Recovery of Visuospatial Neglect With Standard Treatment: A Systematic Review and Meta-Analysis

Stroke, Ahead of Print. BACKGROUND:Visuospatial neglect is a common consequence of stroke and is characterized by impaired attention to contralesional space. Currently, the extent and time course of recovery from neglect are not clearly established. This systematic review and meta-analysis aimed to determine the recovery trajectory of poststroke neglect with standard treatment.METHODS:PsycInfo, Embase, and MEDLINE were searched for articles reporting recovery rates of neglect after stroke. Time since stroke was categorized into early (0–3 months), mid (3–6 months), and late ( >6 months) recovery phases. Random-effects models for pooled prevalence were generated for each phase, and potential sources of heterogeneity were explored with metaregressions. Methodological quality of each study was assessed using the Joanna Briggs Institute checklist, with low-quality studies excluded in sensitivity analyses.RESULTS:The search captured 4130 articles including duplicates, and 111 full-text reviews were undertaken. A total of 27 studies reporting data from 839 stroke survivors with neglect were included for review. Meta-analyses indicated a recovery rate of 42% in the early phase, which increased to 53% in the mid-recovery phase. Additional recovery in the late phase was minimal, with an estimated 56% recovery rate. Heterogeneity of studies was high (I2 >75%) in all 3 phases of recovery. Estimates were robust to sensitivity analyses. Metaregressions showed significantly greater recovery in studies that included patients with left-hemisphere lesions (β=0.275,P

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Luglio 2024

Adolescent idiopathic scoliosis: a prospective randomised trial protocol comparing clinical and radiological outcomes in minimally invasive surgery versus standard posterior spinal fusion in a single-centre, the Rizzoli Orthopaedic Institute, Bologna, Italy

Introduction
Minimally invasive spine surgery (MISS) has been shown to be safe and effective in adolescent idiopathic scoliosis (AIS) correction, even though there is no consensus on which treatment provides the best results.

Methods and analysis
The present study will be a randomised controlled trial with allocation 1:1. We will enrol 126 patients with Cobb≤70° undergoing AIS surgery. Patients will be divided into two groups, according to a randomisation list unknown to the surgeons. Group 1 will be treated with posterior spine fusion and group 2 with MISS. MISS technique: two midline noncontiguous skin incisions of 3 cm in length, 3–4 segments (6–8 pedicles screws) instrumented per skin incision, uniplanar and polyaxial pedicle screws inserted bilaterally on each side of the proximal and distal levels, rod translation manoeuvre and C–D manoeuvre performed on the distal part. Clinical and radiological follow-ups will be performed for 5 years. Values of Cobb angles degrees will be collected to study the correction rate of the structural major curve. Postoperative and preoperative anterior-posterior (AP) direct radiography will be compared with the last follow-up examination. Operative time, preoperative haemoglobin (Hb) and second postoperative day Hb, full length of hospitalisation, time to achieve verticalisation and time to remove the drainage will be recorded. Numeric Rating Scale (NRS) medium score will be assessed immediately after surgery and during the whole postoperative rehabilitation treatment to estimate pain reduction. Complications will be collected postoperatively and throughout the whole follow-up period.
Moreover, questionnaires will be administered at follow-up (NRS, Scoliosis Research Society-22 and Oswestry Disability Index) for the clinical assessment.

Ethics and dissemination
The study protocol has been approved by the local ethic committee Area Vasta Emilia Romagna Centro. Written informed consent will be collected for all the participants. Findings of this study will be disseminated through peer-reviewed publications and conference presentations.

Trial registration number
NCT05860673.

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Luglio 2024

Accuracy of pH strip testing and pH liquid testing versus standard pH meter of gastric contents in critically ill patients: a diagnostic accuracy study

Objective
The utilisation of pH level measurements from gastric contents may indicate the preferred tip position of a nasogastric tube or monitor the efficacy of stress ulcer prophylaxis in critically ill patients. We aimed to determine the accuracy of pH strip (pHS) tests and pH liquid (pHL) tests compared with the standard pH meter (pHM).

Design
Diagnostic accuracy study.

