Prognostic Accuracy of qSOFA, SIRS, and EWSs for In-hospital Mortality in Emergency Department

Study Overview
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Brief Summary
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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). The 2016 SCCM/ESICM task force recommended using qSOFA, while the 2021 Surviving Sepsis Campaign strongly recommended against its use compared with SIRS, NEWS, or MEWS as a single screening tool for sepsis or septic shock. We hypothesised that qSOFA has greater prognostic accuracy than SIRS and EWS (NEWS/NEWS2/MEWS).

Detailed Description
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Over the past decade, medical advances in sepsis continued to focus on sepsis as a prevalent condition that accounts for 10% of admissions to intensive care units (ICUs) and is associated with a 10-20% in-hospital mortality rate. Standardised protocols and physician awareness have significantly improved survival, but mortality rates remain between 20% and 36%, with  270,000 deaths annually in the United States. However, of patients with sepsis, 80% are treated in an emergency department (ED), and the remainder develops sepsis during hospitalisation with other conditions. In 2016, the Society of Critical Care Medicine/European Society of Intensive Care Medicine (SCCM/ESICM) task force redefined sepsis based on organ dysfunction and mortality prediction. Sepsis now is defined as life-threatening organ dysfunction caused by dysregulated host response to infection. This definition emphasises the complexity of the disease that cannot be explained by infection or body response to it. Acute change in Sequential Organ Failure Assessment (SOFA) score ≥2 indicates sepsis-related organ dysfunction, a predictor of excess in-hospital mortality. Systemic Inflammatory Response Syndrome (SIRS) and severe sepsis terms were omitted from the most recent definition. SIRS has been criticised for its poor specificity, while severe sepsis may underestimate sepsis's seriousness. A subset of patients may develop septic shock with underlying profound organ dysfunction and excess mortality. Clinically, septic shock is defined as persistent hypotension requiring vasopressors to maintain mean arterial pressure (MAP) ≥ 65 mm Hg and serum lactate level ≥ 2 mmol/L (18 mg/dL) despite adequate volume resuscitation. 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). The 2016 SCCM/ESICM task force recommended using qSOFA, while the 2021 Surviving Sepsis Campaign strongly recommended against its use compared with SIRS, NEWS, or MEWS as a single screening tool for sepsis or septic shock. We hypothesised that qSOFA has greater prognostic accuracy than SIRS and EWS (NEWS/NEWS2/MEWS).

Official Title
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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): Protocol for an International Multicentre Prospective External Validation Cohort Study

Conditions
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Sepsis, Septic Shock

