Baumgartner Susan L, Buffkin D Eric, Rukavina Elise, Jones Jason, Weiler Elizabeth, Carnes Tony C
etectRx, Inc., Gainesville, FL, United States.
Tensentric, Inc., Boulder, CO, United States.
JMIR Hum Factors. 2021 Nov 8;8(4):e30786. doi: 10.2196/30786.
Medication nonadherence is a costly problem that is common in clinical use and clinical trials alike, with significant adverse consequences. Digital pill systems have proved to be effective and safe solutions to the challenges of nonadherence, with documented success in improving adherence and health outcomes.
The aim of this human factors validation study is to evaluate a novel digital pill system, the ID-Cap System from etectRx, for usability among patient users in a simulated real-world use environment.
A total of 17 patients with diverse backgrounds who regularly take oral prescription medications were recruited. After training and a period of training decay, the participants were asked to complete 12 patient-use scenarios during which errors or difficulties were logged. The participants were also interviewed about their experiences with the ID-Cap System.
The participants ranged in age from 27 to 74 years (mean 51 years, SD 13.8 years), and they were heterogeneous in other demographic factors as well, such as education level, handedness, and sex. In this human factors validation study, the patient users completed 97.5% (196/201) of the total use scenarios successfully; 75.1% (151/201) were completed without any failures or errors. The participants found the ID-Cap System easy to use, and they were able to accurately and proficiently record ingestion events using the device.
The participants demonstrated the ability to safely and effectively use the ID-Cap System for its intended use. The ID-Cap System has great potential as a useful tool for encouraging medication adherence and can be easily implemented by patient users.
药物治疗依从性不佳是一个代价高昂的问题，在临床应用和临床试验中都很常见，会产生严重的不良后果。数字药丸系统已被证明是解决依从性挑战的有效且安全的解决方案，在改善依从性和健康结果方面有成功记录。
本人为因素验证研究的目的是在模拟的真实使用环境中评估一种新型数字药丸系统etectRx的ID-Cap系统在患者用户中的可用性。
共招募了17名定期服用口服处方药的背景各异的患者。在培训和一段时间的培训衰减后，要求参与者完成12个患者使用场景，在此期间记录错误或困难。还就参与者使用ID-Cap系统的体验进行了访谈。
参与者年龄在27至74岁之间（平均51岁，标准差13.8岁），在其他人口统计学因素方面也各不相同，如教育水平、用手习惯和性别。在这项人为因素验证研究中，患者用户成功完成了97.5%（196/201）的总使用场景；75.1%（151/201）的场景完成时没有任何失败或错误。参与者发现ID-Cap系统易于使用，并且能够使用该设备准确、熟练地记录服药事件。
参与者展示了安全有效地使用ID-Cap系统实现其预期用途的能力。ID-Cap系统作为鼓励药物治疗依从性的有用工具具有巨大潜力，并且患者用户可以轻松实施。
