Rhee Chanu, Train Sarah E, Filbin Michael R, Park Steven T, Mohr Nicholas M, Zepeski Anne, Faine Brett A, Roach David J, Porter Emily, Shappell Claire N, Plechot Kamryn, DelloStritto Laura, Yu Tingting, Klompas Michael
Department of Population Medicine, Harvard Pilgrim Health Care Institute, Boston, Massachusetts.
Division of Infectious Diseases, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.
JAMA Netw Open. 2025 Mar 3;8(3):e251100. doi: 10.1001/jamanetworkopen.2025.1100.
The Centers for Medicare & Medicaid Services Severe Sepsis and Septic Shock Management Bundle (SEP-1) is supported by observational studies that report SEP-1 compliance is associated with lower mortality. Most studies, however, adjusted for limited confounders and provided little insight into why bundle-compliant care was not provided.
To identify the clinical factors that complicate the diagnosis and management of sepsis and assess their association with SEP-1 compliance and mortality.
DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study was conducted among 590 adults with sepsis in the emergency department of 4 academic hospitals from January 1, 2019, to December 31, 2022. Patients' medical records were reviewed between September 2022 and December 2023.
Study outcomes were (1) characteristics of patients who received SEP-1-compliant care vs characteristics of patients who received noncompliant care and (2) association between SEP-1 compliance and hospital mortality using multivariable models to adjust for successively more potential confounders (first demographics and comorbidities, then infection source, then severity of illness, and then clinical markers of complexity).
Of 590 patients with sepsis (median age, 65 years [IQR, 53-77 years]; 329 men [55.8%]), 335 (56.8%) received SEP-1-compliant care, and 225 (43.2%) received noncompliant care. Compared with patients in the compliant group, patients in the noncompliant group were more likely to be 65 years or older (142 [55.7%] vs 158 [47.2%]; odds ratio [OR], 1.41 [95% CI, 1.01-1.95]), to have multiple comorbidities (Elixhauser score >20: 99 [38.8%] vs 99 [29.6%]; OR, 1.51 [95% CI, 1.07-2.13]), and to have a higher incidence of septic shock (107 [42.0%] vs 107 [31.9%]; OR, 1.54 [95% CI, 1.10-2.16]), kidney dysfunction (87 [34.1%] vs 80 [23.9%]; OR, 1.65 [95% CI, 1.15-2.37]), and thrombocytopenia (43 [16.9%] vs 37 [11.0%]; OR, 1.16 [95% CI, 1.02-2.62]) on presentation. Compared with patients in the compliant group, those in the noncompliant group also had more nonfebrile presentations (136 [53.3%] vs 121 [36.1%]; OR, 2.02 [95% CI, 1.45-2.82]), impaired mental status (92 [36.1%] vs 94 [28.1%]; OR, 1.45 [95% CI, 1.02-2.05]), need for bedside procedures (57 [22.4%] vs 41 [12.2%]; OR, 2.06 [95% CI, 1.33-3.21]), acute concurrent noninfectious illnesses (140 [54.9%] vs 151 [45.1%]; OR, 1.48 [95% CI, 1.07-2.06]), and noninfectious illness as the primary factor associated with their presentation (84 [32.9%] vs 71 [21.2%]; OR, 1.82 [95% CI, 1.08-3.08]). SEP-1 compliance was associated with lower crude mortality rates compared with noncompliance (40 [11.9%] vs 41 [16.1%]; unadjusted OR, 0.60 [95% CI, 0.37-0.98]), but there was no statistically significant difference between groups after successively adjusting for demographics and comorbidities (adjusted OR [AOR], 0.71 [95% CI, 0.42-1.18]), infection source (AOR, 0.71 [95% CI, 0.43-1.20]), severity of illness (AOR, 0.86 [95% CI, 0.50-1.49]), and clinical markers of complexity (AOR, 1.08 [95% CI, 0.61-1.91]).
In this cohort study of adults with sepsis, complex clinical presentations were more common among patients whose treatment was noncompliant with SEP-1. These nuances are poorly captured in most observational studies but confound the association between SEP-1 compliance and mortality.
医疗保险和医疗补助服务中心的严重脓毒症和脓毒性休克管理集束方案（SEP - 1）得到了观察性研究的支持，这些研究报告称SEP - 1的依从性与较低的死亡率相关。然而，大多数研究对有限的混杂因素进行了调整，并且对未提供符合集束方案治疗的原因几乎没有深入探讨。
确定使脓毒症诊断和管理复杂化的临床因素，并评估它们与SEP - 1依从性和死亡率的关联。
设计、设置和参与者：这项回顾性队列研究于2019年1月1日至2022年12月31日在4家学术医院的急诊科对590例成年脓毒症患者进行。在2022年9月至2023年12月期间对患者的病历进行了审查。
研究结局为：（1）接受符合SEP - 1治疗的患者特征与接受不符合治疗的患者特征；（2）使用多变量模型调整越来越多潜在混杂因素（首先是人口统计学和合并症，然后是感染源，接着是疾病严重程度，最后是复杂性临床标志物）后，SEP - 1依从性与医院死亡率之间的关联。
在590例脓毒症患者中（中位年龄65岁[四分位间距，53 - 77岁]；329例男性[55.8%]），335例（56.8%）接受了符合SEP - 1的治疗，225例（43.2%）接受了不符合的治疗。与符合组患者相比，不符合组患者更可能年龄在65岁及以上（142例[55.7%]对158例[47.2%]；比值比[OR]，1.41[95%置信区间，1.01 - 1.95]），有多种合并症（埃利克斯豪泽评分>20：99例[38.8%]对99例[29.6%]；OR，1.51[95%置信区间，1.07 - 2.13]），脓毒性休克发生率更高（107例[42.0%]对107例[31.9%]；OR，1.54[95%置信区间，1.10 - 2.16]），肾功能不全（87例[34.1%]对80例[23.9%]；OR，1.65[95%置信区间，1.15 - 2.37]），以及就诊时血小板减少（43例[16.9%]对37例[11.0%]；OR，1.16[95[置信区间，(1.02 - 2.62)]）。与符合组患者相比，不符合组患者无发热表现也更多（136例[53.3%]对121例[36.1%]；OR，2.02[95%置信区间，1.45 - 2.82]），精神状态受损（92例[36.1%]对94例[28.1%]；OR，1.45[95%置信区间，1.02 - 2.05]），需要床边操作（57例[22.4%]对41例[12.2%]；OR，2.06[95%置信区间，1.33 - 3.21]），急性并发非感染性疾病（140例[54.9%]对151例[45.1%]；OR，1.48[95%置信区间，1.07 - 2.06]），以及非感染性疾病是其就诊的主要相关因素（84例[32.9%]对71例[21.2%]；OR，1.82[95%置信区间，1.08 - 3.08]）。与不符合相比，SEP - 1依从性与较低的粗死亡率相关（40例[11.9%]对41例[16.1%]；未调整OR，0.60[95%置信区间，0.37 - 0.98]），但在依次调整人口统计学和合并症（调整后OR[AOR]，0.71[95%置信区间，0.42 - 1.18]）、感染源（AOR，0.71[95%置信区间，0.43 - 1.20]）、疾病严重程度（AOR，0.86[95%置信区间，0.50 - 1.49]）和复杂性临床标志物（AOR，1.08[95%置信区间，0.61 - 1.91]）后，两组之间无统计学显著差异。
在这项针对成年脓毒症患者的队列研究中，复杂的临床表现在治疗不符合SEP - 1的患者中更为常见。这些细微差别在大多数观察性研究中未得到充分体现，但混淆了SEP - 1依从性与死亡率之间的关联。
