Search Results for: Cardio-oncology: rivista open access

Introduction
Hypernatraemia, defined as a plasma sodium concentration >145 mmol/L, is a frequent complication in critically ill patients treated in the intensive care unit (ICU) (= ICU-acquired hypernatraemia), with reported prevalence ranging from 4% to 26%. Hypernatraemia adversely affects various physiological functions and is associated with delirium, prolonged length of stay and increased ICU and post-discharge mortality. The sodium load from intravenous drug diluents significantly contributes to ICU-acquired hypernatraemia, with drug infusions comprising about 30% of the daily fluid volume of an average ICU patient. This study aims to investigate if using glucose 5% solution as the default drug diluent, instead of sodium chloride 0.9%, can reduce the prevalence of ICU-acquired hypernatraemia and improve patient outcomes.

Methods and analysis
To test the effectiveness of glucose 5% solution as the default drug diluent, we will conduct a multicentre, pragmatic, embedded, open-label, stepped-wedge, cluster-randomised trial. The study will include twelve clusters (ICUs and one intermediate care unit) across six hospitals in Germany, with a projected total sample size of 4485 patients. In line with the stepped-wedge cluster-randomised design, one ICU will transition every 4 weeks, in a randomised sequence, from using sodium chloride 0.9% as the default drug diluent to glucose 5%.
The primary endpoint is the prevalence of hypernatraemia >150 mmol/L through day 28. The number of days alive and free of the ICU through day 28 will be tested hierarchically as a key secondary endpoint. Other exploratory endpoints include ICU mortality, ICU-free days, hospital-free days and other clinical outcomes. The primary endpoint will be analysed using a logistic mixed-effects model.

Ethics and dissemination
The trial was approved by the Charité—Universitätsmedizin Berlin Ethics Board and by the ethics board of each enrolled hospital. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences.

Trial registration number
The trial protocol was registered with the German Clinical Trials Register on 21 June 2024 prior to initiation of patient enrolment (DRKS00033397).

Objectives
The COVID-19 pandemic induced significant changes in access policies to general practice (GP) in most countries. This study aimed to compare and discuss changes in the diagnostic patterns and GP procedures before and during the pandemic.

Design and setting
A register study including data from 11 Danish GP clinics.

Participants
Enlisted patients from GP followed 1 year before (February 2019 to January 2020; n=48 650) and 1 year during (April 2020 to March 2021; n=47 207) the COVID-19 pandemic.

Outcome measures
Diagnostic patterns, consultation type (face-to-face, email and phone), contact persons (GP or GP staff) and patient characteristics.

Results
The average number of contacts with GP increased from 6.3 contacts per year per patient before the pandemic to 8.3 annual contacts during the pandemic (p

Objectives
To compile and compare the Comprehensive Geriatric Assessment (CGA) models that exist worldwide and their applicability in primary healthcare (PHC).

Introduction
The world’s population is ageing rapidly, but health systems are slow to keep up with this trend, making it difficult to provide care for older adults. The broad concept of frailty has prompted a comprehensive and holistic approach to patients, where the assessment is related not only to functional, physical and cognitive abilities of the older adults, but also their social, environmental and economic context. In recent decades, the approach to frailty has taken the CGA as the gold standard. With this project, we intend to carry out a scoping review to identify and describe tools to help standardise and generalise CGA in PHC.

Inclusion criteria
Individuals aged 65 years or over; CGA in a PHC setting; the CGA methods reported must include at least three domains: physical, cognitive and social; Articles without language restrictions; Articles published in the last 30 years.

Methods
All studies that refer to CGA models and fulfil the inclusion criteria will be selected. A bibliographic search of articles will be carried out using the following electronic scientific publication databases: MEDLINE-PubMed, Embase, Cochrane Library and Web of Science. We will search for grey literature on sites such as ‘OpenGrey’ and thesis repositories such as RCAAP, EBSCO and EThOS, as well as on the WHO pages. The articles will be independently selected by two reviewers, and the data will be presented in narrative format, structured according to the objective, focus and question of the review.

