Medical Research Institute of New Zealand, Wellington, New Zealand; Capital & Coast District Health Board, Wellington, New Zealand; Division of Respiratory Medicine, School of Clinical Sciences, University of Nottingham, Nottingham, United Kingdom.
J Allergy Clin Immunol Pract. 2013 Jan;1(1):83-91. doi: 10.1016/j.jaip.2012.08.004. Epub 2012 Nov 2.
Electronic monitoring of inhaled asthma medications is one method to measure medication adherence and patterns of use. Information on the performance of monitors in a randomized controlled trial allows researchers and clinicians to understand their utility and limitations. The Smartinhaler Tracker is an electronic monitor for metered-dose inhalers (MDIs) that records the date, time, and number of actuations.
To determine the performance of the Smartinhaler monitors used in a 24-week randomized controlled trial of 303 patients with asthma in a real-world setting.
Prestudy use checks involved 2 actuations of the MDI, with a further 2 performed 2 hours later. Within-study monitor checks, performed before dispensing at clinic visits 2 to 4, included a computerized check of monitor clock function, actuation accuracy, and battery life. Within-study data checks involved computerized checks of monitor clock function before data upload.
Two thousand six hundred seventy-eight of 2728 monitors (98.2%) passed prestudy use checks. Seventy-six of 2642 monitors (2.9%) dispensed to participants failed within-study monitor checks. Fifty-one of 2642 monitors (1.9%) malfunctioned before data upload, mostly as a result of fluid immersion. Ninety-three of 2642 monitors (3.5%) were lost or thrown away by participants. Complete data was available from 2498 of 2642 dispensed monitors (94.5%) and 2498 of 2549 returned monitors (98.0%).
The Smartinhaler Tracker is a reliable monitor for measuring MDI use in a real-world setting. Use of extensive monitor and data-checking protocols reduces data loss. In a research or clinical setting, the use of a validated and reliable electronic monitor represents the reference standard for assessing patterns of medication use.
电子监测吸入型哮喘药物是一种测量药物依从性和使用模式的方法。在随机对照试验中，关于监测器性能的信息可以让研究人员和临床医生了解其效用和局限性。Smartinhaler Tracker 是一种用于计量吸入器（MDI）的电子监测器，可记录日期、时间和使用次数。
确定 Smartinhaler 监测器在一项为期 24 周、涉及 303 名哮喘患者的真实世界环境中的随机对照试验中的性能。
预研究使用检查包括两次 MDI 喷雾，然后在两小时后再进行两次。在研究期间的监测器检查中，在诊所就诊 2 至 4 次前进行，包括对监测器时钟功能、喷雾准确性和电池寿命进行计算机化检查。在研究期间的数据检查中，在数据上传前对监测器时钟功能进行计算机化检查。
2728 个监测器中的 2678 个（98.2%）通过了预研究使用检查。2642 个分配给参与者的监测器中有 76 个（2.9%）在研究期间的监测器检查中失败。在数据上传之前，51 个（1.9%）监测器发生故障，主要是由于液体浸泡。2642 个监测器中有 93 个（3.5%）被参与者丢失或扔掉。从 2642 个分配的监测器中获得了 2498 个（94.5%）和从 2549 个返回的监测器中获得了 2498 个（98.0%）完整数据。
Smartinhaler Tracker 是一种在真实环境中测量 MDI 使用情况的可靠监测器。使用广泛的监测器和数据检查协议可减少数据丢失。在研究或临床环境中，使用经过验证和可靠的电子监测器代表评估药物使用模式的参考标准。
