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Understanding factors influencing HPV vaccine uptake among caregivers in Kwara State, Nigeria: A qualitative study

by Abdulmujeeb Opeyemi Muhammad-Olodo, Laura Asher

Introduction

Human papillomavirus (HPV) vaccine prevents over 90% of cervical cancers. In October 2023, Nigeria launched a free HPV vaccination campaign targeting girls aged 9–14 years. Despite removing cost barriers, misinformation about fertility impacts and population control contributed to variable uptake across states. Understanding caregiver decision-making is crucial for improving coverage. This study aimed to explore factors influencing caregivers’ HPV vaccination decisions during Nigeria’s 2023 campaign in Ilorin East Local Government Area, Kwara State.

Methods

A qualitative study using focus group discussions (FGDs) was conducted using purposive and snowball sampling. We recruited 41 caregivers (mean age 47 years; 71% female) of eligible girls from urban and rural communities. Five FGDs were conducted: four with vaccine acceptors (n = 35) and one with decliners (n = 6). Discussions were conducted in Yoruba, audio-recorded, transcribed verbatim, and analysed using Braun and Clarke’s reflexive thematic analysis. Ethical approval was obtained from two institutional review boards.

Results

Four themes emerged from the analysis. Trust operated at multiple levels: institutional (government programmes), interpersonal (healthcare worker competence), and community (religious/traditional leader endorsement). Historical medical mistrust, intensified by COVID-19 experiences, may have manifested as fertility and population control fears. Personal cancer experiences strongly motivated acceptance, whilst concerns about childhood sexuality influenced timing preferences. Despite free provision, barriers included geographic inequities (remote Fulani-Hausa communities were excluded), language barriers (no Hausa translators), school-based delivery gaps, and indirect costs (transport, time). Caregivers recommended house-to-house campaigns, multilingual services, traditional leader engagement, and permanent vaccination centres.

Conclusion

Free vaccine provision is necessary but not sufficient to ensure uptake. Successful HPV vaccination requires rebuilding trust through community engagement, addressing historical medical exploitation concerns, and ensuring equitable access. Integrating these findings into Nigeria’s National Programme on Immunisation could improve coverage from current estimates of 54% to targeted 90%, protecting more girls from cervical cancer whilst respecting community values.

A scoping review of computational models of the diabetic foot

by Yufeng Li, Athia Haron, Chaofan Lin, Yuan Tang, Andrew Weightman, Glen Cooper

The prevalence of diabetes is expected to be 650 million people by 2030, and diabetic foot ulceration (DFU) is one of its most severe complications. It poses a significant challenge to global health and brings substantial social and economic burdens. Although many studies have explored the mechanisms of DFU development, they are still not fully understood. Due to the high cost of the experimental research, many recent studies have employed the computational modelling approaches to simulate the effects of diabetes on foot tissues from mechanical, thermal, fluid, and cellular perspectives. This study aims to provide a comprehensive review of computational modelling approaches used to investigate various factors influencing DFU, discuss current knowledge gaps and limitations, and outline future research directions. A systematic search was conducted in Web of Science, Scopus, and PubMed databases, identifying a total of N = 1631 records up to March 2025, 31 of which studies met the inclusion criteria and were analysed in this study. Results showed that DFU-related computational models can be categorized into five types: mechanical stress models, thermal models, vascular and nerve system models, multiphysics models, and cellular-based models. These models explore the formation mechanisms of DFU from different perspectives, including biomechanics, temperature, fluid dynamics, HHμm neural signalling, and cellular responses. However, except for mechanical stress models, the other approaches remain in the early stages of development, and the single physics modelling strategies are unable to provide understanding on the coupled processes with the foot and their effect on DFU. Future research should further develop modelling approaches and couple these together to develop comprehensive understanding of DFU pathogenesis.

Association of 24-hour movement guideline adherence with mental health symptoms among Colombian university students: a cross-sectional study

Objective

This study aimed to determine the associations between adherence to the 24-hour movement guidelines and symptoms of anxiety and depression among Colombian university students.

Study design

Cross-sectional study.

Participants

1125 individuals (mean age 20.2±2.5 years; 56.7% female).

Setting

Students sampled from a single public university.

