Ono Yasuhisa, Taneda Yusuke, Takeshima Tomomi, Iwasaki Kosuke, Yasui Atsutaka
Medical Department, Nippon Boehringer Ingelheim, Tokyo, Japan.
Milliman Inc., Tokyo, Japan.
Clin Epidemiol. 2020 Apr 8;12:367-375. doi: 10.2147/CLEP.S245555. eCollection 2020.
Observational studies using large claims databases for diabetes patients have been increasingly conducted. While validation of outcomes is important in such studies, validation studies from Japan are still scarce and small in scale with questions remaining on the representativeness of their findings. We examined the positive predictive value (PPV) of outcomes that often develop in type 2 diabetes patients: cardiovascular outcomes including congestive heart failure (CHF), myocardial infarction (MI), stroke-related diseases, and renal outcomes including end stage renal disease (ESRD), and death using a large Japanese database containing administrative claims and electronic medical record (EMR) data.
We used patient-level administrative claims data from 2003 and EMR data from 1985 to the most recent data up to December 2018 provided by Real World Data Co., Ltd. The database consisted of data from over 200 hospitals including ≥12 million uniquely identifiable patients. Among patients who had ≥1 type 2 diabetes diagnosis in the EMR, those who had administrative claims for each outcome were identified, and then the PPV was calculated for each outcome using the EMR as the gold standard.
The numbers of patients identified for each outcome were 1,700 for MI, 2,027 for hemorrhagic stroke, 3,722 for ESRD, 4,723 for ischemic stroke, 5,404 for CHF, 6,678 for any type of stroke, and 10,815 for death. PPVs ranged from 67.4% for ESRD, 78.7% for MI, 80.3% for death, 85.7% for ischemic stroke, 88.9% for any type of stroke, 89.9% for hemorrhagic stroke, and 95.7% for CHF. A post hoc analysis showed PPV for ESRD as 83.8%.
This large-scale validation study on diagnosis in administrative claims showed reasonable PPVs for the outcomes. We believe that the definitions of outcomes can be considered to be appropriate for future studies using Japanese administrative claims data.
利用大型索赔数据库对糖尿病患者进行的观察性研究越来越多。虽然在这类研究中对结果进行验证很重要，但来自日本的验证研究仍然稀缺且规模较小，其研究结果的代表性仍存在疑问。我们使用一个包含行政索赔和电子病历（EMR）数据的大型日本数据库，研究了2型糖尿病患者中常见结局的阳性预测值（PPV），这些结局包括心血管结局，如充血性心力衰竭（CHF）、心肌梗死（MI）、中风相关疾病，以及肾脏结局，如终末期肾病（ESRD）和死亡。
我们使用了2003年的患者级行政索赔数据以及Real World Data Co., Ltd提供的从1985年到2018年12月的最新EMR数据。该数据库包含来自200多家医院的数据，涉及超过1200万具有唯一识别码的患者。在EMR中至少有1次2型糖尿病诊断的患者中，识别出有每种结局行政索赔的患者，然后以EMR作为金标准计算每种结局的PPV。
每种结局识别出的患者数量分别为：MI 1700例、出血性中风2027例、ESRD 3722例、缺血性中风4723例、CHF 5404例、任何类型中风6678例、死亡10815例。PPV范围为：ESRD为67.4%、MI为78.7%、死亡为80.3%、缺血性中风为85.7%、任何类型中风为88.9% 、出血性中风为89.9%、CHF为95.7%。事后分析显示ESRD的PPV为83.8%。
这项关于行政索赔诊断的大规模验证研究显示了这些结局合理的PPV。我们认为这些结局的定义可被视为适用于未来使用日本行政索赔数据的研究。
