Risultati per: Focus su febbre gialla, tifo e epatite A, Meningite

Circulation, Volume 150, Issue Suppl_1, Page A4144724-A4144724, November 12, 2024. Background:Paucity of evidence is available on sex-differences in the progression, left ventricular (LV) remodelling and long-term outcome in patients with native mild-to-moderate aortic stenosis (AS) and preserved LV ejection fraction (LVEF).Objectives:To assess the sex-differences in the progression, LV remodelling and long-term outcome of native AS.Methods:Baseline and follow-up echocardiographic data of patients with at least mild-to-moderate AS [aortic valve area(AVA)≤1.5 cm2, maximum aortic velocity(Vmax) ≥2.5 m/s or mean gradient(MG)≥25 mmHg] were prospectively collected between 2014 and 2019 and retrospectively analysed. Patients with LVEFmild were excluded. AS progression (analysed by annualized progression ratios in echocardiographic parameters), all-cause death, aortic valve replacement (AVR), were investigated stratifying for sex.Results:We included 677 patients with a mean age of 70.8±13.2 years, 258 (38.1%) women. During a median 5 years follow-up, 118(17.4%) deaths and 211(32.2%) AVR occurred. After inverse-propensity-weighting (IPW), men had faster progression rate of AS compared to women (MG: mean difference 1.77[1.10-2.43] mmHg/year, p

Objective
The collection of comprehensive data from post-authorisation trials for conditionally authorised anticancer medicines is frequently delayed. This raises questions about the feasibility of post-authorisation randomised controlled trials (RCTs) that aim to address remaining uncertainties. Therefore, this study explored factors that facilitate or impede the feasibility of post-authorisation RCTs from the perspective of stakeholders directly involved in the design, medical-ethical approval, and conduct of these RCTs.

Design
We conducted four qualitative focus groups (FGs).

Setting
FG discussions focused on the oncology setting in European context.

Participants
Twenty-eight European patients, physicians, medical ethicists and pharmaceutical industry representatives participated in the FGs.

Intervention
Respondents were informed about the topic and the purpose of the FGs before and at the start of FG discussions. An FG script was used to guide the discussion, which was informed by 14 semi-structured interviews with various stakeholders.

Results
We identified factors with the potential to impact feasibility related to trial design, trial conduct, factors external to a trial and post-authorisation interaction with regulators. Factors that may be particularly relevant for the post-authorisation setting include the choice of relevant endpoints and the inclusion of a fair comparator (trial design), strategies to increase patients’ and physicians’ willingness to participate (trial conduct), and external factors relating to a medicine’s commercial availability, the presence of competing medicines and trials and the perceptions about clinical equipoise. Post-authorisation interaction with regulators about how to obtain comprehensive data was deemed necessary in cases where a post-authorisation RCT seems infeasible.

Conclusions
Based on the identified factors, our findings suggest that patient recruitment and retention could be assessed more in-depth during regulatory feasibility assessments at the time of granting conditional marketing authorisation and that sponsors and regulators should better inform patients and physicians about the remaining uncertainties for conditionally authorised medicines and the necessity for post-authorisation RCTs. By enhancing the evaluation of trial feasibility, timely completion of post-authorisation RCTs may be facilitated to resolve the remaining uncertainties within a reasonable timeframe.

Introduction
Clinical guidelines recommend the use of the kidney failure risk equation (KFRE) to guide the referral of individuals with chronic kidney disease (CKD) to secondary kidney care services. People living with CKD frequently experience multiple long-term conditions (multimorbidity) and/or frailty. This may impact patients’ or carers’ perceptions of kidney failure in the context of other health problems and associated risks and emphasises the need for shared decision-making. This paper presents the research protocol for the exploration of patients’ and healthcare professionals’ perspectives on kidney failure risk and the use of the KFRE in the MULTIPle lOng-term condItions aNd frailTy study. This study aims to investigate patient and healthcare professionals’ perspectives and expectations of the use of KFRE in individuals with CKD and multimorbidity and/or frailty, with a focus on shared decision-making.

Methods and analysis
Analysis of semistructured interviews with adults who have CKD and multimorbidity and/or frailty and focus groups with healthcare professionals (who are involved in caring for patients with CKD). Framework analysis, underpinned by normalisation process theory, will be used to develop codes and explore themes from the interviews and focus groups. Patient and public involvement has been pivotal to the study conceptualisation and will continue to be embedded throughout the study.

Ethics and dissemination
The study protocol has undergone peer review by the NHS Greater Glasgow and Clyde Research and Innovation team and has been granted ethical approval in August 2023 by the NHS Health Research Authority following a favourable opinion from the West of Scotland Research Ethics Committee (REC) 3 (IRAS ID: 325848, REC reference: 23WS/0119, Protocol number GN22RE559).
The results of the research will be disseminated through peer-reviewed publications and conferences, as well as to patient and public involvement groups who have been involved in the study and through knowledge exchange events.

