Neha Reddy, Subeesh Viswam, Beulah Elsa, Gouri Nair, Maheswari Eswaran
Department of Pharmacy Practice, M. S. Ramaiah University of Applied Sciences, Bengaluru, India.
Department of Pharmacology, M. S. Ramaiah University of Applied Sciences, Bengaluru, India.
Hosp Pharm. 2021 Jun;56(3):152-158. doi: 10.1177/0018578719882323. Epub 2019 Oct 18.
Notoriety bias is defined as "a selection bias in which a case has a greater chance of being reported if the subject is exposed to the studied factor known to cause, thought to cause, or likely to cause the event of interest." This study aimed to determine the existence of notoriety bias in the FDA Adverse Event Reporting System (FAERS) database and estimate the impact of potential notoriety bias induced by safety alerts on signal estimation using disproportionality analysis. Publicly available FAERS data were downloaded and used for analysis. Thirty-one drugs which had label change/safety alert issued by FDA from 2009 to 2013 were considered. These drugs were reviewed 4 quarters before and after the safety alert notification for the existence of notoriety bias. The impact of notoriety bias induced by safety alerts was analyzed by comparing the signal strength using reporting odds ratio (ROR) and proportional reporting ratio (PRR), 2 years before and after the safety alert. Wilcoxon signed rank test was used to determine whether there were a statistically significant difference before and after the safety alert. There was increased reporting for 11 drugs after the safety alert/label change by the FDA. The reporting of 20 drugs decreased or remained unchanged after the safety alert/label change by the FDA. Wilcoxon signed rank test showed that there is no statistically significant difference with respect to the number of reports before and after the safety alert ( = .330, Z = -0.974). Fourteen (45.16%) drugs had an increase in ROR, while 17 (54.83%) drugs had a decrease in ROR after safety alert issued by FDA ( = .953, Z = -0.059). Fourteen (45.16%) drugs had an increase in PRR, while 17 (54.83%) drugs had a decrease in PRR after safety alert issued by the FDA ( = .914, Z = -0.108). Although few FDA safety alert/warnings had a strong and immediate impact, many had no impact on reporting of AE and signal strength. This study found that overreporting due to notoriety bias does not exist in the FAERS database and the overall disproportionality in signal estimates is not altered by the safety alert.
知名度偏差被定义为“一种选择偏差，即如果受试者暴露于已知会导致、被认为会导致或可能导致感兴趣事件的研究因素，那么该病例被报告的可能性更大”。本研究旨在确定美国食品药品监督管理局不良事件报告系统（FAERS）数据库中是否存在知名度偏差，并使用不成比例分析估计安全警报引发的潜在知名度偏差对信号估计的影响。下载了公开可用的FAERS数据并用于分析。考虑了2009年至2013年期间美国食品药品监督管理局发布了标签变更/安全警报的31种药物。在安全警报通知前后的4个季度对这些药物进行审查，以确定是否存在知名度偏差。通过比较安全警报前后2年使用报告比值比（ROR）和比例报告比值（PRR）的信号强度，分析安全警报引发的知名度偏差的影响。使用Wilcoxon符号秩检验来确定安全警报前后是否存在统计学上的显著差异。美国食品药品监督管理局发布安全警报/标签变更后，11种药物的报告增加。美国食品药品监督管理局发布安全警报/标签变更后，20种药物的报告减少或保持不变。Wilcoxon符号秩检验表明，安全警报前后报告数量没有统计学上的显著差异（P = 0.330，Z = -0.974）。美国食品药品监督管理局发布安全警报后，14种（45.16%）药物的ROR增加，而17种（54.83%）药物的ROR下降（P = 0.953，Z = -0.059）。美国食品药品监督管理局发布安全警报后，14种（45.16%）药物的PRR增加，而17种（54.83%）药物的PRR下降（P = 0.914，Z = -0.108）。虽然很少有美国食品药品监督管理局的安全警报/警告有强烈且即时的影响，但许多对不良事件报告和信号强度没有影响。本研究发现，FAERS数据库中不存在因知名度偏差导致的过度报告，并且安全警报不会改变信号估计中的总体不成比例性。
