Conectar
by Siobhán O’Connor, Sandra M. Malone, Joseph Firnhaber, Sinéad O’Keeffe, John McNamara, Anna Donnla O’Hagan
While mental health literacy is an important component to successful help-seeking, rural populations often face gaps in both knowledge and service provision. Informed by the Theory of Planned Behaviour and Self-Efficacy Theory, we designed the ‘Skills for Resilience’ as a brief, once-off, community-based educational intervention to increase Irish farmers’ mental health literacy and help-seeking intentions. We adopted a quasi-experimental between (group: intervention and control) and within-group design (time: baseline [T1], immediately post-intervention [T2], and ≥ 1 month post-intervention [T3]). A total of 72 participants (intervention n = 37; control n = 35) were recruited from knowledge-sharing discussion groups. Although recruitment was also open to women, all discussion groups consisted of men. A trained facilitator delivered a discussion lasting between 30 and 90 minutes. Five intervention participants also participated in a qualitative interview after T3. Our results identified intervention participants’ mental health literacy increased significantly at T2 and T3 compared to T1, but did not increase between T2 and T3. Mental health literacy was also significantly greater in the intervention group compared to the control group at T2 and T3. Help-seeking intentions and self-efficacy in seeking mental healthcare also increased significantly at T2 compared to T1, but did not increase between T1 and T3 or T2 and T3. There were no significant changes in outcome measures for the control group at any time point. Through reflexive thematic analysis we identified that the intervention also addressed stigma against mental health (Theme 1) and provided important resources for participants and their community’s present and future coping (Theme 2). At T3, 100% of participants enjoyed the discussion and would recommend the intervention to other farmers. This intervention provides a successful example of integrating the Theory of Planned Behaviour and Self-Efficacy Theory to improve mental health literacy in farmers using a brief, educational intervention.
The Quadrivalent human papillomavirus (HPV) Vaccine Evaluation Study with Addition of the Nonavalent Vaccine Study (QUEST-ADVANCE) aims to provide insight into the long-term immunogenicity and effectiveness of one, two and three HPV vaccine doses. Here, we describe the protocol for QUEST-ADVANCE.
QUEST-ADVANCE is an observational cohort study including males and females who are unvaccinated or vaccinated with the quadrivalent or nonavalent HPV vaccine in British Columbia, Canada. Female participants who are unvaccinated or vaccinated with 1–3 doses of the quadrivalent or nonavalent HPV vaccine at 9–14 years of age will be recruited approximately 5 or 12 years postvaccination eligibility. Male participants who are unvaccinated or vaccinated with 1 or 2 doses of the nonavalent HPV vaccine at 9–14 years of age will be recruited at approximately 5 years postvaccination eligibility. The study involves a maximum of four visits over a period of 4–5 years for female participants, and two visits over a 12-month period for male participants. At each visit, self-collected swabs (cervico-vaginal or penile) and questionnaire data will be collected. In each study group, a subset of participants will be invited to participate in a substudy evaluating the long-term humoral immunogenicity of the HPV vaccine. Additional blood samples will be collected from participants who are part of the immunogenicity substudy. The total required sample size is 7180 individuals. The primary objectives are (1) to examine vaccine effectiveness in males and females against prevalent genital HPV infections for one, two and three doses of the HPV vaccine compared with unvaccinated participants and (2) to evaluate if there is non-inferior immunogenicity as indicated by type-specific antibody response of one dose of the HPV vaccine in 20–27-year-old females vaccinated at 9–14 years of age compared with historical data of three doses of the HPV vaccine females vaccinated at 16–26 years of age up to 12 years postvaccination.
QUEST-ADVANCE was approved by the Research Ethics Board of the University of British Columbia/Children’s and Women’s Health Centre of British Columbia (H20-02111). Individual electronic informed consent or assent will be obtained from each participant before any study-specific procedures are undertaken. Results will be published in an international peer-reviewed journal and on the study website.
