Search Results for: Diagnosi e trattamento de cancro dell’ovaio

Individua la malattia prima che compaiano i sintomi

Introduction
The HOLA study is a 12-month randomised, hybrid implementation-effectiveness, phase IV, double-arm, open-label, multicentric study including virologically suppressed people living with HIV (PWH). HOLA, which started in September 2023, evaluates acceptability, appropriateness, feasibility and satisfaction of out-of-hospital administration of cabotegravir and rilpivirine long-acting (CAB+RPV LA).

Methods
A total of 110 PWH who are already under treatment with CAB+RPV LA or switch their antiretroviral therapy to CAB+RPV LA will be recruited from two main hospitals in Barcelona (Germans Trias I Pujol and Vall d’Hebrón) and Costa del Sol Hospital, in Marbella. The patients will be randomised 1:1 into a hospital group (administration of CAB+RPV LA in the hospital) and the outpatient group (out-of-hospital administration), including community or primary care centres. The main objectives of the study are to compare the acceptability at month 12 of the administration of CAB+RPV LA in and out-of-hospital centres from the perspective of patients, and assess and compare the safety and tolerability of CAB+RPV LA. The study takes place at nine clinical units in Catalonia and Andalusia (three tertiary hospitals (recruiting centres), one community centre, one sexually transmitted infection clinic and four primary care centres).

Ethics and dissemination
The current publication refers to V.3.0 of the protocol, with issue date 14 April 2024, as approved by the Comité de Ética de la Investigación con medicamentos del Hospital Universitari Germans Trias i Pujol (approval number AC-23-042-HGT-CEIM). The clinical trial will be conducted according to the principles of the Declaration of Helsinki, Fortaleza, Brazil, October 2013. This study will be conducted according to Spanish regulations regarding clinical trials (Royal Decree 1090/2015) and biomedical investigations (Organic Law 14/2007 of biomedical investigation and the Royal Decree 1716/2011), and the Clinical Trial Regulation (Regulation EU No 536/2014). Confidentiality requirements will follow the required Data Protection legislation. Enrolment completion in the study is expected by the end of May 2024, with an end of study expected in May 2025. Results emerging from this study will be reported in HIV national and international meetings as well as published in international journals with a high impact factor. If the outcome is deemed positive, we will also develop and propose policy guidelines for the integration of the administration of CAB+RPV LA in alternative outpatient facilities into the standard of care in the HIV care pathway.

Trial registration number
NCT06185452/EUCT number: 2023-503963-41-00.

Introduction
Mental health at the workplace has been identified as a major priority by the World Health Organization (WHO). Despite its significance, international studies examining the influence of digital mental health interventions on workplace implementation and outcomes are lacking. The European Platform to Promote Well-being and Health in the Workplace (EMPOWER) platform is an eHealth intervention consisting of a website and web-based app designed to guide employers and employees on the prevention of common health problems, reduce presenteeism and absenteeism in the workplace. The aim of this paper is to describe the rationale and methods that will be used to conduct a maxi impact analysis of the processes undertaken to develop and implement the EMPOWER platform in European workplaces using the Global Impact Analytics Framework (GIAF) methodology.

Methods and analysis
We will undertake a mixed-methods analysis of the impact of the process of implementation in the two phases of implementation (initiation and maturity—the early implementation phase). The primary methodology that will be used for the analysis is the GIAF and toolkit. The GIAF toolkit includes a taxonomy (knowledge map), glossary and checklists to examine and rate the EMPOWER project across various domains of impact: planning, pre-engagement, readiness, usability, dissemination, adoption and uptake. Information will be collected from a range of sources through different methods and used to rate the EMPOWER platform (website and app) on each domain. For reliability and validity, four raters will independently rate the EMPOWER platform using the same information. The analysis will include qualitative and quantitative methods to rate on standardised ladders and scales in the GIAF toolkit. Analysis will include descriptive statistics and non-parametric tests where relevant. The information gained will be reviewed in a subgroup (per country) and group (three country) analysis for formative and key summative learnings. These key learnings will be synthesised to generate organisational learnings and insights for the EMPOWER consortium to improve future intervention implementation processes.

