Ammann Eric M, Schweizer Marin L, Robinson Jennifer G, Eschol Jayasheel O, Kafa Rami, Girotra Saket, Winiecki Scott K, Fuller Candace C, Carnahan Ryan M, Leonard Charles E, Haskins Cole, Garcia Crystal, Chrischilles Elizabeth A
College of Public Health, University of Iowa, Iowa City, IA, USA.
Iowa City VA Health Care System, Iowa City, IA, USA.
Pharmacoepidemiol Drug Saf. 2018 Apr;27(4):398-404. doi: 10.1002/pds.4398. Epub 2018 Feb 15.
The Sentinel Distributed Database (SDD) is a large database of patient-level administrative health care records, primarily derived from insurance claims and electronic health records, and is sponsored by the US Food and Drug Administration for medical product safety evaluations. Acute myocardial infarction (AMI) is a common study endpoint for drug safety studies that rely on health records from the SDD and other administrative databases.
In this chart validation study, we report on the positive predictive value (PPV) of inpatient International Classification of Diseases, Ninth Revision, Clinical Modification AMI administrative diagnosis codes (410.x1 and 410.x0) in the SDD.
As part of an assessment of thromboembolic adverse event risk following treatment with intravenous immune globulin, charts were obtained for 103 potential post-intravenous immune globulin AMI cases. Charts were abstracted by trained nurses and physician-adjudicated based on prespecified diagnostic criteria.
Acute myocardial infarction status could be determined for 89 potential cases. The PPVs for the inpatient AMI diagnoses recorded in the SDD were 75% overall (95% CI, 65-84%), 93% (95% CI, 78-99%) for principal-position diagnoses, 88% (95% CI, 72-97%) for secondary diagnoses, and 38% (95% CI, 20-59%) for position-unspecified diagnoses (eg, diagnoses originating from separate physician claims associated with an inpatient stay). Of the confirmed AMI cases, demand ischemia was the suspected etiology more often for those coded in secondary or unspecified positions (72% and 40%, respectively) than for principal-position AMI diagnoses (21%).
The PPVs for principal and secondary AMI diagnoses were high and similar to estimates from prior chart validation studies. Position-unspecified diagnosis codes were less likely to represent true AMI cases.
哨兵分布式数据库（SDD）是一个包含患者层面医疗保健管理记录的大型数据库，主要来源于保险理赔和电子健康记录，由美国食品药品监督管理局赞助用于医疗产品安全性评估。急性心肌梗死（AMI）是依赖SDD和其他管理数据库中的健康记录进行的药物安全性研究的常见研究终点。
在这项图表验证研究中，我们报告了SDD中住院患者国际疾病分类第九版临床修订本AMI管理诊断代码（410.x1和410.x0）的阳性预测值（PPV）。
作为评估静脉注射免疫球蛋白治疗后血栓栓塞不良事件风险的一部分，获取了103例静脉注射免疫球蛋白后可能发生AMI病例的图表。图表由经过培训的护士进行摘要，并根据预先设定的诊断标准由医生进行判定。
可以确定89例潜在病例的急性心肌梗死状态。SDD中记录的住院AMI诊断的总体PPV为75%（95%CI，65 - 84%），主要位置诊断的PPV为93%（95%CI，78 - 99%），次要诊断的PPV为88%（95%CI，72 - 97%），位置未明确诊断的PPV为38%（95%CI，20 - 59%）（例如，源自与住院相关的不同医生理赔的诊断）。在确诊的AMI病例中，对于编码在次要或未明确位置的病例，需求性缺血作为疑似病因的情况比主要位置AMI诊断更为常见（分别为72%和40%，而主要位置AMI诊断为21%）。
主要和次要AMI诊断的PPV较高，与先前图表验证研究的估计值相似。位置未明确的诊断代码不太可能代表真正的AMI病例。
