Search Results for: Cardio-oncology: rivista open access

Stroke, Ahead of Print. BACKGROUND:For patients with acute ischemic stroke due to a large vessel occlusion admitted in primary stroke centers, helicopter transfer to comprehensive stroke centers is often used to expedite access to mechanical thrombectomy. Some studies have suggested that vibrations generated during helicopter transport might enhance intravenous thrombolysis (IVT) efficacy. We aimed to evaluate the impact of helicopter transfer, compared with ground transportation, on interhospital recanalization and functional outcomes.METHODS:We conducted a retrospective analysis of 2 prospectively collected cohorts of anterior circulation acute ischemic stroke due to a large vessel occlusion patients transferred to 2 comprehensive stroke centers (Stanford, CA, November 2019 to January 2023, and Montpellier, France, January 2015 to January 2017) for mechanical thrombectomy consideration with arterial imaging both at the primary stroke center and on comprehensive stroke center arrival. The primary outcome was interhospital recanalization, determined by comparison of the baseline and posttransfer arterial imaging and defined as revised arterial occlusive lesion scores of 2b to 3. The association between transportation mode (helicopter versus ground) and interhospital recanalization was studied in logistic regression analysis, adjusting for pretransfer IVT use, occlusion site, and transfer duration.RESULTS:Among 520 included patients, 315 (61%) were transferred by helicopter and 259 (50%) received IVT before transfer. Interhospital recanalization rates were similar between helicopter and ground transfers in both the overall cohort (23% versus 19%;P=0.30) and the IVT subgroup (36% versus 33%;P=0.61). Adjusted analyses confirmed no association between helicopter transport and interhospital recanalization (adjusted odds ratio, 1.23 [95% CI, 0.72–2.11];P=0.44). Favorable 3-month functional outcome (modified Rankin Scale score, 0–2) rates were also similar between helicopter and ground transfers in both unadjusted (35% versus 40%;P=0.29) and adjusted analyses (adjusted odds ratio, 1.12 [95% CI, 0.67–1.88];P=0.67).CONCLUSIONS:In this multicenter observational cohort study, helicopter transfer was not associated with improved interhospital recanalization or favorable functional outcomes compared with ground transport. These findings do not support the hypothesis that vibrations during helicopter transport enhance IVT efficacy.

In Reply We designed the ADAPT-Sepsis trial as a superiority study, addressing a prioritized research funding brief and international evidence gaps. Our sample size estimate, type I error rate, and power were largely driven by a clinical effectiveness outcome (total antibiotic treatment duration to 28 days after randomization) and not safety (28-day all-cause mortality). The resulting sample size estimate allowed us to measure safety with a noninferior 28-day all-cause mortality margin of 5.4%, the narrowest reported to date, as indicated by Dr Bosch and colleagues. We primarily reported trial safety for a reduction in total antibiotic duration for the PCT group compared with standard care using this approach. The 95% CI for the difference in 28-day mortality did not exceed 5.4% and crossed 0. Therefore, we have shown that PCT is not worse than standard care and that there is no difference between PCT and standard care. Furthermore, there were no differences in the survival curves to day 28 (Figure 2B in our article) or day 90 (eFigure 7 in the article’s Supplement 3). Unlike Bosch and colleagues, we do not believe that implementing daily PCT monitoring will result in excess mortality given the totality of our reported trial data and the body of open-label trial evidence. However, given our concealed trial intervention methods, we suggest that future systematic open implementation of our PCT protocol should be informed by evidence (inducing adherence data) to be presented from an in-trial process evaluation.

To the Editor In their Viewpoint, Dr Dzau and colleagues paint an intriguing metaphorical picture of 2 successive “valleys of death” that prevent biomedical innovation from advancing health care for the general public.

