Prespecified dose-response analysis for A Very Early Rehabilitation Trial (AVERT)

Abstract

Objective:Our prespecified dose-response analyses of A Very Early Rehabilitation Trial (AVERT) aim to provide practical guidance for clinicians on the timing, frequency, and amount of mobilization following acute stroke.Methods:Eligible patients were aged ≥18 years, had confirmed first (or recurrent) stroke, and were admitted to a stroke unit within 24 hours of stroke onset. Patients were randomized to receive very early and frequent mobilization, commencing within 24 hours, or usual care. We used regression analyses and Classification and Regression Trees (CART) to investigate the effect of timing and dose of mobilization on efficacy and safety outcomes, irrespective of assigned treatment group.Results:A total of 2,104 patients were enrolled, of whom 2,083 (99.0%) were followed up at 3 months. We found a consistent pattern of improved odds of favorable outcome in efficacy and safety outcomes with increased daily frequency of out-of-bed sessions (odds ratio [OR] 1.13, 95% confidence interval [CI] 1.09 to 1.18, p < 0.001), keeping time to first mobilization and mobilization amount constant. Increased amount (minutes per day) of mobilization reduced the odds of a good outcome (OR 0.94, 95% CI 0.91 to 0.97, p < 0.001). Session frequency was the most important variable in the CART analysis, after prognostic variables age and baseline stroke severity.Conclusion:These data suggest that shorter, more frequent mobilization early after acute stroke is associated with greater odds of favorable outcome at 3 months when controlling for age and stroke severity.Classification of evidence:This study provides Class III evidence that shorter, more frequent early mobilization improves the chance of regaining independence after stroke.

Prevalence for delirium in stroke patients: A prospective controlled study

“…Especially close observation of neurological status and vital parameters (e.g., temperature together with fast escalating infection strategies) may reduce incidence of delirium as response to cerebral reaction to infection induced neurotoxic transmitters (Riedel et al, 2014). Furthermore, on the SU in our study delirium screening and evidence-based delirium management is part of daily routine, including nonpharmacological interventions and early mobilization (Bernhardt et al, 2016). Other studies in the field did not reported delirium-related structures and processes; hence a comparison is not feasible.…”

A Very Early Rehabilitation Trial after stroke (AVERT): a Phase III, multicentre, randomised controlled trial

“…Adapted with permission from . 33 Finally, we repeated the regression analysis for the UC group alone because of the potential risk of any unmeasured confounding by treatment group (additional unmeasured differences between treatment groups). This repeat analysis (Table 14) indicated that the same factors were important within the UC group alone.…”

“…Much of this work has already been published by the AVERT group. [30][31][32][33][34][35][36] We will also refer to two related studies that were nested within the AVERT programme. These studies contribute to the understanding of AVERT, but were not specifically included in the original Health Technology Assessment (HTA) programme trial application.…”

“…Adapted with permission from . 33 Copyright © 2016 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.…”

Moving rehabilitation research forward: Developing consensus statements for rehabilitation and recovery research

“…Too often, our choice of intervention type, dose, or scheduling is arbitrarily assigned (as reflected in many meta-analyses of stroke rehabilitation interventions), with a ''more is better'' mantra that is likely too simplistic and may even be harmful at certain points in the recovery pathway. 39 In complex behaviour change research, we see increased attention on codesign of interventions with the health consumer 40 ; turning these types of interventions into standardized protocols for delivery in trials is not simple.…”