejournal.org