Search Results for: Studio REDUCE-IT e appropriatezza prescrittiva degli acidi grassi omega-3

Agisce riducendo i livelli di molecole chiamate acidi biliari

Studio dell’Istituto nazionale tumori su terapia non chirurgica

Studio dell’Istituto nazionale tumori su terapia non chirurgica

Objectives
Patient and public involvement (PPI) was sought in the development of the protocol for the Cognitive Decline after Brain Radiosurgery (CoDe B-Rad) study, which aims to identify potential side effects of stereotactic radiosurgery (SRS). PPI served to refine the research question and methodology.

Design
PPI.

Setting
PPI conducted online with people based in the UK. The CoDe B-Rad study is running in regional National Health Service tertiary care in the UK and is currently nearing recruitment completion.

Participants
Patients and carers with lived experiences of brain radiotherapy. Contributors were identified through national charities.

Procedures
Initial focus groups were planned, but participation proved challenging. Instead, online questionnaires, one-to-one discussions and participation in support groups were completed.

Results
All contributors experienced changes to their cognition and/or quality of life (QoL) after radiotherapy. Quantifying the side effects of SRS and minimising them were identified as a research gap. Discussion group participation proved challenging. PPI plans were altered to accommodate the physical and mental needs of contributors. It was decided to combine the Montreal Cognitive Assessment along with European Organisation for Research and Treatment in Cancer QLQ-C30 and BN20 to capture cognitive status and QoL of patients with brain metastases and meningiomas after SRS. Patients/carers recommended for sessions to be restricted to 30 min and testing to be offered face-to-face, online, in hospital or at patients’ homes. Coproduction was not achievable with our patient population but that did not diminish the input of contributors nor the impact it had on designing the study protocol.

Conclusions
In cancer research, diligent considerations are required to ensure the suitability of involvement methods for this vulnerable population. Flexibility and adaptability of draft PPI plans are essential to achieve meaningful contributions. The protocol of the ongoing CoDe B-Rad study was positively shaped by people with lived experiences of brain radiotherapy.

Trial registration number
NCT06466720 (CoDe B-Rad study).

Objectives
Childhood vitamin D deficiency is a public health issue. This study aims to systematically evaluate vitamin D nutritional status among children and adolescents in Mainland China through a quantitative analysis of literature, providing evidence-based strategies for prevention.

Design
This is a systematic review and meta-analysis, conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

Data sources
A comprehensive search strategy was implemented across eight electronic databases (PubMed, Embase, Web of Science, Cochrane Library, CNKI, VIP, Wanfang and CBM) from inception to February 2024.

Eligibility criteria
We included cross-sectional studies that measured serum 25-hydroxyvitamin D levels and analysed influencing factors (eg, age, season, region) in healthy children and adolescents aged 0–18 years in Mainland China; studies reporting prevalence data of vitamin D deficiency/insufficiency based on standardised thresholds (deficiency

Introduction
Dental neglect in children and adolescents is a form of child maltreatment and can be an indicator of other forms of maltreatment. Early identification of dental neglect is essential to initiate preventive interventions and connect families to appropriate health and social services to avoid further harm and to reduce negative impacts on child development and well-being. Articles that systematically synthesise and compare models for early detection, intersectoral cooperation and care for dental neglect have not been published yet. This scoping review aims to map the evidence on strategies for the identification and prevention of dental neglect in children and adolescents.

Methods and analysis
The study is designed as a scoping review. Based on the Population, Concept and Context (PCC) scheme, the databases PubMed, PsycInfo and Scopus are searched for publications before July 2023. Publications in all languages will be considered in case an abstract in English or German is available. The review will include articles reporting on strategies for identification and prevention related to dental neglect in children and adolescents as conducted in health service and community settings. Data from included articles will be extracted to describe and categorise the available evidence. The review will follow recommendations of the Joanna Briggs Institute Reviewer’s Manual on scoping reviews and the Critical Appraisal Tool for Health Promotion and Prevention Reviews (CAT HPPR).

Ethics and dissemination
Ethical approval is not required, as no personal data will be collected in this literature-based study. The study’s findings will be disseminated through conference presentations, scientific publications and stakeholder meetings.

Introduction
Communication challenges are among the main barriers for people with intellectual disabilities in accessing palliative care. They include inadequate skills among staff and difficulties with confirming understanding and around the presentation and assessment of symptoms. In-depth analysis of interactions between people with an intellectual disability and staff may shed light on these communicative challenges as well as facilitators. However, no studies have closely analysed the interactions between people with an intellectual disability and professionals within palliative care settings.