Setting
Gastric contents from medically critically ill patients.

Participants
In total, 113 gastric samples were collected from 27 critically ill patients.

Outcome measure
The level of pH measured by pHM, pHS and pHL.

Results
The pH values measured by pHM, pHS and pHL were 5.83 (IQR 5.12–6.61), 5.50 (IQR 5.00–6.00) and 5.75 (IQR 5.25–6.25), respectively. The pHS test showed greater accuracy, exhibiting a more positive correlation with the standard pHM measurement than the pHL test, with Y=0.95*X+0.56; rho=0.91, p

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Luglio 2024

Protocol for a hybrid effectiveness-implementation clinical trial evaluating video-assisted electronic consent vs standard consent for patients initiating and continuing haemodialysis in Australia (eConsent HD)

Introduction
Communicating complex information about haemodialysis (HD) and ensuring it is well understood remains a challenge for clinicians. Informed consent is a high-impact checkpoint in augmenting patients’ decision awareness and engagement prior to HD. The aims of this study are to (1) develop a digital information interface to better equip patients in the decision-making process to undergo HD; (2) evaluate the effectiveness of the co-designed digital information interface to improve patient outcomes; and (3) evaluate an implementation strategy.

Methods and analysis
First, a co-design process involving consumers and clinicians to develop audio-visual content for an innovative digital platform. Next a two-armed, open-label, multicentre, randomised controlled trial will compare the digital interface to the current informed consent practice among adult HD patients (n=244). Participants will be randomly assigned to either the intervention or control group. Intervention group: Participants will be coached to an online platform that delivers a simple-to-understand animation and knowledge test questions prior to signing an electronic consent form. Control group: Participants will be consented conventionally by a clinician and sign a paper consent form. Primary outcome is decision regret, with secondary outcomes including patient-reported experience, comprehension, anxiety, satisfaction, adherence to renal care, dialysis withdrawal, consent time and qualitative feedback. Implementation of eConsent for HD will be evaluated concurrently using the Consolidation Framework for Implementation Research (CFIR) methodology. Analysis: For the randomised controlled trial, data will be analysed using intention-to-treat statistical methods. Descriptive statistics and CFIR-based analyses will inform implementation evaluation.

Ethics and dissemination
Human Research Ethics approval has been secured (Metro North Health Human Research Ethics Committee B, HREC/2022/MNHB/86890), and Dissemination will occur through partnerships with stakeholder and consumer groups, scientific meetings, publications and social media releases.

Trial registration number
Australian and New Zealand Clinical Trials Registry (ACTRN12622001354774).

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Luglio 2024

Vascular access specialist teams versus standard practice for catheter insertion and prevention of failure: a systematic review

Objective
Billions of vascular access devices (VADs) are inserted annually for intravenous therapy worldwide. However, their use is not without challenges. Facilitating the process and enhancing results, hospital authorities have created vascular access specialist teams (VASTs) with advanced competencies in the evaluation, insertion, care and management of VADs. The objective is to compare the effectiveness of VASTs versus standard practice regarding cannulation success and vascular access maintenance in hospitalised adults.

Design
Systematic review, using the Mixed Methods Appraisal Tool.

Data sources
We conducted a structured data search on Cochrane Library, MEDLINE, Web of Science, Scopus and EBSCOhost up to 31 May 2023. We did not impose a time limit regarding the date of publication.

Eligibility criteria
Studies were eligible for inclusion in the review if they were randomised and non-randomised trials and observational studies.

Data extraction and synthesis
We included studies that described or evaluated the activity of VASTs compared with clinical practitioners. The outcomes analysed were the success of the cannulation and the incidence of associated adverse effects.

Results
The search strategy produced 3053 papers published between 1984 and 2020, from which 12 were selected for analysis. VASTs are heterogeneously described among these studies, which mainly focus on insertions, frequently for patients with difficult intravenous access. Some patients presented with specific needs or requirement for specific insertion technique or catheter type. Compared with usual practice, these studies indicate that the involvement of a VAST is associated with a higher effectiveness in terms of first attempt insertions and insertion success rates, and a reduction in catheter-associated adverse events. However, meta-analyses confirming this trend are not currently possible.

