Search Results for: Cardio-oncology: rivista open access

Introduction
Revision surgery following primary breast augmentation is common due to well-reported long-term limitations of permanent silicone implants. There are limited options for revision breast augmentation which avoids using silicone implants. Scaffold-guided breast tissue engineering (SGBTE) is a novel technique which uses breast scaffolds additively manufactured from medical grade polycaprolactone (mPCL), which is implanted and filled with autologous fat graft. This approach avoids limitations as observed with permanent silicone breast implants as the scaffold is porous and biodegradable. This clinical trial evaluates the safety and efficacy of SGBTE.

Methods and analysis
This study is an open, single-arm, monocentric, interventional, prospective clinical trial. The trial is being conducted at the Royal Brisbane and Women’s Hospital (RBWH) in Herston (Queensland, Australia) of the Metro North Health Service. The trial investigates 15–20 women who require breast implant surgery and/or congenital breast defect correction surgery, where a mPCL breast scaffold is implanted and filled with autologous fat graft. The primary endpoint is postoperative device safety by assessing the rate of adverse device effect rate. Secondary endpoints include general adverse event frequency and severity, number of revision surgeries, general surgical outcomes and complications, patient-reported outcomes and volume replacement outcomes.

Ethics and dissemination
The RBWH Human Research Ethics Committee (EC00172) has approved this clinical trial (ethics approval: HREC/2021/QRBW/79906). Findings from this clinical trial will evaluate the safety and efficacy of implanting mPCL scaffolds filled with autologous fat graft. The results of this clinical trial will be published in a peer-reviewed journal and presented at scientific meetings.

Trial registration number
NCT05437757.

Introduction
Relational continuity of care is where patients see the same clinicians over time. Evidence suggests relational continuity of care is valued by patients and clinicians and results in better health. While current National Health Service policy aims to maintain relational continuity of care, it has been declining in recent years, which may be linked to the growth in practice size, increased staff turnover, part-time working and the focus on patient access. Our research aims to develop resources to help clinicians measure, manage and improve relational continuity of care.

Methods and analysis
A mixed-methods approach in UK primary care commencing with two workshops drawing patients, clinicians and researchers together to establish an agreed approach on the measurement of continuity of care. Second, analysis of national data will provide insight into how staff turnover, part time working, practice size and funding per patient affects continuity. Third, case studies in a sample of high-performing practices will document the barriers and facilitators to the establishment and maintenance of continuity of care. Fourth, an economic analysis of resource costs and health outcomes using linked primary and secondary care data will show whether costs influence continuity for different patient groups (by age, sex, deprivation status and chronic disease status). Fifth, we will develop practical guidance for clinicians to improve continuity of care, based on the findings from each stage of the research.

Ethics and dissemination
The study has approval from HRA Health and Care Research Wales Research Ethics Committee (HCRW). Findings will be disseminated through peer-reviewed publications, participatory workshops, podcasts, clinical networks and academic conferences.

Annals of Internal Medicine, Ahead of Print.

Objectives
To examine the association between social and biological factors and quality of life (QoL), and whether depression and anxiety mediate this relationship.

Design
Cross-sectional study with individual level as the unit of analysis.

Main outcome measures
Depression and anxiety were measured using the Center for Epidemiologic Studies Short Depression scale and Generalized Anxiety Disorder scale, while QoL was assessed using the EuroQol Five-Dimension scale. Social factors were assessed using the self-reported number of close persons, and biological factors were measured using the number of self-reported physical health comorbidities.

Setting
Country-level data.

Participants
General population aged 18 and older with data available.

Results
Among participants, 849 (4.42%) had depression and 2339 (12.17%) had anxiety. Structural equation modelling (SEM) analysis, adjusted by age and sex, showed that social factors (β=–0.004, p

Introduction
There are a substantial number of patients developing heart failure after transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS), even though AS has been successfully treated. The purpose of this randomised controlled trial was to determine whether the addition of an angiotensin receptor–neprilysin inhibitor (ARNI), sacubitril/valsartan, is superior to conventional medications in lowering N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels in patients undergoing TAVI for AS.

