Search Results for: Cardio-oncology: rivista open access

Objectives
To systematically assess the robustness of meta-analyses based on randomised controlled trials (RCTs) in vascular surgery using the Fragility Index (FI).

Design
Cross-sectional study.

Setting
Meta-analyses published in English from January 2019 to April 2025, identified from EMBASE, PubMed and Web of Science.

Participants
67 articles, with 291 meta-analyses involving RCTs evaluating vascular surgical interventions, covering venous, aortic, peripheral arterial, vascular access and other relevant fields.

Main outcome measures
FI, defined as the minimum number of event changes required to alter the statistical significance of meta-analysis results, and its association with sample size and total number of events, analysed using frequency distribution histograms and restricted cubic spline models.

Results
The median FI was 7, with considerable variation across different fields. Aortic meta-analyses demonstrated higher robustness compared with venous and vascular access meta-analyses. FI showed a non-linear relationship with sample size and total number of events, indicating robustness improved only up to specific thresholds, beyond which robustness declined or plateaued.

Conclusion
Overall robustness of meta-analyses in vascular surgery was moderate, with notable variability among research areas. FI provides valuable insight into the stability of synthesised evidence, suggesting the need for improved methodological quality and advocating broader adoption of FI in meta-analytical research.

Introduction
Care transitions, particularly hospital discharge, present significant risks to patient safety. Deficient medication-related discharge communication is a major contributor, posing substantial risk of harm to older patients. This protocol outlines the Improved Medication communication and Patient involvement At Care Transitions (IMPACT-care) intervention study, designed to evaluate the effects of a multifaceted intervention for older hospitalised patients on medication-related discharge communication compared with usual hospital care.

Methods and analysis
A pre–post intervention study will be conducted in two surgical and one geriatric ward of a university hospital in Sweden. The study will begin with a control period delivering usual care, followed by a training period and then an intervention period. The intervention comprises four components performed by clinical pharmacists: (1) information package provided to patients and/or informal caregivers, (2) preparation of medication-related discharge documentation, (3) facilitation of discharge communication and (4) follow-up call to patients or their informal caregiver. Eligible participants are aged ≥65 years, manage their own medications independently or with informal caregiver support, and are admitted to the study wards. Each study period (control and intervention) will last until 115 patients have been included. The primary outcome is the quality of medication-related discharge documentation, assessed using the Complete Medication Documentation at Discharge Measure (CMDD-M). Secondary outcomes include patients’ perceptions of knowledge and involvement in discharge medication communication, and their sense of security in managing medication post-discharge; adherence to medication changes from hospitalisation that persist after discharge; and unplanned healthcare visits following discharge. A process evaluation is planned to explore how the intervention was implemented. Patient inclusion began in September 2024.

Ethics and dissemination
The study protocol has been approved by the Swedish Ethical Review Authority (registration no.: 2023-03518-01 and 2024-04079-02). Results will be published in open-access international peer-reviewed journals, and presented at national and international conferences.

Trial registration number
NCT06610214.

Objective
To evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary antitumour activity of AMG 404, a fully human IgG1 monoclonal antibody targeting programmed cell death-1, in patients with advanced solid tumours.

Design
First-in-human phase I study comprising eight dose expansion cohorts, including cohorts with microsatellite instability-high (MSI-H) tumours and non-small cell lung cancer with high programmed death-ligand 1 expression (NSCLC/PDL1-H, tumour proportion score ≥50%).

Setting
Conducted across 28 global sites.

Participants
This study enrolled adult patients with histologically or cytologically confirmed metastatic or locally advanced solid tumours not amenable to curative treatment with surgery or radiation. The inclusion criteria included a life expectancy of >3 months, ≥1 measurable or evaluable lesion per modified Response Evaluation Criteria in Solid Tumours (RECIST) V.1.1, an Eastern Cooperative Oncology Group performance status of ≤2 and adequate haematological, renal and hepatic function. Patients with prior treatment with checkpoint inhibitors, primary brain tumour or untreated or symptomatic brain metastases and leptomeningeal disease and history of other malignancy within the past 2 years were excluded.