Intervention / Treatment
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* Diagnostic Test: Measurement of qSOFA score
* Diagnostic Test: Measurement of SIRS criteria
* Diagnostic Test: Measurement of NEWS
* Diagnostic Test: Measurement of NEWS2
* Diagnostic Test: Measurement of MEWS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (age ≥18 years), Suspected infection (based on the opinion of the emergency physician), Planned for hospitalization, Willing to give oral informed consent (if required by recruiting center's IRB). Exclusion Criteria: Presentation to ED is not due to infection (e.g., autoimmune diseases, myocardial infarction, stroke, venous thromboembolism, trauma, intoxication … etc.), Pregnancy, Transferred from another hospitals, Code status is Do-Not-Resuscitate (DNR) Elective admission through ED Initial diagnosis of infection in the ED was not confirmed after finishing of the recruitment and follow-up phase.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Positive qSOFA<br>Adult patients with suspected infection and a qSOFA score ≥ 2 at the triage in the ED who are planned for hospitalization | Diagnostic Test: Measurement of qSOFA score<br>* At the patient's arrival to the ED triage, the nurse will enter the patient's vital signs data into electronic data capture (EDC) system that will calculate the patient's qSOFA score.<br>* Other names: quick Sequential Organ Failure Assessment (qSOFA);|
| Negative qSOFA<br>Adult patients with suspected infection and a qSOFA score < 2 at the triage in the ED who are planned for hospitalization | Diagnostic Test: Measurement of qSOFA score<br>* At the patient's arrival to the ED triage, the nurse will enter the patient's vital signs data into electronic data capture (EDC) system that will calculate the patient's qSOFA score.<br>* Other names: quick Sequential Organ Failure Assessment (qSOFA);|
| Positive SIRS<br>Adult patients with suspected infection and a SIRS criteria ≥ 2 at the triage in the ED who are planned for hospitalization | Diagnostic Test: Measurement of SIRS criteria<br>* At the patient's arrival to the ED triage, the nurse will enter the patient's vital signs data into electronic data capture (EDC) system that will calculate the patient's SIRS criteria.<br>* Other names: Systemic inflammatory response syndrome (SIRS);|
| Negative SIRS<br>Adult patients with suspected infection and a SIRS criteria < 2 at the triage in the ED who are planned for hospitalization | Diagnostic Test: Measurement of SIRS criteria<br>* At the patient's arrival to the ED triage, the nurse will enter the patient's vital signs data into electronic data capture (EDC) system that will calculate the patient's SIRS criteria.<br>* Other names: Systemic inflammatory response syndrome (SIRS);|
| Positive NEWS<br>Adult patients with suspected infection and a NEWS ≥ 5 or red score (i.e., a score of 3 in any one parameter) at the triage in the ED who are planned for hospitalization | Diagnostic Test: Measurement of NEWS<br>* At the patient's arrival to the ED triage, the nurse will enter the patient's vital signs data into electronic data capture (EDC) system that will calculate the patient's NEWS.<br>* Other names: National Early Warning Score (NEWS);|
| Negative NEWS<br>Adult patients with suspected infection and a NEWS < 5 at the triage in the ED who are planned for hospitalization | Diagnostic Test: Measurement of NEWS<br>* At the patient's arrival to the ED triage, the nurse will enter the patient's vital signs data into electronic data capture (EDC) system that will calculate the patient's NEWS.<br>* Other names: National Early Warning Score (NEWS);|
| Positive NEWS2<br>Adult patients with suspected infection and a NEWS2 ≥ 5 or red score (i.e., a score of 3 in any one parameter) at the triage in the ED who are planned for hospitalization | Diagnostic Test: Measurement of NEWS2<br>* At the patient's arrival to the ED triage, the nurse will enter the patient's vital signs data into electronic data capture (EDC) system that will calculate the patient's NEWS2.<br>* Other names: National Early Warning Score 2 (NEWS2);|
| Negative NEWS2<br>Adult patients with suspected infection and a NEWS2 < 5 at the triage in the ED who are planned for hospitalization | Diagnostic Test: Measurement of NEWS2<br>* At the patient's arrival to the ED triage, the nurse will enter the patient's vital signs data into electronic data capture (EDC) system that will calculate the patient's NEWS2.<br>* Other names: National Early Warning Score 2 (NEWS2);|
| Positive MEWS<br>Adult patients with suspected infection and a MEWS ≥ 5 at the triage in the ED who are planned for hospitalization | Diagnostic Test: Measurement of MEWS<br>* At the patient's arrival to the ED triage, the nurse will enter the patient's vital signs data into electronic data capture (EDC) system that will calculate the patient's MEWS.<br>* Other names: Modified Early Warning Score (MEWS);|
| Negative MEWS<br>Adult patients with suspected infection and a MEWS < 5 at the triage in the ED who are planned for hospitalization | Diagnostic Test: Measurement of MEWS<br>* At the patient's arrival to the ED triage, the nurse will enter the patient's vital signs data into electronic data capture (EDC) system that will calculate the patient's MEWS.<br>* Other names: Modified Early Warning Score (MEWS);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital mortality | Mortality rate during hospitalization of patient | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensive care unit admission | Number of participants admitted to an intensive care unit | 30 days | 
| Length of stay in the intensive care unit | Stay in intensive care unit >72 hours | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emergency department, Sepsis, Septic shock, qSOFA, SIRS, EWS, NEWS, NEWS2, MEWS