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

Annals of Internal Medicine, Ahead of Print.

Annals of Internal Medicine, Ahead of Print.

Pubblicato su Social Science Medicine, per l’Italia c’è Torino

Pubblicato su Social Science Medicine, per l’Italia c’è Torino

Introduction
Small for gestational age (SGA) infants are at increased risk of fetal distress in labour requiring emergency operative birth (by caesarean section (CS), vacuum or forceps). We have previously shown that maternal oral sildenafil citrate (SC) in labour halves the need for operative birth for suspected fetal distress in women with appropriately grown term infants.

Methods and analysis
RidStress 2 is a phase III randomised, double-blinded, placebo-controlled trial of 660 women with an SGA or suboptimally grown fetus (estimated fetal weight or abdominal circumference90% power to detect a similar reduction for the secondary outcome of any operative birth (CS or instrumental vaginal birth) for fetal distress.

Ethics and dissemination
Ethics approval was granted by the Mater Misericordiae Limited Human Research Ethics Committee (EC00332) on 11 September 2020. We plan to disseminate the results of this randomised controlled trial through presentations at scientific meetings and peer-reviewed journals, adhering to all relevant reporting guidelines.

Trial registration number
RidStress 2 is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12621000354886, 29/03/2021) and the Therapeutic Goods Association of Australia (date registered: 16 March 2021).

Introduction
Postoperative pancreatic fistula (POPF) occurs in 25% of patients undergoing a high-risk pancreatoduodenectomy (PD) and is a driving cause of major morbidity, mortality, prolonged hospital stay and increased costs after PD. There is a need for perioperative methods to decrease these risks. In recent studies, preoperative chemoradiotherapy in patients with pancreatic ductal adenocarcinoma (PDAC) reduced the rate of POPF seemingly due to radiation-induced pancreatic fibrosis. However, patients with a high risk of POPF mostly have a non-pancreatic periampullary tumour and do not receive radiotherapy. Prospective studies using radiotherapy specifically to reduce the risk of POPF have not been performed. We aim to assess the safety, feasibility and preliminary efficacy of preoperative stereotactic radiotherapy on the future pancreatic neck transection margin to reduce the rate of POPF.

Methods and analysis
In this multicentre, single-arm, phase II trial, we aim to assess the feasibility and safety of a single fraction of preoperative stereotactic radiotherapy (12 Gy) to a 4 cm area around the future pancreatic neck transection margin in patients at high risk of developing POPF after PD aimed to reduce the risk of grade B/C POPF. Adult patients scheduled for PD for malignant and premalignant periampullary tumours, excluding PDAC, with a pancreatic duct diameter ≤3 mm will be included in centres participating in the Dutch Pancreatic Cancer Group. The primary outcome is the safety and feasibility of single-dose preoperative stereotactic radiotherapy before PD. The most relevant secondary outcomes are grade B/C POPF and the difference in the extent of fibrosis between the radiated and non-radiated (uncinate margin) pancreas. Evaluation of endpoints will be performed after inclusion of 33 eligible patients.

Ethics and dissemination
Ethical approval was obtained by the Amsterdam UMC’s accredited Medical Research Ethics Committee (METC). All included patients are required to have provided written informed consent. The results of this trial will be used to determine the need for a randomised controlled phase III trial and submitted to a high-impact peer-reviewed medical journal regardless of the study outcome.

Trial registration number
NL72913 (Central Committee on Research involving Human Subjects Registry) and NCT05641233 (ClinicalTrials).

Newer ways of treating patients who have experienced an acute myocardial infarction (MI) over the past 20 years have reduced rates of sudden death, according to a recent study published in JAMA Cardiology.

Objective
Based on previous studies, urban-poor societies are very vulnerable to stunted children under five. The study aims to determine the appropriate policy targets to reduce the prevalence of stunted under-five children in urban-poor communities in Indonesia.

Design
A study was conducted using a secondary data analysis. The study analysed existing data from the 2022 Indonesian National Nutritional Status Survey.

