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Association between joint tenderness, patient-reported joint pain and ultrasound abnormalities in anti-CCP positive individuals at risk of rheumatoid arthritis: a cross-sectional study from a Leeds (UK) cohort

Por: Garcia-Montoya · L. · Kang · J. · Duquenne · L. · Di Matteo · A. · Harnden · K. · Nam · J. L. · Chowdhury · R. · Wakefield · R. J. · Mankia · K. S. · Emery · P.
Objectives

In individuals at-risk of rheumatoid arthritis (RA), to investigate how joint tenderness and patient-reported joint pain (PRJP) relate to ultrasound abnormalities and assess whether these exploratory results could be used to assist future evaluation of symptom/signs-guided ultrasound scanning approaches in this population.

Methods

This is a cross-sectional analysis from a Leeds (UK) cohort of anti-cyclic citrullinated peptide (anti-CCP) positive individuals with new musculoskeletal complaints and no clinical arthritis. Assessments included physical examination, a mannequin where participants ticked joints that were painful and ultrasound scans of wrists, metacarpo-phalangeal joints 1–5 (MCPs1-5), proximal interphalangeal joints 1–5 (PIPs1-5), elbows, knees, ankles, metatarso-phalangeal joints 1–5 (MTPs1-5), finger flexor tendons (2-5) and extensor carpi ulnaris. Grey scale (GS), power Doppler (PD), tenosynovitis and erosions were assessed. A generalised estimating equations model was used to evaluate potential associations between tenderness/PRJP and ultrasound findings at the joint-level, adjusting for age and sex. Positive and negative predictive values for ultrasound changes were calculated.

Results

323 participants were analysed. Joint tenderness was associated with ultrasound abnormalities, predominantly PD in wrists, MCPs, PIPs, elbows, knees and MTPs. GS and erosions were also associated with tenderness, but to a lesser degree. Association of PRJP with ultrasound abnormalities was more inconsistent and mostly for GS in the feet (all p0.05). Absence of symptoms and signs had a negative predictive value between 97% and 100% in all joints, except in wrists; which was slightly lower.

Conclusions

In anti-CCP positive individuals at risk of RA, tenderness, predominantly in the small joints, was associated with local inflammatory changes on ultrasound. The association of PRJP and ultrasound was limited. In the absence of tenderness, the presence of PD, tenosynovitis or erosions was uncommon. These findings may inform future studies evaluating symptom/sign-guided ultrasound assessment approaches in at-risk populations.

Trial registration number

NCT02012764.

The benefits and costs of domiciliary care: a study protocol for evaluating the cost-effectiveness of domiciliary care in England

Por: Vadean · F. · Mamolis · G. · Rand · S. · Gousia · K. · Teo · H. · Birch · S. · Alvarez Nishio · A. · Towers · A.-M. · Allan · S. · Darton · R. · Gregory · F. · Lambert · C. · Fenton · W. · Davison · S. · Roberts · A. · Nizalova · O.
Introduction

Care provided in people’s own homes (domiciliary care) is an increasingly important part of long-term care. There are various services, including home visits, live-in care and housing with care. Some people directly employ care staff, called personal assistants. Services vary in quality, price and availability, and there is currently little evidence of the value these services provide to the public purse and individuals. This study protocol presents planned research to fill this important gap.

Methods and analysis

This will be a cross-sectional study based on surveys of care recipients, their unpaid carers as well as formal care providers. In the first half of 2026, we will survey 1850 people accessing domiciliary care either through a homecare agency, a housing with care scheme or by directly employing personal assistants and 400 unpaid carers, all based in England. We will conduct a cost-effectiveness analysis taking a ‘production function’ approach and use quality of life as measured by the Adult Social Care Outcomes Toolkit as the main outcome of interest.

Ethics and dissemination

The study received ethical approval from the School of Social Sciences Staff Review Committee at the University of Kent on 20 May 2025 (reference 1195) and the Health Research Authority, London—Camberwell St Giles Research Ethics Committee on 28 October 2025 (reference 25/LO/0652). Implications around consent, data protection and confidentiality, risk and participant payment are discussed. In addition to academic outputs (eg, academic articles, conference presentations), we aim to coproduce news items and blogs with people with lived experience of accessing long-term care and jointly present findings at events aimed at the care sector. Moreover, we will offer participating care providers benchmarking briefs based on our findings.

Long‐Term Communicative Experiences of Tracheostomised Patients 1 Year After Hospital Discharge: A Mixed Methods Study

ABSTRACT

Objective

To explore the long-term communicative experiences of tracheostomised ICU survivors 12 months after discharge; to identify facilitators and barriers to communication with caregivers, family members, and healthcare professionals; to describe coping and communicative adaptation strategies; and to assess perceived quality of life and self-esteem.

Design

This is a qualitative-dominant mixed methods study based on a multicentre Italian sample.