In Reply We appreciate Dr Lindpaintner’s comments on our recent Viewpoint. We agree that high prices represent an important barrier to access, with drug pricing serving as one of the most salient examples of this issue. In fact, this challenge epitomizes what we term the health equity valley of death, wherein systemic factors—including those related to cost and access—hinder the equitable dissemination of medical innovation, particularly to the most vulnerable populations. Lindpaintner accurately quoted our passage regarding the “‘need to…reduce [the] cost of health care, improve access and affordability’ as ways to close the equity gap.” However, although he highlighted our discussion on “digital technology, big data, and artificial intelligence” as potential solutions, he did not acknowledge that we also emphasize a variety of important policy approaches, including the pursuit of universal health care, the strengthening of primary care systems, and the development of social programs and policies to improve access and affordability. Indeed, a major factor in affordability is drug price.

Introduction
Recently, immunotherapy has significantly transformed the treatment landscape of endometrial cancer (EC). Results from KEYNOTE-158, RUBY and AtTEnd showed programmed cell death 1 (PD-1) or programmed cell death-ligand 1 inhibitors with promising efficacy in primary advanced or recurrent EC. However, few studies focused on the role of dual immune checkpoints in primary advanced or recurrent EC. Cadonilimab is an immune checkpoint inhibitor targeting the PD-1 and T-lymphocyte antigen-4, which is expected to show substantial clinical efficacy in EC. Combining cadonilimab with standard chemotherapy may have synergistic effects, making this combination a promising first-line treatment for primary advanced or recurrent EC. Furthermore, incorporating molecular classification for guidance on the use of cadonilimab may hold valuable clinical benefits.

Methods and analysis
In this multicentre, open-label, phase II study, patients with histologically confirmed EC were eligible. Forty-five patients will be recruited. Seventeen patients will be enrolled in stage I, and at least seven cases of complete response (CR) and partial response (PR) should be observed before entering stage II. All patients will receive cadonilimab at a dosage of 10 mg/kg along with carboplatin (area under the curve (AUC)=4–5) plus paclitaxel (175 mg/m2) every 3 weeks (Q3W) for 6–8 cycles. Subsequently, patients with CR, PR or stable disease will receive maintenance of cadonilimab at 10 mg/kg Q3W for 24 months or until progressive disease or adverse events are reported. The objective response rate is the primary endpoint. The secondary endpoints include the disease control rate, duration of response, progression-free survival, overall survival and safety. Additionally, exploratory endpoints involve biomarkers that may predict the efficacy of cadonilimab and chemotherapy, as well as their relationship with molecular classifications. The interim analysis will be conducted after 17 patients have been enrolled.

Ethics and dissemination
The study protocol meets the approval of the ethical committee of Fujian Cancer Hospital (K2023-173-04) and all other participating hospitals. Study findings will be disseminated in peer-reviewed publications.

Trial registration number
NCT06066216.

Objectives
In lung transplantation (LTx), a priority is assigned to each candidate on the waiting list. Our primary objective was to identify the key factors that influence the allocation of priorities in LTx using machine learning (ML) techniques to enhance the process of prioritising patients.

Design
Developing a prediction model.

Setting and participants
Our data were retrieved from the United Network for Organ Sharing (UNOS) open-source database of transplant patients between 2005 and 2023.

Interventions
After the preprocessing process, a feature engineering technique was employed to select the most relevant features. Then, six ML models with optimised hyperparameters including multiple linear regression, random forest regressor (RF), support vector machine regressor, XGBoost regressor, a multilayer perceptron model and a deep learning model were developed based on the UNOS dataset.

Primary and secondary outcome measures
The performance of each model was evaluated using R-squared (R2) and other error rate metrics. Next, the Shapley Additive Explanations (SHAP) technique was used to identify the most important features in the prediction.

Results
The raw dataset contains 196 270 records with 545 features in all organs. After preprocessing, 32 966 records with 15 features remain. Among various models, the RF model achieved a high R2 score. Additionally, the RF model exhibited the lowest error values, indicating its superior precision compared with other regression models. The SHAP technique in conjunction with the RF model revealed the 11 most important features for priority allocation. Subsequently, we developed a web-based decision support tool using Python and the Streamlit framework based on the best-fine-tuned model.

Conclusion
The deployment of the ML model has the potential to act as an automated tool to aid physicians in assessing the priority of lung transplants and identifying significant factors that play a role in patient survival.

