The Australasian Resuscitation in Sepsis Evaluation (ARISE) trial statistical analysis plan

Anthony Delaney, Sandra L Peake, Rinaldo Bellomo, Peter Cameron, Anna Holdgate, Belinda Duval Howe, Alisa M Higgins, Jeffrey J Presneill, Steven Webb

Research output: Contribution to journal › Article › Research › peer-review

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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 emergency department with severe sepsis. Objective: In keeping with current practice, and considering aspects of trial design and reporting specific to non-pharmacological interventions, our plan outlines the principles and methods for analysing and reporting the trial results. The document is prepared before 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 before completion of the two related international studies. Methods: Our statistical analysis plan was designed by the ARISE chief investigators, and reviewed and approved by the ARISE steering committee. We reviewed the data collected by the research team as specified in the study protocol and detailed in the study case report form. We describe information related to baseline characteristics, characteristics of delivery of the trial interventions, details of resuscitation, other related therapies and other relevant data with appropriate comparisons between groups. We define the primary, secondary and tertiary outcomes for the study, with description of the planned statistical analyses. Results: We have developed a statistical analysis plan with a trial profile, mock-up tables and figures. We describe a plan for presenting baseline characteristics, microbiological and antibiotic therapy, details of the interventions, processes of care and concomitant therapies and adverse events. We describe the primary, secondary and tertiary outcomes with identification of subgroups to be analysed. Conclusion: We have developed a statistical analysis plan for the ARISE study, available in the public domain, before the completion of recruitment into the study. This will minimise analytical bias and conforms to current best practice in conducting clinical trials
Original languageEnglish
Pages (from-to)162 - 171
Number of pages10
JournalCritical Care and Resuscitation
Volume15
Issue number3
Publication statusPublished - 2013

Cite this

Delaney, Anthony ; Peake, Sandra L ; Bellomo, Rinaldo ; Cameron, Peter ; Holdgate, Anna ; Howe, Belinda Duval ; Higgins, Alisa M ; Presneill, Jeffrey J ; Webb, Steven. / The Australasian Resuscitation in Sepsis Evaluation (ARISE) trial statistical analysis plan. In: Critical Care and Resuscitation. 2013 ; Vol. 15, No. 3. pp. 162 - 171.
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title = "The Australasian Resuscitation in Sepsis Evaluation (ARISE) trial statistical analysis plan",
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 emergency department with severe sepsis. Objective: In keeping with current practice, and considering aspects of trial design and reporting specific to non-pharmacological interventions, our plan outlines the principles and methods for analysing and reporting the trial results. The document is prepared before 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 before completion of the two related international studies. Methods: Our statistical analysis plan was designed by the ARISE chief investigators, and reviewed and approved by the ARISE steering committee. We reviewed the data collected by the research team as specified in the study protocol and detailed in the study case report form. We describe information related to baseline characteristics, characteristics of delivery of the trial interventions, details of resuscitation, other related therapies and other relevant data with appropriate comparisons between groups. We define the primary, secondary and tertiary outcomes for the study, with description of the planned statistical analyses. Results: We have developed a statistical analysis plan with a trial profile, mock-up tables and figures. We describe a plan for presenting baseline characteristics, microbiological and antibiotic therapy, details of the interventions, processes of care and concomitant therapies and adverse events. We describe the primary, secondary and tertiary outcomes with identification of subgroups to be analysed. Conclusion: We have developed a statistical analysis plan for the ARISE study, available in the public domain, before the completion of recruitment into the study. This will minimise analytical bias and conforms to current best practice in conducting clinical trials",
author = "Anthony Delaney and Peake, {Sandra L} and Rinaldo Bellomo and Peter Cameron and Anna Holdgate and Howe, {Belinda Duval} and Higgins, {Alisa M} and Presneill, {Jeffrey J} and Steven Webb",
year = "2013",
language = "English",
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pages = "162 -- 171",
journal = "Critical Care and Resuscitation",
issn = "1441-2772",
publisher = "Australasian Medical Publishing Co. Pty Ltd. (AMPCo)",
number = "3",

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Delaney, A, Peake, SL, Bellomo, R, Cameron, P, Holdgate, A, Howe, BD, Higgins, AM, Presneill, JJ & Webb, S 2013, 'The Australasian Resuscitation in Sepsis Evaluation (ARISE) trial statistical analysis plan', Critical Care and Resuscitation, vol. 15, no. 3, pp. 162 - 171.

