Janssen Research and Development, Titusville, New Jersey, USA.
Department of Statistics, Columbia University, New York, New York, USA.
CPT Pharmacometrics Syst Pharmacol. 2013 Sep 18;2(9):e76. doi: 10.1038/psp.2013.52.
Undiscovered side effects of drugs can have a profound effect on the health of the nation, and electronic health-care databases offer opportunities to speed up the discovery of these side effects. We applied a "medication-wide association study" approach that combined multivariate analysis with exploratory visualization to study four health outcomes of interest in an administrative claims database of 46 million patients and a clinical database of 11 million patients. The technique had good predictive value, but there was no threshold high enough to eliminate false-positive findings. The visualization not only highlighted the class effects that strengthened the review of specific products but also underscored the challenges in confounding. These findings suggest that observational databases are useful for identifying potential associations that warrant further consideration but are unlikely to provide definitive evidence of causal effects.
药物未被发现的副作用可能对国民健康产生深远影响,而电子医疗保健数据库则提供了加速发现这些副作用的机会。我们应用了一种“药物广泛关联研究”方法,该方法将多元分析与探索性可视化相结合,研究了 4600 万患者的行政索赔数据库和 1100 万患者的临床数据库中四个感兴趣的健康结果。该技术具有良好的预测价值,但没有足够高的阈值来消除假阳性发现。可视化不仅突出了强化特定产品审查的类效应,还强调了混杂的挑战。这些发现表明,观察性数据库可用于识别需要进一步考虑的潜在关联,但不太可能提供因果关系的明确证据。