Limited evidence exists regarding the effectiveness of learning approaches in supporting interprofessional wound care education transnationally. The aim of this pilot study was to explore the feasibility and preliminary impact of an international, online interprofessional masterclass in supporting baccalaureate health students' learning about wound care. Data were collected using multiple methods including quantitative survey, qualitative focus groups, and interviews with baccalaureate nursing, pharmacy, dietetics, podiatry and paramedicine students from two universities based in Australia and Northern Ireland. A retrospective pre-test design was used. A survey retrospectively assessed students' self-reported confidence and understanding before and after the masterclass, while qualitative methods explored students' experiences of interprofessional learning and wound care. Self-reported improvements in students' understanding of wound assessment and management, as well as heightened awareness of interprofessional contributions to patient care indicated the potential value of this interprofessional and international collaboration in supporting wound care education. Qualitative analysis identified four themes: recognising a wound is a person's wound; comparing international healthcare practices; fostering learner engagement; interprofessional recognition, acknowledgment, and understanding of each profession's roles, contributions and expertise. This pilot study has highlighted key issues to be addressed in future research examining the impact of a collaborative online international initiative on baccalaureate students' interprofessional learning about wound care.
by Xie Qiu, Shuo Hu, Shumin Dong, Haijun Sun
ObjectiveTo develop a predictive framework integrating machine learning and clinical parameters for postoperative pulmonary complications (PPCs) in non-small cell lung cancer (NSCLC) patients undergoing video-assisted thoracic surgery (VATS).
MethodsThis retrospective study analyzed 286 NSCLC patients (2022–2024), incorporating 13 demographic, metabolic-inflammatory, and surgical variables. An Improved Blood-Sucking Leech Optimizer (IBSLO) enhanced via Cubic mapping and opposition-based learning was developed. Model performance was evaluated using AUC-ROC, F1-score, and decision curve analysis (DCA). SHAP interpretation identified key predictors.
ResultsThe IBSLO demonstrated significantly superior convergence performance versus original BSLO, ant lion optimizer (ALO), Harris hawks optimization (HHO), and whale optimization algorithm (WOA) across all 12 CEC2022 test functions. Subsequently, the IBSLO-optimized automated machine learning (AutoML) model achieved ROC-AUC/PR-AUC values of 0.9038/0.8091 (training set) and 0.8775/0.8175 (testing set), significantly outperforming four baseline models: logistic regression (LR), support vector machine (SVM), XGBoost, and LightGBM. SHAP interpretability identified six key predictors: preoperative leukocyte count, body mass index (BMI), surgical approach, age, intraoperative blood loss, and C-reactive protein (CRP). Decision curve analysis demonstrated significantly higher net clinical benefit of the AutoML model compared to conventional methods across expanded threshold probability ranges (training set: 8–99%; testing set: 3–80%).
ConclusionThis study establishes an interpretable machine learning framework that improves preoperative risk stratification for NSCLC patients, offering actionable guidance for thoracic oncology practice.
To describe the associations between Rapid Response Team (RRT) patient review and other predefined clinical management actions, with risk of in-hospital cardiac arrest and in-hospital mortality in the first unplanned admission (UPA) to the adult intensive care unit (ICU) from the ward environment for each patient. To describe a novel RRT assessment tool for ward-based care for patients who were deteriorating.
A retrospective cohort study.
A large multispecialty, tertiary referral and teaching hospital in England, UK.
The study included 3175 consecutive adult ICU UPAs from hospital wards over a 6-year period (2014–2019).
Ward-based management of deterioration prior to ICU admission was assessed by the RRT, using a scored checklist—the UPA score. Admissions were compared in two groups according to their exposure to an RRT review in the 72 hours before ICU admission. Associations with in-hospital cardiac arrest within 24 hours before ICU admission and all-cause in-hospital mortality were estimated, using unadjusted and adjusted odds ratios (aORs) with 95%CI.
RRT review occurred in 1413 (44.5%) admissions and was associated with reduced odds of in-hospital cardiac arrest (aOR 0.51; 95% CI 0.36 to 0.78; p
An RRT review in the 72 hours prior to ICU admission was associated with reduced odds of in-hospital cardiac arrest but did not impact in-hospital mortality. Higher UPA scores were associated with increased incidence of both in-hospital cardiac arrest and in-hospital mortality. In addition, this study describes a novel and adaptable RRT scoring tool (the UPA score) for safety monitoring and quality improvement.
by Mengzhen Qin, Mengyuan Qiao, Yuying Dong, Haiyan Wang
ObjectiveCompared with those without such impairment, middle-aged and older adults with sensory impairment (SI) demonstrate a greater prevalence and severity of depressive symptoms, significantly affecting their mental health. We aimed to develop and validate a depression risk prediction model for middle-aged and elderly individuals with SI.