Methods and analysis
The study design is a prospective, single-centre, open-label, randomised, parallel-group, two-arm study, in which participants will be randomised in a 1:1 ratio to receive either conventional medications plus ARNI or conventional medications only. In the ARNI group, if a patient was on an ACE inhibitor or angiotensin II receptor blocker before TAVI, it will be switched to ARNI 100 mg/day (50 mg two times per day) on the first postoperative day. If not, candesartan 4 mg/day will be started 1–2 days before TAVI, and switched to ARNI 100 mg/day on the first postoperative day. As the patient has tolerability to ARNI, dosage will be increased stepwise to 400 mg/day 2–4 weeks apart. ARNI will be continued until at least 6-month follow-up. In the control group, the patient will receive conventional medications. The primary endpoint is the serum NT-proBNP value at 6-month follow-up after TAVI. Each group includes 42 patients (84 total patients).

Ethics and dissemination
Ethical approval for this study has been obtained from the Chiba University Hospital Certified Clinical Research Review Board (CRB3180015). The study is ongoing. Findings from this study will be disseminated through peer-reviewed publications and conference presentations.

Trial registration number
This trial has been registered on the Japan Registry of Clinical Trials: jRCT1031220344.

Background
Adolescent pregnancy is associated with multifaceted challenges that impact countries’ health, education and economic stability. Despite ongoing interventions, in developing countries such as Kenya, adolescent pregnancy rates continue to be high. There is a need for more synthesised evidence on regional-specific risk factors to support tailored prevention strategies.

Objective
This scoping review aims to explore what is known about the risk factors and intervention strategies focused on adolescent pregnancy prevention in Kenya.

Methods and analysis
Using the Arksey and O’Malley framework combined with a three-step search strategy as recommended by the Joanna Briggs Institute, relevant articles will be identified from the PubMed, Scopus, Web of Science, CINAHL and PsycINFO databases. The focus will be on literature published from 1 January 2008 to 31 December 2023, addressing risk factors and public health strategies aimed at adolescent pregnancy prevention in Kenya. The analysis will involve thematic data extraction and charting to highlight patterns in adolescent pregnancy risk factors, intervention outcomes and existing gaps.

Ethics and dissemination
No ethical approval is needed. The dissemination strategy includes peer-review publication and presentation to relevant stakeholders.

Conclusion
This review will provide a comprehensive summary of the literature on the risk contributors and interventions for adolescent pregnancy prevention in Kenya. The evidence map may be used by relevant stakeholders to address adolescent pregnancy prevention gaps in strategy as well as inform interventions that are context-specific.

Registration
Open Science Framework (https://doi.org/10.17605/OSF.IO/Q5F9G); Pre-results.

Stroke, Volume 56, Issue 5, Page e130-e132, May 1, 2025.

Objective
In-hospital cardiac arrest (IHCA) presents a critical challenge with low survival rates and limited prediction tools. Despite advances in resuscitation, predicting 30-day survival remains difficult, and current methods lack interpretability for timely decision-making. This study developed a machine learning (ML) model to predict 30-day survival after IHCA, using peri-arrest variables available on the rescue team’s arrival, while ensuring a balance between predictive accuracy and clinical interpretability through Shapley Additive Explanations (SHAP).

Design
A nationwide, registry-based observational study.

Setting
Data were sourced from the Swedish Cardiopulmonary Resuscitation Registry (2010–2020), merged with the Patient Registry.

Participants
We analysed 25 905 IHCA cases with attempted resuscitation, of which 8166 patients survived for 30 days.

Outcome measure and analysis
30-day survival after IHCA was the outcome measure. An ML model was developed using fivefold cross-validation. Key predictors were identified through in-built variable importance and validated using SHAP. Model performance was evaluated with metrics such as area under the receiver operating characteristics (AUROC), calibration, sensitivity, specificity, false negative rate (FNR) and F-score.

Results
The CatBoost model achieved an AUROC of 0.9136 (95% CI 0.9075 to 0.9191) with all features, and 0.9034 (95% CI 0.8955 to 0.9037) with the top 15 features, along with Brier scores of 0.1028 and 0.1103, respectively. Performance plateaued after including the top 15 predictors, with few key variables, such as epinephrine administration, age, initial rhythm, ROSC within 15 min, breathing on rescue team arrival and witnessed cardiac arrest, being most influential. The model showed strong calibration for patients with low predicted survival probabilities and demonstrated high sensitivity with a low FNR across relevant survival thresholds.

