Search Results for: Approcci terapeutici per il cancro al seno: review

Background
Migrants and refugees with low language proficiency (LLP) in the dominant language of their host country have a higher risk of suffering from certain mental health disorders compared with non-migrant populations. They are also more likely to experience a lack of access to mental healthcare due to language-related and culture-related barriers. As part of the MentalHealth4All project, a digital multilingual communication and information platform was developed to promote access to mental healthcare for LLP migrants and refugees across Europe. This paper describes the study protocol for evaluating the platform in practice, among both health and/or social care providers (HSCPs) and LLP migrants and refugees.

Methods and analysis
We will conduct a pretest–post-test cross-national survey study to evaluate the platform’s effect evaluation (primary objective) and process evaluation (secondary objective). The primary outcomes (measured at T0, T2 and T3) are four dimensions of access to mental healthcare services: availability, approachability, acceptability and appropriateness of mental healthcare. Secondary outcomes (measured at T2) are: actual usage of the platform (ie, tracking data), perceived ease of use, usefulness of content, comprehensibility of information, attractiveness of content and emotional support. Participants will be recruited from nine European countries: Belgium, Germany, Italy, Lithuania, the Netherlands, Poland, Slovakia, Spain and the UK. Using convenience sampling through professional networks/organisations and key figures, we aim to include at least 52 HSCPs (ie, 6–10 per country) and 260 LLP migrants (ie, 30–35 per country). After completing a pretest questionnaire (T0), participants will be requested to use the platform, and HSCPs will participate in an additional personalised training (T1). Next, participants will fill out a post-test questionnaire (T2) and will be requested to participate in a second post-test questionnaire (T3, about 6–8 weeks after T2) to answer additional questions on their experiences through a brief phone interview (T3 is optional for migrants/refugees).

Ethics and dissemination
For all nine countries, the ethical review board of the participating university (hospital) has assessed and approved the protocol. If successful, the MentalHealth4All platform will be made publicly available to help improve access to mental healthcare services, as well as HSCPs’ cultural competencies in delivering such services, for any LLP migrants and refugees across Europe (and beyond). Findings will also be disseminated through peer-reviewed journals and conferences.

Registration details
The ‘MHealth4All project’ was prospectively registered on Open Science Framework, DOI: 10.17605/OSF.IO/U4XSM.

Introduction
Effective health management is critical for patients with tuberculosis (TB), especially given the need for long-term treatment adherence and continuous monitoring. Artificial intelligence (AI)-assisted remote health management services offer a promising solution to increase patient engagement, optimise follow-up and improve treatment outcomes. However, little research has explored TB patients’ preferences for these services, and no discrete choice experiment (DCE) has systematically investigated how they make trade-offs between different service attributes. This study aims to (1) identify key attributes of AI-assisted remote health management services that influence TB patients’ choices, (2) assess how patients with TB evaluate trade-offs between different service options using a DCE and (3) examine whether preferences vary by sociodemographic characteristics and health system factors.

Methods and analysis
Six attributes were identified through a literature review, focus group discussions and expert consultations. A fractional factorial design was used to generate choice sets while maintaining statistical efficiency and minimising respondent burden. The DCE will be analysed using a multinomial logit model to estimate average preferences. A mixed logit model will be applied to explore preference heterogeneity among participants, incorporating interaction terms with sociodemographic and attitudinal variables. Stratified and latent class analyses will also be considered to further investigate sources of heterogeneity.

Ethics and dissemination
This study complies with the Declaration of Helsinki and has been approved by the Ethics Committee of Wuhan Pulmonary Hospital. All participant data will remain anonymous, and individuals may withdraw from the study at any time. The findings will inform the development of patient-centred AI-assisted TB management strategies and contribute to broader policy discussions on AI integration in TB care. The results will be disseminated through peer-reviewed journal publications, policy briefs, conferences and online platforms.

