Journal article
Statistical analysis plan for the adjunctive corticosteroid treatment in critically ill patients with septic shock (Adrenal) trial
L Billot, B Venkatesh, J Myburgh, S Finfer, J Cohen, S Webb, C McArthur, C Joyce, R Bellomo, A Rhodes, A Perner, Y Arabi, D Rajbhandari, P Glass, K Thompson, M Correa, M Harward
Critical Care and Resuscitation | AUSTRALASIAN MED PUBL CO LTD | Published : 2017
Abstract
Background: The Adjunctive Corticosteroid Treatment in Critically Ill Patients with Septic Shock (ADRENAL) trial, a 3800-patient, multicentre, randomised controlled trial, will be the largest study to date of corticosteroid therapy in patients with septic shock. Objective: To describe a statistical analysis plan (SAP) and make it public before completion of patient recruitment and data collection. The SAP will be adhered to for the final data analysis of this trial, to avoid analysis bias arising from knowledge of study findings. Methods: The SAP was designed by the chief investigators and statisticians and approved by the ADRENAL management committee. All authors were blind to treatment all..
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