Search Results for: Standard di qualità sulla Fibrillazione Atriale

Circulation, Ahead of Print. BACKGROUND:High-volume physical activity (PA) is associated with a higher prevalence of subclinical coronary artery disease (CAD). However, the clinical significance of subclinical CAD among high-volume exercisers remains incompletely understood, and the dose–response relationship between high-volume PA and clinical CAD events remains uncertain.METHODS:Individual participant data from the Cooper Center Longitudinal Study (1987–2018) were linked to Medicare claims files. PA volume was determined by self-report and categorized as

Objectives
The scaling-up nutrition (SUN) initiative, which was launched in 2010 to eradicate malnutrition in all its forms by 2030, collaborates with a diverse range of stakeholders, such as governments, non-governmental organisations (NGOs), donors, businesses and academia. Given the widespread adoption of this multisectoral approach, it is crucial to explore methods for evaluating the perspectives of multiple stakeholders in child undernutrition topics.

Design
This scoping review was carried out following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist.

Data sources
Six peer-reviewed databases, including PubMed, Web of Science, Cochrane, Embase, CINAHL and PROQUEST ASSIA, were systematically searched.

Eligibility criteria
Original English studies published between 1 January 2010 and 1 June 2023, focusing on undernutrition in SUN countries.

Data extraction and synthesis
Two reviewers independently screened titles, abstracts and full texts for inclusion and extracted data using Rayyan.

Results
Out of the 4533 articles, 19 met the inclusion criteria for the review, and 5 more were added through manual searches. These studies were conducted in 14 SUN countries, with 62% using mixed methods and the remaining using qualitative methods. Six methods were used to gather stakeholder perspectives, including in-depth interviews, focus group discussions, Net-Map, organisational network analysis and Q methodology. Most studies focused on government, development partners and NGOs, while only two studies involved the business network.

Conclusions
Our study indicates that study on stakeholder perspectives in SUN countries focuses mainly on those showing progress in malnutrition/undernutrition reduction. Future research should explore countries with less progress to improve partnership frameworks. The SUN movement should establish a standard method for evaluating stakeholder perspectives, considering both outcomes and processes.

Trial registration number
The final protocol was registered prospectively with the Open Science Framework in July 2023 (https://osf.io/te7cb).

Introduction
The current diagnostic pathway for patients with a suspected inherited bleeding disorder is long, costly, resource intensive, emotionally draining for patients and often futile, as half of patients will remain without a diagnosis and be labelled ‘bleeding disorder of unknown cause’. Advances in understanding the genetic basis of the inherited bleeding disorders, coupled with both increasing infrastructure for genetic/genomic testing and decreasing costs, have increased the feasibility of introducing genomic testing into the clinical diagnostic pathway as a potential solution to improve the care of these patients. Yet, there remain evidence gaps on the optimal integration of genomic analysis into the diagnostic pathway.

Methods and analysis
Using a multicentre randomised-controlled trial design, we will evaluate an early genomic testing strategy for the diagnosis of newly referred patients with a suspected inherited bleeding disorder. Eligible participants will be randomised to early genomic testing diagnostic pathway (intervention) or standard diagnostic pathway (control) and will be followed for a 12-month period. Patients in the control group who remain undiagnosed at study end will be offered identical early genomic testing to ensure equitable access to the intervention. The study will follow a parallel fixed design with waitlist control group and a 1:1 allocation ratio. The study will be conducted at three tertiary care centres in Ontario, Canada, with a target sample size of 212 participants. Clinical utility will be evaluated via the primary outcome of diagnostic yield, as well as the secondary outcome of time to diagnosis. Additional secondary outcomes will allow for assessment of patient impact via health-related quality of life and patient burden measures, as well as evaluation of economic impact through a cost-effectiveness analysis and budget impact analysis.

Ethics and dissemination
This investigator-initiated study was approved by the Queen’s University Health Sciences and Affiliated Teaching Hospitals Research Ethics Board through Clinical Trials Ontario (CTO-4909). Participant informed consent/assent is required. Findings will be disseminated through academic publications.

