Glocal Clinical Registries: Pacemaker Registry Design and Implementation for Global and Local Integration - Methodology and Case Study
Glocal Clinical Registries: Pacemaker Registry Design and Implementation for Global and Local Integration - Methodology and Case Study
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DOI：
10.1371/journal.pone.0071090
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发表时间：
2013-07-25
期刊：
影响因子：
3.7
通讯作者：
Barros, Jacson V.
中科院分区：
文献类型：
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作者：
da Silva, Katia Regina;Costa, Roberto;Barros, Jacson V.
背景：应用标准和可互操作的解决方案来实现和管理医疗注册，以及从遗留格式和平台到高级标准格式和操作系统的汇总、复制和访问数据集的能力，对于临床医疗保健和生物医学研究设置都至关重要。目的：我们的研究描述了一个可重复的，高度可扩展的，设备注册表实现的标准框架，解决了本地数据质量组件和全局链接问题。方法和结果：我们开发了一个设备注册表框架，涉及以下步骤：(1)研究工作流程的数据标准定义和表示；(2)使用REDCap（研究电子数据捕获）开发电子病例报告表格；(3)根据临床研究工作流程收集数据；(4)通过使用本地电子健康记录、政府数据库和链接的开放数据集丰富注册数据库来增加数据；(5)数据质量控制；(6)通过注册网站传播数据。我们的注册中心采用了美国大学心脏病学/美国心脏协会临床数据标准提出的所有适用的标准化数据元素，以及来自心脏装置随机试验和临床数据交换标准协会的变量。REDCap与来自电子健康记录系统的数据之间实现了本地互操作性。原始数据集也通过纳入巴西政府在起搏器植入住院期间支付的报销值而得到增强。通过将我们的注册表链接到开放数据收集库关联临床试验（LinkedCT），我们发现了130个与我们的起搏器注册表潜在相关的临床试验。结论：本研究展示了如何将标准和可重复的解决方案应用于医疗登记的实施，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，也是可用于其他生物医学登记的有用框架。
Background: 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.Purpose: Our study describes a reproducible, highly scalable, standard framework for a device registry implementation addressing both local data quality components and global linking problems.Methods and Results: 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.Conclusion: 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.