Search Results for: La qualità dei nutraceutici e position paper per l’appropriato uso in medicina generale

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Introduction
The diversity of participating investigators representing diverse disciplines, career stages, stakeholder groups, regions and types of institutions is essential for the success of large-scale research programmes. In 2021, the National Institutes of Health introduced a requirement for some of its large grants to include a separate section that describes the project’s plan for enhancing diverse perspectives (PEDPs). Our project aims to develop consensus-based PEDP evaluation metrics and instruments that can be systematically and sustainably collected across the projects.

Methods and analysis
Evaluation work is organised into three objectives. First, shared knowledge about PEDP infrastructures, activities and outcomes will be elicited through the review of the PEDP texts of funded projects, with 15 as the target sample size. Data will be analysed using a cultural domain analysis approach and assessed for recurrence and salience of PEDP metrics. Second, consensus-based evaluation metrics will be developed using a three-round Delphi method. The descriptive statistics (mean, SD and IQR) and cultural consensus analyses will be applied to the first and last rounds of the Delphi survey. Third, metrics will be piloted for implementation and validation within one of the Human BioMolecular Atlas Programme sites. Work will be completed by Fall 2025.

Ethics and dissemination
The long-term goal of the effort reported in this paper is to develop PEDP common metrics that are generalisable and feasible across diverse projects. This rigorous, focused evaluation development effort aims to inform scientific practices and policies around implementing the plans to enhance diverse perspectives.

Objectives
The study aimed to assess the prevalence of reproductive health problems among youths and the utilisation of services and associated factors in urban Ethiopia.

Design
This paper presents findings related to sexual and reproductive health (SRH) based on a formative assessment of the Integrated Youth Activity which is conducted by cross-sectional study.

Setting
Youths from community and higher education institutions were included from 13 major urban towns of Ethiopia in the study.

Participants
A total of 1954 youths from community settings were included from randomly selected eligible households and 1261 students were included from higher education institutions.

Primary outcomes
The youths’ experience of unwanted pregnancy; exposure to high-risk sexual behaviour (HRSB); SRH service utilisation; and current use of family planning (FP) services.

Results
Among youths, 35% have engaged in HRSB, more than 14% have experienced at least one unwanted pregnancy and 26.7% have used SRH services. Additionally, only 26.4% of female youths use FP. The uptake of SRH services is lower among unmarried youths, those aged 18–19, individuals with no access to mass media and those who do not encounter SRH messages. Unintended pregnancy among women is common among those in higher education, lacking comprehensive HIV knowledge and engaging in HRSB. HRSB is prevalent among youths with no education, aged 18–19, who have not used SRH or FP services, and those with multiple social media accounts.

Conclusion
A relatively high proportion of youths exhibit low uptake of SRH and FP services, with a higher proportion exposed to HRSB and unintended pregnancy. Barriers to the utilisation of SRH services as well as increased risk of HRSB, including unwanted pregnancies, are often linked to poor access to accurate and relevant SRH information. To address this gap, delivering targeted SRH-related messages through social media and mass media broadcasts can play a transformative role. This approach not only broadens youth access to reliable SRH information but also enhances their health literacy by increasing the credibility and relevance of the information provided.

Introduction
Oligodendroglioma (ODG) is a rare type of brain tumour, typically diagnosed in younger adults and associated with prolonged survival following treatment. The current standard of care is maximal safe debulking surgery, radiotherapy (RT) and adjuvant procarbazine, lomustine and vincristine (PCV) chemotherapy. Patients may experience long-term treatment-related toxicities, with RT linked to impairments of neurocognitive function (NCF) and health-related quality of life (HRQoL). With proton beam therapy (PBT), radiation dose falls off sharply beyond the target with reduced normal brain tissue radiation doses compared with photon RT. Therefore, PBT might result in reduced radiation-induced toxicity compared with photon RT.

