Major mistakes or errors in the use of trial sequential analysis in systematic reviews or meta-analyses - the METSA systematic review.

Background: Systematic reviews and data synthesis of randomised clinical trials play a crucial role in clinical practice, research, and health policy. Trial sequential analysis can be used in systematic reviews to control type I and type II errors, but methodological errors including lack of protocols and transparency are cause for concern. We assessed the reporting of trial sequential analysis.

Myths and methodologies: Assessment of dynamic cerebral autoregulation by the mean flow index.

The mean flow index-usually referred to as Mx-has been used for assessing dynamic cerebral autoregulation (dCA) for almost 30 years. However, concerns have arisen regarding methodological consistency, construct and criterion validity, and test-retest reliability. Methodological nuances, such as choice of input (cerebral perfusion pressure, invasive or non-invasive arterial pressure), pre-processing approach and artefact handling, significantly influence mean flow index values, and previous studies correlating mean flow index with other established dCA metrics are confounded by inherent methodological flaws like heteroscedasticity, while the mean flow index also fails to discriminate individuals with presumed intact versus impaired dCA (discriminatory validity), and its prognostic performance (predictive validity) across various conditions remains inconsistent.

Mapping physical activity patterns in hospitalised patients with moderate to severe acquired brain injury - MAP-ABI: Protocol for an observational study.

Introduction: The physical activity level in patients hospitalised for rehabilitation across multiple diagnoses is low. Moderate to severe acquired brain injury further reduces activity levels as impaired physical and cognitive functioning affect mobility independence. Therefore, supervised out-of-bed mobilisation and physical activity training are essential rehabilitation strategies.

Effect of controlled blood pressure increase on cerebral blood flow velocity and oxygenation in patients with subarachnoid haemorrhage.

Background: Patients with aneurysmal subarachnoid haemorrhage (SAH) might have impaired cerebral autoregulation, that is, CBF - and thereby oxygen delivery - passively increase with an increase in CPP. This physiological study aimed to investigate the cerebral haemodynamic effects of controlled blood pressure increase in the early phase after SAH before any signs of delayed cerebral ischaemia (DCI) occurred.

Methods: The study was carried out within 5 days after ictus.

Autonomic response to early head-up tilt in patients with severe traumatic brain injury: Analysis from a randomized feasibility trial.

Patients with severe traumatic brain injury (TBI) may have autonomic dysfunction, one manifestation of which is orthostatic intolerance. This potentially impairs physical rehabilitation. However, the exact mechanisms remain elusive.

Use of the EXOPULSE Mollii for severe ataxia in an adult male 4 months after cardiac arrest.

The EXOPULSE Mollii is designed to reduce spasticity through low-current electrical stimulation of major muscle groups. The effect on severe cerebellar ataxia has not been investigated. This case describes the use of the EXOPULSE Mollii in an adult male with severe cerebellar ataxia 4 months after cardiac arrest and ischaemic stroke.

Glycaemic control for patients with severe acute brain injury: Protocol for a systematic review.

Background: Hyperglycaemia is common in patients with acute brain injury admitted to an intensive care unit (ICU). Many studies have found associations between development of hyperglycaemia and increased mortality in hospitalised patients. However, the optimal target for blood glucose control is unknown.

Reliability of non-invasive arterial blood pressure measurement in patients with aneurysmal subarachnoid haemorrhage.

. Invasively measured arterial blood pressure (ABP) is associated with complications, while non-invasively measured ABP is generally considered risk-free. This study aimed to investigate the reliability of non-invasive ABP measured using finger-cuff volume-clamp device compared to invasive ABP measured by an arterial catheter in patients with aneurysmal subarachnoid haemorrhage (SAH).

Major mistakes and errors in the use of Trial Sequential Analysis in systematic reviews or meta-analyses - protocol for a systematic review.

Background: Adequately conducted systematic reviews with meta-analyses are considered the highest level of evidence and thus directly defines many clinical guidelines. However, the risks of type I and II errors in meta-analyses are substantial. Trial Sequential Analysis is a method for controlling these risks.

Reliability of cerebral autoregulation using different measures of perfusion pressure in patients with subarachnoid hemorrhage.

Dynamic cerebral autoregulation to spontaneous fluctuations in cerebral perfusion pressure (CPP) is often assessed by transcranial Doppler (TCD) in the time domain, yielding primarily the mean flow index (Mx), or in the frequency domain using transfer function analysis (TFA), yielding gain and phase. For both domains, the measurement of blood pressure is critical. This study assessed the inter-method reliability of dynamic cerebral autoregulation using three different methods of pressure measurement.

Mobilising patients with severe acquired brain injury in intensive care (MAWERIC) - Protocol for a randomised cross-over trial.

Introduction: In the early phase after severe brain injury, patients are often bedridden in an attempt to control intracranial homeostasis; however, prolonged immobilisation may trigger complications. There is limited knowledge about the physiological effects of mobilisation in this early phase.

Objective: To investigate changes in brain tissue oxygen tension when patients are mobilised using a Sara Combilizer® in the early phase after severe brain injury, in a randomised cross-over design.

Statistical analysis plan: Early mobilization by head-up tilt with stepping versus standard care after severe traumatic brain injury.