Methods

Twenty-three adult patients from several Italian hospitals were interviewed using a semi-structured guide 12 months after discharge. Qualitative data were analysed using reflexive thematic analysis. Quantitative data were collected through the EQ-5D-5L, EQ-VAS, and Visual Analogue Self-Esteem Scale (VASES), and analysed using descriptive statistics to explore patterns of QoL and self-esteem.

Results

Four major themes emerged: (1) A body that speaks no more, reflecting the initial experience of voicelessness and emotional isolation; (2) Finding new ways to be heard, describing adaptive communicative strategies and the supportive role of family; (3) When the voice returns, so does life, highlighting the transformative meaning of regaining one's voice; and (4) Living differently, capturing long-term psychological and social adjustments. Quantitative data confirmed reduced self-esteem and QoL (mean EQ-5D index = 0.61; EQ-VAS = 58.4; VASES = 54.2). Integrated findings revealed that communication impairment remained a determinant of reduced well-being 1 year after discharge.

Conclusion

This is the first Italian study to investigate in depth the communicative trajectories of tracheostomised ICU survivors. Findings highlight the crucial role of voice recovery in emotional adjustment and quality of life, supporting the need for structured, multidisciplinary post-ICU follow-up focused on communication and psychosocial rehabilitation.

Implications for the Profession

These findings support health professionals in developing individualised post-ICU interventions to restore communication, improve QoL, and enhance social reintegration.

Reporting Method

COREQ checklist was followed.

Patient or Public Contribution

No patient or public contribution.

Randomised, sham-controlled, double-blinded, multicentre international trial to evaluate the efficacy of the Ventfree Respiratory Muscle Stimulator to assist ventilator weaning in critically ill patients: a study protocol of a randomised controlled trial

Por: McCaughey · E. J. · McLachlan · A. J. · Cai · J. · Cohen Freue · G. · Demoule · A. · Gotur · D. B. · Hill · N. S. · Dimatteo · C. · Oliva · S. P. · Patel · M. B. · Girard · T. D. · Heunks · L.
Introduction

Nearly half of patients who receive invasive mechanical ventilation for acute respiratory failure require over 4 days of ventilator support, each day of which is associated with increased morbidity, mortality and cost. Many of these patients develop expiratory muscle atrophy and weakness, which are linked to failed extubation and weaning. We seek to test the hypothesis that exhalation synchronised abdominal functional electrical stimulation reduces mechanical ventilation duration.

Methods and analysis

This pivotal superiority trial will be performed in up to 30 intensive care units (ICUs) in the USA, France, the Netherlands and Australia. Adults (≥22 years old) who have been mechanically ventilated for 24–96 hours and are expected to remain ventilated for another 24+ hours are potentially eligible. We will recruit participants until 150 successful liberations from mechanical ventilation occur. To achieve this, we estimate that a maximum of 272 participants will be randomised in a 1:1 ratio to receive 30 min of active exhalation synchronised abdominal functional electrical stimulation (vs sham). The intervention will be applied using the VentFree Respiratory Muscle Stimulator two times per day, a minimum of 5 days per week, for a maximum of 28 days or until ICU discharge. The primary outcome is time from first intervention to successful liberation from mechanical ventilation. Secondary outcomes include cough peak flow (CPF) and maximum expiratory pressure (MEP) at 24 hours post-extubation, hospital and ICU length of stay, reintubations, complications, ICU readmissions, 90-day mortality and quality of life. The participant, clinical team and outcome assessor are blinded to group allocation. A positive outcome has the potential to improve patient-centred outcomes in ICUs.

Ethics and dissemination

This study was approved by local ethics institutions in the USA, Australia, France and the Netherlands. We describe the methods herein using the Standard Protocol Items for Randomised Trials framework and discuss key design decisions. The results will be disseminated through peer-reviewed journal publications, conference presentations and clinicaltrials.gov updates. Individual country-level approvals are as follows:

France:

  • Ethics committee: Comité de Protection des Personnes Ile-de-France X.

  • Reference numbers: CPP 27-2024; RCB 2024-A00559-38.

  • Initial approval date: 14 May 2024.

  • Australia:

  • Ethics committee: South Eastern Sydney Local Health District Human Research Ethics Committee.

  • Reference number: 2022/ETH02724.

  • Initial approval date: 21 March 2023.

  • Netherlands:

  • Ethics committee: Medisch Ethische Toetsings Commissie Erasmus MC.

  • Reference numbers: MEC-2023-0364; NL84195.000.23.

  • Initial approval date: 30 April 2024.

  • USA:

  • Ethics committee: WCG IRB.

  • IRB tracking number: 20214073.

  • Initial approval date: 13 March 2023.

  • All participating sites are currently approved and operating under protocol version 09 or later.

    Trial registration number

    NCT05759013. Registered 8 March 2023.

