Dataset Information

Glocal clinical registries: pacemaker registry design and implementation for global and local integration--methodology and case study.

ABSTRACT:

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.

SUBMITTER: da Silva KR

PROVIDER: S-EPMC3723676 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature

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Publications

Glocal clinical registries: pacemaker registry design and implementation for global and local integration--methodology and case study.

da Silva Kátia Regina KR Costa Roberto R Crevelari Elizabeth Sartori ES Lacerda Marianna Sobral MS de Moraes Albertini Caio Marcos CM Filho Martino Martinelli MM Santana José Eduardo JE Vissoci João Ricardo Nickenig JR Pietrobon Ricardo R Barros Jacson V JV

PloS one 20130725 7

<h4>Background</h4>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.<h4>Purpose</h4>Our study describes a reproducible, highly scalable, standard framework for a device registry implementation addressing both local data quality c ...[more]

PMID: 23936257

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Dataset Information

Glocal clinical registries: pacemaker registry design and implementation for global and local integration--methodology and case study.

Background

Purpose

Methods and results

Conclusion

Publications

Glocal clinical registries: pacemaker registry design and implementation for global and local integration--methodology and case study.

Similar Datasets

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