Setting and participants
At the national level, Indonesia encompassed 43 284 toddlers.

Interventions
Non-intervention study.

Primary and secondary outcomes
The study’s eight independent factors were the mother’s age, education, marital status, employment, wealth, antenatal care (ANC), children’s age and sex, with nutritional status as the dependent variable. We employed a binary logistic regression test for the most recent exam.

Results
Maternal age was related to stunted toddlers in communities of urban poor in Indonesia. The lower the education, the higher the possibility of having stunted kids. Unemployed mothers were 1.153 times more likely than employed mothers to have stunted under-five children (95% CI 1.145 to 1.160). The poorest were 1.235 times more likely to get stunted under-five than the poorer (95% CI 1.227 to 1.242). Mothers without ANC during pregnancy were 1.212 times more likely to get stunted kids than those with ANC during pregnancy (95% CI 1.186 to 1.240). All kids’ ages were more probable than 0–11 to be stunted. Boys were 1.099 times more likely to be stunted than girls (AOR 1.099; 95% CI 1.093 to 1.105).

Conclusion
The appropriate policy targets to reduce the prevalence of stunted under-five children in urban-poor communities in Indonesia were younger mothers, those with poor education, those unemployed, the most impoverished, those without ANC, those with older under-five and those with boy kids.

Introduction
Very preterm babies are at risk of poor neurodevelopmental outcomes and death. Intraventricular haemorrhage (IVH) after birth is the most prevalent cause of this. Birth by caesarean section may protect against IVH in very preterm babies, but the evidence is limited. The aim is to identify and obtain the quantitative evidence needed to inform a future definitive clinical trial to determine the optimal mode of delivery in preterm birth.

Methods and analysis
We will use three broad workstreams (WS) to answer complementary questions. WSs 1 and 2 involve the analysis of routinely recorded national clinical data held in an established research database. In WS1 (October 2023–March 2024), we will use conventional methods to identify what is needed to undertake a trial: the population of interest, areas of equipoise and a plausible range of effect sizes. In WS2 (April 2024–October 2024), using an emulated target trial framework, we will attempt to make inferences about the treatment effect from such a future trial and will identify potential challenges in recruitment and estimate likely ‘intention-to-treat’ versus ‘per-protocol’ profiles; these analyses will also be useful for power calculations for future possible trials. In WS3 (October 2024–March 2025), we will convene a consensus meeting with key stakeholders, supported by a clinical trials unit, to develop a multicentre clinical trial to identify the optimal mode of birth for preterm deliveries.

Ethics and dissemination
In this study, we will use deidentified data held in the National Neonatal Research Database (NNRD), an established national population database; parents can opt out of their baby’s data being held in the NNRD. HRA/Health and Care Research Wales and National Health Service (NHS) study-specific Research Ethics Committee approval (London—Queen Square Research Ethics Committee) (Ref: 23/LO/0826) ethical approval has been obtained. Key outputs of the PRECIOUS (PREterm Caesarean/vaginal birth and IVH/OUutcomeS) study include the identification of the data, and accordingly of the multidisciplinary team required, to develop, gain funding and complete, a clinical trial to definitively identify the optimal mode of delivery for preterm infants and their mothers.

A comparison of 2 cardiovascular disease risk calculators found that the average 10-year risk of atherosclerotic cardiovascular disease for people with stage 1 hypertension was substantially lower when using the American Heart Association’s new PREVENT tool than when using the older Pooled Cohort Equations (PCEs)—2.9% compared with 5.4%. Considering 30-year total cardiovascular disease risk in addition to 10-year risk could better inform blood pressure treatment decisions by clinicians, according to the authors.

Stroke, Ahead of Print.

This JAMA Internal Medicine Patient Page describes what health misinformation is and how to find more reliable health information online.

Tecnologia dell’Università Carlo Bo esplora uso di globuli rossi

New England Journal of Medicine, Volume 391, Issue 8, Page 699-709, August 22/29, 2024.