Validation of Sepsis-3 using survival analysis and clinical evaluation of quick SOFA, SIRS, and burn-specific SIRS for sepsis in burn patients with suspected infection

Purpose: Sepsis-3 is a life-threatening organ dysfunction caused by dysregulated host responses to infection; and defined using the Sepsis-3 criteria, introduced in 2016, however, the criteria need to be validated in specific clinical fields. We investigated mortality prediction and compared the diagnostic performance of quick Sequential Organ Failure Assessment (qSOFA), systemic inflammatory response syndrome (SIRS), and burn-specific SIRS (bSIRS) in burn patients. Methods: This single-center retrospective cohort study examined burn patients in Seoul, Korea during January 2010–December 2020. Overall, 1,391 patients with suspected infection were divided into four sepsis groups using SOFA, qSOFA, SIRS, and burn-specific SIRS. Results: Hazard ratios (HRs) of all unadjusted models were statistically significant; however, the HR (0.726, p = 0.0080.001) in the SIRS ≥2 group is below 1. In the adjusted model, HRs of the SOFA ≥2 (2.426, p < 0.001), qSOFA ≥2 (7.198, p < 0.001), and SIRS ≥2 (0.575, p < 0.001) groups were significant. The diagnostic performance of dichotomized qSOFA, SIRS, and bSIRS for sepsis was defined by the Sepsis-3 criteria. The mean onset day was 4.13±2.97 according to Sepsis-3. The sensitivity of SIRS (0.989, 95% confidence interval [CI]: 0.982–0.994) was higher than that of qSOFA (0.841, 95% CI: 0.819–0.861) and bSIRS (0.803, 95% CI: 0.779–0.825). Specificities of qSOFA (0.929, 95% CI: 0.876–0.964) and bSIRS (0.922, 95% CI: 0.868–0.959) were higher than those of SIRS (0.461, 95% CI: 0.381–0.543). Conclusion: Sepsis-3 is a good alternative diagnostic tool because it reflects sepsis severity without delaying diagnosis. SIRS showed higher sensitivity than qSOFA and bSIRS and may therefore more adequately diagnose sepsis.研究目的：脓毒症3.0（Sepsis-3）是指宿主对感染产生失调性应答后引发的危及生命的器官功能障碍，其定义基于2016年推出的脓毒症3.0诊断标准，但该标准仍需在特定临床领域中完成验证。本研究旨在开展死亡率预测分析，并比较快速序贯器官衰竭评分（quick Sequential Organ Failure Assessment, qSOFA）、全身炎症反应综合征（systemic inflammatory response syndrome, SIRS）以及烧伤特异性全身炎症反应综合征（burn-specific SIRS, bSIRS）在烧伤患者中的诊断效能。 方法：本研究为单中心回顾性队列研究，纳入2010年1月至2020年12月韩国首尔地区的烧伤患者。最终共纳入1391例疑似感染患者，分别依据序贯器官衰竭评分（SOFA）、qSOFA、SIRS及bSIRS标准将其划分为4个脓毒症分组。 结果：所有未校正模型的风险比（hazard ratio, HR）均具有统计学显著性；但SIRS≥2分组的HR（0.726，p=0.0080.001）小于1。在校正模型中，SOFA≥2分组（HR=2.426，p<0.001）、qSOFA≥2分组（HR=7.198，p<0.001）及SIRS≥2分组（HR=0.575，p<0.001）的HR均具有统计学显著性。本研究以脓毒症3.0标准为参照，评估了二分法qSOFA、SIRS及bSIRS对脓毒症的诊断效能。依据脓毒症3.0标准，患者的平均发病天数为4.13±2.97。SIRS的敏感度（0.989，95%置信区间[CI]：0.982~0.994）高于qSOFA（0.841，95%CI：0.819~0.861）与bSIRS（0.803，95%CI：0.779~0.825）。qSOFA（0.929，95%CI：0.876~0.964）与bSIRS（0.922，95%CI：0.868~0.959）的特异度均高于SIRS（0.461，95%CI：0.381~0.543）。 结论：脓毒症3.0是一种优秀的替代诊断工具，因其可在不延误诊断的前提下反映脓毒症的严重程度。SIRS的敏感度高于qSOFA与bSIRS，因此可更充分地诊断脓毒症。