Center for General Internal Medicine and Emergency Care, Kinki University School of Medicine, Osaka-sayama, Japan.
Pharmacoepidemiol Drug Saf. 2012 Nov;21(11):1221-6. doi: 10.1002/pds.3331. Epub 2012 Aug 6.
Adverse drug events (ADEs) are common health problems worldwide. Developing a prediction rule to identify patients at high risk for ADEs to prevent or ameliorate ADEs could be one attractive strategy.
The Japan Adverse Drug Events (JADE) study is a prospective cohort study including 3459 participants. We randomly divided the JADE study cohort into the derivation and the validation sets, using an automated random digit generator. We calculated the probabilities of ADE in each patient in the validation set after applying the prediction rule developed in the derivation set. The actual incidence and area under the receiver operating characteristic curve (AUC) in the validation set were compared with those in the derivation set to evaluate the prognostic ability of our developed prediction rule.
The developed prediction rule included eight independent risk factors. Each patient in the validation set was classified into three categories of risk for the ADEs according to the probability of ADEs calculated by the developed prediction rule. Eight percent (137/1730) of patients in the validation set fell into the high-risk group, and 35% of this group (48/137) had at least one ADE. The AUC in the validation set was 0.63 (95%CI 0.60-0.66), and the performance to discriminate the probability of ADE was similar (p = 0.08) compared with that in the derivation set.
This prediction rule had the modest predictive ability and could help physicians and other healthcare professionals to make an estimation of patients at high risk for ADEs.
药物不良反应(ADE)是全球常见的健康问题。开发一种预测规则来识别 ADE 高风险患者,以预防或减轻 ADE,可能是一种有吸引力的策略。
日本药物不良反应(JADE)研究是一项包括 3459 名参与者的前瞻性队列研究。我们使用自动随机数字发生器将 JADE 研究队列随机分为推导集和验证集。我们在推导集中应用开发的预测规则后,计算验证集中每个患者发生 ADE 的概率。在验证集中比较实际发生率和接收者操作特征曲线下面积(AUC)与推导集中的发生率和 AUC,以评估我们开发的预测规则的预后能力。
开发的预测规则包括 8 个独立的危险因素。根据推导规则计算出的 ADE 概率,验证集中的每位患者被分为 ADE 风险的三个类别。验证集中 8%(137/1730)的患者属于高危组,该组 35%(48/137)的患者至少发生了一次 ADE。验证集中的 AUC 为 0.63(95%CI 0.60-0.66),与推导集中的性能相比,区分 ADE 概率的性能相似(p=0.08)。
该预测规则具有适度的预测能力,可以帮助医生和其他医疗保健专业人员评估 ADE 高风险患者。