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

In Reply We appreciate the Letter from Osinski et al regarding our investigation of the overtreatment of prostate cancer among men with limited longevity. We recognize the uncertainties in risk stratification that limit the application of population-based estimates of life expectancy to an individual patient. Given these concerns, it is important to note that in population-based analyses, there will be a minority of patients that drastically outlive their estimated life expectancy and may derive meaningful benefit from treatment. Similarly, there will be men with longer life expectancy that do not live long enough to benefit from treatment. Yet, treatment decisions should be driven by evidence-based factors predicting when the vast majority of patients will or will not benefit from treatment.

The Letter to the Editor titled “Challenges in Shared Care Research in Hematopoietic Cell Transplant,” published online on May 15, 2025, and in the July 2025 issue, was corrected to fix an error in the text. Specifically, where it previously read “there were fewer responders at day 100 (5%) compared with day 180,” it now correctly reads “there were fewer responders at day 100 (60.5%) compared with day 180.” This article was corrected online.

Background
Electroconvulsive therapy (ECT) is an established treatment for depression and mania, with its therapeutic effect deriving from the induced seizure rather than the electrical stimulus itself. Anaesthetic agents are routinely used to reduce procedural discomfort, requiring assisted ventilation. However, these agents may raise the seizure threshold, necessitating higher stimulus doses and potentially increasing adverse effects. Although various strategies have been explored, pre-ECT hyperventilation—despite its known ability to lower the seizure threshold—remains insufficiently investigated. This review aims to examine the various ventilation approaches employed during anaesthesia for ECT, assess how hyperventilation has been applied to augment ECT, explore their impact on clinical outcomes and identify the outcome parameters most frequently investigated in ECT studies.

Methods
The reporting of the scoping review will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines. A comprehensive literature search will be conducted in Medline, EMBASE, Scopus and PsycINFO. Grey literature, along with national and international guidelines, will also be included. Studies investigating any form of ventilation during anaesthesia for ECT will be included. An information specialist and a medical librarian will support the development and refinement of the search strategy. Two reviewers will independently screen eligible studies and perform data extraction according to predefined headings. Disagreements will be resolved by a third reviewer. Data will be organised under the following headings: details of the included studies, ventilation strategies investigated, outcome measures studied. Results will be presented narratively and in table form and discussed in relation to the relevant literature.

Ethics and dissemination
Ethical approval is not necessary, as the review synthesises evidence from the existing literature. The results will be disseminated through publication in a peer-reviewed journal and presentation at relevant academic conferences. Findings will also be shared with ECT clinicians to support clinical awareness and inform practice.

Objectives
The inflammatory response from acute infection may trigger cardiovascular events. We aimed to estimate associations between microbiologically confirmed urinary tract infections (UTIs) and first acute myocardial infarction (MI) and stroke.

Design
We used a self-controlled case series, with risk periods 1–7, 8–14, 15–28 and 29–90 days after UTI. Included individuals experienced the outcome and exposure of interest and acted as their own controls.

Setting
We used individually linked general practice, hospital admission and microbiology data for the population of Wales held by the Secure Anonymised Information Linkage databank.

Participants
Included individuals were Welsh residents aged over 30 years with a record of a hospital admission for MI or stroke (outcomes) and evidence of a microbiologically confirmed UTI (exposure) during the study period of 1 January 2010 to 31 December 2020.

Main outcome measures
The primary outcome was acute MI or stroke identified using the International Classification of Disease V.10 codes from inpatient diagnoses recorded in the Patient Episode Database for Wales. We used Poisson regression to estimate incidence rate ratios (IRRs) and 95% CIs for MI and stroke during predefined risk periods, compared with baseline periods.

Results
During the study period, 51 660 individuals had a hospital admission for MI, of whom 2320 (4.5%) had 3900 microbiologically confirmed UTIs, and 58 150 had a hospital admission for stroke, of whom 2840 (4.9%) had 4600 microbiologically confirmed UTIs. There were 120 MIs during risk periods and 2190 during baseline periods, with an increased risk of MI for 1–7 days following UTI (IRR 2.49, 95% CI (1.65 to 3.77)). There were 200 strokes during risk periods and 2640 during baseline periods, with an increased risk of stroke for 1–7 days following UTI (IRR 2.34, 95% CI (1.61 to 3.40)).

