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Statistical analysis plan for the Adjunctive Corticosteroid Treatment in Critically Ill Patients with Septic Shock (ADRENAL) trial.

Billot, L; Venkatesh, B; Myburgh, J; Finfer, S; Cohen, J; Webb, S; McArthur, C; Joyce, C; Bellomo, R; Rhodes, A; et al. Billot, L; Venkatesh, B; Myburgh, J; Finfer, S; Cohen, J; Webb, S; McArthur, C; Joyce, C; Bellomo, R; Rhodes, A; Perner, A; Arabi, Y; Rajbhandari, D; Glass, P; Thompson, K; Correa, M; Harward, M (2017) Statistical analysis plan for the Adjunctive Corticosteroid Treatment in Critically Ill Patients with Septic Shock (ADRENAL) trial. Crit Care Resusc, 19 (2). pp. 183-191. ISSN 1441-2772
SGUL Authors: Rhodes, Andrew

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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 allocation and to the unblinded data produced during two interim analyses conducted by the Data Safety and Monitoring Committee. The data shells were produced from a previously published protocol. Statistical analyses are described in broad detail. Trial outcomes were selected and categorised into primary, secondary and tertiary outcomes, and appropriate statistical comparisons between groups are planned and described in a way that is transparent, available to the public, verifiable and determined before completion of data collection. RESULTS: We developed a standard SAP for the ADRENAL trial, and have produced a trial profile outline and list of mock tables. We describe analyses of baseline characteristics, processes of care, measures of efficacy and outcomes. Six pre-specified subgroups were defined, and statistical comparisons between groups in these subgroups are described. CONCLUSION: We have developed an SAP for the ADRENAL trial. This plan accords with high-quality standards of internal validity to minimise analysis bias.

Item Type: Article
Keywords: Algorithms, Australia, Critical Care, Data Collection, Data Interpretation, Statistical, Double-Blind Method, Hydrocortisone, Infusions, Intravenous, Intensive Care Units, New Zealand, Outcome and Process Assessment (Health Care), Patient Selection, Research Design, Shock, Septic, Software Design, Survival Analysis, 1103 Clinical Sciences
SGUL Research Institute / Research Centre: Academic Structure > Molecular and Clinical Sciences Research Institute (MCS)
Journal or Publication Title: Crit Care Resusc
ISSN: 1441-2772
Language: eng
Dates:
DateEvent
June 2017Published
PubMed ID: 28651515
Go to PubMed abstract
URI: http://openaccess.sgul.ac.uk/id/eprint/109146

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