Table 3 Summary of findings table and GRADE evidence profile for safety tools in IR. The study design is already given in Table 2 and was included in the assessment of the quality
From: Avoiding adverse events in interventional radiology – a systematic review on the instruments
Study | Study subject | N | Effect | Outcome measure | Limitation | Quality according to GRADE |
|---|---|---|---|---|---|---|
Simulator training | ||||||
Cates et al. (2016) [19] | Intraoperative errors for carotid artery angiography | 6 study subjects (simulator trained operators) vs. 6 controls (traditional training) | 49% less intraoperative errors (p < 0.001) | Objectively classified intraoperative error | Small sample size | High |
Nawka et al. (2020) [20] | Dangerous maneuvers in 3 different aneurysm models | 3 experienced vs. 3 inexperienced operators | Less dangerous maneuvers in experienced group (median 0.0; 0.0–1.0 IQR) vs. inexperienced group (1.0; 0.0–1.5) (p = 0.014) | Dangerous maneuversa | In vitro study, small sample size | Very low |
Zaika et al. (2020) [21] | Time spent in incorrect vessel in simulation of R-MCA aneurysm | 8 clinical anatomy graduate students and 6 residents in neurosurgery and radiology specialties | Significant drop of time spent in incorrect vessel over 8 sessions (p < 0.05) | Pre-defined errors (any deviation from correct pathway)a | In vitro study, small sample size | Very low |
Zaika et al. (2023) [22] | Coiling mistakes in simulation of R-MCA aneurysm | 12 participants with minimal or no knowledge of endovascular skills and basic vascular background | Improvement after 6 sessions, but not statistically significant | Coiling errors (protrusion, perforation)a | In vitro study, small sample size | Low |
Team training | ||||||
Ramjeeawon et al. (2020) [23] | Errors during simulation of TEVAR before and after team training | One team simulation before and after training | No decrease of errors (p = 0.109) | Pre-defined errors | In vitro, small study sample | Low |
Checklist | ||||||
Fargen et al. (2013) [25] | Number of adverse events or near-misses before/ after implementation of a checklist in a neurointerventional department | 71 procedures before vs. 60 after implementation of checklist | Significant reduction of total number of adverse events or near-misses (p = 0.001) | Adverse events or near-misses | Low | |
Lutjeboer et al. (2015) [26] | Number of process deviations in pre-procedural planning and sign in for IR procedures when performing an appointment prior to procedure | 110 controls vs. experimental group | Reduction of mean number of process deviations from 0.39 to 0.06 (p < 0.001) | None | EVAR and neuro-interventions were excluded | Very low |
Siewert et al. (2022) [27] | Evaluation of effects after implementation of a postprocedural checkout list | 34 safety reports | Reduction of AEs (0.069% to 0.034%; 43% decrease, p = .05) Reduction of repeat procedures (0.040% to 0.007%; 80% decrease, p = 0.003) | Rate of AEs and repeat procedures | Very short pre-implementation period | Low |
Team Time Out | ||||||
Morbi et al. (2012) [24] | Number of failures before/ after implementation of a preprocedural team rehearsal for vascular interventional procedures | 55 procedures before and 33 after implementation of preprocedural team rehearsal | Decrease of preventable failures (54.6% vs. 27.3%) and failures per hour (18.8 vs. 9.2) (p < 0.001 for both) | Pre-defined failures | Assessed by a medical student with no prior technical knowledge | Low |