Ethics and dissemination
Approved by the ethics committee of the regional health administration of the centre, registered as Project 11/2024 and approved on 8 May 2024. The findings of this study will be disseminated through peer-reviewed publications and national or international conference presentations. Updates of the review will be conducted, as necessary.

Trial registration number
Open Science (DOI 10.17605/OSF.IO/REH43).

Objectives
The aim of this study was to determine the feasibility of delivering personalised isometric exercise (IE) for people with stage 1 hypertension. Is it feasible to deliver an isometric wall squat intervention in the National Health Service and what sample size is required to conduct an appropriately powered effectiveness randomised controlled trial (RCT)?

Design
Randomised controlled open-label multicentre feasibility study of IE compared with standard care in unmedicated people with stage 1 hypertension.

Setting
Initially, the study aimed to recruit through primary care, but this process coincided with the advent of the COVID-19 pandemic. Therefore, we shifted focus to direct-to-public advertising and delivery in secondary care.

Participants
People with unmedicated stage 1 hypertension aged over 18 able to perform IE were included. Patients were excluded if average home systolic blood pressure (sBP)

Objective
This review aimed to map the concept of patient safety culture in emergency departments (EDs), describe the availability of evidence related to patient safety culture as assessed by healthcare workers, identify the key focus areas of existing studies and pinpoint gaps in the current literature.

Design
A scoping review followed a comprehensive methodological process that included five steps based on the framework developed by Arksey and O’Malley and updated by Peters et al.

Eligibility criteria
Studies encompassing original research and all pertinent published and grey literature within the last 15 years (2010–2024) that aligned with the population (healthcare workers), concept (patient safety culture) and context (emergency department) framework for this study were included.

Data sources
PubMed, CINAHL (EBSCOhost), WOS, Embase, MEDLINE (Ovid), and KISS databases were searched for original studies published between 2010 and 2024 that aligned with the topic of this study.

Data extraction and synthesis
Two researchers independently extracted data from 28 eligible articles using a predetermined data extraction tool. A third researcher reviewed the data to ensure accuracy.

Results
A total of 28 articles were included in the review. The findings indicated an increase in research on patient safety culture in emergency departments since 2021. However, no eligible studies have assessed it within North America. Teamwork within units was the most positively perceived dimension, whereas the reporting of patient safety incidents was the least positively perceived dimension.

Conclusions
Although research on patient safety culture in eergency departments has increased, the findings remain limited in their generalisability due to a lack of diverse methodologies. Qualitative studies are needed to deepen the understanding of patient safety culture in multifaceted contexts. This review contributes to the academic field by bringing us closer to developing tailored interventions that can foster a positive patient safety culture in emergency departments.

Protocol registration
The protocol for this scoping review was registered in the Open Science Framework (https://osf.io/9f7qc).

Objectives
To identify and assess the social support interventions provided to caregivers of older adults with dementia. By synthesising the findings, it seeks to provide insights into effective strategies that can enhance caregivers’ support.

Design
A scoping review.

Data sources
The Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews was strictly followed in this study. Searches were systematically conducted across five databases (PubMed, Web of Science, Embase, Cochrane Library, CINAHL) from their inception up to February 2025.

Eligibility criteria for selecting studies
We included original intervention studies published in English that examined social support interventions for caregivers of older adults with dementia, focusing on outcomes reporting social support.

Data extraction and synthesis
Data extraction was conducted using a standardised Microsoft Excel chart based on Arksey and O’Malley’s method. Two reviewers independently collected information on study characteristics (authors, country, publication year, design, sample size, assessment tools, interventions and outcomes). Disagreements were resolved by a third independent reviewer.

Results
A total of 31 studies were selected for this review, revealing six distinct categories of social support interventions for caregivers of older adults with dementia. These categories included peer support (n=7), counselling group intervention (n=2), health education (n=2), mindfulness-based stress reduction intervention (n=1), individual therapy (n=1) and multicomponent interventions (n=18). The findings indicate that these interventions significantly enhanced the social support available to caregivers, leading to positive outcomes such as reduced caregivers burden, anxiety, depression and improved coping skills.

