Statistical analysis plan for the Augmented versus Routine Approach to Giving Energy Trial (TARGET).

BACKGROUND: The Augmented versus Routine Approach to Giving Energy Trial (TARGET) is a 4000-patient randomised, double-blind controlled trial designed to evaluate whether enteral delivery of recommended energy goals using a 1.5 kcal/mL enteral nutrition formulation improves clinical outcomes, compared with a 1 kcal/mL enteral nutrition formulation delivered at the same goal rate, in critically ill patients receiving invasive mechanical ventilation.

OBJECTIVE: In keeping with best practice, and in accordance with other trials conducted by the investigators, a pre-specified statistical analysis plan has been described and made public before completion of patient recruitment and data collection into the TARGET trial.

METHODS: Our statistical analysis plan was designed by the TARGET chief investigators and statisticians and approved by the TARGET Management Committee. We reviewed the data collected as specified in the trial protocol and collected in the case report form. We present information pertaining to data collection, pre-specified subgroups, processes of care and trial outcomes. Primary and secondary outcomes are defined and methods for assessing functional outcomes (secondary outcomes) are described.

RESULTS: We have developed a statistical analysis plan that includes our methods for presenting the trial profile, baseline characteristics, processes of care, outcomes and adverse events. Seven pre-specified subgroups and our methods for statistical comparisons between groups are described.

CONCLUSION: We have developed a pre-specified statistical analysis plan for TARGET. To minimise analytical bias, this plan has been developed and made available to the public domain before completing recruitment and data collection.