Risultati per: Cardio-oncology: rivista open access

Circulation, Ahead of Print. Background: In patients with post-thrombotic syndrome (PTS), stent recanalization of iliofemoral veins or the inferior vena cava can restore venous patency and improve functional outcomes. The risk of stent thrombosis is particularly increased during the first 6 months after intervention. The ARIVA trial tested whether daily aspirin 100 mg plus rivaroxaban 20 mg is superior to rivaroxaban 20 mg alone to prevent stent thrombosis within 6 months after stent placement for PTS.Methods: In this multinational, academic, open-label, independently adjudicated trial, patients with a Villalta score >4 points, a stenosis or occlusion of the inferior vena cava, iliac veins, or common femoral vein, successfully treated with venous stent placement, were randomized in a 1:1 fashion to the study groups. Key exclusion criteria included age 75 years, contraindications to anticoagulant use or acute venous thrombosis

Introduction
Access to care varies by sociodemographic group, with some groups facing higher barriers to care than others. This study will use novel methods to explore barriers and potential solutions as perceived by members of the population groups who are least able to access care. We aim to use rapid yet robust mixed methods that allow us to identify generalisable findings within each programme and testable service modifications to improve equitable access to care; delivering non-tokenistic findings within a matter of weeks.

Methods and analysis
This is a multiphased exploratory sequential mixed methods study. We will use the same approach in four different screening programmes, in Botswana, India, Kenya and Nepal. First, we will conduct interviews with people purposively selected from the sociodemographic subgroups with the lowest odds of accessing care within each programme. We will explore their perceptions of barriers and potential service modifications that could boost attendance at eye clinics among people from these ‘left-behind’ groups. We will use a deductive analytic matrix to facilitate the rapid analysis of qualitative data. Space will be made for the inductive identification of themes that are not necessarily captured in the framework. Sample size will be determined by thematic saturation. Next, we will conduct a survey with a representative sample of non-attenders from the same left-behind groups, asking them to rank each suggested service modification by likely impact. Finally, we will convene a multistakeholder workshop to assess each service modification based on ranking, likely impact, feasibility, cost and potential risks. The most promising service modifications will be implemented and evaluated in a follow-on randomised controlled trial, the methods for which will be reported elsewhere.

Ethics and dissemination
This project has been approved by independent research ethics committees in Botswana, Kenya, India, Nepal and the UK. We will disseminate our findings through local community advisory boards, national eye screening meetings, in peer-reviewed journals and at conferences.

Introduction
Patient navigation is recommended by accrediting bodies such as the Commission on Cancer and is a key element in payment reform demonstration projects, due to the established benefits in reducing barriers to healthcare, improving care coordination and reducing healthcare utilisation. However, oncology practices are often resource constrained and lack the capacity to extend navigation services at the desired intensity for their patient population. The American Cancer Society (ACS) developed the ACS Community Access to Resources, Education, and Support (CARES) programme to expand navigation capacity through the training of students from local universities as volunteers to serve as non-clinical navigators to support cancer patients. Although this approach has great potential for scalability, the best approach to early implementation and impact of volunteer navigation remains unclear.

Methods and analysis
This pragmatic single-arm pre–post study evaluates the implementation and effectiveness of volunteer navigation for patients participating in the 2023–2024 pilot. This study will use data collected during routine care for quantitative implementation and patient outcomes. The Updated Consolidated Framework for Implementation Research will guide evaluation of early programme implementation with three initial pilot sites. This pragmatic evaluation of real-world implementation of volunteer navigation in the oncology setting will support future efforts to scale-up this intervention across US health systems.

Ethics and dissemination
This study was approved by University of Morehouse School of Medicine Social and Behavioral (IRB), which served as the IRB for record for this project (IRB-2025819–2). No consent required for this study protocol. ACS CARES plans to disseminate this model and include additional sites as participants in future years.

Introduction
Despite its therapeutic advantages, postmastectomy radiotherapy (PMRT) increases the risk of complications and often leads to poor cosmesis in women undergoing breast reconstruction. Preoperative radiotherapy followed by skin-sparing mastectomy and deep inferior epigastric perforator (DIEP) flap reconstruction is technically feasible, with low rates of surgical complications and good short-term oncological outcomes. Further evaluation in a randomised trial comparing preoperative radiotherapy versus conventional PMRT in breast reconstruction is required to assess both oncological and patient-reported outcomes (PROs).

