由于缺乏结构和标准数据模型，电子健康记录 (EHR) 数据在研究中的使用受到限制。 ICAREdata（集成临床试验和真实世界终点数据）项目的目标是使用最小的通用肿瘤数据元素 (mCODE) 数据模型来构建 EHR 中的关键研究数据元素，以提取和传输数据。 ICAREdata 项目捕获了两个 EHR临床试验必不可少的数据元素：癌症疾病状态和治疗计划的变化。该项目在参与肿瘤临床试验联盟的临床中心实施。数据从 EHR 中提取，并通过安全的快速医疗互操作性资源消息传递（交换 EHR 的标准）发送到数据库。将选定的元素与试验电子数据采集 (EDC) 系统 Medidata Rave 的相应数据进行比较。 截至 2023 年 12 月，从 10 个地点提取并传输了 35 名患者的数据，涉及 15 项临床试验的 367 次临床病例。截至 2023 年 3 月的数据表明，治疗计划变更和癌症疾病状态要素的一致性分别为 79% 和 34%。当 EHR 和 EDC (n = 15) 报告疾病评估时，癌症疾病状态的一致性为 87%。使用 mCODE 和 ICAREdata 方法记录、提取和聚合 EHR 中的结构化数据元素在多机构癌症中是可行的临床试验。 EDC 作为参考数据集，可以评估 EHR 数据捕获的完整性。未来的举措将侧重于临床和研究环境中具有共享定义的元素以及高效的工作流程。临床试验使用电子病例报告表格来报告数据，并且必须在这些表格上手动输入数据，这既昂贵又耗时。 ICAREdata 方法使用来自临床试验的结构化、有组织的数据，这些数据可以更轻松地共享，而不必在电子健康记录中输入自由文本。© 2024 MITRE Corporation 和作者。 《癌症》由 Wiley periodicals LLC 代表美国癌症协会出版。本文由美国政府雇员撰写，他们的作品在美国属于公共领域。

The use of electronic health record (EHR) data for research is limited by a lack of structure and a standard data model. The objective of the ICAREdata (Integrating Clinical Trials and Real-World Endpoints Data) project was to structure key research data elements in EHRs using a minimal Common Oncology Data Elements (mCODE) data model to extract and transmit data.The ICAREdata project captured two EHR data elements essential to clinical trials: cancer disease status and treatment plan change. The project was implemented in clinical sites participating in Alliance for Clinical Trials in Oncology trials. Data were extracted from EHRs and sent by secure Fast Healthcare Interoperability Resource messaging (a standard for exchanging EHRs) to a database. Selected elements were compared with corresponding data from the trial's electronic data capture (EDC) system, Medidata Rave.By December 2023, data were extracted and transmitted from 10 sites for 35 patients, involving 367 clinical encounters across 15 clinical trials. Data through March 2023 demonstrated that concordance for the elements treatment plan change and cancer disease status was 79% and 34%, respectively. When disease evaluation was reported by both EHR and EDC (n = 15), there was 87% agreement on cancer disease status.Documentation, extraction, and aggregation of structured data elements in EHRs using mCODE and ICAREdata methods is feasible in multi-institutional cancer clinical trials. EDC as a reference data set allowed assessment of the completeness of EHR data capture. Future initiatives will focus on elements with shared definitions in clinical and research environments and efficient workflows.Clinical trials use electronic case report forms to report data, and data must be manually entered on these forms, which is costly and time consuming. ICAREdata methods use structured, organized data from clinical trials that can be more easily shared instead having to enter free text into electronic health records.© 2024 The MITRE Corporation and The Author(s). Cancer published by Wiley Periodicals LLC on behalf of American Cancer Society. This article has been contributed to by U.S. Government employees and their work is in the public domain in the USA.