    Challenging history taking encounters: a systematic review, meta-analysis and phenomenological framework

    Por: Hossain · S. · Murray · K. · Zhang · L. · Jassem · A. M. · Clarke · J. · Somers · J. · Dias · R. · Uridge · A. · Sharma · S. · Teodorczuk · A. · Keijzers · G. · McConnell · H. · Sun · J. · Amey · L. · Broadley · S. A.
    Objectives

    All physicians will experience challenging history taking encounters, where communication is impaired and negatively impacts the diagnostic process. The aims of this systematic review were to (1) undertake a meta-analysis of the frequency of challenging encounters; (2) collate adverse outcomes of challenging encounters; (3) identify underlying causes of challenging encounters; (4) identify strategies to deal with different challenges; and (5) align these strategies with our published phenomenological framework of history taking challenges.

    Design

    This was a systematic review and meta-analysis of prevalence data adhering to the Preferred Reporting Items for Systematic reviews and Meta-Analyses and the Meta-analyses of Observational Studies in Epidemiology guidelines.

    Data sources

    A literature search in MEDLINE, Embase and Cochrane databases was performed on 12 July 2020, and updated on 4 August 2025, focusing on challenging history taking encounters in any clinical setting.

    Eligibility criteria

    Articles reporting on the frequency, adverse outcomes, causative factors or strategies used to address challenges in the history taking process in any clinical area of medicine.

    Data extraction and synthesis

    Factors associated with challenging history encounters (causative or consequential) were categorised using inductive coding and referenced to a phenomenological framework. Meta-analysis was used to estimate the prevalence of history taking encounters using a restricted maximum likelihood model with 2 and I2 as tests for heterogeneity and funnel plot with Egger’s test for publication bias.

    Results

    73 articles were included in the analysis. The overall prevalence of challenging history taking encounters was 19.5% (95% CI 14.2% to 24.7%). Adverse outcomes of patient dissatisfaction (level 1 evidence) and diagnostic uncertainty (level 3 evidence) were identified. Factors associated with (n=22) and strategies to mitigate challenging encounters (n=13) were categorised. Correlation of factors and strategies with a phenomenological approach created a framework to assist novice history takers in approaching such circumstances.

    Conclusions

    Challenging history taking encounters are common. Little is known of the relative importance of factors associated with challenging history taking encounters or the impact of suggested strategies. Many of the suggested strategies to facilitate meaningful communication in these situations involve a departure from standard history taking. More research is required to better define the nature of challenges encountered in history taking with a view to develop better educational models for trainee physicians.

    Nurses' Experience of Redeployment to a New Intermediate Care Unit for Respiratory Patients: A Qualitative Study

    ABSTRACT

    Aim

    To explore the experiences of nurses transitioning from a clinical ward to a newly established respiratory intermediate care unit (IMCU).

    Design

    A qualitative descriptive approach was adopted to capture the lived experiences of redeployed nurses. This design was selected to address the research question: What are the initial experiences of nurses transitioning from general ward settings to a newly established IMCU for respiratory patients?

    Methods

    Two focus groups were conducted in June 2024, involving 14 purposefully selected registered nurses. Data were analysed using Braun and Clarke's thematic analysis framework, with the study reported in line with the Standards for Reporting Qualitative Research.

    Results

    The analysis revealed two interconnected themes reflecting the complexity of the redeployment experience. The first theme, ‘The introspection of waiting amidst change and readiness’, captures the emotional ambivalence nurses felt, characterised by anticipation, uncertainty and a perceived lack of preparedness. This phase was marked by concerns over clinical competence, fear of errors and the weight of new legal and ethical responsibilities. The second theme, ‘The road to organizational change with both driving forces and obstacles’, highlights nurses' concerns about physician readiness, feeling undervalued and limited involvement in planning. At the same time, nurses emphasised the importance of teamwork, structured preparation, experiential training and having the right equipment.

    Conclusion

    The study underscores the complexity of role transitions for nurses moving into semi-critical care settings like IMCUs. It reveals the need for targeted support strategies to reduce uncertainty and enhance role readiness.

    Implications for the Profession and Patient Care

    To improve the redeployment experience and patient outcomes, healthcare organisations should prioritise structured training, tailored preceptorship programmes and inclusive decision-making processes. These measures can strengthen nurses' resilience, support workforce sustainability and ensure the delivery of high-quality, patient-centred care in intermediate care environments.

    Impact

    This study highlights the significant impact of inadequate preparation and communication on redeployed nurses' experiences in respiratory IMCUs, emphasising the need for structured training and supportive team dynamics. These findings can guide healthcare leaders, nurse managers and policymakers in developing evidence-based redeployment strategies that reduce anxiety, strengthen team cohesion and ultimately improve nurse adaptation and patient care in semi-critical settings.

    Reporting Method

    We used the SRQR guidelines for reporting qualitative studies.

    Patient or Public Contribution

    No patient or public contribution.

