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Results of a human factors experiment of the usability and patient acceptance of a new autoinjector in patients with rheumatoid arthritis

机译:人类因素对类风湿关节炎患者使用新的自动注射器的实验结果

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Purpose: This study evaluated the human factors affecting the ease of use of a disposable autoinjector developed for subcutaneous self-injections performed by patients with chronic diseases. Materials and methods: This was a randomized, single-center study conducted with 65 patients with rheumatoid arthritis. Patients performed six simulated injections. Assessments of patient device acceptance and device usability were made by patient reports and independent observations of compliance with the device instruction for use (IFU) following single injections and repeated injections. Results: A total of 390 simulated injections were performed. Patient device acceptance was high; more than 90% of patients found each of the tested criteria to be acceptable (>80% was required for statistical significance; P<0.016). Perceived ease of use and simplicity of the three-step process resulted in high acceptance scores: mean scores (± standard deviation) were 8.71 (±1.18) and 8.05 (±0.37), respectively, on a 0–10-point scale. Patients also expressed their acceptance with the ease and usefulness of the detection of the remaining drug in the autoinjector. In addition, 80% of patients declared that they would recommend the device to someone else. Globally, the human factors tested (age, sex, hand disability [Cochin score], extent of previous experience with self-injection [ie, expert or na?ve]) had no impact on IFU device compliance. In particular, the lack of a Cochin score interaction indicated that the degree of hand disability is not a predictive factor of poor self-injection capability with this autoinjector. Conclusion: This study demonstrated a high level of patient acceptance for self-injection with this autoinjector among patients with rheumatoid arthritis. In particular, patients with severe hand disability were able to successfully comply with device IFU.
机译:目的:本研究评估了影响为慢性病患者进行皮下自我注射而开发的一次性自动注射器的易用性的人为因素。材料和方法:这是一项针对65名类风湿关节炎患者的随机,单中心研究。患者进行了六次模拟注射。在单次注射和重复注射后,通过患者报告和对是否遵守器械使用说明(IFU)的独立观察,评估患者对器械的接受度和可用性。结果:总共进行了390次模拟注射。患者设备接受度很高;超过90%的患者认为每个测试标准都是可以接受的(统计学意义要求> 80%; P <0.016)。可感知的易用性和三步过程的简单性导致了较高的接受分数:在0-10点的量表上,平均分数(±标准偏差)分别为8.71(±1.18)和8.05(±0.37)。患者还表示接受自动注射器中残留药物的简便性和实用性。此外,80%的患者宣称他们会将该设备推荐给其他人。在全球范围内,所测试的人为因素(年龄,性别,手部残疾[Cochin评分],以前的自我注射经验程度(即专家或幼稚))对IFU设备的依从性没有影响。特别是,缺乏Cochin评分交互作用表明,手部残疾程度不是该自动注射器的自我注射能力差的预测因素。结论:该研究表明类风湿性关节炎患者对这种自动注射器的自我注射的接受程度很高。特别是,严重手部残疾的患者能够成功遵守器械IFU。

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