Primary and secondary outcome measures

Participants completed validated self-report instruments: the International Physical Activity Questionnaire-Short Form to assess physical activity (PA), sedentary behaviour (SB) and the Pittsburgh Sleep Quality Index to assess sleep duration. Symptoms of depression and anxiety were measured using the Hospital Anxiety and Depression Scale, with a score of ≥11 used to classify elevated symptoms. Binary logistic regression models were used to estimate associations between adherence to the 24-hour movement guidelines (meeting all three, two, one or none) and mental health outcomes, adjusting for potential confounders.

Results

Only 15.5% of students met all three components of the 24-hour movement guidelines. Meeting a greater number of components was significantly associated with lower odds of depressive and anxiety symptoms. In fully adjusted analyses, students who met all three guidelines were less likely to report anxiety symptoms (OR=0.26; 95%CI 0.13 to 0.54) and depressive symptoms (OR=0.42; 95%CI 0.22 to 0.79) compared with those who met none. Among individual behaviours, sufficient PA and adequate sleep were independently associated with lower odds of both outcomes, whereas high SB was associated with higher odds of elevated symptoms.

Conclusions

In this cross-sectional study, adherence to a greater number of 24-hour movement guideline components was associated with lower levels of anxiety and depressive symptoms in a graded manner. However, the cross-sectional design precludes inference regarding directionality or causality, and bidirectional associations or residual confounding remain possible. Longitudinal and interventional studies are needed to determine whether integrated daily movement behaviours influence mental health outcomes in young adults, particularly in Latin American populations.

Assessing the Impact of Crohn's Disease on Foot Health‐Related Quality of Life: A Case–Control Study

ABSTRACT

Crohn's disease (CD) is primarily characterised by chronic gastrointestinal inflammation; however, its systemic nature frequently leads to musculoskeletal complications. Among these, clinically significant foot pathologies can impair mobility and negatively impact patients' overall quality of life. Despite their relevance, the specific influence of podiatric manifestations on health-related quality of life in individuals with CD remains insufficiently explored, underscoring a critical gap in current disease management. The aim of this study was to assess the extent to which foot-related health issues affect the quality of life in people living with CD compared with a healthy population. This multicenter observational case–control study was conducted across five provinces in southern Spain—Málaga, Granada, Jaén, Sevilla, and Cádiz—between January 2024 and February 2025. The study included 110 participants, evenly divided between individuals diagnosed with CD (n = 55) and healthy controls (n = 55), matched for age, sex, and body mass index. All participants completed the validated Spanish version of the Foot Health Status Questionnaire (SFHSQ), which assesses four foot-specific domains and four general health domains. Due to the non-normal distribution of the data, non-parametric statistical methods were applied, with the Mann–Whitney U test used to evaluate differences between groups. Participants with CD exhibited significantly lower scores across all domains of the SFHSQ, with the exception of the Footwear domain, which showed no statistically significant difference (p = 0.406). Compared with healthy controls, individuals in the CD group reported greater impairments in foot pain, foot function, general foot health, and in broader health-related domains including general health, physical activity, and social capacity (p < 0.01 for all). CD significantly compromises foot-related QoL. These results highlight the need to include podiatric evaluations as part of comprehensive, multidisciplinary care approaches aimed at enhancing mobility, functional capacity, and general well-being in affected individuals.

Validation of a Clinical Decision‐Support Algorithm for Chronic Wound Classification and Treatment: An Expert Consensus

ABSTRACT

Accurate chronic wound classification is essential for appropriate management, yet diagnostic variability persists in routine practice. Transparent, rule-based decision-support tools may improve standardisation but require validation against expert judgement under clearly defined conditions. To evaluate inter-expert agreement, agreement between a rule-based algorithm and an expert-consensus reference standard, diagnostic accuracy as a complementary measure, exploratory comparison with a non-expert nurse, and expert agreement with algorithm-generated therapeutic recommendations. Thirty anonymised standardised clinical cases were classified by the algorithm and one non-expert nurse. Thirty wound-care experts, including 26 nurses, three physicians, and one researcher, were organised into six independent panels of five and classified case subsets, yielding 150 ratings. A consensus reference diagnosis was defined a priori as agreement by at least 3/5 experts. The primary outcome was algorithm–consensus agreement using Cohen's κ. Expert reliability was assessed using Krippendorff's α and Fleiss' κ. Recommendation agreement was dichotomised and analysed exploratorily. Expert agreement was low to moderate (Krippendorff's α = 0.26–0.60), highest for pressure ulcers/injuries and venous leg ulcers, and lowest for mixed or unknown leg ulcers and diabetic foot ulcers. Consensus was reached in 29 of 30 cases. The algorithm achieved 86.2% accuracy (25/29) and substantial agreement (κ = 0.70, 95% CI 0.46–0.94). Nurse accuracy was 72.4% (21/29, p = 0.219). Experts endorsed 85.2% of therapeutic recommendations. The algorithm showed promising agreement under controlled conditions, supporting further prospective validation in larger, balanced real-world datasets.

