Atrial fibrillation (AF) is the most common sustained arrhythmia worldwide, associated with significant morbidity, mortality and healthcare utilisation. AF rhythm control strategies demonstrate attrition with time. A number of modifiable AF risk factors contribute to an atrial cardiomyopathy culminating in incident AF but importantly also recurrence. We propose that a novel multidisciplinary lifestyle intervention (Super Rehab, SR) may improve symptoms and AF burden.

This is a single-centre, randomised controlled study. Patients aged ≥18 years with a body mass index ≥27 kg/m² with paroxysmal or persistent AF will be randomised 1:1 to National Health Service (NHS) usual care (UC) or to SR (together with NHS UC). SR incorporates high-intensity exercise, personalised dietary advice and AF risk factor modification. SR will be undertaken over 12 months. In addition to baseline assessments, follow-up assessments will occur at the 6, 12 and 15-month time points. The primary outcome will be the difference in AF symptom burden at 12 months between groups. Secondary outcomes include AF burden (assessed by an implantable cardiac monitor), changes to cardiac structure and function and computed tomography-based assessment of epicardial adipose tissue.

Ethics approval was granted by London-Chelsea Research Ethics Committee (reference: 22/LO/0479 22/08/2022). All participants will provide written informed consent prior to enrolment. Study findings will be disseminated via presentations to relevant stakeholders, national and international conferences and open-access peer-reviewed research publications. A summary will also be communicated to the participants.

ClinicalTrials.gov ID NCT05596175.

In Africa, 75% of households are exposed to household air pollution (HAP), a key contributor to cardiovascular disease (CVD). In Nigeria, 90 million households rely on solid fuels for cooking, and 40% of adults have hypertension. Though clean fuel and clean stove (CF-CS) technologies can reduce HAP and CVD risk, their adoption in Africa remains limited.

Using the Exploration, Preparation, Implementation and Sustainment framework, this cluster-randomised controlled trial evaluates the implementation and effectiveness of a community mobilisation (CM) strategy versus a self-directed condition (i.e., receipt of information on CF-CS use without CM) on adoption of CF-CS technologies and systolic blood pressure (SBP) reduction among 1248 adults from 624 households across 32 peri-urban communities in Lagos, Nigeria. The primary outcome is CF-CS adoption at 12 months; secondary outcomes are SBP reduction at 12 months and sustainability of CF-CS use at 24 months. Adoption is assessed via objective monitoring of stove usage with temperature-triggered iButton sensors. SBP is assessed in 2 adults per household using validated automated blood pressure monitor. Generalised linear mixed-effects regression models will be used to assess study outcomes, accounting for clustering at the level of the peri-urban communities (unit of randomisation) and households. To date, randomisation is completed, and a total of 1248 households have enrolled in the study. The final completion of the study is expected in June 2026.

The study was approved by the Institutional Review Boards (IRB) of NYU Grossman School of Medicine (primary IRB of record; protocol ID: i21-00586; Version 6.0 approved on 4 June 2024), and Lagos State University Teaching Hospital (protocol ID: LREC 06/10/1621). Written consent was obtained from all participants. Findings will inform scalable and culturally appropriate strategies for reducing HAP and CVD risk in low-resource settings. Results will be disseminated through peer-reviewed publications, conference presentations and stakeholder engagements.

NCT05048147

Communication skills assessment (CSA) is essential for ensuring competency, guiding educational practices and safeguarding regulatory compliance in health professions education (HPE). However, there appears to be heterogeneity in the reporting of validity evidence from CSA methods across the health profession that complicates our interpretation of the quality of assessment methods. Our objective was to map reliability and validity evidence from scores of CSA methods that have been reported in HPE.

Scoping review.

MEDLINE, Embase, PsycINFO, CINAHL, ERIC, CAB Abstracts and Scopus databases were searched up to March 2024.

We included studies, available in English, that reported validity evidence (content-related, internal structure, relationship with other variables, response processes and consequences) for CSA methods in HPE. There were no restrictions related to date of publication.

Two independent reviewers completed data extraction and assessed study quality using the Medical Education Research Study Quality Instrument. Data were reported using descriptive analysis (mean, median, range).