MethodsData from the 2018 China Health and Retirement Longitudinal Study were randomly partitioned into training and validation sets at a 7:3 ratio. Within the training set, least absolute shrinkage and selection operator (LASSO) regression analysis and binary logistic regression were used to identify predictor variables, and a risk prediction column‒line graph was subsequently developed, with depression status among middle-aged and elderly individuals with SI as the dependent variable. Predictive performance of the training and validation sets was assessed via receiver operating characteristic (ROC) curves, calibration plots, and decision curve analysis.
ResultsIn total, 5308 middle-aged and older adults with SI were included, with 50.1% (n = 2657) developing depression. Multifactorial logistic regression analysis identified several depression predictors, including sex, education level, place of residence, marital status, self-rated health, life satisfaction, pension insurance status, nighttime sleep duration, functional impairment status, and pain (all P CI = 0.783–0.811) and 0.778 (95% CI = 0.755–0.800), respectively. The Hosmer–Lemeshow values were P = 0.176 and P = 0.606 (P > 0.05), and the calibration curves revealed significant agreement between the model and actual observations. ROC and DCA curves indicated good predictive performance for the column‒line graph.
ConclusionThis study presents a reliable, validated, and acceptable predictive model for depression risk in middle-aged and elderly individuals with SI, and the identified predictors have potential applications in public health policy and clinical practice.
by Adedapo Olufemi Bashorun, Larry Kotei, Abdoulie F. Jallow, Ousubie Jawla, Emmanuel U. Richard-Ugwuadu, Muhammed Jagana, Lamin Bah, Amadou Tijan Bah, Karamo Conteh, Mamadou S.K. Jallow, Mehrab Karim, Bai Lamin Dondeh, Anne Segonds-Pichon, Gary M. Clifford, Iacopo Baussano, Bruno Pichon, David Jeffries, Ed Clarke
Human papillomavirus (HPV) infection is a primary cause of preventable deaths from cervical cancer, a condition of profound inequality with approximately 90% of deaths occurring in low- and middle-income countries, particularly in sub-Saharan Africa. In May 2018, the WHO Director-General declared a Joint Global Commitment to Cervical Cancer Elimination, highlighting the critical role of HPV vaccines in achieving this goal. However, there is a lack of systemically collected data on HPV prevalence in The Gambia, and impact data from high-income countries may not be reliably extrapolated to West African settings due to geographical variation in HPV types and distinct behavioural, biological, and sociodemographic exposures. The Gambia introduced a two-dose HPV vaccination schedule in 2019, but coverage has been very low, interrupted mainly by the COVID-19 pandemic. This presents a key opportunity to generate vital baseline data on HPV prevalence in the population before potential scale-up of vaccination efforts. The PHASE survey, a multi-stage cluster survey, aims to establish the baseline, population prevalence estimates of high-risk and low-risk, vaccine-type and non-vaccine-type HPV infection in 15- to 49-year-old females in The Gambia by measuring urinary HPV-DNA. The survey will also quantify the effects of various exposures on HPV prevalence, including sexual behaviour, the presence of other sexually-transmitted infections (STIs) - Neisseria gonorrhoea (NG), Chlamydia trachomatis (CT), Trichomonas vaginalis (TV), Mycoplasma genitalium (MG), syphilis, as well as blood borne viruses, human immunodeficiency virus (HIV), hepatitis B and hepatitis C; obstetric history, socio-demographic characteristics, and cervical cancer screening and/or treatment. Additionally, the study will provide important antimicrobial resistance (AMR) data for NG and MG in sub-Saharan Africa, a region poorly represented in global surveillance programs. This data is needed to guide regional treatment guidelines and advocate for new solutions, including gonococcal vaccines. The AMR data are expected to immediately influence recommendations regarding the appropriate choice of antibiotics for syndromic STI management in West Africa and hence to address an important driver of AMR in the sub-region. Leveraging on the Medical Research Council Unit The Gambia funded Health Demographic Surveillance system (HDSS) as its sampling frame, the survey will utilize validated diagnostic assays and culturally sensitive data collection methods, to ensure both scientific rigor and local relevance. Tools such as Audio Computer-Assisted Self-Interviewing (ACASI) technology, developed in consultation with local community advisory boards, are included to reduce social desirability bias in reporting sexual behaviour. This approach aims to maximize both the reliability and cultural appropriateness of the findings. This study directly addresses the critical need for baseline epidemiological data on HPV in a West African setting to accelerate vaccine impact and drive new interventions towards cervical cancer elimination. By understanding other factors that influence HPV (like other STIs, sexual behaviour, etc.), the study aims to ensure that, when the vaccine’s impact is measured later, changes in other confounding factors that may impact on HPV prevalence can be accounted for. The study will also establish the population prevalence of the measured STIs and their relationship to common symptoms and other adverse health outcomes related to STIs.
