Risultati per: Studio REDUCE-IT e appropriatezza prescrittiva degli acidi grassi omega-3

Introduction
In the UK, approximately 300 infants each year die suddenly and unexpectedly, with most deaths remaining unexplained. Population-wide ‘Safer Sleep’ messages have brought rates down but remaining deaths now predominantly occur within families experiencing poverty. Many of these deaths may be preventable as the majority have known, avoidable risks present. New resources and tools for health professionals and families have been developed to address modifiable barriers to implementing safer sleep advice in this priority group of families. This study aims to understand how the Baby Sleep Project resources work to improve the uptake of safer sleep advice, including for whom, and in what contexts they work best.

Methods and analysis
Realist evaluation will be used, including both qualitative and quantitative methods. Data will be collected both pre- and post-health professional training in the new resources. We will invite neonatal staff, health visitors and family nurse partnerships nurses, and primary caregivers of infants to take part. We will carry out qualitative interviews with health professionals and caregivers. Quantitative surveys looking at implementation for health professionals, changes in infant care knowledge and practice, and parenting self-efficacy will be conducted with caregivers. Mechanisms of action, contexts and outcomes from the new resources will be tested against the initial programme theory. The findings from this research will inform evidence-based explanations of how to improve the uptake of health advice in priority populations.

Ethics and dissemination
The study was given a favourable opinion by the South West—Frenchay Research Ethics Committee (ref: 23/SW/0119). We will publish our findings in academic journals and talk about them at conferences. We will make sure the people who took part in the study hear about them first. If the resources are shown to be useful, we will work with charities and the National Health Service to roll them out across the whole of the UK.

Trial registration number
ISRCTN3364337.

Objectives
Incontrovertible evidence surrounds the need to support healthcare professionals after patient safety incidents (PSIs). However, what characterises effective organisational support is less clearly understood and defined. This review aims to determine what support healthcare professionals want for coping with PSIs, what support interventions/approaches are currently available and which have evidence for effectiveness.

Design
Systematic research review with narrative synthesis.

Data sources
Medline, Scopus, PubMed and Web of Science databases (from 2010 to mid-2021; updated December 2022), reference lists of eligible articles and Connected Papers software.

Eligibility criteria for selecting studies
Empirical studies (1) containing information about support frontline healthcare staff want before/after a PSI, OR addressing (2) support currently available, OR (3) the effectiveness of support to help prevent/alleviate consequences of a PSI. Study quality was appraised using the Quality Assessment for Diverse Studies tool.

Results
Ninety-nine studies were identified. Staff most wanted: peer support (n=28), practical support and guidance (n=27) and professional mental health support (n=21). They mostly received: peer support (n=46), managerial support (n=23) and some form of debrief (n=15). Reports of poor PSI support were common. Eleven studies examined intervention effectiveness. Evidence was positive for the effectiveness of preventive/preparatory interventions (n=3), but mixed for peer support programmes designed to alleviate harmful consequences after PSIs (n=8). Study quality varied.

Conclusions
Beyond peer support, organisational support for PSIs appears to be misaligned with staff desires. Gaps exist in providing preparatory/preventive interventions and practical support and guidance. Reliable effectiveness data are lacking. Very few studies incorporated comparison groups or randomisation; most used self-report measures. Despite inconclusive evidence, formal peer support programmes dominate. This review illustrates a critical need to fund robust PSI-related intervention effectiveness studies to provide organisations with the evidence they need to make informed decisions when building PSI support programmes.

PROSPERO registration number
CRD42022325796.

Introduction
Despite the known health and educational benefits of physical activity and the risks of prolonged sedentary behaviour, only one in 10 adolescents globally meet physical activity guidelines, and three-quarters of the school day is spent sitting. TransformUs, an effective and cost-effective whole-of-school programme for promoting primary school children’s physical activity and reducing sedentary behaviour, has been adapted for secondary schools (TransformUs Secondary). The aim of this paper is to describe the protocol for TransformUs Secondary in relation to implementation and scale-up across Australia, and the real-world effectiveness of the intervention on adolescents’ physical activity and sedentary time, as well as sitting time, sleep, well-being and class and school engagement.

