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The Effect of Severe Sepsis and Septic Shock Management Bundle (SEP-1) Compliance and Implementation on Mortality
James S Ford1, Joseph C Morrison2, May Kyaw3
1Department of Emergency Medicine, University of California San Diego, San Diego, California (J.S.F.).
Insights
This review found no strong evidence that the Severe Sepsis and Septic Shock Management Bundle (SEP-1) improves sepsis mortality. The Centers for Medicare & Medicaid Services (CMS) should reconsider its inclusion in value-based purchasing programs.
Area of Science:
- Critical Care Medicine
- Health Services Research
- Quality Improvement
Background:
- The Centers for Medicare & Medicaid Services (CMS) Severe Sepsis and Septic Shock Management Bundle (SEP-1) is incorporated into the Hospital Value-Based Purchasing (VBP) Program.
- This inclusion aims to incentivize improved sepsis care and patient outcomes.
Purpose of the Study:
- To critically assess the existing scientific evidence regarding the impact of SEP-1 compliance and implementation on sepsis-related mortality.
- To determine if current evidence supports SEP-1's effectiveness in reducing deaths from sepsis.
Main Methods:
- A systematic review of studies evaluating the 3- or 6-hour sepsis bundles defined by SEP-1 specifications in adult sepsis patients.
- Searches were conducted across major databases (PubMed, Web of Science, EMBASE, CINAHL, Cochrane Library) up to November 26, 2024.
- Evidence quality was assessed using GRADE and National Quality Forum criteria; risk of bias was evaluated by two independent authors.
Main Results:
- Out of 17 included observational studies, 12 examined SEP-1 compliance and mortality, with only 5 showing a statistically significant benefit, often with methodological limitations.
- Five studies assessed SEP-1 implementation, with only one demonstrating significant benefit, which did not account for pre-implementation mortality trends.
- All included studies were observational, and none possessed a low risk of bias, indicating significant limitations in the evidence base.
Conclusions:
- The current evidence supporting SEP-1 compliance or implementation in reducing sepsis mortality is of low quality and lacks robustness.
- Given the methodological heterogeneity and observational nature of the studies, a meta-analysis was not feasible.
- CMS should reconsider the inclusion of SEP-1 in the Hospital VBP Program due to insufficient evidence of its effectiveness.
Background:
The Centers for Medicare & Medicaid Services (CMS) Severe Sepsis and Septic Shock Management Bundle (SEP-1) is now included in the Hospital Value-Based Purchasing (VBP) Program.
Purpose:
To assess the evidence supporting SEP-1 compliance or SEP-1 implementation in improving sepsis mortality.
Data Sources:
PubMed, Web of Science, EMBASE, CINAHL Complete, and Cochrane Library from inception to 26 November 2024.
Study Selection:
Studies of adults with sepsis that included 3- or 6-hour sepsis bundles defined by SEP-1 specifications.
Data Extraction:
Article screening, full-text review, data extraction, and risk-of-bias assessment were independently performed by 2 authors. Level of evidence was determined using GRADE (Grading of Recommendations Assessment, Development and Evaluation) criteria and National Quality Forum criteria.
Data Synthesis:
A total of 4403 unique references were screened, and 17 studies were included. Twelve studies assessed the relationship between SEP-1 compliance and mortality; 5 showed statistically significant benefit, whereas 7 did not. Among studies showing benefit, 1 did not adjust for confounders, 1 found benefit only among patients with severe sepsis, 1 included only patients with septic shock, and 1 included only Medicare beneficiaries. Five studies assessed the relationship between SEP-1 implementation and sepsis mortality; only 1 showed significant benefit, but it did not adjust for mortality trends before SEP-1 implementation. All 17 studies were observational, and none had low risk of bias.
Limitations:
The conclusions are limited by the underlying quality of the available studies, as all were observational. Because there was considerable methodologic heterogeneity among the included studies, a meta-analysis was not performed as the results could have been misleading.
Conclusion:
This review found no moderate- or high-level evidence to support that compliance with or implementation of SEP-1 was associated with sepsis mortality. CMS should reconsider the addition of SEP-1 to the Hospital VBP Program.
Primary Funding Source:
None. (PROSPERO: CRD42023482787).
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