Risultati per: Cardio-oncology: rivista open access

Introduction
Migration creates new health vulnerabilities and exacerbates pre-existing medical conditions. Migrants often face legal, system-related, administrative, language and financial barriers to healthcare, but little is known about factors that specifically influence migrants’ access to medicines and vaccines. This scoping review aims to map existing evidence on access to essential medicines and vaccines among asylum seekers, refugees and undocumented migrants who aim to reach Europe. We will consolidate existing information and analyse the barriers that limit access at the different stages of the migratory phases, as well as policies and practices undertaken to address them.

Methods
We follow the Arksey and O’Malley framework for knowledge synthesis of research, as updated by Levac et al. For reporting the results of our search and to synthetise evidence, we will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extended reporting guideline for scoping reviews. This scoping review consists of five iterative stages. Bibliographic databases (PubMed, CINAHL, Cochrane Database of Systematic Reviews and Scopus) and grey literature databases (Open Grey, Grey Literature Report and Google Scholar, Web of Science Conference Proceedings, non-governmental organisations and United Nations agency websites) will be searched for relevant studies.

Dissemination and ethics
This review will be disseminated through a peer-reviewed article in a scientific open-access journal and conference presentations. Furthermore, findings will be shared at workshops of research and operational stakeholders for facilitating translation into research and operational practices. Since it consists of reviewing and collecting data from publicly available materials, this scoping review does not require ethics approval.

Introduction
There has been renewed interest in the therapeutic use of bacteriophages (phages); however, standardised therapeutic protocols are lacking, and there is a paucity of rigorous clinical trial data assessing efficacy.

Methods and analysis
We propose an open-label, single-arm trial investigating a standardised treatment and monitoring protocol for phage therapy. Patients included will have exhausted other therapeutic options for control of their infection and phage therapy will be administered under Australia’s Therapeutic Goods Administration Special Access Scheme. A phage product with high in vitro activity against the targeted pathogen(s) must be available in line with relevant regulatory requirements. We aim to recruit 50–100 patients over 5 years, from any public or private hospitals in Australia. The standardised protocol will specify clinical assessments and biological sampling at scheduled time points. The primary outcome is safety at day 29, assessed by the frequency of adverse events, and overseen by an independent Data Safety Monitoring Board. Secondary outcomes include long-term safety (frequency of adverse events until at least 6 months following phage therapy), and feasibility, measured as the proportion of participants with >80% of minimum data available for analysis. Additional endpoints assessed include clinical response, patient/guardian reported quality of life measures, phage pharmacokinetics, human host immune responses and microbiome analysis. All trial outcomes will be summarised and presented using standard descriptive statistics.

Ethics and dissemination
Participant inclusion will be dependent on obtaining written informed consent from the patient or guardian. The trial protocol was approved by the Sydney Children’s Hospitals Network Human Research Ethics Committee in December 2021 (Reference 2021/ETH11861). In addition to publication in a peer-reviewed scientific journal, a lay summary of study outcomes will be made available for participants and the public on the Phage Australia website (https://www.phageaustralia.org/).

Trial registration number
Registered on ANZCTR, 10 November 2021 (ACTRN12621001526864; WHO Universal Trial Number: U1111-1269-6000).

The volume of high-quality evidence supporting exercise as beneficial to cancer survivors has grown exponentially; however, the potential harms of exercise remain understudied. Consequently, the trade-off between desirable and undesirable outcomes of engaging in exercise remains unclear to clinicians and people with cancer. Practical guidance on collecting and reporting harms in exercise oncology is lacking. We present a harms reporting protocol developed and refined through exercise oncology trials since 2015.
Development of the Exercise Harms Reporting Method (ExHaRM) was informed by national and international guidelines for harms reporting in clinical trials involving therapeutic goods or medical devices, with adaptations to enhance applicability to exercise. The protocol has been adjusted via an iterative process of implementation and adjustment through use in multiple exercise oncology trials involving varied cancer diagnoses (types: breast, brain, gynaecological; stages at diagnosis I–IV; primary/recurrent), and heterogeneous exercise intervention characteristics (face to face/telehealth delivery; supervised/unsupervised exercise). It has also involved the development of terms (such as, adverse outcomes, which capture all undesirable physical, psychological, social and economic outcomes) that facilitate the harms assessment process in exercise.
ExHaRM involves: step 1: Monitor occurrence of adverse outcomes through systematic and non-systematic surveillance; step 2: Assess and record adverse outcomes, including severity, causality, impact on intervention and type; step 3: Review of causality by harms panel (and revise as necessary); and step 4: Analyse and report frequencies, rates and clinically meaningful details of all-cause and exercise-related adverse outcomes.
ExHaRM provides guidance to improve the quality of harms assessment and reporting immediately, while concurrently providing a framework for future refinement. Future directions include, but are not limited to, standardising exercise-specific nomenclature and methods of assessing causality.