The objective of this scoping review is to map and synthesise existing literature on interventions aimed at promoting healthy screen use among adolescents. This review identifies the types, functions and settings of interventions, explores the diversity of targeted outcomes and highlights equity considerations and research gaps.
We conducted a scoping review in accordance with the Arksey and O’Malley framework and reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines.
We systematically searched Medline, PsycINFO and ERIC from January 2013 to June 2024. Reference lists of included studies were also manually screened.
We included peer-reviewed experimental, quasi-experimental, observational and qualitative studies reporting on interventions designed to promote healthy screen use among adolescents aged 10–19 years.
One author extracted data using a structured charting form, and a second author verified all entries. Results were synthesised descriptively across key themes including target populations, theoretical frameworks, intervention components and reported outcomes.
From 6433 records, we identified 93 articles on 81 interventions, mainly conducted in high school settings in the USA and Australia. Most examined short-term interventions targeting recreational screen time. Outcomes included media literacy, cyberbullying, internet and gaming addiction, safe internet use, social media use and mental and sexual health. Seventy-eight per cent of interventions attempted to educate adolescents, while 34% offered training activities (eg, educational sessions to elevate risk awareness and skill-based training to enhance digital literacy and self-regulation). Interventions targeting external influences were used less frequently. About 20% of studies showed no statistically significant findings, highlighting the need to promote evidence-based interventions.
This review identifies a need for broader, multilevel strategies that account for contextual factors and social determinants in influencing screen use and its related health issues. Future research should explore long-term effectiveness while examining the potential moderating and mediating effects of social determinants. Equity considerations were not a primary focus of most interventions, underscoring an important gap in this literature. Future interventions could incorporate equity-focused design and evaluation to ensure they respond to the needs of diverse adolescent populations.
To explore the challenges experienced by people with intellectual disability, their carers and health and social care professionals when using and managing medication.
A synthesis of qualitative research using meta-ethnography.
We searched seven databases: MEDLINE, Embase, CINAHL, Science, Social Science and Conference Proceedings Citation Indices (Web of Science), Cochrane Library, PsycINFO and Proquest Dissertations and Theses from inception to September 2022 (updated in July 2023).
We included studies exploring the challenges and perceptions of people with intellectual disability, their carers and health and social care professionals regarding medication management and use.
We reviewed 7593 abstracts and 475 full texts, resulting in 45 included papers. Four major themes were identified: (1) Medication-related issues, (2) navigating autonomy and relationships, (3) knowledge and training needs and (4) inequalities in the healthcare system. We formulated a conceptual framework centred around people with intellectual disability and described the interconnectedness between them, their carers and health and social care professionals in the process of managing and using medication. We identified challenges that could be associated with the person, the medication and/or the context, along with a lack of understanding of these challenges and a lack of capability or resources to tackle them. We developed an overarching concept of ‘collective collaboration’ as a potential solution to prevent or mitigate problems related to medication use in people with intellectual disability.