    Machine learning for medication error detection: a scoping review protocol

    Por: Heche · F. · Yazdani · A. · Ferdowsi · S. · Kabak · R. · Mu · G. · Teodoro · D.
    Introduction

    Medication errors pose a significant threat to public health. Despite efforts by health agencies and the implementation of various interventions, such as staff training, medication reconciliation and automation, the persistence of these incidents highlights the need for more effective, scalable solutions. In recent years, machine learning (ML) has emerged as a promising approach in healthcare, offering potential to detect and predict medication errors through data-driven insights. This scoping review aims to systematically map the existing literature on ML-based approaches to predict or detect medication errors across all stages of the medication use process. The review seeks to identify the range of ML applications in this domain, characterise methodological trends and highlight current knowledge gaps. The findings will provide a structured and accessible overview for both clinicians and researchers, supporting the development of safer, more data-informed medication practices.

    Methods and analysis

    The review will be conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guideline. Structured searches will be performed in PubMed, Embase and Web of Science, covering publications from 1 January 2015 to 28 April 2025. Predefined inclusion and exclusion criteria will be used to identify eligible studies. Key information—including ML models, data sources and type, evaluation methods and clinical contexts—will be extracted and analysed using descriptive statistics, visualisations, thematic analysis and narrative synthesis.

    Ethics and dissemination

    This study involves a review of existing literature and does not involve human participants, personal data or unpublished secondary data. As such, ethical approval was not required. All data analysed were obtained from publicly available sources. Findings of the scoping review will be disseminated through professional networks, conference presentations and publications in scientific journals.

    Trial registration number

    This protocol has been registered on the Open Science Framework (https://doi.org/10.17605/OSF.IO/38SFY).

    Care Needs for Patients Screened Positive for Cognitive Impairment and Delirium: A Cross‐Sectional Observational Study

    ABSTRACT

    Aim

    To describe the point prevalence of cognitive impairment in hospitalised adults and evaluate the association with care needs and perceived risks of complications.

    Design

    Multi-site cross-sectional study on a single day in May 2023.

    Methods

    Trained clinician auditors screened adult inpatients in acute medical, surgical, oncology, geriatric, mental health, convalescent, and rehabilitation wards for cognitive impairment using the 4AT in seven healthcare facilities and recorded need for support with basic activities of daily living, incontinence, and perceived risks of complications (falls, pressure injuries, and malnutrition). Data were summarised and compared across 4AT categories, and the strength of association between 4AT and each outcome was estimated using multivariable regression models.

    Results

    Data were available for 1145 inpatients on 68 wards (mean age 68 years [SD = 18], 583 [58.9%] female, 449 [39.2%] on acute medical units). Cognitive impairment (4AT of 1 or more) was identified in 482 (42.1%) participants. Participants with 4AT 1–3 had 2.0–3.6 times the odds of need for supervision or assistance with activities of daily living, while those with 4AT 4 or more had 2.9–5.3 times the odds of need for assistance.

    Conclusion

    Cognitive impairment is very common in adult inpatients and is associated with significantly higher physical care needs.

    Implications for the Profession and Patient Care

    Hospital care models must support staff to address the higher care needs in people with cognitive impairment to protect a large patient group from hospital-acquired harm.

    Patient or Public Contribution

    No patient or public contribution.

    Reporting Method

    This study adheres to the STROBE reporting guidelines.

    Epidemiological investigation of perinatal depression among pregnant and postpartum women: findings from a cross-sectional survey in the Philippines

    Por: Filoteo · J. A. · Maravilla · J. C. · Mamaat · J. E. · Flores · A. D. · Jumamil · A. N. · Cardenas · R. L. · Quijencio · W. · Bayani · M. A. · Santos · N. · Acena · J. L. · Alfonso · A. L. · Rivera · M. · Guarino · R. · Sarmiento · R. · Flenady · V. · Boyle · F. M. · Loughnan · S. A. · T
    Objective

    This study investigated perinatal depressive symptoms among pregnant and postpartum Filipino women.

    Design

    Cross-sectional survey.

    Setting

    The Philippines.

    Participants

    Participants were recruited online and face-to-face from maternal care facilities.

    Primary outcome measure

    Perinatal depressive symptoms were assessed using the Edinburgh Postnatal Depression Scale (EPDS) score, with prevalence calculated based on ≥13 cut-off, indicating clinically significant symptoms of depression. Patterns of depressive symptoms were examined by demographics, perinatal time period and other obstetric information using adjusted regression coefficients (ab) and risk ratios (aRR).

    Results

    A total of 856 women participated in the study, comprising 356 pregnant and 500 postpartum women. EPDS scores were, on average, similar between pregnant (14.4) and postpartum women (14.1). Using the locally validated cut-off of ≥13 revealed that 69.1% of pregnant and 62.0% of postpartum women reported clinically significant depressive symptoms. Consistent EPDS scores and prevalence were observed across pregnancy trimesters and within 12 months postpartum and beyond. Women who received adequate prenatal care were less likely to experience antenatal (ab=–1.59, 95% CI –3.13 to –0.05) and postpartum (ab=–1.30, 95% CI –2.48 to –0.12) depressive symptoms. Postpartum EPDS scores and depressive symptom prevalence (EPDS score ≥13) were higher among 18–24-year olds (ab=1.96, 95% CI 0.30 to 3.61; aRR=1.23, 95% CI 1.03 to 1.47) and single mothers (ab=3.46, 95% CI 0.22 to 6.71; aRR=1.42, 95% CI 1.07 to 1.90), compared with older and married mothers, respectively.

