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Statistical analysis plan for the Crystalloid Versus Hydroxyethyl Starch Trial (CHEST).

John Myburgh¹, Qiang Li, Stephane Heritier

¹George Institute for Global Health, Sydney, NSW, Australia. jmyburgh@georgeinstitute.org.au

Critical Care and Resuscitation : Journal of the Australasian Academy of Critical Care Medicine

|March 13, 2012

Summary

The Crystalloid Versus Hydroxyethyl Starch Trial (CHEST) established a statistical analysis plan to ensure unbiased results for fluid resuscitation in intensive care. This rigorous approach minimizes bias in comparing hydroxyethyl starch with normal saline.

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Area of Science:

Critical Care Medicine
Clinical Trials Methodology
Fluid Resuscitation Strategies

Background:

The Crystalloid Versus Hydroxyethyl Starch Trial (CHEST) is a large, multicenter, randomized controlled trial.
It compares 6% hydroxyethyl starch (130/0.4) with normal saline for fluid resuscitation in intensive care unit patients.
The trial is modeled after the Saline Versus Albumin Fluid Evaluation (SAFE) study and is the largest fluid resuscitation trial to date.

Purpose of the Study:

To outline and adhere to a predetermined statistical analysis plan (SAP) for the CHEST trial.
To prevent analysis bias by making the SAP public before data collection completion.
To ensure the integrity and validity of the trial's findings.

Main Methods:

The SAP was collaboratively designed by chief investigators and statisticians and approved by the CHEST Management Committee.
Authors maintained blindness to treatment allocation and interim analysis data.
Statistical analyses for baseline characteristics, processes of care, and primary, secondary, and tertiary outcomes were detailed.

Main Results:

A standardized SAP for the CHEST trial was successfully developed.
The SAP included a trial profile, mock tables, and detailed descriptions of planned analyses.
Analyses for baseline characteristics, efficacy measures, six prespecified subgroups, and tertiary outcomes were outlined.

Conclusions:

A predetermined SAP was successfully developed for the CHEST trial.
This plan adheres to high standards of internal validity.
The SAP is designed to minimize analysis bias, ensuring reliable results for fluid resuscitation research.