Search Results for: Cardio-oncology: rivista open access

Introduction
Loop ileostomy and loop colostomy are both used to form a protective stoma after anterior resection. Evidence regarding which of these two procedures is superior is lacking. Furthermore, no studies comparing changes in the microbiome after loop ileostomy or loop colostomy exist.

Methods and analysis
This multicentre, open-label, superiority, individually randomised controlled trial will include patients who undergo anterior rectal resection with primary anastomosis with a protective stoma. The exclusion criteria are patients who already have a stoma, technical inability to create either type of stoma, aged

Background
Sleep disordered breathing is a chronic condition often requiring patient commitment to positive airway pressure (PAP) therapy. Understanding the lived experience of PAP therapy users is crucial for clinicians to support successful treatment and identify research priorities. There is a lack of evidence in this area, and published data predominantly explore the negative experiences of PAP. This study aims to explore the lived experiences of patients using PAP therapy.

Methods and analysis
This study employs a phenomenological approach, appropriate for researching human experiences where there is little existing research. Heideggerian theory underpins the research, recognising that the researcher’s beliefs influence meaning, allowing for rich analysis of the lived experience.
Participants will be recruited from a randomised controlled trial investigating the medium-term clinical impact of customised interfaces for patients requiring PAP therapy. Purposive sampling will be used to seek representation from various demographics, with a maximum of 30 participants.
Data collection will be via 1:1 semistructured interviews. Data will be analysed using Braun and Clarke’s six-phase reflexive thematic analysis. Data will be analysed inductively through an interpretivism lens. Data will be managed with computer-assisted qualitative data analysis software.

Ethics and dissemination
This protocol has been approved by the Hampshire B Research Ethics Committee (REC reference: 22/SC/0405). Results will be disseminated to healthcare professionals and patients through conferences, open-access journals, newsletters, the study webpage, infographics, animations, social media and healthcare awards. Tracy’s eight ‘big tent’ criteria for excellent qualitative research are comprehensive and encompassing, and this protocol has aimed to meet the criteria. The Consolidated Criteria for Reporting Qualitative Research has also been used. The findings of this study will contribute to a more holistic understanding of the lived experience of PAP therapy users, informing clinical practice and future research.

Trial registration number
ISRCTN74082423.

Introduction
To assess the effects of oral dydrogesterone on the recurrence rate of endometrial polyps (EPs) and abnormal uterine bleeding (AUB) symptoms after transcervical resection of polyps (TCRP).

Methods and analysis
A randomised, parallel, open-label, multicentre study will be conducted across 12 hospitals in China, including general and women’s specialty hospitals. In this study, we will recruit female patients aged 18–46 years diagnosed with EPs using transvaginal ultrasonography during two menstrual cycles. Eligible participants who have not received other oestrogen or progesterone treatments will be randomly assigned in a 1:1 ratio to either an intervention or control group. All participants will undergo TCRP, with the time between randomisation and surgery not exceeding 14 days. The intervention group will receive oral dydrogesterone for three menstrual cycles, whereas the control group will receive no hormonal treatment. The primary outcome is the recurrence rate of EPs, which will be evaluated using follow-up transvaginal ultrasonography at 1, 3, 6, 12, 18 and 24 months postsurgery. Secondary outcomes include assessment of AUB and menstrual status. For statistical analyses, a multivariate regression will be used to adjust for confounding factors.

Ethics and dissemination
This study protocol adheres to the Declaration of Helsinki and has been approved by the Women’s Hospital, School of Medicine, Zhejiang University (IRB-20240077-R). All participants in the trial will provide written informed consent. The study findings will be published in peer-reviewed journals and presented at academic conferences.

Trial registration number
ChiCTR2400083097.

Background
Gender-based violence (GBV) is a pervasive global issue that transcends cultural, economic and educational boundaries, with an exceptionally high prevalence among refugees. Despite extensive research on GBV in Ethiopia, evidence of its occurrence in refugee settings remains limited.

Objective
To examine the prevalence and contributing factors of GBV among reproductive-age women in the Okugu Refugee Camp, Gambella, Ethiopia.

Study design
A facility-based cross-sectional study.

Participants
This study analysed 416 reproductive-age women living in Okugu Refugee Camp.

Setting
The study was conducted in the Okugu Refugee Camp from 15 March to 30 May 2023.

Primary and secondary outcome measures
The study’s primary outcome was gender-based violence, while the secondary outcome focused on the factors influencing it.

