Protocolized Care for Early Septic Shock (ProCESS) statistical analysis plan.
BACKGROUND: The 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. OBJECTIVE: To state our analysis plan for trial data. METHODS: Our 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. RESULTS: Our 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. CONCLUSION: By using measures to maintain study conduct and analysis rigour, we hope to improve understanding of early septic shock resuscitation and care of patients.
Pike, F; Yealy, DM; Kellum, JA; Huang, DT; Barnato, AE; Eaton, TL; Angus, DC; Weissfeld, LA; ProCESS Investigators,
Volume / Issue
Start / End Page
Pubmed Central ID
International Standard Serial Number (ISSN)