Interventions
The planned doses were 240 mg, 480 mg and 1050 mg of AMG 404 administered every 4 weeks (Q4W).

Primary and secondary outcome measures
Primary endpoints were dose-limiting toxicities (DLTs), treatment-emergent adverse events, treatment-related adverse events, changes in vital signs and clinical laboratory tests. Secondary endpoints included PK parameters, incidence of antidrug (AMG 404) antibodies and antitumour activity assessed per modified RECIST V.1.1 (objective response, duration of response, progression-free survival (PFS), disease control and duration of stable disease).

Results
A total of 171 patients were enrolled; 168 were treated. Median (range) follow-up was 36.3 weeks (1.6–137.1). No DLTs were observed. Grade 3 and serious treatment-related adverse events occurred in 16 (9.5%) and 12 (7.1%) patients, respectively. The 480 mg Q4W dose was selected as the recommended phase II dose. AMG 404 serum exposure increased approximately dose proportionally. The objective response rate (80% CI) was 19.6% (15.7–24.1) for the overall population and 36.6% (26.4–47.8) and 30.8% (14.2–‍52.3) for cohorts with MSI-H tumours (n=41) and NSCLC/PDL1-H (n=13), respectively. The overall disease control rate (80% CI) was 54.8% (49.5–59.9). The median (80% CI) PFS was 3.7 (3.5–4.5) months for the overall population and 14.8 (9.0–not estimable) and 4.4 (2.2–9.7) months for cohorts with MSI-H tumours and NSCLC/PDL1-H, respectively.

Conclusions
AMG 404 monotherapy was tolerable at the tested doses, with encouraging antitumour activity observed across tumour types.

Trial registration number
NCT03853109.

Objectives
An Inclusion Health movement has gained momentum over the past decade, aiming to address the extreme health inequities faced by socially excluded groups (including people experiencing homelessness, problem substance use, Gypsy, Roma and Traveller communities, vulnerable migrants, sex workers, people in contact with the justice system and victims of modern slavery). Despite this progress, there is a lack of understanding of how the issues are being taught by medical schools. We conducted a scoping review to identify and analyse existing research about Inclusion Health content and pedagogy in undergraduate medical education.

Design
A stepwise scoping review methodology was followed in accordance with the latest manual for evidence synthesis from Joanna Briggs Institute and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines.

Data sources
A search was undertaken across six bibliographic databases, and additional articles were found through citation and grey literature searching.

Eligibility criteria
Primary research studies and evidence reviews from 2013 onwards were included. There were no restrictions on language.

Data extraction and synthesis
Standardised methods were used to screen possible papers. A charting table was developed to record key information from the 74 papers included. Quantitative steps of the analysis included frequency counts of the extent, nature and distribution of the studies; this was followed by basic qualitative content analysis.

Results
Most educational interventions were optional, or student led, with no longitudinal integration across curricula. There was little evidence of co-production with people with lived experience. Challenges included limited curricula time and faculty expertise, being an emotionally challenging subject, limitations of the biomedical model and informal learning perpetuating stigma. Key enablers included structured reflection, support, positive role models, interaction and co-production with people with lived experience, community partnerships and faculty commitment.

Conclusions
Developments in undergraduate medical education are required to produce doctors equipped to meet the needs of socially excluded groups. We have summarised key aspects of the literature that will be useful to clinicians and educators in this endeavour.

Trial registration number
A review protocol was preregistered in the Open Science Framework on 11 May 2023 and can be accessed at https://osf.io/6c2rk/.

Objectives
Evidence-based practice (EBP) is considered an essential principle to arrive at and ensure high-quality healthcare. This study aimed to determine the current knowledge, attitude and awareness among doctors, nurses and allied healthcare workers in the Maldives regarding the principles of EBP and the barriers experienced when practising EBP.

Design and setting
A nationwide, cross-sectional, semiquantitative, digital survey was conducted in 2023 among nurses, doctors and allied healthcare professionals currently working in any healthcare setting in the Maldives. The survey was based on the validated McColl and BARRIERS questionnaires. In addition, basic demographic characteristics of the participants were collected.

