This research aimed to explore student paramedics’ experiences of participating in group-based simulation activities used as part of their summative assessment. It sought to understand their perceptions of the effectiveness of group-based simulation in fostering learning and informing future assessment design.

A qualitative questionnaire-based study.

A UK higher education institution.

A total of 34 first-year (level 4) student paramedics from the September 2022 to September 2023 cohorts.

Following the completion of a summative assessment for the introduction to non-technical skills and simulation module, students were invited to reflect on their experiences of group-based simulation through an online questionnaire. The assessment incorporated team-based simulation scenarios intended to evaluate non-technical competencies within a realistic and supportive environment.

Four key themes emerged through thematic analysis of the responses: experiential learning; autonomous learning; reflective learning; and support and learning. These themes provide insights into the pedagogical value of group-based simulation, with students identifying both individual and collective benefits in developing non-technical skills within a group assessment framework.

Group-based simulation assessments enhance student engagement and promote collaborative decision-making in a context that mimics real paramedic practice. While students often associate realism with increased confidence, their experiences highlight complex interactions between perceived fidelity, assessment pressure and learning. This underscores the need to further investigate how group dynamics and authenticity influence learning outcomes in assessment-focused simulations.

Cisplatin is a widely used chemotherapeutic anti-cancer drug. However, high-dose cisplatin is also known for its dose-limiting toxicities, including irreversible cisplatin-induced hearing loss (CIHL). Sodium thiosulphate (STS) can bind to cisplatin to form an inactive and harmless complex. A topical application is desired, allowing cisplatin to retain its systemic anti-cancer effect.

The SOUND trial is an investigator-initiated randomised controlled multicentre phase III trial to study the efficacy of transtympanic administration of STS against CIHL in a cohort of 100 patients with head and neck cancer treated with cisplatin at a dose of ≥200 mg/m². Each subject will receive transtympanic STS injections in one ear, chosen by randomisation, before each cisplatin infusion. The contralateral ear serves as an internal control. The primary objective is efficacy (ie, clinically relevant benefit) of transtympanic STS injections against CIHL, defined as a difference in threshold shift of ≥10 decibels between baseline and 3 months after treatment in favour of the STS-treated ear. Secondary objectives include the difference in mean threshold shifts on frequencies essential for speech and extended high frequencies, as well as the difference between both ears in the gradation of hearing loss as defined by ototoxicity grading scales.

The medical ethics committee in the Netherlands approved the trial (Clinical Trials Information System (CTIS) 2023-503313-30-00). The results will be disseminated through the CTIS and peer-reviewed scientific journals.

CTIS 2023-503313-30-00 approved by Medical Research Ethics Committee NedMec.

Cancer screening appointments are an opportunity to encourage positive behavioural changes. Up to 80% of cancer screening attendees are open to discussing physical activity during cancer screening, but some say this would deter them from future screening. This study aimed to gain an in-depth understanding of individuals’ receptivity to physical activity advice at cancer screening.

Interview-based qualitative study.

The study was conducted from May 2017 to September 2018 in the UK. Participants were recruited using adverts on two university campuses, Facebook and a participant recruitment agency. To be eligible, participants had to have an upcoming cancer screening appointment within 2 weeks. There were 30 participants.

Participants recorded their receptivity to physical activity advice in the days before and after screening. Data-prompted semi-structured interviews explored these responses. Interviews were analysed using a thematic framework analysis.

Participants felt discussing physical activity at cancer screening would be relevant. However, participants experienced anxiety related to the screening process which could increase or decrease their receptivity. Participants felt if information was delivered in a judgemental way, it could negatively impact future screening participation.

Screening attendees’ receptivity could be influenced by the timing of a discussion and by their levels of anxiety throughout screening. Participants’ anxiety during screening can either reduce their ability to engage in a discussion or increase the relevance of the discussion. The communication style of the healthcare practitioner was key for why some screening attendees could be deterred from future cancer screening.

Lynch syndrome (LS) carriers have a 20–46% lifetime risk of colorectal cancer (CRC) due to mismatch repair gene variants. Mesalamine (5-ASA, 5-aminosalicylic acid), used safely in patients with ulcerative colitis, may reduce CRC risk in LS by decreasing microsatellite instability, a key driver of LS-related cancer. This study evaluates 5-ASA’s efficacy as a tolerable chemopreventive drug, aiming to improve long-term CRC prevention in LS.

