Background: Despite the importance of prompt epinephrine auto-injector (EAI) treatment during anaphylaxis, proper administration technique is often lacking among patients and caregivers. Objective: To compare usability and participant preference of Auvi-Q and EpiPen Jr EAIs in a simulated lifethreatening allergic emergency-use scenario. Methods: In this randomized, crossover, human-factors usability study, untrained adults (18-65 years) were tasked with using 0.15 mg Auvi-Q and EpiPen Jr trainers to simulate epinephrine administration to a childsized manikin. Only written instructions on the device label and/or device voice instructions were available to participants. Endpoints included completing injection tasks per device instructions (primary endpoint), completing key injection tasks, and participant preference/ratings of devices. Completion of injection tasks were evaluated using a McNemar test for paired dichotomous data. Results: Ninety-six adults were included in study analyses. Significantly more participants completed all injection tasks per device instructions with Auvi-Q (85.4%) vs EpiPen Jr (19.8%; P < .001). Significant differences were also observed for completion of key injection tasks (Auvi -Q, 94.8%; EpiPen Jr, 72.9%; P < .001). No digital/hand injection errors were seen with Auvi-Q, whereas 14 participants (14.6%) would have accidentally received a digital/hand injection with EpiPen Jr (P < .001). Overall, significantly more participants preferred Auvi-Q over EpiPen Jr (91.7% vs 6.3%; P < .001 [2.1% no preference]). Median scores for 8 EAI characteristics were also higher for Auvi-Q vs EpiPen Jr. Conclusion: In this study, untrained adults preferred and were more likely to use Auvi-Q correctly vs EpiPen Jr, highlighting the importance of device design for successful epinephrine administration during a lifethreatening allergic emergency.

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RATIONALE: Anaphylaxis in infants and young children is increasing. Currently available epinephrine auto-injectors (EAIs) are not FDA approved for patients weighing <15 kg, and therefore, EAIs are prescribed off-label for these patients. Ultrasound studies suggest currently marketed 0.15 mg EAIs have needle lengths that may strike bone in ;29-43% of patients weighing <15 kg, resulting in possible intraosseous injection. An EAI with a shorter needle length has been developed to help potentially minimize the risk of striking bone during epinephrine injection in patients weighing 7.5 to 15 kg. A human factors usability study was completed to validate the 0.1 mg EAI user interface. METHODS: This study was conducted with parents of severely allergic children to evaluate simulated use of the 0.1 mg EAI by the intended user group. Fifteen participants were enrolled and received training on the 0.1 mg EAI. Approximately 24-hours later, participants completed a simulated emergency-use scenario using the 0.1 mg EAI with an infant mannequin. The primary endpoint was successful simulated administration of a meaningful epinephrine dose. RESULTS: All participants simulated administration of a meaningful epinephrine dose. Fourteen participants successfully used the 0.1 mg EAI per the instructions for use in the simulated emergency-use scenario. One participant did not press the device against the thigh for the length of time defined for this critical task; however, the device was pressed long enough for complete delivery of the 0.1 mg dose. CONCLUSIONS: This study validated the user interface of the 0.1 mg EAI for the intended users, uses, and use environments.

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Anaphylaxis in infants and young children is increasing. Historically, epinephrine auto-injectors (EAI) were not available in a dose or platform designed for patients who weighed <15 kg, and, therefore, 0.15-mg EAIs were prescribed for these patients. Results of ultrasound studies indicate that currently marketed 0.15-mg EAIs have needle lengths that may strike bone in ∼29 to 43% of patients who weigh <15 kg and result in possible intraosseous injection. An EAI with a more weight-appropriate 0.1-mg dose and shorter needle length has been developed to potentially help minimize the risk of striking bone during epinephrine injection in patients who weigh 7.5-15 kg. A human factors usability study was completed to validate the 0.1-mg EAI user interface. This study was conducted with parents of children who were severely allergic so to evaluate simulated use of the 0.1-mg EAI by the intended user group. Fifteen participants were enrolled and received training on using the 0.1-mg EAI. Approximately 24 hours later, the participants completed a simulated emergency-use scenario by using the 0.1-mg EAI with an infant manikin. The primary end point was successful simulated administration of a meaningful epinephrine dose. All the participants simulated administration of a meaningful epinephrine dose. Fourteen participants successfully used the 0.1-mg EAI per the instructions for use in the simulated emergency-use scenario. One participant did not press the EAI against the thigh for the length of time defined for this critical task; however, the EAI was pressed long enough for complete delivery of the 0.1-mg dose. This study validated the user interface of the 0.1-mg EAI for the intended users, uses, and use environments.

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RATIONALE: Despite increasing prevalence rates, anaphylaxis is underdiagnosed and undertreated by physicians, suggesting a gap in medical education. We hypothesized that the early introduction of anaphylaxis education into the medical school curriculum would improve students' knowledge of anaphylaxis diagnosis and management. METHODS: Third-year medical students were studied prospectively during their pediatric clerkship at a children's hospital. Students were randomly assigned to group A (didactic lecture plus simulation laboratory) or group B (didactic lecture only). All students completed a pre-test to assess baseline knowledge of anaphylaxis. All students then received a lecture on anaphylaxis, followed by a post-test. Group A then participated in a scripted anaphylaxis scenario in the Simulation Laboratory. All subjects completed a long-term follow-up test and satisfaction questionnaire 8-12 weeks later. RESULTS: A total of 87 students completed the study. Mean test scores improved significantly for both groups from pre-test (Group A: 5.93 6 1.70, Group B 5.86 6 1.44) to post-test (Group A 9.16 6 1.00, Group B 9.24 6 0.98), p <.01. However, long-term follow-up scores did not differ between Groups A (7.00 6 1.57) and B (6.93 6 1.76), p5.85. Most students reported a positive learning experience (97.8% of Group A and 76.2% of Group B). CONCLUSIONS: Although students strongly support simulation training for anaphylaxis education, the addition of a simulation module to didactic lecture does not improve long-term retention of anaphylaxis knowledge. Future studies should focus on other educational modalities that will enhance medical student knowledge of this potentially fatal condition.