Department of Emergency Medicine and Clinical Informatics Center, UT Southwestern Medical Center, Dallas, Texas, United States.
Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, United States.
Appl Clin Inform. 2024 May;15(3):556-568. doi: 10.1055/a-2297-9129. Epub 2024 Apr 2.
To support a pragmatic, electronic health record (EHR)-based randomized controlled trial, we applied user-centered design (UCD) principles, evidence-based risk communication strategies, and interoperable software architecture to design, test, and deploy a prognostic tool for children in emergency departments (EDs) with pneumonia.
Risk for severe in-hospital outcomes was estimated using a validated ordinal logistic regression model to classify pneumonia severity. To render the results usable for ED clinicians, we created an integrated SMART on Fast Healthcare Interoperability Resources (FHIR) web application built for interoperable use in two pediatric EDs using different EHR vendors: Epic and Cerner. We followed a UCD framework, including problem analysis and user research, conceptual design and early prototyping, user interface development, formative evaluation, and postdeployment summative evaluation.
Problem analysis and user research from 39 clinicians and nurses revealed user preferences for risk aversion, accessibility, and timing of risk communication. Early prototyping and iterative design incorporated evidence-based design principles, including numeracy, risk framing, and best-practice visualization techniques. After rigorous unit and end-to-end testing, the application was successfully deployed in both EDs, which facilitated enrollment, randomization, model visualization, data capture, and reporting for trial purposes.
The successful implementation of a custom application for pneumonia prognosis and clinical trial support in two health systems on different EHRs demonstrates the importance of UCD, adherence to modern clinical data standards, and rigorous testing. Key lessons included the need for understanding users' real-world needs, regular knowledge management, application maintenance, and the recognition that FHIR applications require careful configuration for interoperability.
为了支持一项实用的、基于电子病历（EHR）的随机对照试验，我们应用了以用户为中心的设计（UCD）原则、基于证据的风险沟通策略和互操作软件架构，来设计、测试和部署一个用于急诊科（ED）肺炎患儿的预后工具。
使用经过验证的有序逻辑回归模型来估计严重院内结局的风险，以对肺炎严重程度进行分类。为了使结果可供 ED 临床医生使用，我们创建了一个集成 SMART on Fast Healthcare Interoperability Resources（FHIR）的 Web 应用程序，该应用程序是针对使用不同 EHR 供应商（Epic 和 Cerner）的两家儿科 ED 进行互操作使用而构建的。我们遵循了 UCD 框架，包括问题分析和用户研究、概念设计和早期原型设计、用户界面开发、形成性评估以及部署后的总结性评估。
对 39 名临床医生和护士的问题分析和用户研究揭示了用户对风险规避、可及性和风险沟通时机的偏好。早期原型设计和迭代设计纳入了基于证据的设计原则，包括计算能力、风险框架和最佳实践可视化技术。在经过严格的单元和端到端测试后，该应用程序在两个 ED 成功部署，这有助于试验目的的入组、随机化、模型可视化、数据采集和报告。
在两个不同的 EHR 医疗系统中成功实施了一个用于肺炎预后和临床试验支持的定制应用程序，证明了以用户为中心的设计、遵守现代临床数据标准以及严格测试的重要性。关键经验包括需要了解用户的实际需求、定期知识管理、应用程序维护，以及认识到 FHIR 应用程序需要进行仔细配置才能实现互操作性。
