Abstract
BackgroundSepsis is the leading cause of death in the intensive care unit (ICU). Expediting its diagnosis, largely determined by clinical assessment, improves survival. Predictive and explanatory modelling of sepsis in the critically ill commonly bases both outcome definition and predictions on clinical criteria for consensus definitions of sepsis, leading to circularity. As a remedy, we collected ground truth labels for sepsis.MethodsIn the Ground Truth for Sepsis Questionnaire (GTSQ), senior attending physicians in the ICU documented daily their opinion on each patient’s condition regarding sepsis as a five-category working diagnosis and nine related items. Working diagnosis groups were described and compared and their SOFA-scores analyzed with a generalized linear mixed model. Agreement and discriminatory performance measures for clinical criteria of sepsis and GTSQ labels as reference class were derived.ResultsWe analyzed 7291 questionnaires and 761 complete encounters from the first survey year. Editing rates for all items were > 90%, and responses were consistent with current understanding of critical illness pathophysiology, including sepsis pathogenesis. Interrater agreement for presence and absence of sepsis was almost perfect but only slight for suspected infection. ICU mortality was 19.5% in encounters with SIRS as the “worst” working diagnosis compared to 5.9% with sepsis and 5.9% with severe sepsis without differences in admission and maximum SOFA. Compared to sepsis, proportions of GTSQs with SIRS plus acute organ dysfunction were equal and macrocirculatory abnormalities higher (p < 0.0001). SIRS proportionally ranked above sepsis in daily assessment of illness severity (p < 0.0001). Separate analyses of neurosurgical referrals revealed similar differences. Discriminatory performance of Sepsis-1/2 and Sepsis-3 compared to GTSQ labels was similar with sensitivities around 70% and specificities 92%. Essentially no difference between the prevalence of SIRS and SOFA ≥ 2 yielded sensitivities and specificities for detecting sepsis onset close to 55% and 83%, respectively.ConclusionsGTSQ labels are a valid measure of sepsis in the ICU. They reveal suspicion of infection as an unclear clinical concept and refute an illness severity hierarchy in the SIRS-sepsis-severe sepsis spectrum. Ground truth challenges the accuracy of Sepsis-1/2 and Sepsis-3 in detecting sepsis onset. It is an indispensable intermediate step towards advancing diagnosis and therapy in the ICU and, potentially, other health care settings.
Highlights
Sepsis is the leading cause of death in the intensive care unit (ICU)
Because neurosurgical referrals accounted for almost half of our encounters (Table 2), we examined whether the relatively high illness severity associated with the systemic inflammatory response syndrome (SIRS) label compared to sepsis and severe sepsis was a particular characteristic of this referral group in a subgroup analysis
Clinical criteria for Sepsis-1/2 and Sepsis-3 are commonly used for predictive modeling of sepsis in the critically ill, including by MLbased approaches, while agreement of these definitions with clinical reality remains unclear
Summary
Expediting its diagnosis, largely determined by clinical assessment, improves survival. Predictive and explanatory modelling of sepsis in the critically ill commonly bases both outcome definition and predictions on clinical criteria for consensus definitions of sepsis, lead‐ ing to circularity. Delay of antibiotic treatment initiation in these patients is associated with increased mortality [4,5,6,7,8,9]. Considerable potential for improvement of sepsis outcomes lies in expediting its diagnosis. A gold standard test to establish the timely and definite diagnosis of sepsis and trigger initiation of antimicrobial therapy does not exist, and this treatment decision largely depends on the clinical assessment of a patient [10]. A diagnosis of “sepsis” alerts to an immanently life-threatening condition that empirically requires rapid and specific therapy
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