Risultati per: Cardio-oncology: rivista open access

Introduction
Obstructive sleep apnoea (OSA) is characterised by blood oxygen desaturations and sleep disruptions manifesting undesirable consequences. Existing treatments including oral appliances, positive airway pressure (PAP) therapy and surgically altering the anatomy of the pharynx have drawbacks including poor long-term adherence or often involving irreversible, invasive procedures. Bilateral hypoglossal nerve stimulation (HNSBL) is a new treatment for managing OSA, and this study is intended to determine whether an HNSBL system is a safe and effective treatment option for adults with OSA.

Methods and analysis
This is a pivotal, multicentre, prospective, single-arm study of HNSBL in PAP-intolerant adults with moderate to severe OSA. The device is activated 2 months after implantation with stimulation settings optimised before the final 12-month sleep study. At 12 months, the two coprimary effectiveness endpoints are the percentage of responders based on reduction in the Apnoea-Hypoponea Index, with hypopnoeas associated with 4% oxyhaemoglobin desaturation, and the Oxygen Desaturation Index, using drops in oxygen concentration >4% from baseline (ODI4). Secondary effectiveness endpoints include mean changes in quality-of-life assessments (daytime sleepiness and its effect on activities of daily living, OSA-specific quality of life, daytime sleepiness), levels of intermittent hypoxia, change in hypoxaemic burden and OSA severity.

Ethics and dissemination
The Food and Drug Administration, Advarra Institutional Review Board (IRB), University of Tennessee HSC IRB, University of Pennsylvania IRB, Weill Cornell Medicine IRB, Medical College of Wisconsin/Froedert Hospital, Human Research Protections Programme Vanderbilt University, St. Vincent’s Hospital Melbourne Human Research Ethics Committee, Ethisch Comite Universitair Ziekenhuis Antwerpen and Technische Universitat Munchen reviewed and approved this protocol. Study results will be disseminated through journal publications, updates to ClinicalTrials.gov and the Nyxoah website, and presentations at meetings and conferences.

Trial registration number
NCT03868618.

Stroke, Volume 56, Issue 1, Page 168-169, January 1, 2025.

Although about three-fourths of people using short-acting, reversible contraception reported receiving it in person in a US survey, only about a third considered that their most preferred way to obtain birth control. The findings from a nationally representative survey, published in JAMA Network Open, highlight a need for expanded access to alternative sources, the authors noted.

This cohort study aims to determine whether patient to nurse or patient to social worker staff ratios are associated with access to kidney transplant for adolescents and young adults.

Objective
The aim of this study is to develop, implement the precise reservation path (PRP) and investigate its prediction function for scheduling shunting patients for specialist appointment registration in Shanghai, China.

Design
The PRP system was built on the hospital’s existing information system, integrated with WeChat (WeCom) for user convenience. The outcome analysis employed a mixed-methods approach, integrating quantitative analysis with statistical and machine learning techniques, including multivariate logistic regression, random forest (RF) and artificial neural network (ANN) analysis.

Setting
This study was conducted at Renji Hospital, a premier general tertiary care institution in Shanghai, China, where the innovative PRP system was implemented. The programme was designed to efficiently connect patients requiring specialised care with the appropriate medical specialists.

Participants
The PRP encompassed both voluntary specialists at Renji Hospital, as well as patients seeking outpatient specialist services.

Primary outcome measures
The pass rates of patient for specialist applications.

Secondary outcome measures
Clinical department, specialists’ and patients’ characteristics influencing specialist review result.

Results
From a data set of 58 271 applicants across 26 departments between 1 December 2020 and 30 November 2022, we noted an overall pass rate of 34.8%. The departments of urology, breast surgery and thoracic surgery, along with five others, accounted for 86.65% of applications. Pass rates varied significantly, and demographic distributions of applicants across departments revealed distinct patient profiles, with preferences evident for age and gender. We developed an RF model based on pass rates from 26 specialised departments. The RF model, with 92.31% accuracy, identified age as the primary predictor of pass rates, underscoring its impact on specialist review outcomes. Focus on patient demographics, we conducted univariate and multivariate logistic regression analyses on the 58 271 patient data set to explore the relationship between demographic factors and review outcomes. Key findings from logistic regression included significant associations with gender, age and specialist title. Results indicated that older patients were more likely to be approved in specialist reviews, while middle-aged patients had lower pass rates. The generalised linear model, enhanced with specialist and clinical department variables, showed superior predictive accuracy (67.86–68.26%) and model fit over the previous logistic model. An ANN model also identified specialist and clinical department as the most influential, achieving comparable accuracy (67.72–68.28%).

Conclusions
The PRP programme demonstrates the potential of digital innovation in enhancing the hierarchical medical system. The study’s findings also underscore the value of the PRP programme in healthcare systems for optimising resource allocation, particularly for ageing populations. The programme’s design and implementation offer a scalable model for other healthcare institutions seeking to enhance their appointment systems and specialist engagement through digital innovation.

