The Need for National Registry

  • Yoga Yuniadi JKI

Abstract

Currently medical outcomes research has generally been conducted with 3 sources of data: randomized clinical trials, administrative claims databases, and data registries. Each of these data sources has a unique set of applications, data quality issues, and requirements.1 In United State, clinical trials is part of the pharmaceutical and device pre-approval process thus it has highly regulated requirements for source document verification.2 In contrast, quality control of administrative data is primarily limited to fields directly related to claims adjudication. Thus, administrative claims data are significantly limited for the purposes of performing healthcare research.3 Like administrative claims data, registries are nonrandomized, observational datasets that can be generalized to real-world practice, depending on the representativeness of participants and the completeness of enrollment.4 However, as with the data collected in randomized clinical trials, registries include detailed clinical data using standardized data definitions.

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References

Messenger JC, Ho KK , Young CH, Slattery LE, Draoui JC, Curtis JP, Dehmer GJ, Grover FL, Mirro MJ, Reynolds MR, Rokos IC, Spertus JA, Wang TY, Winston SA, Rumsfeld JS, Masoudi FA. The National Cardiovascular Data Registry (NCDR) Data Quality Brief: the NCDR Data Quality Program in 2012. J Am Coll Cardiol. 2012;60(16):1484-1488.

Jollis JG, Ancukiewicz M, DeLong ER, Pryor DB, Muhlbaier LH, Mark DB. Discordance of databases designed for claims payment versus clinical information systems. Implications for outcomes research. Ann Intern Med. 1993;119(8):844-850.

Shahian DM, Silverstein T, Lovett AF, Wolf RE, Normand SL. Comparison of clinical and administrative data sources for hospital coronary artery bypass graft surgery report cards. Circulation. 2007;115(12):1518-1527.

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Cardiology ESo. EURObservational Research Programme. The new programme of surveys and registries Available at: http://www.escardio.org/guidelines-surveys/eorp/Pages/welcome.aspx. Accessed 12 January, 2014.

Published
2015-03-31

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How to Cite
Yuniadi, Y. (2015). The Need for National Registry. Indonesian Journal of Cardiology, 35(1), 1-3. https://doi.org/10.30701/ijc.v35i1.368