What Determines Prognosis in Sepsis? Evidence for a Comprehensive Individual Patient Risk Assessment Approach to the Design and Analysis of Clinical Trials

Abstract

Patients presenting with sepsis are complexly ill with multiple risk factors for short-term mortality. In order to fully represent this complexity, an accurate comprehensive individual patient risk mortality based on reliable risk factors available at the time of treatment can be constructed from large, contemporary, clinically accurate databases. The individual patient risk assessments produced by this approach can be used within clinical evaluations to ensure that baseline risks for mortality were equally distributed among treatment groups and to investigate whether there is a relationship between baseline risk and efficacy of new therapeutic compounds. If clinical evaluations performed in this manner use common definitions and data collection procedures? then the results of such assessments can futher refine and revise the risk predictions and describe the relative benefit of new compounds or combinations of such compounds for individual patients.