Search Results for: Cardio-oncology: rivista open access

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
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.

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).

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.

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.

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.

Background
The COVID-19 pandemic has widened inequities, affecting migrant and refugee populations in vulnerable situations, who may face elevated risks of infection, constrained healthcare access and discrimination. Inclusive vaccination campaigns are recommended, but barriers persist. This study aimed to identify barriers and facilitators and estimate vaccination coverage among refugees and migrants in low- and middle-income countries, emphasising inclusive policies for effective rollout.

Methods
A mixed-method study was conducted in two phases in Ecuador, Nepal, Pakistan, the Philippines and Rwanda. Phase 1 (March–May 2022) included policy analysis, in-depth interviews and focus-group discussions with 52 key informants analysed with thematic and grounded theory approaches using hybrid coding. Phase 2 (June–August 2022) included a cross-sectional study among refugees and migrants in regular (MIRS) and irregular situations (MIIS) and used descriptive analysis and a COVID-19 Vaccine Equity Index (CVEI).

Results
A total of 1378 individuals responded to the survey (43.8% MIRS, 31.2% MIIS and 25% refugees). 87% reported receiving at least one dose of the COVID-19 vaccine. The CVEI at the global level (0.824) suggested differences in complete vaccination between migrants and other residents in most of the study countries (refugees reported more access to vaccines than MIRS and MIIS). However, the qualitative phase reported delays and inequities in the early stage of the vaccination process in all countries. Overall, 64.2% of respondents perceived that government’ campaigns were successful. Both the qualitative and quantitative phases identified several barriers and facilitators. The main barriers included a lack of trust in authorities, extended waiting times and distance to vaccination centres, discrimination and xenophobia, lack of identity documentation, and adverse reaction concerns. On the other hand, the primary facilitators were the widespread distribution of vaccination centres, sources and provision of information, specific campaigns for refugees and migrants, free vaccination and the motivation to protect others’ health.

Conclusions
Despite the high coverage of COVID-19 vaccines among refugees and migrants in the study countries, the process had significant barriers. Simple vaccination registration procedures, targeted campaigns, mobile vaccination teams for hard-to-reach and vulnerable groups, and building trust in the host country authorities are pivotal for future and inclusive vaccine deployments.

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

New England Journal of Medicine, Ahead of Print.

Advance care planning (ACP) is fundamentally a communication process involving patient, family, and clinician discussions about potential future care that ideally prepares individuals and their surrogates for the difficult decisions that may arise at the end of life. In JAMA Internal Medicine, Wolff et al present findings from a pragmatic randomized clinical trial (henceforth pragmatic trial) that investigates whether their multicomponent primary care–based intervention enhances ACP process and outcomes. They recruited 64 915 adults (including people with dementia) 65 years and older from 51 primary care practices within 2 mid-Atlantic health systems. Patients in the SHARING Choices (NCT04819191) intervention group received an introductory letter to ACP, an agenda-setting checklist for the patient and family, an advance directive with durable medical power of attorney and living will, access to a patient portal, and access to a grant-funded facilitator certified through the Respecting Choices ACP. Clinicians at the intervention sites also received education about dementia. Researchers evaluated new documentation of end-of-life preferences in the electronic health record (EHR) and potentially burdensome care at end-of-life as 2 primary outcomes. Newly documented ACP was observed in 12% of intervention participants vs 7% of controls with a significant treatment effect for the overall cohort; this effect was attenuated among participants identified in the EHR as Black race, 75 years or older, or having diagnosed dementia. Researchers also examined receipt of potentially burdensome care for the 1498 participants who died with serious illness within 18 months after study entry; surprisingly, rates were higher in the intervention (29%) vs control (21%) among people without dementia, but no treatment effects (intervention (20%) vs control (13%) were observed among people with dementia.

This Viewpoint discusses the growing body of evidence that indicates that mifepristone and misoprostol meet the US Food and Drug Administration’s criteria for over-the-counter sale.

In Reply We thank the JAMA Oncology readership for allowing us to clarify some important aspects related to our work. We acknowledge a typographic error in labeling the Kaplan-Meier curves in Figure A, now corrected to ensure that the orange curve refers to the best supportive care (BSC), and the blue curve to the immune checkpoint inhibitor (ICI) group.

Minoritized individuals in the US experience both disproportionally high rates of kidney failure and low rates of kidney transplant. These disparities create an urgent health crisis, since kidney transplant is a superior treatment for kidney failure, resulting in a 30% to 70% lower risk of death and substantially improved quality of life compared to dialysis. Among transplant options, living donor kidney transplant (LDKT) offers superior outcomes. However, only 30% of all kidney transplants result from LDKT. Furthermore, profound inequities in LDKT for Black and other minoritized individuals have been present for decades. In 1995 to 1999, minoritized individuals were between 17% (Hispanic or Latino individuals) and 55% (Black individuals) less likely than White individuals to receive LDKT. Disparities have worsened over time such that in 2010 to 2014, minoritized individuals were between 48% (Hispanic or Latino individuals) and 73% (Black individuals) less likely to receive LDKT when compared to their White counterparts. These stark disparities are heavily influenced—but not entirely explained—by differences in individuals’ health care access and socioeconomic status. Adults older than 65 years are also less likely to receive LDKT compared to others, despite the fact that the median age at kidney failure is 64 years.

This Viewpoint discusses what a value proposition could look like in oncology and how it should reflect a clinician’s commitment to partner with patients to improve outcomes through individualized communication and shared decision-making centered on the patient’s values.