Introduction
Non-response significantly undermines the representativeness of patient-reported outcome (PRO) data, thereby compromising its utility for facilitating high-value, equitable, patient-centred care in cancer clinics. Quality improvement studies are needed to assess the representativeness of PRO data collected in routine care, identify the underlying causes of non-response and develop novel methods to ensure data representativeness. Using a multilevel framework and a mixed-methods approach, we have three aims: (1) characterise the non-response of the Global-10 across clinic, provider and patient levels; (2) identify multilevel causes of non-response and potential strategies to improve representativeness in PRO collection; and (3) develop effective modifications to missing-data methods to enhance the representativeness of pre-existing PRO data.

Methods and analysis
Our primary data source is the Patient Reported Outcomes Measurement Information System Global-10, collected as part of routine care at the Radiation Oncology clinics within the Mass General Brigham (MGB) healthcare system. Other sources include (1) Harvard Catalyst for provider-specific data, (2) MGB administrative data, (3) public Centers for Medicare & Medicaid Services data and (4) the National Plan and Provider Enumeration System. We will conduct quantitative analyses to assess variations in Global-10 non-response across multilevel factors. Additionally, we will use qualitative interviews with patients and clinical professionals to understand the causes of non-response and to formulate strategies to expand the reach of PRO collection to underrepresented cancer patients, improve their completions and enhance overall data representativeness. Finally, we will integrate implementation science knowledge and findings from the first two aims into missing-data methods to manage non-response in the pre-existing Global-10 data and to evaluate their performance in preserving representativeness.

Ethics and dissemination
The study protocol was reviewed and approved by the Institutional Review Board at the Dana-Farber/Harvard Cancer Center (24-225). Written informed consent will be obtained from participants. Study findings will be disseminated through peer-reviewed publications and presentations at national and international conferences.

Introduction
In low- and middle-income countries (LMICs), the persistent lack of access and high inappropriate use of antibiotics, which are fuelled by gender-related factors, continue to facilitate antimicrobial resistance. This in turn reduces the capacity to treat infectious diseases. However, there is a lack of clarity on the nature and extent of the available evidence on gender influence on access to antibiotics and antibiotic use behaviour. This proposed study will systematically review the available literature to map out the scope of evidence on gender differences and, importantly, the related factors influencing antibiotic use and access to antibiotics in LMICs.

Methods and analysis
This scoping review will be conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines for scoping reviews. Major databases (MEDLINE, PsycINFO and CINAHL) will be searched via the EBCOhost and Web of Science platforms for peer-reviewed articles. Title and abstract screening, as well as full paper review, will be conducted by a single reviewer, with 20% of identified citations reviewed independently by two other reviewers. A predefined excel spreadsheet will be used for data extraction and analysis. Findings will be presented thematically in a narrative summary and tables.

Ethics and dissemination
Obtaining ethics approval is not required for this study. The findings will contribute to understanding gender health inequalities and areas for further research on strategies to incorporate gender considerations in antimicrobial stewardship efforts in LMICs. The study findings will be disseminated through presentations in seminars, scientific conferences and publications in peer-reviewed journals.

Introduction
The use of hydroxychloroquine (HCQ) during pregnancies complicated by systemic lupus erythematosus or refractory antiphospholipid antibody syndrome has demonstrated a significant ability to prevent pre-eclampsia (PE). As such, the potential for the administration of HCQ to prevent PE in other high-risk pregnancies is an important clinical research agenda among maternal and fetal medicine specialists. Mechanistically, the anti-inflammatory and immunomodulatory effects of HCQ can offer vascular protection and inhibit the placental dysfunction-associated thrombotic changes underlying the pathophysiology of PE, fetal growth restriction (FGR) and fetal death in utero (FDIU). Placenta-mediated complications exhibit a distinctive overlapping syndrome between pregnancies, and low-dose aspirin is the only prevention method currently in use. This study investigated the effects of improvements in outcomes with HCQ administration in high-risk pregnancies complicated by a previous experience of PE, FGR or FDIU.

Methods and analysis
This multicentre, open-label, single-arm trial commenced on 31 May 2022, in three tertiary hospitals in Korea. Pregnant women with a prior history of PE, FGR or FDIU are eligible to participate. This single-arm study set the previous study with the most similar inclusion criteria, aspirin dose and drug administration period as the comparison group. The required sample size was determined to be 58, with an expected dropout rate of 10%.

Ethics and dissemination
This study protocol was approved by the following institutions and committees: Institutional Review Boards of Chung-Ang University Gwangmyeong Hospital (2304-082-056), Samsung Medical Center (2021-11-087-003) and Kyungpook National University Chilgok Hospital (2021-06-005-006) and the Ministry of Food and Drug Safety. The results will be disseminated to the general public, grant funder, maternal–fetal medicine specialists and other researchers.

Trial registration number
NCT05287321.

New England Journal of Medicine, Ahead of Print.