High Adherence to Remote Monitoring Technology in Patients at Risk for Diabetic Foot Ulcer

ABSTRACT

Globally, a lower-extremity amputation occurs every 20 s as a complication of a diabetic foot ulcer, underscoring the urgent need for effective preventive strategies. Previous studies have shown that temperature-based foot monitoring can reduce both the incidence and severity of diabetic foot ulcers. However, real-world adherence data for remote temperature monitoring remain limited, particularly in diverse or resource-constrained communities. We conducted a pilot implementation study of 20 adults with diabetes and a history of diabetic foot ulcers to assess adherence to a remote foot temperature monitoring mat within the context of receiving podiatric care. Participants are instructed to stand on the mat for 20 s daily, and data are transmitted wirelessly for remote monitoring. Adherence was defined as use of the mat at least four times a week. Participants demonstrated high adherence to the foot monitoring mat, averaging 6 scans per week, with sustained adherence over the 6-month study period. These findings suggest that high-risk patients with diabetes can reliably engage with the foot temperature monitoring technology, supporting its potential as a management tool to improve outcomes and reduce the burden of diabetic foot ulcer-related complications in high-risk, resource constrained patient populations.

How and why digital information interventions support patients and carers during hospital-to-home transitions: a protocol for a realist systematic review

Por: Stepanova · E. · Cooper · M. · Lawson · L. · Harris · V. · Rance · A. · Husband · A. · Lorencatto · F. · Tovey · W. · Crayton · E. · Tolley · C. L. · Wong · G. · Nazar · H.
Introduction

The transition from hospital to home is a vulnerable stage in the patient pathway. Patients and carers often report unmet information needs regarding diagnoses, medication changes, follow-up arrangements and escalation pathways during the post-hospital discharge period. Digital information interventions—such as electronic health records, patient portals or remote communication systems—have been proposed to improve discharge pathways. However, evidence on their impact is unproven. The aim of this review is to understand what works for whom, how, why and in what circumstances in relation to digital information interventions during the hospital-to-home journey.

Methods and analysis

Pawson’s realist review approach will be used. The Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols and Realist and Meta-narrative Evidence Syntheses: Evolving Standards quality and reporting standards will also be followed. The review will follow five steps: (1) Development of the initial programme theory; (2) evidence search; (3) selection and appraisal of data; (4) extraction and organisation of data and (5) data synthesis and analysis. The search will be conducted in MEDLINE (Ovid); Embase; PsycINFO; Web of Science and Cochrane Library and supplemented with citation tracking, grey literature, relevant organisational websites, programme evaluation reports and through consultation with stakeholders. The realist review will be an iterative process, and the initial realist programme theory will be tested (confirmed, refuted or refined) in response to the data searches and stakeholder discussions. Patient and public involvement and engagement will be embedded throughout the review. Patients, carers and health and care stakeholders will contribute to refining the initial programme theory, interpreting emerging programme theory and co-developing dissemination outputs to ensure findings remain grounded in lived realities.

Ethics and dissemination

Ethical approval is not required for this review as it involves secondary analysis of published literature. The review will be conducted in accordance with principles of research integrity, transparency and responsible stakeholder involvement. Findings will inform the co-design of future digital discharge interventions and contribute to national priorities around digital transformation, safety and equity in transitional care. Dissemination will include conference presentations, a peer-reviewed journal article and accessible summaries co-developed with stakeholders to support equitable implementation and impact.

Scoping review of e-cigarette use in the perioperative setting: a protocol

Por: Harrogate · S. R. · Livingstone-Banks · J. · Hinchliffe · R. · Pope · I. · Mouton · R.
Introduction

E-cigarette use (often referred to as ‘vaping’) has increased rapidly over the past decade. Tobacco smoking is a well-established risk factor for adverse perioperative outcomes. While UK guidance supports e-cigarette use as a harm reduction and smoking cessation strategy, the perioperative implications of e-cigarette use are unclear. This scoping review aims to map the breadth and nature of the available evidence on e-cigarette use in the perioperative setting. It will describe how perioperative e-cigarette use is defined and measured, identify the perioperative populations and settings which have been studied, summarise reported perioperative outcomes and identify key knowledge gaps that should be addressed in future research.

