Australasian Resuscitation In Sepsis Evaluation trial statistical analysis plan

Delaney, A., Peake, S.L., Bellomo, R., Cameron, P., Holdgate, A., Howe, B., Higgins, A., Presneill, J. and Webb, S. (2013) Australasian Resuscitation In Sepsis Evaluation trial statistical analysis plan. EMA - Emergency Medicine Australasia, 25 5: 406-415. doi:10.1111/1742-6723.12116

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Author Delaney, A.
Peake, S.L.
Bellomo, R.
Cameron, P.
Holdgate, A.
Howe, B.
Higgins, A.
Presneill, J.
Webb, S.
Title Australasian Resuscitation In Sepsis Evaluation trial statistical analysis plan
Journal name EMA - Emergency Medicine Australasia   Check publisher's open access policy
ISSN 1742-6731
Publication date 2013-01-01
Year available 2013
Sub-type Article (original research)
DOI 10.1111/1742-6723.12116
Open Access Status Not yet assessed
Volume 25
Issue 5
Start page 406
End page 415
Total pages 10
Place of publication Richmond, VIC, Australia
Publisher Wiley-Blackwell Publishing Asia
Language eng
Subject 2711 Emergency Medicine
Abstract Background: The Australasian Resuscitation In Sepsis Evaluation (ARISE) study is an international, multicentre, randomised, controlled trial designed to evaluate the effectiveness of early goal-directed therapy compared with standard care for patients presenting to the ED with severe sepsis. Objective: In keeping with current practice, and taking into considerations aspects of trial design and reporting specific to non-pharmacologic interventions, this document outlines the principles and methods for analysing and reporting the trial results. The document is prepared prior to completion of recruitment into the ARISE study, without knowledge of the results of the interim analysis conducted by the data safety and monitoring committee and prior to completion of the two related international studies. Methods: The statistical analysis plan was designed by the ARISE chief investigators, and reviewed and approved by the ARISE steering committee. The data collected by the research team as specified in the study protocol, and detailed in the study case report form were reviewed. Information related to baseline characteristics, characteristics of delivery of the trial interventions, details of resuscitation and other related therapies, and other relevant data are described with appropriate comparisons between groups. The primary, secondary and tertiary outcomes for the study are defined, with description of the planned statistical analyses. Results: A statistical analysis plan was developed, along with a trial profile, mock-up tables and figures. A plan for presenting baseline characteristics, microbiological and antibiotic therapy, details of the interventions, processes of care and concomitant therapies, along with adverse events are described. The primary, secondary and tertiary outcomes are described along with identification of subgroups to be analysed. Conclusion: A statistical analysis plan for the ARISE study has been developed, and is available in the public domain, prior to the completion of recruitment into the study. This will minimise analytic bias and conforms to current best practice in conducting clinical trials.
Keyword Randomised controlled trial
Statistical analysis plan
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Non HERDC
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Created: Wed, 30 Apr 2014, 10:03:01 EST by Matthew Lamb on behalf of School of Medicine