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


OBJECTIVE
Our study describes a reproducible, highly scalable, standard framework for a device registry implementation addressing both local data quality components and global linking problems.


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.


CONCLUSIONS
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.
Heart Institute, InCor, Clinics Hospital of the University of São Paulo Medical School, São Paulo, Brazil. katia.regina@incor.usp.br
Kátia Regina
KR
da Silva
Roberto
R
Costa
Elizabeth Sartori
ES
Crevelari
Marianna Sobral
MS
Lacerda
Caio Marcos
CM
de Moraes Albertini
Martino Martinelli
MM
Filho
José Eduardo
JE
Santana
João Ricardo Nickenig
JR
Vissoci
Ricardo
R
Pietrobon
Jacson V
JV
Barros
D001938:Brazil; D002986:Clinical Trials as Topic; D003625:Data Collection / Q000592:standards; D057286:Electronic Health Records / Q000592:standards* / Q000706:statistics & numerical data; D006801:Humans; D010138:Pacemaker, Artificial / Q000191:economics / Q000706:statistics & numerical data*; D011786:Quality Control; D012042:Registries / Q000592:standards*; D012107:Research Design; D012984:Software