Health Claim Medical Evaluation Chair BSB, University of Dijon, Dijon, France -
Health Claim Medical Evaluation Chair BSB, University of Dijon, Dijon, France.
Panminerva Med. 2018 Jun;60(2):52-59. doi: 10.23736/S0031-0808.18.03423-7. Epub 2018 Mar 6.
ZENEO® (Crossject, Dijon France) is a novel prefilled, disposable needle-free auto-injector (AI) device under development for drug deliverer in a variety of routine-use or emergency situations. At present, reported user experience and patient preferences are limited. To determine what impact different forms of user instructions may have on successful use of the ZENEO® device.
We conducted a human factors study on 134 healthy volunteers. On enrolment, subjects were provided with different instructive training material; a device quick guide plus either use of a dummy training device, an illustrated leaflet, or a demonstration video. After 6 weeks, subjects returned and performed an unaided simulated injection, and compliance with specific steps necessary for successful use, and avoidance of actions that interfere with appropriate use was recorded by an investigator.
Most subjects (93.3%) successfully performed a simulated injection without major errors (regardless of type of educational instructions), and the great majority (97.5%) reported no difficulty in a range of objective measures of important necessary steps. Compliance with necessary steps and avoidance of detrimental actions was greater in those subjects with prior access to a demonstration video or provided with an illustrated patient leaflet. Prior experience with a dummy training device provided little if any benefit. User satisfaction with the device was high.
The results show that the ZENEO® device can be effectively used with a conventional suite of printed user instructions. Use of a demonstration video provides additional value, whereas use of a dummy training device had limited value.
ZENEO®（Crossject，法国第戎）是一种新型的预充式、一次性无针自动注射器（AI），正在开发中，可用于各种常规或紧急情况下的药物输送。目前，报告的用户体验和患者偏好有限。为了确定不同形式的用户说明对 ZENEO®设备成功使用的影响。
我们对 134 名健康志愿者进行了一项人为因素研究。在入组时，受试者提供了不同的指导培训材料；设备快速指南，外加使用模拟训练装置、插图传单或演示视频。6 周后，受试者返回并进行了未经协助的模拟注射，记录了调查员对成功使用所需特定步骤的依从性以及避免干扰适当使用的操作。
大多数受试者（93.3%）成功进行了模拟注射，没有重大错误（无论使用何种教育指导），绝大多数（97.5%）报告在一系列重要必要步骤的客观测量中没有困难。在那些之前看过演示视频或提供过患者插图传单的受试者中，遵守必要步骤和避免有害操作的比例更高。使用模拟训练装置的经验几乎没有提供任何好处。对设备的用户满意度很高。
结果表明，ZENEO®设备可以有效地与一套常规的印刷用户说明一起使用。使用演示视频提供了额外的价值，而使用模拟训练装置的价值有限。
