Early head-up mobilisation versus standard care for patients with severe acquired brain injury: A systematic review with meta-analysis and Trial Sequential Analysis.

Christian Gunge Riberholt,Jane Lindschou,Christian Gluud,Vibeke Wagner,Kirsten Møller,Jesper Mehlsen,Ivan D Florez

doi:10.1371/journal.pone.0237136

Christian Gunge Riberholt, Jane Lindschou + Show 5 more

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https://doi.org/10.1371/journal.pone.0237136

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Abstract

There is increasing focus on earlier rehabilitation in patients with traumatic or hypoxic brain injury or stroke. This systematic review evaluates the benefits and harms of early head-up mobilisation versus standard care in patients with severe acquired brain injury. We searched Medline, CENTRAL, EMBASE, four other databases and 13 selected clinical trial registries until April 2020. Eligible randomised clinical trials compared early head-up mobilisation versus standard care in patients with severe acquired brain injury and were analysed conducting random- and fixed-effects meta-analyses and Trial Sequential Analysis (TSA). Certainty of evidence was assessed by GRADE. We identified four randomised clinical trials (total n = 385 patients) with severe acquired brain injury (stroke 86% and traumatic brain injury 13%). Two trials were at low risk and two at high risk of bias. We found no evidence of a difference between early mobilisation vs. standard care on mortality or poor functional outcome at end of the intervention (relative risk (RR) 1.19, 95% CI 0.93 to 1.53; I2 0%; very low certainty) or at maximal follow-up (RR 1.03, 95% CI 0.89 to 1.21; I2 0%; very low certainty). We found evidence against an effect on quality of life at maximal follow-up. The proportion of patients with at least one serious adverse event did not differ at end of intervention or at maximal follow-up. For most comparisons, TSA suggested that further trials are needed. We found no evidence of a difference between early mobilisation versus standard care for patients with severe acquired brain injury. Early mobilisation appeared not to exert a major impact on quality of life. This systematic review highlights the insufficient evidence in patients with severe brain injury, and no firm conclusions can be drawn from these data. Protocol uploaded to PROSPERO: April 2018 (revised October 2018, CRD42018088790).

Highlights

There is increasing focus on earlier rehabilitation in patients with traumatic or hypoxic brain injury or stroke
This systematic review highlights the insufficient evidence in patients with severe brain injury, and no firm conclusions can be drawn from these data
We found no evidence of a difference between the early mobilisation group versus standard care on poor functional outcome at the end of the intervention (RR 1.22, 95% CI 0.89 to 1.68; I2 0%) (Fig 8A) and the Trial Sequential Analysis (TSA)-adjusted CI was 0.32 to 4.41 (Table 2)

Summary

Objectives

This systematic review aimed to assess benefits and harms of early head-up mobilisation, with the head and torso elevated more than 50 degrees above the horizontal level, compared with standard care in patients with severe acquired brain injury.The protocol for this systematic review was submitted to the PROSPERO-database (CRD42018088790) in April 2018 (see Protocol in S1 File) and adheres to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) (Checklist in S1 File) [28].Criteria for considering studies for this reviewTypes of studies. This systematic review aimed to assess benefits and harms of early head-up mobilisation, with the head and torso elevated more than 50 degrees above the horizontal level, compared with standard care in patients with severe acquired brain injury. Randomised clinical trials aiming at evaluating benefits and harms of early head-up mobilisation regardless of language, publication date, publication type, or publication status were included. We reported separately any harms they reported, as they may provide information on rare or late occurring adverse events we could not identify in randomised clinical trials [29,30]. We are aware that the decision not to search systematically for all observational studies may have biased our review towards the assessment of benefits and may overlook certain harms, such as late or rare harms

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