Methods and analysis
A type II hybrid implementation-effectiveness trial will be conducted using a mixed-methods design. For the implementation trial, TransformUs Secondary will be disseminated via key organisations nationally (eg, state departments of education) and available to all Australian secondary schools (n=1453). Implementation outcomes will be evaluated using the RE-AIM framework (reach, adoption, implementation and maintenance). Data will be collected at the school and teacher levels via the TransformUs website (website analytics), descriptive quantitative surveys, text messages to teachers and qualitative interviews with teachers, students and representatives from key organisations. Descriptive statistics will summarise quantitative data, with regression analyses examining the associations between implementation strategies and outcomes. Implementation levels will be classified as low, moderate or high based on the extent of intervention delivery. Qualitative data will be thematically analysed.
We will assess effectiveness outcomes in 10 Victorian secondary schools using a pragmatic 1:1 waitlist control design. The target sample is 600 Year 7–10 students (12–16 years). Primary outcomes include adolescents’ physical activity and sedentary time (assessed with accelerometry), and secondary outcomes include health (sleep and well-being), class and school engagement (on-task behaviour assessed via classroom observation and school attendance) and sitting time (assessed with posture monitors). Descriptive analyses will summarise students’ demographics, physical activity, sedentary behaviour and engagement, while mixed models will evaluate intervention effects on these outcomes, adjusted for confounders. Additionally, qualitative data will be thematically analysed using deductive and inductive coding in NVivo.

Ethics and dissemination
These trials were approved by the Deakin University Human Research Ethics Committee (2021–269) and by the following education authorities: Australian Capital Territory Education Directorate (RES 2317), New South Wales Department of Education (2022253), Northern Territory Department of Education (20865), Victoria Department of Education (2023_004712), Queensland Department of Education (550/27/2585), South Australian Department of Education (2022–0019), Tasmanian Department of Education (2022–25), Western Australian Department of Education (D23/1152724), and Melbourne Archdiocese Catholic Schools (1232). Results from this study will be disseminated through peer-reviewed journal articles, scientific conferences, summary reports to students and schools and stakeholder meetings.

Trial registration number
Australian Clinical Trials Registration Registry (ACTRN12622000600741).

Introduction
Heavy alcohol use has the potential to derail progress towards UNAIDS 95-95-95 targets for countries in sub-Saharan Africa (SSA). Within couples, alcohol use is closely linked with factors such as intimate partner violence and economic insecurity and can result in poor adherence to antiretroviral therapy (ART) and HIV clinical outcomes. We hypothesise that a combined economic and relationship intervention for couples that builds on the prior success of standalone economic and relationship-strengthening interventions will be efficacious for improving HIV clinical outcomes and reducing alcohol use. The synergy of these interventions has not been assessed in SSA—specifically among people living with HIV who drink alcohol. To test this hypothesis, we will test Mlambe, an economic and relationship-strengthening intervention, found to be feasible and acceptable in a pilot study in Malawi. We will conduct a full-scale, randomised controlled trial (RCT) to evaluate the efficacy and cost-effectiveness of Mlambe.

Methods and analysis
We will enrol 250 adult married couples having at least one partner living with HIV and reporting heavy alcohol use. There will be two arms: Mlambe or an enhanced usual care control arm. Couples in the Mlambe arm will receive incentivised matched savings accounts and monthly sessions on financial literacy, relationship skills, and alcohol reduction education and counselling. Participants will be assessed at baseline, 11 months, 15 months and 20 months to examine effects on heavy alcohol use, HIV viral suppression, ART adherence and couple relationship dynamics. Study hypotheses will be tested using multilevel regression models, considering time points and treatment arms. Programmatic costs will be ascertained throughout the study and incremental cost-effectiveness ratios will be computed for each arm.