Trial registration number
ClinicalTrials.gov, NCT06736158.

Introduction
Postdischarge suicide risk among psychiatric patients is a great concern. Gamified interventions have demonstrated promise in reducing the risk. This study aims to reduce postdischarge suicide risk through a mHealth intervention that engages and supports patients through gamified features. Built on our previous research, this study will develop, optimise and evaluate a gamified intervention under the Multi-phase Optimization Strategy (MOST) framework in implementation science.

Methods and analysis
This study will be conducted at the Shenzhen Kangning Hospital. Following the MOST framework, we will develop the gamified mHealth app (Tailored Evidence-based Enhancements in Mental Health (TEEM)) with four intervention components in the selection phase. In the optimisation phase, a factorial design randomised controlled trial (RCT) will be conducted to identify the optimised configuration. A total of 320 patients with mental disorders will be recruited and randomised into 16 groups to receive TEEM with different combinations of intervention components, with follow-ups scheduled at 1 week, 1 month, 2 months and 3 months after discharge. In the confirmation phase, we will assess the optimised TEEM through a standard RCT, comparing it to usual care. An additional 320 patients with mental disorders will be recruited for this phase, and the follow-up schedule is the same as in the optimisation phase. Psychiatric patients and family members, clinical and community mental health service providers will be recruited as the community team to help develop and evaluate the TEEM. Quantitative data will be analysed using the intention-to-treat approach and generalised estimating equations, and qualitative data will be coded and categorised to identify key themes.

Ethics/dissemination
The Ethics Committee Review Board of Shenzhen Kangning Hospital has approved this study. All participants will provide written informed consent prior to enrolment. The findings will be disseminated through peer-reviewed scientific journals and conference presentations, and a report will be submitted to the National Natural Science Foundation of China and the mental health authorities in the Shenzhen Municipal Health Commission.

Trial registration number
ClinicalTrials.gov, ID: NCT06358339

Introduction
Polypharmacy is associated with an increased risk of adverse patient outcomes across various settings, including inpatient care. To enhance the appropriateness of medication therapy management for patients during hospital stays, computerised interventions have shown promise with regard to patient safety. This study assesses whether the implementation of a clinical decision support system will optimise the process of inpatient medication therapy to prevent inappropriate medication use and thus promote patient safety.

Methods and analysis
The intervention will be evaluated in a prospective, cluster-randomised controlled trial using a stepped-wedge design. The study will be conducted in 12 hospitals across Germany over a total period of 33 months. Patients will be treated according to the group status of the hospital and receive either standard care or the Transsektorale Optimierung der Patientensicherheit or trans-sectoral optimisation of patient safety intervention. The primary outcome is the combined endpoint of all-cause mortality and all-cause hospitalisation. Secondary endpoints are, for example, inappropriate prescriptions, utilisation of different health services, cost-effectiveness, as well as patient-reported outcome measures. Parameters describing the attitudes of patients and healthcare professionals towards the intervention and organisational change processes will be collected as part of the process evaluation. The primary endpoint will be evaluated using hospital and outpatient claims data from participating statutory health insurances at the population level. There are multiple secondary endpoints with data linkage of primary and secondary data at study participant level. Statistical analysis will make use of (generalised) linear mixed models or generalised estimating equations, taking account of independent covariables. All data analyses of the process evaluation will be descriptive and explorative.

Ethics and dissemination
Data collection, storage and evaluation meet all applicable data protection regulations. The trial has been approved by the Ethics Committees of the University of Wuppertal and the Medical Association of Saarland, Germany. Results will be disseminated through workshops, peer-reviewed publications and local and international conferences.

Trial registration number
DRKS00025485.

Oncologi, ‘per migliore qualità di vita vanno superati i tabu’

L’ha presentata l’unità di elettrofisiologia del ‘Mazzoni’

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
Patients undergoing chemotherapy often experience side effects during treatment, including psychological distress and symptoms of anxiety and depression. Interventions during chemotherapy that divert attention from potentially aversive environmental factors have been demonstrated to have a beneficial impact on these symptoms. Virtual reality (VR) offers the potential to visually and audibly disengage from the surrounding environment and can create an alternative sense of presence. This could facilitate the implementation of active guided interventions that may prove more effective than receptive interventions, such as listening to music. The present study examines the feasibility, acceptance and effectiveness of a VR intervention and a music intervention during chemotherapy.

