The CALORIES trial: statistical analysis plan.

BACKGROUND: The CALORIES trial is a pragmatic, open, multicentre, randomised controlled trial (RCT) of the clinical effectiveness and cost-effectiveness of early nutritional support via the parenteral route compared with early nutritional support via the enteral route in unplanned admissions to adult general critical care units (CCUs) in the United Kingdom. The trial derives from the need for a large, pragmatic RCT to determine the optimal route of delivery for early nutritional support in the critically ill.

OBJECTIVE: To describe the proposed statistical analyses for the evaluation of the clinical effectiveness in the CALORIES trial.

METHODS: With the primary and secondary outcomes defined precisely and the approach to safety monitoring and data collection summarised, the planned statistical analyses, including prespecified subgroups and secondary analyses, were developed and are described.

RESULTS: The primary outcome is all-cause mortality at 30 days. The primary analysis will be reported as a relative risk and absolute risk reduction and tested with the Fisher exact test. Prespecified subgroup analyses will be based on age, degree of malnutrition, acute severity of illness, mechanical ventilation at admission to the CCU, presence of cancer and time from CCU admission to commencement of early nutritional support. Secondary analyses include adjustment for baseline covariates.

CONCLUSION: In keeping with best trial practice, we have developed, described and published a statistical analysis plan for the CALORIES trial and are placing it in the public domain before inspecting data from the trial.