School-aged children frequently experience psychological distress due to academic pressures, a challenge that is often more severe for those from underserved and minority communities. This study aims to evaluate the effectiveness of mental health interventions implemented in school and community settings for children aged 5 to 19. It also seeks to compare the outcomes between children from minority and underserved populations and their peers.
This systematic review will follow Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines to identify relevant studies. Major databases will be searched using a structured search strategy developed by the research team. The review will include randomised controlled trials (RCTs) that assess the impact of interventions conducted in school or community settings to prevent psychological distress—specifically depression, anxiety and stress. To minimise bias, two reviewers will independently select studies and extract data at various stages. The quality of included studies will be assessed. A meta-analysis will be conducted to compare intervention outcomes between children from underserved/minority communities and other children. Pooled prevalence rates and subgroup analyses will be used to explore differences in effectiveness. Heterogeneity among studies and publication bias will also be assessed. Meta-analyses of proportions, ORs and relative risks will be conducted using a random-effects model to estimate effect sizes from multivariate analyses.
Ethical approval was not required, as this study involved secondary analysis of published literature and did not involve human participants. To date, no systematic review has comprehensively compared school-based and community-based interventions in terms of their effectiveness in addressing anxiety, depression and stress among school-aged children. This review aims to fill that gap by providing clinical insights into the comparative effectiveness of various intervention types and settings.
CRD42023479389.
Although Negative Pressure Wound Therapy (NPWT) has been increasingly used in wound care to improve impaired healing, there is little scientific evidence supporting its role and underlying biomolecular mechanisms. Aims of the present study are to provide a quantitative analysis of recent literature investigating NPWT in diabetic wound healing focusing on healing duration, wound closure, hospitalisation period and complications, and qualitative insight into studies analysing biomolecular mechanisms. The systematic review and meta-analysis were conducted following PRISMA guidelines (PROSPERO: CRD42024524813). 21 studies published in PubMed, Cochrane Library, EMBASE between 2019 and 2024 were included. Clinical studies indicated NPWT was superior to standard care dressings (SCD), promoting faster wound healing with significantly reduced hospitalisation times by 7.8 days (95% CI: −14.2 to −1.4, p = 0.017), and significantly reduced complications rates, particularly major and minor amputations (95% CI: −10.2 to −1.3, p = 0.01). Mechanistic in vitro and animal studies highlighted NPWT can reduce local inflammation, oxidative stress, support angiogenesis and improve scarring, essential components of normal healing. Although studies suggest NPWT is more effective than SCD for diabetic wound healing, the paucity of studies, small cohorts and scarce outcomes consistency make defining clear conclusions challenging. There is still more evidence required to fully understand NPWT's role in the complex diabetic wound healing.
Primary healthcare (PHC) emergency services are critical as the first line of defence against life-threatening conditions, significantly reducing mortality and morbidity. Globally, life-threatening emergencies (LTEs) such as acute myocardial infarction, stroke, severe trauma and respiratory failure frequently present first at PHC centres, particularly in low- and middle-income countries. However, inadequate emergency preparedness at the primary care level contributes to substantial avoidable mortality and long-term disability. Many PHC centres, especially in underserved and rural areas, face substantial challenges including inadequate equipment, insufficient training and poor referral systems which compromise emergency care quality and outcomes. Despite the recognised importance of PHC in emergency care, there is currently no synthesised evidence comprehensively mapping the barriers and facilitators that influence LTE management at this level. This systematic review aims to synthesise evidence on barriers and facilitators in managing LTEs at PHC centres to inform effective interventions and policy development.
This systematic review will comprehensively search PubMed/MEDLINE, Scopus and Web of Science for relevant literature published up to 31 May 2026. In accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, two independent researchers will conduct a three-stage screening process: initial title/abstract evaluation, full-text assessment and manual review of reference lists. Any disagreements between reviewers will be adjudicated by the lead investigator. The eligibility criteria and research question will be established using the SPIDER framework, which examines Sample, Phenomenon of Interest, Design, Evaluation and Research Type components. Methodological quality will be appraised using the Mixed Methods Appraisal Tool (2018). Extracted data will be systematically collected using a standardised form. A ‘best fit’ framework synthesis approach, complemented by thematic analysis, will be employed to integrate qualitative evidence.