Methods
The single-centre three-arm, randomised-controlled trial investigates the efficacy of a VR mindfulness intervention and a music intervention in patients with cancer undergoing chemotherapy at the University Hospital Düsseldorf, Germany. Patients were randomly assigned to receive either (a) the VR mindfulness intervention, (b) the receptive music intervention or (c) the standard care (control group) in two consecutive chemotherapy sessions. A comprehensive psychological assessment and self-ratings using visual analogue scales will be conducted with situational anxiety as the primary outcome measure. Additionally, secondary measures will be employed to assess cancer-related anxiety, self-efficacy and chemotherapy-related side effects. Furthermore, salivary cortisol, heart rate and blood pressure will be recorded. At the end of the study, an evaluation questionnaire will be completed. It is planned to enrol 82 patients.

Ethics and dissemination
The study has been approved by the ethics committee of the medical faculty of the Heinrich-Heine-University Düsseldorf (2022-1880). Written informed consent is obtained from the patients prior to participation. The results will be published in international scientific, peer-reviewed journals. Conference presentations are also planned.

Trial registration number
German Clinical Trials Register (DRKS00029738).

Introduction
Non-operative management of early-stage rectal cancer is increasingly recognised as a subject of significant clinical and research interest. Contact X-ray brachytherapy (CXB) offers an alternative to surgery in appropriately selected cases. Current clinical evidence suggests the use of CXB in combination with chemoradiotherapy (CRT). Although proven effective, no randomised evidence exists for the combination of CXB and short-course radiotherapy (SCRT). In this Swedish national randomised phase II trial, we aim to compare the combination of CXB with either CRT or SCRT in patients with early-to-intermediate rectal cancer.

Methods and analysis
A total of 110 eligible, operable patients with early-to-intermediate rectal cancer (cT1–cT3ab), with tumours measuring

Introduction
Patients with mental disorders and a history of childhood trauma show an early onset of psychopathology and often a poor response to standard disorder-specific treatments. They represent a patient group which requires more personalised interventions targeting the transdiagnostic mechanisms related to early trauma and its functional consequences. The mechanism-based modular psychotherapy (MeMoPsy) approach is conceptualised as an innovative framework for psychotherapy development. It comprises independent, flexibly applicable interventions from various theoretical backgrounds and evidence-based programmes within a systematic treatment algorithm, thereby tailoring module selection to the specific needs of traumatised adolescents.

Methods and analysis
In a randomised controlled feasibility trial (RCT), N=80 outpatients between 15 and 25 years of age diagnosed with various mental disorders will receive 28 individual sessions with MeMoPsy or standard cognitive behavioural therapy. MeMoPsy includes a basic module that addresses trauma history and three additional modules focusing on functional impairments known to be associated with childhood trauma: rejection sensitivity, emotion regulation and relationship difficulties. These modules are selected based on a self-report algorithm. Techniques from mentalisation-based therapy, cognitive behavioural analysis system of psychotherapy, dialectical behaviour therapy and systemic therapy are integrated in this personalised modular procedure. This proof-of-concept study aims to provide initial evidence for acceptability, feasibility and changes in self-rated and diagnostician-rated psychopathology (post-treatment and 3 months follow-up) of MeMoPsy and elucidate the mechanisms of change using psychotherapy process research, Ecological Momentary Assessment and functional magnetic resonance imaging (fMRI).

Ethics and dissemination
This RCT obtained approval from independent ethics committees of participating centres and is accompanied by a data and safety monitoring board. Findings will be communicated within the research community as well as with patients and the public by the dissemination strategies of the German Center for Mental Health.

Trial registration number
German Clinical Trials Register DRKS00034058.

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.

