Figure 1.
Registry processes representation.
Legend: ACC/AHA = American College of Cardiology/ American Heart Association; CDISC = Clinical Data Interchange Standards Consortium; CRF = Case Report Form; HL7 = Health Level Seven; NCDR = National Cardiovascular Data Registry; REDCap = Research Electronic Data Capture.
Figure 2.
Footnote: Case report forms are accessible to users who have sufficient access rights and it contains field-specific validation code sufficient to ensure data integrity.
Figure 3.
Pacemaker Registry Use Case Stakeholders.
Figure 4.
Pacemaker Registry Activity Diagram to Support Data Exchange between EHR system and REDCap.
Footnotes: (1) The study design is communicated to Clinical Trial Team, specifically to the Research Coordinator. (2) Case Report Form (CRF) is developed using the REDCap EDC tool hosted at a local server within the firewall of the University of São Paulo. Once built the CRF, the Registry Administrator will assign users rights for system access. (3) Patient is admitted to facility and the healthcare team entered demographic and clinical data into the EHR. (4) Research coordinators identify eligible study subjects by consulting the EHR patients records. (5) After patient enrollment, a REDCap API request is send to the Data Work Group for retrieving and importing socio-demographic information directly from the sources of hospital systems. (6), (7) Information is exchanged between the EHR and REDCap. (8) Registry administrator oversees all data collected by research coordinators. (9) CRF is transmitted from the research coordinators to the Data Work Group for data validation, data quality control e data analysis. (10) Data Work Group transmits CRF and aggregated data to the Research Team and Registry Administrator.
Table 1.
Pacemaker Registry Use Case Description.
Figure 5.
Pacemaker Registry Activity Diagram.
Footnote: This figure represents the alignment between clinical (white flowchart) and research (blue flowchart) workflows.
Table 2.
Pacemaker Registry Clinical Data Standards Elements.
Table 3.
Reimbursed values paid by Brazilian government for pacemaker implantation according to geographic region.
Table 4.
Cardiac Pacemaker Clinical Trials available at LinkedCT.
Figure 6.
Figure 6A – Pacemaker Registry Website – General Information. Figure 6B – Pacemaker Registry Website – Open Data Collection.
Table 5.
Pacemaker Registry Open Data Collection.