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

Carregando...
Imagem de Miniatura
Citações na Scopus
Tipo de produção
article
Data de publicação
2023
Título da Revista
ISSN da Revista
Título do Volume
Editora
ELSEVIER
Citação
METHODSX, v.11, article ID 102454, 9p, 2023
Projetos de Pesquisa
Unidades Organizacionais
Fascículo
Resumo
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 evidencebased 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: center dot Dynamic data monitoring using features of the REDCap (Research Electronic Data Capture) software, including data reports and data quality rules center dot 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.
Palavras-chave
Pacemaker, Artificial, Database, Registries, Data quality, Data management, Data audit, REDCap
Referências
  1. Brasil, 2020, Lei N 13.709 de 14 de agosto de 2018. Lei Geral de Protecao de Dados Pessoais (LGPD). (Redacao dada pela Lei n 13.853, de 2019)
  2. da Silva KR, 2013, PLOS ONE, V8, DOI 10.1371/journal.pone.0071090
  3. Das MK, 2022, INDIAN PEDIATR, V59, P571, DOI 10.1007/s13312-022-2561-y
  4. Ehrlinger L, 2022, FRONT BIG DATA, V5, DOI 10.3389/fdata.2022.850611
  5. Faxon DP, 2016, CIRC-CARDIOVASC INTE, V9, DOI 10.1161/CIRCINTERVENTIONS.116.003866
  6. Gliklich RE, 2020, THER INNOV REGUL SCI, V54, P303, DOI 10.1007/s43441-019-00058-6
  7. Gupta N, 2016, J AM HEART ASSOC, V5, DOI 10.1161/JAHA.115.002798
  8. Harkener S, 2019, STUD HEALTH TECHNOL, V267, P39, DOI 10.3233/SHTI190803
  9. Harris PA, 2009, J BIOMED INFORM, V42, P377, DOI 10.1016/j.jbi.2008.08.010
  10. Houterman S, 2023, NETH HEART J, V31, P334, DOI 10.1007/s12471-022-01752-1
  11. Kaloyanova K., 2021, P INF SYST GRID TECH, P155
  12. Kaloyanova K., 2022, P INF SYST GRID TECH, P358
  13. Klimek P, 2022, JMIR MED INF, V10, DOI 10.2196/34204
  14. Lauricella LL, 2018, J AM COLL SURGEONS, V226, P1128, DOI 10.1016/j.jamcollsurg.2018.03.006
  15. Lee Kathleen, 2017, AMIA Annu Symp Proc, V2017, P1080
  16. Localio AR, 2001, ANN INTERN MED, V135, P112, DOI 10.7326/0003-4819-135-2-200107170-00012
  17. Orlandi BMM, 2020, PLOS ONE, V15, DOI 10.1371/journal.pone.0223343
  18. Malenka DJ, 2022, J AM COLL CARDIOL, V79, P1704, DOI 10.1016/j.jacc.2022.02.034
  19. Mashoufi M, 2023, METHOD INFORM MED, V62, P5, DOI 10.1055/s-0043-1761500
  20. Masoudi FM, 2017, J AM COLL CARDIOL, V70, P1673, DOI 10.1016/j.jacc.2017.08.021
  21. Mendelsohn AB, 2015, THER INNOV REGUL SCI, V49, P146, DOI 10.1177/2168479014532259
  22. Nahm M., 2019, Clinical Research Informatics, P175
  23. Nahm ML, 2008, PLOS ONE, V3, DOI 10.1371/journal.pone.0003049
  24. Nathan M, 2017, ANN THORAC SURG, V103, P629, DOI 10.1016/j.athoracsur.2016.06.111
  25. Prang KH, 2022, CONTEMP CLIN TRIALS, V119, DOI 10.1016/j.cct.2022.106843
  26. Van Bulck L, 2022, EUR J CARDIOVASC NUR, V21, P85, DOI 10.1093/eurjcn/zvab104
  27. VANTONGELEN K, 1989, EUR J CANCER CLIN ON, V25, P1241, DOI 10.1016/0277-5379(89)90421-5
  28. Zozus Meredith N, 2016, AMIA Jt Summits Transl Sci Proc, V2016, P279