Search Results for: Cardio-oncology: rivista open access

Introduction
Efforts to increase engagement with diabetes prevention programmes largely focus on increasing diabetes awareness, with the logic that risk knowledge will motivate behaviour change. However, the salience of perceived risk as it relates to diabetes prevention is contested. The goal of this cross-sectional, embedded mixed-methods study was to examine the relationships between perceived risk, diabetes beliefs and prevention behaviours among adults at elevated risk of type 2 diabetes.

Methods
Data come from the Richmond Stress and Sugar Study (n=125). Diabetes beliefs (ie, internal, chance, powerful others) were assessed using the Multidimensional Health Locus of Control. Preventive behaviours (eg, changing diet, exercise, tobacco, alcohol) were measured by self-report. Perceived risk of developing diabetes was measured using a probability scale (0%–100%). Logistic and Poisson regression models quantified the relationships between beliefs, behaviours and perceived risk. Qualitative themes regarding challenges and facilitators to preventive behaviours were abstracted from open-ended questions and summarised using content analysis.

Results
Perceived risk of developing diabetes was low (median: 35% likelihood) and only 10% of participants had ever attended a prevention class. None of the diabetes belief domains were significantly associated with either engagement in preventive behaviours or perceived diabetes risk. Perceived diabetes risk was not associated with engagement in preventive behaviours; however, having a family history of diabetes was strongly related to perceived risk (OR: 3.35, 95% CI: 1.42 to 7.86). Qualitative facilitators and barriers of preventive behaviours reflected psychosocial factors (eg, determination, stress, preferences) and resources (eg, social support, time, overall health).

Conclusions
Perceptions of risk and health beliefs are not correlated with engagement in preventive behaviours among adults at clinically elevated risk of diabetes. Awareness campaigns may benefit from incorporating family health history information. Diabetes prevention programmes should address barriers beyond health beliefs to promote engagement in behaviour change.

Introduction
Preterm infants born before 32 weeks of gestation are generally admitted to a neonatal intensive care unit (NICU) to receive life-saving treatment, resulting in early exposure to stressful events. Yet, NICU admission is not only stressful for the infant but can also have a long-lasting negative impact on parental mental health, who may worry about their child. Parental mental health problems might affect child development through parental behaviour and the parent–infant relationship. Simultaneously, adverse child development after preterm birth can (further) elevate parental stress and mental health problems, straining parental behaviour, the parent–infant relationship and child development. This systematic review and meta-analysis aims to examine the association between preterm-born children’s development (

Introduction
The prognosis for epithelial ovarian cancer (EOC) is exceedingly poor, with patients diagnosed with stage III/IV tumours typically offered cytoreductive surgery in conjunction with chemotherapy as a standard treatment option. This approach is intended to reduce the risk of surgery and address ovarian cancers that are not amenable to surgical intervention. A promising alternative and important treatment option is neoadjuvant chemotherapy (NACT) in conjunction with interstitial tumour cytoreductive surgery. The combination of neoadjuvant immunotherapy with chemotherapy has recently demonstrated remarkable efficacy, particularly in melanoma and lung cancer, with notable pathological responses and therapeutic benefits in tumour tissue. The NeoAdjuvant chemotherapy with or without tIslelizumab followed by debulking surgery for oVarian cancEr(NAIVE) study aims to assess the clinical efficacy and safety of NACT in combination with tislelizumab (a monoclonal antibody for programmed cell death protein 1) for advanced EOC.

Methods and analysis
The NAIVE study is an investigator-initiated, prospective, single-centre, open-label, randomised controlled trial for advanced EOC with the International Federation of Gynaecology and Obstetrics (FIGO) stage IIIc with a Suidan CT score of 3 or greater or a Fagotti laparoscopic score of 8 or greater; or FIGO stage IV. The primary endpoint of the study is the 1-year progression-free survival (PFS) rate, measured as the percentage of patients who are free of tumour progression or death for 1 year after receiving the first dose of study drug. The secondary endpoints encompassed the R0 resection rate, the clinical response rate and other relevant metrics. Enrolled patients will be randomly assigned in a 1:1 ratio to either the experimental arm, which will receive neoadjuvant platinum-based chemotherapy in combination with tislelizumab, or the control arm, which will receive neoadjuvant platinum-based chemotherapy. The study will enrol 40 patients, with enrolment scheduled to start in April 2021 and complete in April 2025, given a 1-year PFS rate of 60%. The study will provide new evidence regarding the clinical efficacy and safety of NACT in combination with tislelizumab for advanced ovarian cancer. The results will contribute to a deeper understanding of the clinical effects, safety profile and fundamental immunological processes. The findings will contribute to the growing body of evidence in support of the incorporation of immunotherapy into the treatment paradigm for ovarian cancer, thus facilitating the development of more personalised and efficacious therapeutic modalities.