Results
Out of the more than 1000 healthcare professionals invited, 418 responded. The vast majority were female nurses. About half of the respondents worked in a tertiary hospital and had obtained a bachelor’s degree in nursing. EBP was considered (very) useful and relevant for clinical practice, but the attitude towards and promotion of EBP was considered insufficient. Respondents preferred research utilisation through evidence-based guidelines. Slightly over half (52.1%) of the respondents had followed some course in literature searching or EBP. Only one in six respondents thought they had access to PubMed. The highest scoring barriers for EBP were related to organisational challenges; lack of knowledge, reluctance to change among healthcare professionals and management, and lack of time or high workload.

Conclusion
Maldivian healthcare professionals welcome EBP but face organisational and practical challenges to implement this principle in clinical practice. A multidisciplinary team of EBP champions appears useful to promote EBP awareness and skills on a national scale.

Hewa Kankanamge DV, Rubbo B, Morgan K, et al. Domestic violence perpetration, victimisation and self-poisoning in Sri Lanka: a protocol for a hospital-based case-control study. BMJ Open 2025;15:e089913. doi: 10.1136/bmjopen-2024-089913.
This article has been corrected since it was published online.
The license has been updated form CC BY NC to CC BY and the funding section has also been updated to:
This work was supported by the Elizabeth Blackwell Institute for Health Research (University of Bristol) and Wellcome Trust grant number [204813/Z/16/Z].

Introduction
The prevalence of dementia is increasing, both worldwide and in China. This disease is associated with numerous restrictions for those affected but also for caregivers and society. Due to the limited effectiveness of pharmacological interventions, more research on non-pharmacological interventions is needed. For the non-pharmacological multimodal MAKS (M: motor training, A: activities of daily living training, K: cognitive training, S: social-communicative setting) intervention, positive effects on cognition, activities of daily living, and the occurrence of behavioural and psychological symptoms of dementia were identified in two randomised controlled trials in different settings in Germany. Thus, the German MAKS intervention was culturally adapted for China and will now be tested for its efficacy in Chinese nursing homes in a randomised controlled trial.

Methods and analysis
Participants will be residents of Chinese nursing homes in Shenyang, Nanjing and Dalian, fulfilling the ICD-10 criteria for Alzheimer’s dementia, the psychometric criteria for mild to moderate dementia (MMSE 10–23) and none of the exclusion criteria. With n=200, effects with an effect size of Cohen’s d=0.45 and a power of 1-β = 0.80 can be detected. Screening and data collection at baseline, t6 and t12 will be conducted via face-to-face contact by proxy raters in the nursing homes (i.e., trained nursing staff not involved in the intervention) and master students as external testers for the performance tests on cognition and activities of daily living. Participants will be randomly allocated to the intervention or control group. SinoMAKS (i.e., the Chinese version of the MAKS intervention) will be conducted at least three times a week for six months by trained MAKS therapists. The control group will receive care as usual for 12 months after baseline. Thus, the treatment phase is six months with follow-ups after six and 12 months after baseline. In the open phase, from t6 to t12, the nursing homes are free to offer SinoMAKS to the intervention group residents. In line with international guidelines, the primary population for analysis is the intention-to-treat sample. Global cognition (measured with the Addenbrooke’s Cognitive Examination-III) is the primary outcome. The hypotheses will be analysed using multiple linear regression with the outcome variables as dependent variables.

Ethics and dissemination
All procedures were approved by the Ethics Committee of the Medical Faculty of the Friedrich-Alexander-Universität Erlangen-Nürnberg (Ref. 24–162-B) and the Ethics Committee of the China Medical University (Ref. [2024]181). Written informed consent will be obtained from all participants or—if applicable—their legal representatives. Results will be published in peer-reviewed scientific journals and conference presentations.

Trial registration number
ISRCTN10262531.

Objective
This study explored experiences with implementing and using the Epic electronic health record (EHR) across different clinical programmes within a single Canadian hospital system and specifically examined how local configuration decisions and implementation of its features and functionalities integrated well or introduced friction within workflows.

Design
Qualitative description methodology involving semistructured interviews analysed using thematic analysis.

