Bias Implications of Outcome Misclassification in Observational Studies Evaluating Association Between Treatments and All-Cause or Cardiovascular Mortality Using Administrative Claims.
Bias Implications of Outcome Misclassification in Observational Studies Evaluating Association Between Treatments and All-Cause or Cardiovascular Mortality Using Administrative Claims.
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DOI：
10.1161/jaha.120.016906
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发表时间：
2020-09
影响因子：
5.4
通讯作者：
Patorno E
中科院分区：
文献类型：
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作者：
Desai RJ;Levin R;Lin KJ;Patorno E
在基于索赔的研究中，由于死亡率采集不完善而导致的结局错误分类的偏倚影响尚未得到很好的理解。我们确定了2个患者队列：（1）2型糖尿病（n= 860万）和（2）心力衰竭（n= 310万），来自Medicare索赔（2012-2016）。在2个队列中，使用以下方法从索赔中确定死亡率：（1）全因死亡率，（2）院内全因死亡率，（3）全因心血管死亡率（基于死亡日期后30天内重大心血管事件的诊断代码），或（4）院内心血管死亡率，并与国家死亡指数确定的死亡率进行比较。基于2个队列中的观察值，使用经验确定的灵敏度和特异性进行Monte Carlo模拟，以估计差异和非差异误分类情况下的治疗效果。根据国家死亡指数，纳入了2型糖尿病队列中的1 544 805例死亡（549 996例[35.6%]心血管死亡）和心力衰竭队列中的1 175 202例死亡（523 430例[44.5%]心血管死亡）。在2型糖尿病和心力衰竭队列中，全位置全因死亡率方法的灵敏度分别为99.997%和99.207%，而院内全因死亡率方法的灵敏度分别为27.71%和33.71%，具有完美的阳性预测值。对于所有心血管死亡率，2型糖尿病队列和心力衰竭队列的敏感性分别为52.01%和53.83%，阳性预测值分别为49.98%和54.45%。模拟表明治疗效果可能存在实质性偏倚。与国家死亡指数相比，确定索赔死亡率的方法有不同的表现。当使用行政索赔来获取死亡率时，研究者应预期结局错误分类的偏倚可能性。
The bias implications of outcome misclassification arising from imperfect capture of mortality in claims‐based studies are not well understood. We identified 2 cohorts of patients: (1) type 2 diabetes mellitus (n=8.6 million), and (2) heart failure (n=3.1 million), from Medicare claims (2012–2016). Within the 2 cohorts, mortality was identified from claims using the following approaches: (1) all‐place all‐cause mortality, (2) in‐hospital all‐cause mortality, (3) all‐place cardiovascular mortality (based on diagnosis codes for a major cardiovascular event within 30 days of death date), or (4) in‐hospital cardiovascular mortality, and compared against National Death Index identified mortality. Empirically identified sensitivity and specificity based on observed values in the 2 cohorts were used to conduct Monte Carlo simulations for treatment effect estimation under differential and nondifferential misclassification scenarios. From National Death Index, 1 544 805 deaths (549 996 [35.6%] cardiovascular deaths) in the type 2 diabetes mellitus cohort and 1 175 202 deaths (523 430 [44.5%] cardiovascular deaths) in the heart failure cohort were included. Sensitivity was 99.997% and 99.207% for the all‐place all‐cause mortality approach, whereas it was 27.71% and 33.71% for the in‐hospital all‐cause mortality approach in the type 2 diabetes mellitus and heart failure cohorts, respectively, with perfect positive predicted values. For all‐place cardiovascular mortality, sensitivity was 52.01% in the type 2 diabetes mellitus cohort and 53.83% in the heart failure cohort with positive predicted values of 49.98% and 54.45%, respectively. Simulations suggested a possibility for substantial bias in treatment effects. Approaches to identify mortality from claims had variable performance compared with the National Death Index. Investigators should anticipate the potential for bias from outcome misclassification when using administrative claims to capture mortality.