Department of Information Medicine, Asan Medical Center, Seoul.
Industrial and Management System Engineering, Kyung Hee University, Yongin.
Medicine (Baltimore). 2021 Apr 2;100(13):e25276. doi: 10.1097/MD.0000000000025276.
Clinical information systems (CISs) that do not consider usability and safety could lead to harmful events. Therefore, we aimed to develop a safety and usability guideline of CISs that is comprehensive for both users and developers. And the guideline was categorized to apply actual clinical workflow and work environment.The guideline components were extracted through a systematic review of the articles published between 2000 and 2015, and existing CIS safety and/or usability design guidelines. The guideline components were categorized according to clinical workflow and types of user interface (UI). The contents of the guideline were evaluated and validated by experts with 3 specialties: medical informatics, patient safety, and human engineering.Total 1276 guideline components were extracted through article and guideline review. Of these, 464 guideline components were categorized according to 5 divisions of the clinical workflow: "Data identification and selection," "Document entry," "Order entry," "Clinical decision support and alert," and "Management". While 521 guideline components were categorized according to 4 divisions of UI: UIs related to information process steps, "Perception," "Recognition," "Control," and "Feedback". We developed a guideline draft with 219 detailed guidance for clinical task and 70 for UI. Overall appropriateness and comprehensiveness were proven to achieve more than 90% in experts' survey. However, there were significant differences among the groups of specialties in the judgment of appropriateness (P < .001) and comprehensiveness (P = .038).We developed and verified a safety and usability guideline for CIS that qualifies the requirements of both clinical workflows and usability issues. The developed guideline can be a practical tool to enhance the usability and safety of CISs. Further validation is required by applying the guideline for designing the actual CIS.
临床信息系统（CIS）如果不考虑可用性和安全性，可能会导致不良事件。因此，我们旨在为用户和开发者开发一个全面的 CIS 安全和可用性指南。该指南根据实际临床工作流程和工作环境进行分类。指南的组成部分是通过对 2000 年至 2015 年期间发表的文章以及现有的 CIS 安全和/或可用性设计指南进行系统回顾提取出来的。指南的组成部分根据临床工作流程和用户界面（UI）的类型进行分类。指南的内容由具有医学信息学、患者安全和人机工程学 3 个专业的专家进行评估和验证。通过文章和指南回顾共提取了 1276 条指南组成部分。其中，464 条指南根据临床工作流程的 5 个部分进行分类：“数据识别和选择”、“文档录入”、“医嘱录入”、“临床决策支持和警报”和“管理”。而 521 条指南根据 UI 的 4 个部分进行分类：与信息处理步骤相关的 UI、“感知”、“识别”、“控制”和“反馈”。我们制定了一份包含 219 条详细临床任务指导和 70 条 UI 指导的指南草案。专家调查结果表明，总体适宜性和全面性均超过 90%。然而，在适宜性（P < .001）和全面性（P = .038）的判断方面，不同专业组之间存在显著差异。我们开发并验证了 CIS 的安全和可用性指南，符合临床工作流程和可用性问题的要求。所开发的指南可以成为增强 CIS 可用性和安全性的实用工具。需要通过应用该指南来设计实际的 CIS 进行进一步验证。