Setting
A large community hospital in Canada.

Participants
Healthcare providers, administrative staff and clinical leaders from seven clinical programmes.

Results
66 individuals participated in interviews. Participants described that Epic’s implementation impacted communication and teamwork, workflow and efficiency, and patient care, with these impacts varying across different programme settings. Participants reported that Epic improved inpatient care and safety, communication and teamwork, workflow and efficiency. However, several programmes also experienced challenges, including information overload and increased clerical tasks, impacting workflow efficiency. In programmes with an outpatient component, such as surgery and oncology, there were additional difficulties, such as connecting with external partners, user interface complexities that hindered task completion and concerns about potential compromises in patient care quality.

Conclusion
Health systems must consider the diverse needs of various clinical programmes when implementing an EHR. Customising the system interface and iteratively codesigning how health system staff incorporate the technology into their workflows are crucial to ensure an EHR seamlessly integrates across different settings, fosters high-quality care delivery and minimises user friction.

Introduction
Kinesiophobia is a significant factor which influences the prognosis of patients with chronic non-specific low back pain (CNLBP). The restriction of functional training can severely impede functional recovery and contribute to negative emotional states (including anxiety and depression) and a heightened risk of insomnia while exacerbating the economic burden on patients. Although several randomised controlled trials have evaluated the effects of various non-pharmacological interventions on kinesiophobia in CNLBP, their relative efficacy and potential adverse effects remain ambiguous. This study will conduct a systematic review and network meta-analysis to identify which non-pharmacological intervention may represent the most effective treatment for kinesiophobia in patients with CNLBP.

Methods and analysis
Comprehensive searches will be conducted across English and Chinese databases (including The Cochrane Library, PubMed, Scopus, Springer, Embase, Wanfang Data, the Chongqing VIP Database and China National Knowledge Infrastructure) from the date of their inception to 20 November 2024. Only Chinese or English studies will be considered for analysis. The primary outcomes will include a significant reduction in secondary movement phobia associated with CNLBP, pain alleviation and enhancement of the functional status of the lumbar muscles. The Cochrane Bias Risk Assessment Tool will be used to conduct a bias risk assessment.
Pairwise meta-analysis will be performed by Review Manager V.5.3 software, Stata V.16.0 and Open BUGS V.3.2.3 software will be used to conduct a network meta-analysis. The Grading of Recommendations, Assessment, Development and Evaluation framework will be employed to assess the quality of evidence.

Ethics and dissemination
All of the data included in this study will be derived from the literature; therefore, ethical approval is not necessary. The findings will be disseminated via peer-reviewed journals and academic conferences.

PROSPERO registration number
CRD42024605343.

Objective
Missed hospital appointments are common among outpatients and have significant clinical and economic consequences. The purpose of this study is to develop a predictive model of missed hospital appointments and to evaluate different overbooking strategies.

Study design
Retrospective cross-sectional analysis.

Setting
Outpatient clinics of the Royal Hospital in Muscat, Oman.

Participants
All outpatient clinic appointments scheduled between January 2014 and February 2021 (n=947 364).

Primary and secondary outcome measures
Predictive models were created using logistic regression for the entire cohort and individual practices to predict missed hospital appointments. The performance of the models was evaluated using a holdout set. Simulations were performed to compare the effectiveness of predictive model-based overbooking and organisational overbooking in optimising appointment utilisation.

Results
Of the 947 364 outpatient appointments booked, 201 877 (21.3%) were missed. The proportion of missed appointments varied by clinic, ranging from 13.8% in oncology to 28.3% in urology. The area under the receiver operating characteristic curve (AUC) for the overall predictive model was 0.771 (95% CI: 0.768 to 0.775), while the AUC for the clinic-specific predictive model was 0.845 (95% CI: 0.836 to 0.855) for oncology and 0.738 (95% CI: 0.732 to 0.744) for paediatrics. The overbooking strategy based on the predictive model outperformed systematic overbooking, with shortages of available appointments at 10.4% in oncology and 25.0% in gastroenterology.

