Dhond Rupali, Acher Ryan, Leatherman Sarah, Page Sarah, Sanford Randolph, Elbers Danne, Meng Frank, Ferguson Ryan, Brophy Mary T, Do Nhan V
VA Boston Healthcare System, Boston, MA, USA.
Boston University School of Medicine, Boston, MA, USA.
Inform Med Unlocked. 2021;27:100788. doi: 10.1016/j.imu.2021.100788. Epub 2021 Nov 12.
Veterans Health Administration (VHA) services are most frequently used by patients 65 years and older, an age group that is disproportionally affected by COVID-19. Here we describe a modular Clinical Trial Informatics Solution (CTIS) that was rapidly developed and deployed to support a multi-hospital embedded pragmatic clinical trial in COVID-19 patients within the VHA. Our CTIS includes tools for patient eligibility screening, informed consent tracking, treatment randomization, EHR data transformation for reporting and interfaces for patient outcome and adverse event tracking. We hope our CTIS component descriptions and practical lessons learned will serve as a useful building block for others creating their own clinical trial tools and have made application and database code publicly available.
退伍军人健康管理局（VHA）的服务最常被65岁及以上的患者使用，而这个年龄组受新冠病毒病（COVID-19）的影响尤为严重。在此，我们描述了一种模块化的临床试验信息学解决方案（CTIS），该方案是迅速开发并部署的，以支持在VHA内针对COVID-19患者开展的一项多医院嵌入式务实临床试验。我们的CTIS包括用于患者资格筛选、知情同意跟踪、治疗随机化、用于报告的电子健康记录（EHR）数据转换以及患者结局和不良事件跟踪接口的工具。我们希望我们的CTIS组件描述和实际经验教训能成为其他人创建自己的临床试验工具的有用基石，并已将应用程序和数据库代码公开。
