A Data Warehouse Based Retrospective Post-marketing Surveillance Method: A Feasibility Test with Fluoxetine

Park, Man Young; Lee, Young Ho; Kim, Eun Yeob; Kim, Woo Jae; Kam, Hye Jin; Choi, Jong Pill; Han, Tae Hwa; Kang, Un Gu; Park, Rae Woong

doi:10.4258/jksmi.2009.15.2.191

Cited by 1 publication

(2 citation statements)

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“…Integrating electronic medical data from different hospitals is a difficult, tedious and multistep process not only in terms of technical problems of integrating heterogeneous database schema, but also problems of institutional policies, privacy and security problems. The detailed processes of data warehouse or data mart construction have been reported elsewhere [ 24 ]. Although massive data-driven analysis, such as the present study, has not been described to explain a causal relationship compared to well-designed clinical trial, nonetheless, it can be useful to get a simple and quick insight into a problem.…”

Section: Discussionmentioning

confidence: 99%

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Analysis of Relationship between Levofloxacin and Corrected QT Prolongation Using a Clinical Data Warehouse

Park

Kim²,

Lee

et al. 2011

Healthc Inform Res

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ObjectiveThe aim of this study was to examine whether or not levofloxacin has any relationship with QT prolongation in a real clinical setting by analyzing a clinical data warehouse of data collected from different hospital information systems.MethodsElectronic prescription data and medical charts from 3 different hospitals spanning the past 9 years were reviewed, and a clinical data warehouse was constructed. Patients who were both administrated levofloxacin and given electrocardiograms (ECG) were selected. The correlations between various patient characteristics, concomitant drugs, corrected QT (QTc) prolongation, and the interval difference in QTc before and after levofloxacin administration were analyzed.ResultsA total of 2,176 patients from 3 different hospitals were included in the study. QTc prolongation was found in 364 patients (16.7%). The study revealed that age (OR 1.026, p < 0.001), gender (OR 0.676, p = 0.007), body temperature (OR 1.267, p = 0.024), and cigarette smoking (OR 1.641, p = 0.022) were related with QTc prolongation. After adjusting for related factors, 12 drugs concomitant with levofloxacin were associated with QTc prolongation. For patients who took ECGs before and after administration of levofloxacin during their hospitalization (n = 112), there was no significant difference in QTc prolongation.ConclusionsThe age, gender, body temperature, cigarette smoking and various concomitant drugs might be related with QTc prolongation. However, there was no definite causal relationship or interaction between levofloxacin and QTc prolongation. Alternative surveillance methods utilizing the massive accumulation of electronic medical data seem to be essential to adverse drug reaction surveillance in future.

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Section: Discussionmentioning

confidence: 99%

“…The method how to make data mart for this study was partly introduced in the previous work in detail [ 24 ]. Briefly, patients who were administrated subject drug (levofloxacin) during their hospitalization within the period mentioned above were selected.…”

Section: Methodsmentioning

confidence: 99%