Cao Zhun, Villa Kathleen F, Lipkin Craig B, Robinson Scott B, Nejadnik Bijan, Dvorak Christopher C
a Premier Research Services , Charlotte , NC , USA.
b Jazz Pharmaceuticals , Palo Alto , CA , USA.
J Med Econ. 2017 Aug;20(8):871-883. doi: 10.1080/13696998.2017.1336623. Epub 2017 Jun 14.
Sinusoidal obstruction syndrome (SOS) is a life-threatening complication of hematopoietic stem cell transplantation (HSCT) associated with significant morbidity and mortality. Healthcare utilization, costs, and mortality were assessed in HSCT patients diagnosed with SOS, with and without multi-organ dysfunction (MOD).
This retrospective observational study identified real-world patients undergoing HSCT between January 1, 2009 and May 31, 2014 using the Premier Healthcare Database. In absence of a formal ICD-9-CM diagnostic code, SOS patients were identified using a pre-specified definition adapted from Baltimore and Seattle criteria and clinical practice. Severe SOS (SOS/MOD) and non-severe SOS (SOS/no-MOD) were classified according to clinical evidence for MOD in the database.
Of the 5,418 patients with a discharge diagnosis of HSCT, 291 had SOS, with 134 categorized as SOS/MOD and 157 as SOS/no-MOD. The remaining 5,127 patients had HSCT without SOS. Overall SOS incidence was 5.4%, with 46% having evidence of MOD. Distribution of age, gender, and race were similar between the SOS cohorts and non-SOS patients. After controlling for hospital profile and admission characteristics, demographics, and clinical characteristics, the adjusted mean LOS was 31.0 days in SOS/MOD compared to 23.9 days in the non-SOS cohort (medians = 26.9 days vs 20.8 days, p < .001). The adjusted mean cost of SOS/MOD patients was $140,653, which was $41,702 higher than the non-SOS cohort (medians = $105,749 vs $74,395, p < .001). An almost 6-fold increased odds of inpatient mortality was associated with SOS/MOD compared to the non-SOS cohort (odds ratio = 5.88; 95% CI = 3.45-10.33).
Limitations of retrospective observational studies apply, since the study was not randomized. Definition for SOS was based on ICD-9 diagnosis codes from a hospital administrative database and reliant on completeness and accuracy of coding.
Analysis of real-world data shows that SOS/MOD is associated with significant increases in healthcare utilization, costs, and inpatient mortality.
窦性阻塞综合征（SOS）是造血干细胞移植（HSCT）的一种危及生命的并发症，与显著的发病率和死亡率相关。对诊断为SOS的HSCT患者（伴有或不伴有多器官功能障碍（MOD））的医疗资源利用情况、费用及死亡率进行评估。
这项回顾性观察性研究利用Premier医疗数据库确定了2009年1月1日至2014年5月31日期间接受HSCT的真实世界患者。在没有正式的ICD - 9 - CM诊断代码的情况下，根据从巴尔的摩和西雅图标准及临床实践改编的预先指定的定义来确定SOS患者。根据数据库中MOD的临床证据将严重SOS（SOS/MOD）和非严重SOS（SOS/无MOD）进行分类。
在5418例出院诊断为HSCT的患者中，291例患有SOS，其中134例归类为SOS/MOD，157例归类为SOS/无MOD。其余5127例患者进行了HSCT但无SOS。总体SOS发病率为5.4%，其中46%有MOD证据。SOS队列与非SOS患者之间的年龄、性别和种族分布相似。在控制了医院概况、入院特征、人口统计学和临床特征后，SOS/MOD患者调整后的平均住院时间为31.0天，而非SOS队列中为23.9天（中位数分别为26.9天和20.8天，p <.001）。SOS/MOD患者调整后的平均费用为140,653美元，比非SOS队列高41,702美元（中位数分别为105,749美元和74,395美元，p <.001）。与非SOS队列相比，SOS/MOD患者住院死亡率的几率增加了近6倍（优势比 = 5.88；95%置信区间 = 3.45 - 10.33）。
由于该研究未随机分组，存在回顾性观察性研究的局限性。SOS的定义基于医院管理数据库中的ICD - 9诊断代码，且依赖于编码的完整性和准确性。
对真实世界数据的分析表明，SOS/MOD与医疗资源利用、费用及住院死亡率的显著增加相关。
