Several studies were published to validate quick-SOFA (qSOFA), namely in comparison with Systemic Inflammatory Response Syndrome (SIRS) criteria. We performed a systematic review and a metaanalysis with the aim of comparing qSOFA and SIRS in patients outside the ICU.
We searched the MEDLINE, CINAHL, and Web of Science database, from February 23rd, 2016 until June 30th, 2017, to identify full-text English language studies published after the Sepsis-3 publication that compared qSOFA and SIRS as well as sensitivity or specificity to diagnose sepsis, the hospital and ICU length of stay (LOS) and hospital mortality. Data extraction from the selected studies followed the recommendations of the MOOSE group and the PRISMA statement.
From 4,022 citations, ten studies met the inclusion criteria. Pooling all the studies, a total of 229,480 patients were evaluated. The meta-analysis of sensitivity for the diagnosis of sepsis comparing qSOFA and SIRS was in favor of SIRS (1.32 [0.40-2.24], p<0.0001, I2=100%). One study described the specificity for the diagnosis of infection comparing SIRS (84.4% [76.2–90.6]) to qSOFA (97.3% [92.1–99.4]) and demonstrated a better specificity of qSOFA. The meta-analysis of AUROC of six studies comparing qSOFA and SIRS was in favor of qSOFA (0.03 [0.01-0.05], p=0.002, I2=48%) as a predictor of in-hospital mortality.
The SIRS was significantly superior than qSOFA for sepsis diagnosis and qSOFA was slightly better than SIRS in predicting hospital mortality. The association of both criteria could provide a better model to initiate or escalate therapy in sepsis patients.
The Sepsis 3.0 Criteria for the diagnosis of sepsis were released in February 2016 with much fanfare.  In essence, the presence of 2 or more of the following criteria (qSOFA) were used to diagnose sepsis outside the ICU:
- Respiratory Rate > 20
- SBP < 100mmHg
- Altered mental status
and a SOFA score of 2 or more (assuming a baseline SOFA score of 0) was used to diagnose sepsis in the ICU. As a “clinical scientist” I believe that Sepsis 3.0 is a step backward and not forward. While the SIRS concept was not perfect,[2,3] it provided a useful clinical framework to screen for sepsis, with the realization that 12% of patients with sepsis would prove to be “SIRS negative”. As the meta-analysis of Serafim et al demonstrated (see Figure) SIRS outperformed qSOFA as a tool to diagnose sepsis (outside the ICU). While qSOFA may better predict mortality, this attribute is of little worth to the bedside clinician.
As far as I can tell, the SOFA score is not routinely measured in ICU patients (at least in the USA), therefore the use of this criteria to diagnose the development of sepsis in an ICU patient is problematic. Furthermore, it assumes that the patient has a baseline SOFA score of 0; this is usually not the case in many ICU patients who frequently have multiple co-morbidities.
In my Books, sepsis is best defined (at this time) as “Infection PLUS organ dysfunction” (any organ dysfunction)… Just Keep it Simple!. As diagnostic tests to identify sepsis improve (biomarkers, bacterial PCR, etc), it is likely that in the future “laboratory tests” will be included in the variables used to diagnose sepsis, resulting in diagnostic criteria that have greater sensitivity and accuracy.
In summary, Sepsis 3.0 was clearly not developed by clinicians for clinicians, and should be abandoned.
- Singer M, Deutschman CS, Seymour CW et al. The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA 2016; 315:801-10.
- Kaukonen KM, Baily M, Pilcher D et al. Systemic inflammatory response syndrome criteria criteria in defining severe sepsis. N Engl J Med 2015; 372:1629-38.
- Vincent JL, Opal SM, Marshall JC et al. Sepsis definitions: time for change. Lancet 2013; 381:774-75.