SIRS or qSOFA? Is that the question? Clinical and methodological observations from a meta-analysis and critical review on the prognostication of patients with suspected sepsis outside the ICU

The purpose of the study was to assess the prognostic performances, in terms of in-hospital mortality, of the quick sequential organ failure assessment (qSOFA) score and the systemic inflammatory response syndrome (SIRS) criteria applied to patients with suspected infection outside the ICU, and to critically reappraise the results and the clinical impact of the SEPSIS-3 study and of the subsequent trials. We performed bivariate meta-analysis, evaluation of the Bayesian post-test probabilities of death, and computation of the unidentified deaths for every 1000 screened cases (UDS1000). The use of qSOFA for screening instead of the SIRS implies a relevant increase in the UDS1000. However, this difference appears far smaller in the SEPSIS-3 study, largely due to an underestimation of SIRS sensitivity. The increment in the pre-test probability of death implied by a positive qSOFA is higher than that implied by a positivity of the SIRS. However, the included studies use highly variable definitions of suspected sepsis and carry very high levels of heterogeneity. SIRS overperforms qSOFA as a rule-out tool for mortality, while qSOFA shows a higher rule-in power. However, the evident lack of consistency across the published studies undermines the significance of both the meta-analytic approach and the reproducibility of the outcomes, and demands for a standardized definition of the target population.