A total of 146 eligible studies were identified, including 98 394 participants. Most studies were conducted in human medicine (124 studies) and participants were mostly undergraduate students (85 studies). Performance-based, simulated, inperson CSA was most prevalent, comprising 115 studies, of which 68 studies were objective structured clinical examination-based. Other types of methods that were reported were workplace-based assessment; asynchronous, video-based assessment; knowledge-based assessment and performance-based, simulated, virtual assessment. Included studies used a diverse range of communications skills frameworks, rating scales and raters. Internal structure was the most reported source of validity evidence (130 studies (90%), followed by content-related (108 studies (74%), relationships with other variables (86 studies (59%), response processes (15 studies (10%) and consequences (16 studies (11%).

This scoping review identified gaps in the sources of validity evidence related to assessment method that have been used to support the use of CSA methods. These gaps could be addressed by studies explicitly defining the communication skill construct(s) assessed, clarifying the validity source(s) reported and defining the intended purpose and use of the scores (ie, for learning and feedback, for decision making purposes). Our review provides a map where targeted CSA development and support are needed. Limitations of the evidence come from score interpretation being constrained by the heterogeneity of the definition of communication skills across the health professions and the reporting quality of the studies.

This study aimed to examine the reproductive concerns and their influencing factors among adolescents and young adults with acute leukaemia and to explore the relationship between reproductive concerns and patients’ quality of life.

A cross-sectional study.

The haematology departments of four tertiary-level hospitals in Hunan province, China.

Convenience sampling method was used to recruit 233 adolescents and young adults with acute leukaemia, from June 2024 to December 2024.

The primary outcome was assessed using the Chinese version of the Reproductive Concerns After Cancer and the secondary outcome was measured by the 12-item Short Form Health Survey.

Adolescents and young adults with acute leukaemia had a mean reproductive concerns score of 55.57±7.57, a quality of life physical component summary (PCS) score of 38.54±8.58 and a mental component summary (MCS) score of 39.84±8.78. Univariate analysis showed significant differences in reproductive concerns based on fertility status, place of residence, education level, fertility counselling and family history of acute leukaemia (p

Adolescents and young adults with acute leukaemia exhibited moderately high levels of reproductive concerns, particularly those who had no children, had a low education level, resided in rural areas, had a family history of acute leukaemia or had received fertility counselling. Therefore, we suggest that healthcare providers prioritise addressing reproductive concerns in high-risk patients by offering tailored, high-quality and continuous fertility counselling and psychological support. Strengthening these strategies can help alleviate reproductive concerns and improve both mental health and overall quality of life in this population.

While digital technologies can increase the availability and access to evidence-based interventions, little is known about how users engage with them and the mechanisms associated with effective outcomes. Process evaluations are an important component in understanding the aforementioned factors. The ‘SPARX-UK’ study is a randomised controlled pilot and feasibility trial evaluating personalised human-supported (from an ‘eCoach’) vs a self-directed computerised cognitive behavioural therapy intervention (cCBT), called SPARX (Smart, Positive, Active, Realistic, X-factor thoughts), aimed at adolescents with mild to moderate depression. We are comparing supported vs self-directed delivery of SPARX to establish which format should be used in a proposed definitive trial of SPARX. The control is a waitlist group. We will conduct a process evaluation alongside the trial to determine how the intervention is implemented and provide context for interpreting the feasibility trial outcomes. We will also look at the acceptability of SPARX and how users engage with the intervention. This protocol paper describes the rationale, aims and methodology of the SPARX-UK trial process evaluation.

The process evaluation will use a mixed-methods design following the UK Medical Research Council’s 2015 guidelines, comprising quantitative and qualitative data collection. This will include analysing data usage of participants in the intervention arms; purposively sampled, semi-structured interviews of adolescents, parents/guardians, eCoaches and clinicians/practitioners from the SPARX-UK trial; and analysis of qualitative comments from a survey from those who dropped out early from the trial. Quantitative data will be analysed descriptively. We will use thematic analysis in a framework approach to analyse qualitative data. Quantitative and qualitative data will be mixed and integrated to provide an understanding of how the intervention was implemented and how adolescents interacted with the intervention. This process evaluation will explore the experiences of adolescent participants, parents/guardians, eCoaches and clinicians/practitioners in relation to a complex digital intervention.

Ethical approval was granted by the National Health Service (NHS) Health Research Authority South West - Cornwall & Plymouth Research Ethics Committee (Ethics Ref: 22/SW/0149).