Methods and analysis

This review will be conducted in accordance with Joanna Briggs Institute methodology and reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) guidelines. MEDLINE, EMBASE, CINAHL, PsycINFO, Cochrane Central, Web of Science and grey literature sources will be systematically searched from 2003, when the first commercially available e-cigarette was introduced, to February 2026. Studies will be screened, and data extracted by two independent reviewers. Studies of any design examining perioperative e-cigarette use in the perioperative period, across all surgical specialities, will be included. Data will be synthesised narratively and presented using tabular and visual summaries. The study will be undertaken between 9 February and 1 August 2026.

Ethics and dissemination

Ethical approval is not required for scoping reviews. Findings will be disseminated by conference presentation and publication in a peer-reviewed open-access journal and communication with stakeholders.

Designing interventions guided by digital phenotype and pharmacogenetics in Spain for suicidal behaviour based on retrospective data: the multicentre SMARTomicS study protocol

Por: Artes · C. · Porras-Segovia · A. · Ruiz-Veguilla · M. · Giner · L. · Garcia-Campayo · J. · Lopez del Hoyo · Y. · Alejandra-Saiz · P. · Garcia-Fernandez · A. · Martinez-Jambrina · J. J. · Villa-Diez · R. · Gili · M. · Roca · M. · de Andres · F. · Perez Sola · V. · Elices · M. E. · Gra
Introduction

Each year, suicide claims approximately 700 000 lives worldwide and generates a significant financial burden. Integrating genomic data, exposomic factors and digital phenotypes can enhance the development of short-term predictive models. Current knowledge and available tools provide the basis for designing personalised treatment strategies that incorporate real-time interventions to prevent suicide attempt recurrence cost-effectively. This study aims to develop a predictive algorithm for suicidal behaviour integrating psychiatric assessments, genetic risk markers, digital phenotypes and exposomic data.

Methods and analysis

This protocol describes a retrospective multicentre study that will recruit participants with a clinical history of suicide across 25 hospitals across Spain with a catchment area of 8.6 million people (17.8% of Spain’s population). Our sample target is over 5000 participants, aged over 12 years old, ensuring 93.5% statistical power for genetic analysis. Eligible participants must be over 12 years old. Data collection will include psychiatric assessments, biospecimen collections (DNA, RNA, plasma and serum), Google Takeout data for digital phenotyping, and a standardised set of administrative and clinical data registered for each patient. Genotyping will be performed with the Axiom Spanish array (>750 000 markers), and genome-wide association studies (GWAS) will be performed after genetic imputation in a whole sample of >10 000 individuals (5000 suicide attempters; 5000 controls). Prescription and clinical history will also be retrospectively integrated, and codified data statistics forms will periodically be sent to the Government. Statistical analyses will combine traditional regression models and AI-based algorithms to identify predictive behavioural, genomic profiles, and digital markers of suicidal behaviour. Cost-effectiveness analyses of pharmacogenomic markers for antidepressant response will also be conducted.

By successfully implementing this project, we aim to help reduce suicide reattempts and lessen the emotional and economic burden on families and the healthcare system.

Ethics and dissemination

This study has been approved by the Ethics Committee of the Fundación Jiménez Díaz (PIC301-24_FJD) and complies with the Declaration of Helsinki. It adheres to the GDPR (EU Regulation 2016/679), Spain’s Organic Law 3/2018 on Personal Data Protection and Digital Rights, and Law 41/2002 on patient autonomy. All required data protection measures will be implemented, including those under Real Decreto 1718/2010 on prescriptions and treatment adherence. Underaged participants will require parental consent for participation. The results will be disseminated through publication in peer-reviewed scientific journals and presentations at psychiatric conferences.

Trial registration number

NCT07422090.

Moderating role of supervisor support in the association between job demands and distress: a mixed-effects analysis in a population-based cohort study

Por: Lettinga · H. A. M. · Proper · K. I. · van Wier · M. F. · Kramer · S. E. · van Oostrom · S. H. · Anema · J. R.
Objectives

To study the association between job demands and distress among working adults and to test whether perceived supervisor support moderates this relationship.

Design

Mixed-effects analysis of repeated measures from a population-based cohort study, estimating overall (combined within-person and between-person) associations.

Setting

The Netherlands Longitudinal Study on Hearing (NL-SH), an ongoing Dutch cohort with nationwide recruitment and follow-up including four measurement waves.