The protocol for this systematic review has received ethical approval from the Research Ethics Committee of Tabriz University of Medical Sciences (approval number: IR.TBZMED.VCR.REC.1404.061). The committee confirmed that the study objectives do not involve direct patient contact or clinical interventions, and therefore, the review meets ethical standards for research based exclusively on published literature. Findings will be disseminated through peer-reviewed publication, conference presentations and policy briefs.
Registration number PROSPERO CRD420251071584.
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.
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.
To estimate the contribution of ultraprocessed foods (UPF) to total energy intake and to macronutrient and micronutrient intakes among very old people aged 85 years in the Newcastle 85+ Study.
Cross-sectional observational analysis of baseline dietary and demographic data from the Newcastle 85+ cohort.
Community-dwelling and institutionalised adults in Newcastle on Tyne and North Tyneside, UK, recruited through general practice registered between June 2006 and October 2007.
Eight hundred participants (62% female) aged 85 years at baseline, with two complete non-consecutive 24-hour dietary recalls.
The primary outcome was the contribution of UPF (Nova group 4) to total energy intake, macronutrient intakes, expressed as percentage of total energy for carbohydrate, protein, total fat, saturated fat and added sugars, as grams per day for fibre and to micronutrient intakes (vitamins A, B, B₁2, C, D, E and folate) and minerals (calcium, potassium, magnesium, zinc, selenium, phosphorus, iron and sodium). All evaluated across sex, education and socioeconomic status, adjusted tertiles of UPF intake.
Among the 800 participants included in the analysis, UPF contributed 56% of total energy intake, surpassing that from unprocessed foods (27%). Total energy intake did not differ across tertiles of UPF consumption (lowest vs highest tertile: 1759.5 kcal/day (95% CI 1684.6 to 1834.4) vs 1740.0 kcal/day (1667.3 to 1812.7)). Higher UPF intake was associated with a higher proportion of energy from carbohydrates and added sugars, and a lower proportion from protein and saturated fat. Intakes of several micronutrients were lower in the highest versus the lowest UPF tertile, including vitamin C (59.9 mg/day (49.8 to 70.0) vs 94.0 mg/day (83.7 to 104.4)) and potassium (2455.9 mg/day (2334.1 to 2577.6) vs 2786.3 mg/day (2660.8 to 2911.8)). By contrast, calcium from fortified foods increased across tertiles (6.3 mg/day (3.7 to 8.9) to 15.4 mg/day (12.9 to 17.9)).
This study highlights the potential role of UPF in the diets of very old people: higher UPF intake was not associated with higher energy intakes often observed in younger populations. Some UPF, particularly fortified products, may contribute to meeting micronutrient requirements in very old people where dietary inadequacies are common. Further research is needed to confirm these findings and to inform dietary guidance for very old people.
by Sosina Workineh Tilahun, Adiam Nega, Lealem Wagaw, Adamu Addissie
BackgroundShared decision-making is crucial for alignment of treatment options with patient values and preferences. However, currently in Ethiopia, shared decision-making in clinical care of cancer, in which cervical cancer is not exceptional, is not well understood.
AimThis study aimed to assess the perceived level of shared decision-making and its predictors in cervical cancer care at Tikur Anbessa Specialized Hospital in Addis Ababa, Ethiopia.
MethodsWe employed a convergent parallel mixed-methods study design from February 18 to May 23, 2025, at Tikur Anbessa Specialized Hospital. The study used interviewer-administered questionnaires for 203 cervical cancer patients and in-depth interviews for 15 cervical cancer patients and 10 clinical oncologists. Using SPSS v26, multiple linear regression analysis was used to determine significant predictors of the perceived level of shared decision-making, with statistical significance set at P Results
The overall mean score for the perceived level of shared decision-making was 24.94 (± 9.12), with a range of 7–44, and the standardized mean score was 2.77 (± 1.01). The perceived level of shared decision-making had positive linear associations with increased trust in oncologists (0.32, 95% CI (0.21, 0.44); p Conclusions
The study emphasized the complex interplay of factors influencing the practice of shared decision-making in clinical care of cervical cancer. Therefore, understanding these dynamics may help to enhance the practice of shared decision-making in clinical cervical cancer care.
