Proposed Strategies for Designing and Analysing Sepsis Trials
We discuss the design and analysis of trials of drugs and biologics designed to combat sepsis. We consider the variety of trials that have been conducted, and comment on the problems that have occurred in their conduct. These include variation in populations, therapies, controls, and endpoints. Optimistic estimates of effect sizes have led to studies which have been underpowered. Analyses using the proportional hazards model may be underpowered if the data do not satisfy the assumption of proportionality.
KeywordsSeptic Shock Risk Score Risk Index National Hospital Discharge Survey Sepsis Trial
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