Search Results for: Standard Italiani per la cura del diabete mellito

DiagnostiCare, prestazioni con donazioni a favore di chi non può

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.

Al Policlinico di Palermo, per i pazienti predisposti al tipo 1

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
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.

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
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

Pallaroni (Assalzoo),dare più informazione soprattutto a giovani

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.

Objective
The purpose of this study was to determine how strongly mean systolic blood pressure (mSBP, mm Hg) was related to hypertension control and if an mSBP

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.

Message The removal of colorectal polyps followed by histological evaluation is the current standard of care. Intracolonoscopy computer-aided characterisation (computer-assisted diagnosis (CADx)) has emerged as an alternative strategy to possibly avoid histopathology after removal. However, each of these approaches can be limited by cases in which a diagnosis is not possible or inaccurate. We conducted a post hoc analysis of a prospective clinical study involving 249 diminutive polyps diagnosed by CADx in 164 consecutive patients. Of those polyps, 29 were diagnosed as ‘normal mucosa’ on histopathology (11.6%). Polyps diagnosed as ‘normal mucosa’ were reviewed by two independent blinded pathologists, and 24.1% were reassessed as adenomas after additional sections were performed. Besides superficial sectioning (24.1%), fragmentation (44.8%) and inadequate specimen preparation and handling (31.0%) were considered as reasons for misdiagnosis. Reassessment decreased the overall accuracy of histopathology to 88.4% (95% CI 83.7% to 92.1%). On the other hand, in…

Pancreatic ductal adenocarcinoma (PDAC) remains one of the most lethal malignancies, with a dismal 5-year survival rate of less than 10%.1 Despite significant advances in cancer treatment over the past decades, PDAC has stubbornly defied progress, with most patients showing limited response to standard chemotherapy regimens. Perhaps most disappointingly, the revolutionary success of immunotherapy in various cancer types has not translated to PDAC, with checkpoint inhibitors and other immunomodulatory strategies showing dismally low response rates.2 This lack of efficacy is thought to be largely due to the characteristic PDAC tumour microenvironment (TME) that contributes to make this cancer immunologically ‘cold’.3 Characterised by a dense stromal compartment, low T cell infiltration and an overall immunosuppressive microenvironment, PDACs present a formidable barrier to the immune system that ultimately explains the inefficiency of current immunotherapeutic approaches. Whether and to what extent strategies can be identified to…

We read with interest the letter from Han et al about our study1 and we thank those authors for underlining points to be discussed about the real place of single use and reusable endoscope strategies. Although the benefits for reducing cross-infections seem significant, assessing the positive indirect environmental impact is difficult, as the number of patients involved in high-infection risk2 care remains very low compared with the daily endoscopy practice evaluated in this study, with conventional gastroscopes, disinfected in the standard way, in a routine activity and not in intensive care units with high-level disinfection processes.3 Moreover, this study focused on gastroscopes, with low risk of cross-infections in opposition to duodenoscopes. Of course, the weight of the endoscope’s plastic is an important element in the analysis, explaining the difference between our results and those reported for lighter disposable endoscopes (anaesthesia or urology)

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