Coleman Craig I, Vaitsiakhovich Tatsiana, Nguyen Elaine, Weeda Erin R, Sood Nitesh A, Bunz Thomas J, Schaefer Bernhard, Meinecke Anna-Katharina, Eriksson Daniel
Department of Pharmacy Practice, University of Connecticut School of Pharmacy, Storrs, Connecticut.
Real-World Evidence Strategy and Outcomes Data Generation, Bayer AG, Berlin, Germany.
Clin Cardiol. 2018 Jan;41(1):119-125. doi: 10.1002/clc.22861. Epub 2018 Jan 23.
Schemas to identify bleeding-related hospitalizations in claims data differ in billing codes used and coding positions allowed. We assessed agreement across bleeding-related hospitalization coding schemas for claims analyses of nonvalvular atrial fibrillation (NVAF) patients on oral anticoagulation (OAC).
We hypothesized that prior coding schemas used to identify bleeding-related hospitalizations in claim database studies would provide varying levels of agreement in incidence rates.
Within MarketScan data, we identified adults, newly started on OAC for NVAF from January 2012 to June 2015. Billing code schemas developed by Cunningham et al., the US Food and Drug Administration (FDA) Mini-Sentinel program, and Yao et al. were used to identify bleeding-related hospitalizations as a surrogate for major bleeding. Bleeds were subcategorized as intracranial hemorrhage (ICH), gastrointestinal (GI), or other. Schema agreement was assessed by comparing incidence, rates of events/100 person-years (PYs), and Cohen's kappa statistic.
We identified 151 738 new-users of OAC with NVAF (CHA2DS2-VASc score = 3, [interquartile range = 2-4] and median HAS-BLED score = 3 [interquartile range = 2-3]). The Cunningham, FDA Mini-Sentinel, and Yao schemas identified any bleeding-related hospitalizations in 1.87% (95% confidence interval [CI]: 1.81-1.94), 2.65% (95% CI: 2.57-2.74), and 4.66% (95% CI: 4.55-4.76) of patients (corresponding rates = 3.45, 4.90, and 8.65 events/100 PYs). Kappa agreement across schemas was weak-to-moderate (κ = 0.47-0.66) for any bleeding hospitalization. Near-perfect agreement (κ = 0.99) was observed with the FDA Mini-Sentinel and Yao schemas for ICH-related hospitalizations, but agreement was weak when comparing Cunningham to FDA Mini-Sentinel or Yao (κ = 0.52-0.53). FDA Mini-Sentinel and Yao agreement was moderate (κ = 0.62) for GI bleeding, but agreement was weak when comparing Cunningham to FDA Mini-Sentinel or Yao (κ = 0.44-0.56). For other bleeds, agreement across schemas was minimal (κ = 0.14-0.38).
We observed varying levels of agreement among 3 bleeding-related hospitalizations schemas in NVAF patients.
在索赔数据中识别与出血相关住院情况的方案在使用的计费代码和允许的编码位置上存在差异。我们评估了用于口服抗凝治疗(OAC)的非瓣膜性心房颤动(NVAF)患者索赔分析的与出血相关住院编码方案之间的一致性。
我们假设先前在索赔数据库研究中用于识别与出血相关住院情况的编码方案在发病率方面会有不同程度的一致性。
在MarketScan数据中,我们识别出2012年1月至2015年6月开始新接受OAC治疗的NVAF成年患者。使用Cunningham等人、美国食品药品监督管理局(FDA)Mini-Sentinel项目以及Yao等人开发的计费代码方案来识别与出血相关的住院情况,以此作为大出血的替代指标。出血被细分为颅内出血(ICH)、胃肠道(GI)或其他类型。通过比较发病率、每100人年(PYs)的事件发生率以及Cohen's kappa统计量来评估方案的一致性。
我们识别出151738名新接受OAC治疗的NVAF患者(CHA2DS2-VASc评分 = 3,[四分位间距 = 2 - 4],HAS-BLED评分中位数 = 3 [四分位间距 = 2 - 3])。Cunningham方案、FDA Mini-Sentinel方案和Yao方案分别在1.87%(95%置信区间[CI]:1.81 - 1.94)、2.65%(95%CI:2.57 - 2.74)和4.66%(95%CI:4.55 - 4.76)的患者中识别出任何与出血相关的住院情况(相应发生率 = 3.45、4.90和8.65事件/100 PYs)。对于任何与出血相关的住院情况,各方案之间的Kappa一致性为弱到中等(κ = 0.47 - 0.66)。对于与ICH相关的住院情况,FDA Mini-Sentinel方案和Yao方案之间观察到近乎完美的一致性(κ = 0.99),但将Cunningham方案与FDA Mini-Sentinel方案或Yao方案进行比较时,一致性较弱(κ = 0.52 - 0.53)。对于胃肠道出血,FDA Mini-Sentinel方案和Yao方案之间的一致性为中等(κ = 0.62),但将Cunningham方案与FDA Mini-Sentinel方案或Yao方案进行比较时,一致性较弱(κ = 0.44 - 0.56)。对于其他出血情况,各方案之间的一致性极小(κ = 0.14 - 0.38)。
我们观察到在NVAF患者的3种与出血相关住院情况方案之间存在不同程度的一致性。