Ethics and dissemination
This trial has received ethical approval from the Institutional Ethics Committee of the Second Affiliated Hospital of the Medical College of Zhejiang University. Presentations at scientific and professional meetings and publication in peer-reviewed journals will disseminate the results of the study.

Trial registration number
NCT04815408.

A study has found that about 29% of the nearly 90 000 retail pharmacies in the US operating between 2010 and 2021 have closed, and they were more likely to shut down if they were in predominantly Black and Latino neighborhoods than in White neighborhoods, in urban vs rural neighborhoods, or were independent pharmacies rather than chains.

The more years ice hockey players spent on the ice, the more at risk they were for developing severe chronic traumatic encephalopathy (CTE), a recent cross-sectional study found. The results are in line with previous findings about American football, with similar implications for neurological degeneration, the researchers noted in JAMA Network Open.

In the US, cancer prevention and screening have saved more lives from 5 types of cancer combined than treatment advances over the past 45 years, according to a modeling study published in JAMA Oncology. An estimated 5.9 million breast, cervical, colorectal, lung, and prostate cancer deaths were avoided from 1975 to 2020 due to prevention, screening, and treatment efforts, but prevention and screening alone were responsible for averting about 4.8 million—4 out of 5—of those deaths.

Introduction
As a result of improving survival rates, the adverse consequences of rectal cancer surgery are becoming increasingly recognised. Low anterior resection syndrome (LARS) is one such consequence and describes a constellation of bowel symptoms after rectal cancer surgery which includes urgency, faecal incontinence, stool clustering and incomplete evacuation. LARS has a significant adverse impact on quality of life (QoL) and symptoms are present in up to 75% of patients in the first year after surgery. Despite this, little is known about the natural history and there is poor evidence to support current treatment options.

Methods and analysis
The objectives of POLARiS are to explore the natural history of LARS and to evaluate the clinical and cost-effectiveness of transanal irrigation (TAI) or sacral neuromodulation (SNM) compared with optimised conservative management (OCM) for people with major LARS.
POLARiS is a prospective, international, open-label, multi-arm, phase 3 randomised superiority trial within a cohort design, with internal pilot phase, qualitative sub-study, process evaluation and economic evaluation. Approximately 1500 adult participants from UK hospitals and 500 from Australian hospitals who have undergone a high or low anterior resection for colorectal cancer in the last 10 years will be recruited into the cohort. Six-hundred participants from the UK and 200 participants from Australia, with major LARS symptoms, defined as a LARS score of ≥30, will be recruited to the randomised controlled trial (RCT) element. Participants entering the RCT will be randomised between OCM, TAI or SNM, all with equal allocation ratios.
Cohort and RCT participants will be followed up for a 24-month period, completing a series of questionnaires measuring LARS symptoms and QoL, as well as clinical review for those in the RCT. A process evaluation, qualitative sub-study and economic evaluation will also be conducted.
The primary outcome measure of the POLARiS cohort and RCT is the LARS score up to 24 months post-registration/randomisation. Analyses of the RCT will be conducted on an intention-to-treat basis. Comparative effectiveness analyses for each endpoint will consist of two pairwise treatment comparisons: TAI versus OCM and SNM versus OCM. Secondary outcomes include health-related QoL, adverse events, treatment compliance and cost-effectiveness (up to 24 months post-registration/randomisation).

Ethics and dissemination
Ethical approval has been granted by Wales REC 4 (reference: 23/WA/0171) in the UK and Sydney Local Health District HREC (reference: 2023/ETH00749) in Australia. The results of this trial will be disseminated to participants on request and published on completion of the trial in a peer-reviewed journal and at international conferences.

Trial registration number
ISRCTN12834598; ACTRN12623001166662.

Objective
The primary study aims were to evaluate the implementation, mechanisms and context of a timely short-term specialised palliative care intervention for older people with frailty (Frailty+ intervention) as well as to assess the feasibility of a randomised controlled trial to evaluate Frailty+. Our secondary aim was to describe any preliminary effects of Frailty+.

Design
Pilot randomised controlled trial with process evaluation.

Setting/Participants
We aimed to recruit 50 adults (≥70 years) with Clinical Frailty Scale score 5–7, and complex care needs and their main family carer, if available, from two Belgian hospitals on discharge.

Interventions
Patients were randomised to the Frailty+ intervention alongside standard care or standard care alone.

