Infectious disease/Original research
Low Accuracy of Positive qSOFA Criteria for Predicting 28-Day Mortality in Critically Ill Septic Patients During the Early Period After Emergency Department Presentation

https://doi.org/10.1016/j.annemergmed.2017.05.022Get rights and content

Study objective

We determine the diagnostic performance of positive Quick Sequential Organ Failure Assessment (qSOFA) scores for predicting 28-day mortality among critically ill septic patients during the early period after emergency department (ED) presentation.

Methods

This was a retrospective cohort study at a tertiary care academic center. We reviewed a registry of adult (≥18 years) patients who received a diagnosis of severe sepsis or septic shock during an ED stay from August 2008 through September 2014. We identified the point at which patients met 2 or more of the 3 qSOFA criteria (indicating a positive qSOFA score) simultaneously during the initial 24 hours. The diagnostic performance of positive qSOFA score for predicting 28-day mortality was assessed (on ED arrival and within 3, 6, and 24 hours after ED presentation).

Results

A total of 1,395 patients were included, and the overall 28-day mortality was 15%. For patients with positive qSOFA score, 28-day mortality was 23% (95% confidence interval [CI] 19% to 28%) on ED arrival, 20% (95% CI 17% to 23%) at 3 hours, 20% (95% CI 17% to 22%) at 6 hours, and 17% (95% CI 15% to 20%) at 24 hours. Positive qSOFA score for predicting 28-day mortality had a sensitivity, specificity, and area under the receiver operating curve, respectively, of 39% (95% CI 32% to 46%), 77% (95% CI 75% to 80%), and 0.58 (95% CI 0.55 to 0.62) on ED arrival; 68% (95% CI 62% to 75%), 52% (95% CI 49% to 55%), and 0.60 (95% CI 0.57 to 0.63) within 3 hours; 82% (95% CI 76% to 87%), 41% (95% CI 38% to 44%), and 0.61 (95% CI 0.58 to 0.64) within 6 hours; and 91% (95% CI 86% to 94%), 23% (95% CI 21% to 25%), and 0.57 (95% CI 0.54 to 0.59) within 24 hours.

Conclusion

The diagnostic performance of positive qSOFA score for predicting 28-day mortality was low in critically ill septic patients, particularly during the early period after ED presentation. The study requires further prospective validation because of limitations with its retrospective design and use of single-center data.

Introduction

Sepsis is a public health concern affecting millions of people each year, and it is a leading cause of morbidity and mortality among hospitalized patients.1 However, the complexities and heterogeneity of the disease make it challenging for health care providers to identify patients with sepsis. In the past 2 decades, a consensus definition based on systemic inflammatory response syndrome has been used to diagnose sepsis.2

Editor’s Capsule Summary

What is already known on this topic

The Quick Sequential Organ Failure Assessment (qSOFA) was recently introduced as an easy tool to identify infected patients with high risk of subsequent deterioration.

What question this study addressed

The prognostic performance of qSOFA scores during the initial 24 hours of hospitalization to predict 28-day mortality among 1,395 patients identified in the emergency department (ED) with sepsis.

What this study adds to our knowledge

Positive qSOFA score (2 or more points) at ED presentation and 3, 6, and 24 hours had poor sensitivity and specificity for predicting 28-day mortality.

How this is relevant to clinical practice

This informs clinical practice by suggesting that qSOFA may need more investigation and refinement before widespread use as a method of risk stratification of ED patients with suspected infection.

Recently, the definitions of sepsis and septic shock were updated by the Third International Consensus Definitions Task Force.3 In accordance with the new definitions, the quick Sequential [Sepsis-related] Organ Failure Assessment (qSOFA) score was introduced as a novel risk-stratification tool outside the ICU. The qSOFA score consists of 3 clinical variables: systolic blood pressure less than or equal to 100 mm Hg, respiratory rate greater than or equal to 22 breaths/min, and altered mentation.4 The presence of 2 or more of these criteria, which is considered a positive qSOFA score, is an initial way to identify patients with suspected infection who are at high risk for poor outcomes (inhospital mortality or ICU stay ≥3 days) and to prompt further evaluation for organ damage and initiate a higher level of care.

