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Critical Care
Published in: Critical Care 1/2019

Open Access 01-12-2019 | Septicemia | Review

The SOFA score—development, utility and challenges of accurate assessment in clinical trials

Authors: Simon Lambden, Pierre Francois Laterre, Mitchell M. Levy, Bruno Francois

Published in: Critical Care | Issue 1/2019

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Abstract

The Sequential Organ Failure Assessment or SOFA score was developed to assess the acute morbidity of critical illness at a population level and has been widely validated as a tool for this purpose across a range of healthcare settings and environments.
In recent years, the SOFA score has become extensively used in a range of other applications. A change in the SOFA score of 2 or more is now a defining characteristic of the sepsis syndrome, and the European Medicines Agency has accepted that a change in the SOFA score is an acceptable surrogate marker of efficacy in exploratory trials of novel therapeutic agents in sepsis. The requirement to detect modest serial changes in a patients’ SOFA score therefore means that increased clarity on how the score should be assessed in different circumstances is required.
This review explores the development of the SOFA score, its applications and the challenges associated with measurement. In addition, it proposes guidance designed to facilitate the consistent and valid assessment of the score in multicentre sepsis trials involving novel therapeutic agents or interventions.
Conclusion
The SOFA score is an increasingly important tool in defining both the clinical condition of the individual patient and the response to therapies in the context of clinical trials. Standardisation between different assessors in widespread centres is key to detecting response to treatment if the SOFA score is to be used as an outcome in sepsis clinical trials.
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Metadata
Title
The SOFA score—development, utility and challenges of accurate assessment in clinical trials
Authors
Simon Lambden
Pierre Francois Laterre
Mitchell M. Levy
Bruno Francois
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Critical Care / Issue 1/2019
Electronic ISSN: 1364-8535
DOI
https://doi.org/10.1186/s13054-019-2663-7

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