Outcome measures
Implementation and trial feasibility were assessed through interviews, focus groups and quantitative data. The primary outcome to be used in a potential full-scale trial if the study is feasible and implementable was mean change in five palliative care symptoms over 8 weeks.

Results
We enrolled 37 patients (19 intervention, 18 control) and 26 family carers (15 intervention, 11 control). Patients and family carers valued the home visits from palliative care nurses, and nurses saw value in Frailty+. But most patients received only one visit over 8 weeks, and nurses did not organise foreseen multidisciplinary meetings, referring to absence of urgent needs. Many aspects of the trial methods were feasible, but recruitment was challenging. The baseline mean score on the five palliative care symptoms was 6.0 and 5.6 in intervention and control group, respectively; and 4.5 and 4.1 at 8 weeks (adjusted ratio 1.0, ie, no effects on symptoms).

Conclusions
While Frailty+ was generally welcomed by older people with frailty, families and palliative care nurses, our process evaluation uncovered multiple barriers, mostly rooted in the current organisation of specialised palliative care that is tailored to advanced stages of illness. Ensuring timely access requires efforts beyond timely referral alone, and implies profound organisational and cultural change.

Trial registration number
ISRCTN39282347.

Objectives
This study explored general practitioners’ (GPs) understanding of physical activity advocacy to patients and their own self-care, how GPs perceive their own physical activity behaviours, how their personal experience of physical activity affects how they promote it in practice and how they define the limitations of their role in this.

Design
A qualitative design, involving online semi-structured interviews, was employed. Data was analysed by an interdisciplinary team of researchers using an inductive thematic approach.

Setting and participants
Participants were GPs (n=21) and were recruited from an education and research network.

Findings
A single meta-theme was identified—moving towards more physically active lifestyles through the art of medicine—with three related subthemes. Subthemes relate to how GPs determine the extent of their role and responsibilities, how physical activity promotion is adapted to the context and how ‘what I’ say is not necessarily ‘what I do’. After many consultations, mutual trust can develop when the GP’s role is clarified, and the GP can educate and support the initiation and maintenance of physical activity behavioural change by sharing personal experiences of physical activity behaviour.

Conclusion
Based on personal experience and enduring relationships with their patients, GPs are in a unique position to discuss appropriate physical activity with their patients and perform an important role in explaining and gaining access to physical activity for their patients. Support in the form of community-based resources and programmes as well as brief intervention skills could enhance GP ability to further promote physical activity.

Introduction
The Mobile Health (mHealth) Intervention for Dementia Prevention through lifestyle Optimisation (MIND-PRO) study addresses the increasing prevalence of dementia among populations with lower socio-economic status (SES) and/or a migration background. The study aims to evaluate the effectiveness and implementation of an mHealth intervention designed for self-managing lifestyle modifications with remote coaching to reduce dementia risk factors.

Methods and analysis
This prospective randomised open-label blinded end point (PROBE) trial follows a type 2 hybrid effectiveness-implementation design with a 12-month intervention period. It aims to recruit 692 participants in Dutch primary care. Entry criteria include age 50–75 years, low SES and/or migration background, one or more dementia risk factors (hypertension, dyslipidaemia, diabetes mellitus, physical inactivity, smoking, depression and overweight) or manifest cardiovascular disease and possession of a smartphone. Participants are randomised to a coach-supported, interactive app facilitating self-management of dementia risk factors or to a control app with static health information. The primary effectiveness outcome is a composite score of systolic blood pressure, non-high-density lipoprotein cholesterol and body mass index. Implementation outcomes include coverage, adoption, acceptability, appropriateness, feasibility, fidelity, costs and sustainability of the intervention. Secondary outcomes include the Cardiovascular Risk Factors, Ageing and Dementia risk score and its individual risk factors, and disability, physical activity, depressive symptoms, cognitive functioning and daily distance moved.

Ethics and dissemination
The MIND-PRO trial is funded by the Netherlands Organisation for Health Research and Development (ZonMw, grant number 10510032120004) and approved by the Ethics Committee of Amsterdam UMC (reference: METC 2023.0770). Results are expected in 2026 and will be submitted for publication in a peer-reviewed journal, and presented at scientific conferences.

Trial registration number
ISRCTN92928122.

Introduction
Pregnant women and their babies are a highly vulnerable population to health effects from air pollution. This scoping review aims to understand the extent and type of evidence concerning the mediating and moderating factors between air pollution and birth outcomes. By gathering and synthesising this evidence, this review aims to identify key concepts, themes and knowledge gaps. In turn, these findings will serve as a valuable resource for researchers and policymakers by highlighting potential pathways and gaps in evidence.