Methods and analysis
The CAPPELLA trial is a prospective, multicentre, open-label, randomised controlled trial across nine centres comparing PROs and safety outcomes between preoperative and postoperative radiotherapy in patients with locally advanced breast cancer requiring immediate DIEP flap reconstruction. Female patients aged >18 years with breast cancer who are treated with neoadjuvant systemic treatment, require both mastectomy and radiotherapy and are suitable for DIEP flap reconstruction will be included. Patients will be randomly assigned (1:1) to a preoperative radiotherapy group or a postoperative radiotherapy group. Stratification will be performed by cancer centre at initial diagnosis. The radiation volumes will include the ipsilateral breast/chest wall, supraclavicular lymph nodes, undissected axilla and internal mammary nodes. The dose regimen will be 42.56 Gy in 16 fractions. The primary endpoint will be satisfaction with the breast domain of the BREAST-Q at 2 years postoperatively. The secondary endpoints will include PROs at 3, 12 and 24 months postoperatively in both groups, aesthetic assessment, complication rates, rates of total pathological complete response (tpCR) and tumour safety. All patients will be followed up for 36 months postoperatively. The app software will be used to collect all data prospectively. Data will be analysed using SPSS and Stata software. The target sample size will be 80 participants.

Ethics and dissemination
This study will be performed according to the Helsinki Declaration. All patients will be asked to provide informed consent before enrolment. Approval for this study was provided by the independent ethics committee and institutional review board of Fudan University Shanghai Cancer Centre. We will present the study results at national and international meetings and publish them in a scientific peer-reviewed journal.

Trial registration number
NCT05512286.

Introduction
Despite repeated vaccinations against SARS-CoV-2 virus, patients who are immunocompromised remain at very high risk of catching SARS-CoV-2 virus and becoming unwell. AZD7442 (Evusheld) is a long-acting monoclonal antibody treatment that has been shown in clinical trials to prevent SARS-CoV-2 infection for up to a year after a single dose. Vaccines require a healthy immune system to generate protective immunity. AZD7442 may prevent SARS-CoV-2 infection in immunocompromised individuals that may not have responded to repeated vaccinations against SARS-CoV-2 virus. Unlike vaccinations, AZD7442 reaches effective levels within the body a few hours after a single dose. The RAPID-PROTECTION trial will determine the levels of immune protection that AZD7442 offers patients at the very highest risk of SARS-CoV-2 infection and whether this protection can be further enhanced by repeated vaccination against SARS-CoV-2 virus.

Methods
RAPID-PROTECTION is a multicentre, interventional and open-label adaptive platform trial that aims to recruit 350 immunocompromised participants across five UK centres. Participants will be administered AZD7442 on day 0 followed by a SARS-CoV-2 vaccination 28 days later. Participants will be randomised (1:1) to the Moderna vaccine or Pfizer/BioNTech vaccine. Participant samples will be taken at baseline and at multiple timepoints after the administration of AZD7442.

Analysis
The participant samples will be analysed to measure the function and magnitude of SARS-CoV-2 specific antibody and T-cell responses at baseline and at multiple timepoints after the administration of AZD7442. The immunological effect of the study interventions will be determined by comparison of the results of immunological assessments at baseline and subsequent timepoints.

Ethics and dissemination
The trial protocol was approved by the research ethics committee of the National Health Service (reference 22/HRA/0359), Health Research Authority and Health and Care Research Wales on 25 July 2022. Findings will be disseminated through peer-reviewed journals and presented at scientific conferences.

Trial registration number
ISRCTN53507177.

Overall, the evidence from this study is compatible with fluoxetine having a weak in vivo antiviral activity against SARS-CoV-2, although the primary endpoint is also compatible with no effect. This level of antiviral efficacy is substantially less than with other currently available antiviral drugs.

Background
It is unknown which maintenance therapy is the most effective option for patients admitted for an acute severe ulcerative colitis (ASUC) episode responding to intravenous steroids.

