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Abstract Background Sepsis is a leading cause of death and serious illness that requires early recognition and therapeutic management to improve survival. The quick-SOFA score helps in its recognition, but its diagnostic performance is insufficient. To develop a score that can rapidly identify a community acquired septic situation at risk of clinical complications in patients consulting the emergency department (ED). Methods We conducted a monocentric, prospective cohort study in the emergency department of a university hospital between March 2016 and August 2018 (NCT03280992). All patients admitted to the emergency department for a suspicion of a community-acquired infection were included. Predictor variables of progression to septic shock or death within the first 90 days were selected using backward stepwise multivariable logistic regression to develop a clinical score. Receiver operating characteristic (ROC) curves were constructed to determine the discriminating power of the area under the curve (AUC). We also determined the threshold of our score that optimized the performance required for a sepsis-worsening score. We have compared our score with the NEWS-2 and qSOFA scores. Results Among the 21,826 patients admitted to the ED, 796 patients were suspected of having community-acquired infection and 461 met the sepsis criteria; therefore, these patients were included in the analysis. The median [interquartile range] age was 72 [54–84] years, 248 (54%) were males, and 244 (53%) had respiratory symptoms. The clinical score ranged from 0 to 90 and included 8 variables with an area under the ROC curve of 0.85 (confidence interval [CI] 95% 0.81–0.89). A cut-off of 26 yields a sensitivity of 88% (CI 95% 0.79–0.93), a specificity of 62% (CI 95% 57–67), and a negative predictive value of 95% (CI 95% 91–97). The area under the ROC curve for our score was 0.85 (95% CI, 0.81–0.89) versus 0.73 (95% CI, 0.68–0.78) for qSOFA and 0.66 (95% CI, 0.60–0.72) for NEWS-2. Conclusions Our study provides an accurate clinical score for identifying septic patients consulting the ED early at risk of worsening disease. This score could be implemented at admission.

Abstract Background Validation studies on an ICD-10-based algorithm to identify major bleeding events are scarce, and mostly focused on positive predictive values. Objective To evaluate the sensitivity and specificity of an ICD-10-based algorithm in adult patients referred to hospital. Methods This was a cross-sectional, retrospective analysis. Among all hospital stays of adult patients referred to Rennes University Hospital, France, through the emergency ward in 2014, we identified major bleeding events according to an index test based on a list of ICD-10 diagnoses. As a reference, a two-step process was applied: firstly, a computerized request for electronic health records from the emergency ward, using several hemorrhage-related diagnostic codes and specific emergency therapies so as to discard stays with a very low probability of bleeding; secondly, a chart review of selected records was conducted by a medical expert blinded to the index test results and each hospital stay was classified into one of two exclusive categories: major bleeding or no major bleeding, according to pre-specified criteria. Results Out of 16,012 hospital stays, the reference identified 736 major bleeding events and left 15,276 stays considered as without the target condition. The index test identified 637 bleeding events: 293 intracranial hemorrhages, 197 gastrointestinal hemorrhages and 147 other bleeding events. Overall, sensitivity was 65% (95%CI, 62 to 69), and specificity was 99.0%. We observed differential sensitivity and specificity across bleeding types, with the highest values for intracranial hemorrhage. Positive predictive values ranged from 59% for “other” bleeding events, to 71% (95%CI, 65 to 78) for gastrointestinal hemorrhage, and 96% for intracranial hemorrhage. Conclusions Low sensitivity and differential measures of accuracy across bleeding types support the need for specific data collection and medical validation rather than using an ICD-10-based algorithm for assessing the incidence of major bleeding.

BackgroundMajor bleedings other than gastrointestinal (GI) and intracranial (ICH) and mortality rates associated with antiplatelet drugs in real-world clinical practice are unknown. The objective was to estimate major bleeding risk and mortality among new users of antiplatelet drugs in real-world clinical practice.Methods and findingsA population-based prospective cohort using the French national health data system (SNIIRAM), identified 69,911 adults living within five well-defined geographical areas, who were new users of antiplatelet drugs in 2013-2015 and who had not received any antithrombotics in 2012. Among them, 63,600 started a monotherapy and 6,311 a dual regimen. Clinical data for all adults referred for bleeding was collected from all emergency departments within these areas, and medically validated. Databases were linked using common key variables. The main outcome measure was time to major bleeding (GI, ICH and other bleedings). Secondary outcomes were death, and event-free survival (EFS). Hazard ratios (HR) were derived from adjusted Cox proportional hazard models. We used Inverse Propensity of Treatment Weighting as a stratified sensitivity analysis according to the antiplatelet monotherapy indication: primary prevention without cardiovascular (CV) risk factors, with CV risk factors, and secondary prevention. We observed 250 (0.36%) major haemorrhages, 81 ICH, 106 GI and 63 other types of bleeding. Incidences were twice as high in dual therapy as in monotherapy. Compared to low-dose aspirin (≤ 100 mg daily), high-dose (> 100 up to 325 mg daily) was associated with an increased risk of ICH (HR = 1.80, 95%CI 1.10 to 2.95). EFS was improved by high-dose compared to low-dose aspirin (1.41, 1.04 to 1.90 and 1.32, 1.03 to 1.68) and clopidogrel (1.30, 0.73 to 2.3 and 1.7, 1.24 to 2.34) respectively in primary prevention with and without CV risk factors.ConclusionThe incidence of major bleeding and mortality was low. In monotherapy, low-dose aspirin was the safest therapeutic option whatever the indication.Trial registrationNCT02886533.