West Suzanne L, D'Aloisio Aimee A, Ringel-Kulka Tamar, Waller Anna E, Clayton Bordley W
Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599-7521, USA.
Pharmacoepidemiol Drug Saf. 2007 Dec;16(12):1255-67. doi: 10.1002/pds.1502.
Anaphylaxis is a life-threatening condition; drug-related anaphylaxis represents approximately 10% of all cases. We assessed the utility of a statewide emergency department (ED) database for identifying drug-related anaphylaxis in children by developing and validating an algorithm composed of ICD-9-CM codes.
There were 1 314,760 visits to South Carolina (SC) emergency departments (EDs) for patients <19 years in 2000-2002. We used ICD-9-CM disease or external cause of injury codes (E-codes) that suggested drug-related anaphylaxis or a severe drug-related allergic reaction. We found 50 cases classifiable as probable or possible drug-related anaphylaxis and 13 as drug-related allergic reactions. We used clinical evaluation by two pediatricians as the 'alloyed gold standard'1 for estimating sensitivity, specificity, and positive predictive value (PPV) of our algorithm.
ED-treated drug-related anaphylaxis in the SC pediatric population was 1.56/100,000 person-years based on the algorithm and 0.50/100,000 person-years based on clinical evaluation. Assuming the disease codes we used identified all potential anaphylaxis cases in the database, the sensitivity was 1.00 (95%CI: 0.79, 1.00), specificity was 0.28 (95%CI: 0.16, 0.43), and the PPV was 0.32 (0.20, 0.47) for the algorithm. Sensitivity analyses improved the measurement properties of the algorithm.
E-codes were invaluable for developing an anaphylaxis algorithm although the frequently used code of E947.9 was often incorrectly applied. We believe that our algorithm may have over-ascertained drug-related anaphylaxis patients seen in an ED, but the clinical evaluation may have under-represented this diagnosis due to limited information on the offending agent in the abstracted ED records. Post-marketing drug surveillance using ED records may be viable if clinicians were to document drug-related anaphylaxis in the charts so that billing codes could be assigned properly.
过敏反应是一种危及生命的状况;药物相关的过敏反应约占所有病例的10%。我们通过开发和验证一种由ICD - 9 - CM编码组成的算法,评估了一个全州范围的急诊科(ED)数据库在识别儿童药物相关过敏反应方面的效用。
2000 - 2002年,南卡罗来纳州(SC)急诊科有1314760次针对19岁以下患者的就诊。我们使用了ICD - 9 - CM疾病或损伤外部原因编码(E编码),这些编码提示药物相关的过敏反应或严重的药物相关过敏反应。我们发现50例可归类为可能或疑似药物相关过敏反应的病例,以及13例药物相关过敏反应病例。我们将两位儿科医生的临床评估作为我们算法灵敏度、特异度和阳性预测值(PPV)的“混合金标准”。
基于该算法,SC儿科人群中经急诊科治疗的药物相关过敏反应为每100000人年1.56例,基于临床评估为每100000人年0.50例。假设我们使用的疾病编码识别了数据库中所有潜在的过敏反应病例,该算法的灵敏度为1.00(95%CI:0.79,1.00),特异度为0.28(95%CI:0.16,0.43),PPV为0.32(0.20,0.47)。灵敏度分析改善了该算法的测量特性。
E编码对于开发过敏反应算法非常重要,尽管常用的E947.9编码经常被错误应用。我们认为我们的算法可能高估了在急诊科就诊的药物相关过敏反应患者,但由于急诊科摘要记录中关于致病因素的信息有限,临床评估可能低估了这一诊断。如果临床医生在病历中记录药物相关过敏反应以便正确分配计费编码,那么利用急诊科记录进行上市后药物监测可能是可行的。