Infant feeding practices in the first 2 years of life are linked to long-term weight trajectories. Despite the importance of obesity prevention interventions, there are no randomised controlled trials (RCTs) evaluating early childhood education and care (ECEC) and primary caregiver-targeted interventions on child weight and feeding outcomes.
To assess the efficacy of an 18-month digital health intervention (Tiny Bites) delivered to ECEC services and primary caregivers of children aged 4 to ≤12 months on child age-adjusted and sex-adjusted body mass index-for-age z-score (zBMI) relative to usual care control in the Hunter New England (HNE) region of New South Wales, Australia.
This type 1 hybrid cluster RCT will include up to 60 ECEC services and 540 children/caregiver dyads. The intervention supports ECEC services and caregivers to deliver recommended responsive feeding practices to infants. ECEC services will receive access to an online assessment platform, training and resources, and implementation support. Primary caregivers will receive text messages, monthly e-newsletters, online links and direct communication from ECEC services. We will assess the impact on child zBMI at 18-month follow-up. Secondary outcomes include duration of consuming any breastmilk, child diet and caregiver responsive feeding practices. We will also assess ECEC policy and practice implementation related to targeted feeding practices, programme cost effectiveness, adverse effects and engagement with the programme (ECECs and caregivers). For the primary outcome, between-group differences will be assessed for paired data using two-level hierarchical linear regression models.
Ethics approval has been provided by HNE Human Research Ethics Committee (HREC) (2023/ETH01158), Deakin University (2024-202) and University of Newcastle HREC (R-2024-0039). Trial results will be submitted for publication in peer-reviewed journals, presented at scientific conferences locally and internationally and to relevant practice stakeholders.
ACTRN12624000576527.
The management of severe traumatic brain injury (sTBI) in the intensive care unit (ICU) is focused on preventing secondary brain insults, by ensuring adequate cerebral perfusion, oxygenation and substrate delivery. Despite optimisation of intracranial pressure (ICP) and cerebral perfusion pressure (CPP) using evidence-based guidelines, brain tissue hypoxia can still occur and is strongly associated with adverse functional outcomes post sTBI.
The Brain Oxygen Neuromonitoring in Australia and New Zealand Assessment – Global Trial (BONANZA-GT) is an international, two-arm, open-label, parallel group, randomised controlled trial comparing sTBI management incorporating early brain tissue oxygen (PbtO2) monitoring and optimisation, with ICP/CPP-based management alone. A total of 860 adults admitted to participating institutions with non-penetrating sTBI and requiring insertion of an ICP monitor (as determined by the treating neurosurgeon) will be enrolled. The primary outcome is the proportion of patients with favourable neurological outcomes, as defined by a Glasgow Outcome Score-Extended (GOS-E) >4, at 6 months following injury. Key secondary outcomes include all-cause mortality at ICU discharge, hospital discharge, adverse events, as well as hospital and ICU length of stay and GOS-E at 12 months. The BONANZA-GT will determine whether a protocolised therapeutic strategy guided by continuous PbtO2 monitoring in addition to ICP/CPP targets results in improved neurological outcomes when compared with standard care using ICP/CPP-guided management alone.
Approval has been obtained from relevant ethics boards in every jurisdiction that is participating in the trial. Inclusion of adults who lack capacity for informed consent will be governed in accordance with the legal requirements of each participating site. Study findings will be presented at scientific meetings and disseminated via peer-review publications.
Australian and New Zealand Clinical Trials Registry (ACTRN 12619001328167).
International consensus guidelines support the initial administration of 30 mL/kg of intravenous fluids for haemodynamic resuscitation of newly diagnosed septic shock. Practice variation exists between the volume of fluids administered and timing of vasopressor commencement. The optimal approach in patients with septic shock is uncertain.
Australasian Resuscitation In Sepsis Evaluation: FLUid or vasopressors In emergency Department Sepsis is a 1000-participant multicentre, randomised, open-label, parallel group clinical trial conducted in patients with septic shock presenting to the emergency department in participating sites in Australia, New Zealand and Ireland. Participants are randomised (1:1) to either restricted fluids and early vasopressors or a larger initial intravenous fluid volume and later vasopressors. The primary outcome is days alive and out of hospital at day 90 postrandomisation. Secondary outcomes are all-cause mortality at day 90, time from randomisation until death (to day 90), days alive and at home at day 90 and ventilator-free, vasopressor-free and renal replacement-free days to day 28 postrandomisation and death or disability at 6-month and 12-month postrandomisation. Health-related quality of life will be assessed at day 180 and 12 months following randomisation.