Methods and analysis
This protocol describes a pilot study assessing the feasibility and acceptability of conducting a Conversation Analysis study involving video-recording palliative care conversations between people with intellectual disabilities and professionals.
Three conversations between patients with an intellectual disability, their companions and palliative care staff will be video recorded in a UK hospice. Recordings will be transcribed and analysed using Conversation Analysis. Communication phenomena of interest and worth further exploration will be identified in collaboration with key stakeholders.

Ethics and dissemination
The study received a favourable opinion by a UK research ethics committee in February 2025. All participants must provide informed consent to take part in the study. It will be carefully assessed that potential participants with an intellectual disability have capacity to consent to take part. Accessible study information materials for participants with an intellectual disability are available (ie, easy-read and video).
Study findings will be disseminated in academic papers and conference presentations. Progress and findings will also be shared via social media and with relevant groups of people with intellectual disabilities, family carers, service providers and academics.

Objective
There are no clearly defined family profiles with an overall view of the predictors of early childhood caries (ECCs). The aim of our study was to identify the profiles of families that are particularly affected by ECCs. We also examined the factors that can be acted on to promote oral health.

Design
In this single-centre cross-sectional study, the researchers examined the mouths of 300 children with caries and recorded the Decayed, Missing and Filled Teeth Index (dmft). These observations were supplemented by a questionnaire completed by the families, focusing in particular on their sociodemographic characteristics (e.g. age, parents’ professions and jobs, social assistance and family composition).

Setting
This work was conducted at Lille University Hospital between 2019 and 2024.

Participants
The participants included 300 caregiver-child dyads with children under the age of 6 years.

Primary and secondary outcome measures
Childhood Caries Index (dmft) and family characteristics associated with ECCs.

Statistical analyses
A multiple correspondence analysis was used, followed by a hierarchical clustering on principal components analysis, to identify the family profiles associated with ECC risk.

Result
Of the patients included in the study, 42% were girls, 58% were boys and their mean age was 4 years (±1.1 years). The mean dfmt index was 8.7 (±4.6); 77% of the participants had lesions on the smooth surfaces of the teeth, and 80% of the participants had a severe stage of caries disease. The analysis revealed three high-risk profiles based on the characteristics of the child’s mother and the family sibling composition. The first profile was larger families where the focal child was not the eldest. The second profile was families with foreign-born mothers and a low socioeconomic level. The third profile was families with mothers facing geographical and financial difficulties in accessing healthcare.

Conclusion
This study enabled us to identify the profiles of families at risk of caries. These at-risk profiles highlight the need to implement specific interventions acting at different levels and focused on oral health education in interprofessional practice during the key period of the first 1000 days of life. These factors could help to bridge the gap between oral health and general health, improve children’s oral health and reduce social health inequalities.

Ethics and dissemination
This human study has been ethically approved by the French Committee for the Protection of Individuals (N° 2019-A00827-50).

Trial registration number
The protocol is recorded on clinicaltrials.gov, with ID: NCT04195607.

A base di cellule pancreatiche derivate da staminali, studio 1/2

RZV vaccination is associated with a reduced risk of HZ among patients with RA aged 50 years and older. While we observed a reduction in all-cause mortality among RZV recipients, this finding should be interpreted with caution, as the effect size may not be entirely attributable to HZ prevention alone. Given the established efficacy of RZV in preventing HZ and its potential to reduce mortality, vaccination should be prioritized among eligible patients with RA.

Objective
For every 100 women having a vaginal birth, approximately four will experience a severe (third-degree or fourth-degree) perineal tear. Severe perineal tears are associated with significant short-term and long-term consequences if not recognised and repaired. There are global efforts to reduce incidence of severe perineal tears including initiatives to strengthen education and training of clinicians in perineal anatomy and perineal tear assessment and classification. This systematic review aimed to describe and evaluate the effectiveness of these initiatives.

Design
Systematic review, reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.

Data sources
Medline (Ovid), CINAHL Complete (EBSCO), MIDIRS and EMBASE (Ovid) were searched through 15 February 2024.

Eligibility criteria
Studies reporting simple or complex interventions aimed at improving the skills and knowledge of clinicians in perineal anatomy and/or the clinical assessment and classification of perineal tears were eligible.

Data extraction and synthesis
Two reviewers independently screened studies for eligibility and appraised the quality of individual studies using the Cochrane Risk of Bias (RoB) 2.0 tool or Risk of Bias in Non-Randomised Studies of Interventions (ROBINS-I) tool.

Results
In total, 7645 citations were screened and 39 studies included. We identified nine unique interventions including training programmes, short workshops and senior obstetrician supervision. Many studies were from high-income countries, in primary care settings and at high risk of bias.