Conclusion
The CatBoost model provides an effective and interpretable tool for predicting 30-day survival after IHCA. Key predictors such as epinephrine administration, age and initial rhythm inform clinical decision-making. This model has strong clinical utility and can be externally validated via the open-access Application Programming Interface (API) at www.gocares.se

Introduction
The management of immunoglobulin A (IgA) nephropathy remains a topic of debate. Hydroxychloroquine and mycophenolate mofetil (MMF) are two immunosuppressive agents that have recently garnered increased attention among patients with IgA nephropathy in China. Several studies have shown the comparable efficacy between MMF and enteric-coated mycophenolate sodium (EC-MPS), with lower adverse event rates for EC-MPS. The present study aims to evaluate the efficacy and safety of EC-MPS combined with hydroxychloroquine as an immunosuppressive regimen for patients with high-risk progressive IgA nephropathy, despite receiving routine supportive treatment.

Methods and analysis
This study is a multicentre, prospective, randomised controlled, open-label, blinded endpoint trial. 96 patients diagnosed with IgA nephropathy and persistent proteinuria from 12 general hospitals in Shanxi Province of China will be recruited and randomly assigned to receive either EC-MPS plus hydroxychloroquine or hydroxychloroquine alone in a 1:1 ratio. We will compare the efficacy and safety of hydroxychloroquine combined with or without oral EC-MPS (720–1080 mg/day for 6 months, and tapered to 360–540 mg/day for another 6 months) on a background of supportive care. All enrolled patients will receive standard basic treatment to achieve optimum blood pressure and the maximum tolerated dose of ACE inhibitors or angiotensin receptor blockers. The primary outcome is the change in 24-hour urine protein at 6 months relative to baseline. Participants will be subject to regular follow-up for a duration of 12 months.

Ethics and dissemination
This study has received ethical approval from the Ethics Committee of Shanxi Medical University Second Hospital (No. 2024YX-481). A duly signed and dated informed consent form must be obtained from each participant or his/her legal guardian prior to any operational procedures related to the trial. The result of this study will be presented and published at international conferences and in scientific journals.

Trial registration number
ChiCTR2400093530.

Introduction
Further improvement of cognitive–behavioural therapy for eating disorders (CBT-ED) is required that can provide better outcomes. Recent work showed that the length of therapy is not critical in improving outcomes. Rather, stratifying the treatment to individual needs is required to produce significant improvements. The current study adopts the approach of evaluating augmentations to ten-session CBT (CBT-T) where initial response to therapy is gradual rather than rapid.

Methods and analysis
Clients aged 15 years and over presenting to the Flinders University Services for Eating Disorders between January 2025 and June 2028 will be randomised to receive either CBT-T as usual or CBT-T augmented with therapy modules (CBT-TA) matched to obstacles to progress for gradual responders. Rapid response, assessed using the Eating Disorder Examination Questionnaire, is defined as ≥1.13 decrease in global ED psychopathology at session 4. In CBT-TA, the therapist and gradual responder will collaboratively choose at least one of nine augmentations to incorporate into therapy. Rapid responders in this group will be given access to the augmentations for use in their own time. Data for the main intent-to-treat analyses will be collected on five occasions: baseline assessment (T1), immediately preceding session 4 (T2), end of treatment (T3) and 3-month and 6-month follow-up (T4 and T5). The primary outcome is ED psychopathology, and secondary outcomes include behavioural indicators of the ED, impairment caused by the ED, general negative emotion, self-harm and hope. Analyses will be undertaken on an intention-to-treat basis and will include all participants in the group to which they were randomised.

Ethics and dissemination
Ethics approval was provided by the Social and Behavioural Research Ethics Committee at Flinders University (7992). This trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12624001495516). The findings arising from the study protocol will be reported to participants and presented at scientific conferences and disseminated by publications submitted to peer-reviewed journals.

Trial registration number
Australian New Zealand Clinical Trials Registry (ACTRN12624001495516).

Introduction
Out-of-hospital cardiac arrest is a public health concern with a high mortality rate. Hypoxic ischaemic brain injury is the primary cause of death in patients admitted to the intensive care unit (ICU) after return of spontaneous circulation (ROSC). Several systemic factors, such as hypotension, can exacerbate brain injuries. International guidelines recommend targeting a mean arterial pressure (MAP) of at least 65 mm Hg. Several observational studies suggest that a higher MAP may be associated with better outcomes, but no randomised trials have shown an effect of higher MAP. The ongoing METAPHORE (mean arterial pressure after out-of-hospital cardiac arrest) trial aims to compare a standard MAP threshold (MAP ≥65 mm Hg) with a high MAP threshold (MAP ≥90 mm Hg) to evaluate whether implementing a higher MAP threshold can improve neurological outcomes in patients admitted to ICU after cardiac arrest.

