The Effect of Severe Sepsis and Septic Shock Management Bundle (SEP-1) Compliance and Implementation on Mortality Among Patients With Sepsis : A Systematic Review.

Summary

Across 17 observational studies, SEP-1 compliance or implementation showed inconsistent associations with mortality and no moderate/high-level evidence of benefit. Methodologic heterogeneity and confounding limited inference; the authors recommend CMS reconsider SEP-1’s inclusion in the Value-Based Purchasing Program.

Key Findings

• Seventeen studies met inclusion; 12 evaluated SEP-1 compliance with 5 showing benefit and 7 showing no mortality benefit.
• Five studies assessed SEP-1 implementation; only one showed benefit and failed to adjust for pre-implementation mortality trends.
• All studies were observational with no low risk of bias; substantial heterogeneity precluded meta-analysis.
• Authors conclude no moderate/high-level evidence that SEP-1 compliance or implementation reduces sepsis mortality and advise CMS to reconsider SEP-1 in VBP.

Clinical Implications

Hospitals and clinicians should prioritize evidence-based, patient-centered interventions over process compliance. Quality programs may need to shift from timing bundles toward outcome-oriented measures and risk-adjusted benchmarking.

Limitations

• All included studies were observational with residual confounding
• Substantial methodological heterogeneity precluded quantitative meta-analysis

Future Directions

Cluster-randomized or pragmatic trials and robust quasi-experimental designs (e.g., interrupted time series) are needed to test causal effects of sepsis bundles on patient-centered outcomes.