Conclusions
Effective education included practical components, such as hands-on skills and training in perineal anatomy, assessment and classification, rather than senior supervision alone. Ongoing review of practice appears to be crucial for maintaining knowledge and skills. Future research should focus on interventions tailored to limited-resource settings, and the optimal length and intensity of training programmes to assess and classify perineal tears.

PROSPERO registration number
CRD42020185431.

Introduction
Individual participant data meta-analysis (IPD-MA) is regarded as the gold standard for evidence synthesis. However, diverse recommendations and guidance on its conduct exist, and there is no consensus-based tool for the critical appraisal of a completed IPD-MA. We aim to close this gap by systematically identifying quality items and developing and validating a critical appraisal checklist for IPD-MA.

Methods and analysis
This study will comprise three phases, as follows:
Phase 1: a systematic methodology review to identify potential checklist domains and items; this will be conducted according to the Cochrane methods for systematic reviews and reported following the Preferred Reporting Items for Systematic Reviews and Meta-analysis 2020 guidance. We will include studies that address methodological guides and essential statistical requirements for IPD-MA. We will use the proposed items to prepare a preliminary checklist for the e-Delphi study.
Phase 2: at least two rounds of an e-Delphi survey will be conducted among panels with expertise in IPD-MA research, consensus development, healthcare providers, journal editors, healthcare policymakers, patients and public partners from diverse geographic locations with experience in IPD-MA. Participants will use Qualtrics software to rate items on a 5-point Likert scale. The Wilcoxon matched signed rank test will estimate response stability across rounds. Consensus on including an item will be achieved if ≥75% of the panel rates the item as ‘strongly agree’ or ‘agree’ and items will be excluded if ≥75% rates it as ‘strongly disagree’ or ‘disagree’. A convenience sample of 10 reviewers with experience in conducting an IPD-MA will pilot-test the checklist to provide practical feedback that will be used to refine the checklist.
Phase 3: critical appraisal checklist validation: to improve confidence in the tool’s uptake, a subset of the e-Delphi participants and graduate students of epidemiology and biostatistics will conduct content validity and reliability testing, respectively, per the Consensus-based Standards for the Selection of Health Measurement Instruments.

Ethics and dissemination
Ethics approval has been obtained from the Western University Health Science Research Ethics Board in Canada. The validated checklist will be published in a peer-reviewed open-access journal and shared across the networks of this study’s steering committee, Cochrane IPD-MA group and the institutions’ social media platforms.

Background
 Machine Learning (ML) has been transformative in healthcare, enabling more precise diagnostics, personalised treatment regimens and enhanced patient care. In cardiology, ML plays a crucial role in risk prediction and patient stratification, particularly for heart failure (HF), a condition affecting over 64 million people globally and imposing an economic burden of approximately $108 billion annually. ML applications in HF include predictive analytics for risk assessment, identifying patient subgroups with varying prognoses and optimising treatment pathways. By accurately predicting the likelihood of hospitalisation and rehospitalisation, ML tools help tailor interventions, reduce hospital visits, improve patient outcomes and lower healthcare costs.

Objective
To conduct a comprehensive review of existing ML models designed to predict hospitalisation risk in individuals with HF.

Methods
A database search including PubMed, SCOPUS and Web of Science was conducted on 31 March 2024. Studies were selected based on inclusion criteria focusing on ML models predicting hospitalisation risks in adults with HF. The data from 27 studies meeting the criteria were extracted and analysed, with a focus on the predictive performance of the ML models and the presence of economic analysis.

Results
Most studies focused on predicting readmission rather than first-time hospitalisation. All included studies employed supervised ML algorithms, with ensemble-based methods generally yielding the highest predictive performance. For 30-day hospitalisation or readmission risk, Extreme Gradient Boosting (XGBoost) achieved the highest mean area under the curve (AUC) (0.69), followed by Naïve Bayes (0.68) and Deep Unified Networks (0.66). For 90-day risk, the best-performing models were Least Absolute Shrinkage and Selection Operator and Gradient Boosting, both with a mean AUC of 0.75, followed by Random Forest (0.67). When the prediction timeframe was unspecified, Categorical Boosting achieved the highest performance with a mean AUC of 0.88, followed by Generalised Linear Model Net and XGBoost (both 0.79).
Electronic health records were the primary data source across studies; however, few models included patient-reported outcomes or socioeconomic variables.
None of the studies conducted an economic evaluation to assess the cost-effectiveness of these models.

Conclusions
ML holds substantial potential for improving HF care. However, further efforts are needed to enhance the generalisation of models, integrate diverse data sources and evaluate the cost-effectiveness of these technologies.