This multicentre, multinational, randomised, double-blind, two-arm, phase II clinical study will compare the effects of a 2-year daily intake of 5-ASA (2000 mg) to placebo in LS carriers. The primary objective is to assess whether mesalamine reduces colorectal neoplasia, both benign and malignant, compared with placebo in LS carriers, as detected by colonoscopy at the end of the treatment period (24 months±1 month) and on study completion. Secondary objectives include evaluating whether 5-ASA reduces neoplasia/tumour multiplicity and progression compared with placebo at specified time points, examining variations in the effects of 5-ASA versus placebo based on cancer history, sex and age (

The trial is currently open for enrolment, having received ethical approval from the Regional Ethical Review Board in Stockholm and funding from the Swedish Research Council. The study protocol is the finalised V.10.0 (11 April 2024), transitioned to the European Clinical Trials Information System. LS remains underdiagnosed, which may limit recruitment. The results are of global interest and will be published in peer-reviewed journals and presented at scientific conferences.

ClinicalTrials.gov: NCT04920149. EudraCT: 2019-003011-55. EU CT: 2024-514765-19-01.

Fibrosis is a pathological feature that can occur in a wide range of diseases including diabetes mellitus. We investigated whether in people with type 1 (T1DM) or type 2 diabetes mellitus (T2DM), glycaemia or diabetes-related complications are associated with fibrotic diseases.

Retrospective cohort study using UK Clinical Resource Datalink (CPRD) Aurum and Hospital Episode Statistics.

We included people with prevalent T1DM or T2DM as of 31 December 2015 (recorded in CPRD Aurum), eligible for linkage with Hospital Episode Statistics and followed up for 3 years.

We defined diabetes status using blood/urine biomarkers and complications. In the T2DM cohort, we also investigated exposures of hyperglycaemia, insulin resistance and metformin prescription. Fibrotic condition diagnoses were determined from both primary and secondary care records. Logistic regression analyses were undertaken to understand the strength of association between diabetes status/diabetic complications and fibrotic conditions, respectively.

The T1DM cohort consisted of 9669 people while the T2DM cohort included 504 066 people. In T1DM, we found that albuminuria was associated with lung fibrosis (ORadj: 2.07, 99% CI 1.35 to 2.17), and microvascular complications were associated with atherosclerosis (ORadj: 1.81, 99% CI 1.18 to 2.77) and cardiomyopathy (ORadj 1.53, 99% CI:1.15 to 2.04). In the T2DM cohort, both glycaemia above target and diabetes complications were associated with most fibrotic conditions.

Within the T1DM population, no consistent association between diabetes status and all fibrotic diseases was observed. More research is required to understand whether the association between diabetes complications and fibrotic diseases is due to shared risk factors or whether glycaemia in T2DM may be influenced by fibrotic pathology.

Hearing loss is highly prevalent and impacts many aspects of a person’s life, including communication, social engagement, employment, general health and well-being. Yet, many people do not access hearing healthcare and are unaware of the range of hearing healthcare options available. Barriers to hearing healthcare include poor understanding of hearing loss and its impact; poor knowledge of help-seeking for hearing healthcare options; minimal support to help decide which option is best; and stigma related to hearing loss. These barriers lead to many people not receiving the hearing healthcare they need. Guided by theories of behaviour change and implementation science, HearChoice, an online tailored decision support intervention, has been co-developed to empower adults with hearing difficulties by offering them choice and control over their own hearing healthcare. HearChoice aims to facilitate informed decisions, accessibility and uptake of hearing healthcare, including a wide range of interventions, for adults with hearing difficulties. The objectives of the trial are to evaluate the effectiveness, health economics and feasibility of HearChoice.

This online randomised controlled trial will recruit participants with hearing difficulties across Australia, with an anticipated sample size of 640. Participants will be randomised to either HearChoice (treatment) or an Australia-specific Hearing Option Grid (active control), both delivered online. Outcomes will be assessed at baseline when the interventions will be offered, at 7 days post-intervention (primary endpoint) and at 3 months post-intervention. An email reminder will be sent at 1-month post-intervention. The primary outcome is decisional conflict. Secondary outcomes include measures of readiness and self-efficacy to take action, hearing-related quality of life and empowerment, assessment of the value and impact of HearChoice, work performance and health, and feasibility measures. Primary analysis will compare outcomes between HearChoice and the active control at the primary endpoint.

