Division of Epidemiology and Biometry, Carl von Ossietzky University of Oldenburg, Oldenburg, Germany.
Institute for Laboratory Medicine and Microbiology, Klinikum Oldenburg, Carl von Ossietzky University of Oldenburg, Oldenburg, Germany.
Pharmacoepidemiol Drug Saf. 2019 Oct;28(10):1344-1352. doi: 10.1002/pds.4855. Epub 2019 Aug 1.
Acute liver injury (ALI) is an important adverse drug reaction. We estimated the positive predictive values (PPVs) of ICD-10-GM codes of ALI used in an international postauthorisation safety study (PASS).
Analyses used routine data (2007 to 2016, adults) from a German academic hospital in a cross-sectional design. Two algorithms from the PASS were applied to extract potential cases from the hospital information system: specific end point (A) (discharge diagnosis of liver disease-specific codes) and less specific end point (B) (discharge and outpatient-specific and nonspecific codes suggestive of liver injury). ALI cases were confirmed on the basis of plasma liver enzyme activity elevation. Secondary analysis was performed following exclusion of cases with known cancer, chronic liver, biliary and pancreatic disease, heart failure, and alcohol-related disorders, as applied in the PASS.
On the basis of ICD codes: outcome A, 154 cases (143 with case notes and lab data for case verification); outcome B, 485 cases (357 with case notes and lab data). ALI was confirmed in 71 outcome A cases, PPV of 49.7% (95% confidence interval [CI], 41.2%-58.1%), and 100 outcome B cases, PPV of 28.0% (95% CI, 23.4%-33.0%). Applying exclusion criteria increased PPV (95% CI) to 62.7% (50.0%-74.2%) for outcome A and 45.7% (37.2%-54.3%) for outcome B.
In safety studies on hepatotoxicity based on routine data using ICD-10-GM discharge codes and when validation of potential cases is not feasible, only the more specific codes should be used to describe ALI, and competing diagnoses for liver injury should be excluded to avoid substantial misclassification.
急性肝损伤（ALI）是一种重要的药物不良反应。我们评估了用于国际上市后安全性研究（PASS）的 ALI 的 ICD-10-GM 代码的阳性预测值（PPV）。
分析使用了德国一家学术医院的常规数据（2007 年至 2016 年，成人），采用横断面设计。PASS 应用了两种算法从医院信息系统中提取潜在病例：特定终点（A）（肝脏疾病特定代码的出院诊断）和非特异性终点（B）（出院和门诊特定和非特异性代码提示肝损伤）。根据血浆肝酶活性升高确认 ALI 病例。次要分析是根据 PASS 中的排除标准进行的，排除了已知癌症、慢性肝病、胆道和胰腺疾病、心力衰竭和与酒精相关的疾病的病例。
根据 ICD 代码：结果 A，154 例（143 例有病例记录和实验室数据进行病例验证）；结果 B，485 例（357 例有病例记录和实验室数据）。在结果 A 中，154 例病例中有 71 例 ALI 得到了确认，PPV 为 49.7%（95%置信区间[CI]，41.2%-58.1%），结果 B 中有 485 例病例中有 100 例 ALI 得到了确认，PPV 为 28.0%（95% CI，23.4%-33.0%）。应用排除标准后，结果 A 的 PPV（95% CI）增加至 62.7%（50.0%-74.2%），结果 B 的 PPV（95% CI）增加至 45.7%（37.2%-54.3%）。
在使用 ICD-10-GM 出院代码基于常规数据的药物肝毒性安全性研究中，并且当潜在病例的验证不可行时，仅应使用更具体的代码来描述 ALI，并排除肝脏损伤的竞争诊断，以避免大量的错误分类。