The effective management of medication for people with intellectual disability requires a collaborative and holistic approach. By fostering person-centred care and shared decision-making, providing educational and practical support, and nurturing strong relationships between all partners involved to form a collective collaboration surrounding people with intellectual disability, improved medication adherence and optimised therapeutic outcomes can be achieved.
CRD42022362903.
Although as many as 92% of survivors of physical intimate partner violence (IPV) report impacts to the head and/or non-fatal strangulation (NFS) that raise clinical suspicion of brain injury (BI), there are no evidence-based methods to document and characterise BI in this vulnerable population, limited clinical practice guidelines and insufficient understanding about long-term risks for conditions including Alzheimer’s Disease and Related Dementias (ADRD). This leaves most survivors of IPV-caused BI (IPV-BI), overwhelmingly women, without adequate access to medical care and support, safe housing, back-to-school/work accommodations or follow-up care for long-term neurocognitive health. Although traumatic brain injury (TBI) is an established ADRD risk factor, little is known about the attributable risk of ADRD due to IPV-BI, particularly in women.
Our overarching objectives are to (1) use plasma biomarkers as novel tools to assist clinicians to improve diagnosis of IPV-BI at the acute, subacute and chronic stages in a manner sensitive to the needs of this vulnerable population and (2) raise awareness of the importance of considering IPV-BI as a potential ADRD risk factor. A prospective observational study funded by the US Department of Defense (HT9425-24-1-0462), Brain Canada (6200) and the Canadian Institutes of Health Research (523320-NWT-CAAA-37499) leverages collaborative research at multiple clinical sites in British Columbia to maximise equity, diversity and inclusion among participants, with a target enrolment of n=600 participants.
The Advocates, Academics, Survivors and Clinicians to END Intimate Partner Violence Biomarkers study, which is predicated on pre-specified research questions, represents one of the most significant community-based studies on plasma biomarkers affected by an IPV-BI incident. Of particular significance is the fact our study uses robust biomarker approaches being applied in the TBI and ADRD fields to determine how the biomarker profile after IPV-BI compares to typical TBI and the early stage of neurodegenerative disorders.
This study was approved by the University of British Columbia Clinical Research Ethics Board (H24-01990, H22-02241 and H16-02792) and the Island Health Research Ethics Board (H22-03510). Upon publication of primary papers, de-identified data and biospecimens will be made widely available, including the US Federal Interagency Traumatic Brain Injury Research (FITBIR) federated database. Our data and integrated knowledge translation activities with persons with lived experience of IPV-BI and those working in the healthcare sector will be synthesised into co-designed and implemented knowledge tools to improve outcomes for survivors of IPV-BI.
The standard treatment of oral cavity cancers (OCC) relies on surgery and postoperative radiotherapy (poRT) for advanced stages or poor factors. In more than 75% of cases, reconstructive surgery with a flap aims to restore the function lost with tumour resection. Current poRT planning and delineation guidelines omit the presence of a flap. It may be assumed that poRT with flap sparing may allow for reducing radio-induced toxicities and improving functional outcomes, without impairing local primary control. The OPTIFLAP trial assesses non-inferior locoregional control using flap sparing compared with conventional flap-agnostic radiotherapy in patients with OCC, while reducing treatment-related toxicity and improving functional outcomes.
The OPTIFLAP study is a French, multicentre, 1:1 randomised, phase III, controlled trial. It will recruit 348 patients with OCC with a flap. Recruitment is active with the first enrolment on 2 July 2025 and is planned over 48 months. The primary outcome is non-inferior 2-year locoregional control rate using flap sparing compared with flap-agnostic radiotherapy (as per standard routine practice) in completely resected OCCs undergoing poRT. Key secondary outcomes include rates of toxicities, locoregional relapse-free survival, progression-free survival, overall survival, quality of life, functional outcomes (assessed by the Performance Status Scales for Head and Neck Cancer, the MD Anderson Dysphagia Inventory (self-questionnaire) and the Phonation Handicap Index (self-questionnaire)), flap doses and outcomes between arms depending on dosimetric parameters. The trial incorporates translational ancillary studies addressing individual radiosensitivity, salivary microbiome evolution, radiomics and dosiomics of flap changes, as well as medico-economic evaluation.