Ethics and dissemination
The RCT has been approved by the University of California, San Francisco (UCSF) (Human Research Protection Program; Protocol Number 23-40642), and the study has been approved by the National Health Sciences Research Committee (NHSRC; Protocol Number 24/05/4431) in Malawi. Adverse events and remedial actions will be reported to authorities both in Malawi and at UCSF. Results will be disseminated to study participants, local health officials and HIV policy makers and through presentations at conferences and publications in peer-reviewed journals.

Trial registration number
ClinicalTrials.gov Protocol Registration; NCT06367348 registered on 19 April 2024; https://register.clinicaltrials.gov/. Protocol Version 1.0: 22 October 2024.

Introduction
Individuals with stroke are at risk of long-term overweight and obesity due to biopsychosocial factors. Being overweight and obese is associated with an increased risk of numerous chronic conditions, including recurrent stroke. Unfortunately, recommendations for nutritional interventions vary. The objective of this scoping review is to identify and map the body of literature on professional nutritional interventions aimed at preventing or reducing overweight and obesity during postacute stroke rehabilitation.

Methods and analysis
The review follows the Joanna Briggs Institute methodology for scoping reviews. A three-step librarian-assisted search strategy will be conducted using the bibliographic databases MEDLINE (PubMed), Embase, CINAHL and Web of Science. Indexed and grey literature in English and Scandinavian languages, from January 2010 to the present, will be considered for inclusion. The scoping review will include materials such as research articles, methodological papers and clinical guidelines that report on nutritional interventions aimed at preventing or reducing overweight and obesity among individuals with stroke (aged ≥18 years) from admission to rehabilitation hospitals. We will map and identify any kind of nutritional intervention in rehabilitation hospitals, nursing homes or their own environments in high-income countries. Two independent reviewers will conduct an iterative process for screening the identified literature, paper selection and data extraction. Disagreements will be resolved through discussion or with an additional reviewer. A data extraction form will be used to guide the data extraction.

Ethics and dissemination
This review will involve the collection and analysis of secondary sources that have been published and/or are publicly available. Therefore, ethical approval is not required. The results will be published in an international peer-reviewed journal, presented at scientific conferences and disseminated through digital science communication platforms.

Trial registration number
The protocol is registered in the Open Science Framework: https://osf.io/ga63n/view_only=ee07beace7bb48d6b9c82cbf79cf2e95.

Annals of Internal Medicine, Volume 178, Issue 2, Page JC23, February 2025.

Annals of Internal Medicine, Ahead of Print.

pearls slipping off a string, one slick diver followed by another, round and containing light, pried from a cool oyster shell and brought out to swelter in summer,

Introduction
The PRIME-UK randomised controlled trial (RCT) aims to establish whether a model of care that seeks to be proactive, integrated and empower participants, caregivers and healthcare professionals can improve outcomes in people with parkinsonism. Given that this intervention is novel and complex, understanding whether and how the intervention will be acceptable, implementable, cost-effective and scalable across contexts are key questions beyond that of whether ‘it works’. We describe an embedded process evaluation to answer these questions, which aims to support interpretation of the trial results, refinement of the intervention and support future scaling of the PRIME-Parkinson model of care.

Methods and analysis
A mixed-methods approach will be used to collect data across four process evaluation domains: implementation, mechanism of change, acceptability and context. Quantitative data will be collected prospectively from all participants and analysed descriptively with exploratory tests of relationships as power allows. Qualitative data will be collected through semistructured interviews with a purposively sampled subpopulation of participants, caregivers and staff members as well as case studies where relevant. Interview transcripts will be analysed thematically using interpretive qualitative analysis. Synthesis of quantitative and qualitative data will also be performed to draw conclusions.

Ethics and dissemination
The quantitative data will be collected as part of the main PRIME-UK RCT which was been granted NHS REC approval (21/LO/0387) on 27 July 2021. The qualitative data will be collected as part of a substudy, ‘PRIME-Qual’, which was granted NHS REC approval (21/LO/0388) on 14 July 2021. The mixed-methods process evaluation will be published after the conclusion of the trial in addition to the main trial findings.