    Conclusions

    At least 60% Filipino mothers experienced clinically significant perinatal depressive symptoms, which exceeds the established global average of 25%. Younger and single postpartum women were at greater risk, while pregnant and postpartum women who attended adequate prenatal visits were less likely to report depressive symptoms. Our study underscores the need for further research to uncover the true burden of poor perinatal mental health and calls for targeted early interventions and integrative public health strategies to support at-risk mothers, particularly those from socially disadvantaged backgrounds.

    Mutuality and Self‐Care in the Patient–Caregiver Dyads in the Context of Coronary Heart Disease: An Exploration of the Mediating Role of Self‐Efficacy

    ABSTRACT

    Aims

    To evaluate the effect of mutuality on self-care in people with CHD and the contribution of their caregivers, and whether such relationships can be mediated by self-efficacy.

    Design

    Secondary analysis of baseline data from a multi-centre longitudinal study.

    Methods

    Patients at the onset of coronary artery disease who underwent angioplasty, along with their caregivers, were included in the sample. Data from 136 patients and 136 caregivers were used for the analysis. Mutuality between patients and caregivers was measured using the Mutuality Scale. Self-care was measured using the Self-Care of Coronary Heart Disease Index and the Caregiver Contribution to Self-Care of Coronary Heart Disease Index. The actor–partner interdependence mediation models were used to assess the mediating role of self-efficacy for self-care between perceived mutuality and self-care behaviours.

    Results

    An actor indirect effect was found between patient mutuality and their self-care maintenance, self-care monitoring, and self-care management, through the mediation of their self-efficacy. Caregiver mutuality had a positive indirect effect on their contribution to self-care maintenance, self-care monitoring, and self-care management, through the mediation of their self-efficacy. Caregiver mutuality had a positive indirect effect on patient self-care maintenance and on patient self-care monitoring, through the mediation of patient self-efficacy. All models demonstrated satisfactory fit to the data.

    Conclusions

    Mutuality between patients and caregivers enhances self-care behaviours in patients with coronary heart disease, and self-efficacy is a crucial mediator in this relationship. Interventions targeting both mutuality and self-efficacy within patient–caregiver dyads may improve self-care outcomes.

    Reporting Method

    We adhered to STROBE guidelines.

    Patient or Public Contribution

    Patients and members of the public were not involved in the design, conduct, reporting, or dissemination plans of this research.

    Stress and Health‐Related Quality of Life in Adults With Type 1 Diabetes: The Mediating Role of Perceived Support and Treatment Adherence

    ABSTRACT

    Aims

    To examine the associations among diabetes-related stress, treatment adherence, perceived social support, and health-related quality of life (HRQoL) in adults with type 1 diabetes mellitus (DM1), and to explore the mediating roles of support and adherence in this relationship.

    Design

    A cross-sectional observational study using self-report standardised measures and mediation analysis.

    Methods

    A total of 772 Spanish adults with DM1 completed validated instruments measuring diabetes-related distress, perceived social support, treatment adherence, and HRQoL. Hierarchical multiple regression and serial mediation analysis (PROCESS Model 6, 10,000 bootstraps) were conducted, controlling for age, sex, and time since diagnosis.

    Data Sources

    Not applicable (primary data collection, not a review).

    Results

    Diabetes-related stress was the strongest predictor of lower HRQoL. Perceived social support and treatment adherence also contributed significantly. Mediation analyses indicated that the impact of stress on HRQoL was partially mediated by perceived social support and, in sequence, by treatment adherence. The indirect path through social support alone and the sequential path involving both mediators were significant.

    Conclusion

    Stress and social support are critical in understanding and improving HRQoL in adults with DM1. Treatment adherence appears to be influenced by perceived support, highlighting an indirect mechanism linking stress to quality of life.

    Implications for the Profession and/or Patient Care

    Healthcare professionals should integrate psychosocial assessments and interventions into routine diabetes care. Targeting stress reduction and enhancing social support may improve adherence and overall well-being in adults with DM1.

    Impact

    What problem did the study address? The study addressed the need to understand how psychosocial factors—specifically stress, perceived social support, and treatment adherence—contribute to HRQoL in adults with DM1. While prior research often focused on paediatric or clinical populations and rarely explored mediation models, this study sought to fill those gaps with data from a large community sample of adults.