The study protocol has been approved by the Medical Ethics Committee East III (January 2025; Ref 24.05832.000442) and the French Agency for Medical and Health Products Safety (December 2024; ID-RCB: 2024-A01764-43) and was validated by review boards of all participating centres. Written informed consent will be obtained from all participants. Study results will be published in international peer-reviewed scientific journals and presented at relevant scientific conferences.
The development of effective vaccines targeting human papillomavirus (HPV) has significantly contributed to disease prevention, highly relevant in immunosuppressed patients who have higher incidence of HPV-related cancers than their non-immunosuppressed counterparts. However, the acceptance and uptake of the HPV vaccine among immunosuppressed individuals pose unique challenges. Immunocompromised patients’ acceptance of the HPV vaccine is influenced by multifaceted factors, including concerns about safety and effectiveness, interactions with immunosuppressive medications and uncertainties due to their compromised immunity. This systematic review aims to identify the main factors influencing HPV vaccine acceptance among immunosuppressed patients.
A comprehensive search strategy will be executed across databases such as MEDLINE/PubMed, Embase, Scopus, Web of Science, ScienceDirect, Latin American and Caribbean Literature in Health Sciences, Cumulative Index to Nursing and Allied Health Literature and Cochrane Database. The review will encompass the three WHO-endorsed HPV vaccines (quadrivalent, bivalent and nonavalent) and will consider studies related to HPV vaccines and their administration. The scope includes study focusing on immunosuppressed patients who received organ transplants, cancer treatments or are HIV-positive. No temporal restrictions will be applied, and searches will be conducted until December 2025. Observational studies, including retrospective/prospective cohorts, case–control and cross-sectional studies, reporting factors influencing HPV vaccination in immunosuppressed populations will be included. Studies with overlapping patient populations will be excluded. Data extraction will include study details, demographics, vaccine type, risk/protective factors, outcomes and medical history. Validation and cross-verification will ensure data accuracy. Risk of bias will be assessed using ROBINS-I (Risk Of Bias In Non-randomised Studies of Interventions), and GRADE (Grading of Recommendations Assessment, Development and Evaluation) will rate evidence certainty. Meta-analysis, guided by Cochrane and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, will employ fixed/random-effects models, assessing heterogeneity using I² statistics.
This research will analyse previously published data, so ethical approval is not required. The results of the systematic review will be submitted for publication in a peer-reviewed journal.
CRD42023452537.
Overexpression of p16 has been documented in a variety of human tumours. Nonetheless, the association between p16 overexpression and the clinicopathological characteristics of patients with cervical cancer remains a subject of debate. This meta-analysis sought to systematically assess the relationship between p16 expression and the clinicopathological features of patients with cervical cancer.
Systematic review and meta-analysis.
The PubMed, Embase, Cochrane Library (Central), Web of Science (SCI Expanded), and Chinese databases (CNKI, VIP, Wanfang and CBM) were searched through 1 March 2024.
Case-control studies examining the association between p16 expression and cervical cancer were analysed to evaluate whether p16 expression was correlated with the clinicopathological characteristics of patients with cervical cancer.
Two independent reviewers employed standardised methods to search, screen and code the included studies. The risk of bias was evaluated using the Cochrane Collaboration tools and the Newcastle-Ottawa Scale. Statistical analyses and data processing were conducted using Review Manager V.5.4, which included heterogeneity tests and sensitivity analyses. Additionally, STATA V.16.0 was used for further sensitivity analyses of the included studies, and publication bias was assessed using Begg’s test.
The p16 protein is strongly associated with the onset and progression of cervical cancer and serves as a valuable biomarker for its early detection and diagnosis.
CRD42024546241.
To address the lack of accurate and accessible mental health medicines-information resources for children, young people and their parents/guardians using design thinking to co-design free-to-use, video resources tailored to this audience.
A multiphase qualitative case study using the Double Diamond model of Design Thinking: Discover, Define, Develop and Deliver. This included iterative prototyping, thematic analysis and public and patient involvement throughout.
Dublin, Ireland with online distribution of the final resources internationally through a free, open-access platform.