Result
A total of 422 reproductive-age women participated in the study, with a response rate of 98.6%. The prevalence of gender-based violence was 64.4% (95% CI: 59% to 69%). Among the participants, 51.9% experienced physical violence, while 34.9% had a history of sexual violence. Factors, illiterate women (AOR=2.73, 95% CI: 1.509 to 4.942), those who had lived in the camp for more than 4 years (AOR=3.24, 95% CI: 1.964 to 5.372), women who did not discuss sexual intercourse with their family or intimate partner (AOR=4.7, 95% CI: 2.83 to 7.80) and women who consumed alcohol (AOR=2.19, 95% CI: 1.30 to 3.69) were at significantly higher risk of experiencing gender-based violence.

Conclusion
Gender-based violence in the study area was highly prevalent. Key determinants included illiteracy, alcohol consumption, lack of discussion and prolonged stay in the camp. Stakeholders should prioritise interventions such as promoting female education, fostering open discussions and addressing substance use to mitigate gender-based violence in the refugee camp.

Introduction
Women with a history of gestational diabetes mellitus (GDM) have a high lifetime risk of developing type 2 diabetes. Diabetes prevention programmes may reduce this risk. However, challenges related to the successful implementation of diabetes prevention programmes after GDM exist. Our objective is to map the components of the effective implementation of diabetes prevention programmes after GDM. We also plan to connect the available evidence on the effective implementation of diabetes prevention programmes to the Consolidated Framework for Implementation Research.

Methods and analysis
We will conduct a scoping review following Levac’s adaptation of Arksey and O’Malley’s framework for scoping reviews. We will report it according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. Using a peer-reviewed search strategy, we will search Medline, Embase, PsycInfo and Emcare for primary studies describing the effective implementation of diabetes prevention programmes after GDM. Study selection will be completed in DistillerSR by two independent reviewers. Data will be extracted by one reviewer and verified by a second reviewer for accuracy using data extraction forms in DistillerSR.

Ethics and dissemination
Ethics approval was not required. Study results will be published in a peer-reviewed journal and presented at relevant conferences.

Study registration details
This scoping review protocol was registered with Open Science Framework (OSF; preregistration, 15 April 2024; registration ID: 10.17605/OSF.IO/MPNQD).

Objectives
This study aimed to investigate the association between the type and severity of disabilities and depression among adolescents aged 15–17 years living in underdeveloped areas of Indonesia.

Design
Cross-sectional study.

Setting
Data were derived from the 2018 Indonesia Basic Health Research, a nationally representative data of Indonesia.

Participant
We used information collected from 4811 adolescents aged 15–17 living in underdeveloped areas of Indonesia.

Primary outcome
The primary outcome was depression, based on the conditions experienced by respondents during the last 2 weeks.

Results
The analysis showed that 5.65% of adolescents aged 15–17 years living in underdeveloped areas of Indonesia had depressive symptoms. Adolescents with severe physical and psychological disabilities were most at risk, exhibiting significantly higher odds of developing depression (aOR=12.09, 95% CI: 5.41 to 27.03, p

This Medical News article is an interview with Harvard Medical School’s Arjun Manrai and Thomas Buckley about how open-source large language models could allow for high-performing, locally run diagnostic tools in clinical care settings.

Objective
This study aims to shed light on the transformative potential of artificial intelligence (AI) in the early detection and risk assessment of non-communicable diseases (NCDs).

Study design
Bibliometric analysis.

Setting
Articles related to AI in early identification and risk evaluation of NCDs from 2000 to 2024 were retrieved from the Scopus database.

Methods
This comprehensive bibliometric study focuses on a single database, Scopus and employs narrative synthesis for concise yet informative summaries. Microsoft Excel V.365 and VOSviewer software (V.1.6.20) were used to summarise bibliometric features.

Results
The study retrieved 1745 relevant articles, with a notable surge in research activity in recent years. Core journals included Scientific Reports and IEEE Access, and core institutions included the Harvard Medical School and the Ministry of Education of the People’s Republic of China, while core countries comprised China, the USA, India, the UK and Saudi Arabia. Citation trends indicated substantial growth and recognition of AI’s impact on NCDs management. Frequent author keywords identified key research hotspots, including specific NCDs like Alzheimer’s disease and diabetes. Risk assessment studies demonstrated improved predictions for heart failure, cardiovascular risk, breast cancer, diabetes and inflammatory bowel disease.

Conclusion
Our findings highlight the increasing role of AI in early detection and risk prediction of NCDs, emphasising its widening research impact and future clinical potential.

Objective
To describe primary care providers’ (PCPs) experience and satisfaction with receiving risk communication documents on their patient’s breast cancer (BC) risk assessment and proposed screening action plan.

Design
Descriptive cross-sectional study.

Setting
A survey was distributed to all 763 PCPs linked to 1642 women participating in the Personalized Risk Assessment for Prevention and Early Detection of Breast Cancer: Integration and Implementation (PERSPECTIVE I&I) research project in Quebec, approximately 1–4 months after the delivery of the risk communication documents. The recruitment phase took place from July 2021 to July 2022.