The Australasian Resuscitation in Sepsis Evaluation (ARISE) trial statistical analysis plan. / Delaney, Anthony; Peake, Sandra L; Bellomo, Rinaldo; Cameron, Peter; Holdgate, Anna; Howe, Belinda Duval; Higgins, Alisa M; Presneill, Jeffrey J; Webb, Steven.

In: Critical Care and Resuscitation, Vol. 15, No. 3, 2013, p. 162 - 171.

Research output: Contribution to journal › Article › Research › peer-review

TY - JOUR

T1 - The Australasian Resuscitation in Sepsis Evaluation (ARISE) trial statistical analysis plan

AU - Delaney, Anthony

AU - Peake, Sandra L

AU - Bellomo, Rinaldo

AU - Cameron, Peter

AU - Holdgate, Anna

AU - Howe, Belinda Duval

AU - Higgins, Alisa M

AU - Presneill, Jeffrey J

AU - Webb, Steven

PY - 2013

Y1 - 2013

N2 - 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 emergency department with severe sepsis. Objective: In keeping with current practice, and considering aspects of trial design and reporting specific to non-pharmacological interventions, our plan outlines the principles and methods for analysing and reporting the trial results. The document is prepared before 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 before completion of the two related international studies. Methods: Our statistical analysis plan was designed by the ARISE chief investigators, and reviewed and approved by the ARISE steering committee. We reviewed the data collected by the research team as specified in the study protocol and detailed in the study case report form. We describe information related to baseline characteristics, characteristics of delivery of the trial interventions, details of resuscitation, other related therapies and other relevant data with appropriate comparisons between groups. We define the primary, secondary and tertiary outcomes for the study, with description of the planned statistical analyses. Results: We have developed a statistical analysis plan with a trial profile, mock-up tables and figures. We describe a plan for presenting baseline characteristics, microbiological and antibiotic therapy, details of the interventions, processes of care and concomitant therapies and adverse events. We describe the primary, secondary and tertiary outcomes with identification of subgroups to be analysed. Conclusion: We have developed a statistical analysis plan for the ARISE study, available in the public domain, before the completion of recruitment into the study. This will minimise analytical bias and conforms to current best practice in conducting clinical trials

AB - 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 emergency department with severe sepsis. Objective: In keeping with current practice, and considering aspects of trial design and reporting specific to non-pharmacological interventions, our plan outlines the principles and methods for analysing and reporting the trial results. The document is prepared before 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 before completion of the two related international studies. Methods: Our statistical analysis plan was designed by the ARISE chief investigators, and reviewed and approved by the ARISE steering committee. We reviewed the data collected by the research team as specified in the study protocol and detailed in the study case report form. We describe information related to baseline characteristics, characteristics of delivery of the trial interventions, details of resuscitation, other related therapies and other relevant data with appropriate comparisons between groups. We define the primary, secondary and tertiary outcomes for the study, with description of the planned statistical analyses. Results: We have developed a statistical analysis plan with a trial profile, mock-up tables and figures. We describe a plan for presenting baseline characteristics, microbiological and antibiotic therapy, details of the interventions, processes of care and concomitant therapies and adverse events. We describe the primary, secondary and tertiary outcomes with identification of subgroups to be analysed. Conclusion: We have developed a statistical analysis plan for the ARISE study, available in the public domain, before the completion of recruitment into the study. This will minimise analytical bias and conforms to current best practice in conducting clinical trials

UR - http://www.ncbi.nlm.nih.gov/pubmed/23944201

M3 - Article

VL - 15

SP - 162

EP - 171

JO - Critical Care and Resuscitation

JF - Critical Care and Resuscitation

SN - 1441-2772

IS - 3

ER -

Delaney A, Peake SL, Bellomo R, Cameron P, Holdgate A, Howe BD et al. The Australasian Resuscitation in Sepsis Evaluation (ARISE) trial statistical analysis plan. Critical Care and Resuscitation. 2013;15(3):162 - 171.

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