by José Manuel García-Moreno, Tyler Adams, Amber Beynon, Janine Vlaar Olthuis, Stephan U. Dombrowski, Richelle Witherspoon, Niels Wedderkopp, Jeffrey J. Hébert
BackgroundRehabilitation and behavior change interventions are commonly used after lumbar surgery to improve recovery, but their effects on physical capacity and physical activity remain unclear. This study aimed to investigate the effectiveness of rehabilitation and behavior change interventions on physical capacity and physical activity behavior in patients following lumbar surgery for degenerative disease.
MethodsEMBASE, MEDLINE, PsycINFO, and CENTRAL were searched from inception to September 2025 and reference lists were hand-searched. Randomized controlled trials assessing rehabilitation or behavior change interventions on physical capacity or physical activity behavior in adults with lumbar degenerative disc disease who underwent lumbar surgery were included. Review author pairs independently extracted data and assessed included studies. Risk of bias was assessed with the Cochrane tool, and study quality with the Grading of Recommendations Assessment, Development and Evaluation classification. Results were pooled using random-effects models and reported as standardized mean differences (SMD) with 95% confidence intervals (CI).
ResultsExercise was more effective than minimal or usual care in improving trunk extension endurance in the immediate term (SMD, 1.54; 95% CI, 0.93–2.16). Supervised exercise outperformed self-directed exercise in improving trunk extension endurance in the immediate term (SMD, 1.28; 95% CI, 0.75–1.81). Psychologically informed rehabilitation was more effective than minimal or usual care in increasing physical activity levels in the intermediate term (SMD, 0.26; 95% CI, 0.02–0.49), but not in the immediate term (SMD, 0.17; 95% CI, −0.14 to 0.49). Physical activity advice did not increase physical activity levels compared to minimal or usual care in the immediate term (SMD, 0.21; 95% CI, −0.13 to 0.55). Prehabilitation was more effective than minimal or usual care in increasing physical activity levels in the intermediate term (SMD, 0.28; 95% CI, 0.03–0.53). Certainty of evidence ranged from low to moderate.
ConclusionsFor adults with lumbar degenerative disease who underwent lumbar surgery, exercise, especially supervised programs, improved trunk extension endurance in the immediate term. Psychologically informed rehabilitation and prehabilitation increased physical activity levels in the intermediate term, while physical activity advice showed no benefit. Findings are limited by low certainty of evidence and high risk of bias.
by Gift Treighcy Banda-Mtaula, Ibrahim Simiyu, Sangwani Nkhana Salimu, Stephen A. Spencer, Nateiya M. Yongolo, Marlen Chawani, Hendry Sawe, Jamie Rylance, Ben Morton, Adamson S. Muula, Eve Worall, Felix Limbani, Miriam Taegtmeyer, Rhona Mijumbi, on behalf of the Multilink consortium
Multimorbidity, the presence of multiple chronic health conditions, is a leading cause of death globally. In Malawi, chronic noncommunicable and communicable diseases such as HIV frequently co-exist, putting pressure on an under-resourced system. However, the health system is primarily structured around disease-specific [vertical] programs, which hinders person-centred care approaches to multimorbidity. Our study focuses on multimorbidity care and explores the perceptions of healthcare workers on the patient pathways and service organisation throughout the patient’s interaction with the health facilities. This cross-sectional qualitative study took an interpretivist approach. We conducted 13 days of clinical observations at Queen Elizabeth Central Hospital and Chiradzulu District Hospital. We also conducted 13 days of clinical observations and semi-structured in-depth interviews with different cadres of purposively sampled healthcare workers (n = 22) at Queen Elizabeth Central Hospital and Chiradzulu District Hospital. Through thematic analysis, we identified an understanding of the organisation of care and healthcare workers’ perspectives on the delivery of services. Findings showed both hospitals provided services for inpatients and outpatients with multimorbidity, including screening, management, prevention of secondary conditions and rehabilitation. Patient diagnosis and management for multimorbidity were often delayed due to frequent stockouts of medication and consumables necessary for diagnostic testing