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

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

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).

Study Overview

• Status: Completed
• Conditions: Sepsis; Septic Shock
• Intervention / Treatment: 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

Detailed Description

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).

• Study Type: Observational
• Enrollment (Actual): 3274

Contacts and Locations

Study Locations

• Bahrain
  • Muharraq, Bahrain
    • King Hamad University Hospital
  • Southern Governorate
    • Ar Rifā', Southern Governorate, Bahrain, 947
      • Bahrain Defence Force Hospital
• Kuwait
  • Kuwait, Kuwait
    • Amiri Hospital
• Oman
  • Muscat, Oman, 111
    • Armed Forces Hospital Oman
• Qatar
  • Doha, Qatar
    • Hamad Medical Corporation
• Saudi Arabia
  • Riyadh, Saudi Arabia
    • Sulaiman Al-Habib Hospital
  • Aseer Province
    • Abha, Aseer Province, Saudi Arabia, 62523
      • Aseer Central Hospital (ACH)
    • Khamis Mushait, Aseer Province, Saudi Arabia, 62413
      • Armed Force Hospital Southern Region-Khamis Mushayt (AFHSR-KM)
  • Eastern Province
    • Dammam, Eastern Province, Saudi Arabia, 32253
      • King Fahad Specialist Hospital
    • Dhahran, Eastern Province, Saudi Arabia, 34465
      • Johns Hopkins Aramco Healthcare
    • Jubail, Eastern Province, Saudi Arabia, 31961
      • Royal Commission Hospital in Jubail
  • Makkah Al Mukarramah Province
    • Jeddah, Makkah Al Mukarramah Province, Saudi Arabia, 22252
      • King AbdulAziz University Hospital
    • Jeddah, Makkah Al Mukarramah Province, Saudi Arabia, 23311
      • King Fahd Armed Forces Hospital
  • Northern Borders Province
    • Arar, Northern Borders Province, Saudi Arabia, 73241
      • North Medical Tower
  • Riyadh Province
    • Riyadh, Riyadh Province, Saudi Arabia, 11564
      • King Abdullah bin Abdulaziz University Hospital (KAAUH)
    • Riyadh, Riyadh Province, Saudi Arabia, 12231
      • King Fahad Medical City (KFMC)
    • Riyadh, Riyadh Province, Saudi Arabia, 12746
      • King Saud Medical City (KSMC)
• Turkey
  • Kocaeli, Turkey, 41380
    • Kocaeli University Hospital
• United Arab Emirates
  • Abu Dhabi, United Arab Emirates
    • Sheikh Shakhbout Medical City
  • Dubai, United Arab Emirates
    • Rashid Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All consecutive adult patients (age ≥18 years) presenting to the ED with suspected infection who planned to be hospitalized and willing to give informed consent (if required by recruiting center IRB) are eligible. A presumptive diagnosis of infection will be judged based on the opinion of the emergency physician upon the initial patient presentation to the ED. We will exclude patients with evidence of other causes of presentation to the ED other than infection (e.g., autoimmune diseases, myocardial infarction, trauma, …etc.), pregnant ladies, those who transferred from other hospitals, those not planned for hospitalization, or those who admitted electively to the hospital through ED. We will also exclude patients whose initial diagnosis of infection in the ED was not confirmed after the recruitment and follow-up.

Description

Inclusion Criteria:

1. Adult patients (age ≥18 years),
2. Suspected infection (based on the opinion of the emergency physician),
3. Planned for hospitalization,
4. Willing to give oral informed consent (if required by recruiting center's IRB).

Exclusion Criteria:

1. Presentation to ED is not due to infection (e.g., autoimmune diseases, myocardial infarction, stroke, venous thromboembolism, trauma, intoxication … etc.),
2. Pregnancy,
3. Transferred from another hospitals,
4. Code status is "Do-Not-Resuscitate" (DNR)
5. Elective admission through ED
6. Initial diagnosis of infection in the ED was not confirmed after finishing of the recruitment and follow-up phase.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

10

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Positive qSOFA; 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; 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.; Other Names: quick Sequential Organ Failure Assessment (qSOFA)
Negative qSOFA; 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; 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.; Other Names: quick Sequential Organ Failure Assessment (qSOFA)
Positive SIRS; 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; 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.; Other Names: Systemic inflammatory response syndrome (SIRS)
Negative SIRS; 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; 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.; Other Names: Systemic inflammatory response syndrome (SIRS)
Positive NEWS; 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; 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.; Other Names: National Early Warning Score (NEWS)
Negative NEWS; 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; 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.; Other Names: National Early Warning Score (NEWS)
Positive NEWS2; 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; 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.; Other Names: National Early Warning Score 2 (NEWS2)
Negative NEWS2; 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; 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.; Other Names: National Early Warning Score 2 (NEWS2)
Positive MEWS; 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; 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.; Other Names: Modified Early Warning Score (MEWS)
Negative MEWS; 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; 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.; Other Names: Modified Early Warning Score (MEWS)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Aseer Central Hospital
• Collaborators: Armed Force Hospital Southern Region-Khamis Mushayt (AFHSR-KM); King Khalid University (KKU)
• Investigators: Principal Investigator: Abdullah M Algarni, MBBS, Aseer Central Hospital (ACH)

Publications and helpful links

General Publications

• Algarni AM, Alfaifi MS, Bshabshe AAA, et al. 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. medRxiv. 2022.2019.22272537.

Helpful Links

• Protocol preprint

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2021
• Primary Completion (Actual): September 11, 2023
• Study Completion (Actual): September 11, 2023

Study Registration Dates

• First Submitted: December 3, 2021
• First Submitted That Met QC Criteria: December 11, 2021
• First Posted (Actual): December 29, 2021

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 10, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Septic shock; Sepsis; SIRS; qSOFA; Emergency department; EWS; NEWS; NEWS2; MEWS
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Shock; Sepsis; Emergencies; Shock, Septic
• Other Study ID Numbers: ACH-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No