Introduction
Histopathological evaluation of prostate biopsies using the Gleason scoring system is critical for prostate cancer diagnosis and treatment selection. However, grading variability among pathologists can lead to inconsistent assessments, risking inappropriate treatment. Similar challenges complicate the assessment of other prognostic features like cribriform cancer morphology and perineural invasion. Many pathology departments are also facing an increasingly unsustainable workload due to rising prostate cancer incidence and a decreasing pathologist workforce coinciding with increasing requirements for more complex assessments and reporting. Digital pathology and artificial intelligence (AI) algorithms for analysing whole slide images show promise in improving the accuracy and efficiency of histopathological assessments. Studies have demonstrated AI’s capability to diagnose and grade prostate cancer comparably to expert pathologists. However, external validations on diverse data sets have been limited and often show reduced performance. Historically, there have been no well-established guidelines for AI study designs and validation methods. Diagnostic assessments of AI systems often lack preregistered protocols and rigorous external cohort sampling, essential for reliable evidence of their safety and accuracy.

Methods and analysis
This study protocol covers the retrospective validation of an AI system for prostate biopsy assessment. The primary objective of the study is to develop a high-performing and robust AI model for diagnosis and Gleason scoring of prostate cancer in core needle biopsies, and at scale evaluate whether it can generalise to fully external data from independent patients, pathology laboratories and digitalisation platforms. The secondary objectives cover AI performance in estimating cancer extent and detecting cribriform prostate cancer and perineural invasion. This protocol outlines the steps for data collection, predefined partitioning of data cohorts for AI model training and validation, model development and predetermined statistical analyses, ensuring systematic development and comprehensive validation of the system. The protocol adheres to Transparent Reporting of a multivariable prediction model of Individual Prognosis Or Diagnosis+AI (TRIPOD+AI), Protocol Items for External Cohort Evaluation of a Deep Learning System in Cancer Diagnostics (PIECES), Checklist for AI in Medical Imaging (CLAIM) and other relevant best practices.

Ethics and dissemination
Data collection and usage were approved by the respective ethical review boards of each participating clinical laboratory, and centralised anonymised data handling was approved by the Swedish Ethical Review Authority. The study will be conducted in agreement with the Helsinki Declaration. The findings will be disseminated in peer-reviewed publications (open access).

Background
Trans Tasman Radiation Oncology Group 20.01 CHEST-RT (Chemotherapy and Immunotherapy in Extensive Stage Small cell with Thoracic Radiotherapy) is a single-arm, open-label, prospective, multicentre phase II trial study that aims to establish the safety, feasibility and describe the efficacy of incorporating thoracic radiotherapy (TRT) (concurrent or sequential) to chemotherapy and immunotherapy in patients with extensive-stage small-cell lung cancer.

Methods
A single arm of up to 30 evaluable participants given TRT concurrent or sequentially with chemoimmunotherapy will be enrolled. Participants should commence radiotherapy with cycle 3 or cycle 4 of chemotherapy. Those not suitable for concurrent radiotherapy due to large tumour volumes may receive sequential radiotherapy. Accounting for a 15% non-evaluable rate, up to 35 participants will be enrolled. An independent data and safety monitoring committee will review the data and assess safety and feasibility. Progression to a phase III trial would be considered feasible if ≤20% of participants experienced ≥grade 3 oesophageal toxicity and ≤10% experienced ≥grade 3 pneumonitis. This approach would be considered feasible if there is ≤20% treatment discontinuation of systemic therapy secondary to radiation toxicities and ≥75% of participants have tumour volumes that can be safely treated to a dose of 30 Gy in 10 fractions. The primary outcome of the trial is safety and feasibility, and survival and responses will be assessed as secondary endpoints. A predefined subgroup analysis of toxicity will be performed on group 1 (concurrent TRT) versus group 2 participants (consolidation TRT).

Ethics and dissemination
This study was approved by the Peter MacCallum Human Research Ethics Committee (HREC/73189/PMCC-2021). The protocol, technical and clinical data will be disseminated by conference presentations and publications. Any modifications to the protocol will be formally documented by administrative letters and will be submitted to the approving HREC for review and approval.

