Indonesian Journal of Cardiology
Vol. 35, No. 1 Januari - Maret 2014

The Need for National Registry

Yoga Yuniadi (JKI)



Article Info

Publish Date
31 Mar 2015

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.

Copyrights © 2014






Journal Info

Abbrev

ijc

Publisher

Subject

Health Professions Medicine & Pharmacology

Description

Indonesian Journal of Cardiology (IJC) is a peer-reviewed and open-access journal established by Indonesian Heart Association (IHA)/Perhimpunan Dokter Spesialis Kardiovaskular Indonesia (PERKI) [www.inaheart.org] on the year 1979. This journal is published to meet the needs of physicians and other ...