Search Results for: AGA: linee guida sulla de-prescrizione degli inibitori della pompa protonica

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.

Vaccinare contro influenza e bronchioliti. La Guida dei pediatri

Introduction
Cachexia is strongly associated with digestive cancers, particularly oesogastric cancer. Mitochondria in adipose tissue are involved in the regulation of metabolism and physiopathology of cancer cachexia in animal studies. Chemotherapeutic regimens used to control tumour development could also alter mitochondrial function in adipose tissue. We hypothesise that cachexia induces an increase in adipose tissue mitochondrial energy metabolism and that chemotherapy can mitigate this. The purpose of the ChiFMeOE study is to identify adipocyte factors involved in the energy imbalance associated with the cachectic process and their response to chemotherapeutic treatments in patients with oesogastric cancer.

Methods and analysis
ChiFMeOE is a single-centre observational study that will prospectively include 60 patients referred to chemotherapy and surgery for oesophageal and gastro-oesophageal junction adenocarcinomas at the University Hospital of Clermont-Ferrand, France. Visceral and subcutaneous adipose tissue biopsies will be collected during surgery scheduled before and after neoadjuvant chemotherapy administration, as well as cachexia and nutritional assessment. The primary outcome is the maximum mitochondrial respiration rate (Vmax) measured by high-resolution respirometry. Secondary outcomes are other mitochondrial parameters (ie, enzymatic activities, proteins content and gene expression), tumour characteristics, nutritional status and body composition.

Ethics and dissemination
The study was approved by an independent institutional review board on June 2023 (Comité de protection des personnes Sud-Méditerranée V; 2023-A00582-43) and declared to the French regulatory authority for research. Written informed consent will be obtained prior to patient inclusion. The principal investigator will be notified of any changes in patient’s health status requiring a modification of his management and/or treatment during the course of the protocol. Results will be published in peer-reviewed journals.

Trial registration number
ClinicalTrials.gov, NCT05954117.

Introduction
The COVID-19 pandemic has had a major impact on nursing staff, resulting in alarming turnover rates. As part of the Quebec (Canada) government’s response to the pandemic, nurses have been offered exceptional financial incentives. Considering the cost of these measures, the current article presents the research protocol of a study aiming to explore the impact of financial incentives on full-time equivalent, and retention rates among the nursing staff in two healthcare settings in Quebec.

Methods and analysis
A sequential mixed design (QUANT- >QUAL) will be used. The quantitative phase will involve a quantitative descriptive analysis and the qualitative phase will consist of a qualitative descriptive study. Administrative data (working hours, employment status and retention rate) will be analysed over a 4.5-year follow-up (from 1 January 2019 to 30 June 2023) to explore the impact of the financial incentives. Focus groups will explore nurses’ views on financial incentives. The results will inform the development of future interventions to mitigate attrition problems among nurses and ultimately improve access to and the continuity of public health services.

Ethics and dissemination
The study has been approved by ethics committees of the participating healthcare settings (Comité d’éthique de la recherche sectorial en santé des populations et première ligne du CIUSSS de la Capitale-Nationale; Comité d’éthique de la recherche du CISSS de Chaudière-Appalaches). The results will be disseminated mainly in scientific publications and at academic conferences in addition to presentations tailored to various non-academic audiences.

Introduction
Despite several calls to deprescribe benzodiazepine receptor agonists (BZRA) in older adults, their use among nursing home residents (NHRs) remains high. Therefore, we developed an intervention targeting general practitioners’ and healthcare professionals’ behaviours regarding BZRA deprescribing in nursing homes (NHs): The END-IT NH (bENzodiazepines Deprescribing InTerventions Nursing homes) 6-component intervention. Before moving on to a large-scale effectiveness and cost-effectiveness evaluation, this feasibility study aims at: (1) assessing the feasibility of the intervention implementation in NHs, (2) assessing the feasibility of conducting a larger-scale evaluation, in terms of recruitment and data collection and (3) conducting an exploratory cost-effectiveness evaluation.

Methods and analysis
We will conduct a cluster-randomised controlled trial in a sample of 6 NHs, with 10–15 NHRs included per NHs. Four NHs will be randomised into the intervention group, and two NHs will deliver usual care (control group). Data collection will occur at baseline, 3, and 6 months (study end). We will collect information to explore implementation fidelity, mechanisms of impact and contextual factors at patient-level, NH-level and healthcare professional-level, using both quantitative and qualitative measures. The feasibility of the study conduction will be assessed by measuring recruitment and attrition rates and completeness of data collection. An exploratory cost-effectiveness evaluation will be conducted based on quality of life and healthcare use and cost data.

