Risultati per: Cardio-oncology: rivista open access

Introduction
Palliative care (PC) is a medical specialty focusing on providing relief from the symptoms and stress of serious illnesses such as cancer. Early outpatient specialty PC concurrent with cancer-directed treatment improves quality of life and symptom burden, decreases aggressive end-of-life care and is an evidence-based practice endorsed by national guidelines. However, nearly half of patients with advanced cancer do not receive specialty PC prior to dying. The objective of this study is to test the impact of an oncologist-directed default PC referral orders on rates of PC utilisation and patient quality of life.

Methods and analysis
This single-centre two-arm pragmatic randomised trial randomises four clinician-led pods, caring for approximately 250 patients who meet guideline-based criteria for PC referral, in a 1:1 fashion into a control or intervention arm. Intervention oncologists receive a nudge consisting of an electronic health record message indicating a patient has a default pended order for PC. Intervention oncologists are given an opportunity to opt out of referral to PC. Oncologists in pods randomised to the control arm will receive no intervention beyond usual practice. The primary outcome is completed PC visits within 12 weeks. Secondary outcomes are change in quality of life and absolute quality of life scores between the two arms.

Ethics and dissemination
This study has been approved by the Institutional Review Board at the University of Pennsylvania. Study results will be disseminated in peer-reviewed journals and scientific conferences using methods that describe the results in ways that key stakeholders can best understand and implement.

Trial registration number
NCT05365997.

Introduction
Xeroderma pigmentosum (XP) is a rare intractable disease without a fundamental treatment, presenting with severe photosensitivity, freckle-like pigmented and depigmented maculae and numerous skin cancers before the age of 10 years without strict sun protection. About 70% of the patients exhibit extremely severe sunburn reactions and most of them develop neurological symptoms, including sensorineural hearing impairment and progressive peripheral and central nervous disorders beginning from childhood ages. In the preclinical study, we found that N-acetyl-5-methoxytryptamine was effective in suppressing skin tumour development in addition to improvement of auditory brainstem response in chronically ultraviolet-irradiated XP-A model mice.

Methods and analysis
On the bases of the preclinical study, we conduct a clinical trial on the efficacy of NPC-15 for patients with XP with exaggerated sunburn reaction type by a multicentre, double-blinded placebo-controlled, two-group crossover study followed by a 52 weeks open study.

Ethics and dissemination
Ethics approval is overseen by the Kobe University Institutional Review Board and Osaka Medical and Pharmaceutical University Institutional Review Board, and the study is conducted in accordance with the approved protocol. All participants will be required to provide written informed consent. Findings will be disseminated through scientific and professional conferences and peer-reviewed journal publications. The data sets generated during the study will be available from the corresponding author on reasonable request.

Trial registration number
jRCTs051210181.

Introduction
Women living in rural and regional Australia often experience difficulties in accessing long-acting reversible contraception (LARC) and medical abortion services. Nurse-led models of care can improve access to these services but have not been evaluated in Australian general practice. The primary aim of the ORIENT trial (ImprOving Rural and regIonal accEss to long acting reversible contraceptioN and medical abortion through nurse-led models of care, Tasksharing and telehealth) is to assess the effectiveness of a nurse-led model of care in general practice at increasing uptake of LARC and improving access to medical abortion in rural and regional areas.

Methods and analysis
ORIENT is a stepped-wedge pragmatic cluster-randomised controlled trial. We will enrol 32 general practices (clusters) in rural or regional Australia, that have at least two general practitioners, one practice nurse and one practice manager. The nurse-led model of care (the intervention) will be codesigned with key women’s health stakeholders. Clusters will be randomised to implement the model sequentially, with the comparator being usual care. Clusters will receive implementation support through clinical upskilling, educational outreach and engagement in an online community of practice. The primary outcome is the change in the rate of LARC prescribing comparing control and intervention phases; secondary outcomes include change in the rate of medical abortion prescribing and provision of related telehealth services. A within-trial economic analysis will determine the relative costs and benefits of the model on the prescribing rates of LARC and medical abortion compared with usual care. A realist evaluation will provide contextual information regarding model implementation informing considerations for scale-up. Supporting nurses to work to their full scope of practice has the potential to increase LARC and medical abortion access in rural and regional Australia.

Ethics and dissemination
Ethics approval was obtained from the Monash University Human Research Ethics Committee (Project ID: 29476). Findings will be disseminated via multiple avenues including a knowledge exchange workshop, policy briefs, conference presentations and peer-reviewed publications.

Trial registration number
This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12622000086763).