Methods and analysis
This scoping review protocol is based on the Joanna Briggs Institute (JBI) methodology for scoping reviews and will be reported in full with a Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping review (PRISMA-ScR) flow diagram. This review will search eight databases: Web of Science, Scopus, PubMed, Embase, GreenFILE, CINAHL Ultimate, APA PsycINFO and MIDIRS. Results will be limited to those written or translated into English and peer-reviewed studies with no restriction on publication date. The study selection and data extraction will be completed within the software Covidence by two or more independent reviewers, with conflicts solved by group discussion. The data extracted from this process will include publication details, study characteristics and population characteristics.

Ethics and dissemination
This study will not collect primary data; therefore, no formal ethical approval is required. The findings will be disseminated to academic and non-academic audiences through conferences, publications and focus groups.

Trail registration number
Open Science Framework (https://doi.org/10.17605/OSF.IO/6Y2D9).

Introduction
Manual investigation of falls incidents for quality improvement is time-consuming for clinical staff. Routine care delivery generates a large volume of relevant data in disparate systems, yet these data are seldom integrated and transformed into real-time, actionable insights for frontline staff. This protocol describes the co-design and testing of a safe mobility and falls informatics platform for automated, real-time insights to support the learning response to inpatient falls.

Methods
Underpinned by the learning health system model and human-centred design principles, this mixed-methods study will involve (1) collaboration between healthcare professionals, patients, data scientists and researchers to co-design a safe mobility and falls informatics platform; (2) co-production of natural language processing pipelines and integration with a user interface for automated, near-real-time insights and (3) platform usability testing. Platform features (data taxonomy and insights display) will be co-designed during workshops with lay partners and clinical staff. The data to be included in the informatics platform will be curated from electronic health records and incident reports within an existing secure data environment, with appropriate data access approvals and controls. Exploratory analysis of a preliminary static dataset will examine the variety (structured/unstructured), veracity (accuracy/completeness) and value (clinical utility) of the data. Based on these initial insights and further consultation with lay partners and clinical staff, a final data extraction template will be agreed. Natural language processing pipelines will be co-produced, clinically validated and integrated with QlikView. Prototype testing will be underpinned by the Technology Acceptance Model, comprising a validated survey and think-aloud interviews to inform platform optimisation.

Ethics and dissemination
This study protocol was approved by the National Institute for Health Research Imperial Biomedical Research Centre Data Access and Prioritisation Committee (Database: iCARE—Research Data Environment; REC reference: 21/SW/0120). Our dissemination plan includes presenting our findings to the National Falls Prevention Coordination Group, publication in peer-reviewed journals, conference presentations and sharing findings with patient groups most affected by falls in hospital.

Objective
This study aimed to investigate the trends and factors associated with congenital anomalies (CAs) among newborns in Eastern Ethiopia from 2015 to 2022.

Design
Open cohort study.

Setting
The Kersa Health and Demographic Surveillance System (KHDSS), which is located in the Kersa district of the Oromia region in Eastern Ethiopia, covering 24 kebeles.

Population
Newborns registered at birth in the database of the KHDSS site in Eastern Ethiopia.

Methods
The KHDSS tracks demographic and health changes in the community. Newborn data were extracted using a checklist. Trends in CAs over time (in years) were analysed and the associated factors were identified through logistic regression analysis.

Outcome measure
Newborn CAs, which are structural or functional abnormalities present at birth, were assessed through thorough physical examinations and detailed interviews conducted by trained data collectors using a standardised questionnaire.

Results
Between 2015 and 2022, a total of 27 350 newborns were recorded in the KHDSS, 104 of whom had CAs. The overall rate of CAs was 3.83 per 1000 live births (95% CI 3.19, 4.61). There was a significant increase in the trend of CAs over the study period, with a Mantel-Haenszel 2 of 82.76 (p=0.001). Factors associated with CA included maternal age over 35 years (adjusted OR (AOR)=1.68, 95% CI 1.07, 2.62), place of birth (AOR=2.04, 95% CI 1.04, 4.02) and normal birth weight (AOR=0.14, 95% CI 0.04, 0.47).

Conclusion
The data from the KHDSS revealed a rising trend in CAs. CA was associated with factors such as the mother’s age, place of birth and the baby’s birth weight. It is crucial for healthcare providers and stakeholders to consider these factors in efforts to reduce the prevalence of CAs.

