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Review
. 2019 Nov 27;23(1):374.
doi: 10.1186/s13054-019-2663-7.

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

Simon Lambden  1 , Pierre Francois Laterre  2 , Mitchell M Levy  3 , Bruno Francois  4
Affiliations
Review

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

Simon Lambden et al. Crit Care. .

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.ConclusionThe 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.

Keywords: Clinical Trials; Critical Care trials; Multiple organ failure; SOFA; Sepsis; Sequential Organ Failure Assessment; Surrogate endpoints.

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Conflict of interest statement

SL, BF, ML and PFL are all involved in the design and conduct of clinical trials of novel therapeutic agents that utilise the change in SOFA score as a key endpoint. SL reports consultancy fees from Inotrem SA, during the conduct of the study and is the founding director of Critical Pressure Ltd., outside the submitted work. PFL reports personal fees from Inotrem, during the conduct of the study. ML reports non-financial support from Inotrem, during the conduct of the study. BF reports personal fees from Inotrem, during the conduct of the study, and personal fees from Biomérieux, Aridis, Ashai-Kasai, Polyphor, AM-Pharma and Ferring, outside the submitted work.

SL is a founding director of critical pressure ltd, a biotechnology company developing novel vasopressors for the treatment of shock. He also receives consultancy fees from Inotrem SA Ltd. for his work developing novel therapeutics for septic shock.

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