for NCDs at the hospital level. Some healthcare workers were not equipped with the knowledge, skills, or guidelines to manage multimorbidity. As HIV care is currently better resourced than other chronic conditions, healthcare facilities may strengthen the supply chain, healthcare workers’ training sessions and monitoring and evaluation tools to ensure NCDs are well managed, learning from HIV programmes.Knee osteoarthritis (KOA) is a prevalent degenerative joint disorder, often accompanied by comorbidities like type 2 diabetes mellitus (T2DM). These conditions have a significant impact on patients’ sleep quality and metabolic health. Current treatments for KOA primarily focus on symptom management, while innovative approaches targeting interconnected health outcomes remain underexplored. The lumbar knee recovery device, a non-invasive device patented in Iran, offers potential benefits by enhancing lumbar-knee synchronisation, improving blood circulation and optimising cellular metabolism. This randomised controlled trial (RCT) aims to evaluate the device’s effectiveness in improving sleep quality and regulating blood glucose levels in diabetic patients with KOA.
This RCT aims to evaluate the impact of using the lumbar knee recovery device (Kamarasa) on sleep quality, blood glucose levels, HbA1c (blood glucose control level over the past 90 days) and body mass index (BMI) in patients with T2DM and grade 1–3 KOA. The study will be conducted at the Orthopedic Clinic of Imam Khomeini Hospital, Tehran, and the Health and Wellness Clinic. Eligible participants will be randomly allocated into two groups: the intervention group (receiving 10 supervised sessions using the Recovery device over 3 months) and the control group (receiving standard KOA and diabetes care). A total of 37 participants will be included in each group. The primary outcome, sleep quality, will be assessed using the Pittsburgh Sleep Quality Index at baseline and 3 months post intervention. Secondary outcomes will include random blood glucose levels, which will be measured at 10 intervals during the study; BMI, measured at the start and end of the study and HbA1c, assessed at both baseline and post intervention. The Western Ontario and McMaster Universities Arthritis Index will be used to assess pain, stiffness and physical function, also at both baseline and 3 months. Appropriate statistical tests, including two-sample t-tests, ² tests, analysis of covariance or linear regression, will be performed based on the type of variables using SPSS V.23. Additionally, standardised intervention effect sizes will be calculated for each outcome.
Ethical approval for this study was obtained from the Research Ethics Committee of the School of Nursing and Midwifery at Tehran University of Medical Sciences with reference number (IR.TUMS.FNM.REC.1403.145). Additionally, the study protocol was registered with the IRCT under the identifier IRCT20191027045257N7 on 24 November 2024.
Iranian Registry of Clinical Trials (IRCT20191027045257N7). This clinical trial was registered on 24 November 2024.
Scar outcomes are known to vary by skin tone and race, yet few studies have systematically evaluated these differences using validated tools. To evaluate differences in scar maturation across Fitzpatrick skin types and racial groups from 3 to 12 months postoperatively using the modified Patient and Observer Scar Assessment Scale (POSAS) scale. We conducted a prospective observational study of 40 patients undergoing breast surgery at a single academic centre. All scars were assessed at 3 and 12 months postoperatively using the modified POSAS. Fitzpatrick skin types were categorized into I–II, III–IV, and V–VI, and racial groups included Caucasian, Black, and Hispanic patients. Fitzpatrick Types I–II had the greatest vascularity reduction (–2.06 ± 2.10), while Types V–VI showed the least improvement (–0.80 ± 1.61). Pigmentation increased in Types V–VI (+0.35 ± 1.89) and improved in lighter skin tones. Black and Hispanic patients had significantly lower odds of favourable pigmentation outcomes (p < 0.07). Fitzpatrick Types V–VI also had lower odds of improved scar relief (OR = 0.125, p = 0.034). This study highlights differences in scar maturation across skin tone and racial categories using a standardized scale. These trends underscore the importance of tailoring postoperative scar counselling and interventions to individual patients’ skin types and racial backgrounds.
