Glocal Clinical Registries: Pacemaker Registry Design and Implementation for Global and Local Integration – Methodology and Case Study

Abstract

BackgroundThe 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.PurposeOur 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 ResultsWe 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.ConclusionThis 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.

Linked Open Data in Health and Clinical Care A Review of the Literature

“…As reported in Table 1, and in Figure 1, the literature search identified 37 citations in PubMed and 2806 citations in Scopus applying ¡"Linked Open Data"[All Fields]¿ as a search string. Specifying the search strings according to the aim of the review, and the inclusion criteria ( Figure 1), 9 papers have been considered and examined [23][24][25][26][27][28][29][30][31].…”

“…In Table 2, the attributes for answering research question 1 are presented for each paper. In 4 out of 9 papers, a framework -or system -supporting LOD datasets is developed locally for specific purposes (papers 2, 3, 5, and 7) [24,25,27,29], see Table 2. In papers, 6, 8, and 9 the aim is the development of ontologies in RDF format [28,30,31].…”

“…Finally, in the paper 1 [23], a database has been developed with open data access, without Semantic Web technologies. As for the data sources involved, papers 2, 3, 5, and 7 [24,25,27,29], include data collected locally and LOD sources to use for integrating or enriching those data in RDF format. In papers, 6, 8, 9, some LOD ontologies have been used as a base for the developed ones [28,30,31].…”

“…In paper 1, LOD sources have not been used (Table 2). Finally, the publication year for 3 out of 9 papers (papers 1, 2, and 3) [23][24][25] is 2013, for 3 out of 9 papers (papers 4, 5, and 6) [26-28] is 2014, for 1 out of 9 papers (paper 7) [29] is 2015, and for 2 out of 9 papers (paper 8, and 9) [30,31] is 2016, Table 2.…”

Need of informatics in designing interoperable clinical registries

“…Gliklich et al (29) provided a comprehensive user guide to design and develop a clinical registry. Silva et al developed a standard framework for developing a device registry (30). In this study, we emphasized the role of informatics in designing clinical registry.…”