Abstract

Objective

The study sought to conduct an informatics analysis on the National Evaluation System for Health Technology Coordinating Center test case of cardiac ablation catheters and to demonstrate the role of informatics approaches in the feasibility assessment of capturing real-world data using unique device identifiers (UDIs) that are fit for purpose for label extensions for 2 cardiac ablation catheters from the electronic health records and other health information technology systems in a multicenter evaluation.

Materials and Methods

We focused on data capture and transformation and data quality maturity model specified in the National Evaluation System for Health Technology Coordinating Center data quality framework. The informatics analysis included 4 elements: the use of UDIs for identifying device exposure data, the use of standardized codes for defining computable phenotypes, the use of natural language processing for capturing unstructured data elements from clinical data systems, and the use of common data models for standardizing data collection and analyses.

Results

We found that, with the UDI implementation at 3 health systems, the target device exposure data could be effectively identified, particularly for brand-specific devices. Computable phenotypes for study outcomes could be defined using codes; however, ablation registries, natural language processing tools, and chart reviews were required for validating data quality of the phenotypes. The common data model implementation status varied across sites. The maturity level of the key informatics technologies was highly aligned with the data quality maturity model.

Conclusions

We demonstrated that the informatics approaches can be feasibly used to capture safety and effectiveness outcomes in real-world data for use in medical device studies supporting label extensions.

中文翻译：

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从多个中心的健康信息技术系统捕获真实世界数据以评估心脏消融装置结果的可行性：一份适合目的的信息学分析报告

 抽象的

 客观的

该研究旨在对国家卫生技术协调中心评估系统心脏消融导管测试案例进行信息学分析，并证明信息学方法在使用唯一设备标识符（UDI）捕获真实世界数据的可行性评估中的作用，适用于多中心评估中电子健康记录和其他健康信息技术系统中 2 根心脏消融导管的标签扩展。

 材料和方法

我们重点研究国家卫生技术协调中心数据质量评估体系框架中规定的数据捕获和转换以及数据质量成熟度模型。信息学分析包括 4 个要素：使用 UDI 识别设备暴露数据、使用标准化代码定义可计算表型、使用自然语言处理从临床数据系统捕获非结构化数据元素以及使用通用数据模型用于标准化数据收集和分析。

 结果

我们发现，通过在 3 个卫生系统实施 UDI，可以有效识别目标设备暴露数据，特别是对于特定品牌的设备。研究结果的可计算表型可以使用代码定义；然而，需要消融登记、自然语言处理工具和图表审查来验证表型的数据质量。不同站点的通用数据模型实施状态各不相同。关键信息技术的成熟度水平与数据质量成熟度模型高度一致。

 结论

我们证明，信息学方法可以切实地用于捕获真实世界数据中的安全性和有效性结果，用于支持标签扩展的医疗器械研究。