    What were the main findings? The main findings indicate that diabetes-related stress is the most significant predictor of reduced HRQoL. This relationship is partially mediated by perceived social support and, sequentially, by treatment adherence. While stress directly affects HRQoL, its negative impact is also channelled through diminished social support and decreased adherence. The indirect effect through treatment adherence alone was not significant.

    Where and on whom will the research have an impact? The research has implications for adults living with DM1, particularly those in community settings outside of clinical supervision. It informs healthcare providers, diabetes educators, and policymakers on the importance of addressing emotional distress and strengthening support networks to improve both treatment adherence and overall quality of life.

    Reporting Method

    This study adhered to the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) guidelines for cross-sectional studies. All methods and results are reported in alignment with EQUATOR Network recommendations for transparent and rigorous research reporting.

    Patient or Public Contribution

    The study was conducted in collaboration with the Spanish Diabetes Federation (FEDE), which supported participant recruitment and dissemination through its affiliated associations. Patient input was incorporated throughout the study. A person with lived experience of type 1 diabetes contributed to the conceptual development of the research questions and the interpretation of findings. Their perspective helped ensure that the study design, choice of measures, and implications were relevant and meaningful to people living with the condition. This involvement supported a patient-centred approach to both the research and the manuscript preparation. Patients' participation as voluntary contributors was essential to the data collection process.

    Validation of a Trained AI Imaging Model for Detecting Diabetic Foot Deformities

    ABSTRACT

    Diabetes is a leading cause of morbidity and mortality, contributing to complications such as cardiovascular disease, kidney failure and lower-limb amputations. Diabetic foot complications, such as structural deformities, ulceration and infection, present significant risks, necessitating early detection and intervention. This study explores the development and validation of artificial intelligence (AI) image analysis for diabetic foot screening, focusing on structural deformity identification which includes callus, hallux valgus and hammer toes, because they represent the earliest detectable visual risk markers for ulceration, preceding wound formation. Leveraging datasets comprising over 1000 healthy foot images and 215 diabetic foot deformity images, the model employed YOLOv5 for object detection, a convolutional autoencoder for anomaly detection, and DenseNet201 for anomaly classification. Initial internal validation yielded 91.1% anomaly detection accuracy, while anomaly classification accuracy improved to 88.57% following refinement. External validation using 27 participants achieved an overall accuracy of 85.2% and anomaly classification accuracy of 66.7%. Final evaluation on 35 unlabelled images demonstrated promising performance, with 88.57% accuracy, 90.47% precision and an F1 score of 86.11%. Integrated into the ‘Foot at Risk’ (FAR) mobile application, this AI-driven solution offers a scalable tool for early diabetic foot deformity detection. With larger dataset input for training and development, it can be utilised as an early screening tool for diabetic foot and integrated into existing community diabetic care model, facilitating timely intervention and improving patient outcomes.

    Age-dependent patterns of cardiac complexity unveiled by topological data analysis of pediatric heart rate variability

    by Andy Domínguez-Monterroza, Alfonso Mateos Caballero, Antonio Jiménez-Martín

    Heart rate variability (HRV) is a well-established marker of autonomic regulation and undergoes profound maturation during early human development. In this study, topological data analysis (TDA) is applied to investigate the evolving geometric complexity of HRV across pediatric developmental stages. Using persistent homology in homological dimension 1, we extracted topological descriptors from time-delay embedded RR interval series of 127 individuals aged 1 month to 17 years. We identified statistically significant, age-dependent transformations in the topological structure of HRV signals. Neonates and infants exhibited a greater number and strength of persistent features, reflecting highly heterogeneous cardiac control dynamics during early autonomic maturation. In contrast, adolescents displayed reduced topological complexity and increased entropy, suggesting a shift toward more uniform and structured physiological control. Topological measures correlated with conventional HRV indices, confirming their physiological relevance. Furthermore, pairwise distances between persistence landscapes revealed an inverse relationship between intra-group topological variability and classical HRV measures. Collectively, our findings demonstrate that persistent homology provides a powerful, multiscale-aware framework to capture developmental trajectories in cardiac autonomic regulation, with potential applications in pediatric monitoring, developmental physiology, and early detection of dysautonomia.

    Development of a practical guide for patient participation in value-based healthcare: an action research study

    Objectives

    Value-based healthcare (VBHC) strives to improve the healthcare system by focusing on value of care, that is, patient relevant outcomes relative to the costs for achieving these outcomes. Within VBHC, patient participation is crucial to identify patient relevant outcomes and value improvement potential. However, patient participation in VBHC initiatives remains limited. Therefore, we aimed to improve patient participation within VBHC teams with the ultimate aim to develop a practical guide for patient participation in VBHC.

    Design

    An action research study.

    Setting

    This study was conducted in seven collaborating Dutch hospitals from March 2023 to November 2024.

    Participants

    Seven VBHC teams were selected to participate in the cyclical action research steps, that is, orientation, planning, implementation, and evaluation, in which patient participation was implemented or improved. These included the following patient groups: prostate cancer, vulnerable elderly, breast cancer, diabetes, maternity care, colorectal cancer and chronic kidney disease.