Introduction
Acute liver failure (ALF) has no effective treatment other than liver transplantation and is commonly caused by paracetamol overdose. New treatments are needed to treat and prevent ALF. Alternatively-activated macrophages (AAMs) can promote resolution of liver necrosis and stimulate hepatocyte proliferation. Using AAMs in unscheduled care requires the use of an allogeneic product. A clinical trial is needed to determine the safety and tolerability of allogeneic AAMs.

Methods and analysis
A single-centre, open-label, dose-escalation, phase 1 randomised trial to determine whether there is dose-limiting toxicity of AAMs in patients with paracetamol-induced acute liver injury. Randomisation will occur at higher doses. Between 17 and 30 patients will receive treatment, subject to dose-limiting toxicity and an adaptive trial design which aims to reduce the risk of allocation bias through blinding and randomisation.

Ethics and dissemination
The trial will be conducted according to the ethical principles of the Declaration of Helsinki 2013 and has been approved by North East—York Research Ethics Committee (reference 23/NE/0019), National Health Service Lothian Research and Development department, and the UK Medicines and Healthcare products Regulatory Agency. When the trial concludes, results will be shared by presentation and publication.

Trial registration number
ISRCTN12637839.

Objectives
Globally, there is a lack of evidence regarding access to and utilisation of antigen rapid diagnostic tests (Ag-RDTs). This might hinder public health interventions to increase testing. We conducted a survey to understand access to and utilisation of COVID-19 Ag-RDT among residents in Phnom Penh, Cambodia.

Design
This is a representative household survey using linear regression models with random effects to account for clustering and a logistic model with random effects to assess factors associated with Ag-RDT access.

Setting
We conducted the study in 10 villages in Phnom Penh between August and mid-September 2022.

Participants
We enrolled one member per household (n=280), aged between 18 and 65 years.

Outcome measures
Both access and utilisation were defined at the individual level (self-reports). We defined access as having undergone COVID-19 rapid testing within 6 months and utilisation as having administered this test (to themselves or others) within 12 months, prior to the study interview.

Results
In a clustering-adjusted linear model, access to Ag-RDTs among the general population from the 10 villages was 34% (n=95) and utilisation was 28% (n=77). Price and advice from the pharmacist were commonly reported to be the main selection criteria for Ag-RDTs, with 41% (n=111) and 62% (n=175), respectively. In the logistic model, those with higher educational attainment were more likely to have access to the Ag-RDT compared with those with lower education levels (adjusted OR4.42, 95% CI 1.82 to 10.74).

Conclusions
Unfamiliarity with Ag-RDT tests and low education levels negatively affect access and utilisation of Ag-RDTs among the general population in Phnom Penh.

This Viewpoint outlines the missions of academic cancer centers and how they are being affected by the oncology industrial complex along with challenges and suggestions for an aligned way forward.

This Viewpoint explores whether the Inflation Reduction Act’s provisions and price negotiations could affect investment in trials of new oncology therapies or indications.

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.

Objectives
Many patients presenting with acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in primary care do not benefit from antibiotics. Excessive use wastes resources, promotes antimicrobial resistance and can harm patients.

Design
We conducted a within-trial economic evaluation, using a UK National Health Service perspective, as part of the multicentre, parallel-arm, open, individually randomised, controlled PACE trial.

Setting
Participating general practices in primary care.

Participants
PACE included 324 and 325 consenting participants presenting with AECOPD in the usual-care and CRP-guided groups, respectively.

Intervention
We assessed the cost-effectiveness (CE) of a C-reactive protein point-of-care-test (CRP-POCT) in addition to usual clinical assessment to guide antibiotic prescribing for AECOPD in primary care.

Primary and secondary outcome measures
A cost-effectiveness analysis (CEA) of incremental cost per 1% antibiotic consumption reduction at 4 weeks and a cost-utility analysis (CUA) at 6 months were performed, based on a modified intention-to-treat population. Sensitivity analyses assessed the impact of uncertainty on the results. CE acceptability curves represent the probability of CRP-POCT being cost-effective at different willingness-to-pay (WTP) thresholds.

Results
Both groups had similar clinical outcomes, but a 20% absolute reduction in antibiotic consumption was observed in the CRP-guided group. CRP-POCT costs of £11.31 per test were largely offset by savings in healthcare resource use related to COPD. The mean incremental CE ratios of CRP-POCT were £120 per 1% absolute reduction in antibiotic consumption at 4 weeks and £1054 per quality-adjusted life-year (QALY) gained at 6 months. Sensitivity analysis showed that the CEA results were most affected by changes in healthcare costs, while CUA was sensitive due to marginal differences in costs and outcomes. There is a 73% probability of CRP-POCT being cost-effective at WTP ≤£20 000 per QALY gained.

Conclusion
CRP-POCT is a cost-effective intervention for safely reducing antibiotic consumption in patients with AECOPD.

Trial registration number
ISRCTN24346473

This study identifies state policies authorizing law enforcement access to prescription drug monitoring program data and discusses the characteristics of those policies, particularly in states with laws banning gender-affirming care.