Methods and analysis
METAPHORE is a randomised, controlled, multicentre, open-label trial with a blinded primary outcome assessor, comparing two parallel groups of patients 18 years of age or older, receiving invasive mechanical ventilation for coma defined by a Glasgow Coma Score ≤8/15 after out-of-hospital cardiac arrest and sustained ROSC. Eligible patients are randomly assigned in a 1:1 ratio to either a MAP target threshold of 65 mm Hg or higher throughout the ICU stay (control group) or a MAP target threshold of 90 mm Hg or higher during the first 24 hours after randomisation, followed by 65 mm Hg or higher for the remainder of the ICU stay (intervention group). Both groups receive the same general care concerning post-cardiac arrest syndrome management according to international guidelines. The primary endpoint is the proportion of patients with a favourable neurological outcome as defined by a modified Rankin scale (mRS) of 0 to 3 measured on day 180 after inclusion by a psychologist blinded to the allocation of the intervention. Secondary outcomes are the proportion of patients alive at ICU and hospital discharge, at day 28 and day 180; proportion of patients alive at ICU discharge with a mRS of 0 to 3; the EuroQOL-5D-5L at day 180; the Clinical Frailty Scale at day 180; the number of ICU-free days, ventilator-free days, catecholamine-free days and renal replacement therapy-free days at day 28; the proportion of patients with acute kidney injury stage 3 and need for renal replacement therapy within ICU stay and proportion of patients with persistent need for renal replacement therapy at ICU discharge; and safety outcomes (cardiovascular, neurological, cutaneous, digestive and haemorrhagic complications within 7 days after inclusion). Subgroup analyses are planned according to initial cardiac arrest rhythm (shockable or non-shockable), chronic hypertension and Cardiac Arrest Hospital Prognosis score. Outcomes will be analysed on an intention-to-treat basis. Recruitment started in October 2024 in 27 French ICUs, and a sample of 1380 patients is expected by October 2027.

Ethics and dissemination
The study received approval from the national ethics review board on 8 February 2024 (Comité de Protection des Personnes Sud-Est V – 2023-A00257-38). Patients are included after informed consent has been obtained either from a proxy or through an emergency procedure. Results will be submitted for publication in peer-reviewed journals.

Trial registration number
ClinicalTrials.gov: NCT05486884.

Background
Social networks are an important, although overlooked, component of community-based health promotion. Advances in social network research have highlighted different social network intervention (SNI) strategies to improve community-based health promotion. The aim of this project is to collaborate with community and policy stakeholders to explore how to best apply these SNI strategies to improve the resilience, health and well-being of adults in Amsterdam, and more broadly in the Netherlands.

Methods and analysis
To this end, we will collaboratively develop an intervention planning tool called the ‘Health in All Networks Simulator (HANS)’. This tool will be capable of virtually testing different SNI strategies and forecasting their possible impact on resilience, health and well-being. Taking a mixed-methods approach consisting of a combination of interviews, group model building workshops and agent-based modelling with members of two communities in Amsterdam and policy stakeholders, we will foster a shared learning process while ensuring ownership and relevance of HANS to ongoing community-based health promotion practice.

Ethics and dissemination
The research project has been approved by the research ethics committee of Wageningen University (approval numbers: 2024-039; 2024-226). HANS will be shared directly with stakeholders. The results will be made available to the public via open-access publications and conferences.

Introduction
Standard premedication for paclitaxel-based chemotherapy includes dexamethasone and an histamine 1-antagonist to prevent hypersensitivity reactions (HSRs). However, the pharmacological rationale for dexamethasone is limited, and its use is associated with adverse effects such as hyperglycaemia, insomnia and immunodeficiency, negatively impacting health-related quality of life (HRQoL). No clear link has been established between dexamethasone dose, administration route and HSR incidence. Previous studies suggest that discontinuing dexamethasone beyond the second administration does not increase HSR risk. Despite this, dexamethasone remains standard practice. This trial evaluates whether complete omission of dexamethasone as paclitaxel premedication is non-inferior to the standard regimen in preventing clinically relevant HSRs (Common Terminology Criteria for Adverse Events (CTCAE) grade≥3).

