SEP-1—Taking the Measure of a Measure

Autor: Foster, Gesten, Laura, Evans
Rok vydání: 2021
Předmět:
Zdroj: JAMA Network Open
ISSN: 2574-3805
DOI: 10.1001/jamanetworkopen.2021.38823
Popis: Key Points Question Was implementation of the CMS Severe Sepsis and Septic Shock Early Management Bundle (SEP-1) in October 2015 associated with improvements in sepsis-associated mortality? Findings In this cohort study of 117 510 adult patients admitted to 114 US hospitals with clinical evidence of suspected sepsis between October 2013 and December 2017, SEP-1 implementation was associated with an immediate increase in lactate testing rates, no change in already-increasing rates of broad-spectrum antibiotic use, and no change in the combined outcome of in-hospital death or discharge to hospice. Meaning These findings suggest SEP-1 was not associated with improved sepsis outcomes and that alternate approaches to preventing sepsis deaths in hospitals are needed.
This cohort study evaluates the association of implementation of the Severe Sepsis and Septic Shock Early Management Bundle (SEP-1) with sepsis treatment patterns and outcomes in US hospitals.
Importance In October 2015, the Centers for Medicare & Medicaid Services began requiring US hospitals to report adherence to the Severe Sepsis and Septic Shock Early Management Bundle (SEP-1). Objective To evaluate the association of SEP-1 implementation with sepsis treatment patterns and outcomes in diverse hospitals. Design, Setting, and Participants This retrospective cohort study with interrupted time-series analysis and logistic regression models was conducted among adults admitted to 114 hospitals from October 2013 to December 2017 with suspected sepsis (blood culture orders, ≥2 systemic inflammatory response syndrome criteria, and acute organ dysfunction) within 24 hours of hospital arrival. Data analysis was conducted from September 2020 to September 2021. Exposures SEP-1 implementation in the fourth quarter (Q4) of 2015. Main Outcomes and Measures The primary outcome was quarterly rates of risk-adjusted short-term mortality (in-hospital death or discharge to hospice). Secondary outcomes included lactate testing and administration of anti–methicillin-resistant Staphylococcus aureus (MRSA) or antipseudomonal β-lactam antibiotics within 24 hours of hospital arrival. Generalized estimating equations with robust sandwich variances were used to fit logistic regression models to assess for changes in level or trends in these outcomes, adjusting for baseline characteristics and severity of illness. Results The cohort included 117 510 patients (median [IQR] age, 67 years [55-78] years; 60 530 [51.5%] men and 56 980 [48.5%] women) with suspected sepsis. Lactate testing rates increased from 55.1% (95% CI, 53.9%-56.2%) in Q4 of 2013 to 76.7% (95% CI, 75.4%-78.0%) in Q4 of 2017, with a significant level change following SEP-1 implementation (odds ratio [OR], 1.34; 95% CI, 1.04-1.74). There were increases in use of anti-MRSA antibiotics (19.8% [95% CI, 18.9%-20.7%] in Q4 of 2013 to 26.3% [95% CI, 24.9%-27.7%] in Q4 of 2017) and antipseudomonal antibiotics (27.7% [95% CI, 26.7%-28.8%] in Q4 of 2013 to 40.5% [95% CI, 38.9%-42.0%] in Q4 of 2017), but these trends preceded SEP-1 and did not change with SEP-1 implementation. Unadjusted short-term mortality rates were similar in the pre–SEP-1 period (Q4 of 2013 through Q3 of 2015) vs the post–SEP-1 period (Q1 of 2016 through Q4 of 2017) (20.3% [95% CI, 20.0%-20.6%] vs 20.4% [95% CI, 20.1%-20.7%]), and SEP-1 implementation was not associated with changes in level (OR, 0.94; 95% CI, 0.68-1.29) or trend (OR, 1.00; 95% CI, 0.97-1.04) for risk-adjusted short-term mortality rates. Conclusions and Relevance In this cohort study, SEP-1 implementation was associated with an immediate increase in lactate testing rates, no change in already-increasing rates of broad-spectrum antibiotic use, and no change in short-term mortality rates for patients with suspected sepsis. Other approaches to decrease sepsis mortality may be warranted.
Databáze: OpenAIRE
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