Heart Institute, InCor, Clinics Hospital of the University of São Paulo Medical School, São Paulo, Brazil.
PLoS One. 2013 Jul 25;8(7):e71090. doi: 10.1371/journal.pone.0071090. Print 2013.
The ability to apply standard and interoperable solutions for implementing and managing medical registries as well as aggregate, reproduce, and access data sets from legacy formats and platforms to advanced standard formats and operating systems are crucial for both clinical healthcare and biomedical research settings.
Our study describes a reproducible, highly scalable, standard framework for a device registry implementation addressing both local data quality components and global linking problems.
We developed a device registry framework involving the following steps: (1) Data standards definition and representation of the research workflow, (2) Development of electronic case report forms using REDCap (Research Electronic Data Capture), (3) Data collection according to the clinical research workflow and, (4) Data augmentation by enriching the registry database with local electronic health records, governmental database and linked open data collections, (5) Data quality control and (6) Data dissemination through the registry Web site. Our registry adopted all applicable standardized data elements proposed by American College Cardiology / American Heart Association Clinical Data Standards, as well as variables derived from cardiac devices randomized trials and Clinical Data Interchange Standards Consortium. Local interoperability was performed between REDCap and data derived from Electronic Health Record system. The original data set was also augmented by incorporating the reimbursed values paid by the Brazilian government during a hospitalization for pacemaker implantation. By linking our registry to the open data collection repository Linked Clinical Trials (LinkedCT) we found 130 clinical trials which are potentially correlated with our pacemaker registry.
This study demonstrates how standard and reproducible solutions can be applied in the implementation of medical registries to constitute a re-usable framework. Such approach has the potential to facilitate data integration between healthcare and research settings, also being a useful framework to be used in other biomedical registries.
能够应用标准且可互操作的解决方案来实现和管理医学注册，并将来自传统格式和平台的数据集合聚合、复制和访问到高级标准格式和操作系统，这对于临床医疗保健和生物医学研究环境都至关重要。
我们的研究描述了一种可重现的、高度可扩展的标准框架，用于实现设备注册，解决本地数据质量组件和全局链接问题。
我们开发了一个设备注册框架，包括以下步骤：（1）数据标准定义和研究工作流程表示，（2）使用 REDCap（研究电子数据捕获）开发电子病例报告表，（3）根据临床研究工作流程进行数据收集，以及（4）通过丰富注册数据库与本地电子健康记录、政府数据库和链接开放数据集合来增强数据，（5）数据质量控制和（6）通过注册网站传播数据。我们的注册采用了美国心脏病学会/美国心脏协会临床数据标准提出的所有适用标准化数据元素，以及源自心脏设备随机试验和临床数据交换标准协会的变量。REDCap 与电子健康记录系统导出的数据之间进行了本地互操作性。原始数据集还通过纳入巴西政府在起搏器植入住院期间支付的报销值进行了扩充。通过将我们的注册与开放数据集合库 Linked Clinical Trials（LinkedCT）链接，我们发现了 130 项与我们的起搏器注册相关的临床试验。
本研究表明，标准和可重现的解决方案如何应用于医学注册的实现，以构成可重复使用的框架。这种方法有可能促进医疗保健和研究环境之间的数据集成，也是在其他生物医学注册中使用的有用框架。