Contextualising how the intervention was implemented, and the variations in uptake and engagement, will help us to understand the trial findings in greater depth. The findings from this process evaluation will also inform the decision about whether and how to proceed with a full randomised controlled trial, as well as the development of more effective interventions which can be personalised more precisely via varying levels of human support. We plan to publish the findings of the process evaluation and the wider project in peer-reviewed journals, as well as disseminate via academic conferences.

ISRCTN: ISRCTN15124804. Registered on 16 January 2023, https://www.isrctn.com/ISRCTN15124804.

European cardiovascular guidelines recommend systematic atrial fibrillation (AF) screening in community-dwelling high-risk patients. However, little is known about the impact of abnormal screening findings, including AF and non-AF incidental findings on the target population. This gap highlights the need to assess both the benefits and potential harms from patients’ perspectives to fully understand the impact of AF screening. Therefore, the aim of this study is to explore patients’ experiences with AF screening among those who received abnormal findings from ambulatory ECG monitoring.

We conducted a qualitative study using semistructured interviews, analysed thematically. Participants in the PATCH-AF trial, based in Amsterdam primary care, were purposively sampled based on their screening results (AF or non-AF incidental findings), sex and socioeconomic status.

We achieved data saturation after conducting 16 interviews (6 with interviewees diagnosed with AF and 10 with non-AF incidental findings). Participants had a median age of 76 (73–79) years, and 56% were male. Their experiences, whether positive or negative, fluctuated throughout the screening process and depended on their initial motivations for participation in AF screening (seeking extra health checks, finding explanations for pre-existing symptoms or contributing to medical research), expectations and perceived benefits from clarification, diagnostic workup or treatment. Influencing factors included the type of finding (AF or non-AF incidental finding), healthcare provider communication and individual characteristics such as age, socioeconomic status and medical history.

This qualitative study highlights both positive and negative AF screening experiences from the patients’ perspective. It underscores how patients’ motivations and expectations for participation, the type of ambulatory ECG finding and communication and follow-up by healthcare providers shape their overall experiences. Healthcare providers should be aware of these factors to optimise screening consultations. Clear guidelines on communicating abnormal ambulatory ECG findings, especially incidental findings, are warranted.

The Netherlands Trial Register (NTR) number NL9656.

Unplanned hospital readmission (UHR) after paediatric neurosurgery is an important indicator of surgical outcomes. As this field deals with complex cases, there is an increased likelihood of potential complications and the subsequent need for readmission. We estimated paediatric neurosurgery UHR rates globally and identified significant factors contributing to 30-day and 90-day UHR rates in children undergoing neurosurgical procedures.

A systematic review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

Embase, Medline, CINAHL and Global Index Medicus databases were searched on 17th December 2023.

We included studies that reported unplanned readmissions in the paediatric population within 30 days and 90 days of an index neurosurgical procedure.

Two independent qualified researchers screened studies and extracted data using standardised methods. Risk of bias assessment was done using the Newcastle-Ottawa scale. Narrative synthesis was performed.

2593 titles were identified following the search strategy. 52 studies were included after screening, full-text review and quality appraisal. Most studies were from the USA and are retrospective cohorts. The majority were cranial procedures (n=30), with common ones being shunt procedures for hydrocephalus and cranial tumour resections. 30-day readmissions ranged from 1.4% to 28% while 90-day readmissions ranged from 1.31% to 38.64%. 34 different risk factors were identified. Aetiology-related factors, procedure-specific complexities and age emerged as the three most common. Other common risk factors were complex chronic conditions, race, length of hospital stay and type of medical insurance. The patient’s age was a significant non-modifiable predictor, with younger children generally facing higher odds compared with their older counterparts across different procedures. While early readmissions could be due to disease progression, some were linked to preventable causes. Heterogeneity was also present due to variations in definitions and inclusion of studies from both national databases and single institutions.

Findings from this study contribute to a collective understanding of factors affecting unplanned readmissions in paediatric neurosurgery. UHRs reflect the interplay among surgical complexity, patient characteristics such as age and disease aetiology.

