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

AI Article Synopsis

  • The Sequential Organ Failure Assessment (SOFA) score is a widely validated tool used to evaluate the severity of critical illness and has gained importance in assessing sepsis, particularly with a change of 2 points or more being significant.
  • Recent acceptance by the European Medicines Agency allows the SOFA score to serve as a marker of treatment efficacy in exploratory trials for sepsis therapies.
  • The review highlights the need for standardized approaches in measuring the SOFA score across different healthcare settings to ensure accurate assessment and comparison in clinical trials.

Article 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.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6880479PMC
http://dx.doi.org/10.1186/s13054-019-2663-7DOI Listing

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