Departments of Biomedical Informatics and Medicine, Vanderbilt University Medical Center, Nashville, TN.
MITRE Corporation, Bedford, MA.
JCO Clin Cancer Inform. 2020 Oct;4:993-1001. doi: 10.1200/CCI.20.00059.
Because of expanding interoperability requirements, structured patient data are increasingly available in electronic health records. Many oncology data elements (eg, staging, biomarkers, documentation of adverse events and cancer outcomes) remain challenging. The Minimal Common Oncology Data Elements (mCODE) project is a consensus data standard created to facilitate transmission of data of patients with cancer.
In 2018, mCODE was developed through a work group convened by ASCO, including oncologists, informaticians, researchers, and experts in terminologies and standards. The mCODE specification is organized by 6 high-level domains: patient, laboratory/vital, disease, genomics, treatment, and outcome. In total, 23 mCODE profiles are composed of 90 data elements.
A conceptual model was published for public comment in January 2019 and, after additional refinement, the first public version of the mCODE (version 0.9.1) Fast Healthcare Interoperability Resources (FHIR) implementation guide (IG) was presented at the ASCO Annual Meeting in June 2019. The specification was approved for balloting by Health Level 7 International (HL7) in August 2019. mCODE passed the HL7 ballot in September 2019 with 86.5% approval. The mCODE IG authors worked with HL7 reviewers to resolve all negative comments, leading to a modest expansion in the number of data elements and tighter alignment with FHIR and other HL7 conventions. The mCODE version 1.0 FHIR IG Standard for Trial Use was formally published on March 18, 2020.
The mCODE project has the potential to offer tremendous benefits to cancer care delivery and research by creating an infrastructure to better share patient data. mCODE is available free from www.mCODEinitiative.org. Pilot implementations are underway, and a robust community of stakeholders has been assembled across the oncology ecosystem.
由于互操作性要求不断扩大，电子健康记录中越来越多地提供了结构化的患者数据。许多肿瘤学数据元素（例如分期、生物标志物、不良事件和癌症结果的记录）仍然具有挑战性。最小共同肿瘤学数据元素（mCODE）项目是一个共识数据标准，旨在促进癌症患者数据的传输。
2018 年，mCODE 通过 ASCO 召集的工作组开发，该工作组包括肿瘤学家、信息学家、研究人员以及术语和标准方面的专家。mCODE 规范由 6 个高级别域组织：患者、实验室/生命体征、疾病、基因组学、治疗和结果。总共有 23 个 mCODE 配置文件由 90 个数据元素组成。
2019 年 1 月发布了概念模型供公众评论，经过进一步改进，第一个公共版本的 mCODE（版本 0.9.1）快速医疗保健互操作性资源（FHIR）实现指南（IG）于 2019 年 6 月在 ASCO 年会上展示。该规范于 2019 年 8 月获得健康水平 7 国际（HL7）投票批准。2019 年 9 月，mCODE 以 86.5%的赞成率通过了 HL7 投票。mCODE IG 作者与 HL7 审核人员合作解决了所有负面意见，导致数据元素数量略有增加，并与 FHIR 和其他 HL7 约定更加紧密一致。mCODE 版本 1.0 FHIR IG 标准于 2020 年 3 月 18 日正式发布供试用。
mCODE 项目有可能通过创建更好地共享患者数据的基础设施，为癌症护理提供和研究带来巨大益处。mCODE 可免费从 www.mCODEinitiative.org 获取。正在进行试点实施，并在肿瘤学生态系统中组建了一个由利益相关者组成的强大社区。