Conclusions
Predictive models can effectively estimate the probability of missing a hospital appointment with high accuracy. Using these models to guide overbooking strategies can enable better appointment scheduling without burdening clinics and reduce the impact of missed appointments.

Introduction
Cancer is the second leading cause of death in the USA. Cancer genetics and genomic studies have improved our understanding of risk, onset and progression. However, disparities by race and ethnicity have resulted in a lack of representation for minorities in these studies, contributing to unequal reductions in the cancer burden across populations. Moreover, the reasons why some individuals decline to participate in cancer genetics and/or genomic studies across diverse populations remain unclear. This review will summarise the main reasons (concerns) associated with declining to participate in cancer genetics and/or genomic studies for individuals with a history of cancer living in the USA and Puerto Rico (PR), considering race and ethnicity.

Methods and analysis
We will follow the methodology presented by the Joanna Briggs Institute and the Preferred Reporting Items for Systematic Reviews Statement extended to Scoping Reviews to guide manuscript generation. A standardised search strategy developed in collaboration with a health sciences librarian will be deployed in Medline (PubMed), Embase (Ovid) and Scopus from database inception till present. The search strategy consists of three concepts: (1) cancer; (2) genetics and genomic research; (3) declination to participate in research studies. Title and abstract screening, followed by full-text review, will be conducted by independent reviewers to determine study inclusion. Only the peer-reviewed literature in English, conducted in the USA and PR will be considered. Findings will be presented as a numerical summary, graphical presentation and narrative review of the literature.

Ethics and dissemination
Ethical review is not required for scoping reviews. This review aims to facilitate the development of targeted strategies to increase participation in cancer genetics and/or genomic studies across diverse populations. Results will be disseminated through a peer-reviewed publication and conference presentations. The protocol is registered in the Open Science Framework (www.osf.io).

This past year, 2024, brought many exciting practice-changing publications to JAMA Oncology across a wide variety of topics. Throughout the year, we published several randomized clinical trials that changed the course of clinical care and a substantial number of studies on cancer survivorship. These articles addressed how to ameliorate the long-term adverse effects of treatment and also how to identify long-term health risks. We continued to receive works defining the persistent impacts of COVID-19 infections and mandates on oncology patients. The science of oncology also filled our journal with topics ranging from unraveling the microbiome and how its composition affects oncologic outcomes, defining new biomarkers to better predict responses to immunotherapy, and advances in circulating or cell-free DNA analysis as prognostic or predictive tools. We have also seen machine learning and artificial intelligence address important clinical questions that will add precision to everyday practice, and we look forward to informatics as a growing sector of the journal.

This review describes version 6.0 of the Children’s Oncology Group Long-Term Follow-Up Guidelines for Survivors of Childhood, Adolescent, and Young Adult Cancers.

The Special Communication titled “Advancing Global Pharmacoequity in Oncology,” published online November 14, 2024, and in the January 2025 issue, was corrected to fix a spelling error in the sixth author’s name. The author name “Bychkovksy” has been corrected to “Bychkovsky.” This article was corrected online.

Mandated step therapy (MST) is a practice used by insurers and government payors to limit access to high-cost medications. Although physicians often lament these roadblocks, the underlying intention of MST is to help with economic sustainability of a health care system by ensuring the use of more cost-effective options when medically appropriate. However, this is often not the result in practice, where patients with severe skin disease experience treatment delays during the MST process before ultimately receiving approval for the medication(s) they need. In certain health care systems, such as the system in Canada, MST is nonnegotiable, in which patients with severe psoriasis must fail 2 of 3 initial systemic therapies before initiating therapy with biologics. MST can not only limit access for patients with severe disease but also impact health equity, disproportionately delaying access for younger patients and those with government insurance such as Medicaid.

In Reply We thank Xie for his comments regarding our study published in a recent issue of JAMA Psychiatry and for drawing attention to several important sociodemographic groups, including those defined by immigrant status, disability status, sexual orientation, and gender identity with limited access to psychotherapy. Given evidence of mental health care inequities across these groups, a better understanding of their trends in outpatient psychotherapy use could inform policies to address critical impediments to mental health care equity.