Introduction
Fibrotic interstitial lung diseases (F-ILD) are severe and often progressive lung disorders that frequently lead to respiratory failure, with patients experiencing high symptom burdens, including severe dyspnoea. This is also evident in patients with severe chronic obstructive pulmonary disease (COPD). Many patients will eventually require ambulatory oxygen therapy (AOT) due to exertional desaturation. Although AOT has shown benefits like increased walking distance and improved quality of life, adherence remains a challenge due to practical issues. AOT can be given by oxygen bottles that provide continuous oxygen flow or as portable concentrators; however, there is a lack of studies comparing the different methods and assessing patient preferences. Data from the present study help guide the selection of patients for different AOTs and provide information on patient preferences.

Methods and analysis
The study design is a single-centre, randomised, open-label cross-over exploratory comparative study to investigate the efficacy of two different oxygen delivery systems. Patients with COPD or F-ILD who, during a 6-minute walk test (6MWT), can walk at least 50 m and desaturate below 88% are eligible for inclusion in the study. The participants are randomised to perform the 6MWT with either oxygen bottles or portable concentrators first. The primary endpoint is the difference in the lowest oxygen saturation (SpO2) between the two systems. Secondary endpoints include, among others, the difference in percentage of time and number of minutes when SpO2 falls below 88%, mean and maximum pulse rate, and distance and time taken to recover during the 6MWT. Quality of life and patient preferences will be evaluated by scores from the COPD assessment test and the King’s Brief Interstitial Lung Disease health status questionnaire to help gain a better understanding of symptom impact during activity and limitations in daily life.

Ethics and dissemination
The study has been approved by the Central Denmark Region Committees on Health Research Ethics (1-10-72-115-24). The results of this trial will be submitted for publication in an international peer-reviewed journal.

Trial registration number
NCT06767904.

Objectives
Amidst low recognition and treatment for mental health conditions among people living with heart failure (PLWHF), this study aimed to identify factors affecting access to mental health services for PLWHF.

Design
Semi-structured phone interviews were conducted with PLWHF (n=13) and clinicians and researchers (n=9).

Setting
Heart failure remote management programme at a large urban academic hospital in Ontario, Canada.

Results
Using inductive reflexive thematic analysis, 14 themes were created and mapped to Levesque’s patient-centred access to care framework, revealing barriers at the system and patient levels. System-level barriers included service approachability (ie, difficulties detecting mental health concerns; unpreparedness for referral conversations), availability and accommodation (ie, limited mental health services; poorly timed services; inconsistent care pathways) and affordability (ie, limited human resources; lack of options for choice or finding fit; insufficiency of generic mental health services). Patient-level barriers included limitations in the ability to perceive mental health needs (ie, low mental health literacy), as well as seek (ie, stigma), reach (ie, inconvenience of in-person delivery) and pay (ie, lack of full insurance coverage and high cost of psychological services) for mental healthcare.

Conclusions
The findings suggest enhancing the approachability, availability and appropriateness of mental health services and promoting the ability of PLWHF to recognise their mental health needs as potential interventional targets.

Objective
There is limited evidence on the economic implications of assessing patients’ access to personalised treatments through Comprehensive Genomic Profiling (CGP) and Molecular Tumour Board (MTB), prompting the need to analyse their impact on the cost of the cancer diagnostic journey (from hospital admission to MTB evaluation) and accessibility to personalised therapies.

Design
Retrospective observational cohort.

Setting
Patients discussed from April 2020 to September 2021 by the institutional MTB operating at Fondazione IRCCS Istituto Nazionale Tumori of Milan, an Italian centre of excellence in oncology pertaining to the national health system.

Participants
676 patients focused on: non-small cell lung cancer (NSCLC), cholangiocarcinoma (CCA), pancreatic carcinoma (PC) and gastro-oesophageal carcinoma (GEC). We defined two different scenarios: (1) patients tested with small Next-Generation Sequencing (NGS) panels (≤60 biomarkers) vs (2) patients tested with comprehensive panels ( >60 biomarkers).

Main outcomes and measures
We measured (1) patients’ eligibility to personalised therapies based on genomic data obtained using targeted somatic NGS panels, (2) MTB cost and the overall diagnostic journey cost and (3) the cost to find a patient eligible to access personalised treatments.