Ethics and dissemination
The impact analysis study protocol has been approved by the Research Ethics Committees of the University of Canberra (ID:202311841) and also the Fundació Sant Joan de Déu (PIC-39-20). The participating countries for the RCT (EMPOWER study) also obtained ethical approval through their respective ethical organisations in the participating countries. The impact analysis is registered with the Open Science Framework ID osf.io/eysc9. The EMPOWER project trial is registered at ClinicalTrial.gov with trial ID NCT04907604. The outcomes of the impact analysis study will be disseminated via conference presentations, peer-reviewed journals and key organisational learnings presented in relevant forums.

Trial registration number
NCT04907604.

Introduction
Postoperative atrial fibrillation (POAF) affects approximately 20% of patients undergoing thoracic surgery and is associated with severe complications such as stroke, myocardial infarction, heart failure, and increased mortality. Early diagnosis is critical to mitigate these risks, but conventional monitoring is limited in detecting asymptomatic episodes. Smartwatches equipped with single-lead ECG and atrial fibrillation (AF) detection algorithms offer a novel approach for early POAF detection. This study aims to evaluate the effectiveness of smartwatch-based monitoring compared with standard care in identifying POAF following thoracic surgery.

Methods and analysis
The THOFAWATCH trial is a randomised, bicentric open-label study enrolling 302 adult patients undergoing major thoracic surgery (pneumonectomy or lobectomy) with one-lung ventilation. Eligible patients will be randomised into two groups: (1) the ‘Smartwatch Monitoring’ group, where participants will undergo rhythm monitoring using a smartwatch and (2) the ‘Conventional Monitoring’ group, receiving standard care without smartwatch monitoring. In the intervention group, any smartwatch-detected POAF episodes will be confirmed by 12-lead ECG. The primary outcome is the incidence of POAF within 7-day postsurgery. Secondary outcomes include the rate of asymptomatic POAF, cardiovascular prognosis evaluated at 2 and 6 months (composite major adverse cardiovascular events outcome), feasibility of smartwatch usage (device usage time and success rate of single-lead ECGs) and recurrence or management of AF at follow-up. Inclusion criteria include adults ( >18 years) undergoing scheduled thoracic surgery and able to use the smartwatch device. Exclusion criteria encompass patients with prior AF, those requiring telemetry, or undergoing reoperations. Statistical analysis will assess the primary outcome using 2 or Fisher’s exact test (α=5%), while secondary outcomes will include descriptive and inferential statistics, with analysis conducted using SAS V.9.4.

Ethics and dissemination
Ethical approval for this bicentric study has been granted by the institutional review board (IRB) of the University Hospital of Amiens (Comité de Protection des Personnes sud-ouest et outre-mer 1, 21050 Toulouse, France, registration number ID RDB: 2022-A02028-27 in November 2024). The trial is registered under ClinicalTrials.gov (ID: (NCT06724718)). Results will be disseminated through peer-reviewed publications and scientific conferences to inform clinical practice regarding POAF detection and management following thoracic surgery.

Trial registration number
NCT06724718; clinical trial.

Presentati i dati, 391 le biopsie eco guidate e stereotassiche e 123 le diagnosi

Introduction
Mammographic screening identifies many women with small breast cancers with favourable biological features, which have an excellent prognosis. Some of these may never have become clinically apparent without screening and are commonly described as ‘overdiagnosed’ cancers. Despite this, all patients with screen-detected cancers are currently treated with surgical excision and sentinel lymph node biopsy, although this may represent overtreatment. There is, therefore, a need for less invasive approaches to reduce treatment burden for patients while maintaining current excellent oncological outcomes. Vacuum-assisted excision (VAE) may represent such an alternative treatment approach, and the SMALL (Open Surgery versus Minimally invasive-vacuum Assisted excision for smaLL screen-detected breast cancer) trial aims to investigate the use of VAE for the safe de-escalation of surgical treatment for such excellent prognosis invasive breast cancers.

