The Protocolised Management in Sepsis (ProMISe) trial statistical analysis plan
G Sarah Power1, David A Harrison, Paul R Mouncey
1Clinical Trials Unit, Intensive Care National Audit and Research Centre, London, United Kingdom. promise@icnarc.org.
Summary
The Protocolised Management in Sepsis (ProMISe) trial statistical analysis plan details evaluating early resuscitation for severe sepsis. This plan ensures unbiased assessment of treatment effectiveness and patient outcomes in emergency departments.
Area of Science:
- Critical Care Medicine
- Clinical Trials Methodology
- Health Services Research
Background:
- Severe sepsis and septic shock pose significant mortality risks in emergency departments (EDs).
- Previous research indicated potential benefits of early, goal-directed resuscitation.
- The Protocolised Management in Sepsis (ProMISe) trial investigates this approach in the UK.
Purpose of the Study:
- To outline the statistical analysis plan for the ProMISe trial.
- To ensure objective evaluation of clinical effectiveness before data inspection.
- To prevent data-derived decisions by finalizing the plan in advance.
Main Methods:
- Defined primary and secondary outcomes for clinical effectiveness.
- Summarized safety monitoring and data collection procedures.
- Detailed planned statistical analyses, including subgroup and secondary analyses.
Main Results:
- Primary outcome: 90-day all-cause mortality.
- Primary analysis: Fisher exact test for relative risk and absolute risk reduction.
- Subgroup analyses: age, sepsis scores, and time to randomization; secondary analyses include covariate adjustment and learning curve effects.
Conclusions:
- A robust statistical analysis plan was developed for the ProMISe trial.
- The plan adheres to best practices for clinical trial evaluation.
- Making the plan public domain ensures transparency and rigor.
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