{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,8,6]],"date-time":"2024-08-06T07:42:26Z","timestamp":1722930146971},"reference-count":16,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2013,9,9]],"date-time":"2013-09-09T00:00:00Z","timestamp":1378684800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Emerg Medicine Australasia"],"published-print":{"date-parts":[[2013,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>The <jats:styled-content style=\"fixed-case\">A<\/jats:styled-content>ustralasian <jats:styled-content style=\"fixed-case\">R<\/jats:styled-content>esuscitation <jats:styled-content style=\"fixed-case\">I<\/jats:styled-content>n <jats:styled-content style=\"fixed-case\">S<\/jats:styled-content>epsis <jats:styled-content style=\"fixed-case\">E<\/jats:styled-content>valuation (<jats:styled-content style=\"fixed-case\">ARISE<\/jats:styled-content>) study is an international, multicentre, randomised, controlled trial designed to evaluate the effectiveness of early goal\u2010directed therapy compared with standard care for patients presenting to the <jats:styled-content style=\"fixed-case\">ED<\/jats:styled-content> with severe sepsis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>In keeping with current practice, and taking into considerations aspects of trial design and reporting specific to non\u2010pharmacologic 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 <jats:styled-content style=\"fixed-case\">ARISE<\/jats:styled-content> 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>The statistical analysis plan was designed by the <jats:styled-content style=\"fixed-case\">ARISE<\/jats:styled-content> chief investigators, and reviewed and approved by the <jats:styled-content style=\"fixed-case\">ARISE<\/jats:styled-content> 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A statistical analysis plan was developed, along with a trial profile, mock\u2010up 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>A statistical analysis plan for the <jats:styled-content style=\"fixed-case\">ARISE<\/jats:styled-content> 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.<\/jats:p><\/jats:sec>","DOI":"10.1111\/1742-6723.12116","type":"journal-article","created":{"date-parts":[[2013,9,10]],"date-time":"2013-09-10T02:59:17Z","timestamp":1378781957000},"page":"406-415","update-policy":"http:\/\/dx.doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["<scp>A<\/scp>ustralasian <scp>R<\/scp>esuscitation <scp>I<\/scp>n <scp>S<\/scp>epsis <scp>E<\/scp>valuation trial statistical analysis plan"],"prefix":"10.1111","volume":"25","author":[{"given":"Anthony","family":"Delaney","sequence":"first","affiliation":[{"name":"Malcolm Fisher Department of Intensive Care Medicine Royal North Shore Hospital  St Leonards New South Wales Australia"},{"name":"Northern Clinical School Sydney Medical School University of Sydney  Sydney New South Wales Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sandra L","family":"Peake","sequence":"additional","affiliation":[{"name":"Department of Epidemiology and Preventive Medicine School of Public Health and Preventative Medicine Faculty of Medicine Nursing and Health Sciences Monash University  Melbourne Victoria Australia"},{"name":"Department of Intensive Care Medicine The Queen Elizabeth Hospital School of Medicine  Adelaide South Australia Australia"},{"name":"Discipline of Acute Care Medicine Faculty of Health Science University of Adelaide  South Australia Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rinaldo","family":"Bellomo","sequence":"additional","affiliation":[{"name":"School of Medicine University of Melbourne  Melbourne Victoria Australia"},{"name":"School of Medicine Monash University  Melbourne Victoria Australia"},{"name":"Howard Florey Institute Melbourne University  Melbourne Victoria Australia"},{"name":"Department of Intensive Care Medicine Austin Hospital  Heidelberg Victoria Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Cameron","sequence":"additional","affiliation":[{"name":"Department of Epidemiology and Preventive Medicine School of Public Health and Preventative Medicine Faculty of Medicine Nursing and Health Sciences Monash University  Melbourne Victoria Australia"},{"name":"Department of Emergency Medicine Alfred Hospital  Melbourne Victoria Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anna","family":"Holdgate","sequence":"additional","affiliation":[{"name":"South West Clinical School University of New South Wales  Sydney New South Wales Australia"},{"name":"Department of Emergency Medicine Liverpool Hospital  Sydney New South Wales Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Belinda","family":"Howe","sequence":"additional","affiliation":[{"name":"Australian and New Zealand Intensive Care Research Centre School of Epidemiology and Preventive Medicine Monash University  Melbourne Victoria Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alisa","family":"Higgins","sequence":"additional","affiliation":[{"name":"Australian and New Zealand Intensive Care Research Centre School of Epidemiology and Preventive Medicine Monash University  Melbourne Victoria Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jeffrey","family":"Presneill","sequence":"additional","affiliation":[{"name":"Adult Intensive Care Unit Mater Health Services  Brisbane Queensland Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Steve","family":"Webb","sequence":"additional","affiliation":[{"name":"Australian and New Zealand Intensive Care Research Centre School of Epidemiology and Preventive Medicine Monash University  Melbourne Victoria Australia"},{"name":"Intensive Care Unit Royal Perth Hospital  Perth Western Australia Australia"},{"name":"School of Medicine Pharmacology and Public Health University of Western Australia  Perth Western Australia Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"ARISE Investigators","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2013,9,9]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0902413"},{"key":"e_1_2_6_3_1","first-page":"58","article-title":"The RENAL (Randomised Evaluation of Normal vs. Augmented Level of Replacement Therapy) study: statistical analysis plan","volume":"11","author":"Finfer S","year":"2009","journal-title":"Crit. 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