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Related Experiment Video

Updated: Dec 26, 2025

The Participant-Reported Implementation Update and Score PRIUS: A Novel Method for Capturing Implementation-Related Data Over Time
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Driving blind: instituting SEP-1 without high quality outcomes data.

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  • 1Critical Care Medicine Department, Clinical Center, National Institutes of Health, Bethesda, MD, USA.

Journal of Thoracic Disease
|March 10, 2020
PubMed
Summary

The Centers for Medicare and Medicaid Services (CMS) sepsis performance measure (SEP-1) lacks strong scientific evidence and has shown low compliance and no significant survival benefit. SEP-1 should be based on high-quality randomized controlled trials to ensure patient safety.

Keywords:
Sepsisbundlemanagementperformance measureseptic shocktreatment

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Area of Science:

  • Healthcare policy
  • Sepsis management
  • Clinical quality measures

Background:

  • The Centers for Medicare and Medicaid Services (CMS) implemented the sepsis performance measure bundle (SEP-1) in 2015.
  • Systematic reviews indicate low-quality evidence supports most SEP-1 interventions.
  • Concerns persist regarding SEP-1's prescriptive nature, lack of scientific basis, and potential risks.

Purpose of the Study:

  • To evaluate the scientific basis and impact of the SEP-1 measure on sepsis care.
  • To assess the evidence supporting SEP-1's interventions and its effect on patient survival.
  • To advocate for evidence-based mandates in sepsis management.

Main Methods:

  • Analysis of existing systematic reviews and observational studies on SEP-1 compliance and outcomes.
  • Review of the scientific evidence supporting individual SEP-1 interventions.
  • Examination of the limitations and biases inherent in retrospective studies.

Main Results:

  • Low compliance rates (approximately 50%) observed across multiple studies.
  • Largest observational studies found no significant improvement in survival with SEP-1.
  • Smaller studies reporting survival benefits were confounded by study design and simultaneous protocols.

Conclusions:

  • SEP-1 is based on low-quality evidence and lacks a sound scientific foundation.
  • The measure's low compliance and unproven survival benefits raise concerns about its mandate.
  • High-quality evidence from randomized controlled trials is necessary to guide sepsis care mandates and ensure patient safety.