Controlli cruciali,riemerse in Europa malattie credute eradicate

Objectives
The aim of this study, which was embedded into the ASPIRED randomised controlled trial (ISRCTN10278811), was to explore patient and healthcare professional usability and acceptability of an enhanced (14-day) ambulatory ECG monitoring patch to manage and facilitate discharge of emergency department patients with unexplained syncope.

Design
A qualitative study using semistructured interviews. Data were analysed using thematic analysis and mapped using the theoretical framework of acceptability.

Participants
A sample of 20 syncope patients recruited to the ASPIRED RCT and 10 healthcare professionals who had a direct care provider and clinical decision role for syncope patients (eg, consultants, junior doctors, advanced nurse practitioners, advanced care practitioners, emergency nurse practitioners and physician associates) were recruited from four hospitals (two in England and two in Scotland) between February 2023 and January 2024.

Results
Three overarching themes developed that mapped to six of the seven constructs within the theoretical framework of acceptability. The themes were: (1) Efficacy: Patients and healthcare professionals felt that the remote intervention would increase patient reassurance. Healthcare professionals perceived the intervention would improve clinical care pathways by overcoming delays for Holter monitors, but that a standard protocol would be required to ensure appropriate intervention use. (2) Burden: Patients considered that the device was non-obstructive and easy to use. However, healthcare professionals noted that although attaching the device was simple, there would be associated time and resource costs (eg, documentation). (3) Communication and education: Comprehensive verbal and written information were considered necessary to ensure that the intervention was usable by, and acceptable to, patients. Healthcare professionals suggested additional training would be required. Additionally, they considered that feedback from patient monitoring would reinforce their decision-making and improve healthcare professionals’ self-efficacy to use the device appropriately.

Conclusions
An immediate, enhanced (14-day) ambulatory ECG monitoring patch was positively received by patients and offered healthcare professionals an acceptable route for monitoring emergency department patients with unexplained syncope. However, future use should be controlled using standardised pathways to prevent inappropriate use.

Trial registration number
ISRCTN10278811.

Between 2020 and 2050, the world’s population aged 80 years and over will triple, drastically increasing the prevalence of frailty and associated healthcare costs. Multimodal exercise programmes have proven to be an ideal countermeasure for frailty, but the current Flemish standard of care does not include them. The purpose of this study is to investigate the effect of the home-based exercise programme for frail community-dwelling older adults ( >70 years), ACTIVE-AGE@home, on frailty-associated outcomes, when delivered by professionals or volunteers, as well as its cost-effectiveness. A pragmatic randomised controlled trial will be conducted. Participants will be randomised into three parallel groups using permuted block randomisation. There will be two intervention groups: in one group, the intervention is delivered by professionals with a bachelor or masters’ degree in physiotherapy, occupational therapy and/or physical education, and in the other by trained volunteers. Both groups will be compared with a control group receiving usual care. Participants (n=195) are community-dwelling physically frail older adults ( >70 years), as defined by Fried et al. (2001). The intervention is a 24 week programme that consists of three 1 hour visits per week and contains aerobic, strength, balance, flexibility, coordination and dual tasking exercises, accompanied by goal-setting and motivational interviewing. The Timed Chair Stand (TCS) test is the primary outcome. Functional ability, cognition, loneliness, self-management, health-related quality of life, healthcare utilisation and meaningful activities will be measured in all groups at 0, 24 and 48 weeks. Time and expenses invested by professionals or volunteers will be kept in diaries for trial and model-based cost-effectiveness analyses, expressed in incremental cost per QALY (quality-adjusted life year). The model will be designed to associate the frailty at the end of follow-up with further expected healthcare expenses beyond the duration of the trial. Statistical analysis will be blinded to group allocation, and outcome assessors will be blinded to the maximal extent possible.
Ethics and dissemination
Ethics approval has been obtained from the Medical Ethics Committee of UZ Brussel (O.G. 016), Peer reflection group Biomedical Ethics, Laarbeeklaan 101, 1090 Brussels. Results will be disseminated in publications and other relevant platforms. This study was registered at Clinicaltrials.gov on 6 July 2023 and posted on 14 July 2023 after National Library of Medicine quality control review. Registration details: NCT05946109

Trial registration number
NCT05946109.