Background: Early mobilization on a tilt table with stepping versus standard care may be beneficial for patients with severe brain injury, but data from randomized clinical trials are lacking. This detailed statistical analysis plan describes the analyses of data collected in a randomized clinical feasibility trial for early mobilization by head-up tilt with stepping versus standard care after severe traumatic brain injury.

Methods: Primary feasibility outcomes are the proportion of included participants who were randomized out of all screened patients; the proportion of participants allocated to the experimental intervention who received at least 60% of the planned exercise sessions; and safety outcomes such as adverse events and reactions and serious adverse events and reactions.

Scoping review to identify and map non-pharmacological, non-surgical treatments for dysphagia following moderate-to-severe acquired brain injury.

Introduction: Dysphagia is a common and critical consequence of acquired brain injury (ABI) and can cause severe complications. Dysphagia rehabilitation is transforming from mainly compensatory strategies to the retraining of swallowing function using principles from neuroscience. However, there are no studies that map interventions available to retrain swallowing function in patients with moderate-to-severe ABI.

Reliability and validity of the mean flow index (Mx) for assessing cerebral autoregulation in humans: A systematic review of the methodology.

Cerebral autoregulation is a complex mechanism that serves to keep cerebral blood flow relatively constant within a wide range of cerebral perfusion pressures. The mean flow index (Mx) is one of several methods to assess dynamic cerebral autoregulation, but its reliability and validity have never been assessed systematically. The purpose of the present systematic review was to evaluate the methodology, reliability and validity of Mx.

Dynamic cerebral autoregulation during early orthostatic exercise in patients with severe traumatic brain injury: Further exploratory analyses from a randomized clinical feasibility trial.

In patients with severe traumatic brain injury, there is limited evidence of the clinical effect of early orthostatic exercise, although such exercise may strengthen systemic or cerebral hemodynamic responses to head-up tilt, thereby minimizing orthostatic intolerance. We measured dynamic cerebral autoregulation (dCA) and the occurrence of orthostatic intolerance after four weeks of regular orthostatic exercise by head-up tilt using a tilt table with integrated stepping using the ERIGO® tilt-table and comparing it to standard care. Thirty-four patients with severe traumatic brain injury admitted to a neurocritical care unit were included in this randomized clinical trial.

Early Orthostatic Exercise by Head-Up Tilt With Stepping vs. Standard Care After Severe Traumatic Brain Injury Is Feasible.

Intensive rehabilitation of patients after severe traumatic brain injury aims to improve functional outcome. The effect of initiating rehabilitation in the early phase, in the form of head-up mobilization, is unclear. To assess whether early mobilization is feasible and safe in patients with traumatic brain injury admitted to a neurointensive care unit.

Reliability of the transcranial Doppler ultrasound-derived mean flow index for assessing dynamic cerebral autoregulation in healthy volunteers.

The transcranial Doppler ultrasound-derived mean flow index (Mxa) is widely used for assessing dynamic cerebral autoregulation (dCA) in different clinical populations. This study aimed at estimating the relative and absolute reliability of Mxa in healthy participants in the supine position and during head-up tilt (HUT). Fourteen healthy participants were examined on two separate occasions during which, mean middle cerebral artery blood flow velocity (MCAv), non-invasive blood pressure, and heart rate were continuously recorded in the supine position and during HUT.

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

Background: 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.

Methods: We searched Medline, CENTRAL, EMBASE, four other databases and 13 selected clinical trial registries until April 2020.

Development of muscle contractures and spasticity during subacute rehabilitation after severe acquired brain injury: a prospective cohort study.

: This study investigated the development of contractures, passive stiffness, and spasticity in the ankle joint in patients with severe acquired brain injury (ABI) from admission to rehabilitation unit until 1-year post-injury compared to healthy controls. : An observational longitudinal cohort study : Nineteen patients (26 affected ankle joints) with severe ABI >17 years old and with paresis of a lower limb admitted to sub-acute neurorehabilitation were compared to 14 healthy controls (28 ankle joints). Passive and reflex-mediated ankle joint stiffness was obtained measuring torque, range of motion, velocity and acceleration of the ankle movements.

Protocol for a scoping review study to identify and map treatments for dysphagia following moderate to severe acquired brain injury.

Introduction: Dysphagia is highly prevalent in patients with acquired brain injury (ABI) and is associated with high morbidity and mortality. However, dysphagia management varies greatly between units and internationally, and there is currently no consensus, standard intervention or treatment. A review mapping the existing literature on dysphagia treatment is needed.

Early mobilisation by head-up tilt with stepping versus standard care after severe traumatic brain injury - Protocol for a randomised clinical feasibility trial.

Background: Intensive rehabilitation of patients with severe traumatic brain injury is generally applied in the subacute stages of the hospital stay. Few studies have assessed the association between early and intensive physical rehabilitation and functional outcomes. The aim of this trial is to assess the feasibility of an intensive physical rehabilitation intervention focusing on mobilisation to the upright position, starting as early as clinically possible versus standard care in the intensive care unit.

Impaired Cerebral Autoregulation during Head Up Tilt in Patients with Severe Brain Injury.

Early mobilization is of importance for improving long-term outcome for patients after severe acquired brain injury. A limiting factor for early mobilization by head-up tilt is orthostatic intolerance. The purpose of the present study was to examine cerebral autoregulation in patients with severe acquired brain injury and a low level of consciousness.