A multidisciplinary co-design team including two specialist mental health pharmacists, two academic pharmacists, five consultant psychiatrists, a psychiatric nurse, a youth content specialist, three youth activists and a parent representative.
26 co-designed, medicines-information videos were created, including versions for children (voiced by children), parents/guardians and young people. Videos feature storytelling formats with Bitmoji characters. Feedback from youth and parent collaborators guided design and content. Since launch, www.youthmed.info has had over 25 000 website views and more than 30 000 video views, with engagement from over 91 countries. The resources are also linked on national and international clinical and charity platforms.
Youth Med.Info addresses a gap in accessible, accurate mental health medicines-information by placing users – children, young people, parents/guardians and clinicians—at the centre of its design.
The management of bleeding and coagulation after total knee arthroplasty (TKA) has long been recognised as a significant challenge for orthopaedic surgeons. Despite the notable success of empirical anticoagulation in preventing venous thromboembolism (VTE) following TKA, the increased risk of postoperative bleeding has also raised extensive concern. Ecchymosis, as one of the most common manifestations indicating postoperative bleeding, holds the potential to indicate the balance of bleeding and hypercoagulation. However, there is still a lack of evidence-based medical research to determine the importance of postoperative ecchymosis and related personalised anticoagulation therapy. Therefore, we have designed a randomised controlled trial aimed at assessing the safety and efficacy of personalised delayed anticoagulation strategies in the management of postoperative bleeding in TKA patients.
This is a prospective, randomised, controlled trial. Patients diagnosed with end-stage knee osteoarthritis will be grouped based on the presence of ecchymosis after TKA. Those without ecchymosis will receive standard anticoagulation therapy, while those with ecchymosis will be randomised in a 1:1 ratio into either the standard anticoagulation group or the delayed anticoagulation group. The primary outcomes will compare the blood routine examination, coagulogram, thromboelastography and the incidence of VTE. The secondary outcomes will include surgical-related complications. Additionally, patient baseline data and surgery-related data will also be recorded and analysed.
Ethics approval has been obtained from The First Affiliated Hospital of Chongqing Medical University (2024-194-01). The results will be disseminated at international conferences and in peer-reviewed publications.
ChiCTR2400084440.
Difficulty with walking can lead to reduced quality of life for people with Parkinson’s disease (pwPD); improving walking is considered a treatment priority. Drug therapies can control PD symptoms; however, pwPD often still experience mobility problems.
Functional electrical stimulation (FES) induces movement in weak muscles via external electrical stimulation. FES is used in stroke and multiple sclerosis patients to correct dropped foot by stimulating the common peroneal nerve and is associated with improved quality of life and mobility. The randomised feasibility study preceding this definitive study showed that daily FES can produce a clinically meaningful improvement in walking speed in pwPD; this was sustained 4 weeks after FES was withdrawn. STEPS II is the first definitive randomised controlled trial, with blinded outcome assessment, aiming to determine the efficacy of FES in pwPD.
STEPS II is a two-group, parallel, assessor-blinded, superiority randomised controlled trial with an internal pilot, designed to compare FES plus usual care versus usual care alone. 234 participants will be randomised across eight UK sites. Telephone pre-screening and face-to-face screening will determine eligibility. The intervention group will attend four unblinded FES visits to receive the device and assess walking with and without FES. All participants have blinded assessments at baseline and weeks 2, 6, 18 and 22. The primary objective is to compare whole body bradykinesia at 18 weeks post-baseline via changes in 10m walking speed. Secondary objectives will assess the wider effects of FES on Parkinsonian gait and quality of life. An embedded qualitative component will explore wider experiences of FES.