The study was approved by Northern Sydney Local Health District Human Research Ethics Committee (HREC2020/ETH02874) on 21 January 2021. Patients will be enrolled under a waiver of prior consent. The patient or next-of-kin (or equivalent according to local jurisdiction) is approached at the first available opportunity and given a trial information sheet. According to local approvals, the patient or next-of-kin chooses to either continue in the trial or opt-out/decline continued participation. Results will be disseminated in peer-reviewed journals and presented at academic conferences.
Social accountability is a key value and aspirational goal of many medical institutions. While much has been studied on social accountability in the context of medical education and institutions, less research has examined how social accountability influences research. In light of this absence, the objective of our scoping review is to research the following questions: (1) What characterises socially accountable research (SAR), and how is it expressed and experienced? (2) How do language, positionality, and worldview influence SAR?, and (3) What structures and considerations are necessary to support successful SAR in local and global contexts?
To answer the above research questions, the Arksey and O’Malley, Levac et al, Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews and Joanna Briggs Institute (JBI) guidelines will be followed. The search strategy was adapted and applied to MEDLINE, Embase, ERIC, and CINAHL databases. A total of n=5289 eligible articles were identified. Articles were excluded if they were published before 1995, were in a language other than English, or were duplicates, leaving n=2840 articles for title/abstract screening.
Ethical approval is not required to complete this study. We will take an integrated knowledge translation approach. Throughout the project, results will be disseminated to knowledge users (ie, consultations, following Arksey and O’Malley). Our findings will be presented to the larger academic community, policymakers, and healthcare practitioners through presentations, reports, newsletters, and an online repository.
Open Science Framework 16 July 2024. osf.io/mvhnu.
Simulation offers a feasible modality to prepare nurses for challenges communicating with patients with dementia. Elderspeak communication is speech that sounds like baby talk and can lead to rejection of care by patients with dementia. However, it is unknown if simulation can be used to capture elderspeak communication in dementia care. The purpose of this mixed-methods study was to determine if simulation accurately captures elderspeak communication by nursing staff in hospital dementia care.
A 3-part mixed-methods design in which (1) three dementia care simulations were designed and validated by a panel of experts, (2) communication by nursing staff completing each simulation was quantitatively compared to communication during actual patient care, and (3) views on the realism were explored using within- and across-case coding.
Three simulations using different modalities (manikin, role-play, and standardised patient) were designed and validated with eight experts using the Lynn Method. Ten nursing staff were audio-recorded and their communication was coded for elderspeak communication. Results for each simulation were compared using Wilcoxon signed-rank test to recordings taken during actual dementia care encounters. Debriefings were coded for realism and results were converged.
The average time using elderspeak during naturalistic care was 29.9% (SD = 20.9%) which did not differ from the average amount of elderspeak used across the three simulations modalities which ranged from 29.1% to 30.4%. Qualitative results suggested a lack of realism with the manikin condition and the nursing staff indicated preference for the simulation with the standardised patient.
Communication elicited in the dementia care simulations was congruent to communication produced in actual dementia care but preference was for the standardised patient.
Elderspeak communication can be accurately produced in the simulated environment which indicates that simulation is a valid method for person-centred communication training in nursing staff.
Simulation offers a feasible modality to prepare nurses for challenges communicating with patients with dementia. Elderspeak communication is speech that sounds like baby talk and can lead to rejection of care by patients with dementia. However, it is unknown if simulation can be used to capture elderspeak communication in dementia care. Elderspeak communication captured in the simulated environment was congruent to communication nursing staff use during actual patient care to hospitalised persons living with dementia. This study empirically identifies that communication is elicited in similar patterns by nursing staff in the simulated environment compared to the naturalistic care environment which demonstrates that simulation can be used as a valid tool for education and research on person-centred communication.
STROBE.
No Patient or Public Contribution.