Hermann M M, Diestelhorst M
Department of Opthalmology, University of Cologne, Cologne, Germany.
Br J Ophthalmol. 2006 Jul;90(7):830-2. doi: 10.1136/bjo.2005.088526. Epub 2006 Mar 15.
BACKGROUND/AIMS: The effectiveness of a self administered eye drop medication can only be assessed if the compliance is known. The authors studied the specificity and sensitivity of a new microprocessor controlled monitoring device.
The monitoring system was conducted by an 8 bit microcontroller for data acquisition and storage with sensors measuring applied pressure to the bottle, temperature, and vertical position. 10 devices were mounted under commercial 10 ml eye drops. Test subjects had to note down each application manually. A total of 15 applications each within 3 days was intended.
Manual reports confirmed 15 applications for each of the 10 bottles. The monitoring devices detected a total of 149 events; one was missed; comprising a sensitivity of 99%. Two devices registered three applications, which did not appear in the manual protocols, indicating a specificity of about 98%. Refrigerated bottles were correctly identified. The battery lifetime exceeded 60 days.
The new monitoring device demonstrated a high reliability of the collected compliance data. The important, yet often unknown, influence of compliance in patient care and clinical trials shall be illuminated by the new device. This may lead to a better adapted patient care. Studies will profit from a higher credibility and results will be less influenced by non-compliance.
背景/目的:只有在知晓依从性的情况下,才能评估自行滴眼用药的效果。作者研究了一种新型微处理器控制监测设备的特异性和敏感性。
监测系统由一个8位微控制器进行数据采集和存储,传感器测量施加在药瓶上的压力、温度和垂直位置。在10毫升商用滴眼液瓶下安装了10个设备。测试对象必须手动记录每次用药情况。计划在3天内各进行15次用药。
手动报告确认10个药瓶中的每一个都有15次用药。监测设备共检测到149次事件;有1次未被检测到;敏感性为99%。有两个设备记录了3次用药情况,而手动记录中未出现,表明特异性约为98%。冷藏的药瓶被正确识别。电池续航时间超过60天。
新型监测设备显示所收集的依从性数据具有高度可靠性。这种新设备将揭示依从性在患者护理和临床试验中重要但往往未知的影响。这可能会带来更合适的患者护理。研究将因更高的可信度而受益,结果受不依从性的影响也会更小。