Methods and analysis
APPROACH is a multicentre open-label phase III randomised controlled trial of PBT versus photon RT in patients with ODG, investigating the impact of PBT on long-term NCF measured using the European Organisation for Research and Treatment of Cancer (EORTC) Core Clinical Trial Battery Composite (CTB COMP). The trial will randomise 246 participants from 18 to 25 UK RT sites, allocated 1:1 to receive PBT or photon RT, with PBT delivered at one of the two UK PBT centres. Participants with grade 2 and grade 3 ODG will receive 54 Gy in 30 fractions and 59.4 Gy in 33 fractions, respectively, followed by 6×6-weekly cycles of PCV chemotherapy. The trial contains staged analyses, with an internal pilot for feasibility of recruitment at 12 months, early assessment of efficacy at 2 years, futility assessment and final primary endpoint comparison of NCF between arms at 5 years. Secondary endpoints include additional NCF, treatment compliance, acute and late toxicities, endocrinopathies, HRQoL, tumour response, progression-free survival and overall survival.

Ethics and dissemination
Ethical approval was obtained from Newcastle North Tyneside REC (reference 22/NE/0232). Final trial results will be published in peer-reviewed journals and adhere to International Committee of Medical Journal Editors (ICMJE) guidelines.

Trial registration number
ISRCTN:13390479.

Introduction
The primary therapeutic approach to glaucoma involves the long-term use of intraocular pressure (IOP)-lowering eyedrops. However, the prevalent use of benzalkonium chloride (BAK) as a preservative in glaucoma eyedrops has been associated with ocular side effects, prompting a demand for alternatively preserved (AP) or preservative-free (PF) eyedrops. Studies comparing various preservatives have shown conflicting evidence concerning the safety of BAK-preserved (BP) eyedrops, some studies indicating no notable concerns and others reporting adverse effects. The current protocol concerns a network meta-analysis enabling systematic investigation of the IOP-lowering efficacy and safety profiles of BP, AP and PF eyedrops in patients with glaucoma for whom randomised controlled trials (RCTs) are available.

Methods and analysis
This study will evaluate the IOP-lowering effects of glaucoma eyedrops, comparing formulations with and without preservatives in patients with glaucoma. A systematic search for RCTs, regardless of language or publication date, will be conducted across three electronic databases (Cochrane search engine, Embase and MEDLINE) from 1 March 2024. Two reviewers will conduct a sequential screening of titles and abstracts, followed by full-text papers, to extract useful data. The two reviewers will also assess the internal validity of studies using the relevant and domain-based risk of bias assessment tool. Overall evidence quality will be assessed using the Confidence in Network Meta-Analysis approach and presented in summarised form with network diagrams. Forest plots will be generated for enhanced visualisation of the included glaucoma eyedrops’ effects, and pairwise effect sizes will be calculated based on available evidence in the network.

Ethics and dissemination
No ethics review or approval is required for this work, as it will synthesise evidence obtained from published studies. A paper presenting the findings will be submitted to a peer-reviewed journal for publication.

PROSPERO registration number
CRD42024498328

Per mutazioni genetiche ‘prevenzione e medicina di precisione’

VII Rapporto Farmacia, forti disparità regionali e generazionali

Claessens Z, Fieuws S, Daems J, et al. Do European regulatory measures accelerate national market access in Belgium? A retrospective analysis of medicines centrally authorised between 2015 and 2020. BMJ Open 2025;15:e091361. doi:10.1136/bmjopen-2024–0 91 361
This article has been corrected since it was published online. Figure 4 of the paper has been updated from (lacking number of medicines included in conditional marketing authorisation)
to (including the number of medicines with conditional marketing authorisation)

Introduction
People with tuberculosis (TB) who continue to smoke are more likely to have poor health outcomes than those who quit. Established smoking cessation approaches such as mHealth may help patients with TB quit smoking. This paper summarises the methodology proposed to assess the effectiveness and cost-effectiveness of mTB-Tobacco (an mHealth intervention) in helping patients with TB stop smoking and have improved health outcomes.