Results
Tumour profiling with comprehensive NGS panels improved patients’ eligibility to personalised therapies compared with small panels (NSCLC: 39% comprehensive panel vs 37% small panel; CCA: 43% vs 17%; PC: 35% vs 3%; GEC: 40% vs 0%). The overall diagnostic journey cost per patient was between 3.2K and 7.4K (NSCLC: 7.4K comprehensive panel vs 6.4K small panel; CCA: 4.9K vs 3.7K; PC: 5.8K vs 4.5K; GEC: 4.2K vs 3.2K). MTB discussion accounted for only 2–3% of the diagnostic journey cost per patient (around 113/patient). The cost to find patient eligible for personalised treatments varied significantly according to panel size and tumour setting (NSCLC: 5K comprehensive panel vs 2.8K small panel; CCA: 4.4K vs 4.4K; PC: 5.5K vs 27K; GEC: 5.2K vs not measurable since none of the patients analysed with small NGS panels were eligible).

Conclusions and relevance
MTB discussion of genomic data obtained with NGS comprehensive panels significantly increases patient eligibility to targeted therapies and optimise the cost to find a patient eligible to personalised treatments, mainly for CCA, PC and GEC patients.

Introduction
Shortening the duration of postoperative radiotherapy (RT) for breast cancer while maintaining efficacy and safety has become a significant trend. The 3-week regimen of 40–42.5 Gy in 15–16 fractions is now a preferred option in clinical practice. Following the publication of the 5-year outcomes from the Fast-Forward trial, interest in 1-week regimens has surged, prompting the initiation of multiple studies. However, trials exploring the 1-week regimen for regional nodal irradiation (RNI), especially involving internal mammary nodes (IMN), remain scarce. Additionally, the optimal fractionation scheme for tumour bed boost in the era of ultra-hypofractionated regimens is still debated. To address these gaps, we initiated the adjuvant regional nodal radiation therapy for one week in breast cancer (ARROW) trial to evaluate the feasibility of a 1-week regimen for RNI of 26 Gy in five fractions, with optional sequential tumour bed boost of 10.4 Gy in two fractions. The findings from our trial are expected to extend the application of ultra-hypofractionated regimens to include sequential tumour bed boosts and RNI, pioneering its use in IMN irradiation.

Methods and analysis
The ARROW trial is an open-label, single-arm, multicentre phase II trial, encompassing four teaching hospitals in China. Enrolled patients will receive a total of 26 Gy in five fractions to ipsilateral whole breast/chest wall and regional regions, including supraclavicular/infraclavicular nodes, IMN and any portion of the undissected axilla deemed at risk. A sequential tumour bed boost of 10.4 Gy in two fractions is delivered in patients at high risk for recurrence, which is at the discretion of the radiation oncologist. The sample size for the ARROW trial was 197 patients. Both intensity-modulated radiation therapy and proton therapy are permitted. The primary endpoint is acute radiation-induced toxicity, graded according to Radiation Therapy Oncology Group (RTOG) criteria and CTCAE V.3.0. Secondary endpoints include cosmetic outcomes for breast-conserving surgery, late radiation-induced toxicity, local regional recurrence, distant metastasis, invasive tumour-free survival, overall survival and quality-of-life assessment.

Ethics and dissemination
The trial has been approved by the Ethical Committee of Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine, as well as approvals from the ethical committees of each participating centre have also been obtained. Research findings will be submitted for publication in peer-reviewed journals.

Trial registration number
ARROW trial: NCT04509648.

Objectives
Persons diagnosed with anorexia nervosa (AN) may receive care in general psychiatric inpatient care (GPIC) for several reasons including severity of their condition, comorbidities and lack of access to specialised inpatient care. However, scant research has explored how this specific setting may impact persons with AN, either positively or negatively. Additionally, there is limited evidence regarding the most effective form of care for AN within GPIC. This integrative literature review provides a comprehensive overview of research focusing on care for AN in GPIC settings, shedding light on person-centred care and power within this specific context.