The study was approved by the Curtin University Human Ethics Committee (HRE2023-0024). All participants will provide written informed consent prior to participation. A broad dissemination plan of the study findings includes peer-reviewed publications, scientific conference presentations, articles and presentations for the wider community and public written in lay and accessible language, and social media.

Australian New Zealand Clinical Trials Registry (ACTRN12624001139561).

Engaging patients in surgical safety is challenging and has not been thoroughly investigated. Although surgical checklists and other safety protocols have been introduced across various surgical fields, preventable adverse events still occur, highlighting the need for additional research. A Patient’s Safety Checklist (PASC) has been developed and validated for use by surgical patients. Its effect on patient safety and patient outcomes is currently being investigated in a Stepped Wedge Cluster Randomised Controlled Trial (NCT03105713). In connection with this trial, we have examined elective patients’ experiences with using the PASC.

An exploratory qualitative study was conducted based on individual in-depth telephone interviews with 31 elective surgical patients. The interviews were carried out across three Norwegian hospitals including seven surgical specialties. The patients interviewed were part of the trial’s intervention arm and had used PASC. The interviews were transcribed verbatim, and reflective thematic analysis was applied.

Three themes were identified in the data: patient awareness, patient actions and utility value. Patients perceived PASC to increase awareness around surgical information, preparations, what to speak up about and which information to seek and repeat. This awareness led to a series of actions, such as ensuring medication control, optimising their own health, contacting healthcare professionals, asking questions, and for some no actions were needed. Patients perceived PASC to have high utility value for their surgical preparation.

The PASC enhanced patients’ involvement in surgical care and safety by ensuring they received systematic, accurate, clear, and understandable information and instructions throughout the surgical pathway. It is one of the few existing interventions that specifically focuses on assisting patients in preparing for surgery and managing their recovery. Further research is needed on the implementation of PASC and its adaptation to other clinical settings.

NCT03105713.

A thoracic aortic aneurysm (TAA) is often considered a precursor to an acute type A aortic dissection (ATAAD), a life-threatening condition requiring immediate surgical intervention. While both conditions share histopathological similarities, less is known about their overlap in clinical cardiovascular risk factors. This study aimed to map the cardiovascular disease burden in patients with ATAAD and compare it with patients with TAA.

A multicentre retrospective study.

The data were collected from electronic health records of two academic hospitals located in the Netherlands.

Patients who were treated surgically for ATAAD or TAA between 2000 and 2022 were eligible. This study included 731 patients with ATAAD and 480 patients with TAA.

Hypertension was equally prevalent in both groups (50.9% vs 50.6%, p=0.921). Diabetes was uncommon (3.3% vs 6.7%, p=0.638). Hyperlipidaemia (9.6% vs 20.0%, p=0.001) and peripheral arterial disease (8.8% vs 22.7%, p

This study suggests distinct cardiovascular risk profiles in patients with ATAAD and patients with TAA, highlighting the importance of tailored treatment strategies for aortic disease. Further research is needed to investigate the pathophysiological mechanisms underlying these differences and their impact on thoracic aortopathy.

Mental health issues such as depression and anxiety are highly and disproportionally prevalent among university students. Beyond the academic rigour, stressors imposed by a new environment result in them being vulnerable to the onset and manifestation of mental health symptomatology. Leveraging smartphones and wearables for digital phenotyping capabilities is an innovative approach for monitoring and intervening in the mental health conditions of university students. This provides a unique opportunity to collect and identify digital and behavioural biomarkers, subsequently enabling the development of predictive models to identify university students at risk.

This study—Brightline—will employ an observational study design over a 6-month period, recruiting 500 students from a major public university in Singapore. Passive data collection will occur continuously throughout the monitoring period through a wearable device (Fitbit Charge 6) and smartphone sensors via the Brightline app, which uses a digital phenotyping data collection platform. Active data collection will consist of self-report questionnaires to be completed at the beginning of the study and follow-up assessments at 1, 3 and 6 months after. The passive and active data collected will be analysed to identify the digital biomarkers associated with depression, anxiety, stress, loneliness and affect among university students. Predictive models of these mental health issues will also be developed.

