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

Publication ,  Journal Article
da Silva, KR; Costa, R; Crevelari, ES; Lacerda, MS; de Moraes Albertini, CM; Filho, MM; Santana, JE; Vissoci, JRN; Pietrobon, R; Barros, JV
Published in: PLoS One
2013

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.

Duke Scholars

Published In

PLoS One

DOI

EISSN

1932-6203

Publication Date

2013

Volume

8

Issue

7

Start / End Page

e71090

Location

United States

Related Subject Headings

  • Software
  • Research Design
  • Registries
  • Quality Control
  • Pacemaker, Artificial
  • Humans
  • General Science & Technology
  • Electronic Health Records
  • Data Collection
  • Clinical Trials as Topic
 

Citation

APA
Chicago
ICMJE
MLA
NLM
da Silva, K. R., Costa, R., Crevelari, E. S., Lacerda, M. S., de Moraes Albertini, C. M., Filho, M. M., … Barros, J. V. (2013). Glocal clinical registries: pacemaker registry design and implementation for global and local integration--methodology and case study. PLoS One, 8(7), e71090. https://doi.org/10.1371/journal.pone.0071090
Silva, Kátia Regina da, Roberto Costa, Elizabeth Sartori Crevelari, Marianna Sobral Lacerda, Caio Marcos de Moraes Albertini, Martino Martinelli Filho, José Eduardo Santana, João Ricardo Nickenig Vissoci, Ricardo Pietrobon, and Jacson V. Barros. “Glocal clinical registries: pacemaker registry design and implementation for global and local integration--methodology and case study.PLoS One 8, no. 7 (2013): e71090. https://doi.org/10.1371/journal.pone.0071090.
da Silva KR, Costa R, Crevelari ES, Lacerda MS, de Moraes Albertini CM, Filho MM, et al. Glocal clinical registries: pacemaker registry design and implementation for global and local integration--methodology and case study. PLoS One. 2013;8(7):e71090.
da Silva, Kátia Regina, et al. “Glocal clinical registries: pacemaker registry design and implementation for global and local integration--methodology and case study.PLoS One, vol. 8, no. 7, 2013, p. e71090. Pubmed, doi:10.1371/journal.pone.0071090.
da Silva KR, Costa R, Crevelari ES, Lacerda MS, de Moraes Albertini CM, Filho MM, Santana JE, Vissoci JRN, Pietrobon R, Barros JV. Glocal clinical registries: pacemaker registry design and implementation for global and local integration--methodology and case study. PLoS One. 2013;8(7):e71090.

Published In

PLoS One

DOI

EISSN

1932-6203

Publication Date

2013

Volume

8

Issue

7

Start / End Page

e71090

Location

United States

Related Subject Headings

  • Software
  • Research Design
  • Registries
  • Quality Control
  • Pacemaker, Artificial
  • Humans
  • General Science & Technology
  • Electronic Health Records
  • Data Collection
  • Clinical Trials as Topic