While survival rates following neonatal surgery for congenital heart disease (CHD) have improved over the years, neurodevelopmental delays are still highly prevalent in these patients. After correcting for the CHD subtype, the severity of developmental impairment is dependent on multiple factors, including intraoperative brain injury, which is more frequent and more severe in those undergoing aortic arch repair with deep hypothermic circulatory arrest (DHCA). It is proposed that brain injury may be reduced if cooling is stopped at the point of electrocerebral inactivity (ECI) on electroencephalogram (EEG), but there is limited evidence to support this as few centres perform perioperative EEG routinely. This study aims to assess the feasibility of EEG monitoring during neonatal aortic arch repair and investigate the relationship between temperature and EEG to inform the design of a future clinical trial.

Single-centre prospective observational cohort study in a UK specialist children’s hospital, aiming to recruit 74 neonates (≤4 weeks corrected age) undergoing aortic arch repair with DHCA. EEG will be acquired at least 1–3 hours before surgery, and brain activity will be monitored continuously until 24 hours following admission to intensive care. Demographic, clinical, surgical and outcome variables will be collected. Feasibility will be measured by the number of patients recruited, data collection procedures, technically successful EEG recordings and adverse events. The main outcomes are the temperature at which ECI is achieved and its duration, EEG patterns at key perioperative steps and neurodevelopmental outcomes at 24 months postsurgery.

The study was approved by the Yorkshire and The Humber Sheffield National Health Service Research Ethics Committee (20/YH/0192) on 18 June 2020. Written informed consent will be obtained from the participant’s parent/guardian prior to surgery. Findings will be disseminated to the academic community through peer-reviewed publications and presentations at conferences. Parents/guardians will be informed of the results through a newsletter in conjunction with local charities.

High-quality clinical practice guidelines and hospital standards on falls prevention and management now exist, yet their implementation into clinical practice is variable. Insights from consumers could help to guide the development of a process to improve the implementation of falls prevention and management, particularly in rehabilitation hospitals where fall rates are high.

A qualitative descriptive study will incorporate semistructured interviews and focus groups to explore the perspectives of hospital consumers on how hospital falls prevention evidence can best be implemented into rehabilitation practice. Thematic analysis of the data will be conducted in NVivo using a six-phase thematic coding process guided by Braun and Clarke. Evaluation and synthesis of the data will also follow the Consolidated Criteria for Reporting Qualitative Research checklist. Consideration of the results from the interviews and focus groups will provide insights into the views of people with lived experience of hospitalisation and falls. Thematic analysis will be supported by direct quotes for each key theme and will highlight how the themes relate to the study aims and the rehabilitation context.

The study was approved by La Trobe University Human Research Ethics Committee (HEC24526). The study will be published in a peer-reviewed journal, and findings will be presented at conferences, workshops and online events.

Type 1 diabetes (T1D) is associated with changes in brain structure, cognition, mental health, and functional outcomes. While these changes have been linked to dysregulated glycaemic control, findings are inconsistent, and their long-term impact remains unclear. Most evidence comes from cross-sectional or short-term longitudinal studies, limiting insights into causal associations. To address this, we aim to study individuals with T1D approximately 30 years after onset to assess how early dysglycaemic insults during neurodevelopment influence cognitive and functional outcomes in mid-adulthood.

This protocol paper outlines an observational, case/control, cross-sectional/longitudinal and descriptive study that follows up the original Royal Children’s Hospital (RCH) Diabetes Cohort Study. The initial study recruited children in Australia diagnosed with T1D between 1990 and 1992, conducting five waves of data collection. We now introduce the Cognition and Longitudinal Assessments of Risk Factors over 30 Years (CLARiFY) Diabetes Complications Study to assess brain, cognition and functional outcomes in mid-adulthood, approximately 30 years post-T1D onset. Both T1D participants from the original cohort and healthy controls will participate in semistructured interviews, neuroimaging and cognitive testing. T1D participants will also undergo complications screening. Data from this study and previous waves will be used to (Aim 1) explore cross-sectional and longitudinal impacts of T1D on brain health over 30 years. Linear regression will analyse cross-sectional outcomes, and multivariate analysis will assess cognitive variables jointly. Longitudinal outcomes will be examined using linear mixed-effects regression for IQ patterns, with secondary outcomes analysed via generalised linear models. Additionally, linear mixed-effects regression (Aim 2) will identify T1D-related metabolic factors affecting brain outcomes, with covariate selection informed by the construction of directed acyclic graphs (DAGs).

The study was approved by the Royal Children’s Hospital Human Research Ethics Committee (HREC 35 240F and 2019.065). The research findings will be disseminated through peer-reviewed publications, conference presentations, and print and social media. Participants will receive a summary of the study findings on its completion.