Methods and analysis
A two-arm, parallel, open-label, multicentre, cluster randomised, two-stage adaptive design trial is proposed to first evaluate the superiority of mTB-Tobacco, compared with usual care and then the non-inferiority of mTB-tobacco compared with face-to-face behaviour support. Study settings include TB treatment centres in Bangladesh and Pakistan. The study population includes adult patients, newly diagnosed (within 4 weeks) with pulmonary TB disease, daily smokers, willing to quit and have access to mobile phones. The primary outcome includes biochemically verified continuous smoking abstinence assessed at 6 months per Russell Standard. A generalised linear mixed-effects model will be used to assess the impact of mTB-Tobacco intervention on continuous outcomes, incorporating fixed effects for the intervention, random effects for clusters and relevant covariates. Cost-effectiveness analysis will be done to estimate the cost per quitter and cost per quality-adjusted life year gained, calculate the incremental cost-effectiveness ratios to establish the value for money for mTB-Tobacco.

Ethics and dissemination
This trial will be conducted in compliance with International Council on Harmonisation – Good Clinical Practice guidelines and the Declaration of Helsinki. The study has been approved by the ethics committees of the University of Edinburgh Medical School Research Ethics Committee (EMREC) of UK, the Bangladesh Medical Research Council (BMRC) and the National Bioethics Committee (PMRC) of Pakistan. The results of this trial will be disseminated in peer-reviewed journals and presented in academic conferences.

Trial registration number
ISRCTN86971818 (https://doi.org/10.1186/ISRCTN86971818); pre-enrolment, submission date: 29 August 2023; registration date: 11 September 2023.

Introduction
Anxiety problems are prevalent in childhood and, without intervention, can persist into adulthood. Effective evidence-based interventions for childhood anxiety disorders exist, specifically cognitive–behavioural therapy (CBT) in a range of formats. However, only a small proportion of children successfully access and receive treatment. Conducting mental health screening in schools and integrating evidence-based interventions for childhood anxiety problems may be an effective way to ensure support reaches children in need. The Identifying Child Anxiety Through Schools—Identification to Intervention (iCATS i2i) trial involves screening for childhood anxiety problems and offering a brief online parent-led CBT intervention. This paper presents the protocol for the process evaluation of the iCATS i2i trial, which aims to examine the implementation and acceptability of the study procedures, the mechanisms of change and whether any external factors had an impact on procedure engagement or delivery.

Methods and analysis
This process evaluation will use both quantitative and qualitative methods to evaluate the implementation and acceptability of and barriers/facilitators to engagement and delivery of the iCATS screening/intervention procedures. Quantitative data sources will include opt-out and completion rates of baseline measures and usage analytics extracted from the online intervention platform. Qualitative interviews will be conducted with children, parents, school staff, iCATS i2i clinicians and researchers delivering study procedures. The Medical Research Council framework for process evaluations will guide study design and analysis.

Ethics and dissemination
This study has received ethical approval from the University of Oxford Research Ethics Committee (R66068_RE003). Findings from the study will be disseminated via peer-reviewed publications in academic journals, conferences, digital and social media platforms and stakeholder meetings.

Trial registration
ISRCTN76119074.

Circulation, Ahead of Print. Groundbreaking achievements in science and medicine have contributed to reductions in cardiovascular disease and stroke mortality over the past 7 decades. Many of these advances were supported through investments by the National Institutes of Health, the global leader in funding biomedical research. This public investment has produced important economic returns, including supporting >400 000 jobs and roughly $93 billion in economic activity in the United States. Unfortunately, public funding has not kept pace with the burden of disease or rates of inflation. As the nation’s oldest and largest volunteer organization dedicated to fighting heart disease and stroke, research is critical to the American Heart Association’s mission. Given the American Heart Association’s unique position in representation of patients, clinicians, and scientists and as a research funder, we offer the following principles to optimize the future of the US biomedical research enterprise in general and the National Institutes of Health in particular. Specifically, the United States should continue to prioritize innovative and impactful research; to improve efficiency and transparency in its peer review process; to lead in translating evidence into practice; to support the current and future biomedical workforce; and to ensure robust and reliable public investment for the future. The American Heart Association reiterates our strong support for the National Institutes of Health and federal agencies that fund and implement biomedical and population-based research initiatives, which yield important economic returns. These agencies are vital to support today’s current and future health challenges, to drive foundational science, to improve patient health, to reduce the global disease burden, to address upstream and preventive strategies, and to improve the value of our public health and health care investments.