Methods
SMALL is a prospective, multicentre, randomised phase III trial of VAE versus surgery in patients with small, biologically favourable screen-detected invasive breast cancer. SMALL has an innovative hybrid design with coprimary endpoints. These include a randomised non-inferiority comparison of surgical re-excision rates following initial treatment, and a single-arm analysis of local recurrence at 5 years following VAE. Secondary outcomes include complication rates, overall survival, quality of life and a health economic analysis. The trial includes a QuinteT Recruitment Intervention to support recruitment.

Ethics and dissemination
Ethical approval was obtained from the Office for Research Ethics (Northern Ireland) for all UK sites. Results will be submitted for publication in a peer-reviewed journal, presented, shared with patient partners and with relevant professional organisations to inform future guideline development for the management of screen-detected breast cancer.

Trial registration number
ISRCTN12240119.

Purpose
To determine prognostic factors of disability in multiple sclerosis (MS), that is, (1) identify determinants of the dynamics of disability progression; (2) study the effectiveness of disease-modifying treatments (DMTs); (3) merge determinants and DMTs for creating patient-centred prognostic tools and (4) conduct an economic analysis.

Participants
Individuals registered in the French Observatoire Francais de la Sclérose en Plaques (OFSEP) database were included in this OFSEP-high definition cohort if they had a diagnosis of MS, were ≥15 years old and had an Expanded Disability Status Scale (EDSS) score

E su diagnosi precoci. Assessore, la ricerca è fondamentale

E su diagnosi precoci. Assessore, la ricerca è fondamentale

Concluso progetto pilota per anticipare diagnosi

Introduction
A significant number of critically ill patients who survive their illness will experience new sequelae or a worsening of their baseline health status following their discharge from the hospital. These consequences may be physical, cognitive and/or psychological and have been labelled postintensive care syndrome (PICS). Prior research has demonstrated that spiritual care aligned with a specific creed during hospitalisation in the intensive care unit (ICU), as part of a comprehensive care plan, may be an effective strategy for preventing psychological sequelae in surviving critically ill patients. However, there is a gap in clinical literature regarding the effectiveness of generalist spiritual care in preventing psychological sequelae associated with PICS. This pilot study aims to explore the feasibility of implementing a generalist spiritual care strategy in the ICU and to evaluate its preliminary effectiveness in preventing anxiety and depression symptoms and post-traumatic stress disorder in critically ill patients.

Methods and analysis
This is a single-site, feasibility randomised controlled pilot trial of a generalist spiritual care intervention compared with the current standard of care. A total of 30 adults who are critically ill and have undergone invasive mechanical ventilation for a minimum of 72 hours without alterations in consciousness will be randomly assigned to either the spiritual care group or the usual care group at a ratio of 1:1. The primary outcome will be the feasibility and acceptability of the spiritual care strategy in critically ill patients. Secondary aims include evaluating the differences in anxiety and depression symptoms and post-traumatic stress disorder between the spiritual care group and the usual care control group at 3 months after ICU discharge. Subjects will be followed up until 3 months post-ICU discharge.

Ethics and dissemination
The Ethics Committee for Medical Sciences of Pontificia Universidad Católica de Chile (#220111005) and the Ethics Committee of Servicio de Salud Metropolitano Sur Oriente approved the study. Pontificia Universidad Católica de Chile funded the study (project number 105699/DPCC2021). The findings will be widely disseminated through peer-reviewed publications, academic conferences, local community-based presentations, partner organisations and the Chilean Intensive Care Society.

Trial registration number
NCT06048783.

Introduction
Regular physical activity (PA) and good motor performance are essential for children’s physical and mental health. However, historical trends suggest that levels of PA and motor performance in children and adolescents are at a low point. The relationships between PA, motor performance, health and their respective determinants, as well as their individual development throughout childhood and adolescence, are not yet fully understood. Therefore, continuous monitoring of PA, motor performance and health is needed to identify vulnerable subpopulations and provide data for policy-makers and health promotion professionals. The Motorik Monitoring 2.0-Study aims to analyse the developmental, historical and periodic trends in motor performance and PA, as well as the underlying determinants, in children and adolescents in Germany.