Our study was designed to assess whether paired normal-tumour testing increased access to targeted therapy, clinical trials and influenced cancer screening recommendations given to patients and their families.

Prospective cohort study.

Academic cancer centre in the Pacific Northwest region of the USA.

Patients newly diagnosed between 01 January 2021 and 31 December 2022 with cancers of the oesophagus, gastro-oesophageal junction and stomach (CEGEJS) were included. All other cancer diagnoses such as head and neck, duodenal and lower gastrointestinal tract cancers were excluded.

Paired germline and tumour genetic test within 90 days of new patient visit.

Number of targeted therapies received (or not) when eligible, follow-up treatment data and number of inherited predispositions to cancers identified. No secondary outcome measures.

Of 42 patients, 32 (76.2%) were eligible for at least one targeted therapy. 19 patients received immunotherapy, when 16 had a biomarker predicting immunotherapy benefit, and benefit of immunotherapy was unclear for 3. Another 11 did not have this biomarker, and 6 of them received immunotherapy. Six pathogenic variants were identified in four high-risk genes. By 01 January 2024, 18 patients (42.9%) had died of complications of cancer.

More than 75% of patients who received tumour testing were eligible for a targeted therapy regardless of their stage at diagnosis, emphasising the need to expand access to testing with staging workup to improve survival outcomes. Six families received personalised screening recommendations, thanks to this study.

This study aimed to describe how healthcare providers perceived the impacts of implementing and using an electronic health record (EHR) on quality, safety and person-centredness of care.

A qualitative descriptive design using semistructured interviews.

In October 2020, a large Canadian community hospital implemented a new EHR system (Epic) across three sites, transitioning from a previously fragmented (combination of paper-based and electronic) system.

Sixty-two healthcare providers and clinical leaders.

Participants shared their experiences regarding the impact of EHR implementation on quality of care, which were analysed into common themes including task efficiency, information management, patient interactions and patient safety. While the system significantly altered their routines and introduced new responsibilities like additional documentation requirements, it also facilitated adherence to clinical guidelines, improved information visibility and enhanced documentation, benefiting overall quality of care and patient safety. Participants reported that EHR implementation led to increased efficiency, freeing up time for patient care and improving communication with patients and other providers.

EHRs have the potential to improve quality of care and patient safety, but this depends on their perceived value and how well healthcare providers can integrate their various features into clinical routines.

The aim of this study, which was embedded into the ASPIRED randomised controlled trial (ISRCTN10278811), was to explore patient and healthcare professional usability and acceptability of an enhanced (14-day) ambulatory ECG monitoring patch to manage and facilitate discharge of emergency department patients with unexplained syncope.

A qualitative study using semistructured interviews. Data were analysed using thematic analysis and mapped using the theoretical framework of acceptability.

A sample of 20 syncope patients recruited to the ASPIRED RCT and 10 healthcare professionals who had a direct care provider and clinical decision role for syncope patients (eg, consultants, junior doctors, advanced nurse practitioners, advanced care practitioners, emergency nurse practitioners and physician associates) were recruited from four hospitals (two in England and two in Scotland) between February 2023 and January 2024.

Three overarching themes developed that mapped to six of the seven constructs within the theoretical framework of acceptability. The themes were: (1) Efficacy: Patients and healthcare professionals felt that the remote intervention would increase patient reassurance. Healthcare professionals perceived the intervention would improve clinical care pathways by overcoming delays for Holter monitors, but that a standard protocol would be required to ensure appropriate intervention use. (2) Burden: Patients considered that the device was non-obstructive and easy to use. However, healthcare professionals noted that although attaching the device was simple, there would be associated time and resource costs (eg, documentation). (3) Communication and education: Comprehensive verbal and written information were considered necessary to ensure that the intervention was usable by, and acceptable to, patients. Healthcare professionals suggested additional training would be required. Additionally, they considered that feedback from patient monitoring would reinforce their decision-making and improve healthcare professionals’ self-efficacy to use the device appropriately.

An immediate, enhanced (14-day) ambulatory ECG monitoring patch was positively received by patients and offered healthcare professionals an acceptable route for monitoring emergency department patients with unexplained syncope. However, future use should be controlled using standardised pathways to prevent inappropriate use.

ISRCTN10278811.