Introduction
The efficacy of taurolidine containing lock solutions for the prevention of central line-associated bloodstream infections (CLABSI) in paediatric oncology patients is still unknown. If the taurolidine-citrate-heparin lock appears to decrease the incidence of CLABSIs, we hope to increase the quality of life of children with cancer by subsequently reducing the central venous access device (CVAD)-removal rates, dispense of antibiotics, hospital admissions and incidence of severe sepsis resulting in intensive care unit admission.

Methods and analysis
This assessor-blinded randomised controlled trial including 462 patients was designed to compare the taurolidine-citrate-heparin lock to the heparin-only lock for the prevention of CLABSIs in paediatric oncology patients. Patients receiving their first CVAD at the Princess Máxima Centre for Paediatric Oncology, Utrecht, the Netherlands, are eligible for inclusion. The primary outcome of this study is the incidence of first CLABSIs from CVAD insertion until the end of the study, maximum follow-up of 90 days. An intention-to-treat and a per-protocol analysis will be performed. An interim analysis will be performed after the inclusion of 50% of the patients. The results of the interim analysis and overall conduct of the trial will be discussed by a data safety monitoring board.

Ethics and dissemination
The medical ethics committee NedMec, Utrecht, the Netherlands, has approved this research (number 20/370). Written informed consent for participation in this trial and publication of the trial data is obtained from all patients and/or their parents/guardians. The results of this trial will be published in a peer-reviewed journal and the data will be made available on reasonable request after publication of the main results manuscript.

Trial registration numbers
NTR6688; NCT05740150.

Objective
To estimate the cost-effectiveness of running a paediatric oncology unit in Ethiopia to inform the revision of the Ethiopia Essential Health Service Package (EEHSP), which ranks the treatment of childhood cancers at a low and medium priority.

Methods
We built a decision analytical model—a decision tree—to estimate the cost-effectiveness of running a paediatric oncology unit compared with a do-nothing scenario (no paediatric oncology care) from a healthcare provider perspective. We used the recently (2018–2019) conducted costing estimate for running the paediatric oncology unit at Tikur Anbessa Specialized Hospital (TASH) and employed a mixed costing approach (top-down and bottom-up). We used data on health outcomes from other studies in similar settings to estimate the disability-adjusted life years (DALYs) averted of running a paediatric oncology unit compared with a do-nothing scenario over a lifetime horizon. Both costs and effects were discounted (3%) to the present value. The primary outcome was incremental cost in US dollars (USDs) per DALY averted, and we used a willingness-to-pay (WTP) threshold of 50% of the Ethiopian gross domestic product per capita (USD 477 in 2019). Uncertainty was tested using one-way and probabilistic sensitivity analyses.

Results
The incremental cost and DALYs averted per child treated in the paediatric oncology unit at TASH were USD 876 and 2.4, respectively, compared with no paediatric oncology care. The incremental cost-effectiveness ratio of running a paediatric oncology unit was USD 361 per DALY averted, and it was cost-effective in 90% of 100 000 Monte Carlo iterations at a USD 477 WTP threshold.

Conclusions
The provision of paediatric cancer services using a specialised oncology unit is most likely cost-effective in Ethiopia, at least for easily treatable cancer types in centres with minimal to moderate capability. We recommend reassessing the priority-level decision of childhood cancer treatment in the current EEHSP.

Introduction
Acute gastrointestinal bleeding (GIB) is a life-threatening emergency with a critical economic burden. As a result of bleeding, anaemia often requires intravenous or oral iron supplementation. Elderly patients are even more prone to untoward outcomes after hospital discharge if iron supplementation is inefficient. There is a gap in current guidelines on which supplementation route clinicians should choose. We aim to investigate the effect of one dose of intravenous iron therapy versus 3-month oral iron administration on anaemia in an elderly population.

Methods and analysis
The FIERCE study is an open-label, randomised controlled, two-armed trial. At least 48 hours after the acute non-variceal GIB treatment, patients will be recruited in participating centres. A random sequence generator will allocate the participants to group A (intravenous ferric carboxymaltose, 1000 mg) or group B (oral ferrous sulfate (FS), ca. 200 mg every day) with an allocation ratio of 1:1 on the day of the planned discharge from the hospital. Randomisation will be stratified for participating centres and the need for transfusion within the same hospitalisation before recruitment to the trial. Quality of life assessment, functional measurement and laboratory tests will be performed at baseline, 1 and 3 months±7 days after enrolment to the trial. The primary endpoint is a composite endpoint, including all-cause mortality, anaemia-associated unplanned emergency visit and anaemia-associated unplanned hospital admission within 3 months of enrolment in the trial.

Ethics and dissemination
The study has been approved by the relevant organisation, the Scientific and Research Ethics Committee of the Hungarian Medical Research Council (46395-5/2021/EÜIG). We will disseminate our results to the medical community and will publish our results in peer-reviewed journals.