Conclusions
UTI may be a trigger for MI or stroke. Further work is needed to understand mechanisms and test interventions to reduce the risk of cardiovascular events among people with UTIs in primary care.

Introduction
Previous studies have pointed out that persistent cough is a common complication after pulmonary resection and its occurrence is closely related to inflammatory response. However, there are no clinical studies to date that directly verify that the use of non-steroidal anti-inflammatory drugs (NSAIDs) can reduce the incidence of persistent cough after pulmonary resection (CAP). In view of this, this study aimed to explore and confirm whether exposure to NSAIDs can effectively reduce the incidence of CAP through a prospective cohort study.

Methods and analysis
We will conduct a single-centre, prospective cohort comparative study to investigate the impact of NSAIDs use on persistent cough after video-assisted thoracoscopic (VATS) lung resection surgery. The study will include all patients without preoperative cough symptoms who are scheduled for VATS lung resection. These patients will be divided into exposed and non-exposed groups according to whether they used NSAIDs after surgery. The primary outcome measures of this study are the incidence of CAP and the association between NSAIDs exposure and the incidence of CAP in patients undergoing VATS lung resection, while the secondary outcome parameter was set as severity of cough.

Ethics and dissemination
This research was approved by the Ethics Committee of the 920th Hospital of the Joint Logistics Support Force of the Chinese People’s Liberation Army (2024-041-01). The study findings will be published in peer-reviewed journals and presented at professional conferences.

Trial registration number
NCT06476249.

Objectives
The Idea, Development, Evaluation, Assessment and Long-term follow-up (IDEAL) framework was designed to improve the quality of surgical research and evaluation of surgical innovation. It has become a widely cited tool for evaluating innovative devices and procedures, yet challenges remain concerning the definition and reporting of incremental innovative modifications, hindering evolution and evaluation of innovations and potentially risking patient safety. This systematic review examined IDEAL studies to identify such modifications and establish recent practices around modification reporting to inform the development of future guidance to facilitate safe, transparent and efficient surgical innovation.

Design
Systematic review and thematic synthesis of studies reporting surgical innovation.

Data sources
Web of Science and Scopus were searched in July 2023 using citation tools to identify studies following the IDEAL framework (citing any of 13 key IDEAL/IDEAL framework publications and guideline papers).

Eligibility criteria
Primary research studies of any design that involved invasive innovative devices or procedures.

Data extraction and synthesis
Study characteristics and verbatim text for all reported modifications, including contextual information, were extracted. Data were analysed and synthesised using thematic synthesis.

Results
Of 1071 records screened, 104 studies published between 2011–2023 were included (n=87 (83.6%) study reports; n=17 (16.3%) protocols). 425 modifications were reported in 76 (73.1%) studies, including modifications to procedures (n=283, 66.6%), devices (n=94, 22.1%) and patient selection (n=48, 11.3%). Procedure/device modifications included technical, non-technical and cessation (conversion to other procedures or abandonment). Modifications were most often reported within IDEAL stage 2a (n=30/44, 68.2%), whereas there was considerable variation across other stages, such as stage 0 (n=2/3, 66%) and stage 2b (n=4/12, 33.3%).

Conclusion
Reporting modifications is imperative for evaluating surgical innovation. However, this review found inconsistent approaches to reporting and describing modifications. Findings will inform the development of a checklist for reporting modifications that aims to complement the IDEAL framework and further promote shared learning, avoiding the repetition of harmful/ineffective modifications and enhancing patient safety.

PROSPERO registration number
CRD42023427704.

Introduction
Sepsis-induced left ventricular (LV) dysfunction participates in cardiovascular dysfunction and associated organ failure in patients with septic shock. The tested hypothesis is that dobutamine will reduce tissue hypoperfusion and secondary organ dysfunction in increasing oxygen delivery in fluid-filled patients with septic shock and associated symptomatic septic cardiomyopathy with documented low-flow state.