Trial registration numbers
Australian New Zealand Clinical Trials Registry (ACTRN12621000586819) and ClinicalTrials.gov identifier (NCT05796089).

Introduction
Most older adults living in residential aged care facilities (RACFs) have at least one marker of potentially suboptimal prescribing. Pharmacists play a crucial role in medication management, with their effectiveness enhanced by using computerised decision support tools. The Pharmacists Review to Optimise Medicines in Residential Aged Care (PROMPT-RC) study aims to optimise medicine use by providing pharmacists in RACFs with an electronic medicine management app with integrated decision support (AusTAPER App/Pathway) to use as part of medication reviews they undertake.

Methods and analysis
The PROMPT-RC study is a parallel cluster randomised controlled trial design involving Australian RACFs. It will assess if pharmacists’ use of the AusTAPER App/Pathway for medication reviews improves medication regimens for RACF residents compared with usual care. Pharmacists in RACFs randomised to the intervention arm will be trained to use the AusTAPER App/Pathway, which flags potentially inappropriate medicines (PIMs) across a person’s entire medicine regimen. Pharmacists in RACFs randomised to the control arm will not have access to the AusTAPER App/Pathway—they will continue to provide usual care. The primary outcome is the difference in the number of regular medicines between treatment arms at 12 months. Secondary outcomes will measure the number of regular and pro re nata medicines, PIMs, medicine administration times, medicine regimen complexity, use of antipsychotics, antidepressants, and benzodiazepines, quality of life, mortality, instances of physical restraint, and the number of falls, hospitalisations and general practitioner/health professional visits. The cost-effectiveness of the AusTAPER App/Pathway compared with usual care will be calculated. Data collection will occur at baseline, 3, 6, 9 and 12 months postrandomisation and 3 and 6 months prebaseline. We aim to recruit 668 participants to adjust for an estimated 10% loss to follow-up, giving 334 participants in each arm. Data analysis will follow an intention-to-treat approach using a linear mixed model.

Ethics and dissemination
Ethical approval was obtained from The University of Western Australia Human Research Ethics Committee (Reference: 2024/ET000525; approved 14 August 2024). Reciprocal approval was also obtained in other states. This study is registered on the Australian New Zealand Clinical Trials Registry (https://anzctr.org.au). Trial findings will be disseminated through national and international peer-reviewed publications and conferences.

Trial registration number
ACTRN12624001409561.

This Rational Clinical Examination systematic review aims to identify predictors of physical abuse among young children with a traumatic injury.

Ricercatori Biogem, si apre la strada a cure mirate

Ricercatori Biogem, si apre la strada a cure mirate

Inflammatory bowel diseases (IBDs), which include ulcerative colitis (UC) and Crohn’s disease (CD), are chronic conditions characterised by inflammation of the intestinal tract. Alterations in virtually all intestinal cell types, including immune, epithelial and stromal cells, have been described in these diseases. The study of IBD has historically relied on bulk transcriptomics, but this method averages signals across diverse cell types, limiting insights. Single-cell omic technologies overcome the intrinsic limitations of bulk analysis and reveal the complexity of multicellular tissues at a cell-by-cell resolution. Within healthy and inflamed intestinal tissues, single-cell omics, particularly single-cell RNA sequencing, have contributed to uncovering novel cell types and cell functions linked to disease activity or the development of complications. Collectively, these results help identify therapeutic targets in difficult-to-treat complications such as fibrostenosis, creeping fat accumulation, perianal fistulae or inflammation of the pouch. More recently, single-cell omics have gradually been adopted in studies to understand therapeutic responses, identify mechanisms of drug failure and potentially develop predictors with clinical utility. Although these are early days, such studies lay the groundwork for the implementation in clinical practice of new technologies in diagnostics, monitoring and prediction of disease prognosis. With this review, we aim to provide a comprehensive survey of the studies that have applied single-cell omics to the study of UC or CD, and offer our perspective on the main findings these studies contribute. Finally, we discuss the limitations and potential benefits that the integration of single-cell omics into clinical practice and drug development could offer.

