Clinical outcome monitoring in a reproductive surgery unit: a prospective cohort study in 796 patients

Objective To systematically monitor the frequency and risk factors of adverse events (AEs) in a reproductive surgery endoscopy unit. Design Prospective cohort study. Setting Academic research institution. Patient(s) All consecutive surgical patients of a reproductive surgery unit from December 2005 to March 2007. Intervention(s) Monitoring for predefined AEs by trained observers. Main Outcome Measure(s) Number of preventable and not preventable AEs, medical errors, and system problems. Univariate analysis and multivariate logistic regression were used to identify risk factors of AEs. Result(s) Seven hundred ninety-six women were included. We identified 60 AEs in 45 patients (risk 6%; 95% confidence interval [CI] 1%–11%). Adverse events were postoperative fever (n = 1), wound breakdown (n = 1), intraoperative or postoperative administration of packed erythrocytes (n = 6), surgical revision (n = 7), unplanned readmission (n = 5), transfer to intensive care unit (n = 1), conversion (n = 8), intraoperative organ injury (n = 9), blood loss >500 mL (n = 3), surgery canceled (n = 15), and other AEs (n = 4). Six patients (risk 0.8%; 95% CI 0–2%) had multiple AEs. One (0.01%) and 11 (1.4%) AEs were deemed due to medical errors and system problems, respectively. Twelve and 48 AEs were deemed preventable and not preventable, respectively. In a univariate and multivariate analysis, only duration of surgery (odds ratio 3.78; 95% CI 1.95–7.33) was significantly associated with having an AE. Conclusion(s) Clinical outcome monitoring is a useful tool for assessing the outcome quality of reproductive surgery by identifying potentially preventable AEs and associated risk factors.