Development and Evaluation of a Novel Instrument to Measure Severity of Intraoperative Events

Background Adverse events occur frequently in the operating rooms (OR) and often lead to morbidity, mortality, and increased healthcare costs. To better understand the nature, patterns, and impact of intraoperative events on patient outcomes, a reliable structured measurement of intraoperative events is essential. Methodology First, we performed a systematic review of published articles to synthesize evidence related to identification and detection of intraoperative events. Second, we performed a prospective cohort study of consecutive patients undergoing elective laparoscopic general surgery procedures to characterize intraoperative events using direct observation method. Third, we developed and evaluated a novel instrument to measure severity of intraoperative events and quality of associated rectification processes. Results In the systematic review, we found that frequencies of reported intraoperative events appeared to vary depending on the detection methods, with higher numbers reported when direct observations took place in the OR. When severity of intraoperative events was measured, most studies stratified it based on the seriousness of post-operative outcomes or the invasiveness of additional interventions required. Corrective processes to rectify intraoperative events were rarely assessed. In the prospective cohort study, we demonstrated that the surgical teams committed events frequently and encountered high amounts of auditory and cognitive distractions. Intraoperative events were classified as bleeding, mechanical, thermal, ischemic events and insufficient closure of anastomosis. We developed and evaluated a novel instrument to measure severity of intraoperative events on directly observed laparoscopic gastrointestinal operations called the SEVerity of intraoperative Events and REctifications (SEVERE). In its present format, the SEVERE index classifies events into five types and provides weighted item scores for severity and rectification of events. There is evidence of acceptable content validity and inter-rater reliability. It has yet to demonstrate evidence of criterion predictive validity. However, evidence of construct validity, specifically linking patient factors and procedure durations to SEVERE scores, exists. Conclusions We developed a novel instrument to measure severity of intraoperative events via direct observation method through a robust development phase and evaluated content and construct validity evidence. Once fully validated, the SEVERE index may prove to be a useful instrument in identifying patients at higher risk of developing post-operative complications.Ph.D