Conclusions
It seems apparent that VASTS contribute to improving the health of patients during the administration of intravenous. VASTs seem to increase the effectiveness of VAD insertion and care and reduce complications.

PROSPERO registration number
CRD42021231259.

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Luglio 2024

Infant formula supplemented with milk fat globule membrane compared with standard infant formula for the cognitive development of healthy term-born formula-fed infants: protocol for a randomised controlled trial

Introduction
Milk fat globule membrane (MFGM) is a complex lipid–protein structure in mammalian milk and human milk that is largely absent from breastmilk substitutes. The objective of this trial is to investigate whether providing infant formula enriched with MFGM versus standard infant formula improves cognitive development at 12 months of age in exclusively formula-fed full-term infants.

Methods and analysis
This is a randomised, controlled, clinician-blinded, researcher-blinded and participant-blinded trial of two parallel formula-fed groups and a breastfed reference group that were recruited in the suburban Adelaide (Australia) community by a single study centre (a medical research institute). Healthy, exclusively formula-fed, singleton, term-born infants under 8 weeks of age were randomised to either an MFGM-supplemented formula (intervention) or standard infant formula (control) from enrolment until 12 months of age. The reference group was not provided with formula. The primary outcome is the Cognitive Scale of the Bayley Scales of Infant Development, Fourth Edition (Bayley-IV) at 12 months. Secondary outcomes are the Bayley-IV Cognitive Scale at 24 months, other Bayley-IV domains (language, motor, emotional and behavioural development) at 12 and 24 months of age, infant attention at 4 and 9 months of age, parent-rated language at 12 and 24 months of age, parent-rated development at 6 and 18 months of age as well as growth, tolerance and safety of the study formula. To ensure at least 80% power to detect a 5-point difference in the mean Bayley-IV cognitive score, >200 infants were recruited in each group.

Ethics and dissemination
The Women’s and Children Health Network Human Research Ethics Committee reviewed and approved the study (HREC/19/WCHN/140). Caregivers gave written informed consent prior to enrolling in the trial. Findings of this study will be disseminated through peer-reviewed publications and conference presentations.

Trial registration number
ACTRN12620000552987; Australian and New Zealand Clinical Trial Registry: anzctr.org.au.

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Luglio 2024

Respiratory support with standard low-flow oxygen therapy, high-flow oxygen therapy or continuous positive airway pressure in adults with acute hypoxaemic respiratory failure in a resource-limited setting: protocol for a randomised, open-label, clinical trial – the Acute Respiratory Intervention StudiEs in Africa (ARISE-AFRICA) study

Rationale
Acute hypoxaemic respiratory failure (AHRF) is associated with high mortality in sub-Saharan Africa. This is at least in part due to critical care-related resource constraints including limited access to invasive mechanical ventilation and/or highly skilled acute care workers. Continuous positive airway pressure (CPAP) and high-flow oxygen by nasal cannula (HFNC) may prove useful to reduce intubation, and therefore, improve survival outcomes among critically ill patients, particularly in resource-limited settings, but data in such settings are lacking. The aim of this study is to determine whether CPAP or HFNC as compared with standard oxygen therapy, could reduce mortality among adults presenting with AHRF in a resource-limited setting.

Methods
This is a prospective, multicentre, randomised, controlled, stepped wedge trial, in which patients presenting with AHRF in Uganda will be randomly assigned to standard oxygen therapy delivered through a face mask, HFNC oxygen or CPAP. The primary outcome is all-cause mortality at 28 days. Secondary outcomes include the number of patients with criteria for intubation at day 7, the number of patients intubated at day 28, ventilator-free days at day 28 and tolerance of each respiratory support.

Ethics and dissemination
The study has obtained ethical approval from the Research and Ethics Committee, School of Biomedical Sciences, College of Health Sciences, Makerere University as well as the Uganda National Council for Science and Technology. Patients will be included after informed consent. The results will be submitted for publication in peer-reviewed journals.

Trial registration number
NCT04693403.

Protocol version
8 September 2023; version 5.

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Luglio 2024