This study was approved by the Nanyang Technological University Institutional Review Board (IRB-2023-894). Findings from this study will be published in peer-reviewed journals and presented at academic conferences.

NCT06770075.

Ventilation tube insertion for paediatric otitis media (POM), including acute otitis media (AOM) and otitis media with effusion (OME), has been signalled in the past for potential unwarranted treatment variation. Quality improvement initiatives, like Audit & Feedback (A&F), often ignore the care pathway when identifying such variation, possibly overestimating variation at a specific care step. To gain more insight into the effect of prior care steps, this study examined (1) the degree of regional variation in each step of the care pathway (general practitioner (GP) contacts, referrals and surgeries) and (2) investigated the effect of adjusting for prior care steps.

Observational study using general practice electronic health record data linked to specialist claims data.

272 790 children ≤12 years with and without POM registered in 320 GP practices between 2017 and 2018.

Using multilevel logistic regression, the degree of regional variation in each step of the POM care pathway was assessed by calculating the coefficient of variation (CV).

The effect of adjusting for prior care steps was determined by estimating correlations between subsequent care steps and analysing the impact on the CV.

Regional variation in POM treatment was larger in each subsequent step in the care pathway (CV POM GP contacts 0.110; referral 0.179; surgery 0.239). In regions with a higher proportion of children with frequent AOM/persistent OME, referral rates were higher (POM: OR: 1.06; 95% CI: 1.02 to 1.11) and surgical rates were higher (for OME only: OR: 1.08; 95% CI: 1.02 to 1.15). Regional variation in referrals and surgery decreased after adjusting for the regional frequent AOM/persistent OME rate (CV referrals POM 0.103 vs 0.128; CV surgery OME 0.047 vs 0.059).

Regional variation is observed in GP contact rates for POM and is larger in referrals and surgeries. Adjusting for the proportion of frequent AOM/persistent OME significantly reduces regional variation in POM treatment. Future A&F should adjust for prior care processes and develop tailored interventions for quality improvement.

Acute low back pain (LBP) is a prevalent condition with various non-surgical treatment options, yet no comprehensive network meta-analysis has systematically compared their relative efficacy for pain and disability. This study aims to fill that gap by synthesising available evidence on the efficacy of different types of non-surgical interventions for acute LBP, such as various medications, manual therapies and education-based therapies. Our coprimary objectives are to (1) compare each active treatment to an inert reference for measures of LBP and related disability and (2) rank the efficacy of treatments.

We will conduct a systematic search across multiple databases, including grey literature, to identify randomised controlled trials evaluating non-surgical treatments for acute LBP. Eligible studies must report on pain and/or disability outcomes in adults. The risk of bias will be assessed using the Risk of Bias tool, and the certainty of evidence will be graded using CINeMA (Confidence in Network Meta-Analysis). We will use a frequentist network meta-analysis to pool standardised mean differences in pain and disability, employing random-effects models to account for heterogeneity. A qualitative analysis will assess study characteristics and transitivity, while a quantitative analysis will evaluate efficacy and inconsistency. Results will be presented using network geometry, p-scores, forest plots, funnel plots, Egger’s test, Q-statistics and league tables to visualise both direct and indirect evidence and to identify potential biases.

This review protocol does not involve any primary research with human participants, animal subjects or medical record review. Consequently, this work did not require approval from an institutional review board or ethics committee. Results will be submitted to a peer-reviewed journal and presented at conference(s). De-identified data will be made available in a public repository.

Endovascular aortic aneurysm repair (EVAR) requires long-term surveillance to detect and treat postoperative complications. However, prediction models to optimise follow-up strategies are still lacking. The primary objective of this study is to develop predictive models of post-operative outcomes following elective EVAR using Artificial Intelligence (AI)-driven analysis. The secondary objective is to investigate morphological aortic changes following EVAR.

This international, multicentre, observational study will retrospectively include 500 patients who underwent elective EVAR. Primary outcomes are EVAR postoperative complications including deaths, re-interventions, endoleaks, limb occlusion and stent-graft migration occurring within 1 year and at mid-term follow-up (1 to 3 years). Secondary outcomes are aortic anatomical changes. Morphological changes following EVAR will be analysed and compared based on preoperative and postoperative CT angiography (CTA) images (within 1 to 12 months, and at the last follow-up) using the AI-based software PRAEVAorta 2 (Nurea). Deep learning algorithms will be applied to stratify the risk of postoperative outcomes into low or high-risk categories. The training and testing dataset will be respectively composed of 70% and 30% of the cohort.

