February 26th, 2016: This week has seen the announcement of a revised set of definitions by the Sepsis International Consensus Definitions Task Force (the ‘Task Force’).
The UK Sepsis Trust welcomes these evidence-based definitions, in particular the Task Force’s view that the Systemic Inflammatory Response Syndrome (SIRS) criteria as proposed by Bone et al and subsequently modified by Levy et al are poorly specific to sepsis and should not be used in its formal diagnostic criteria. We further welcome the adoption of a change in Sepsis-related Organ Failure Assessment (SOFA) score as a better tool to formally identify sepsis-associated organ dysfunction for purposes of research and comparison than the organ dysfunction criteria proposed in 2001; and the simplification of language such that we will now only use the terminology ‘infection’, ‘sepsis’ (or ‘Red Flag Sepsis’) and ‘septic shock’.
Mindful of the need for a ‘bedside’ test for likely sepsis, the Task Force has proposed the ‘optional’ adoption of a simplified set of criteria called ‘quick-SOFA’ or ‘qSOFA’. This tool would require that an aggregate of two parameters breaching threshold have been identified to predict adverse outcome (death or a prolonged Intensive Care stay).
qSOFA will present some operational difficulty to many organisations to implement, in particular those already using aggregate scoring systems such as the National Early Warning Score (NEWS). Some additional concerns have been expressed by clinicians and bodies nationally and internationally:
- qSOFA has yet to be robustly prospectively validated
- It is likely to be difficult to operationalize the introduction of a second aggregate scoring system for patients who are likely to have already been identified as at risk using an aggregate track and trigger system such as the National Early Warning Score (NEWS)
- Within the U.K, we await the launch of a revised NEWS score and escalation standard. Meanwhile, the thresholds for qSOFA differ from NEWS
- Since qSOFA has not been shown to be superior (or inferior) to either NEWS or Red Flag Sepsis in identifying patients with infective illness at risk of deterioration, and since the minimum NEWS score compatible with a qSOFA score of 2 (the recommended trigger threshold) is 4, it seems reasonable that the existing NEWS escalation recommendations of an individual parameter score of 3 (as used in the Sepsis Trust’s Red Flag Sepsis pathways) or an aggregate score of 5 be used as a trigger to screen for sepsis.
- Despite the Task Force’s own work showing that, at each level of qSOFA score, lactate provided additional prediction of death (see Seymour CW et al. JAMA. doi:10.1001/jama.2016.0288 Supplementary online content, eFigure 12), lactate is excluded as a relevant POC test for the bedside identification of risk
- Patients are described as only having ‘infection’ or ‘sepsis’. There is, unlike in the Red Flag Sepsis pathways and the 2001 definitions set, no ‘interim’ group in which early scheduled review can be readily recommended. Outside hospitals, on which the validity of data the Task Force have used is not entirely clear, it may well be that qSOFA (predicting death or prolonged Critical Care stay) occurs at a point in the course of illness later than ideal for transfer to hospital
- We eagerly await the release of the National Institute for Health and Care Excellence (NICE) Clinical Guideline on Sepsis in July of this year. The qSOFA and SOFA criteria will all be captured in either the ‘moderate to high risk’ or ‘high risk’ criteria within the draft document, and we believe that subject to there being no significant change this presents a safer and more operationally deliverable strategy particularly outside hospitals.
The reality is that we do not yet know whether qSOFA will be a better tool than NEWS and Red Flag Sepsis, and there has been a degree of organisational learning toward the latter. Further prospective work in the UK health system is needed- among others, the UK Sepsis Trust is working with partners to further evaluate this, and if qSOFA proves of greater value then we will immediately seek to offer operational solutions.
Meanwhile we suggest that:
- Providers continue to work toward the implementation of the National Early Warning Score (NEWS) as a tool to assist in the identification of the deteriorating patient
- NEWS (with or without a narrative around a patient who ‘looks sick’) be used with immediate (or as near immediate as possible) effect to replace SIRS as a prompt to screen for sepsis in organisations currently employing SIRS-based screening
- Organisations benefiting from the use of electronic observations and automated review and decision prompting include qSOFA alongside other recognition strategies as an important addition (‘redundancy’) to existing mechanisms to identify a risk of deterioration from sepsis in the deteriorating patient.
- Organizations wishing to formally diagnose sepsis for research, quality improvement or other purposes move to the new definitions for organ dysfunction (a change in SOFA score of 2 or more points) rather than the 2001 definitions set proposed by Levy et al
- Organizations using either the UK Sepsis Trust/ NHS England/ Royal Colleges Red Flag Sepsis criteria and screening tools either:
- Continue to do so pending the release and interpretation of the NICE Clinical Guideline (and revised UK Sepsis Trust toolkits) in July 2016, or
- Pilot and evaluate the UK Sepsis Trust’s draft ‘NICE-compatible draft screening tool 2016’ available under our Clinical Toolkits pages.
With very best wishes
Dr Ron Daniels BEM
On behalf of the UK Sepsis Trust and Clinical Advisory Group