ABSTRACT
INTRODUCTION: The standard of care for reversal of opioid-induced respiratory depression associated with opioid overdose is injectable naloxone. This study compared the usability of two naloxone delivery devices, a naloxone auto-injector (NAI) and a naloxone intranasal delivery system (NXN), in the administration of naloxone during a simulated opioid overdose emergency. NAI (EVZIO (®) ; kaleo, Inc., Richmond, VA, USA) is a Food and Drug Administration approved single-use pre-filled auto-injector containing 0.4 mg of naloxone. METHODS: Study participants were randomly assigned to administer naloxone using NAI and NXN, sequentially. The primary endpoint was successful administration of a simulated dose of naloxone into a mannequin during a simulated opioid emergency, both before and after receiving training. Secondary endpoints included using the NAI or NXN in accordance with the instructions-for-use and the comparative measurement of successful completion time of administration for both NAI and NXN. RESULTS: A total of 42 healthy participants aged 18-65 years were enrolled in the study. The proportion of participants able to successfully administer a simulated dose of naloxone was significantly greater for NAI compared to NXN both before (90.5% vs. 0.0%, respectively, P < 0.0001) and after (100% vs. 57.1%, respectively, P < 0.0001) participant training. The proportion of participants able to administer a simulated dose of naloxone in accordance with the instructions-for-use was also significantly greater for NAI compared to NXN before (85.7% vs. 0.0%, respectively, P < 0.0001) and after (100% vs. 0.0%, respectively, P < 0.0001) participant training. The average time to task completion for administration attempt before training was 0.9 ± 0.25 min for NAI versus 6.0 ± 4.76 min for NXN and after training was 0.5 ± 0.15 min for NAI versus 2.0 ± 2.15 min for NXN. CONCLUSION: Laypersons experienced substantially greater success administering a simulated dose of naloxone, both before and after training, using NAI versus NXN during a simulated opioid overdose emergency. No participants correctly used NXN without training.
ABSTRACT
BACKGROUND: The Virtual Basic Laparoscopic Skill Trainer (VBLaST) is a developing virtual-reality-based surgical skill training system that incorporates several of the tasks of the Fundamentals of Laparoscopic Surgery (FLS) training system. This study aimed to evaluate the face and construct validity of the VBLaST system. MATERIALS AND METHODS: Thirty-nine subjects were voluntarily recruited at the Beth Israel Deaconess Medical Center (Boston, MA) and classified into two groups: experts (PGY 5, fellow and practicing surgeons) and novice (PGY 1-4). They were then asked to perform three FLS tasks, consisting of peg transfer, pattern cutting, and endoloop, on both the VBLaST and FLS systems. The VBLaST performance scores were automatically computed, while the FLS scores were rated by a trained evaluator. Face validity was assessed using a 5-point Likert scale, varying from not realistic/useful (1) to very realistic/useful (5). RESULTS: Face-validity scores showed that the VBLaST system was significantly realistic in portraying the three FLS tasks (3.95 +/- 0.909), as well as the reality in trocar placement and tool movements (3.67 +/- 0.874). Construct-validity results show that VBLaST was able to differentiate between the expert and novice group (P = 0.015). However, of the two tasks used for evaluating VBLaST, only the peg-transfer task showed a significant difference between the expert and novice groups (P = 0.003). Spearman correlation coefficient analysis between the two scores showed significant correlation for the peg-transfer task (Spearman coefficient 0.364; P = 0.023). CONCLUSIONS: VBLaST demonstrated significant face and construct validity. A further set of studies, involving improvement to the current VBLaST system, is needed to thoroughly demonstrate face and construct validity for all the tasks.