Irccs Negrar ha isolato virus in liquido seminale di un paziente

Firmò e cofinanziò uno studio su Nature. Credeva in una svolta

Background
Childhood adversity is associated with a host of negative health and socioeconomic outcomes far into adulthood. The process of avoiding such outcomes is often referred to as resilience. Mapping resilience comprehensively and across contexts is highly relevant to public health, as it is a step towards understanding environments and interventions that contribute to preventing or reversing negative outcomes after early adverse experiences.

Objectives
This review scoped out the literature on resilience factors in relation to adulthood outcomes as diverse as mental health and educational attainment. Our aim was to understand where there is untapped research potential, by examining the current evidence base on resilience factors in terms of (a) resources that can buffer the impact of childhood adversity and (b) the pathways linking adversity to long-term outcomes. Furthermore, we aimed to identify gender patterns in these resources and pathways, which has not been a primary interest of reviews on resilience to date, and which can add to our understanding of the different ways in which resilience may unfold.

Eligibility criteria
Studies had to include an adversity experienced in childhood, an outcome considered indicative of resilience in adulthood, and at least one putative resilience factor, which had to be approached via mediation or moderation analysis. We considered cohort, case–control and cross-sectional studies.

Sources of evidence
We searched PubMed, Scopus and PsycINFO and included original, peer-reviewed articles published before 20 July 2023 in English, German, French, Spanish, Dutch and Swedish.

Charting methods
All three authors collaborated on the extraction of information relevant to answering the research questions. The results were visually and narratively summarised.

Results
We included 102 studies. Traditionally anchored in the field of psychology, the resilience literature focuses heavily on individual-level resilience factors. Gender was considered in approximately 22% of included studies and was always limited to comparisons between men and women. There is no evidence that childhood adversity impacts men and women differently in the long term, but there is some evidence for gender differences in resilience factors.

Conclusions
There is untapped potential in resilience research. By considering structural-level factors simultaneously with individual-level factors, and including gender as one of the elements that shape resilience, we can map resilience as a heterogeneous, multilevel process from a public health perspective. This would complement the extensive existing literature on individual-level factors and help reframe resilience as a concept that can be intervened on at a structural level, and that is subject to societal norms and forces, such as gender. There is a lack of quantitative studies including transgender and gender-non-conforming persons.

Bollettino Iss, 222 casi neuroinvasivi, i decessi salgono a 16

11 raccomandazioni da Società europea oncologia,’azione globale’

In provincia di Ancona già eseguiti più di 15mila prelievi

We were delighted to read the article by Jarosova et al, which presents the results of a randomised controlled trial investigating the efficacy of endobiliary radiofrequency ablation (eRFA).1 The authors should be commended for conducting this large trial not only in pancreatic cancer but also, much rarer, perihilar cholangiocarcinoma (pCCA) patients. Endobiliary RFA uses high frequency current to generate heat, which results in coagulation and local tumour necrosis, possibly leading to delayed tumour growth. Theoretically, the potential benefit of eRFA is larger in tumours that originate from the bile duct itself rather than compressing the bile duct, such as pancreatic cancer. The safety and feasibility have been shown in multiple studies, but the efficacy has not been sufficiently studied in randomised trials yet.2–4 Unfortunately, current trial has not been able to show the superiority of eRFA prior to stent placement over…

Introduction
The human gut microbiota is associated with gestational diabetes mellitus (GDM), which imposes a risk of developing long-term health problems for mother and child. Most studies on GDM and microbiota have been cross-sectional, which makes it difficult to make any conclusions on causality. Furthermore, it is important to assess if a dysbiotic microbiota is passed from the mother to the child, and then being at risk of developing metabolic health problems later in life. The DANish Maternal and Offspring Microbiome study aims to identify gut microbiota-related factors involved in metabolic dysfunction in women with GDM and their offspring. Importantly, the study design allows for early detection of biological changes associated with later development of metabolic disease. This could provide us with unique tools to support early diagnosis or implement preventative measures.

Methods and analysis
Pregnant women are included in the study after the 11–14 weeks’ prenatal ultrasound scan and followed throughout pregnancy with enrolment of the offspring at birth. 202 women and 112 children have been included from North Denmark Regional Hospital and Aalborg University Hospital in Denmark. Mother and child are followed until the children reach the age of 5 years. From the mother, we collect faeces, urine, blood, saliva, vaginal fluid and breast milk samples, in addition to faeces and a blood sample from the child. Microbiota composition in biological samples will be analysed using 16S rRNA gene sequencing and compared with demographic and clinical data from medical charts, registers and questionnaires. Sample and data collection will continue until July 2028.