Design
The review was conducted according to the methods of Whittemore and Knafl. We searched the academic databases PubMed, CINAHL and PsycInfo, with the latest search conducted in March 2025, in accordance with a specific search strategy and analysed the data using a constant comparison method. The review is reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist for systematic reviews.

Results
The synthesis revealed three perspectives of care for persons with AN in the context of GPIC: management of the symptoms, treatment of the patient and support for the person. Overall, the findings suggest that GPIC can aid in weight gain, but the impact on recovery is unclear.

Conclusion
Research indicates that GPIC possesses the biomedical knowledge necessary to save lives, but there is a lack of research focusing on the perspectives of persons with AN. This gap in understanding may affect treatment outcomes, the possibility of recovery and the personal experience of care for those with AN in this context.

PROSPERO registration number
CRD42023426095.

Objective
The aim of this study was to examine the epidemiology of disability in India and assess access to disability support and rehabilitation services by people with disability (PWD).

Design
This study is a secondary analysis of data from the 76th round of the National Sample Survey (2018), focusing on disability in India.

Setting
The survey employed a stratified two-stage sampling design based on Census 2011, covering all states and union territories of India. Villages and urban blocks were selected in the first stage, while households were chosen in the second stage across rural and urban areas.

Participants
The survey included data from a population of 576 796 individuals residing in 118 152 households from 8992 village/urban blocks (5378 rural villages and 3614 urban blocks). The analysis focused on 107 125 individuals (61 707 male and 45 305 female) who reported at least one disability.

Outcome measures
The primary outcome was ‘any disability’. Secondary outcomes included access to disability support and rehabilitation services, which assessed difficulties in accessing public buildings and transport, loss of employment after disability, availability of government support, enrolment in special schools, and possession of a disability certificate.

Results
The overall weighted disability prevalence was 2.2%, with significant disparities across sociodemographic characteristics. Among PWD, 45.9% of those who acquired disability after birth were aged between 15 years and 59 years, and 20.8% received no government aid. About 40% of PWD struggled to use public transport, and 57.7% had difficulties accessing public buildings. Additionally, 60.7% reported job loss due to disability, and 69.6% lacked a disability certificate.

Conclusion
This study highlights disparities faced by PWD in accessing disability support and rehabilitation services. There is an urgent need for concerted efforts to minimise such experiences. This will help us enhance the well-being and participation of PWD and empower them to contribute to society with their true potential.

Introduction
Hospitals have been identified as one of the drivers accelerating climate change, and in response, they have recently been incorporating environmentally sustainable goals into their organisations. Given the significant role that healthcare workers play in pursuing hospitals’ environmental goals through such actions as energy conservation and waste reduction, the scoping review is intended to comprehensively map and summarise the literature on these workers’ green behaviours within hospital settings.

Methods and analysis
The scoping review will follow Joanna Briggs Institute methodology and will report findings according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for Scoping Reviews checklist. A comprehensive search for relevant sources published from database inception through 31 January 2025 will be conducted across seven electronic databases (PubMed, Cumulative Index of Nursing and Allied Health Literature, Embase, Scopus, Web of Science, PsycINFO and Emerald Journals), using key terms such as “hospital,” “healthcare workers” and “green behavior”. We will include peer-reviewed journal articles focusing on healthcare workers’ green behaviours in hospitals and relevant grey literature in order to provide an extensive review. Articles that are not written in English or that are intervention-based will be excluded. The study selection process will be presented in a flow diagram, and the text will summarise the findings of eligible studies according to key characteristics.

Ethics and dissemination
The scoping review will not require ethical approval. The findings will be disseminated through publication in a peer-reviewed journal and conference presentation.

Trial registration number
This protocol has been registered with the Open Science Framework (https://doi.org/10.17605/OSF.IO/YU345).

Introduction
Stillbirth and second trimester miscarriage have wide-reaching consequences for women, their partners and their families. There is currently little community-based care provision within the National Health Service for women and partners who have had a stillbirth or second trimester miscarriage. There is a research gap in the evidence to guide best practice. This review will seek to understand how, when and where this care is best delivered.