Clinical psychology interventions for reducing obesity have developed alongside pharmacological and surgical treatments, but usually as interventions for individual patients. Any healthcare intervention rests on a logic model: assumptions that through specific physical and social mechanisms, it will produce certain intended outcomes, provided that conducive background conditions (‘contexts’) exist. Using evidence from the feasibility trial preceding a full randomised controlled trial (RCT), this paper assesses the empirical validity of the initial logic model of a new group-based weight management intervention: PROGROUP, designed for patients with body mass index (BMI) ≥40 kg/m2 or ≥35 kg/m2 with comorbidities. We aimed to test whether:
PROGROUP’s programme components produce the intended outcomes at all, whatever their size and how. The intervention can practicably be implemented (‘delivered’) as designed. How the programme and delivery components affected each other.
Multimethod proof-of-concept study by means of realist evaluation of the initial PROGROUP logic model. We:
Elicited the logic model underlying the intervention design. Compared these assumptions with data from a pre-RCT feasibility study in two English and one Welsh National Health Service (NHS) sites during 2021–2023. Revised the logic model in light of the data, noting how much variation in delivery the programme components (therapeutic mechanisms) could tolerate.
Specialised ambulatory mental health services in the English NHS.
Adults with severe obesity (BMI ≥40 kg/m2 or ≥35 kg/m2 with comorbidities).
Group-building techniques to enhance group members’ adoption of evidence-based methods of behaviour change affecting their dietary behaviour and physical activity.
Qualitative outcomes. What kinds of:
Mechanisms were established and triggered by the attempt to implement PROGROUP (secondary outcome, see objective 1 above). Patient behaviours resulted and whether patients sustained them after the intervention ended (primary outcome; see objective 1 above); and what kinds of context affected that (objectives 2 and 3).
Quantitative measures not used.
The initial logic model assumed that the following sequence of mechanisms would produce weight loss: referral from GP to specialist weight management services; further referral to PROGROUP; preparatory individual consultation; facilitated group sessions produce a group identity; group identity reinforces weight management capability and motivation; further individual consultations adjust for individual circumstances; behaviour change outside the treatment setting, producing weight loss. Contexts necessary for these mechanisms to work included: sufficient catchment population; group size, continuity and membership retention; suitable location; facilitator training; and practical support outside the treatment setting.
The findings suggested revisions to the logic model, but more in the delivery components and contextual assumptions than the core therapeutic mechanisms. There was scope to simplify the referral mechanisms. Different professions could implement the model. A realist evaluation of a pre-RCT feasibility study can be used to make the intervention’s logic model more securely evidence-based, serving as a proof-of-concept test for the intervention. It indicated the conditions under which such group psychological interventions might be more widely used.
Food retail outlets in sports and recreation facilities often fail to support healthy eating, despite aligning with healthy lifestyles and goals of local governments (LGs) that often own or manage them. LGs face barriers to implementing facility changes including inadequate staffing, training and incentives. The Promoting CHANGE initiative was co-designed to support LGs in improving and sustaining healthier food and drink offerings in these settings.
A 3-year, type 2 effectiveness-implementation hybrid cluster randomised controlled trial will evaluate the Promoting CHANGE capacity-building and support package in three Intervention and four Control LGs in Victoria, Australia (August 2023–July 2026). The co-designed initiative includes human resource support, training, tools, technical assistance, community-of-practice groups, feedback based on food outlet audit and sales data and small grant incentives. Using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) evaluation framework, the trial’s co-primary outcomes are the percentage of least healthiest food and drinks (1) displayed (implementation) and (2) sold weekly (effectiveness). Key secondary outcomes are effectiveness (sales and revenue); facility-level adoption, implementation, maintenance of healthy changes; cost-effectiveness (within-trial modelled economic evaluation). Findings will provide evidence of the initiative’s effectiveness and scalability, informing recommendations for advancing healthier food environments in over 6000 community-based food outlets across 500 Australian LGs, with implications globally.