Methods and analysis
ADAPT–Dobutamine is a blinded, two parallel group, add-on, multicentre, randomised 1:1 and placebo-controlled trial. Patients will be included if hospitalised in the intensive care unit with septic shock (Sepsis-3 definition) and septic cardiomyopathy, identified using echocardiography (LV ejection fraction ≤40% and LV outflow tract velocity–time integral 130 bpm, severe ventricular arrhythmia, obstructive cardiomyopathy, severe aortic stenosis, ongoing acute coronary syndrome and indication for extracorporeal life support. Primary outcome will be the evolution of a modified Sequential Organ Failure Assessment score (excluding the neurologic system) during the initial intensive care unit stay encompassing screening (before randomisation), and from Day 1 to 3 after randomisation. Randomisation will be stratified on participating centres and previously documented heart failure (ejection fraction ≤40%). The use of open-labelled Dobutamine as a rescue therapy will be allowed in refractory shock based on strict clinical requirements. The use of alternative inotropes will not be allowed.

Ethics and dissemination
Approved by the Comité de Protection des Personnes Nord-Ouest IV from Lille (France) on 19 December 2019 (approval reference #19.04.05.36321). The results will be published in a peer-reviewed journal and presented in various congresses.

Trial registration number
NCT04166331.

Circulation, Ahead of Print. BACKGROUND:Equal access to care for patients with congenital heart disease (CHD) remains unrealized globally. The ASSIST project (Academic Medical Hospitals–Local Institutions collaboration) is an ongoing national quality initiative implemented in low-resource settings in China attempting to reduce gaps in access to CHD care. This study sought to evaluate its feasibility and effectiveness.METHODS:Shanghai Children’s Medical Center, an academic medical center, has partnered with 4 local hospitals in low-resource regions to enhance local CHD programs since 2021. Comparison was made between patients receiving treatments in these 4 local hospitals before (2013–2020) versus after the ASSIST project (2021–2024). In addition, contemporaneous patients receiving treatments in Shanghai Children’s Medical Center (2021–2024) were compared with the post-ASSIST cohort of patients. The primary outcome was a composite of postoperative mortality and multiorgan dysfunction. A key secondary outcome was delayed treatment, defined as an interval of more than 6 months between the time of surgery and the time when the clinicians recommended surgery at the initial presentation.RESULTS:The analysis cohort included 11 895 pediatric patients (median age, 2.0 years [25th–75th percentile 0.7–5.0]; 5933 female [49.9%]), with 3333 cases in the pre-ASSIST group, 1566 in the post-ASSIST group, and 6996 in the Shanghai Children’s Medical Center group. Lower family educational attainment (odds ratio, 1.50 [95% CI 1.21–1.85];P

Stroke, Ahead of Print. BACKGROUND:As indications for and utilization of mechanical thrombectomy continue to expand, there has been an increasing focus on developing improved tools for functional outcome prediction. We aim to evaluate the reliability of utilizing the areas of contrast staining for the Alberta Stroke Program Early Computed Tomography Score (s-ASPECTS) rating in immediate postthrombectomy flat-panel computed tomography and investigate its outcome predictive performance.METHODS:Retrospective analysis of a prospectively collected institutional mechanical thrombectomy database spanning March 2018 to February 2024. s-ASPECTS was calculated. We used ordinal logistic regression models to estimate the relationship between s-ASPECTS and the 90-day modified Rankin Scale and the additional value of these findings to the linear predictor of the MR-PREDICTS tool.RESULTS:One thousand sixty-three patients were included in this study with a mean age of 65±15 years, with 53% being male. s-ASPECTS was independently associated with functional outcomes. s-ASPECTS was observed to have more relevance in the clinical predictive model compared with baseline Alberta Stroke Program Early Computed Tomography Score, as well as to occlusion site and final expanded Thrombolysis in Cerebral Infarction grade. s-ASPECTS was lower among patients with more proximal occlusions, with a lower degree of final reperfusion, with a higher number of passes and longer procedures. The information gathered from flat-panel computed tomography added 18% of new information to MR-PREDICTS, as assessed by the ratio of the variances of the estimated probabilities of good functional outcome with an interobserver consensus score of κ=0.63.CONCLUSIONS:s-ASPECTS was reliably reported and found to be a stronger predictor of outcome compared with baseline Alberta Stroke Program Early Computed Tomography Score, characterizing it as an important prognostic tool for evaluating functional outcomes of patients following mechanical thrombectomy. Further studies are warranted.