This cohort study evaluates the rate of systemic anticancer therapy use among patients dying of cancer.

The Original Investigation titled “Pooled Analysis of Meningioma Risk Following Treatment for Childhood Cancer,” which published online October 6, 2022, has changed license status to open access (CC-BY license). This article was updated online.

This cross-sectional study estimates all US Food and Drug Administration anticancer approvals in recent years and evaluates if an association exists between their cost and efficacy.

JAMA Oncology is committed to publishing influential original research, opinions, and reviews that advance the science of oncology and improve the clinical care of patients with cancer.

New England Journal of Medicine, Ahead of Print.

Objective
Adults

E’ stato visitato da oltre 140mila persone, per il 40% straniere

New England Journal of Medicine, Volume 387, Issue 21, Page 2006-2008, November 2022.

This cross-sectional spatial analysis examines travel time from each census tract in the contiguous US to the nearest abortion facility before and after the Dobbs v Jackson Women’s Health Organization US Supreme Court decision.

Introduction
Prior to the COVID-19 pandemic, substance use health services for treatment of alcohol use disorder and problematic alcohol use (AUD/PAU) were fragmented and challenging to access. The pandemic magnified system weaknesses, often resulting in disruptions of treatment as alcohol use during the pandemic rose. When treatment services were available, utilisation was often low for various reasons. Virtual care was implemented to offset the drop in in-person care, however accessibility was not universal. Identification of the characteristics of treatment services for AUD/PAU that impact accessibility, as perceived by the individuals accessing or providing the services, will provide insights to enable improved access. We will perform a scoping review that will identify characteristics of services for treatment of AUD/PAU that have been identified as barriers to or facilitators of service access from the perspectives of these groups.

Methods and analysis
We will follow scoping review methodological guidance from the Joanna Briggs Institute. Using the OVID platform, we will search Ovid MEDLINE including Epub Ahead of Print and In-Process and Other Non-Indexed Citations, Embase Classic+Embase, APA PsychInfo, Cochrane Register of Controlled Trials, the Cochrane Database of Systematic Reviews and CINAHL (Ebsco Platform). Multiple reviewers will screen citations. We will seek studies reporting data collected from individuals with AUD/PAU or providers of treatment for AUD/PAU on service-level factors affecting access to care. We will map barriers to and facilitators of access to AUD/PAU treatment services identified in the relevant studies, stratified by service type and key measures of inequity across service users.

Ethics and dissemination
This research will enhance awareness of existing evidence regarding barriers to and facilitators of access to services for the treatment of alcohol use disorder and problematic alcohol use. Findings will be disseminated through publications, conference presentations and a stakeholder meeting. As this is a scoping review of published literature, no ethics approval was required.

Introduction
Hepatocellular carcinoma (HCC) remains a major clinical problem as more than half of these cases recur after radical resection. Natural killer (NK) cells are at the forefront of the innate immune system and attack microcarcinomas and circulating tumour cells. The objective of this study was to evaluate the feasibility and toxicity of peripheral blood CD34+ stem cell-derived NK cell infusion after radical hepatectomy for HCC.

Methods and analysis
This is an open-label, single-arm, single-centre phase I study. Patients who have undergone initial hepatectomy for HCC with three or more risk factors for recurrence (≥10 ng/mL of Alpha fetoprotein (AFP), ≥360 mAU/mL of PIVKA-II, multiple tumours and ≥3 peripheral blood circulating tumour cells) will be enrolled and be treated with three peripheral blood CD34+ stem cell-derived NK cell infusions every 3 months. The primary endpoint will be safety assessment including the type and severity of adverse events, frequency of occurrence and duration of occurrence. The secondary endpoints will include survival, effect of immune response and clinical laboratory test results.

Ethics and dissemination
Ethical approval of the trial was obtained from the Certified Committee for Regenerative Medicine Hiroshima University in Japan. The trial results will be shared with the scientific community at international conferences and by publication in a peer-reviewed journal.

Trial registration number
jRCTb060200020.