AVERT-DOSE Statistical Analysis Plan

Statistical Analysis Plan | medRxiv Skip to main content Home About Submit ALERTS / RSS Search for this keyword Advanced Search Statistical Analysis Plan View ORCID Profile Julie Bernhardt , View ORCID Profile Leonid Churilov the AVERT-DOSE Collaboration doi: https://doi.org/10.64898/2026.03.11.26348100 Julie Bernhardt 2 Florey Institute of Neuroscience and Mental Health Find this author on Google Scholar Find this author on PubMed Search for this author on this site ORCID record for Julie Bernhardt Leonid Churilov 1 The University of Melbourne Find this author on Google Scholar Find this author on PubMed Search for this author on this site ORCID record for Leonid Churilov For correspondence: leonidc{at}unimelb.edu.au Abstract Full Text Info/History Metrics Data/Code Preview PDF 1. Abstract This paper reports the statistical analysis plan for the AVERT-DOS trial: A Phase 3, Multi Arm, Multi Stage, Covariate Adjusted, Response Adaptive, Randomised Trial to Determine Optimal Early Mobility Training after Stroke. It contains a trial overview, regulatory information and details of the planned main analyses for the study protocol version Version 5; 15 June 2025. Competing Interest Statement The authors have declared no competing interest. Clinical Trial ACTRN12619000557134 Funding Statement This study was funded by the National Health and Medical Research Council (NHMRC) of Australia (Project Grants no: 1139712) and had no input into the study design, data collection, data analysis, data interpretation or writing of this protocol. Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Approval for this study has been granted by: Australia central: HREC/43406/Austin/2018 UK central IRAS: 270352 (2019) Brazil central: CONEP 5337969 India central: IECCCML/128362019 Singapore, Malaysia and Ireland, all participating site individual HREC approvals. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Data Availability All data produced in the present study are available upon reasonable request to the authors 2. Abbreviations ADL Activities of Daily Living AE Adverse Event aIRR adjusted Incidence Rate Ratio (aIRR) aOR adjusted Odds Ratio acOR adjusted common Odds Ratio acHR Adjusted cause specific Hazard Ratio AVERT Phase 3 randomised controlled, blinded outcome trial of very early mobilisation versus standard care in acute stroke patients. 1 CFS Clinical Frailty Scale CARA Covariate-Adjusted, Response-Adaptive CRIq Cognitive Reserve Index questionnaire DSMB Data Safety and Monitoring Committee ECR Endovascular Clot Retrieval eCRF electronic Case Report Form EQ-5D-5L EuroQol, 5 dimensions, 5 levels questionnaire FAC Functional Ambulation Classification FAS Fatigue Assessment Scale FDA Food and Drug Administration FMA Fugl-Meyer Assessment FMA-UL Fugl-Meyer Assessment of Upper Limb FMA-LL Fugl-Meyer Assessment of Lower Limb GCP Good Clinical Practice HADS Hospital Anxiety and Depression Scale HR Hazard Ratio ICH International Conference on Harmonisation ID Identification IME Important Medical Event IQR Inter-Quartile Range MAMS Multi-Arm Multi-Stage mITT Modified Intention To Treat mmHg millimetres of Mercury MoCA Montreal Cognitive Assessment MRI Magnetic Resonance Imaging mRS modified Rankin Scale MSAS Mobility Scale for Acute Stroke NEADL Nottingham Extended ADL scale NHMRC National Health and Medical Research Council NIHSS National Institute of Health Stroke Scale OR Odds Ratio PHP Hypertext Preprocessor SADQ-H 10 Stroke Aphasic Depression Questionnaire – Hospital Version 10 items SAE Serious Adverse Event SBP Systolic Blood Pressure SD Standard Deviation SGPALS Saltin-Grimby Physical Activity Level Scale sRD standardized Risk Difference SRRR Stroke Recovery and Roundtable TOAST Trial of ORG 10172 in Acute Stroke Treatment. (Stroke subtype Classification) UK United Kingdom VAS Visual Analogue Scale 10MWT Ten Metre Walk Test Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission. Back to top Previous Next Posted March 18, 2026. Download PDF Data/Code Email Thank you for your interest in spreading the word about medRxiv. NOTE: Your email address is requested solely to identify you as the sender of this article. Your Email * Your Name * Send To * Enter multiple addresses on separate lines or separate them with commas. You are going to email the following Statistical Analysis Plan Message Subject (Your Name) has forwarded a page to you from medRxiv Message Body (Your Name) thought you would like to see this page from the medRxiv website. 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