背景:有必要协调和标准化临床研究病例报告表(CRF)中使用的数据变量,以促进在多个临床研究中收集的患者数据的合并和共享。对于专注于传染病的临床研究尤其如此。公共卫生可能高度依赖于这些研究的结果。因此,有一种更高的紧迫性来产生有意义的,可靠的见解,理想情况下基于高样本数量和质量数据。核心数据元素的实施和互操作性标准的合并可以促进统一的临床数据集的创建。
目的:本研究的目的是比较,协调,并标准化变量,这些变量集中在6项国际传染病临床研究中用作CRF一部分的诊断测试中,最终,然后为正在进行的和未来的研究提供全研究通用数据元素(CDE),以促进跨试验收集数据的互操作性和可比性.
方法:为了确定CDE,我们回顾并比较了包含在所有6项传染病研究中和所有研究中用于数据收集的CRF的元数据。我们检查了医学系统化命名法-临床术语中国际语义标准代码的可用性,国家癌症研究所词库,和逻辑观察标识符名称和代码系统,用于明确表示构成CDE的诊断测试信息。然后,我们提出了2个数据模型,这些模型结合了已识别的CDE的语义和句法标准。
结果:在分析范围内考虑的216个变量中,我们确定了11个CDE来描述诊断测试(特别是,血清学和测序)用于传染病:病毒谱系/进化枝;测试日期,type,表演者,和制造商;目标基因;定量和定性结果;和样本标识符,type,和收集日期。
结论:确定用于感染性疾病的CDE是促进整个临床研究中数据子集的交换和可能合并的第一步(并且,大型研究项目),以进行可能的共享分析,以增加发现的力量。为了互操作性,临床研究数据的协调和标准化路径可以以两种方式铺就。首先,映射到标准术语确保每个数据元素的(变量)定义是明确的,并且它有一个,跨研究的独特解释。第二,这些数据的交换是通过以标准交换格式“包装”来辅助的,如快速医疗保健互操作性资源或临床数据交换标准联盟的临床数据采集标准协调模型。
It is necessary to harmonize and standardize data variables used in case report forms (CRFs) of clinical studies to facilitate the merging and sharing of the collected patient data across several clinical studies. This is particularly true for clinical studies that focus on infectious diseases. Public health may be highly dependent on the findings of such studies. Hence, there is an elevated urgency to generate meaningful, reliable insights, ideally based on a high sample number and quality data. The implementation of core data elements and the incorporation of interoperability standards can facilitate the creation of harmonized clinical data sets.
This study\'s objective was to compare, harmonize, and standardize variables focused on diagnostic tests used as part of CRFs in 6 international clinical studies of infectious diseases in order to, ultimately, then make available the panstudy common data elements (CDEs) for ongoing and future studies to foster interoperability and comparability of collected data across trials.
We reviewed and compared the metadata that comprised the CRFs used for data collection in and across all 6 infectious disease studies under consideration in order to identify CDEs. We examined the availability of international semantic standard codes within the Systemized Nomenclature of Medicine - Clinical Terms, the National Cancer Institute Thesaurus, and the Logical Observation Identifiers Names and Codes system for the unambiguous representation of diagnostic testing information that makes up the CDEs. We then proposed 2 data models that incorporate semantic and syntactic standards for the identified CDEs.
Of 216 variables that were considered in the scope of the analysis, we identified 11 CDEs to describe diagnostic tests (in particular, serology and sequencing) for infectious diseases: viral lineage/clade; test date, type, performer, and manufacturer; target gene; quantitative and qualitative results; and specimen identifier, type, and collection date.
The identification of CDEs for infectious diseases is the first step in facilitating the exchange and possible merging of a subset of data across clinical studies (and with that, large research projects) for possible shared analysis to increase the power of findings. The path to harmonization and standardization of clinical study data in the interest of interoperability can be paved in 2 ways. First, a map to standard terminologies ensures that each data element\'s (variable\'s) definition is unambiguous and that it has a single, unique interpretation across studies. Second, the exchange of these data is assisted by \"wrapping\" them in a standard exchange format, such as Fast Health care Interoperability Resources or the Clinical Data Interchange Standards Consortium\'s Clinical Data Acquisition Standards Harmonization Model.