Risultati per: Cardio-oncology: rivista open access

Introduction
It remains uncertain whether the most appropriate management for women with an unfavourable cervix after 24 hours of cervical ripening is repeating the ripening procedure or proceeding directly to induction by oxytocin. No adequately powered trial has compared these strategies. We hypothesise that induction of labour with oxytocin among women who have just undergone an ineffective first ripening procedure is not associated with a higher risk of caesarean delivery than a repeated cervical ripening with prostaglandins.

Methods and analysis
We will conduct a multicentre, non-inferiority, open-label, randomised controlled trial aimed at comparing labour induction by oxytocin with a second cervical ripening that uses prostaglandins (slow-release vaginal dinoprostone; oral misoprostol 25 µg; dinoprostone vaginal gel 2 mg). Women (n=1494) randomised in a 1:1 ratio in 10 French maternity units must be ≥18 years with a singleton fetus in vertex presentation, at a term from ≥37+0 weeks of gestation, and have just completed a 24-hour cervical ripening procedure by any method (pharmacological or mechanical) with a Bishop score ≤6. Exclusion criteria comprise being in labour, having more than 3 contractions per 10 min, or a prior caesarean delivery or a history of uterine surgery, or a fetus with antenatally suspected severe congenital abnormalities or a non-reassuring fetal heart rate. The primary endpoint will be the caesarean delivery rate, regardless of indication. Secondary outcomes concern delivery, perinatal morbidity, maternal satisfaction and health economic evaluations. The nature of the assessed procedures prevents masking the study investigators and patients to group assignment.

Ethics and dissemination
All participants will provide written informed consent. The ethics committee ‘Comité de Protection des Personnes Ile de France VII’ approved this study on 2 April 2021 (No 2021-000989-15). Study findings will be submitted for publication and presented at relevant conferences.

Trial registration number
NCT04949633.

Circulation, Volume 147, Issue 16, Page e716-e716, April 18, 2023.

Objectives
Late presentation and delays in diagnosis and treatment consistently translate into poor outcomes in sub-Saharan Africa (SSA). The aim of this study was to collate and appraise the factors influencing diagnostic and treatment delays of adult solid tumours in SSA.

Design
Systematic review with assessment of bias using Risk of Bias in Non-randomised Studies of Exposures (ROBINS-E) tool.

Data sources
PubMed and Embase, for publications from January 1995 to March 2021.

Eligibility criteria
Inclusion criteria: quantitative or mixed-method research, publications in English, on solid cancers in SSA countries. Exclusion criteria: paediatric populations, haematologic malignancies, and assessments of public perceptions and awareness of cancer (since the focus was on patients with a cancer diagnosis and treatment pathways).

Data extraction and synthesis
Two reviewers extracted and validated the studies. Data included year of publication; country; demographic characteristics; country-level setting; disease subsite; study design; type of delay, reasons for delay and primary outcomes.

Results
57 out of 193 full-text reviews were included. 40% were from Nigeria or Ethiopia. 70% focused on breast or cervical cancer. 43 studies had a high risk of bias at preliminary stages of quality assessment. 14 studies met the criteria for full assessment and all totaled to either high or very high risk of bias across seven domains. Reasons for delays included high costs of diagnostic and treatment services; lack of coordination between primary, secondary and tertiary healthcare sectors; inadequate staffing; and continued reliance on traditional healers and complimentary medicines.

Conclusions
Robust research to inform policy on the barriers to quality cancer care in SSA is absent. The focus of most research is on breast and cervical cancers. Research outputs are from few countries. It is imperative that we investigate the complex interaction of these factors to build resilient and effective cancer control programmes.

Introduction
Athletes are not immune to mental health issues but are less likely to seek help than non-athletes and experience barriers including lack of access to services, lack of knowledge as to how to access services and negative past experiences for help-seeking. Formal (eg, university counsellors, general practitioners and psychologists) and semi-formal (eg, academic tutor, sports coach and physiotherapist) sources of support provided in healthcare, the sport context and higher education are key places for athletes to seek help for mental health, and there is a need to synthesise the evidence on athletes’ access, attitudes to and experiences of these services, to understand how to improve these services specific to athletes’ mental health needs. This protocol outlines a scoping review that will be used to map the evidence, identify gaps in the literature and summarise findings on athletes’ access, attitudes to and experiences of help-seeking for their mental health.

