External Validation of a Risk Score for Major Toxicity Among Nonsteroidal Anti-Inflammatory Drug Users: Real-World Application.
External Validation of a Risk Score for Major Toxicity Among Nonsteroidal Anti-Inflammatory Drug Users: Real-World Application.
复制标题
非甾体抗炎药使用者主要毒性风险评分的外部验证：现实世界应用。
DOI：
10.1002/acr2.11134
复制
发表时间：
2020
影响因子：
3.4
通讯作者：
Kremer,JoelM
中科院分区：
文献类型：
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作者：
Solomon,DanielH;Paynter,NinaP;Guan,Hongshu;Kremer,JoelM
我们之前在一项随机对照试验中推导并验证了NSAID使用者1年以上主要非甾体抗炎药（NSAID）毒性的风险评分。这项工作被扩展到检查风险评分的性能在外部人口使用真实的世界的data.MethodsPatients入组的Corrona风湿性关节炎（RA）登记处，如果他们开始使用的NSAID。我们定义了先前在主要NSAID毒性风险评分中确定的原始风险因素：年龄;男性;心血管疾病、高血压和糖尿病史;烟草使用;他汀类药物使用;血清肌酐和红细胞压积值升高; RA。此外，我们定义了主要毒性的发生，包括主要不良心血管事件、急性肾损伤、重大胃肠道事件和死亡率。原始风险因素在考克斯回归中进行了评估，检查区分和校准。低（小于1%），中间（1%-4%），和高（超过4%）的风险类别为1年的风险适用于population.ResultsA共5231例患者从Corrona谁有一个新的NSAID暴露期。原始风险评分模型显示出良好的区分度（C指数0.70）。在真实的世界数据中，并非所有原始变量都具有统计学显著性。使用原始风险评分权重，1363例（26.1%）患者的预测风险小于1%，3571例（68.3%）患者的预测风险为1%-4%，297例（5.7%）患者的预测风险大于4%。结论原始NSAID主要毒性风险评分在该外部真实的世界队列中表现出良好的模型拟合特征。这些结果表明，这种风险评分在典型实践中是有效的，可以考虑用于临床护理。
ObjectiveWe previously derived and validated a risk score for major nonsteroidal anti‐inflammatory drug (NSAID) toxicity over 1 year among NSAID users in a randomized controlled trial. This work was extended to examine the risk score's performance in an external population using real‐world data.MethodsPatients enrolled in the Corrona Rheumatoid Arthritis (RA) Registry were included if they initiated use of an NSAID. We defined the original risk factors previously identified in the risk score for major NSAID toxicity: age; male sex; history of cardiovascular disease, hypertension, and diabetes; tobacco use; statin use; elevated serum creatinine and hematocrit values; and RA. Additionally, we defined the occurrence of major toxicity, including major adverse cardiovascular events, acute kidney injury, significant gastrointestinal events, and mortality. The original risk factors were assessed in Cox regression examining discrimination and calibration. Low (less than 1%), intermediate (1%‐4%), and high (more than 4%) risk categories for 1‐year risk were applied to the population.ResultsA total of 5231 patients from Corrona who had a new NSAID exposure period were included. The original risk score model showed good discrimination (C‐index 0.70). Not all of the original variables were statistically significant in real‐world data. Using the original risk score weights, 1363 (26.1%) patients had predicted risk of less than 1%, 3571 (68.3%) had predicted risk of 1% to 4%, and 297 (5.7%) had predicted risk of more than 4%.ConclusionThe original NSAID major toxicity risk score demonstrated good model fit characteristics in this external real‐world cohort. These results suggest that such a risk score is valid in typical practice and could be considered for clinical care.