Trial registration number
NCT05127057.

Introduction
Only 30%–50% of people referred to clinics during community-based eye screening are able to access care in Botswana, India, Kenya and Nepal. The access rate is even lower for certain population groups. This platform trial aims to test multiple, iterative, low-risk public health interventions and simple service modifications with a series of individual randomised controlled trials (RCT) conducted in each country, with the aim of increasing the proportion of people attending.

Methods and analysis
We will set up a platform trial in each country to govern the running of a series of pragmatic, adaptive, embedded, parallel, multiarm, superiority RCTs to test a series of service modifications suggested by intended service users. The aim is to identify serial marginal gains that cumulatively result in large improvements to equity and access. The primary outcome will be the probability of accessing treatment among the population group with the worst access at baseline. We will calculate Bayesian posterior probabilities of clinic attendance in each arm every 72 hours. Each RCT will continually recruit participants until the following default stopping rules have been met: >95% probability that one arm is best; >95% probability that the difference between the best arm and the arms remaining in the trial is

This randomized clinical trial compares the effectiveness of an integrated pain team vs pharmacist collaborative management on pain and opioid dosage.

Circulation, Ahead of Print. BACKGROUND:Patients with acute myocardial infarction and angiographically obstructive non-culprit lesions are at high risk for recurrent major adverse cardiac events (MACEs). However, it remains largely unknown whether events are due to stenosis severity or due to the underlying high-risk lesion morphology.METHODS:Between January 2017 and December 2021, 1312 patients with acute myocardial infarction underwent optical coherence tomography of all the 3 main epicardial arteries after successful percutaneous coronary intervention. Patients and lesions were categorized according to the presence or absence of (1) 1 or more non-culprit angiographic obstructive stenoses with a visual diameter stenosis of ≥50% and (2) 1 or more lesions with an underlying high-risk morphology defined as an optical coherence tomography thin-cap fibroatheroma (TCFA). Patients were followed for up to 5 years (median 4.1 [interquartile range: 3.0–5.0] years). MACEs comprised cardiac death, non-fatal myocardial infarction, and unplanned coronary revascularization.RESULTS:Overall, 492 patients had at least 1 obstructive non-culprit lesion, 352 had a single lesion, and 140 had multiple obstructive non-culprit lesions. The presence and number of angiographic obstructive non-culprit lesions correlated with the proportion and number of optical coherence tomography–derived TCFAs. At the lesion level, the prevalence of TCFA was twice as high in obstructive lesions compared with nonobstructive lesions. Patients with obstructive non-culprit lesions had an increased risk of overall MACEs (17.7% versus 12.8%; hazard ratio, 1.39 [95% CI, 1.02–1.91]) and non-culprit lesion–related MACEs (8.7% versus 3.9%; HR, 2.13 [95% CI, 1.26–3.59). Results were similar when patients were categorized on the basis of the underlying TCFA. A proportionally higher rate of overall and non-culprit lesion–related MACEs was observed as the number of obstructive stenoses or TCFAs in non-culprit segments increased. The lesion-specific HRs for obstructive lesion and TCFA were 2.03 (95% CI, 1.06–3.89) and 2.39 (95% CI, 1.29–4.43), respectively. Optical coherence tomography–derived TCFA, but not angiographic obstructive stenosis, was independently predictive of recurrent MACEs in both patient-level and lesion-level multivariable models in which these 2 characteristics were introduced simultaneously.CONCLUSIONS:The long-term prognostic implications of the presence and extent of angiographic obstructive non-culprit lesions in patients with acute myocardial infarction are primarily due to their correlation with the underlying high-risk morphology, which confers an increased risk of recurrent MACEs.