Zeng X. Unleashing the potential of exosome ncRNAs for early gastric cancer detection—a critical appraisal of machine learning approaches. Gut 2025;74:1191–1192.
This letter1 has been retracted by Gut due to apparent peer review manipulation.
BMJ has evidence that this letter’s peer review process was compromised. Two reviewers, recommended by the authors, used the same computer to submit their peer review comments as the submitting author used to submit the article to the journal. The authors and reviewers were asked to respond to these concerns and provide an explanation, but did not provide a satisfactory response.

Introduction: the hidden labour behind clinical guidelines The British Society of Gastroenterology’s (BSG) latest 5-year national guideline for inflammatory bowel disease (IBD)1 has recently completed. This adjunct commentary to the guideline contains the reflections of two chairs—one methodological, one clinical—who steered the process. It is not written to seek praise or indulgence but rather to lay bare the pragmatic decisions, structural challenges and emerging questions that surfaced while leading the guideline process. We offer five key insights to inform future BSG guideline work and to contribute to international dialogue on how we produce, update and future-proof clinical guidance in increasingly complex evidence environments. Breadth versus usability: how big is too big? The scope of this guideline is vast—over 100 000 words, 43 recommendations, 114 good practice statements with nearly 800 original manuscripts referenced, prompting peer review to suggest relegating many visual and tabular summaries to supplementary…

Circulation, Volume 152, Issue 1, Page 58-73, July 8, 2025. The increasing demand for donor hearts presents both a critical challenge and a significant opportunity for innovation in cardiac transplantation. Advancements in immunosuppressive regimens and genetic engineering have reignited recent interest in xenotransplantation. Notably, 2 human patients have received genetically modified pig hearts under expanded-access authorization. They survived for 40 and 60 days, with xenograft failure preceding death in both cases. Concurrently, decedent studies have focused on monitoring the short-term physiological function of genetically modified cardiac xenografts in legally brain-dead recipients, representing a novel experimental paradigm for preclinical testing to help bridge the gap between nonhuman primate studies and clinical trials. These contemporary achievements build on a large body of exploratory efforts in cardiac xenotransplantation in nonhuman primates. Despite significant progress in overcoming hyperacute rejection, adaptive cellular and humoral immunological barriers remain. This review aims to critically evaluate the current advancements in xenotransplantation, to explore ongoing challenges, and to discuss the future potential of this innovative approach in addressing the growing demand for donor organs in cardiac transplantation.

Objective
The aim of this study was to construct a quality evaluation indicator system for extended care in patients with chronic obstructive pulmonary disease (COPD), provide beneficial references for quality evaluation and practice standardisation of extended care.

Design
This study was conducted from April to November 2023. Based on the three-dimensional quality structure model of ‘structure–process–result’, we used literature review and Delphi method to form the quality evaluation indicator system for extended care in patients with COPD and determined the weight of each indicator by analytic hierarchy process (AHP).

Setting
Zhengzhou Central Hospital Affiliated to Zhengzhou University and School of Nursing and Health, Zhengzhou University, Zhengzhou, Henan, China.

Participants
20 experts from different universities and hospitals in China participated in the study. They all had profound attainments in clinical treatment, nursing and extended care of COPD.

Primary outcome measures
Effective questionnaire response rate, coefficient of expert authority, arithmetic mean, proportion of maximum score, Kendall harmony coefficient, scores of importance, variation coefficient and weight were used to evaluate the quality evaluation indicator system for extended care.

Results
In the two rounds of Delphi expert consultation, the effective questionnaire response rates were both 100%. The coefficients of expert authority were 0.83 and 0.89, respectively. Kendall harmony coefficients were 0.088 and 0.215, respectively. The final formed quality evaluation indicator system for extended care included 3 primary indicators, 10 secondary indicators and 40 tertiary indicators. For each indicator, the variation coefficient was 0.063–0.151 and the weight was 0.001–0.065.

