kaleo, Inc., Richmond, Virginia.
kaleo, Inc., Richmond, Virginia.
Ann Allergy Asthma Immunol. 2019 Sep;123(3):256-262. doi: 10.1016/j.anai.2019.06.005. Epub 2019 Jun 19.
Despite the importance of prompt epinephrine auto-injector (EAI) treatment during anaphylaxis, proper administration technique is often lacking among patients and caregivers.
To compare usability and participant preference of Auvi-Q and EpiPen Jr EAIs in a simulated life-threatening allergic emergency-use scenario.
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 child-sized 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.
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.
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 life-threatening allergic emergency.
尽管在过敏反应期间及时使用肾上腺素自动注射器（EAI）至关重要，但患者和护理人员通常缺乏正确的给药技术。
在模拟危及生命的过敏紧急情况下，比较 Auvi-Q 和 EpiPen Jr EAI 的可用性和参与者偏好。
在这项随机、交叉、人为因素可用性研究中，未经训练的成年人（18-65 岁）被要求使用 0.15 毫克 Auvi-Q 和 EpiPen Jr 训练器模拟对儿童大小的人体模型进行肾上腺素给药。参与者只能使用设备标签上的书面说明和/或设备语音说明。主要终点是根据设备说明完成注射任务（主要终点）、完成关键注射任务以及参与者对设备的偏好/评分。使用配对二分类数据的 McNemar 检验评估注射任务的完成情况。
96 名成年人纳入研究分析。使用 Auvi-Q 完成所有设备说明注射任务的参与者明显多于 EpiPen Jr（85.4% vs 19.8%；P <.001）。对于关键注射任务的完成情况也观察到显著差异（Auvi-Q，94.8%；EpiPen Jr，72.9%；P <.001）。使用 Auvi-Q 未观察到数字/手部注射错误，而 14 名参与者（14.6%）可能会意外接受 EpiPen Jr 的数字/手部注射（P <.001）。总体而言，与 EpiPen Jr 相比，更多参与者更喜欢 Auvi-Q（91.7% 对 6.3%；P <.001[2.1% 无偏好]）。Auvi-Q 的 8 项 EAI 特征的中位数评分也高于 EpiPen Jr。
在这项研究中，未经训练的成年人更喜欢并更有可能正确使用 Auvi-Q 而不是 EpiPen Jr，这强调了在危及生命的过敏紧急情况下成功给予肾上腺素时设备设计的重要性。