Methods
We conducted a multicentre, parallel-group, open-label randomised controlled trial among 23 French centres in thiopurine and biologics-naïve adults admitted for ASUC responding to intravenous steroids. Eligible patients were randomly assigned to receive infliximab (IFX) and azathioprine (AZA) with a 7-day steroid tapering scheme (IFX+AZA arm) or AZA and conventional standardised steroid tapering regimen (AZA arm). The primary composite endpoint was treatment failure at week 52, defined as the absence of steroid-free clinical remission, the absence of endoscopic response, the use of a prohibited treatment for relapse, severe adverse event leading to treatment interruption, colectomy or death. Multiple imputation for missing data was performed.

Findings
Among the 64 patients randomised (Lichtiger score 13.5±2.0; median age of 34.5 (P25–P75 26.3–50.3) years, median C reactive protein of 29.0 (12.8–96.8) mg/L at baseline): 32 were assigned to the IFX+AZA arm and 32 to the AZA arm. In the ITT population, treatment failure at week 52 was observed in 22/27 (81.5%) in the AZA arm and 16/30 (53.3%) in the IFX+AZA arm (risk ratio 3.85, 95% CI (1.15 to 12.88), p=0.03). 29 adverse events were severe, including 13 disease exacerbations, 6 severe infections without any difference between both arms.

Interpretation
Combination therapy with IFX+AZA was more effective at 1 year than AZA alone to avoid treatment failure in patients with ASUC responding to intravenous steroids.

Trial registration number
NCT02425852.

Objective
As an emerging technology, Android-based open-source closed-loop system also called Android Artificial Pancreas System (AAPS), has been increasingly validated by evidence for its effectiveness in improving glycaemic outcomes, positioning it as a crucial option for managing type 1 diabetes (T1D). However, there are still only a few studies examining the experiences of using AAPS, and relevant qualitative studies have not been conducted in Asia so far. This study aimed to explore the experiences and opinions of adult patients with T1D on the AAPS.

Design
Semi-structured interviews and the Insulin Dosing Systems: Perceptions, Ideas, Reflections and Expectations questionnaires were conducted among patients. The questionnaire was scored on a 100-point scale. Thematic analysis was adopted to analyse the transcribed text. Recruitment of interviewees would be halted when no new themes emerged. The scores of the questionnaire on AAPS satisfaction were calculated, and the Mann-Whitney U test was used to compare the results of different sections of the questionnaire.

Setting
Guangdong Province in China.

Participants
This study recruited patients with T1D from the Guangdong T1D translational medicine study and the ‘Tang Tang Quan’ T1D online community in China, who participated in a clinical trial on the efficacy and safety of AAPS.

Results
The study interviewed 20 adults with T1D aged 32±9.94 years. The T1D duration was 10.93±6.26 years and the glycated haemoglobin was 7.38±0.53%. Five main themes were identified: (1) expectations and feedback on AAPS; (2) impact on quality of life; (3) impact on blood glucose management; (4) user experiences; (5) suggestions for AAPS. The average score of AAPS satisfaction was 73.69 (65.94, 85.94). Mann-Whitney U test suggested that the satisfaction derived from glucose management with AAPS surpassed the satisfaction attributed to the enhancement of their overall quality of life (p

Objectives
This study evaluates the prevalence and correlates of opioid agonist therapy (OAT) discontinuation across British Columbia (BC), using a sample of individuals who used substances and accessed harm reduction sites.

Design
This study uses data from the 2019 cross-sectional Harm Reduction Client Survey (HRCS).

Setting
The 2019 survey was administered from October to December at 22 harm reduction supply distribution sites across the 5 Regional Health Authorities of BC.

Participants
The 2019 HRCS was administered among individuals who used illicit substances in the past 6 months and were aged 19 years and above.

Primary and secondary outcome measures
The primary outcome was defined as self-reported discontinuation of OAT in the past 6 months. Measures of association (2 and Fisher’s exact tests) and logistic regression models were used to assess the strength of association between OAT discontinuation and demographic, socioeconomic, accessibility, drug use and harm reduction correlates.

Results
Of the 194 participants included, 59.8% self-identified as cis man, 37.6% self-identified as Indigenous, 38.1% were aged 30–39 years and 43.8% had discontinued OAT in the past 6 months. Multivariable logistic regression analyses identified that those aged ≥50 years (AOR=0.12, 95% CI (0.03 to 0.45)) and those who took the survey in medium/large urban areas (AOR=0.27, 95% CI (0.07 to 0.98)) were significantly less likely to discontinue OAT, while those who experienced an overdose in the past 6 months were significantly more likely (AOR=3.77, 95% CI (1.57 to 9.03)) to have discontinued OAT in the past 6 months. Substance use, including opioids and stimulants, was similar among those who continued and discontinued OAT. Of the 73 participants who discontinued OAT and provided a reason, one-third reported discontinuing OAT because treatment was not effective, 27.4% could not get to the pharmacy during open hours, 23.3% could not make their clinic appointment and 15.1% reported challenges with transportation/travel.

