Design and Rationale for Common Data Elements for Clinical Research in Pediatric Critical Care Medicine.
Design and Rationale for Common Data Elements for Clinical Research in Pediatric Critical Care Medicine.
复制标题
针对小儿重症监护医学临床研究的常见数据元素的设计和理由。
DOI：
10.1097/pcc.0000000000002455
复制
发表时间：
2020-11
期刊：
影响因子：
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通讯作者：
Khemani RG
中科院分区：
文献类型：
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作者：
Ward SL;Flori HR;Bennett TD;Sapru A;Mourani PM;Thomas NJ;Khemani RG
公共数据元素（cde）是一个精确定义的问题与一组指定的回答的组合。cde有助于nih支持的研究数据公平原则（可查找、可访问、可互操作和可重用）。在儿科重症监护研究中常规使用cde和标准化定义可能促进合作，提高数据收集的质量和一致性，提高研究或试验设置的整体效率，并促进交叉研究比较、荟萃分析和研究队列合并。本PCCM视角的目的是建立一个基于多国、多学科共识的CDEs发展路线图，该CDEs可适用于任何儿科重症监护学科领域。我们描述了创建研究“核心领域”（例如，患者结果、健康相关条件或健康方面）的多步骤过程，以及在每个核心领域内开发cde。我们根据每个CDE与未来研究和感兴趣领域内临床实践的相关性定义了一种分层的数据收集方法。此外，我们描述了使用德尔菲方法，以达成共识的这些CDE文件使用国际，多学科专家小组。
Common Data Elements (CDEs), are a combination of a precisely defined question paired with a specified set of responses. CDEs contribute to the NIH-supported principle of FAIRness (Findable, Accessible, Interoperable, and Reusable) of research data. Routine use of CDEs and standardized definitions within pediatric critical care research is likely to promote collaboration, improve quality and consistency of data collection, improve overall efficiency of study or trial setup, and facilitate cross-study comparisons, meta-analysis and merging of study cohorts. The purpose of this PCCM Perspective is to establish a road map for the development of multinational, multidisciplinary consensus based CDEs that could be adapted for use within any pediatric critical care subject area. We describe a multi-step process for the creation of “core domains” of research (e.g. patient outcomes, health related conditions or aspects of health), and the development of CDEs within each core domain. We define a tiered approach to data collection based on relevance of each CDE to future studies and clinical practice within the field of interest. Additionally, we describe the use of the Delphi methods to achieve consensus of these CDE documents using an international, multi-disciplinary panel of experts.