Methods and analysis
The aim of this review is to identify the key elements of community-based care following a stillbirth or second trimester miscarriage. As this is a complex intervention, a realist approach will be used to establish for whom, how, when and where this care is best delivered. An initial programme theory will be constructed which will be tested against the available evidence and refined. A wide range of evidence including qualitative, quantitative, mixed-methods and experiential knowledge will be identified through secondary sources, extracted and synthesised to develop and refine the programme theory.

Ethics and dissemination
This review will not require ethical approval as it does not involve primary data collection. The findings will be submitted for open-access publication to a peer-reviewed journal and disseminated to stakeholders.

PROSPERO registration number
CRD42024587365.

Introduction
Vast empirical evidence highlights the importance of early identification, diagnosis and support for autistic children. Caregivers of autistic children often experience high levels of psychological distress; hence there is a need for parallel child and caregiver support. Autism New Zealand’s Let’s Play programme is a caregiver-mediated, community-based programme based on the principles of developmental and relational interventions (henceforth, developmental). Developmental interventions are evidence-based supports designed to enhance children’s learning within the context of developmentally appropriate, naturalistic settings (eg, everyday routines, play). We aim to evaluate the effects of the Let’s Play programme on autistic children’s engagement and caregiver stress.

Methods and analysis
This study will be a single-blind (rater) randomised controlled trial with two parallel arms: immediate programme access (intervention) versus a waitlist control. Participants will be 64 caregivers of children aged 0–5 years with diagnosed or suspected autism, allowing for 20% attrition, based on power calculations. The Let’s Play programme will be delivered over 9 weeks using a combination of small group workshops and in-home coaching. Primary outcome variables include child engagement and caregiver stress. Caregivers will complete measures at three time points (baseline, immediately post-programme and at the 6-month follow-up), and effectiveness will be analysed using generalised estimating equation models and intention-to-treat and per protocol analyses.

Ethics and dissemination
This trial was approved by Aotearoa New Zealand Ministry of Health’s Health and Disability Ethics Committee (2022 FULL 13041). Findings will be communicated nationally and internationally via conferences, journal publications and stakeholder groups (eg, service providers for autistic children). Results will be shared regardless of magnitude or direction of effect.

Trial registration number
ACTRN12622001139763.

Introduction
Residual thrombosis risk is an important contributor to ischaemic events in patients with acute coronary syndrome (ACS) after percutaneous coronary intervention (PCI). Although previous studies have shown that rivaroxaban 2.5 mg two times per day in ACS patients with high ischaemic risk can significantly reduce the risk of ischaemic recurrence and mortality, individualised treatment with low-dose rivaroxaban is still rare. Using D-dimer and PARIS (Patterns of non-Adherence to Anti-Platelet Regimen in Stented Patients) coronary thrombosis risk score to identify ACS patients at high ischaemic risk, we aim to investigate whether 3-month low-dose rivaroxaban therapy on the basis of dual antiplatelet therapy (DAPT) could result in reduced ischaemic events without increasing bleeding.

Methods and analysis
This study is a multicentre, prospective, open-label, randomised controlled trial involving 3944 ACS patients undergoing PCI from more than 40 tertiary hospitals in China (ClinicalTrials.gov NCT05638867). Patients with PARIS coronary thrombosis score ≥3 or D-dimer ≥0.28 µg/mL will be 1:1 randomised to the experimental group (rivaroxaban 2.5 mg two times per day for 3 months on the basis of 1 year standard DAPT) or the control group (1 year standard DAPT only). The primary endpoint of this study is major adverse cardiovascular and cerebrovascular events (MACCE), a composite of death, myocardial infarction, unplanned ischaemia-driven revascularisation and systemic embolic events. The safety endpoint is Bleeding Academic Research Consortium (BARC) type 3 and 5 bleeding events.

Ethics and dissemination
Institutional Review Board (IRB) approval by the Ethics Committee of Fuwai Hospital was obtained on 22 April 2023 (Approval No. 2023–1980). The investigators will have access to the final dataset. Trial results will be made public through publication in professional journals.

Trial registration number
NCT05638867.