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 -