Journal Article

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

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

2019

Overview

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.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Clinical Trials / Clinical Trials as Topic - methods / Critical care / Critical Care Medicine / Critical Care trials / Emergency Medicine / Health aspects / Human health and pathology / Humans / Illnesses / Infection / Infectious diseases / Intensive / Life Sciences / Medical research / Medical screening / Medicine / Medicine & Public Health / Morbidity / Mortality / Multiple organ failure / Organ Dysfunction Scores / Patients / Physiology / Program Development - methods / Questionnaires / Research - standards / Research - trends / Review / Santé publique et épidémiologie / Sepsis / Sequential Organ Failure Assessment / Severity of Illness Index / SOFA / Surrogate endpoints