Methods and analysis
The methodological frameworks of Arksey and O’Malley (2005), Levac et al (2010) and the Joanna Briggs Institute (2020 and 2021) were used to inform this scoping review protocol alongside the Preferred Reporting Items for Systematic review and Meta-Analysis Protocols checklist and published scoping review protocols within sport and health. The six stages of Arksey and O’Malley’s (2005) framework have been used for this scoping review. The searches were conducted between 30 March 2022 and 3 April 2022 in the following databases: APA PsycINFO (via OVID), Embase (via Ovid), MEDLINE (via Ovid), APA PsycArticles Full Text (via OVID), Web of Science Core Collection, SPORTDiscus (via EBSCO), CINAHL (via EBSCO), Scopus, ProQuest (Education Database), ProQuest (Education Collection), ProQuest (Health & Medical Collection), ProQuest (Nursing & Allied Health database), ProQuest (Psychology Database), ProQuest (Public Health Database) and ProQuest (Sports Medicine & Education). The main inclusion criteria of this review are: papers that focus on past help-seeking behaviour, attitudes towards help-seeking and future behavioural intentions, papers that refer to formal and semi-formal sources of support and peer-reviewed literature, primary research articles, systematic or scoping reviews and interventions. During title and abstract screening and full-text review, at least two reviewers will be involved. Data to be extracted from studies includes: details of the study population, whether the paper focuses on formal and/or semi-formal sources of support and whether the focus is on access, attitudes or experiences to help-seeking for mental health.

Ethics and dissemination
The evidence will be mapped numerically and through content analysis to describe studies and highlight key concepts, themes and gaps in the literature. The published scoping review will be disseminated to relevant stakeholders and policymakers including those in healthcare, the sporting context and the higher education system. The resulting outputs will be in the form of both peer-reviewed and non-peer reviewed publications (eg, multimedia in the form of a blog post and at conferences). The dissemination plan will be informed by patient and public involvement. Ethics approval was not required for this study.

Introduction
Acute kidney injury (AKI) is a common complication after cardiac surgery (CS) and is associated with adverse short-term and long-term outcomes. Alpha-1-microglobulin (A1M) is a circulating glycoprotein with antioxidant, heme binding and mitochondrial-protective mechanisms. RMC-035 is a modified, more soluble, variant of A1M and has been proposed as a novel targeted therapeutic protein to prevent CS-associated AKI (CS-AKI). RMC-035 was considered safe and generally well tolerated when evaluated in four clinical phase 1 studies.

Methods and analysis
This is a phase 2, randomised, double-blind, adaptive design, parallel group clinical study that evaluates RMC-035 compared with placebo in approximately 268 cardiac surgical patients at high risk for CS-AKI. RMC-035 is administered as an intravenous infusion. In total, five doses will be given. Dosing is based on presurgery estimated glomerular filtration rate (eGFR), and will be either 1.3 or 0.65 mg/kg.
The primary study objective is to evaluate whether RMC-035 reduces the incidence of postoperative AKI, and key secondary objectives are to evaluate whether RMC-035 improves postoperative renal function compared with placebo. A blinded interim analysis with potential sample size reassessment is planned once 134 randomised subjects have completed dosing. An independent data monitoring committee will evaluate safety and efficacy data at prespecified intervals throughout the trial. The study is a global multicentre study at approximately 30 sites.

Ethics and dissemination
The trial was approved by the joint ethics committee of the physician chamber Westfalen-Lippe and the University of Münster (code ‘2021-778 f-A’) and subsequently approved by the responsible ethics committees/relevant institutional review boards for the participating sites. The study is conducted in accordance with Good Clinical Practice, the Declaration of Helsinki and other applicable regulations. Results of this study will be published in a peer-reviewed scientific journal.

Trial registration number
NCT05126303.

Objectives
In the first full year of the COVID-19 pandemic (2020), South Asians living in the Greater Toronto and Hamilton Area (GTHA) and Greater Vancouver area (GVA) experienced specific barriers to accessing SARS-CoV-2 testing and reliable health information. However, between June 2021 and February 2022, the proportion of people having received at least one COVID-19 vaccine dose was higher among this group (96%) than among individuals who were not visible minorities (93%). A better understanding of successful approaches and the challenges experienced by those who remain unvaccinated among this highly vaccinated group may improve public health outreach in subsequent waves of the current pandemic or for future pandemic planning. Using qualitative methods, we sought to explore the perceptions of COVID-19 risk, vaccine access, uptake and confidence among South Asians living in Canada.