Trial registration
The trial has been registered at ClinicalTrials.gov (NCT05060731).

This Viewpoint explains the obstacles faced by individuals seeking gender-affirming care and summarizes needed changes to improve quality of care and access to care.

Introduction
With 65 million cases globally, chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death and imposes a heavy burden on patients’ lives and healthcare resources worldwide. Around half of all patients with COPD have frequent (≥2 per year) acute exacerbations of COPD (AECOPD). Rapid readmissions are also common. Exacerbations impact significantly on COPD outcomes, causing significant lung function decline. Prompt exacerbation management optimises recovery and delays the time to the next acute episode.

Methods/analysis
The Predict & Prevent AECOPD trial is a phase III, two arm, multi-centre, open label, parallel-group individually randomised clinical trial investigating the use of a personalised early warning decision support system (COPDPredict) to predict and prevent AECOPD. We aim to recruit 384 participants and randomise each individual in a 1:1 ratio to either standard self-management plans with rescue medication (RM) (control arm) or COPDPredict with RM (intervention arm).
The trial will inform the future standard of care regarding management of exacerbations in COPD patients. The main outcome measure is to provide further validation, as compared with usual care, for the clinical effectiveness of COPDPredict to help guide and support COPD patients and their respective clinical teams in identifying exacerbations early, with an aim to reduce the total number of AECOPD-induced hospital admissions in the 12 months following each patient’s randomisation.

Ethics and dissemination
This study protocol is reported in accordance with the guidance set out in the Standard Protocol Items: Recommendations for Interventional Trials statement. Predict & Prevent AECOPD has obtained ethical approval in England (19/LO/1939). On completion of the trial and publication of results a lay findings summary will be disseminated to trial participants.

Trial registration number
NCT04136418.

Objectives
This study examines how access to COVID-19 information and adherence to preventive measures varies by sociodemographic characteristics, and whether the associations differ among the migrant origin and the general Finnish population. Additionally, the association of perceived access to information with adherence to preventive measures is examined.

Design
Cross-sectional, population-based random sample.

Background
Equity in access to information is crucial for securing individual well-being and successful management of a crisis at population level.

Setting
Persons who have a residence permit in Finland.

Participants
Migrant origin population constituted of persons aged 21–66 years born abroad, who took part in the Impact of the Coronavirus on the Wellbeing of the Foreign Born Population (MigCOVID) Survey conducted from October 2020 to February 2021 (n=3611). Participants in the FinHealth 2017 Follow-up Survey conducted within the same time frame, representing the general Finnish population, constituted the reference group (n=3490).

Outcome measures
Self-perceived access to COVID-19 information, adherence to preventive measures.

Results
Self-perceived access to information and adherence to preventive measures was overall high both among the migrant origin and the general population. Perceived adequate access to information was associated with living in Finland for 12 years or longer (OR 1.94, 95% CI 1.05–3.57) and excellent Finnish/Swedish language skills (OR 2.71, 95% CI 1.62–4.53) among the migrant origin population and with higher education (OR 3.56, 95% CI 1.49–8.55 for tertiary and OR 2.87, 95% CI 1.25–6.59 for secondary) among the general population. The association between examined sociodemographic characteristics with adherence to preventive measures varied by study group.

Conclusions
Findings on the association of perceived access to information with language proficiency in official languages highlight the need for rapid multilingual and simple language crisis communications. Findings also suggest that crisis communications and measures designed to influence health behaviours at population level may not be directly transferable if the aim is to influence health behaviours also among ethnically and culturally diverse populations.

Objectives
Low attendance rates for community health services reflect important barriers that prevent people from receiving the care they need. Services and health systems that seek to advance Universal Health Coverage need to understand and act on these factors. Formal qualitative research is the best way to elicit barriers and identify potential solutions, however traditional approaches take months to complete and can be very expensive. We aim to map the methods that have been used to rapidly elicit barriers to accessing community health services and identify potential solutions.

Methods and analysis
We will search MEDLINE, Embase, the Cochrane Library and Global Health for empirical studies that use rapid methods (

Circulation, Ahead of Print. Background:Despite the well-established potent benefit of mechanical thrombectomy (MT) for large vessel occlusion (LVO) stroke, access to MT has not been studied globally. We conducted a worldwide survey of countries on 6 continents to define MT access (MTA), the disparities in MTA, and its determinants on a global scale.Methods:Our survey was conducted in 75 countries through the Mission Thrombectomy 2020+ global network between November 22, 2020, and February 28, 2021. The primary end points were the current annual MTA, MT operator availability, and MT center availability. MTA was defined as the estimated proportion of patients with LVO receiving MT in a given region annually. The availability metrics were defined as ([current MT operators×50/current annual number of estimated thrombectomy-eligible LVOs]×100 = MT operator availability) and ([current MT centers×150/current annual number of estimated thrombectomy-eligible LVOs]×100= MT center availability). The metrics used optimal MT volume per operator as 50 and an optimal MT volume per center as 150. Multivariable-adjusted generalized linear models were used to evaluate factors associated with MTA.Results:We received 887 responses from 67 countries. The median global MTA was 2.79% (interquartile range, 0.70–11.74). MTA was

