Department for Biomedical Informatics and Mechatronics, Institute of Health Informatics, UMIT - University for Health Sciences, Medical Informatics and Technology, Austria.
Health Inf Manag. 2012;41(2):14-21. doi: 10.1177/183335831204100202.
It is essential for new health information technologies (IT) to undergo rigorous evaluations to ensure they are effective and safe for use in real-world situations. However, evaluation of new health IT is challenging, as field studies are often not feasible when the technology being evaluated is not sufficiently mature. Laboratory-based evaluations have also been shown to have insufficient external validity. Simulation studies seem to be a way to bridge this gap. The aim of this study was to evaluate, using a simulation methodology, the impact of a new prototype of an electronic medication management system on the appropriateness of prescriptions and drug-related activities, including laboratory test ordering or medication changes. This article presents the results of a controlled simulation study with 50 simulation runs, including ten doctors and five simulation patients, and discusses experiences and lessons learnt while conducting the study. Although the new electronic medication management system showed tendencies to improve medication safety when compared with the standard system, this tendency was not significant. Altogether, five distinct situations were identified where the new medication management system did help to improve medication safety. This simulation study provided a good compromise between internal validity and external validity. However, several challenges need to be addressed when undertaking simulation evaluations including: preparation of adequate test cases; training of participants before using unfamiliar applications; consideration of time, effort and costs of conducting the simulation; technical maturity of the evaluated system; and allowing adequate preparation of simulation scenarios and simulation setting. Simulation studies are an interesting but time-consuming approach, which can be used to evaluate newly developed health IT systems, particularly those systems that are not yet sufficiently mature to undergo field evaluation studies.
新的健康信息技术(IT)必须经过严格的评估,以确保其在实际情况下有效且安全。然而,新的健康 IT 的评估具有挑战性,因为当所评估的技术不够成熟时,通常无法进行现场研究。基于实验室的评估也被证明缺乏外部有效性。仿真研究似乎是弥合这一差距的一种方法。本研究旨在使用仿真方法评估一种新的电子药物管理系统原型对处方和药物相关活动(包括实验室检测订单或药物变更)的适当性的影响。本文介绍了一项有 50 次模拟运行的对照模拟研究的结果,包括 10 名医生和 5 名模拟患者,并讨论了在进行研究时的经验和教训。尽管与标准系统相比,新的电子药物管理系统在改善药物安全性方面表现出了一些趋势,但这种趋势并不显著。总的来说,确定了五个新的药物管理系统有助于改善药物安全性的不同情况。这项仿真研究在内部有效性和外部有效性之间取得了良好的平衡。然而,在进行仿真评估时,需要解决几个挑战,包括:准备充分的测试用例;在使用不熟悉的应用程序之前对参与者进行培训;考虑到进行仿真的时间、精力和成本;评估系统的技术成熟度;以及为仿真场景和仿真设置留出足够的准备时间。仿真研究是一种有趣但耗时的方法,可以用于评估新开发的健康 IT 系统,特别是那些还不够成熟,无法进行现场评估研究的系统。