Stroke, Volume 56, Issue Suppl_1, Page ATP144-ATP144, February 1, 2025. Introduction:Limiting the rate of unplanned emergency department (ED) revisits for patients with acute ischemic stroke is an important aspect of secondary stroke prevention. This is influenced by patients’ demographics, comorbidities, stroke severity, disposition destination, and may be impacted by early outpatient follow-up where stroke risk factors and etiology continue to be evaluated.Methods:We retrospectively identified all acute ischemic stroke patients discharged from an 11-hospital network, the largest healthcare system in the state of Georgia, from October 1, 2022 to March 31, 2024; we excluded patients who were discharged to a long-term acute care or hospice facility. Baseline characteristics, inpatient metrics and post-discharge outpatient follow-up were assessed to identify factors associated with ED visits within 30- and 90-days after discharge.Results:Of 2,191 patients, 143 (6.5%) had ED visits within 30 days and 296 (13.5%) within 90 days. The median age was 68 [IQR 57, 77]. History of heart failure (HF), atrial fibrillation (AF), chronic kidney disease and end stage renal disease each increased the likelihood of an ED re-visit within 30 and 90 days whereas diabetes mellitus increased the likelihood of an ED re-visit at 90 days only. In multiple logistic regression analyses, factors independently associated with 30-day ED visit was a history of HF (OR 1.57, 95% CI 1.07-2.28; p=0.02) and AF (OR 1.49, 95% CI 1.00-2.19; p=0.04); at 90 days, only an increased Charlson Comorbidity Index score was associated with ED visit (OR 1.09, 95% CI 1.02-1.16; p=0.01). There were 501 (23%) patients who completed an outpatient neurology clinic follow-up within 30 days of discharge, including 81 patients (4%) who completed a telemedicine outpatient visit; patients completing a telemedicine visit were less likely to have a 30-day ED visit than those who had an in-person visit (OR= 0.13, 95% CI 0.01-0.62; p=0.05).Conclusion:ED revisits after hospitalization for acute ischemic stroke are relatively common and associated with patients who have comorbid conditions including HF and AF. Our study suggests that telemedicine-based follow-ups were associated with lower rates of unplanned ED revisits within 30 days. Efforts to increase outpatient neurology clinic access through telemedicine may reduce ED visits after discharge for acute ischemic stroke patients.

Stroke, Volume 56, Issue Suppl_1, Page AWP14-AWP14, February 1, 2025. Introduction:The use of IV thrombolysis (IVT) in acute ischemic stroke patients presenting with an NIHSS of ≤ 5 has failed to demonstrate benefit, particularly when the symptoms are considered non-disabling. This critical disability distinction, however, is often made subjectively by the treating physician at the bedside. This may complicate and delay decision-making or lead to unnecessary dosing of thrombolytic agents, especially when symptoms such as paresis, visual field loss (VFL), or aphasia are present, despite having no impact on clinical outcome.HypothesisThe implementation of an objective scoring system, as used in the ARAMIS Trial, utilizing non-disabling NIHSS individual sub-score cut-offs (NdSSC) [≤ 1 for single limb weakness, aphasia, VFL and neglect] will reduce excess utilization of IVT in this patient population.Methods:This single-center, retrospective cohort study included IVT candidates with an NIHSS ≤ 5, either in-person or via tele-stroke, from 2019 to 2023. Baseline characteristics were compared between those treated and not treated based solely on an exclusion of “mild non-disabling symptoms.” A logistic regression analysis was performed to identify any variables influencing this treatment decision. Potential excess utilization of IVT was determined by applying objective NdSSC criteria to patients who received IVT, and the Kappa statistic was calculated to evaluate agreement.Results:A total of 2,565 patients were included in the analysis, with 47.2% (n = 1210) receiving IVT. 72.4% (876/1210) of these patients who received IVT would not have been recommended for therapy under the NdSSC Criteria. In the overall population, a net total 32.8% more patients received lytic therapy than would have been recommended under the NdSSC Criteria. (Kappa = 0.26 [95% CI 0.23 – 0.29]) (Table 1). Adjusted analyses did not show any significant effect on treatment decision for age, race, time of day, tele-stroke vs. in-house, paresis, aphasia, visual loss, and neglect (Table 2).Conclusion:In acute ischemic stroke patients with an NIHSS ≤ 5, using standard of care, subjective decision-making, compared to objective criteria, led to a potential excess use of IVT in over 30% of cases.