Conclusions
OAT discontinuation prevention efforts for individuals using substances in BC need to address disparities in healthcare accessibility, especially in rural areas and among younger individuals. Continued access to harm reduction services can allow for safer consumption of substances for individuals enrolled in OAT programs.

Objectives
Vascular access (VA) stenoses play a significant role in the morbidity of the haemodialysed population. Classifications for diagnosis, assessment and proposal of treatment strategies can be useful clinical and methodological tools. This review aims to present a comprehensive summary and propose further methodological approaches.

Design
A systematic review of the literature, evaluating classifications for dialysis-related VA stenosis.

Data sources
Web of Science, Scopus, PubMed, Google Scholar and the ClinicalTrials.gov registry were searched from inception to 7 December 2024.

Eligibility criteria
All articles containing classifications regarding dialysis VA were eligible, with no restrictions on the study type or language of the full text.

Data extraction and synthesis
Two independent researchers performed the search and initial screening. Four vascular surgeons assessed the included classifications using a modified Buchbinder’s critical appraisal tool to evaluate quality.

Results
From 4771 screened papers, 59 full-text papers were retrieved and 24 articles contained classifications. Three classifications were dedicated to VA stenosis, all based on the anatomical location of lesions. According to the modified Buchbinder’s appraisal, the classifications were assessed as moderate-to-good quality. The literature disposes of immense inconsistency in terms of the definition of significant stenosis indicated for treatment.

Conclusions
VA significant stenosis and its classification is a non-uniformly understood issue with many different criteria and categorisations. This basic methodological problem leads to inconsistent results. We recommend the unification of the criteria and their validation in prospective studies.

Introduction
Intimate partner violence (IPV) and sexual assault are pervasive public health and human rights concerns that disproportionately impact trans and gender-diverse (TGD) individuals. Experiences of cisgenderism and transphobia, compounded by racism and other forms of discrimination and structural violence, can hinder access to appropriate supports in a safe and non-stigmatising environment across a variety of sectors, including but not limited to healthcare, social services, criminal justice, and legal. TGD individuals may also have unique health and social needs requiring support that is not yet in place. Recent research has identified the need to better understand barriers to accessing support for TGD survivors of IPV and sexual assault as a top priority. This study aims to address this need for evidence to facilitate improved access to inclusive and equitable services for TGD survivors.

Methods and analysis
This qualitative study will involve semi-structured interviews with approximately 60 adult TGD survivors of IPV and/or sexual assault who wanted to access, attempted to access, or used services. A diverse array of participants from across Canada will be recruited via purposeful and snowball sampling through partner organisations, Peer Leader Advisors and their networks, as well as promotion in physical and virtual spaces (eg, flyers and social media). An interview guide was developed based on Levesque’s access to care model. Virtual interviews will be thematically analysed using Braun and Clarke’s iterative phases of reflexive thematic analysis. An intersectionality lens will be applied throughout the research process.

Ethics and dissemination
Research Ethics Board approval was obtained from Women’s College Hospital (WCH REB #: 2023-0033-E). Findings will be shared in peer-reviewed publications, at academic conferences, and through the burgeoning trans-LINK Canada Network WebPortal (https://www.translinknetwork.com/) using a variety of media, including newsletters, infographics, and webinars.

New England Journal of Medicine, Volume 392, Issue 3, January 16, 2025.

This study quantifies losses and gains of obstetric care services at US rural and urban short-term acute care hospitals between 2010 and 2022.

Background
At the European level, several regulatory measures (ie, priority medicines (PRIME) scheme, accelerated assessment, conditional marketing authorisation and authorisation under exceptional circumstances) are in place with the aim to expedite the marketing authorisation process for medicines targeting unmet medical needs (UMNs). However, the potential impact of these measures on subsequent decisions regarding market access at the national level, and ultimately if medicines making use of these supporting measures reach the patient earlier, remains unclear.