Circulation, Volume 151, Issue 5, Page 318-330, February 4, 2025. Representativeness in randomized clinical trials remains a critical concern, affecting the external validity of trial results, equitable access to the risks and benefits of research participation, and public trust in clinical research. Although representative participation by members of groups traditionally underrepresented in clinical trials is just a surrogate for true diversity, equity, inclusion, and belonging in clinical trials, it can be quantified, allowing stakeholders to add empirical rigor to diversity, equity, inclusion, and belonging efforts. Multiple ways to measure representativeness have been proposed, including the participation-to-prevalence ratio, raw participation proportions or numbers for relevant subgroups, and enrollment fraction for relevant subgroups. These methods have strengths and weaknesses and may be appropriate to report in certain circumstances, depending on why stakeholders seek to assess representativeness. Stakeholders—including regulatory agencies, journal editors, clinical trial investigators, and trial sponsors—may use quantitative measures of representativeness to establish trial enrollment standards, monitor equitable participation in ongoing trials, and condition funding or drug or device approval on achieving specific representativeness targets. However, using quantitative measures of representativeness in this way could have unintended consequences, including researchers “gaming” recruitment strategies to meet target numbers, overlooking nuanced variations within communities, and potentially incentivizing problematic and exploitative recruitment strategies. Although no single method of measuring representativeness offers a comprehensive solution for increasing diversity, equity, inclusion, and belonging in all randomized clinical trials, a carefully designed, multifaceted approach to measuring representativeness may provide stakeholders with useful perspectives for measuring progress in increasing the diversity of clinical trial participation. For stakeholders seeking a single number to assess the representativeness of a trial enrolling patients with a disease state with well-delineated demographics, the participation-to-prevalence ratio is ideal; however, for a more nuanced view of representativeness, the combination of enrollment fraction in subgroups of relevance plus a full report of the demographics of patients approached for enrollment may be more appropriate.

Background
The traditional neoadjuvant chemoradiotherapy (nCRT) combined with total mesorectal excision has been widely accepted as the standard treatment for patients with locally advanced rectal cancer (LARC). New strategies such as total neoadjuvant therapy (TNT) and neoadjuvant immunotherapy have shown great promise in certain patient populations. Currently, there is an urgent need to stratify patients before treatment to adopt the appropriate neoadjuvant strategies. Our previous study has shown that circulating tumour DNA (ctDNA) effectively reflects tumour burden and genetic characteristics and has significant predictive value for tumour recurrence, demonstrating great potential in guiding the choice of neoadjuvant strategies.

Methods and analysis
The CINTS-R trial is a multicentre, open-label, randomised controlled trial designed to evaluate the efficacy and safety of a ctDNA-guided neoadjuvant treatment strategy compared with conventional neoadjuvant therapy regime in patients with LARC. The trial will enrol 470 patients diagnosed with LARC (staged cT3-4N0 or cTanyN1-2) with tumours located ≤12 cm from the anal verge across seven centres in China. Patients will be randomly assigned in a 2:1 ratio to the experimental group or the control group. Patients in the experimental group will receive different intensities of neoadjuvant chemoradiotherapy (TNT or modified nCRT) or neoadjuvant immunotherapy based on the molecular features of the tumour, baseline ctDNA concentration and changes in ctDNA status early in treatment. Patients in the control group will receive modified nCRT. The primary endpoint is the 2-year disease-related treatment failure rate. The secondary endpoints include time to recurrence, 2-year overall survival, 2-year disease-free survival, clinical complete response (cCR) rate, near cCR rate and pathologically complete response rate, pathological tumour regression grade and quality of life.

Ethics and dissemination
This protocol has been approved by the ethics committee of Peking Union Medical College Hospital, with approval number I-23PJ157, and by the institutional review boards of all the participating centres. All data will be collected and stored in a specially designed database. The results of our trial will be disseminated through peer-reviewed publications and presented at national and international academic conferences.

Trial registration number
This trial is registered on ClinicalTrials.gov and the registration ID is NCT05601505.

Introduction
Only 30%–50% of people referred to clinics during community-based eye screening are able to access care in Botswana, India, Kenya and Nepal. The access rate is even lower for certain population groups. This platform trial aims to test multiple, iterative, low-risk public health interventions and simple service modifications with a series of individual randomised controlled trials (RCT) conducted in each country, with the aim of increasing the proportion of people attending.

Methods and analysis
We will set up a platform trial in each country to govern the running of a series of pragmatic, adaptive, embedded, parallel, multiarm, superiority RCTs to test a series of service modifications suggested by intended service users. The aim is to identify serial marginal gains that cumulatively result in large improvements to equity and access. The primary outcome will be the probability of accessing treatment among the population group with the worst access at baseline. We will calculate Bayesian posterior probabilities of clinic attendance in each arm every 72 hours. Each RCT will continually recruit participants until the following default stopping rules have been met: >95% probability that one arm is best; >95% probability that the difference between the best arm and the arms remaining in the trial is