This study received ethical approval from the Yorkshire and The Humber-Sheffield Research Ethics Committee (reference 23/YH/0193). A Data Monitoring Committee and Trial Steering Committee will provide independent oversight. Dissemination will be via publications, conferences and social media. FES intervention and training materials will be made open access.
by Dong Min Jung, Yong Jae Kwon, Yong Wan Cho, Jong Geol Baek, Dong Jae Jang, Yongdo Yun, Seok-Ho Lee, Gahee Son, Hyunjong Yoo, Min Cheol Han, Jin Sung Kim
Volumetric modulated arc therapy (VMAT) for lung cancer involves complex multileaf collimator (MLC) motion, which increases sensitivity to interplay effects with tumour motion. Current dynamic conformal arc methods address this issue but may limit the achievable dose distribution optimisation compared with standard VMAT. This study examined the clinical utility of a VMAT technique with monitor unit limits (VMATliMU) to mimic conformal arc delivery and reduce interplay effects while maintaining plan quality. VMATliMU was implemented by applying monitor unit limitations during VMAT reoptimisation to minimise MLC encroachment into target volumes. Using mesh-type reference computational phantom CT images, treatment plans were generated for a simulated stage I lung cancer case prescribed to 45 Gy in three fractions. VMATliMU, conventional VMAT, VMAT with leaf speed limitations, dynamic conformal arc therapy, and constant dynamic conformal arc therapy were compared. Plans were optimised for multiple isodose line prescriptions (50%, 60%, 70%, 80%, and 90%) to investigate the impact of dose distribution. Evaluation parameters included MLC positional accuracy using area difference ratios, dosimetric indices, gradient metrics, and organ-at-risk doses. VMATliMU prevented MLC encroachment into the internal target volume across 60%–90% isodose lines, showing superior MLC accuracy compared with other methods. At the challenging 50% isodose line, VMATliMU had 4.5 times less intrusion than VMAT with leaf speed limits. VMAT plans had better dosimetric indices than dynamic conformal arc plans. VMATliMU reduced monitor units by 5.1%–19.2% across prescriptions. All plans met the clinical dose constraints, with the aortic arch below tolerance and acceptable lung doses. VMATliMU combines VMAT’s dosimetric benefits with the dynamic conformal arcs’s simplicity, minimising MLC encroachment while maintaining plan quality. Reduced monitor units lower low-dose exposure, treatment time, and interplay effects. VMATliMU is usable in existing planners with monitor unit limits, offering a practical solution for lung stereotactic body radiation therapy.
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.
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.
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.
by Charlotte J. Whiffin, Kathleen Joy O. Khu, Brandon G. Smith, Isla Kuhn, Santhani M. Selveindran, Laura Hobbs, Samin Davoody, Yusuf Docrat, Orla Mantle, Upamanyu Nath, Lara Onbaşı, Stasa Tumpa, Ignatius N. Esene, Harry Mee, Fergus Gracey, Shobhana Nagraj, Tom Bashford, Angelos G. Kolias, Peter J. Hutchinson
Following calls for more qualitative research in neurosurgery, this scoping review aimed to describe the range and reach of qualitative studies relevant to the field of neurosurgery and the patients and families affected by neurosurgical conditions. A systematic search was conducted in September 2024 across six databases: Medline via Ebsco; Embase via OVID; PsycINFO via Ebsco; Scopus; Web of Science Core Collection; and Global Health via Ebsco. Eligibility criteria were based on Population, Concept, and Context. The search identified 18,809 hits for screening with 812 included in the final analysis. Seven themes were identified from a content analysis of study aims: 1 Perspectives of living with a neurosurgical condition; 2 Family perspectives; 3 Perceptions of neurosurgery; 4 Perceptions of general healthcare care; 5 Decision making; 6 Advancing neurosurgery; and, 7 Understanding neurosurgical conditions. Traumatology was identified as the most researched sub-specialty (43.2%) yet few studies were led explicitly by a neurosurgeon (1.6%) or those with a neurosurgical affiliation (10.5%). Lead authors were predominantly from high income countries (93.7%), as were most multi-author teams (86.6%). There was a trend towards increasing publication over time; however, only 8.4% of papers were published in neurosurgical specific journals. The data set had an average Field Weighted Citation Impact of 0.96 and Field Weighted Views Impact of 1.11, 18.9% were cited in policy documents in 15 countries. This scoping review provides a comprehensive picture of the current qualitative research base in neurosurgery and suggests ways to improve the conduct and reporting of such studies in the future. Addressing these challenges is crucial if qualitative research is to advance the neurosurgical evidence base in a rigorous way.
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