• Crit Care Resusc · Dec 2013

    Randomized Controlled Trial

    Protocolized Care for Early Septic Shock (ProCESS) statistical analysis plan.

    • Francis Pike, Donald M Yealy, John A Kellum, David T Huang, Amber E Barnato, Tammy L Eaton, Derek C Angus, Lisa A Weissfeld, and ProCESS Investigators.
    • Department of Biostatistics, Pitt Public Health, University of Pittsburgh, Pittsburgh, Pa, United States. lweis@pitt.edu.
    • Crit Care Resusc. 2013 Dec 1; 15 (4): 301-10.

    BackgroundThe Protocolized Care for Early Septic Shock study is a randomised, multicentre, prospective, three-arm, parallel-group trial of alternative resuscitation strategies for early septic shock.ObjectiveTo state our analysis plan for trial data.MethodsOur plan is to guide data collection and analysis using pre-existing definitions and testing, with local consensus-based efforts where needed. We examine protocolised care (two experimental approaches) and compare this to usual "wild type" care.ResultsOur plan is to address three aims (clinical efficacy, biology of illness and recovery, and costs and cost-effectiveness) and four hypotheses, and we specify rules for handling data and determining outcomes.ConclusionBy using measures to maintain study conduct and analysis rigour, we hope to improve understanding of early septic shock resuscitation and care of patients.

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