Zijp Tanja R, Touw Daan J, van Boven Job F M
Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.
Department of Pharmaceutical Analysis, University of Groningen, Groningen Research Institute of Pharmacy, Groningen, the Netherlands.
Patient Prefer Adherence. 2020 Mar 20;14:625-634. doi: 10.2147/PPA.S240443. eCollection 2020.
Smart medication adherence monitoring devices can provide objective and granular drug utilization data and help patients engaging with their treatment. In this proof-of-concept study, the acceptability and technical robustness of a novel smart pill bottle prototype (SPBP) were assessed in order to allow further optimization.
The SPBP is an app-controlled automatic dispense system, capturing real-time data on a web-based platform, which sends text reminders and measures storage conditions. A heterogeneous group of ten volunteers was asked to dispense placebo capsules with the SPBP and to follow a predefined dosing schedule for a trial period of 2 weeks. Afterwards, a questionnaire was filled out during a short interview. Primary outcome was dispense adherence as measured by the bottle. Other study outcomes included system acceptability (System Usability Scale [SUS]), self-reported adherence (MARS) and technical robustness of the bottle's mechanics (electronic pill dispenser) and sensors (bottle temperature).
The overall dispense adherence rate as measured by the SPBP was 88%. All participants completed the study and four participants had an adherence rate of 100% during the study. The dispense adherence rates corresponded well with participants' self-reported adherence with an average MARS total score of 23.6 (out of 25). Participants judged the system easy to use, with a mean SUS score of 79.3 (range: 57.5-97.5). The overall mean temperature difference between the bottle sensor and calibrated external sensor was -0.82°C (range: -1.37°C to -0.21°C).
The SPBP was well accepted and this study provides data for further optimization and follow-up studies. Smart adherence technologies such as these may change the way healthcare professionals, trialists and patients manage medication adherence.
智能药物依从性监测设备可以提供客观且详细的药物使用数据，并帮助患者坚持治疗。在这项概念验证研究中，对一种新型智能药瓶原型（SPBP）的可接受性和技术稳健性进行了评估，以便进一步优化。
SPBP是一个由应用程序控制的自动分发系统，在基于网络的平台上捕获实时数据，该平台会发送文本提醒并测量储存条件。一组由十名志愿者组成的异质性群体被要求使用SPBP分发安慰剂胶囊，并在为期2周的试验期内遵循预定义的给药方案。之后，在一次简短访谈中填写一份问卷。主要结局是通过药瓶测量的分发依从性。其他研究结局包括系统可接受性（系统可用性量表[SUS]）、自我报告的依从性（MARS）以及药瓶机械装置（电子药丸分配器）和传感器（药瓶温度）的技术稳健性。
通过SPBP测量的总体分发依从率为88%。所有参与者都完成了研究，四名参与者在研究期间的依从率为100%。分发依从率与参与者自我报告的依从性非常吻合，MARS总分平均为23.6（满分25分）。参与者认为该系统易于使用，SUS平均评分为79.3（范围：57.5 - 97.5）。药瓶传感器与校准后的外部传感器之间的总体平均温差为 -0.82°C（范围：-1.37°C至 -0.21°C）。
SPBP得到了很好的接受，本研究为进一步优化和后续研究提供了数据。此类智能依从技术可能会改变医疗保健专业人员、试验人员和患者管理药物依从性的方式。
