BACKGROUND AND AIMS OF THE STUDY
Gastrointestinal endoscopic procedures have evolved significantly in the last 50 years, thereby revolutionizing the diagnosis and treatment of gastroenterological diseases. Although using the body’s natural openings to access the region of interest skillfully bypasses disruption of superficial tissues or muscular planes, endoscopy remains an invasive technical procedure, which is thus associated with risks and complications. As a part of every quality program in medicine, tracking adverse events represents a quality indicator, which has been widely accepted as a monitoring measure. This study’s aim was to elaborate a practical system for reporting the endoscopic procedure-associated adverse events occurring in the department of gastroenterology of the Saint-Luc University Hospital.
PATIENTS AND METHODS
Two parallel tracking tools were chosen for the study: 1) a voluntary reporting of adverse events using a questionnaire filled in by the performing endoscopist; 2) a retrospective analysis of the patient electronic records regarding all procedure-related data, along with relevant post-procedural clinical, imaging, and surgical information in order to detect adverse events potentially missed by the first method. For the definition of “adverse events”, we referred to the American Society of Gastroenterology paper “A lexicon for endoscopic adverse events”. All endoscopic procedures carried out from February to April 2016 were included.
A total of 2,668 endoscopic procedures were reviewed. Overall, 52 adverse events were reported, 27 of which by the endoscopist. The adverse event rate was 1.01% according to the voluntary reporting system vs. 1.95% in the retrospective analysis (p-value <0.01). When stratifying adverse events by severity, it appeared that the voluntary reporting system mostly missed mild adverse events (mild adverse event incidence 0.3% vs. 0.9%; p-value <0.01). The adverse events were at times difficult to classify because of the lack of clear international definitions. For a descriptive purpose, we analyzed the incidence of commonly recorded adverse events (such as colonoscopy perforation rate, post-ERCP pancreatitis, post-polypectomy bleeding, and postmucosectomy perforation), and no difference in performance was found when compared to international guideline reports.
The adverse event tracking process proved to be a laborious and time-consuming task, and comparative analysis showed that voluntary reporting was unreliable. The retrospective analysis system was significantly more accurate, but it is hardly implementable in everyday practice because of the work load. We believe that a new electronic reporting system would facilitate post hoc analysis of adverse events. A major issue in this field is the lack of sharp international definitions of an “adverse event”, thus rendering any comparison difficult. In summary, more univocal comparative studies are required to obtain a definitive answer to the practical problems involved in the adverse event tracking process. However, the study provided major pointers for improving the quality of care in a large hospital setting.