Design
Semistructured interviews conducted with 25 participants analysed using thematic analysis. Throughout this process, we held frequent discussions with members of the study’s advisory group to guide data collection (community engagement, recruitment and data analysis).

Setting
Communities of the GTHA and GVA with interviews conducted virtually over Zoom or telephone.

Participants
25 participants (15 from Ontario and 10 from British Columbia) were interviewed between July 2021 and January 2022. 10 individuals were community members, 9 were advocacy group leaders and 6 were public health staff.

Results
Access to and confidence in the COVID-19 vaccine was impacted by individual risk perceptions; sources of trusted information (ethnic and non-ethnic); impact of COVID-19 and the pandemic on individuals, families and society; and experiences with COVID-19 mandates and policies (including temporal and generational differences). Approaches that include community-level awareness and tailored outreach (language and cultural context) were considered successful.

Conclusions
Understanding factors and developing strategies that build vaccine confidence and improve access can guide approaches that increase vaccine acceptance in the current and future pandemics.
Visual abstract can be found at https://drive.google.com/file/d/1iXdnJj9ssc3hXCllZxP0QA9DhHH-7uwB/view

This Viewpoint discusses the benefits of expanded access research, the usefulness of expanded access data, the issues surrounding cost and transparency, and the adjusted role of institutional review boards.

This essay urges action in the aftermath of a war that destroyed the health care system, specifically women’s cervical cancer screening and treatment, in Tigray.

This Viewpoint proposes 3 changes to the Enhancing Oncology Model of the US Centers for Medicare & Medicaid Services.

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

This cross-sectional study evaluated data from a large US survey (2013-2018) to determine how health status and access have changed among lesbian, gay, and bisexual adults compared with heterosexual counterparts.

Most of the literature available on Inflammatory Bowel Disease (IBD) comes from studies performed in white population. Recent studies indicate a potential shift in the epidemiology of IBD in the United States, with significantly greater increases in incidence rates noted in non-White patients. (1) However, the burden of this disease on black and non-black Hispanic is unknown. This prompts a re-examination of the challenges these populations face including access to care issues and financial barriers.

Inflammatory bowel disease is a chronic inflammatory condition for which patients may require care on a more urgent basis. Response times can be delayed when clinics are inundated with calls or when providers are not available for immediate patient care. We developed and tested an algorithm to empower nurses to effectively triage phone calls and improve access.

It has been estimated that about 25% of patients with inflammatory bowel disease (IBD) are diagnosed before the age of 18. Food insecurity, limited or lack of access to enough food, has been associated with poor outcomes in childhood health including mental health problems. United States Department of Agriculture (USDA) defines a food desert as a census tract that meets criteria for low access to a grocery store and low income. Depression and anxiety have been well documented in pediatric patients with IBD.

Neihulizumab (ALTB-168) is a novel immune checkpoint agonistic antibody that binds to human CD162 (PSGL-1), and leads to downregulation of activated T-cells. Early-phase trials of neihulizumab have suggested a benefit in patients with immune conditions, including psoriasis, psoriatic arthritis and steroid-refractory acute graft-versus-host disease. Here, we report the results of a Phase II study investigating the use of neihulizumab for ulcerative colitis (UC) (ClinicalTrials.gov Identifier: NCT03298022).

Introduction
This is a multicentre, open-label, single-arm clinical trial to evaluate the efficacy and safety of apalutamide in patients with metastatic castration-resistant prostate cancer.

Methods and analysis
The trial will be performed at 4 university hospitals and 14 city hospitals in Japan. The target number of patients will be 110. The patients will be orally administered 240 mg apalutamide once daily during the treatment period. The primary outcome is the prostate-specific antigen (PSA) response rate. PSA response is defined as ≥50% decline from baseline at 12 weeks. Secondary outcomes are time to PSA progression, progression-free survival, overall survival, progression-free survival during second therapy, ≥50% decline in PSA from baseline at 24 and 48 weeks, ≥90% decline in PSA from baseline or lower PSA detection sensitivity after the initial dose at 12, 24 and 48 weeks, PSA maximal changes, accumulated PSA response from screening to 24 and 48 weeks, and grade 3 or 4 adverse events according to the Common Terminology Criteria for Adverse Events version 4.0.

Ethics and dissemination
This study has been approved by the Certified Research Review Board of Kobe University (No. CRB5180009). 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 datasets generated during the study will be available from the corresponding author on reasonable request.

Trial registration number
jRCTs051220077.