Introduction
Stress is omnipresent in our everyday lives and a key risk factor for our physical and mental health. Yet little is known about the impact of geographic life environments, linked to our daily activities and mobility patterns, on our momentary and daily stress levels.
We propose this review to gather evidence on the spatio-temporal determinants of momentary or daily stress in studies using ecological momentary assessment (EMA) or experience sampling methods (ESM) in addition to global positioning systems (GPS) tracking. We will focus on the spatio-temporal definition and modelling of environmental exposures accounting for participant daily activities and mobility patterns and their association with stress.

Methods and analysis
This scoping review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses framework for scoping reviews (2018). We will search the PubMed/Medline, Web of Science, PsycInfo and Scopus databases. We will include papers using EMA or ESM and GPS measuring chronic, daily or momentary stress as an outcome; these methods are also referred to as geographically-explicit ecological momentary assessment.
Articles published from January 2000–June 2025 will be screened. Two independent reviewers will screen titles and abstracts to agree on the inclusion of articles. No geographical or population limitation will be imposed.

Ethics and dissemination
This study is a scoping review based on previously published and publicly available literature. It does not involve the collection of primary data, human participants, or the processing of personal or sensitive information. Therefore, ethical approval is not required in accordance with institutional and international research ethics guidelines. The results will be submitted in peer-reviewed journals and presented at international conferences.

Objectives
Low-level viremia (LLV) is a risk factor affecting the prognosis of patients with chronic hepatitis B (CHB). The objective of this study was to systematically assess the prevalence of LLV, thereby providing robust evidence-based medical insights into effective clinical interventions and preventative measures against LLV.

Design
Systematic review and meta-analysis.

Data sources
A comprehensive literature search was conducted across various databases, including China National Knowledge Infrastructure, Wanfang Data (Wanfang), China Science And Technology Journal Database (VIP-CSTJ), China Biology Medicine disc (CBMdisc), PubMed, Embase, Web of Science and the Cochrane Library, spanning from the inception of these databases up to 5 January 2024.

Eligibility criteria
The research type included either a cross-sectional study or a cohort study focusing on the Chinese population, with the outcome being LLV. The languages were limited to both Chinese and English. Studies with any of the following were excluded: subjects with other comorbidities, original articles inaccessible or data unavailable, and duplicate publications.

Data extraction and synthesis
Literature management used EndNote X9.1, and an information extraction table was created using Microsoft Excel to record research information, including first author, year of publication and study type. The prevalence of LLV was assessed via meta-analysis. Meta-analyses were conducted in RStudio using the ‘metaprop ()’ function. Subgroup analysis and sensitivity analysis were used to identify sources of heterogeneity, and funnel plots and AS-Thompson tests were employed to evaluate publication bias.

Results
18 studies, encompassing a total sample of 9773 patients, were included in the analysis. Of these, 3336 patients were identified with LLV. The meta-analysis revealed that the prevalence of LLV among treated CHB patients stands at 33.6% (95% CI 30.2 to 37.0). The antigen status, antiviral treatment regimen (type of drugs and nucleos(t)ide analogues (NAs)), treatment duration, medication adherence and baseline hepatitis B virus DNA levels all affected the prevalence of LLV. Sensitivity analysis further corroborated the stability of these meta-analysis findings. The funnel plot and AS-Thompson test indicated no significant publication bias (t = –0.01, p=0.995).

Conclusions
The prevalence of LLV among CHB patients was established at 33.7% (95% CI 29.8% to 37.6%). Thus, it is imperative for clinical decision-makers to consider the various influencing factors of LLV when formulating treatment plans in order to mitigate any potential adverse outcomes.

Introduction
Perinatal care continuity across the full continuum is essential for optimising maternal and infant health; however, a stark gap occurs post partum, with less than one half of Indian mothers receiving postpartum care due to significant logistical and sociocultural barriers, particularly for periurban and rural residents. To overcome these barriers and reduce women’s postpartum isolation, our international team of maternal and infant health clinicians and researchers developed and pilot-tested a culturally-tailored mobile interactive education and support group intervention, Kushal Maa (‘informed-mother’), confirming feasibility and acceptability and preliminary effectiveness. The current study seeks to estimate the effectiveness of the Kushal Maa intervention compared with standard care on maternal and neonatal health-related behaviours and health, characterise the mechanisms of intervention impact and evaluate the cost-effectiveness of the Kushal Maa intervention in improving postpartum maternal and neonatal health compared with the standard of care.

