Risultati per: Screening, cura e trattamento dell’Epatite C

Colpito almeno il 7% italiani, solo il 10% dei pazienti lo sa

Introduction
ISMiHealth is a clinical decision support system, integrated as a software tool in the electronic health record system of primary care, that aims to improve the screening performance on infectious diseases and female genital mutilation (FGM) in migrants. The aim of this study is to assess the health impact of the tool and to perform a process evaluation of its feasibility and acceptability when implemented in primary care in Catalonia (Spain).

Methods and analysis
This study is a cluster randomised control trial where 35 primary care centres in Catalonia, Spain will be allocated into one of the two groups: intervention and control. The health professionals in the intervention centres will receive prompts, through the ISMiHealth software, with screening recommendations for infectious diseases and FGM targeting the migrant population based on an individualised risk assessment. Health professionals of the control centres will follow the current routine practice.
A difference in differences analysis of the diagnostic rates for all aggregated infections and each individual condition between the intervention and control centres will be performed. Mixed-effects logistic regression models will be carried out to identify associations between the screening coverage and predictor factors. In addition, a process evaluation will be carried out using mixed methodology.

Ethics and dissemination
The study protocol has been approved by the institutional review boards at Hospital Clínic (16 June 2022, HCB/2022/0363), Clinical Research Ethics Committee of the Primary Care Research Institute IDIAPJGol (22 June 2022, 22/113-P) and the Almería Research Ethics Committee (27 July 2022, EMC/apg). The study will follow the tenets of the Declaration of Helsinki and Good Clinical Practice. All researchers and associates signed a collaboration agreement in which they undertake to abide by good clinical practice standards.
Findings will be disseminated in peer-reviewed journals and communications to congresses.

Trial registration number
NCT05868005.

Introduction
Microwave imaging presents several potential advantages including its non-ionising and harmless nature. This open, multicentric, interventional, prospective, non-randomised trial aims to validate MammoWave’s artificial intelligence (AI)-based classification algorithm, leveraging microwave imaging, to achieve a sensitivity exceeding 75% and a specificity exceeding 90% in breast screening.

Methods and analysis
10 000 volunteers undergoing regular mammographic breast cancer screening will be recruited across 9 European centres and invited to participate in the clinical study, involving MammoWave testing on both breasts. MammoWave results will be checked against the reference standard, to be intended as the output of conventional breast examination path (with histological confirmation of cancer cases) with 2 years follow-up. Anonymised clinical and MammoWave’s results, including microwave images, associated features and a label provided by the AI-based classification algorithm, will be collected and stored in a dedicated electronic case report form. The prospective study will involve a comparative analysis between the output of the conventional breast examination path (control intervention) and the labels provided by MammoWave’s AI system (experimental intervention). These labels will categorise breasts into two groups: breast With Suspicious Finding, indicating the presence of a suspicious lesion or No Suspicious Finding, indicating the absence of a lesion or the presence of a low-suspicion lesion. This trial aims to provide evidence regarding the novel MammoWave’s AI system for detecting breast cancer in asymptomatic populations during screening.

Ethics and dissemination
This study was approved by the Research Ethics Committee of the Liguria Region (CET), Italy (CET-Liguria: 524/2023—DB id 13399), the Research Ethics Committee of Complejo Hospitalario de Toledo (CEIC), Spain (CEIC-1094), the National Ethics Committee for Clinical Research (CEIC), Portugal (CEIC-2311KC814), the Bioethical Committee of Pomeranian Medical University in Szczecin, Poland (KB-006/23/2024) and the Zurich Cantonal Ethics Commission, Switzerland (BASEC 2023-D0101). The findings of this study will be disseminated through academic and scientific conferences as well as peer-reviewed journals.

Trial registration number
NCT06291896.

Dermatomyositis (DM) is an autoimmune disease of unknown etiology belonging to the family of idiopathic inflammatory myopathies (IIMs). The association of DM with cancer has long been established and there is increased prevalence of various cancers, including breast, ovarian, colorectal, lung, nasopharyngeal, and lung cancers. Cancers in IIMs are frequently diagnosed at later stages, making cancer the leading cause of death in adults with IIMs. Despite this increased prevalence of and worse prognosis associated with underlying cancer, screening recommendations for cancer detection in patients with IIM have been debated for many years, with wide variability in screening practices. This lack of clarity regarding ideal cancer screening practices became further complicated with the expanding knowledge of myositis-specific antibodies and their association with cancer risk, which raised the question of how to apply serology status to screening protocols. Finally, there has been a need to balance early cancer detection with avoidance of unnecessary screening procedures, given that cancer prevalence is best estimated at only 15% to 25% of patients with DM. Thus, applying screening to all patients is associated with many unnecessary procedures.

This Viewpoint explores how guideline groups can come together to agree on a framework that produces clear and unified recommendations.

This Viewpoint discusses the potential risks and benefits for starting screening at 40 rather than 50 years of age and whether clinicians or patients should decide based on risk rather than age.

This cohort study investigates the performance of the International Myositis Assessment and Clinical Studies Group cancer screening recommendations in a community setting.

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Annals of Internal Medicine, Ahead of Print.

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