Ethics and dissemination
The study protocol has been approved by the North Denmark Region Committee on Health Research Ethics (N20190007). Written informed consent is obtained from all participants prior to study participation. Study results will be published in international peer-reviewed journals and presented at international conferences. The results will also be presented to the funders of the study and study participants.

Background
Proof-of-concept (PoC) development is a key step in implementation sciences. However, there is a dearth of studies in this area and the use of this term in health and social sciences is ambiguous.

Objective
The objective was to remove the ambiguity surrounding the PoC and pilot study stage in the research development process using a standard system to rate the development of projects and applications provided by the Technology Readiness Levels (TRL) framework.

Design
Mapping review and critical analysis using TRL as the standard measure.

Search strategy and charting method
PubMed and PsycInfo databases were searched for papers that reported PoC studies of mental health interventions up to August 2023. Data were extracted, described and tabulated.

Eligibility criteria
Included were PoC studies in mental health implementation research. Exclusion criteria were research relating to biomedical (drugs) development, neurocognitive tools, neuropsychology, medical devices, literature reviews or discussion papers or that did not include the term ‘proof-of-concept’ in the title, abstract or text.

Results
From the 83 citations generated from the database search, 22 studies were included in this mapping review. Based on the study title, abstract and text, studies were categorised by research development stage according to the TRL framework. This review showed 95% of the studies used PoC incorrectly to describe the development stage of their research but which were not at this specific level of project development.

Conclusions
The TRL was a useful reference framework to improve terminological clarity around the term ‘proof-of-concept’ in implementation research. To extend the use of TRL in implementation sciences, this framework has now been adapted and validated to a health and social science-related research context accompanied by a health-related glossary of research process terms and definitions to promote a common vocabulary and shared understanding in implementation sciences.

Circulation, Ahead of Print. The American Heart Association (AHA), founded in 1924, is anchored in the core belief that scientific research can lead the way to better prevention, treatment, recovery, and ultimately a cure for cardiovascular disease. Historically, the association’s involvement in international efforts centered on scientific cooperation. Activities mostly involved AHA leadership presenting at international scientific meetings and leaders from other countries sharing scientific and medical information at AHA meetings. Although the AHA’s and American Stroke Association’s international efforts have expanded substantially since those early days, global knowledge exchange remains the bedrock of its international endeavors. As the AHA turns 100, we reflect on the successful global efforts in prevention, resuscitation, global advocacy, quality improvement, and health equity that have guided the organization to a place of readiness for “advancing health and hope, for everyone, everywhere.” Motivated by the enormous potential for population health gains in an aging world, the AHA is entering its second century with redoubled commitment to improving global cardiovascular and cerebrovascular health for all.

Objectives
To characterise the exposure to valproate within a cohort of pregnant women using electronic health records (EHRs) from Catalonia (System for the Development of Research in Primary Care, SIDIAP).

Design
Drug-utilisation cohort study covering the period from January 2011 to June 2020. The study included pregnancy episodes of women from Catalonia identified by the algorithm.

Setting
Data were sourced from SIDIAP, a comprehensive EHR repository that includes information from various data sources: recorded prescriptions (both hospital and primary care), diagnoses and sociodemographic characteristics identified by primary care physicians, and sexual and reproductive health data from ASSIR (used by gynaecologists and midwives).

Participants
Women aged 12–50 with at least one pregnancy episode occurred during January 2011–June 2020 and at least a prescription of valproate during pregnancy.

Primary and secondary outcomes
Primary outcomes included valproate exposure, measured through prevalence and cumulative incidence in pregnancy episodes and by trimester. The impact of regulatory measures (risk mitigation measures, RMMs) was assessed, and prescriptions over time were analysed using interrupted time series analysis. Secondary outcomes included health issues, pregnancy outcomes, smoking habits and socioeconomic characteristics.

Results
A total of 99 605 pregnancies were identified, with at least 3.03 (95% CI 2.69 to 3.39) exposed to valproate at some point (302 pregnancies, 276 women). The median pregnancy duration was 38.30 weeks (IQR 12.6–40.1), and the median age at pregnancy was 32.37 years (IQR 27.20–36.56). Epilepsy was the most frequent health issue. The prevalence and cumulative incidence of valproate prescriptions decreased during pregnancy and increased postpregnancy. The RMMs implemented in 2014 led to a reduction in monthly valproate prescriptions during pregnancy in this cohort.

Conclusions
The study highlights the decline in valproate prescriptions during pregnancy due to RMMs and underscores the need for standardised methodologies in future studies to ensure the safety of pregnant patients and optimise scientific evidence.

Secondo notificato in Toscana in pochi giorni