Prognostic accuracy of qSOFA score, SIRS criteria, and EWSs for in-hospital mortality among adult patients presenting with suspected infection to the emergency department (PASSEM) Multicenter prospective external validation cohort study protocol
Authors: Algarni Abdullah M. , Alfaifi Musa S. , Al Bshabshe Ali A. , Omair Othman M. , Alsultan Mohammed A. , Alzahrani Hasan M. , Alali Hadi E. , Alsabaani Abdullah A. , Alqarni Ali M. , Alghanem Salah A. , Al Mufareh Bandar S. , Almemari Ayesha M. , Sindi Abdulrahman A. , Ozturan Ibrahim U. , Alhadhira Abdullah A. , Shujaa Asaad S. , Alotaibi Abdullah H. , Awladthani Moosa M. , Alsaad Ahmed A. , Almarshed Abdullah A. , AlQahtani AlHanouv M. , Harris Tim R. , Alyahya Bader A. , Assiri Saad A. , Abuzeyad Feras H. , Kazim Sara N. , Al-Fares Abdulrahman A. , Almazroua Faisal Y. , Marzook Naif T. , Basri Abdullah A. , Elsafti Abdallah M. , Alalshaikh Abdulaziz S. , Özturan Cansu A. , Alawad Yousef I. , AlOmari Awad , Alkhateeb Malek A. , Farooq Moonis M. , AlMutairi Latifa Ali , Alasfour Muneera M. , Al Haber Mohammad I. , Umar Umma-Kulthum A. , Bokhary Nidal H. , Alqahtani Saeed F. , Almutairi Abdulrhman , Alyahya Hisham F. , Alzahrani Wejdan S. , Alsalmi Fawziah , Omair Abdulmajeed M. , Alasmari Faysal M. , Alfifi Sultan Y. , Al-Nujimi Mohammed S. , Foroutan Farid 
Published: January 2024

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).