title: Validation of the new Sepsis-3 definitions: proposal for improvement in early risk identification.
abstract: OBJECTIVE
  Sepsis-3 definitions generated controversies regarding their general applicability. The Sepsis-3 Task Force outlined the need for validation with emphasis on the quick Sequential Organ Failure Assessment (qSOFA) score. This was done in a prospective cohort from a different healthcare setting.
  
  
  METHODS
  Patients with infections and at least two signs of systemic inflammatory response syndrome (SIRS) were analysed. Sepsis was defined as total SOFA ≥2 outside the intensive care unit (ICU) or as an increase of ICU admission SOFA ≥2. The primary endpoints were the sensitivity of qSOFA outside the ICU and sepsis definition both outside and within the ICU to predict mortality.
  
  
  RESULTS
  In all, 3346 infections outside the ICU and 1058 infections in the ICU were analysed. Outside the ICU, respective mortality with ≥2 SIRS and qSOFA ≥2 was 25.3% and 41.2% (p <0.0001); the sensitivities of qSOFA and of sepsis definition to predict death were 60.8% and 87.2%, respectively. This was 95.9% for sepsis definition in the ICU. The sensitivity of qSOFA and of ≥3 SIRS criteria for organ dysfunction outside the ICU was 48.7% and 72.5%, respectively (p <0.0001). Misclassification outside the ICU with the 1991 and Sepsis-3 definitions into stages of lower severity was 21.4% and 3.7%, respectively (p <0.0001) and 14.9% and 3.7%, respectively, in the ICU (p <0.0001). Adding arterial pH ≤7.30 to qSOFA increased sensitivity for prediction of death to 67.5% (p 0.004).
  
  
  CONCLUSIONS
  Our analysis positively validated the use of SOFA score to predict unfavourable outcome and to limit misclassification into lower severity. However, qSOFA score had inadequate sensitivity for early risk assessment.
authors.affiliation: 4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece. Electronic address: egiamarel@med.uoa.gr.
authors.forename: E J
authors.initials: EJ
authors.lastname: Giamarellos-Bourboulis
authors.affiliation: 4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.
authors.forename: T
authors.initials: T
authors.lastname: Tsaganos
authors.affiliation: 2(nd) Department of Critical Care Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.
authors.forename: I
authors.initials: I
authors.lastname: Tsangaris
authors.affiliation: 2(nd) Department of Internal Medicine, Sismanogleion General Hospital, Athens, Greece.
authors.forename: M
authors.initials: M
authors.lastname: Lada
authors.affiliation: 1(st) Department of Critical Care Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.
authors.forename: C
authors.initials: C
authors.lastname: Routsi
authors.affiliation: Department of Clinical Therapeutics, National and Kapodistrian University of Athens, Medical School, Athens, Greece.
authors.forename: D
authors.initials: D
authors.lastname: Sinapidis
authors.affiliation: 1(st) Department of Internal Medicine, Thriasion Elefsis General Hospital, Elefsina, Greece.
authors.forename: M
authors.initials: M
authors.lastname: Koupetori
authors.affiliation: Department of Urology, Lamia General Hospital, Lamia, Greece.
authors.forename: M
authors.initials: M
authors.lastname: Bristianou
authors.affiliation: 1(st) Department of Internal Medicine, "G.Gennimatas" Athens General Hospital, Athens, Greece.
authors.forename: G
authors.initials: G
authors.lastname: Adamis
authors.affiliation: Intensive Care Unit, Korgialeneion-Benakeion General Hospital, Athens, Greece.
authors.forename: K
authors.initials: K
authors.lastname: Mandragos
authors.affiliation: Department of Medicine and Research Laboratory of Internal Medicine, Larissa University Hospital, University of Thessaly, Medical School, Larissa, Greece.
authors.forename: G N
authors.initials: GN
authors.lastname: Dalekos
authors.affiliation: Department of Surgery, Nafplion General Hospital, Nafplion, Greece.
authors.forename: I
authors.initials: I
authors.lastname: Kritselis
authors.affiliation: Department of Internal Medicine, Chios General Hospital, Chios, Greece.
authors.forename: G
authors.initials: G
authors.lastname: Giannikopoulos
authors.affiliation: 2(nd) Department of Surgery, Aristotle University of Thessaloniki, Thessaloniki, Greece.
authors.forename: I
authors.initials: I
authors.lastname: Koutelidakis
authors.affiliation: Department of Internal Medicine, Argos General Hospital, Argos, Greece.
authors.forename: M
authors.initials: M
authors.lastname: Pavlaki
authors.affiliation: Intensive Care Unit, "G.Gennimatas" General Hospital, Thessaloniki, Greece.
authors.forename: E
authors.initials: E
authors.lastname: Antoniadou
authors.affiliation: Intensive Care Unit, "Aghios Dimitrios" General Hospital, Thessaloniki, Greece.
authors.forename: G
authors.initials: G
authors.lastname: Vlachogiannis
authors.affiliation: Department of Critical Care Medicine, University of Ioannina, Medical School, Ioannina, Greece.
authors.forename: V
authors.initials: V
authors.lastname: Koulouras
authors.affiliation: Intensive Care Unit, Tzaneion General Hospital, Piraeus, Greece.
authors.forename: A
authors.initials: A
authors.lastname: Prekates
authors.affiliation: 2(nd) Department of Critical Care Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.
authors.forename: G
authors.initials: G
authors.lastname: Dimopoulos
authors.affiliation: 1(st) Department of Pulmonary Medicine, National and Kapodistrian University of Athens, Athens, Greece.
authors.forename: A
authors.initials: A
authors.lastname: Koutsoukou
authors.affiliation: Department of Critical Care Medicine, Alexandroupolis University Hospital, Alexandroupolis, Greece.
authors.forename: I
authors.initials: I
authors.lastname: Pnevmatikos
authors.affiliation: Intensive Care Unit, Korinthos General Hospital, Korinthos, Greece.
authors.forename: A
authors.initials: A
authors.lastname: Ioakeimidou
authors.affiliation: 1(st) Department of Critical Care Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.
authors.forename: A
authors.initials: A
authors.lastname: Kotanidou
authors.affiliation: 2(nd) Department of Critical Care Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.
authors.forename: S E
authors.initials: SE
authors.lastname: Orfanos
authors.affiliation: 2(nd) Department of Critical Care Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece.
authors.forename: A
authors.initials: A
authors.lastname: Armaganidis
authors.affiliation: Department of Internal Medicine, University of Patras, Medical School, Patras, Greece.
authors.forename: C
authors.initials: C
authors.lastname: Gogos
mesh_terms: D005260:Female; D006801:Humans; D007362:Intensive Care Units; D008297:Male; D016017:Odds Ratio; D063305:Organ Dysfunction Scores; D011379:Prognosis; D015203:Reproducibility of Results; D018570:Risk Assessment; D012680:Sensitivity and Specificity; D018805:Sepsis / Q000175:diagnosis* / Q000401:mortality; D012720:Severity of Illness Index
keywords: Definitions; Infection; Mortality; Sepsis; Septic shock