The impact of data quality monitoring of a multicenter prospective registry of cardiac implantable electronic devices.

Data quality monitoring plays a crucial role in multicenter prospective registries. By maintaining high data accuracy, completeness, and consistency, researchers can improve the overall quality and reliability of the registry data, enabling meaningful conclusions and supporting evidence-based decisions. The purpose of the present study was to evaluate data quality metrics (completeness, accuracy, and temporal plausibility) of a Multicenter Registry of Cardiac Implantable Electronic Devices (CIEDs) and to perform a direct data audit of a random sample of records to assess the agreement levels with the source documents. The CIED Registry was a prospective, multicenter, real-world observational study carried out from January 2020 to December 2022 in five designated centers across Sao Paulo, Brazil. We assessed the data quality of the CIED Registry by using two distinct approaches:•Dynamic data monitoring using features of the REDCap (Research Electronic Data Capture) software, including data reports and data quality rules•Direct data audit in which information from a random sample of 10 % of cases from the coordinating center was compared with original source documents Our findings suggest that the methodological approach applied to the CIED Registry resulted in high data completeness, accuracy, temporal plausibility, and excellent agreement levels with the source documents.

Validity and reliability of the Brazilian Portuguese version of the Florida Patient Acceptance Survey for patients with implantable cardioverter defibrillators.

Device acceptance is a crucial factor in identifying implantable cardioverter defibrillator (ICD) patients at risk for psychosocial distress and unfavorable quality of life outcomes. The purpose of this study was to examine the evidence of the validity of internal structure (construct) and reliability of the Florida Patient Acceptance Survey (FPAS) in a sample of ICD patients, comparing the psychometric indicators of the complete (FPAS-18 item) and abbreviated (FPAS-12 item) versions. The sample included 151 participants (97 males, mean age of 55.7 ± 14.1 years) who completed the cross-culturally adapted version of the FPAS instrument for the Brazilian context. The psychometric properties of both versions of the FPAS instrument were evaluated by two distinct approaches:•Exploratory and confirmatory factor analysis: used to test the internal structure of the instrument•Cronbach's Alpha and McDonald's Omega: used to determine the reliability of the instrument The two versions of the FPAS-Br instrument showed consistent evidence of internal structure validity and reliability. However, the FPAS-Br 12-item showed a better psychometric adjustment, confirmed by the analysis of the quality indicators of the models.