Conclusion
This review underscores the variety of interventions designed to enhance social support for caregivers of older adults with dementia. The findings provide valuable insights for caregivers, administrators and other stakeholders, emphasising the critical need to adopt and promote effective social support strategies for this population.

Trial registration details
A review protocol was registered on the OSF(Open Science Framework) registries, with the following registration doi: https://doi.org/10.17605/OSF.IO/D9C53.

Introduction
Pharmacomechanical thrombectomy (PMT) can be a useful treatment for restoring vein patency quickly, especially for extensive acute deep vein thrombosis (DVT). However, previous evidence failed to validate the effectiveness of PMT in reducing the incidence of post-thrombotic syndrome (PTS). To address this controversy, the reformation study aims to improve rheolytic thrombectomy for acute DVT of the lower limb through primary popliteal vein thrombosis clearance.

Method and analysis
Reformation is a prospective randomised multicentre trial. It has 160 patients in two groups: the modified access group (80 patients) and the traditional access group (80 patients). The purpose of this study is to assess whether the modified access approach for removing inflow thrombus in a one-stage procedure is more effective in enhancing the success rate of the procedure and reducing the incidence of PTS during a 24-month follow-up period, for patients with acute whole limb DVT.

Ethics and dissemination
The reformation study has been registered at www.clinicaltrials.gov. The study protocol has been approved by the Institutional Review Board and Human Research Ethics Committee of Renji Hospital, School of Medicine, Shanghai Jiao Tong University (approved number: KY2021-067-A). The results will be disseminated by publication in a peer-reviewed journal.

Trial registration number
NCT05286710.

Protocol version and date
V.1.2, 20 August 2022.

Objectives
To estimate the proportion and correlates of self-reported financial difficulty among patients with multiple myeloma (MM) or chronic lymphocytic leukaemia (CLL).

Setting
Sixty-six US community and minority oncology practices affiliated with the National Cancer Institute Community Oncology Research Programme (NCORP).

Participants
A total of 521 patients (≥18 years) with MM or CLL consented and 416 responded to a survey (completion rate=79.8%). Respondents had a MM diagnosis (74.0%), an associate degree or higher (53.4%), were White (89.2%), insured (100%) and treated with clinician-administered drugs (68.0%).

Study design
Observational, theoretical model and protocol-based patient survey administered between May 2019 and June 2020.

Primary and secondary outcome measures
Financial difficulty was assessed using a single-item measure, the EORTC QLQC30: ‘Has your physical condition or medical treatment caused you financial difficulties in the past year?’ and using an ‘any-or-none’ composite measure of 22 items assessing financial difficulty, worries and the use of cost-coping strategies. Multivariable logistic regression models assessed the association of financial difficulty with diagnosis, socioeconomic and treatment characteristics.

Results
About 16.8% reported experiencing financial difficulty using the single-item measure and 60.3% using the composite measure. Most frequently endorsed items in the composite measure were financial worry about having to pay large medical bills related to cancer and difficulty paying medical bills. Financial difficulty using the single-item measure was associated with having MM vs CLL (adjusted OR (aOR), 0.34; 95% CI, 0.13 to 0.84; p=0.02), having insurance other than Medicare (aOR, 2.53; 95% CI, 1.37 to 4.66; p=0.003), being non-White (aOR, 2.21; 95% CI, 1.04 to 4.72; p=0.04) and having a high school education or below (aOR, 0.36; 95% CI, 0.21 to 0.64; p=0.001). Financial difficulty using the composite measure was associated with having a high school education or below (aOR, 0.62; 95% CI, 0.41 to 0.94; p=0.03).

Conclusions
US patients with MM and CLL report financial difficulty, especially those with low socio-economic status. Interventions are needed to mitigate patients’ financial difficulty.

Trial registration number
NCT03870633.