Objectives
This study seeks to (1) assess the impact of such European regulatory measures on the number of successful applications and time to reimbursement of this group of medicines in the national context of Belgium and (2) evaluate the association between the application of European regulatory measures and Belgian measures (ie, early access pathways and managed entry agreements).

Design
A total of 322 medicines granted a European centralised marketing authorisation between 2015 and 2020, excluding generic products/biosimilars, were included in the study. For this set of medicines, data on European and Belgian regulatory and market access measures were extracted from the websites of the responsible European and Belgian authorities and completed with requested information up to December 2022. Regression analysis was used to assess the association between the application of European regulations and Belgian measures. Survival and regression analysis was used to test the impact of such regulatory measures on the time to and rate of reimbursement in Belgium.

Results
From the total sample (n=322), 34% (n=108) received a European regulatory measure, and also 34% (n=108) had a Belgian measure applied. Overall, 63% (n=202) of the total sample was submitted for reimbursement in Belgium, and of these, 83% (n=167) were reimbursed at the time of assessment. The median regulatory assessment time at the European level was approximately 14 months, while the median Belgian reimbursement assessment time was approximately 11 months. The study found that regulatory measures did not significantly impact the European or national assessment times or status. A significant reduction in European regulatory assessment time was observed only in the cases of the PRIME scheme (p=0.0087) and accelerated assessment (p

Introduction
Omalizumab, an anti-IgE monoclonal antibody, is effective in treating antihistamine-refractory chronic spontaneous urticaria (CSU). However, tapering strategies for omalizumab are currently not well-studied, and patients may be treated longer than needed. Here, we present the rationale and design of the EXtending Omalizumab Treatment Intervals in patients with Chronic spontaneous urticaria trial, a multicentre, randomised, open-label, non-inferiority clinical trial. The objective of this trial is to investigate if patients with well-controlled CSU, achieved by standard treatment of 300 mg omalizumab administered subcutaneously every 4 weeks (Q4W) for 12 weeks, can maintain disease control with every 6 weeks (Q6W) dosing interval.

Methods and analysis
Participants who achieve an Urticaria Control Test (UCT) score ≥12 after 12 weeks on omalizumab will be randomised to 300 mg omalizumab treatment Q4W or Q6W. Treatment arms will be followed for a total of 36 weeks. The primary endpoint is the absolute difference in average UCT score between treatment arms at week 36. Blood samples, Weekly Urticaria Activity Score, Chronic Urticaria Quality of Life Questionnaire, Dermatology Life Quality Index and records of side effects and flares will be obtained throughout the study at weeks 0, 12, 24 and 36.

Ethics and dissemination
The study has been approved by the Scientific Ethical Committee of the Capital Region in Denmark, the local Data Protection Agency and the Danish Medicines Agency. All study participants must provide written informed consent. The study will be conducted according to the Helsinki Declaration and Good Clinical Practice. Findings will be disseminated through publication in peer-reviewed journals and presented at international conferences.

Trial registration number
EU CT no. 2023-506187-14-00, ClinicalTrials.gov: NCT05916937.

Introduction
Preclinical studies have shown that oxygen therapy can improve ischaemic brain tissue oxygen tension, reduce reperfusion injury after revascularisation, promote neuroregeneration and inhibit inflammatory responses potentially exerting a beneficial effect after endovascular treatment (EVT) in patients with acute ischaemic stroke (AIS). However, the optimal fraction of inspired oxygen (FiO2) during EVT under general anaesthesia is currently unknown. Therefore, we are conducting a randomised controlled trial (RCT) to evaluate the impact of high-concentration oxygen vs low-concentration normobaric oxygen on early neurological function after EVT.

Methods and analysis
The Oxy-TARGET trial is an ongoing prospective, open-label, parallel-design RCT being conducted at Beijing Tiantan Hospital, Capital Medical University. It aims to enrol 200 anterior circulation AIS patients undergoing EVT under general anaesthesia between February 2024 and December 2026. Eligible participants are randomly assigned at a 1:1 ratio to receive FiO2=80% or FiO2=30% through endotracheal intubation, with the gas flow rate set at 4 L/min. The inspiratory oxygen concentration at the tracheal intubation site (delivered FiO2) was recorded concurrently. The primary outcome is the incidence of early neurological improvement (a National Institutes of Health Stroke Scale (NIHSS) score