Participants

A total of 989 employed individuals (≥12 hours/week) with 1858 observations had complete data on distress, job demands, supervisor support and covariates.

Primary and secondary outcome measures

The dependent variable was distress, measured using the 16-item distress subscale (range 0–32) of the Four-Dimensional Symptom Questionnaire. Job demands and supervisor support were assessed with subscales from the Job Content Questionnaire. Multilevel linear models were used to estimate main and interaction effects, adjusted for age, sex, educational level, hearing impairment, contract type and chronic diseases.

Results

Higher job demands were associated with greater distress (B=0.22, 95% CI (0.17 to 0.27)). Higher supervisor support was associated with lower distress (B=–0.26, 95% CI (–0.38 to –0.15)). The interaction between job demands and supervisor support was statistically significant (B=-0.02, 95% CI (-0.04 to 0.001), p=0.042). Stratified analyses showed that the association between job demands and distress was stronger among employees with low supervisor support (B=0.27, p

Conclusions

Job demands and supervisor support were independently associated with distress. Supervisor support appeared to buffer the impact of job demands, as the association between job demands and distress was stronger among employees reporting low levels of supervisor support. These findings underscore the importance of strengthening supportive supervisor practices, alongside addressing excessive job demands, as integral components of workplace mental health strategies.

Mapping same day, urgent and emergency care services across the UK: a mixed methods study protocol

Introduction

In the UK, a range of services provide same day, urgent and emergency care (UEC). Urgent medical needs can be addressed through pharmacy services, same day general practice (GP) appointments, phone or online triage services, out-of-hours GP appointments and urgent treatment centres (or equivalents). For emergency medical needs, patients can access emergency departments (EDs) and ambulance services. These services are highly vulnerable to excessive strain due to rising, unpredictable demand and limitations in patient flow across the system. The workforce operates in time-critical situations, often with limited resources, which can lead to staff burnout, low job satisfaction and retention and poor health. The organisation of services and their workforce continues to evolve in response to local and national pressures and varies considerably across the UK, where there are four distinct, publicly funded healthcare systems managed separately in each country. This makes it difficult to describe and compare services within and across regions and understand the impact of workforce organisation on service delivery, staff well-being and patient care. This study aims to develop a comprehensive understanding of the range and types of UK UEC services, the relative experiences of the workforce and the available workforce data.

Methods and analysis

This mixed-methods study includes two components, integrated through an explanatory sequential design. Study 1 will use data on NHS service availability and direct enquiry to map UEC services and populate a structured database, which will facilitate the generation of a UEC typology of the range and types of services and regional variation across the UK. Multiple case studies will be conducted in a subset of services using qualitative interviews (n=136–220) with service leaders (n=3–5), workforce (n=10–12), and patients or carers (n=4–5), as well as document analysis where relevant, in each service of interest (n=8–10). Study 2 will create a metadata catalogue of workforce data and produce descriptive summaries of key metrics (eg, staffing levels and skill mix). The study will be supported by our Community Inclusion and Engagement (CIE) panel and Patient and Public Advisory Group (PPAG) to ensure relevance, inclusivity and impact.

Ethics and dissemination

This study received ethical approval from Yorkshire and The Humber - Sheffield Research Ethics Committee (04/08/2025, IRAS ID: 357276, REC Reference: 25/YH/0125) and HRA and Health and Care Research Wales approval (12/08/2025). Data collection poses minimal risk, informed consent will be obtained, and participants may withdraw at any time. Dissemination will follow knowledge mobilisation principles to maximise impact. We will build on our existing networks and work with our CIE panel and PPAG to tailor study outputs to different audiences. The outputs will improve understanding of the variation in how UEC services and workforces are organised across the UK, as well as the type and format of available workforce data, and provide benchmarks for future research.

Registration

Research Registry (REF: researchregistry11555; https://www.researchregistry.com/register-now/%23home/registrationdetails/68d402672341e502cd0ce888/)

Effectiveness of amoxicillin and amoxicillin-clavulanate for the treatment of community-acquired pneumonia in adults and children: a systematic review and meta-analysis

Por: Potter-Schwartz · L. · Swe · M. M. · Sharland · M. · Bielicki · J. A. · Cooper · B. S. · Lim · C.
Objectives

The aim of this study is to evaluate existing evidence on the effectiveness of amoxicillin and amoxicillin-clavulanate for community-acquired pneumonia in children and adults.

Design

Systematic review and meta-analysis.

