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首页> 外文期刊>Patient Preference and Adherence >Evaluation of performance, acceptance, and compliance of an auto-injector in healthy and rheumatoid arthritic subjects measured by a motion capture system
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Evaluation of performance, acceptance, and compliance of an auto-injector in healthy and rheumatoid arthritic subjects measured by a motion capture system

机译：通过运动捕捉系统对健康和类风湿关节炎受试者的自动注射器的性能，可接受性和依从性进行评估

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Purpose: The study aimed to develop a motion capture system that can track, visualize, and analyze the entire performance of self-injection with the auto-injector. Methods: Each of nine healthy subjects and 29 rheumatoid arthritic (RA) patients with different degrees of hand disability performed two simulated injections into an injection pad while six degrees of freedom (DOF) motions of the auto-injector and the injection pad were captured. We quantitatively measured the performance of the injection by calculating needle displacement from the motion trajectories. The max, mean, and SD of needle displacement were analyzed. Assessments of device acceptance and usability were evaluated by a survey questionnaire and independent observations of compliance with the device instruction for use (IFU). Results: A total of 80 simulated injections were performed. Our results showed a similar level of performance among all the subjects with slightly larger, but not statistically significant, needle displacement in the RA group. In particular, no significant effects regarding previous experience in self-injection, grip method, pain in hand, and Cochin score in the RA group were found to have an impact on the mean needle displacement. Moreover, the analysis of needle displacement for different durations of injections indicated that most of the subjects reached their personal maximum displacement in 15?seconds and remained steady or exhibited a small amount of increase from 15 to 60?seconds. Device acceptance was high for most of the questions (ie, >4; >80%) based on a 0–5-point scale or percentage of acceptance. The overall compliance with the device IFU was high for the first injection (96.05%) and reached 98.02% for the second injection. Conclusion: We demonstrated the feasibility of tracking the motions of injection to measure the performance of simulated self-injection. The comparisons of needle displacement showed that even RA patients with severe hand disability could properly perform self-injection with this auto-injector at a similar level with the healthy subjects. Finally, the observed high device acceptance and compliance with device IFU suggest that the system is convenient and easy to use.
机译：目的：该研究旨在开发一种运动捕捉系统，该系统可以跟踪，可视化和分析自动注射器的自我注射的整体性能。方法：9名健康受试者和29名手部残疾程度不同的类风湿性关节炎（RA）患者分别对注射垫进行了两次模拟注射，同时捕获了自动注射器和注射垫的六个自由度（DOF）运动。我们通过从运动轨迹计算针头位移来定量测量注射性能。分析了针头位移的最大值，平均值和标准差。通过调查问卷和对是否遵守设备使用说明（IFU）的独立观察来评估设备的可接受性和可用性。结果：总共进行了80次模拟注射。我们的结果显示，在所有受试者中，RA组的针头移位稍大但无统计学意义，表现相似。特别是，在RA组中，以前的自我注射，握法，手部疼痛和Cochin评分方面的经验没有发现对平均针头移位有影响的显着影响。此外，对不同注射持续时间的针头位移的分析表明，大多数受试者在15秒内达到其个人最大位移，并保持稳定或表现出从15秒到60秒的少量增加。基于0-5分的评分或接受百分比，大多数问题的设备接受度都很高（即，> 4;> 80％）。第一次注射对设备IFU的总体依从性很高（96.05％），第二次注射达到98.02％。结论：我们证明了跟踪注射运动以测量模拟自注射性能的可行性。针头位移的比较显示，即使是严重手部残疾的RA患者也可以使用这种自动注射器以与健康受试者相似的水平正确进行自我注射。最后，观察到的高设备接受度和对设备IFU的遵从性表明，该系统既方便又易于使用。

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