    Outcomes

    Both qualitative and quantitative data were collected. Qualitative data included observations and minutes of meetings with the intervention teams. Quantitative data included responses to the Public and Patient Engagement Evaluation Tool (PPEET) by multiple members of the intervention (n=7) and control teams (n=94) at three time points (T1=6 months, T2=12 months, T3=end of study). Qualitative data were thematically analysed and quantitative data were analysed descriptively. Finally, the data were triangulated to create an overview of lessons learnt in improving patient participation.

    Results

    Patient participation goals varied across teams, leading to diverse actions, such as establishing a diabetes patient panel and distributing questionnaires to patients with colorectal cancer. PPEET results show that 71% of intervention team members reported that patient participation had an impact on the team’s outcomes compared with 44% in control teams (T3). Furthermore, 80% of the intervention team members initially wanted training in patient participation (T1), which dropped to 29% at T3. Overall, 22 lessons in improving patient participation in multidisciplinary project teams were identified and compiled into a practical guide.

    Conclusions

    The action research process improved the process and impact of patient participation in the intervention teams. Furthermore, the results indicate that the action research process enhanced the team members’ knowledge and skills on patient participation. The practical guide developed in this study can be used to support implementation of patient participation in VBHC.

    A Qualitative Study of Follow‐Up Needs in Patients With Diabetic Foot Ulcers Based on the Biopsychosocial Model

    ABSTRACT

    Aim

    The aim of this study was to explore the follow-up needs of patients with diabetic foot ulcers.

    Design

    A qualitative descriptive study was conducted, guided by Engel's biopsychosocial model.

    Methods

    Purposive sampling was used to recruit 17 patients with diabetic foot ulcers of Wagner grade ≥ 1. These patients had received care in the Endocrinology and Metabolism Department or the Wound Clinic of a tertiary hospital in Xi'an, China. Guided by the biopsychosocial model, individual face-to-face semi-structured interviews were conducted between April and July 2024. Data were analysed using thematic analysis.

    Results

    Nine themes were identified. In the biological domain, patients reported needs for disease care and lifestyle modification. In the psychological domain, they highlighted the importance of emotional coping support and building trust with healthcare providers. In the social domain, patients expressed needs for personalised follow-up, equitable access to healthcare, financial support, community assistance, and management of family caregiving role conflicts.

    Conclusions

    This study identified biological, psychological, and social follow-up needs among patients with diabetic foot ulcers, highlighting the importance of holistic follow-up to promote recovery and improve quality of life after discharge.

    Implications for the Profession

    Nurses should assess and address the biological, psychological, and social follow-up needs of patients with diabetic foot ulcers after discharge, providing tailored care to promote ulcer healing and prevent recurrence.

    Reporting Methods

    This study was reported in accordance with the Consolidated Criteria for Reporting Qualitative Research checklist.

    Patient or Public Contribution

    None.

    Synchronous remote-based interventions for suicidal behaviour prevention: a systematic review and meta-analyses of clinical trials

    Por: Comendador · L. · Jimenez Villamizar · M. P. · Losilla · J.-M. · Sanabria-Mazo · J. P. · Mateo Canedo · C. · Sanz · A. · Cebria · A. I. · Palao · D.
    Objectives

    Suicide is a leading cause of preventable death worldwide. Evidence supports the impact of providing active contact for individuals who have attempted suicide. The current systematic review and meta-analyses aim to investigate the effects of suicide prevention strategies implemented through remote and synchronous technology-based interventions.

    Design

    Systematic review, narrative synthesis and meta-analysis.

    Data sources

    Electronic databases (PubMed, PsycINFO, Scopus and Web of Science) and grey literature sources (ClinicalTrials.gov and Google Scholar) were searched until December 2024.

    Eligibility criteria

    Eligible articles assessed suicide prevention interventions for participants over 12 years with prior suicidal behaviour. Eligible study designs included randomised controlled trials and non-randomised clinical trials published in English or Spanish.

    Data extraction and synthesis

    Screening, selection process, data extraction and risk of bias assessment were performed independently by two reviewers. Data on suicide-related factors and adherence to treatment were extracted. Meta-analyses were conducted to determine effect sizes (Hedges’ g) for suicidal ideation, risk ratios (RR) for suicide attempts and Peto odds ratios (OR) for suicide. Heterogeneity was assessed using the Cochrane’s Q test, tau2 statistic and I2 value. Publication bias was investigated employing funnel plots and Egger’s test.