Methods and analysis
We will conduct a prospective, parallel block-randomised controlled trial with a 1:1 allocation ratio among 2100 pregnant women across three geographically diverse Indian states. Inclusion criteria for women: aged 18+years of age at enrolment, in the last trimester of pregnancy (30–33 weeks of gestation), with any parity, carrying single or multiple gestation (1-2), with knowledge of site-specific local language and had access to a mobile phone. Participants will be block-randomised in groups of 15. Intervention participants will receive 28 tailored education and support sessions weekly via audio/video conference facilitated by trained moderators (four prenatal and 24 weekly postpartum sessions through 6 months) and will be engaged in WhatsApp groups for health education videos and peer discussion via text chat. Control participants receive the standard of care. Data will be collected at four points: 30–33 weeks of pregnancy (enrolment), 6 weeks, 3 months and 6 months postpartum (endline). Investigators, outcome assessors and data analysts will be blinded to group allocation. Primary outcomes will be measured at 6 weeks, 3 months and 6 months post partum and include: postpartum depression (using Edinburgh Postnatal Depression Scale), exclusive breastfeeding and met need for postpartum family planning. Secondary outcomes include other maternal and child health knowledge, outcomes and maternal and newborn healthcare use indicators. We will use intention-to-treat analysis. Mixed-effects models will account for clustering due to the group-oriented delivery of the intervention and repeated measures.

Ethics and dissemination
This study has been approved by the Health Ministry Screening Committee, Government of India and approved by ethics boards at the Post-Graduate Institute for Medical Education and Research, Chandigarh (Ref:001208, IEC-06/2022–2471), Maharashtra University of Health Sciences (Ref: MUHS/EC/06/2024), Sangath (Ref: AB_2022_81) and the University of California, San Francisco (Ref: 21–35730). All research activities will be performed in accordance with the Declaration of Helsinki. On completion, findings will be disseminated to stakeholders through diverse strategies. Results will be published in academic journals and presented at conferences.

Trial registration number
ClinicalTrials.gov: NCT05268588 Clinical Trials Registry – India: CTRI/2022/07/043889.

Objective
To develop and validate a prediction model of Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ALL).

Design
A single-centre retrospective study.

Participants
This study analysed 471 newly diagnosed patients with ALL at the Second Affiliated Hospital of Army Medical University from January 2014 to December 2023.

Methods
Clinical and laboratory parameters were collected, and the important characteristic parameters were selected using BorutaShap. Multiple machine learning (ML) models were constructed and optimised by using the active learning (AL) algorithm. Performance was evaluated using the area under the curve (AUC), comprehensive indicators and decision curve analysis. The interpretability of the model was evaluated by using SHapley Additive Interpretation (SHAP), and external validation was conducted on an independent test cohort.

Results
10 parameters were selected to construct multiple ML models. The CatBoost model integrated with an AL algorithm (CatBoost-AL) was found to be the most effective model for predicting Ph+ALL within the validation data set. This model achieved an AUC of 0.797 (95% CI 0.710 to 0.884), along with sensitivity, specificity and F1 score of 0.667, 0.864 and 0.777, respectively. The prediction performance of CatBoost-AL was further validated with an external testing set, where it maintained a strong AUC of 0.794 (95% CI 0.707 to 0.881). Using SHAP for global interpretability analysis, age, monocyte count, -glutamyl transferase, neutrophil count and alanine aminotransferase were identified as crucial parameters that significantly influence the diagnostic accuracy of CatBoost-AL.

Conclusion
An interpretable ML model and online prediction tool were developed to determine whether newly diagnosed patients with ALL are Ph+ALL. The key parameters identified by the optimal model provided a further understanding of Ph+ALL characteristics and were valuable for accurate diagnosis and treatment of Ph+ALL.

Risultati incoraggianti da studio fase 3 su sotatercept