Conclusion
The quality evaluation indicator system for extended care based on mature theoretical basis and scientific method is scientific and reliable. And the weight of each indicator is set reasonably and accurately, which could provide a basis for quality evaluation and continuous quality improvement of extended care.

Introduction
Urban green and blue space (UGBS) interventions, such as the development of an urban greenway, have the potential to provide public health benefits and multiple co-benefits in the realms of the environment, economy and society. This paper presents the protocol for a 5-year follow-up evaluation of the public health benefits and co-benefits of an urban greenway in Belfast, UK.

Methods and analysis
The natural experiment evaluation uses a range of systems-oriented and mixed-method approaches. First, using group model building methods, we codeveloped a causal loop diagram with stakeholders to inform the evaluation framework. We will use other systems methods including viable systems modelling and soft systems methodology to understand the context of the system (ie, the intervention) and the stakeholders involved in the development, implementation and maintenance phases. The effectiveness evaluation includes a repeat cross-sectional household survey with a random sample of 1200 local residents (adults aged ≥16 years old) who live within 1 mile of the greenway. The survey is complemented with administrative data from the National Health Service. For the household survey, outcomes include physical activity, mental well-being, quality of life, social capital, perceptions of environment and biodiversity. From the administrative data, outcomes include prescription medications for a range of non-communicable diseases such as cardiovascular disease, type II diabetes mellitus, chronic respiratory and mental health conditions. We also investigate changes in infectious disease rates, including COVID-19, and maternal and child health outcomes such as birth weight and gestational diabetes. A range of economic evaluation methods, including a cost-effectiveness analysis and social return on investment (SROI), will be employed. Findings from the household survey and administrative data analysis will be further explored in focus groups with a subsample of those who complete the household survey and the local community to explore possible mechanistic pathways and other impacts beyond those measured. Process evaluation methods include intercept surveys and direct observation of the number and type of greenway visitors using the Systems for Observing Play and Recreation in Communities tool. Finally, we will use methods such as weight of evidence, simulation and group model building, each embedding participatory engagement with stakeholders to help us interpret, triangulate and synthesise the findings.

Ethics and dissemination
To our knowledge, this is one of the first natural experiments with a 5-year follow-up evaluation of an UGBS intervention. The findings will help inform future policy and practice on UGBS interventions intended to bring a range of public health benefits and co-benefits. Ethics approval was obtained from the Medicine, Health and Life Sciences Research Ethics Committee prior to the commencement of the study. All participants in the household survey and focus group workshops will provide written informed consent before taking part in the study. Findings will be reported to (1) participants and stakeholders; (2) funding bodies supporting the research; (3) local, regional and national governments to inform policy; (4) presented at local, national and international conferences and (5) disseminated by peer-review publications.

Objectives
To determine how high performing is defined in relation to a health system and chart the literature on the definitions and key concepts of high-performing healthcare systems.

Design
Scoping review.

Data sources
MEDLINE, EMBASE, CINAHL and the Cochrane Central Register of Controlled Trials were searched from inception to July 2024. The grey literature was also searched.

Eligibility criteria
Included studies reported on health systems and high performance to identify explicit definitions, research outcomes and knowledge gaps.

Results
Two reviewers independently screened 5721 citations and 507 full-text articles, resulting in the inclusion of 35 primary articles and 47 companion documents in the review. Three independent definitions for a high-performance health system were identified. 24 research studies reported outcomes on the elements of a high-performing health system (58%), system evaluation (32%) and tool development or validation (10%). Knowledge gaps identified were the lack of a common definition, a lack of common indicators, strategies for moving evidence into policy and practice, and difficulties with comparisons across health systems.

Conclusions
We found limited definitions and a lack of empirical evidence on our topic. There is an opportunity for primary research in the area of health systems and high performance.