Component of qSOFA score and SIRS criteria.

Background
Early identification of a patient with infection who may develop sepsis is of utmost importance. Unfortunately, this remains elusive because no single clinical measure or test can reflect complex pathophysiological changes in patients with sepsis. However, multiple clinical and laboratory parameters indicate impending sepsis and organ dysfunction. Screening tools using these parameters can help identify the condition, such as SIRS, quick SOFA (qSOFA), National Early Warning Score (NEWS), or Modified Early Warning Score (MEWS). We aim to externally validate qSOFA, SIRS, and NEWS/NEWS2/MEWS for in-hospital mortality among adult patients with suspected infection who presenting to the emergency department.
Methods and analysis
PASSEM study is an international prospective external validation cohort study. For 9 months, each participating center will recruit consecutive adult patients who visited the emergency departments with suspected infection and are planned for hospitalization. We will collect patients’ demographics, vital signs measured in the triage, initial white blood cell count, and variables required to calculate Charlson Comorbidities Index; and follow patients for 90 days since their inclusion in the study. The primary outcome will be 30-days in-hospital mortality. The secondary outcome will be intensive care unit (ICU) admission, prolonged stay in the ICU (i.e., ≥72 hours), and 30- as well as 90-days all-cause mortality. The study started in December 2021 and planned to enroll 2851 patients to reach 200 in-hospital death. The sample size is adaptive and will be adjusted based on prespecified consecutive interim analyses.
Discussion
PASSEM study will be the first international multicenter prospective cohort study that designated to externally validate qSOFA score, SIRS criteria, and EWSs for in-hospital mortality among adult patients with suspected infection presenting to the ED in the Middle East region.
Study registration
The study is registered at ClinicalTrials.gov (NCT05172479).

背景
感染患者中可能进展为脓毒症者的早期识别至关重要。然而，目前这一目标仍难以实现，因为尚无单一临床指标或检测手段能够反映脓毒症患者复杂的病理生理变化。不过，多项临床与实验室参数可提示脓毒症即将发生及器官功能障碍。基于此类参数构建的筛查工具可辅助该病的识别，例如全身炎症反应综合征（Systemic Inflammatory Response Syndrome, SIRS）、快速脓毒症相关器官衰竭评分（quick SOFA, qSOFA）、国家早期预警评分（National Early Warning Score, NEWS）以及改良早期预警评分（Modified Early Warning Score, MEWS）。本研究旨在针对急诊科（Emergency Department, ED）就诊的疑似感染成年患者，对qSOFA、SIRS以及NEWS/NEWS2/MEWS用于院内死亡的预测效能进行外部验证。

方法与分析
本研究为PASSEM研究，是一项国际性前瞻性外部验证队列研究。研究周期为9个月，各参与中心将连续纳入急诊科就诊、疑似感染且拟住院治疗的成年患者。我们将收集患者的人口统计学资料、分诊时测得的生命体征、初始白细胞计数以及计算查尔森合并症指数（Charlson Comorbidities Index）所需的变量，并自患者入组起对其进行为期90天的随访。主要结局指标为30天院内死亡率；次要结局指标包括重症监护病房（Intensive Care Unit, ICU）收治、ICU停留时长≥72小时、30天及90天全因死亡率。本研究于2021年12月启动，计划纳入2851例患者以达成200例院内死亡的目标。样本量为自适应设计，将基于预先设定的连续中期分析结果进行调整。

讨论
PASSEM研究将是中东地区首个针对急诊科就诊的疑似感染成年患者，对外验证qSOFA评分、SIRS标准及早期预警评分（Early Warning Scores, EWSs）用于院内死亡预测效能的国际性多中心前瞻性队列研究。

研究注册
本研究已在ClinicalTrials.gov注册（注册号：NCT05172479）。