Ethics and dissemination
This study protocol received approval from the ethical committee of CHU UCL Namur on the 20 June 2023. All data are confidential and will be anonymised prior to analysis. De-identified data will be shared on a data depository with a 2-year embargo. The results of the study will be disseminated through a scientific paper and will be communicated to local stakeholders and policymakers through a local symposium.

Trial registration number
NCT05929443.

Objective
To evaluate the impact of coadministering statins with direct oral anticoagulants (DOACs) on the risk of major bleeding events in patients with venous thromboembolism (VTE).

Design
Observational cohort analysis based on a multicentre international registry.

Setting
Data were extracted from the Registro Informatizado de Enfermedad TromboEmbolica Registry, which involves 205 centres across 27 countries.

Participants
A total of 73 659 patients diagnosed with VTE were classified based on their anticoagulant therapy (DOACs) versus low-molecular-weight heparin (LMWH) or vitamin K antagonists (VKAs) and concurrent use of statins.

Methods
Multivariable Cox proportional hazards models adjusted for confounding variables to assess the risk of major bleeding events stratified by the type of anticoagulant use and statin use.

Results
From October 2013 to February 2023, 73 659 patients were recruited: 2573 were statin users on DOACs, 14 090 were statin users on LMWH or VKA therapy, 10 088 were non-statin users on DOACs and 46 908 were non-statin users on LMWH or VKA therapy. Statin users were 10 years older and more likely to have hypertension, diabetes, renal failure or prior artery disease. During anticoagulation (median, 187 days), 1917 patients (2.6%) suffered major bleeding. Rates of major bleeding per 100 patient-years were 2.33 (95% CI 1.72 to 3.09), 3.75 (95% CI 3.43 to 4.10), 1.39 (95% CI 1.13 to 1.69) and 3.10 (95% CI 2.93 to 3.27), respectively. On multivariable analysis, patients treated with DOACs had a significantly lower risk of major bleeding compared with those on LMWH or VKA therapy (adjusted HR 0.59; 95% CI 0.48 to 0.74). The adjusted HR in statin users versus non-users was 1.03 (95% CI 0.92 to 1.14), while in statin users on DOACs versus the rest of patients, it was 1.18 (95% CI 0.79 to 1.76).

Conclusions
In patients with VTE receiving statins, long-term anticoagulation with DOACs was associated with a reduced risk of major bleeding, regardless of the statin use. These findings support the safety profile of DOACs over VKAs or LMWH in the management of VTE in patients requiring statins.

Introduction
Internationally, the number of individuals living with dementia continues to rise. Individuals living with dementia, their care partners and their care team face many barriers and challenges to accessing dementia care resources and supports. One solution to address the multifaceted care needs of this population is patient navigation (PN).

Methods and analysis
This protocol describes the implementation and evaluation plan for a pilot PN programme in New Brunswick (NB) Canada for individuals living with dementia, their care partners and care providers. This project will include two components: (1) an in-person PN programme called Navigating Dementia NB/ Naviguer la démence NB and (2) two virtual peer-to-peer navigational support groups. The PN programme will be codesigned with stakeholders including researchers, patient partners, clinicians and health system managers. Patient navigators will be housed at six primary care sites across the province and the services will be offered in English and French. We will conduct a mixed-methods evaluation to explore the characteristics and experiences of participants who enrol in the PN programme and the navigational support groups, as well as the facilitators and barriers to implementation. Data collection will include navigation charts, Facebook analytics, as well as postintervention surveys, semistructured interviews and focus groups. All participants will provide written informed consent to take part in the intervention and have their data collected for research and evaluation purposes. Demographic data will be analysed using frequency and central tendency measures, while qualitative data from interviews and focus groups will undergo thematic analysis. Content analysis will be used to analyse posts published to the Facebook groups. The evaluation will assess the programme’s effectiveness in the short and medium terms, evaluating its ability to achieve the intended outcomes.

Ethics and dissemination
This study has been approved by the research ethics boards at the University of New Brunswick, Université de Moncton, Horizon Health Network and Vitalité Health Network. Knowledge translation activities (eg, presentations at local, national and international conferences; publications for open-access journals; reports and lay summaries) will be undertaken to share the findings from this pilot project with diverse stakeholders, such as decision-makers, health system managers, clinicians and the general public.

We performed an updated systematic review and network meta-analysis to inform the 2024 American Gastroenterological Association (AGA) Clinical Guidelines on the management of moderate-to-severe ulcerative colitis (UC).