Aim: To assess the performance of a prospective adverse event (AE) reporting system.
Materials And Methods: Four hundred and seventy-one consecutive arterial procedures were performed in 465 patients (median age, 65 years; interquartile range, 54-77; 276 men) over 2 years by four interventional radiologists at a single centre where clinical follow-up was not performed routinely by interventional radiology (IR). AEs were reported prospectively using a radiology information system or in interventional radiologists' electronic records and combined in a departmental listing of adverse events (DLAE). A retrospective medical record review was performed to identify a reference standard list of AEs for this observational cohort study. AEs were graded according to the Society of Interventional Radiology AE classification system. Descriptive statistics were calculated for the performance of the DLAE. A model comparing the rate of reporting of AEs with and without integration of clinical follow-up was tested for significance.
Results: Thirty-eight of the 471 (8%) IR procedures had an AE according to the reference standard. The DLAE identified 20/38 (53%) of AEs (K=0.67 [good agreement], 95% confidence interval [CI] agreement=0.53-0.81; p=0.0001; sensitivity 52.6% [95% CI, 36-69%], specificity 100% [95% CI, 99-100%], positive predictive value [PPV] 100%, negative predictive value [NPV] 96 [95% CI, 94.5-97%], accuracy 96% [95% CI, 94-97%]). The performance of the AE reporting system will improve with integration of clinical follow-up (p=0.0015).
Conclusion: A prospective AE reporting system without clinical integration will not detect all procedure complications.
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