Stroke, Volume 56, Issue Suppl_1, Page AWP84-AWP84, February 1, 2025. Purpose:Decreasing door to needle and door to transfer times drives patient outcomes. When treating acute stroke patients, time is brain. The shorter the door to treatment time the faster patients can receive the thrombolytic therapy. The rapidly evolving use of telemedicine in acute stroke is state-of-the-art for identifying therapeutic indications such as IV thrombolysis and mechanical thrombectomy in patients with large vessel occlusion (LVO) (Schröter et al., 2023).Method:Our facility is a Joint Commission certified Primary Stroke Center with two Acute Stroke Ready certified freestanding emergency departments (ED), caring for >67,000 patients a year with >700 being diagnosed with stroke. In 2023 our EDs transferred 35 patients with an LVO and 21 year to date in 2024.A review of data illustrated an opportunity with our teleneurology program, staffed by an internal team of neurologists from our comprehensive stroke center. The development of the teleneurology program began at our health system in March 2021. ED providers had the ability to consult teleneurology, via telephone or video consult. When first launched, the new process was inconsistent.Through ongoing chart audits, we identified ED providers were reliant on the recommendations from the teleneurologists. Upon review, a barrier to care was identified which caused delays in door to decision. In November 2023, we implemented a new stroke alert process, mandating that all stroke alert activations automatically received a teleneurology consult. By refining the process, we have demonstrated improvements in our door to needle and door to transfer times. Since the therapeutic success is strongly dependent on time, an early, accurate decision-making process is essential for timely transfer of the patient to a mechanical thrombectomy-competent center for appropriate stroke-oriented imaging and therapy (Schröter et al., 2023).Results:Post-implementation, our door in door out times decreased by 20% within eight months. Our median door in door out time decreased by 22.5 minutes. Of the LVO’s we have transferred, five patients were transferred in

Stroke, Volume 56, Issue Suppl_1, Page AWP117-AWP117, February 1, 2025. Background and Aims:Non-invasive, frequency-tuned, low-intensity electromagnetic network targeting field (ENTF) stimulation therapy has shown signals of reducing global disability at 90 days post-stroke in subacute ischaemic stroke patients with moderate-severe disability and upper-extremity impairment in the EMAGINE 1 randomized trial, but the pace of potential response has not been delineated.Methods:We conducted a multicenter, double-blind, randomized, sham-controlled, trial enrolling participants 4-21 days post-stroke with baseline modified Rankin Scale 3-4 and Fugl-Meyer Assessment Upper-Extremity 10-45. Participants were allocated to active or sham treatment, of stimulation paired with an evidence-based, functional, repetitive, home-based physical exercises regimen for 45 one-hour sessions, five times per week within the first 90 days from stroke. Global disability mRS was assessed at baseline, day 45, and day 90.Results:Participant age was 59.0 (+12.5), 33% were female, and study treatment was initiated at day 14 (IQR 12-19) post-stroke. The evolution of mRS distribution in the active and sham stimulation groups is shown in the Figure. At day 45, there was evidence of potential treatment benefit for functional independence (mRS 0-2, active vs sham 50% vs 35%, adjusted p=0.05) though not in freedom-from-disability (mRS 0-1, 5% vs 2%). By day 90, after further recovery in both treatment groups, there was evidence of potential treatment benefit for both freedom-from-disability (mRS 0-1, 26% vs 11%, adjusted p=0.03) and functional independence (mRS 0-2, 83% vs 74%, p=0.13). Shift on the mRS trichotomized at 0-1/2/3-6 similarly showed signals of benefit at day 45 (adjusted p=0.07) in addition to day 90 (adjusted p=0.02).Conclusion:ENTF therapy showed safety and preliminary efficacy in reducing global disability among subacute ischaemic stroke patients with severe baseline disability, with potential benefit accruing at mRS 0-2 by day 45 and at both mRS 0-1 and 0-2 by day 90. These results require confirmation in an adequately powered prospective trial.