背景:为了进一步推进临床数据交换标准联盟(CDISC)操作数据模型(ODM)标准的研究和开发,必须充分理解现有的研究。本文对ODM文献进行了方法学综述。具体来说,它开发了一个分类模式,根据该标准在临床研究数据生命周期中的应用方式对ODM文献进行分类.本文提出了未来研究和开发的领域,以解决ODM的局限性并利用其优势来支持临床研究信息学的新趋势。
方法:对以下数据库进行了系统扫描:(1)ABI/Inform,(2)ACM数字,(3)AIS电子图书馆,(4)欧洲中央PubMed,(5)谷歌学者,(5)IEEEXplore,(7)PubMed,和(8)科学直接。还进行了WebofScience引文分析。在所有数据库上使用的搜索词是\"CDISCODM。“两个主要的纳入标准是:(1)研究必须检查ODM作为信息系统解决方案组件的使用,或者(2)研究必须针对规定的解决方案使用场景批判性地评估ODM。在确定的2686篇文章中,266名被列入标题级别审查,共183篇文章。随后进行了抽象评论,产生121篇剩余文章;经过全文扫描后,69篇文章符合纳入标准。
结果:随着对互操作性的需求增加,ODM已显示出显著的灵活性,并已扩展到涵盖范围广泛的数据和元数据要求,远远超出ODM的原始用例。这种灵活性产生了涵盖各种主题领域的研究文献。创建了反映ODM在临床研究数据生命周期中使用的分类模式,以提供ODM文献的分类和综合视图。该框架的要素包括:(1)EDC(电子数据捕获)和EHR(电子健康记录)基础设施;(2)计划;(3)数据收集;(4)数据表和分析;(5)研究档案。该分析回顾了ODM作为分类模式的每个部分中的解决方案组件的优势和局限性。本文还确定了未来ODM研究和开发的机会,包括改进的语义与外部术语对齐的机制,更好地表示在临床研究数据生命周期中端到端使用的CDISC标准,改进了对实时数据交换的支持,使用EHR进行研究,并纳入完整的研究设计。
结论:ODM的使用方式最初没有预料到,并涵盖了整个临床研究数据生命周期中的各种用例。ODM已被用作数据交换的研究元数据标准。很大一部分文献涉及整合EHR和临床研究数据。ODM的简单性和可读性可能有助于其作为数据和元数据标准的成功和广泛实施。保持核心ODM模型专注于最基本的用例,在使用扩展来处理边缘情况时,保持标准易于开发人员学习和使用。
BACKGROUND: In order to further advance research and development on the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM) standard, the existing research must be well understood. This paper presents a methodological
review of the ODM literature. Specifically, it develops a classification schema to categorize the ODM literature according to how the standard has been applied within the clinical research data lifecycle. This paper suggests areas for future research and development that address ODM\'s limitations and capitalize on its strengths to support new trends in clinical research informatics.
METHODS: A systematic scan of the following databases was performed: (1) ABI/Inform, (2) ACM Digital, (3) AIS eLibrary, (4) Europe Central PubMed, (5) Google Scholar, (5) IEEE Xplore, (7) PubMed, and (8) ScienceDirect. A Web of Science citation analysis was also performed. The search term used on all databases was \"CDISC ODM.\" The two primary inclusion criteria were: (1) the research must examine the use of ODM as an information system solution component, or (2) the research must critically evaluate ODM against a stated solution usage scenario. Out of 2686 articles identified, 266 were included in a title level
review, resulting in 183 articles. An abstract
review followed, resulting in 121 remaining articles; and after a full text scan 69 articles met the inclusion criteria.
RESULTS: As the demand for interoperability has increased, ODM has shown remarkable flexibility and has been extended to cover a broad range of data and metadata requirements that reach well beyond ODM\'s original use cases. This flexibility has yielded research literature that covers a diverse array of topic areas. A classification schema reflecting the use of ODM within the clinical research data lifecycle was created to provide a categorized and consolidated view of the ODM literature. The elements of the framework include: (1) EDC (Electronic Data Capture) and EHR (Electronic Health Record) infrastructure; (2) planning; (3) data collection; (4) data tabulations and analysis; and (5) study archival. The analysis reviews the strengths and limitations of ODM as a solution component within each section of the classification schema. This paper also identifies opportunities for future ODM research and development, including improved mechanisms for semantic alignment with external terminologies, better representation of the CDISC standards used end-to-end across the clinical research data lifecycle, improved support for real-time data exchange, the use of EHRs for research, and the inclusion of a complete study design.
CONCLUSIONS: ODM is being used in ways not originally anticipated, and covers a diverse array of use cases across the clinical research data lifecycle. ODM has been used as much as a study metadata standard as it has for data exchange. A significant portion of the literature addresses integrating EHR and clinical research data. The simplicity and readability of ODM has likely contributed to its success and broad implementation as a data and metadata standard. Keeping the core ODM model focused on the most fundamental use cases, while using extensions to handle edge cases, has kept the standard easy for developers to learn and use.