Zhu Tiantian, Zhang Yuan, Ye Xiaofei, Hou Yongfang, Liu Jia, Shi Wentao, Xu Jinfang, Guo Xiaojing, He Jia
Department of Health Statistics, Second Military Medical University, Shanghai, China.
General Hospital of Jinan Military Command, Jinan, Shandong, China.
Pharmacoepidemiol Drug Saf. 2018 Nov;27(11):1257-1264. doi: 10.1002/pds.4661. Epub 2018 Sep 19.
Signal evaluation is considered to be a tedious process owing to the large number of disproportional signals detected. This study aimed to apply a biclustering algorithm in the spontaneous reporting system of China and to obtain the optimal parameters. The biclustering algorithm is expected to improve the efficiency of signal evaluation by identifying similar signal groups.
Information component (IC) was the method used for disproportionality analysis. By using IC thresholds of various strengths (0.05-4.00), the original quantitative data matrix was transformed into 80 different binary data matrices, where each cell contained either a 1 or 0. The biclustering results were obtained using a total of 720 Bimax algorithm parameters (minimal number of columns and rows was 3, 4, or 5). Next, the optimal parameters were determined through the comprehensive evaluation of the rank sum ration. Finally, we examined the biclustering results under the optimal parameters and evaluated the effect of biclustering analysis on adverse drug reaction (ADR) data in China.
The optimal strength of the IC threshold was 0.80, and the minimum number of rows and columns was 3. After taxonomic evaluation, we also found that 1836 biclusters (42.8%) contained similar drugs or similar ADRs, which accounted for 72.3% of signals unevaluated.
Applying biclustering analysis in spontaneous reporting system could provide support in confirming unrecognized ADRs, identifying rare ADRs, and screening drug-ADR pairs, which need more attention. Biclustering algorithm could improve the efficiency of signal detection and evaluation in China.
由于检测到的不成比例信号数量众多,信号评估被认为是一个繁琐的过程。本研究旨在将双聚类算法应用于中国的自发报告系统并获得最优参数。预计双聚类算法可通过识别相似信号组来提高信号评估效率。
信息成分(IC)是用于不成比例分析的方法。通过使用不同强度(0.05 - 4.00)的IC阈值,将原始定量数据矩阵转换为80个不同的二进制数据矩阵,其中每个单元格包含1或0。使用总共720个Bimax算法参数(列和行的最小数量为3、4或5)获得双聚类结果。接下来,通过秩和比的综合评估确定最优参数。最后,我们检查了最优参数下的双聚类结果,并评估了双聚类分析对中国药品不良反应(ADR)数据的影响。
IC阈值的最优强度为0.80,行和列的最小数量为3。经过分类评估,我们还发现1836个双聚类(42.8%)包含相似药物或相似ADR,占未评估信号的72.3%。
在自发报告系统中应用双聚类分析可为确认未识别的ADR、识别罕见ADR以及筛选需要更多关注的药物 - ADR对提供支持。双聚类算法可提高中国信号检测和评估的效率。