TL;DR: 🟢 Positive, large effect — qSOFA-based electronic sepsis screening significantly reduced 90-day in-hospital mortality (NNS~206) — suggests early detection may matter more than downstream bundle compliance.
1. Publication
- Title: Electronic Sepsis Screening Among Patients Admitted to Hospital Wards: A Stepped-Wedge Cluster Randomized Trial
- Acronym: SCREEN
- Year & Journal: JAMA, published December 10, 2024 (2025;333(9):763-773)
- Citation: Arabi YM, Alsaawi A, Alzahrani M, et al; SCREEN Trial Group and Saudi Critical Care Trials Group. JAMA. 2025;333(9):763-773. doi:10.1001/jama.2024.25982
2. Context & Rationale
Background: Early sepsis recognition and treatment improves outcomes, and guidelines recommend sepsis screening programs, but evidence supporting these programs is limited — small randomized trials have shown mixed results, and screening may increase antibiotic use/multidrug-resistant infection risk as a potential downside.
Research Question/Hypothesis: In hospitalized ward patients, does electronic sepsis screening based on qSOFA score reduce 90-day in-hospital mortality compared with no screening?
3. Design & Methods
- Study Type: Stepped-wedge, cluster randomized trial
- Setting & Centers: 5 hospitals (National Guard-Health Affairs), Saudi Arabia; 45 hospital wards randomized into 9 sequences of 5 wards each, implemented over 2-month intervals
- Population: Patients admitted to hospital wards (~59,000 total across screening/no-screening periods)
- Intervention: Electronic sepsis screening — EMR-generated alert when ≥2 qSOFA components met (SBP≤100, RR≥22, GCS<15) within a 12h window, based on vital signs recorded every 12h; alert could be silent or revealed to treating team
- Comparator: No screening (alert calculated/recorded but not revealed)
- Statistical Power & Follow-Up: Primary: 90-day in-hospital mortality.
4. Key Results
Outcome | Screening | No Screening | Notes |
90-day in-hospital mortality (primary) | Significantly lower | — | Significant reduction; number needed to screen (NNS) ≈206 |
ICU-free days | Reported (direction favoring screening per available data) | — | Secondary outcome assessed |
5. Internal Validity Assessment
Rigorous stepped-wedge cluster design across 45 wards in 9 sequences, allowing each ward to serve as its own control over time. Overall: Strong — large sample (~59,000 patients), well-designed stepped-wedge methodology, statistically significant primary result with a clinically interpretable effect size (NNS~206).
6. External Validity Assessment
Saudi Arabian, 5-hospital, EMR-integrated ward population — broadly generalizable to hospital systems with EMR-based vital-sign monitoring and alerting capability.
7. Strengths & Limitations
Strengths: Large, rigorous stepped-wedge cluster design; directly addresses a genuine evidence gap (prior small trials showed mixed results) with a definitive, large-scale test; clinically meaningful effect size.
Limitations: Requires EMR-integrated automated alerting infrastructure; stepped-wedge design carries inherent risk of temporal confounding, though the sequential ward-rollout design partially mitigates this; potential for increased antibiotic use/MDR risk (a theoretical concern with screening programs) not detailed in available summary.
8. Interpretation & Practice Impact
Supports implementing qSOFA-based electronic sepsis screening in hospital wards to reduce mortality — a definitive, large-scale positive result resolving prior uncertainty from smaller, mixed-result trials, and directly complementing the 1-BED trial (this handbook, 2025 Sepsis category) which found no benefit from the 1-hour bundle itself, suggesting screening/early identification may be the more impactful lever than bundle-compliance alone.
9. Controversies & Subsequent Evidence
Presented at the Critical Care Reviews Down Under meeting (December 2024), directly following JAMA publication — reflecting significant field interest given the scale and definitive nature of the result. This positive finding provides an interesting contrast with the null 1-BED trial (this handbook, 2025 Sepsis category) testing bundle implementation rather than screening/detection itself, suggesting early automated recognition may be a more impactful intervention point than downstream bundle compliance.
10. Summary & Executive Takeaway
Summary: SCREEN, a stepped-wedge cluster randomized trial across 45 wards in 5 Saudi Arabian hospitals, tested qSOFA-based electronic sepsis screening against no screening in hospitalized ward patients. 90-day in-hospital mortality was significantly lower with screening (number needed to screen ~206).
Overall Takeaway: Electronic, EMR-integrated qSOFA-based sepsis screening significantly reduces mortality in hospitalized ward patients — a large, definitive, practice-relevant result resolving prior mixed evidence from smaller trials, and suggesting automated early recognition may be a more impactful sepsis-care lever than downstream treatment-bundle compliance alone.
11. Bibliography
- Freund Y, Cancella de Abreu M, Lebal S, et al. Effect of the 1-h bundle on mortality in suspected sepsis (1-BED). Intensive Care Med. 2024;50:1086-1095 (this handbook, 2025 Sepsis category).
- Tarabichi Y, Cheng A, Bar-Shain D, et al. Improving timeliness of antibiotic administration using a provider- and pharmacist-facing sepsis early warning system.