Botsis Taxiarchis, Ball Robert
Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD, USA.
Stud Health Technol Inform. 2011;169:564-8.
The identification of signals from spontaneous reporting systems plays an important role in monitoring the safety of medical products. Network analysis (NA) allows the representation of complex interactions among the key elements of such systems. We developed a network for a subset of the US Vaccine Adverse Event Reporting System (VAERS) by representing the vaccines/adverse events (AEs) and their interconnections as the nodes and the edges, respectively; this subset we focused upon included possible anaphylaxis reports that were submitted for the H1N1 influenza vaccine. Subsequently, we calculated the main metrics that characterize the connectivity of the nodes and applied the island algorithm to identify the densest region in the network and, thus, identify potential safety signals. AEs associated with anaphylaxis formed a dense region in the 'anaphylaxis' network demonstrating the strength of NA techniques for pattern recognition. Additional validation and development of this approach is needed to improve future pharmacovigilance efforts.
自发报告系统中信号的识别在监测医疗产品安全性方面发挥着重要作用。网络分析(NA)能够呈现此类系统关键要素之间的复杂相互作用。我们通过将疫苗/不良事件(AE)及其相互联系分别表示为节点和边,开发了美国疫苗不良事件报告系统(VAERS)一个子集的网络;我们关注的这个子集包括针对甲型H1N1流感疫苗提交的可能过敏反应报告。随后,我们计算了表征节点连通性的主要指标,并应用孤岛算法识别网络中最密集的区域,从而识别潜在的安全信号。与过敏反应相关的不良事件在“过敏反应”网络中形成了一个密集区域,证明了网络分析技术在模式识别方面的优势。需要对该方法进行进一步验证和改进,以提升未来的药物警戒工作。