Data sources

PubMed, Cochrane Library, Web of Science and Ovid-MEDLINER were searched with no language restrictions through 16 July 2024.

Eligibility criteria

We included studies comparing the effectiveness of amoxicillin or amoxicillin-clavulanate versus other antibiotics or placebo.

Data extraction and synthesis

Only randomised controlled trials comparing amoxicillin or amoxicillin-clavulanate with another antibiotic or placebo with a primary outcome of clinical resolution or clinical failure were eligible for our review. We used random-effects and fixed-effects logistic regression models to estimate the pooled treatment effect size. Heterogeneity of the studies was evaluated using the statistic. We performed an unplanned frequentist random-effects network meta-analysis for the indirect comparison between amoxicillin and amoxicillin-clavulanate. The revised Cochrane risk of bias tool for randomised trials was used to assess and categorise studies into low risk of bias, some concerns or high risk of bias.

Results

We extracted data from 44 studies including 45 400 patients. We found no evidence of a differential effect on clinical resolution when comparing amoxicillin with other antibiotics (n=15 trials; pooled OR 0.88; 95% CI 0.56 to 1.38, where >1 favours amoxicillin) or amoxicillin-clavulanate with other antibiotics (n=17; OR 0.89; 95% CI 0.76 to 1.04). Similarly, evidence of difference in clinical failure between amoxicillin and other antibiotics was unclear and unable to rule out clinically important benefits or harms (n=8; OR 0.76; 95% CI 0.55 to 1.06, where 1 favours amoxicillin-clavulanate). Sixty-three per cent and 29% of amoxicillin and amoxicillin-clavulanate studies, respectively, had low risk of bias according to the Cochrane risk of bias tool for randomised trials.

Conclusions

Current evidence is unclear as to whether amoxicillin or amoxicillin-clavulanate differs from other antibiotics, or from each other, in the treatment of community-acquired pneumonia, owing to the small number of trials and substantial heterogeneity in comparators used across study settings.

PROSPERO registration number

CRD42024568554.

Dose dE-eScalaTion IN prostATe radIOtherapy usiNg an MR-Linac in 2 Fractions (DESTINATION 2): protocol for a randomised, phase II/R-IDEAL2b trial

Por: Cooper · S. · Alexander · S. · Breitkreutz · D. · Casey · F. · Christodouleas · J. · Dassen · M. G. · Dellacqua · V. · Dunlop · A. · Herbert · T. · Kolias · P. · Mitchell · A. · Pos · F. J. · Westley · R. · Tree · A. C. · Van Der Heide · U. A. · Vesprini · D.
Introduction

Stereotactic body radiotherapy (SBRT) delivered on an MRI-guided linear accelerator (MR-linac) enables highly conformal prostate cancer irradiation. The DESTINATION 2 trial is a federated, randomised phase II/R-IDEAL 2b study evaluating whether de-escalating the dose to prostate tissue, while maintaining a high dose to MRI-visible tumour(s) in two fractions, reduces genitourinary (GU) treatment-related adverse events (AE) without compromising disease control in men with localised prostate cancer.

Methods

200 men worldwide with localised, MRI-visible prostate cancer will be randomised 1:1 to receive either (1) prescribed uniform dose MR-linac SBRT (27 Gy in two fractions to the whole prostate and seminal vesicles with 0 mm CTV-PTV margin) or (2) de-escalated SBRT (20 Gy in two fractions to whole prostate with 0 mm CTV-PTV margin and 27 Gy in two fractions to MRI-visible tumour(s) with a 4 mm intraprostatic margin applied to the GTV. All treatments are delivered using MRI-guided adaptive Radiotherapy (MRIgRT). The primary endpoint is the absolute and relative risk reduction in acute grade 2+GU AE (CTCAE v5) within 12 weeks of completing radiotherapy. Secondary endpoints include late GU AE, acute and late gastrointestinal (GI) AE, sexual AE, patient-reported outcomes, dosimetry, technical feasibility and 2-year biochemical relapse-free survival.

Ethics and dissemination

This is a federated trial design in which each centre operates independently with its own sponsor, ethics committee approval and regulatory oversight. Each centre is responsible for obtaining and maintaining local ethics approval in accordance with their national and institutional requirements. The UK centre (The Royal Marsden NHS Foundation Trust) has received ethical approval from the East of England–Cambridge South Research Ethics Committee (REC reference: 24/EE/0163; IRAS: 338368). Results will be disseminated via peer-reviewed publications and conference presentations.