Introduction
Physiotherapy is a recommended treatment for a wide range of conditions. However, waitlists can delay access to care, leading to poorer patient outcomes and added strain on healthcare systems. Group-based physiotherapy treatments have shown comparable clinical effectiveness to individual care and may help address these challenges. Despite this potential, their implementation in practice remains limited. Therefore, this systematic review aims to: (1) identify the determinants of use, intention to use, satisfaction, attitudes and experience with group-based treatments of patients and physiotherapy professionals, such as physiotherapists or physiotherapy technologists and (2) assess the factors that may influence patients’ and professionals’ preferences for group-based treatments over individual treatments.

Methods and analysis
Systematic searches were conducted on 6 September 2024 in the Medline, Embase, Web of Science, EBSCO CINAHL and Cochrane databases to identify studies published in French or English, in line with the language proficiency of the review team. Eligible studies will use quantitative, qualitative or mixed-method designs and report original data on the use or intention to use, satisfaction with, attitudes toward and experiences with group-based physiotherapy treatments, from either patients or physiotherapy professionals. Studies will be screened by two independent reviewers, with any discrepancy resolved through consensus or by involving a third reviewer. Data will be extracted from the included studies by two independent reviewers using a predefined data extraction form, with any discrepancy similarly resolved. For quantitative findings, the direction of the relationship between the outcomes and their determinants will be reported, along with the magnitude and significance of the coefficients, where available. For qualitative findings, relevant quotes will be provided to illustrate the relationship between the outcomes and their determinants. All included studies will be assessed by two independent reviewers using the Mixed Methods Appraisal Tool, with any discrepancy resolved again through consensus or by involving a third reviewer.

Ethics and dissemination
Ethical approval is not required for this review as it involves the collection of data from existing publications only. The findings will be disseminated through publication in a peer-reviewed scientific journal and presentations at relevant conferences.

Trial registration number
CRD42024574513.

This Viewpoint discusses the unintended consequences of the 21st Century Cures Act for patients and clinicians.

This cohort study assesses changes in cancer drug use after negative confirmatory trials and removal of accelerated approval indications from US Food and Drug Administration–approved labeling.

Ten years ago, when we started JAMA Oncology, our goal was to create a journal that would be “one-stop shopping” for oncology clinical science. Our scope was to publish scientific discoveries and innovations that would have either immediate importance to the reader or have the potential to be practice changing within the next 5 years. Our north star was, and still is, science that impacts patient care. We reached out to the scientific community broadly with editors who were medical, surgical, and radiation oncologists. Over the years, we have cultivated a diverse group of authors and readers: physicians, PhD scientists, nurses, pharmacists, patients, and many others. This diverse community has given JAMA Oncology its edge—there is always some unique topic within our table of contents.

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.

In JAMA Oncology, Reyngold and colleagues report their experience with ablative radiation (A-RT) in 25 consecutive patients with localized, operable pancreatic cancer who were identified as high-risk candidates for surgery due to medical comorbidities and advanced age. All patients received a biologically effective dose of at least 97.5 Gy and 17 of the 25 received induction chemotherapy prior to A-RT. Median survival from the time of A-RT was 22 months (longer if measured from the time of diagnosis) with a 2-year survival of 44%. Local disease control was achieved in the majority of patients, and local progression at 2 years was 21%. The authors conclude that A-RT represents an excellent form of local tumor control in patients at high risk for pancreatic cancer surgery and who have no evidence of distant disease. The authors are to be commended for their exceptional work in advancing the use of radiation for patients with pancreatic cancer.

In the Original Investigation titled “Stereotactic Body Radiotherapy vs Sorafenib Alone in Hepatocellular Carcinoma: The NRG Oncology/RTOG 1112 Phase 3 Randomized Clinical Trial,” published online December 19, 2024, and in the February 2025 issue, there were errors in the Key Points and Table 1. In the Key Points Findings section, the percentage of patients with macrovascular invasion was updated to 74%. In Table 1, the values in the HCC volume/liver volume row were updated to percentages. This article was corrected online.

This cross-sectional study examines the inclusion of individuals from the Middle East and North African region in oncology clinical trials.