Methods
The DEXASTOP trial is a prospective, multicentre, randomised, non-inferiority study conducted in four hospitals in the Netherlands. 500 adult patients receiving paclitaxel-based chemotherapy for any solid tumour indication will be randomised 1:1 to receive either standard premedication with dexamethasone or an experimental regimen without dexamethasone for up to five paclitaxel administrations. The primary endpoint is the incidence of clinically relevant HSRs (CTCAE grade≥3). Secondary endpoints include the incidence and severity of all-grade HSRs, the number of paclitaxel administrations before the first HSR, dexamethasone-related adverse events, HRQoL and cost-effectiveness from a healthcare and societal perspective.

Ethics and dissemination
This study has been approved by the Erasmus Medical Centre Ethics Committee (reference MEC-2024-0030, protocol version 3, May 2024). Study findings will be published open access in peer-reviewed journals and presented at national and international meetings. Results will be shared with patients, healthcare professionals and the public. Positive outcomes will be implemented in clinical practice, and trial data will be submitted to the EU Clinical Trials Information System for public access.

Trial registration number
NCT06118710.

Objectives
Considerable resources are invested in health system innovation and strengthening. This calls for efforts to ensure the sustainability of such interventions. We conducted a scoping review to identify factors influencing the sustainability of externally funded health system strengthening interventions targeting primary healthcare, the sustainability outcomes observed in such interventions and the methods used to measure sustainability.

Design
Scoping review following the Joanna Briggs Institute scoping review guidelines.

Data sources
Web of Science, Ovid Medline and Embase databases were searched through 11 March 2024.

Eligibility criteria
Studies in English with no restriction on study type or country. Externally funded health system strengthening interventions targeting primary health systems and measuring sustainability.

Data extraction and synthesis
One reviewer screened all titles and abstracts, and two independent pairs of reviewers read full texts. Relevant study data were extracted from the articles and descriptively analysed.

Results
From the 6439 titles retrieved, eight eligible studies were identified and included in the final analysis. Only four studies presented a sustainability definition. Institutionalisation and continued programme activities were described four times as sustainability outcomes, followed by capacity building twice and continued health impact and benefits once. Sustainability was assessed in five studies after intervention completion and in three studies during the implementation period. The sustainability factors were mostly related to processes (n=19), inner context (n=18), intervention characteristics (n=12) and outer context (n=11), with stakeholder engagement and partnership (n=6) as well as funding (n=3) being the most reported factors.

Conclusion
This review highlights the limited documentation on the sustainability of externally funded health system strengthening interventions. Sustainability was mainly assessed retrospectively. Influencing factors spanned over all categories of the integrated sustainability framework, with stakeholder engagement and funding playing key roles. Planning for sustainability assessments with clear definitions, methods and timeframes can enhance evidence on achieving lasting impacts of health system strengthening interventions.

Registration
Open Science Framework, https://osf.io/hazqp/?view_only=d53472afbba447e790049d81ca60aa29.

Objectives
To assess the prevalence of anxiety, depression and post-traumatic stress disorder (PTSD) and their associated factors among the caregivers of children diagnosed with cancer in Oman and explore the changes in psychological outcomes over time.

Design
A multicentre, prospective, cohort study.

Setting
The National Oncology Centre of the Royal Hospital, the Sultan Qaboos University Hospital and the Sultan Qaboos Comprehensive Cancer Care and Research Centre in Muscat, Oman.

Participants
Caregivers of Omani children and adolescents diagnosed with cancer at the three primary cancer referral centres in Oman.

Outcome measures
Validated Arabic versions of the State-Trait Anxiety Inventory, the Centre for Epidemiologic Studies Depression Scale and the Impact of Event Scale-Revised were used to screen for symptoms of anxiety, depression and PTSD, respectively. The first assessment (T1) was conducted any time within the first 3 months of the child’s diagnosis, while the second assessment (T2) was conducted 3–6 months after T1. Multivariate linear regression models were used to investigate the association between socio-demographic and clinical characteristics and average anxiety, depression and PTSD scores.

Results
Of the 92 caregivers of Omani children and adolescents diagnosed with cancer, 45.7%, 53.3%, 45.7% and 68.5% exhibited state anxiety, trait anxiety, depression and PTSD at T1. Subsequently, prevalence rates of these conditions decreased to 32.6%, 42.4%, 33.7% and 55.4%, respectively, at T2. Between T1 and T2, the prevalence of state anxiety decreased significantly, as did average state anxiety and PTSD scores (p

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