Introduction
Ischaemia–reperfusion (I/R) injury remains a major challenge in heart transplantation, with mortality risk increasing significantly when allograft ischaemic time exceeds 4 hours. Non-ischaemic heart preservation (NIHP), using continuous hypothermic perfusion, has shown promise in preliminary studies for reducing I/R injury and improving outcomes. This randomised controlled trial aims to compare NIHP with standard static cold storage (SCS) in adult heart transplantation.

Methods and analysis
The trial is a prospective, open-label, multicentre, single-blinded, randomised controlled trial including 66 adult heart transplant recipients across four Swedish hospitals. Participants will be randomised into 1:1 ratio to NIHP or SCS preservation groups and undergo a 12-month follow-up period. The primary outcome is 1-year survival free from acute cellular rejection or retransplantation. Secondary outcomes include quality of life, I/R injury markers, graft function and adverse events. Substudies will evaluate renal function using MRI and continuously monitor physical activity and heart rhythm via wearable devices. Analysis will follow intention-to-treat principles, with time-to-event analysis using Cox proportional hazard models and Kaplan-Meier estimates.

Ethics and dissemination
The study has been approved by the Swedish Ethical Review Authority. It will be conducted according to the Declaration of Helsinki and relevant local and international regulations. Results will be published in peer-reviewed journals following Consolidated Standards of Reporting Trials guidelines.

Trial registration number
NCT04066127.

Introduction
The Belgian healthcare system is to a large extent hospital-centred, prompting government initiatives to shift care towards patient’s homes and reduce hospital stays. To avoid unnecessary hospital stays and offer alternative and innovative forms of care, the Belgian federal health authorities selected five pilot projects for transmural care for chronically ill children. Guided by the Medical Research Council framework, this study aims to evaluate the paediatric transmural care projects to inform new models for paediatric care.

Methods and analysis
Using a mixed-methods realist evaluation, the study comprises three phases: (1) initial programme theory development, (2) initial programme theory testing and (3) programme theory refinement. In a first phase, the initial programme theory rooted in the normalisation process theory will be refined from insights retrieved from document review and focus group interviews with healthcare professionals. In the second phase, the initial programme theory will be tested using empirical data. Routine data and questionnaires will examine whether characteristics of participants and outcomes are in line with the quintuple aim framework. Focus groups with children, parents and stakeholders, and document analysis will be used to evaluate the structure of the intervention, examine the process and context, and understand more in-depth the outcomes. A budget impact analysis will be used to assess whether the pilot project is affordable. In a third phase, qualitative and quantitative data will be analysed using a convergent mixed-methods model, involving continuous triangulation of multiple data sets to facilitate greater understanding of the context and refinement of the programme theory.

Ethics and dissemination
The study protocol was reviewed and approved by the Ethics Committee of the Ghent University Hospital (Belgian Registration Number B6702024000193) after consultation with all Ethics Committees of the participating hospitals. Written informed consent will be obtained from participants or their legal representatives prior to data collection. Participant confidentiality will be maintained throughout the study. Study results will be published in international peer-reviewed journals and will be presented at national and international conferences. The general population will be informed of the aggregated results.

Trial registration number
ClinicalTrials.gov, NCT06679595.

Introduction
Potassium-enriched salt substitutes have favourable effects on blood pressure, but it has not been tested in Iran. The present protocol is a double-blinded, randomised-controlled trial designed to investigate the effects of potassium-enriched salt substitutes on blood pressure in Iranian hypertensive patients.

Methods and analysis
The primary objectives are to determine the effects on systolic and diastolic blood pressure at 3 months and 6 months. The secondary objectives are to assess the effects on serum levels of potassium, sodium, urea and creatinine; the urinary ratio of sodium to potassium; participants’ attitudes toward the use of salt or salt substitutes; the recurrence of hypertensive crisis; and the occurrence and/or reoccurrence of strokes, transient ischaemic attack and cardiovascular accidents. Eligible individuals will receive the usual salt (100% sodium chloride) in the control group or salt substitute (70% sodium chloride and 30% potassium chloride) in the intervention group. A total of 500 hypertensive participants aged 40–65 years will be recruited and randomised to intervention or control groups. Potassium-enriched salt substitution in Iran will be considered to improve CVD complications and prevent deaths. Continuous and categorical baseline characteristics will be tested using the independent t-test and 2 test. The effect of the intervention on primary and secondary outcomes will be assessed using the intention-to-treat method and two-way mixed ANOVA models.

Ethics and dissemination
This study has been approved by Alborz University of Medical Sciences (0-0-103-6369) and has received ethics approval (IR.ABZUMS.REC.1402.293). We will publish our study findings for peer-reviewed publications, conference presentations and digital stories.

Trial registration number
IRCT20240121060757N1.