The study protocol is designed to ensure that the sponsor and the investigators comply with the principles of the Declaration of Helsinki and the ICH E6 good clinical practice guideline. The study has been approved by the ethics committee of the University Hospital of Patras (Patras, Greece) under the number 492/05.12.2024. The results of the study will be presented at relevant national and international conferences and submitted for publication to peer-review journals.

To investigate physical activity (PA) promotion practices among primary care health professionals in England. To assess whether attitudes, confidence, role perceptions, knowledge of PA guidelines, and PA behaviour were related to PA promotion practices. To examine the barriers to and facilitators of PA promotion practices.

A cross-sectional online survey study with open (free text) questions.

National survey and online-administered survey conducted in England.

The outcome variables were attitudes, confidence, role perceptions, PA behaviour, knowledge of the PA guidelines and PA promotion practices. Structural equation modelling evaluated associations between these variables.

A total of 181 primary care healthcare professionals completed an online survey. The majority were general practitioners (GPs) (66.7%), followed by first contact physiotherapists (13.8%), practice nurses (12.2%) and link workers (7.7%).

Most (59%) healthcare professionals did not meet recommended levels of PA and could not accurately identify the PA guidelines (53%). Most provided PA advice to patients but fewer than 40% assessed PA, supported behaviour change or made referrals to PA support programmes. More first contact physiotherapists and link workers reported more frequent engagement in collaborative aspects of PA promotion, including assessing PA motivation, supporting behaviour change and providing follow-up. Confidence in promoting PA (β=0.30, p

Most primary care professionals routinely provide PA advice and feel confident doing so. However, with fewer than half able to accurately recall current PA guidelines and routine assessment and behaviour change support rarely reported, the quality and specificity of this advice remain unclear. While time constraints remain a major barrier to PA promotion, particularly among GPs, the addition of first contact physiotherapists and link workers is likely to enhance capacity for promoting PA in busy primary care settings.

Despite growing evidence to characterise cancer-associated cognitive decline (CACD) in women with breast cancer, interventions to mitigate CACD are limited. Emerging evidence suggests aerobic exercise may enhance cognition after breast cancer diagnosis and treatment; yet, CACD remains an understudied outcome of exercise, and few high-quality studies have been conducted. In addition to knowledge gaps in effectiveness, the translation of exercise interventions to community settings remains challenging. The Breast cancer Reasoning and Activity INtervention (BRAIN) investigates the effectiveness of aerobic exercise training, delivered in a community-based setting, for improving cognitive function in women with breast cancer and gathers information on the implementation success of the intervention.

This Hybrid Type I effectiveness–implementation study is conducted at an academic medical centre in the southwestern United States in partnership with a non-profit, community health and wellness organisation. The study enrols 160 women diagnosed with stage I–IIIa breast cancer and within 3–36 months of treatment completion into a 1:1 randomised controlled trial. Individuals randomised to the exercise group receive a 6-month, individually tailored aerobic exercise programme delivered by exercise trainers employed at local community fitness centres. The programme is progressive in nature and designed to help participants achieve aerobic exercise levels consistent with guidelines for cancer survivors. Individuals randomise to the control group receive a 6-month health education control intervention delivered virtually by hospital-based health educators. Cognitive performance (primary), self-reported cognition, patient-reported outcomes, physical activity and cardiorespiratory fitness are measured at baseline, 6 months (postintervention) and 12 months (follow-up). Brain structure and function are measured via magnetic resonance imaging (MRI) at baseline and 6 months. Implementation outcomes are defined by the RE-AIM framework, which includes reach, effectiveness, adoption, implementation and maintenance. RE-AIM outcomes are measured at baseline, 6 months, 12 months and ongoing during the study.

This study was approved by the Mayo Clinic Institutional Review Board (#23-000020). All participants provide informed consent prior to participation. Findings will be disseminated to scientific, clinical and community audiences through manuscripts, presentations and newsletters.

NCT04816006.