Methods and analysis
A representative sample of children and adolescents aged 4–17 years is drawn across 195 sample points in Germany. The assessment, carried out by test instructors, includes (1) a PA questionnaire covering different settings, including determinants, (2) anthropometric measures, (3) fine and gross motor performance tests focusing on coordination, flexibility, strength and endurance, (4) 24 hours device-based measured physical behaviour by accelerometry for 1 week and (5) a health interview focusing on health behaviour, physical and mental health as well as socioeconomic status. In addition, external data may be linked to the study using geographical information systems (eg, area deprivation, access to sports facilities). Analyses will be conducted using mixed-effects models to account for the nationwide structure of the study.

Ethics and dissemination
Ethical approval was obtained from the Ethics Committee of the Karlsruhe Institute of Technology. Results will be published in open-access scientific journals and disseminated at congresses for scientists, policy-makers and stakeholders.

Trial registration number
The study was registered in the NFDI4health database (https://csh.nfdi4health.de/resource/1034). The NFDI4health database is a central platform of the National Research Data Infrastructure for Personal Health Data. It is used to collect, manage and provide health data for scientific research and facilitates access to high-quality data for epidemiological and clinical studies.

Pérez-Porta I, FlórezGarcía MT, García-Pérez F, et al. Effects of a web application based on multimedia animations to support therapeutic exercise for rotator cuff-related shoulder pain: protocol for an open-label randomised controlled trial. BMJ Open 2024;14:e085381. doi:10.1136/bmjopen-20240 85 381
This article has been corrected since it was published online. The funding information has been updated. ‘This trial has received funding from the Instituto de Salud Carlos III and the European Union (PI19/01490). The funder has no influence on the study’s design, execution, analysis, or publication of results.’

Introduction
Breast cancer is a global public health challenge. It is the most commonly diagnosed cancer and the leading cause of cancer-related death in women. Several inequalities remain among women facing this disease, depending on their country of birth and their sociodemographic characteristics. The SENOVIE study (Therapeutic mobility and breast cancer) aims to understand the life trajectories of women born in France and in sub-Saharan Africa treated for breast cancer in four hospitals in the greater Paris area.

Methods and analysis
The SENOVIE study is a mixed methods study, combining a quantitative and a qualitative approach. A quantitative retrospective life-event survey is conducted in four hospital centres in the greater Paris area, France, to (1) understand how breast cancer (diagnosis, treatment and possibly reconstruction) impacts the life trajectories of women in many spheres (migration, family life, professional life, financial situation, etc); (2) study the access to healthcare by women living with breast cancer and their determinants; and (3) examine how gender relations may shape breast cancer experience. Women born in France and women born in sub-Saharan Africa are recruited: 1000 women, including 500 per group. In the standardised, face-to-face questionnaire, each dimension of interest is collected year by year from birth until the time of the survey. Clinical and laboratory information is documented with a short medical questionnaire filled out by the medical teams. The qualitative survey is conducted specifically with women born in sub-Saharan Africa who came to France for treatment to better understand their trajectories and the specific obstacles they faced. To analyse the quantitative data collected, descriptive analyses will be used to visualise trajectories (sequence analysis), along with longitudinal analysis methods (survival models and duration models).

Ethics and dissemination
The study is conducted in accordance with the Declaration of Helsinki. The French Data Protection Authority (Commission Nationale de l’Informatique et des Libertés, declaration number 2231238) and the Committee for Persons’ Protection East I (Comité de Protection des Personnes Est I, national number 2023-A01311-44) approved it. We will disseminate the findings through scientific publications, policy briefs, conferences and workshops.

Trial registration number
The SENOVIE France study is registered on Clinicaltrial.gov (NCT06503393; registration date: 7 September 2024; https://clinicaltrials.gov/study/NCT06503393).