Introduction
As educators and health professionals, school nurses are in an optimal position to improve and advocate for adolescent reproductive and sexual health. This report outlines a protocol for a systematic review to synthesize evidence on the effects of school nurse-led education interventions and barriers and facilitators to implementing the interventions to improve students’ knowledge, attitudes and behaviours related to sexual and reproductive health in high-income countries.

Methods and analysis
We will develop a protocol to systematically review school nurse-led education interventions aimed at promoting adolescent sexual and reproductive health. This protocol will be based on the methodology of the Cochrane Handbook for Systematic Reviews of Interventions. The search will be conducted in Ovid-MEDLINE, CINAHL, Cochrane Library, Ovid-Embase, PsycINFO, Koreamed and ScienceON using relevant Medical Subject Headings and text words to identify the literature on different types of studies examining school nurse-led sexual and reproductive health education interventions in April 2024. Two independent reviewers will select relevant studies and extract data using a predefined template. We will assess methodological quality using the risk-of-bias tools appropriate for study designs and will resolve discrepancies through discussion with the review team. Where appropriate, we will conduct meta-analyses to estimate the effectiveness of school nurse-led sexual and reproductive health education interventions. Additionally, a qualitative evidence synthesis will be performed for the qualitative research included in the review. Finally, both a quantitative synthesis and a qualitative synthesis will be combined into a secondary synthesis addressing the facilitators and barriers of sexual and reproductive health educational interventions provided by school nurses to adolescents.

Ethics and dissemination
This review will synthesise publicly available resources and does not require ethical approval. The findings will provide insights into how school nurses can improve students’ sexual and reproductive health. The results will be disseminated through peer-reviewed publications, reports and academic conferences.

PROSPERO registration number
CRD42022347625.

Che attesta l’eccellenza, la garanzia di qualità e la sicurezza

Introduction
Becoming a parent presents profound changes and numerous challenges, notably the necessity for reliable information regarding their child’s health. Given the overabundance of information available today, it is important for parents to acquire the skills necessary to find, understand, evaluate and apply health information. Research demonstrates that this ability, known as parental health literacy (PHL), is crucial for developing and maintaining a healthy lifestyle during childhood. However, there is currently no reliable instrument for measuring PHL in the field of prevention and health promotion. This paper presents the development and validation of a new questionnaire designed to assess parents’ ability to process health-related information to support the healthy development of their children aged 3–6 years.

Methods and analysis
The development of the item pool is based on Sørensen et al’s conceptualisation of general health literacy (finding, understanding, evaluating and applying health information). Empirical findings suggest that communication with healthcare providers and the social network represents another important skill area for parents and is therefore included as an additional subscale. The questionnaire will be developed in four stages, including a literature search and analysis, expert consultations via Delphi study, cognitive interviews with parents and a validation study. The validation study uses exploratory (EFA) and confirmatory factor analysis (CFA) for construct validity, first identifying test dimensions through EFA, then confirming these dimensions with CFA to ensure the factor structure aligns with theoretical expectations. This methodology, alongside reliability and correlational analyses, seeks to assess the questionnaire’s validity and reliability, expecting strong correlations with existing related constructs.

Ethics and dissemination
Ethical approval was obtained from the Ethics Committee of Fulda University of Applied Sciences. All participants receive a consent form together with the study information, in which they give their written consent to the storage, processing and linking of all data collected. The results of the study will be presented at national and international conferences and published in specialist journals.

Trial registration number
DRKS00033482.

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