qSOFA is simple and can be performed quickly and repeatedly at the bedside according to clinical parameters, without any laboratory tests. In addition, the predictive validity of the qSOFA score for inhospital mortality among patients with suspected infection outside the ICU was greater than that of the full Sequential [Sepsis-related] Organ Failure Assessment (SOFA) score or the systemic inflammatory response syndrome criteria.4 However, the illness severity of the cohort of the original qSOFA study was relatively low, and emergency department (ED) populations were not analyzed separately, which makes the role of the qSOFA in the ED unclear. qSOFA requires further assessment for appropriate ED application.

The aim of this study was to investigate the diagnostic performance of positive qSOFA score for predicting 28-day mortality among critically ill septic patients from ED arrival to 24 hours after ED presentation. We also evaluated the cumulative proportions of positive qSOFA score and the positive components of each qSOFA criterion during the first 24 hours after ED arrival.

Section snippets

Study Design and Setting

This was a single-center, retrospective study of patients who presented to the ED at Samsung Medical Center (a 1,960-bed, university-affiliated, tertiary care referral hospital located in a metropolitan city with an annual census of 70,000). The study period was from August 2008 through September 2014.

Adult patients who met the criteria for severe sepsis or septic shock during their ED stay were registered for data collection and quality improvement activity in our institution’s registry, under

Characteristics of Study Subjects

A total of 1,728 patients with severe sepsis or septic shock were identified during the study period. Of these, 333 patients were excluded, and the remaining 1,395 patients were included in the final analysis. Of the eligible patients, 717 (51%) showed positive qSOFA scores within 3 hours (Figure 1). The baseline characteristics of all patients and comparisons based on a positive qSOFA score within 3 hours of ED arrival are shown in Table 1. We present the baseline characteristics according to

Limitations

There are some limitations to this study that should be considered. First, our study population consisted of critically ill patients with severe sepsis and septic shock, half of whom required ICU admission. We did not include patients with uncomplicated infections or patients receiving end-of-life care who might decline initial diagnostic tests or treatments. Originally, our study data were collected primarily for performance improvement of initial management of severe sepsis and septic shock

Discussion

In this study, we investigated the diagnostic performance of qSOFA for predicting 28-day mortality in critically ill septic patients who presented to the ED. We found that a considerable number of patients did not meet the criteria for positive qSOFA score, resulting in low sensitivity, particularly during the early period after ED presentation. The sensitivity of qSOFA was lowest on patient ED arrival and gradually increased. Overall, qSOFA criteria for predicting mortality had low accuracy in

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    • Clinical prediction rule is more useful than qSOFA and the Sepsis-3 definition of sepsis for screening bacteremia

      2021, American Journal of Emergency Medicine
      Citation Excerpt :

      Early identification of sepsis and bacteremia, i.e., associated with mortality, is important for the medical decision-making of bacterial infection, and obtaining blood cultures is recommended before the initial administration of antibiotics [1]; however, identifying which patients require blood cultures is difficult. Quick-SOFA, a screening tool for patients likely to have sepsis that was introduced in 2016, has been reported to have high specificity in the early detection of sepsis and in-hospital mortality [5,16,17]; however, qSOFA was criticized for its low sensitivity in identifying sepsis and in-hospital mortality [18-21]. Furthermore, relationships between qSOFA and Sepsis-3 definition of sepsis, and bacteremia are not well discussed [11,17].

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    Please see page 2 for the Editor’s Capsule Summary of this article.

    Supervising editor: Alan E. Jones, MD

    Author contributions: TGS and SYH conceived the study, designed the data collection instrument, and managed the database. IJJ, WCC, and MSS performed statistical analysis in the study. SYH, HY, SUL, and TRL contributed to the drafting of the article. TGS, SYH, and HY contributed to revisions of the article. TGS takes responsibility for the paper as a whole.

    All authors attest to meeting the four ICMJE.org authorship criteria: (1) Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND (2) Drafting the work or revising it critically for important intellectual content; AND (3) Final approval of the version to be published; AND (4) Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

    Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see www.icmje.org). The authors have stated that no such relationships exist.

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