Introduction
Over-the-scope clip (OTSC) has been used recently for primary haemostasis of peptic ulcers. This study aimed to compare the efficacy of OTSC to standard endoscopic therapy in primary treatment of patients with peptic ulcer bleeding that are of size ≥1.5 cm. The target population accounts for only 2.5% of all upper GI bleeders.

Methods
This was a multicentre international randomised controlled trial from July 2017 to October 2020. All patients with Forest IIa or above peptic ulcers of ≥1.5 cm were included. Primary outcome was 30-day clinical rebleeding. Secondary endpoints include 3-day all-cause mortality, transfusion requirement, hospital stay, technical and clinical success, and further interventions. 100 patients are needed to yield a power of 80% to detect a difference of –0.15 at the 0.05 significance level (alpha) using a two-sided Z-test (pooled).

Results
100 patients were recruited. Success in achieving primary haemostasis was achieved in 46/50 (92%) and 48/50 (96%) in the OTSC and conventional arm, respectively. Among patients who had success in primary haemostasis, 2/46 (4.35%) patients in the OTSC arm and 9/48 (18.75%) patients in the conventional arm developed 30-day rebleeding (p=0.03). However, in an intention-to-treat analysis, there was no difference in rebleeding within 30 days (5/50 (10%) OTSC vs 9/50 (18%) standard, p=0.23) or all-cause mortality (2/50 (4%) OTSC vs 4/50 (8%) standard, p=0.68; OR=2.09, 95% CI 0.37 to 11.95). There was also no difference in transfusion requirement, hospital stay, intensive care unit admission and further interventions.

Conclusion
The routine use of OTSC as primary haemostasis in large bleeding peptic ulcers was not associated with a significant decrease in 30-day rebleeding.

Trial registration number
NCT03160911.

Introduction
Attachment to a primary care provider is an important component of primary care as it facilitates access. In Québec, Canada, attachment to a family physician is a concern. To address unattached patients’ barriers to accessing primary care, the Ministry of Health and Social Services mandated Québec’s 18 administrative regions to implement single points of access for unattached patients (Guichets d’accès première ligne (GAPs)) that aim to better orient patients towards the most appropriate services to meet their needs. The objectives of this study are to (1) analyse the implementation of GAPs, (2) measure the effects of GAPs on performance indicators and (3) assess unattached patients’ experiences of navigation, access and service utilisation.

Methods and analysis
A longitudinal mixed-methods case study design will be conducted. Objective 1. Implementation will be analysed through semistructured interviews with key stakeholders, observations of key meetings and document analysis. Objective 2. GAP effects on indicators will be measured using performance dashboards produced using clinical and administrative data. Objective 3. Unattached patients’ experiences will be assessed using a self-administered electronic questionnaire. Findings for each case will be interpreted and presented using a joint display, a visual tool for integrating qualitative and quantitative data. Intercase analyses will be conducted highlighting the similarities and differences across cases.

Ethics and dissemination
This study is funded by the Canadian Institutes of Health Research (# 475314) and the Fonds de Soutien à l’innovation en santé et en services sociaux (# 5-2-01) and was approved by the CISSS de la Montérégie-Centre Ethics Committee (MP-04-2023-716).

Stroke, Ahead of Print.

Introduction
There is little to no evidence in Canada on the barriers that youth face when accessing contraception. We seek to identify the contraception access, experiences, beliefs, attitudes, knowledge, and needs of youth in Canada, from the perspectives of youth and youth service providers.

Methods and analysis
This prospective, mixed-methods, integrated knowledge mobilisation study, the Ask Us project, will involve a national sample of youth, healthcare and social service providers, and policy makers recruited via a novel relational mapping and outreach approach led by youth. Phase I will centre the voices of youth and their service providers through in-depth one-on-one interviews. We will explore the factors influencing youth access to contraception, theoretically guided by Levesque’s Access to Care framework. Phase II will focus on the cocreation and evaluation of knowledge translation products (youth stories) with youth, service providers, and policy makers.

Ethics and dissemination
Ethical approval was received from the University of British Columbia’s Research Ethics Board (H21-01091). Full open-access publication of the work will be sought in an international peer-reviewed journal. Findings will be disseminated to youth and service providers through social media, newsletters, and communities of practice, and to policy makers through invited evidence briefs and face-to-face presentations.

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