The RENAL (Randomised Evaluation of Normal vs. Augmented Level of Replacement Therapy) study: statistical analysis plan.
BACKGROUND
The Randomised Evaluation of Normal vs. Augmented Level of Replacement Therapy (RENAL) study is the largest interventional trial ever conducted in patients with acute renal failure.


OBJECTIVE
To develop and report a pre-determined statistical analysis plan which the investigators will adhere to in analysing the data from the trial.


METHODS
The data collected by the researchers as part of the trial protocol was reviewed and formally assessed. Information relevant to baseline characteristics was selected and, for each item, statistically relevant descriptive elements were described. Information relevant to the process of care and delivery of prescribed trial therapy was similarly classified and, for each item, appropriate descriptive statistical analysis was planned with appropriate comparison between groups. Finally, trial outcomes were selected, and an appropriate statistical comparison between groups was planned and described.


RESULTS
A standard analysis plan for the RENAL trial results was developed, which allows a comprehensive description of baseline characteristics, features of the process of care and trial treatment delivery, and pre-determined statistical assessment of relevant outcome measures in a way that is transparent, available to the public, verifiable and predetermined before the actual analysis of data.


CONCLUSIONS
We have developed a pre-determined statistical analysis plan for the RENAL trial. This plan will be adhered to in order to avoid introducing any analysis bias associated with prior knowledge of study findings.
Finfer
Simon
S
The George Institute for International Health, Sydney, NSW. sfinfer@george.org.au
Cass
Alan
A
Gallagher
Martin
M
Lee
Joanne
J
Su
Steve
S
Bellomo
Rinaldo
R
D058186:Acute Kidney Injury / Q000628:therapy*; D000328:Adult; D003422:Critical Care; D003627:Data Interpretation, Statistical; D017583:Hemodiafiltration / Q000379:methods*; D017052:Hospital Mortality; D006801:Humans; D007902:Length of Stay; D017063:Outcome Assessment, Health Care; D012107:Research Design