Participants
PCPs.

Main outcome measures
Descriptive analyses were conducted to report participants’ experiences and satisfaction with receiving risk communication. Responses to two open-ended questions were subjected to content analysis.

Results
A total of 168 PCPs answered the survey, from which 73% reported being women and 74% having more than 15 years of practice. Only 38% were familiar with the risk-based BC screening approach prior to receiving their patient risk category. A majority (86%) agreed with the screening approach and would recommend it to their patients if implemented at the population level. A majority of PCPs also reported understanding the information provided (92%) and expressed agreement with the proposed BC screening action plan (89%). Some PCPs recommended simplifying the materials, acknowledging the potential increase in workload and emphasising the need for careful planning of professional training efforts.

Conclusion
PCPs expressed positive attitudes towards a risk-based BC screening approach and were generally satisfied with the information provided. This study suggests that, if introduced in Canada in a manner similar to the PERSPECTIVE I&I project, risk-based BC screening would likely be supported by most PCPs. However, they emphasised the importance of addressing concerns such as professional training and the potential impact on workload if the approach were to be implemented at the population level. Future qualitative studies are needed to further explore the training needs of PCPs and to develop strategies for integrating this approach with the high workloads faced by PCPs.

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.

Objectives
This study investigated the correlation between the type of health insurance membership as a proxy for the economic status of patients and the severity of their type two diabetes mellitus (T2DM) in Indonesia.

Design
The study conducted a secondary analysis of National Health Insurance (Jaminan Kesehatan Nasional) claim data provided by the Indonesian Social Security Agency, Badan Penyelenggara Jaminan Sosial (BPJS). We used ordered logistic regression with four severity levels for T2DM (0=outpatient, I=mild, II=moderate, III=severe) as dependent variables. The main independent variables (insurance membership categories) included subsidised insurance members (PBI), a combination of formally employed and nonsalaried informal workers (PBPU & PPU) and nonworkers (BP).

Setting
Secondary healthcare facilities in Indonesia.

Participants
The dataset included 2 989 618 claims for hospital visits of people with T2DM from 2018 to 2022.

Primary outcome measures
Severity level of T2DM patients.

Result
A higher percentage of T2DM patients who visited healthcare facilities with subsidised insurance (PBI), which represents a low-income group, have severe disease (6.9%) than patients in the PBPU & PPU (4.9%) and BP categories (5.5%). Moreover, regression analysis revealed that having PBI membership status was associated with a greater OR of having severe T2DM than nonsubsidised members. Among T2DM patients in the nonsubsidised insurance category, workers (PBPU & PPU) had an OR of 0.74 (95% CI: 0.735 to 0.745; p

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.

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.

Introduction
Diet and nutrition play a vital role in all stages of chronic kidney disease (CKD) prevention, treatment and management. In particular, dietary interventions are essential to manage hyperphosphataemia, a common metabolic complication in CKD consistently associated with an increased risk of cardiovascular disease and all-cause morbidity and mortality. Unfortunately, dietary management of any kind in this cohort of patients also comes with the added challenge of limited and variable access to renal dietitians, logistical difficulties and multiple medical appointments. Given the complexity of managing diet in patients on dialysis, there is a need for novel interventions that not only help patients navigate daily challenges but could also be integrated into clinical practice to support the work of dietitians. We are testing if the use of digital health (via a new, specifically designed smartphone App) plus standard care compared to standard care alone is a feasible and effective method of delivering nutritional advice to patients with elevated phosphate levels undertaking dialysis.

Methods and analysis
This is a multicentre codesigned randomised controlled trial (RCT) that will recruit individuals aged 18 years or over on maintenance dialysis for a minimum of 3 months who have a serum phosphate level of ≥1.6 mmol/L. Participants will be recruited from 23 different dialysis sites across Australia. They will be block randomised into two groups in a 1:1 ratio that will either be the intervention group (receive the TeleKinesis App for 3 months in addition to standard care) or the control group (standard care alone). The primary outcome of the study is to assess the effect of this intervention on the change in patients’ serum phosphate levels. The RCT will assess the effectiveness of the programme by comparing serum phosphate at baseline, 3 months and follow-up at 6 months. A total recruitment target of n=180 participants is expected.

Ethics and dissemination
Ethics approval was received from the Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee on 5 December 2022 (reference RGS0000005559). Informed consent will be given by participants once they have read and signed the patient information and consent form. The results are expected to be published in scientific journals and presented at clinical research conferences and to the consumers who have taken part in the trial. This is protocol 1.0 dated 10 November 2024.

Trial registration number
ACTRN12621000746831.

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.

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.