Trial registration number

NCT06638541.

Development of a core screening, assessment and outcome set for cancer prehabilitation: an international Delphi consensus study protocol

Por: Parkington · T. · Humphreys · L. J. · West · M. · Myers · A. · Keen · C. · Denehy · L. · Gillis · C. · Edbrooke · L. · Moore · J. · Steffens · D. · Bongers · B. C. · Slooter · G. D. · Nile · K. · Garner · N. · Copeland · R. · The National Cancer Prehabilitation Coll The Royal Marsden
Introduction

A core screening, assessment and outcome set is needed in cancer prehabilitation to standardise what is measured in both research and services. Currently, there is significant variation in measures used, which limits comparability between studies and evidence synthesis. Standardising measures will improve the quality, comparability and impact of research by reducing heterogeneity between studies, minimising reporting bias, improving trial efficiency, enabling data synthesis into large datasets, supporting international collaboration and data sharing, and accelerating the implementation of best practices.

Methods and analysis

An international Delphi consensus process will be conducted involving patients, healthcare professionals and researchers to identify screening, assessment and outcomes and their corresponding measurement instruments, to be included in a core set. The study consists of three phases: (1) A scoping review to identify screening, assessment and outcomes and associated measurement instruments currently used in cancer prehabilitation. (2) At least two rounds of a modified Delphi survey to prioritise the identified screening, assessment and outcomes using a 1–9 Likert scale. Consensus will be defined across stakeholder groups using prespecified thresholds. A consensus meeting will be held if agreement is not reached. (3) Measurement instruments corresponding to each retained screening, assessment and outcome will be assessed for quality for measurement properties and feasibility. Further Delphi rounds will be conducted to reach consensus on the most appropriate measurement instrument for each core screening, assessment and outcome.

Ethics and dissemination

The study has ethical approval (Ref: 25/NW/0159). Findings will be disseminated through peer-reviewed publications, conference presentations, stakeholder networks and made publicly available via the Core Outcome Measures in Effectiveness Trials database.

Outcomes of Pilonidal Surgery Performed in the Setting of Standard Adjunct Laser Hair Removal: A Retrospective Cohort Study

ABSTRACT

Pilonidal sinus disease (PSD) is associated with substantial morbidity because of wound complications and recurrence after surgery. Adjunct laser hair removal (LHR) has been incorporated into postoperative management in some settings, but real-world outcomes in cohorts treated uniformly with LHR remain incompletely described. This study aimed to characterize postoperative outcomes after PSD surgery in a large integrated healthcare system in which adjunctive LHR was standard practice and to compare outcomes by surgical approach. We performed a retrospective descriptive cohort study of patients aged 14–89 years who underwent operative treatment of PSD with adjunctive LHR at Kaiser Permanente Northern California between 2012 and 2024. Outcomes included repeat procedures, 30-day surgical site infection (SSI), and unplanned clinic visits. Outcomes were summarized as proportions overall and by surgical approach. Exploratory bivariable logistic regression examined associations between sex or body mass index (BMI) and outcomes. Multivariable modeling was not performed because of low event counts and sparse covariate distributions, which resulted in unstable models. Among 168 patients, the overall repeat procedure rate was 16.7%, the 30-day SSI rate was 14.4%, and 39.3% had at least one unplanned clinic visit. Patients treated with Bascom flap closure had fewer repeat procedures (10.4% vs. 20.8%) and fewer unplanned visits (33.8% vs. 43.6%) than those undergoing pilocystectomy, with similar SSI rates (14.9% vs. 14.0%). In exploratory analyses, sex and BMI were not significantly associated with outcomes in either surgical group. In this real-world cohort managed uniformly with adjunctive LHR, postoperative outcomes appeared to vary more by surgical approach than by sex or BMI. These findings are descriptive and do not estimate the independent effect of LHR. Controlled comparative studies are needed to determine the contribution of LHR to PSD outcomes.

