Lo Re Vincent, Carbonari Dena M, Forde Kimberly A, Goldberg David, Lewis James D, Haynes Kevin, Leidl Kimberly B F, Reddy Rajender K, Roy Jason, Sha Daohang, Marks Amy R, Schneider Jennifer L, Strom Brian L, Corley Douglas A
Division of Infectious Diseases, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Center for Clinical Epidemiology and Biostatistics, Department of Biostatistics and Epidemiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Pharmacoepidemiol Drug Saf. 2015 Jul;24(7):676-83. doi: 10.1002/pds.3774. Epub 2015 Apr 10.
Identification of acute liver failure (ALF) is important for post-marketing surveillance of medications, but the validity of using ICD-9 diagnoses and laboratory data to identify these events within electronic health records is unknown. We examined positive predictive values (PPVs) of hospital ICD-9 diagnoses and laboratory tests of liver dysfunction for identifying ALF within a large, community-based integrated care organization.
We identified Kaiser Permanente Northern California health plan members (2004-2010) with a hospital diagnosis suggesting ALF (ICD-9 570, 572.2, 572.4, 572.8, 573.3, 573.8, or V42.7) plus an inpatient international normalized ratio ≥1.5 (off warfarin) and total bilirubin ≥5.0 mg/dL. Hospital records were reviewed by hepatologists to adjudicate ALF events. PPVs for confirmed outcomes were determined for individual ICD-9 diagnoses, diagnoses plus prescriptions for hepatic encephalopathy treatment, and combinations of diagnoses in the setting of coagulopathy and hyperbilirubinemia.
Among 669 members with no pre-existing liver disease, chart review confirmed ALF in 62 (9%). Despite the presence of co-existing coagulopathy and hyperbilirubinemia, individual ICD-9 diagnoses had low PPVs (range, 5-15%); requiring prescriptions for encephalopathy treatment did not increase PPVs of these diagnoses (range, 2-23%). Hospital diagnoses of other liver disorders (ICD-9 573.8) plus hepatic coma (ICD-9 572.2) had high PPV (67%; 95%CI, 9-99%) but only identified two (3%) ALF events.
Algorithms comprising relevant hospital diagnoses, laboratory evidence of liver dysfunction, and prescriptions for hepatic encephalopathy treatment had low PPVs for confirmed ALF events. Studies of ALF will need to rely on medical records to confirm this outcome.
急性肝衰竭（ALF）的识别对于药物上市后监测很重要，但在电子健康记录中使用国际疾病分类第九版（ICD - 9）诊断和实验室数据来识别这些事件的有效性尚不清楚。我们在一个大型的、基于社区的综合医疗组织中，研究了医院ICD - 9诊断和肝功能障碍实验室检查对识别ALF的阳性预测值（PPV）。
我们确定了北加利福尼亚凯撒医疗集团健康计划的成员（2004 - 2010年），这些成员有医院诊断提示ALF（ICD - 9编码为570、572.2、572.4、572.8、573.3、573.8或V42.7），加上住院期间国际标准化比值≥1.5（停用华法林）且总胆红素≥5.0mg/dL。肝病专家审查医院记录以判定ALF事件。确定了个体ICD - 9诊断、诊断加上肝性脑病治疗处方以及在凝血障碍和高胆红素血症情况下诊断组合的确诊结果的PPV。
在669名无既往肝病的成员中，病历审查确诊62例（9%）为ALF。尽管存在并存的凝血障碍和高胆红素血症，但个体ICD - 9诊断的PPV较低（范围为5% - 15%）；需要肝性脑病治疗处方并未增加这些诊断的PPV（范围为2% - 23%）。医院诊断的其他肝脏疾病（ICD - 9 573.8）加上肝昏迷（ICD - 9 572.2）的PPV较高（67%；95%可信区间，9% - 99%），但仅识别出两例（3%）ALF事件。
包含相关医院诊断、肝功能障碍实验室证据以及肝性脑病治疗处方的算法对于确诊的ALF事件PPV较低。ALF研究将需要依靠病历记录来确认这一结果。