    Results

    A total of 28 studies, comprising 10 015 participants in the intervention group and 10 726 in the comparison group, were included in the systematic review and meta-analyses. Synchronous remote-based interventions were effective in preventing repeated suicide attempts at 1 month (RR 0.73, 95% CI 0.62 to 0.85, I2=0.0%, Q=0.70, tau2=0.00), 6 months (RR 0.56, 95% CI 0.34 to 0.95, I2=85.4%, Q=54.92, tau2=0.36) and 12 months (RR 0.68, 95% CI 0.49 to 0.96, I2=87.6%, Q=72.63, tau2=0.27). Additionally, these interventions were associated with a reduction in suicide-related deaths at 18 months (Peto OR 0.18, 95% CI 0.08 to 0.44, I2=0.0%, Q=0.03, tau2=0.00). Effects on suicidal ideation were not statistically significant at any time point (Hedges’ g –0.07 to –0.28, I2=0.0 to 69.3%, Q=1.16 to 7.38, tau2=0.00 to 0.14).

    Conclusions

    Synchronous remote-based interventions demonstrate a potential benefit in preventing suicide attempts and deaths by suicide and may serve as an adjunct to usual treatment; however, the effect on suicidal ideation appears limited. The observed heterogeneity warrants caution when interpreting these findings. Future research should prioritise methodological enhancements to improve the quality and consistency of evidence, as well as investigate the mediating processes underlying their effectiveness in reducing suicidal behaviour.

    PROSPERO registration number

    CRD42021275044.

    Synthesising evidence regarding artificial intelligence-generated radiological reports based on medical images: a scoping review protocol

    Por: Feng · W. · Yazdani · A. · Bornet · A. · Platon · A. · Teodoro · D.
    Introduction

    The increasing volume of radiological images and the associated workload of report generation necessitate efficient solutions, making artificial intelligence (AI) a crucial tool to streamline this process for radiologists. Recent years have seen a surge in research exploring AI-driven radiological report generation directly from images, particularly with the emergence of large vision language models. However, a comprehensive understanding of the current landscape, including specific limitations and the extent to which efforts move beyond abnormality detection to full textual report generation, remains unclear. This scoping review aims to systematically map the existing literature to provide an overview of the current state of AI in generating radiological reports from medical images, including the scope and limitations of existing research. To our knowledge, no prior scoping review has comprehensively mapped this landscape, especially considering recent advancements in foundation models in medicine and related AI architectures. Considering the explosive growth of related studies in recent years, a comprehensive scoping review will be significant in mapping the current research status and understanding relevant limitations.

    Methods and analysis

    This scoping review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for Scoping Reviews guidelines to map the literature on AI generating radiological reports from medical images. We will search PubMed, Scopus and Web of Science for peer-reviewed articles (January 2016 to March 2025) using keywords related to AI, radiological reports and medical images. Original research in English focusing on AI-driven report generation from images will be included and studies without report generation or not using medical images as input will be excluded. Two independent reviewers will perform a two-stage screening. Data extraction, guided by the Critical Appraisal and Data Extraction for Systematic Reviews of Prediction Modelling Studies checklist and focusing on study characteristics, AI methods, image modalities, report features, limitations and key findings, will be analysed using narrative and descriptive synthesis, with results presented in tables, figures and a narrative summary.

    Ethics and dissemination

    This protocol describes a scoping literature review methodology that does not involve research on humans, animals or their data; therefore, no ethical approval is required. Following the review, the results will be considered for publication in a relevant peer-reviewed journal and may be shared with stakeholders through reports or summaries.

    Development and evaluation of the first fertility preservation patient decision aid to support boys and young men with cancer: The Cancer, Fertility and Me for Boys and Young Men research protocol.

    Por: Jones · G. L. · Musson · D. S. · ODonnell · N. · Lewis · A. · Williamson · M. · Yeomanson · D. · Pacey · A. · Lane · S. · Folan · A.-M. · Gough · B. · Phillips · B. · Porteous · C. · Anderson · R. · Mitchell · R. T.
    Introduction

    Many cancer treatments can result in reduced fertility, impacting survivors’ opportunities for biological parenthood. Fertility preservation (FP) methods for boys and young men, such as cryopreservation of testicular tissue or sperm, offer hope but are currently underused among young male patients with cancer. Despite guidelines recommending early discussion of fertility implications, many newly diagnosed males do not receive FP counselling or referral to fertility services. Male cancer survivors face a higher likelihood of infertility than their peers, yet focused FP decision-making support is lacking. This study aims to address this gap by developing and evaluating the first dedicated patient decision aid (PtDA) for boys and young male patients with cancer aged 11–25 years old, to help them make informed FP decisions before receiving cancer treatment.

    Methods and analysis

    The current study follows a multistage process: developing the PtDA, alpha testing for acceptability with former patients, parents and healthcare professionals, and beta testing in clinical settings to ensure effective integration into routine care. Using a combination of interviews and questionnaire data, this research will assess the PtDA’s acceptability and impact on decision-making.

    Ethics and dissemination

    This study has been prospectively registered on the Research Registry (10273). Ethics approval has been obtained from Leeds Beckett University and the National Health Service/Health Research Authority before undertaking data collection. The final resource will be disseminated widely and made freely available online via our dedicated Cancer, Fertility and Me website, for use in clinical and research practice.

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