Lower Limb Symmetry Index in Cavus and Normal Feet by Means of a Baropodometric Platform: A Case–Control Study

ABSTRACT

High-arched feet affect approximately 10%–15% of the general population. Although the relationship between plantar pressure and bilateral symmetry is well studied, there is limited evidence regarding the use of Symmetry Index and pressure platforms. The objective of the study is to compare dynamic foot pressures and Symmetry Index during gait between subjects with Pes Cavus and subjects with normal feet. The analysis of asymmetric pressure patterns could benefit from studies that compare dynamic foot pressures and Symmetry Index values in subjects with high-arched feet and normal feet. This analysis can promote better clinical understanding of gait alterations and help solve biomechanical problems that may lead to pathologies, as well as prevent and treat them. A descriptive case–control study was developed from October to December 2024 with 82 participants, 41 with Pes Cavus and 41 normal feet and 71 females of 25.52 ± 5.99 years through a consecutive nonrandom technique. For this study, a baropodometry platform (Neo-Plate, Herbitas) was used, which acquired dynamic gait with a 2-step protocol. The inclusion criteria regarding the selection of subjects were age 18–65 years; if both cavus feet, Navicular Drop Test (NDT) < 9 mm; neutral feet and no lower limb problem or surgery. Regarding SI use, the PC demonstrated to have large asymmetries compared to the control group. Left anterior pressure was lower (44.93% ± 4.59% vs. 48.60% ± 3.43%, p = 0.014), left posterior pressure was higher (55.07% ± 4.58% vs. 51.40% ± 3.43%, p = 0.013) and the left Initial Contact Phase (ICP) was prolonged (123.34 ± 51.75 ms vs. 91.30 ± 31.86 ms, p = 0.036); right medial pressure was higher (58.18% ± 4.08% vs. 53.77% ± 4.79%, p = 0.034). SI measurements were greater in normal foot group than in the PC group with SI 94.15% ± 5.00% versus 93.75% ± 4.59%, p = 0.001, respectively; ICP and lateral SI were both p = 0.001. Findings confirmed that subjects with cavus feet tend to present greater alterations in bilateral symmetry, specifically posteromedial pressure movements and altered gait phases, which are indicative of more probability of future injuries. For this reason, pressure platforms are excellent tools for understanding, analysing and therefore applying the correct treatment according to the SI.

Pressure Injury Malpractice Litigation: A Retrospective Medicolegal Study

ABSTRACT

Medical malpractice imposes a substantial clinical and economic burden worldwide. Pressure injuries (PIs) are amongst the most frequently litigated adverse events and represent a major source of preventable patient harm. To characterise the medicolegal landscape of PI-related malpractice, the Westlaw legal database was queried for cases litigated between 1990 and 2024. A total of 590 cases met inclusion criteria, with data extracted from court documents. The mean patient age was 71 years; 53.4% were female and 46.6% male. Nursing homes were the most commonly named defendants (59.8%), followed by hospitals and outpatient surgical practices (37.3%) and individual physicians (14.1%). The mean settlement was $383 099, compared with a mean jury award of $2 100 787. Adverse legal outcomes were strongly associated with allegations of inadequate care, poor clinical outcomes and gross provider negligence. When prevention and timely management fail, the consequences extend beyond patient harm to substantial legal and financial liability. Targeted interventions such as standardised risk assessment, rigorous documentation, staff education, appropriate staffing ratios and institutional accountability may mitigate both PI incidence and litigation risk. Strengthening these measures represents a critical opportunity to improve patient safety whilst reducing medicolegal exposure.

Predictors of Complications and Recurrence After Pressure Injury Reconstruction in Spinal Cord Injury: A Systematic Review and Meta‐Analysis

ABSTRACT

Spinal cord injury (SCI) predisposes patients to pressure injuries (PIs) often requiring surgery. Multiple factors influence postoperative complications and recurrence, though their associations remain unclear. We performed a PRISMA-guided systematic review and meta-analysis to assess predictors of acute postoperative complications and PI recurrence in SCI patients undergoing surgery. PubMed, Scopus and Embase were searched. Studies with ≥ 15 participants were eligible; 24 (n = 2566 subjects) were included, with 15 (n = 1976 subjects) quantitatively synthesized. Risk of bias was assessed with the Newcastle-Ottawa Scale. A random-effects model meta-analysis was performed, and odds ratios (OR) were pooled when > 2 studies were available; otherwise, findings were narratively synthesized. Moderate-quality evidence showed prior flap reconstruction increased complication risk (aOR = 4.98). Low-quality evidence linked diabetes (OR = 1.39) and smoking (OR = 1.35) with complications. Higher recurrence risk was associated with prior flap reconstruction (OR = 1.80) and thoracic injury (OR = 2.21), while cervical injury was protective (OR = 0.37). Prior flap reconstruction resulted as the strongest predictor of complications and significantly increased the odds of recurrence. These findings underscore the importance of a multidisciplinary approach for preventing the first occurrence of flap reconstruction and subsequent procedures.

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