This study has received approval from the Deakin University Human Research Ethics Committee (reference number HEAG-H 92_2023). The results will be published in scientific peer-reviewed journals along with plain language summaries for participants.
ACTRN12621001120864.
by Sian E. Wanstall, Brandon W. J. Brown, Meagan E. Crowther, Claire Dunbar, Robert J. Adams, Anjum Naweed, Amy C. Reynolds
BackgroundParamedics face unique occupational hazards, including high operational demands, trauma exposure, and shift work, all of which impact mental well-being. Suboptimal sleep is also common in this workforce and closely linked to adverse mental health outcomes. This scoping review synthesizes evidence to date on interventions to support paramedic mental well-being including sleep-based interventions.
Materials and methodsThis review was pre-registered on the Open Science Framework (https://doi.org/10.17605/OSF.IO/7VSD9). Systematic database searches were conducted in October 2024 for original research published after 2004. Data were narratively synthesised, and findings reported following established guidelines.
ResultsNineteen sources were included, involving 1,067 participants across seven countries. Seventeen interventions were examined, predominantly via randomized controlled trials (58%), utilizing a total of 43 different measurement scales to evaluate mental health and sleep outcomes. Interventions included psychological (37%), sleep, fatigue and/or shift work (32%), and complementary and alternative medicine (32%) approaches which primarily focussed on the individual-level (94%). Studies were limited by sample sizes, design and quality, limited long term follow-up, and low baseline symptoms.
ConclusionsThis review highlights a critical gap in robust, evidence-based, system-level interventions to address poor sleep and mental well-being in paramedics. Future research should prioritise co-designed, context-sensitive approaches, ideally integrated within organisational structures to ensure relevance and accessibility.
Losses of functional reserve across multiple physiological systems have been identified in frail patients, yet the exact aetiology of frailty remains unclear. Although strongly associated with chronological age, frailty often develops at a younger age in patients with organ failure. Frailty is prevalent in patients with kidney failure; however, individuals experience improvements in physical frailty measures following kidney transplantation. This makes younger patients with kidney failure a unique population for studying both the accelerated onset of frailty and its reversal. This research project aims to test the hypothesis that frailty secondary to organ failure and age-related frailty are associated with similar molecular and physiological measures.
This longitudinal study will recruit 150 patients in three groups. Group A (kidney transplant recipients aged ≥40 years; n=50) and Group B (patients aged ≥40 years active on the kidney transplant waitlist; n=50) will comprise younger adults with frailty from organ failure. Group C (adults aged ≥65 years (or ≥55 years for Aboriginal and Torres Strait Islander patients); n=50) will comprise older community dwellers. The primary outcome is the Frailty Index (FI). Secondary outcomes include the change in FI over time, and at baseline when considering various clinical metadata, immune parameters, kidney function and nutrition intake which will be measured at baseline and 12-month time points. Longitudinal changes in frailty will be analysed using linear mixed models with multiple testing corrections for false discovery rates.
Endocrine profiles and metabolomics, measures of immune function and microcirculatory dysfunction, will be measured by liquid chromatography-mass spectrometry and/or gas chromatography-mass spectrometry. The gut microbiome will be sequenced via shotgun metagenomics (Illumina NextSeq500, 150 bp paired-end, 3Gbp/sample). Circulating cell-free DNA/mitochondrial DNA will be quantified through droplet digital PCR. Microcirculation will be assessed via sublingual dark field videomicroscopy with glycocalyx markers measured by ELISA.
This study will be conducted with all stipulations of this protocol, and the conditions of the ethics committee approval. Ethical principles have their origin in the Declaration of Helsinki, all Australian and local regulations and in the spirit of the standard of Good Clinical Practice (as defined by the International Conference on Harmonisation). Organs/tissues will be sourced ethically and will not be sourced from executed prisoners or prisoners of conscience or other vulnerable groups.
Ethics approval was received by the Metro South Health Research Ethics Committee (HREC/2023/QMS/95392) and ratified by the University of Queensland.
Results will be disseminated through peer-reviewed publications, academic conferences, participant newsletters and health organisation collaboration.
by Adam V. Wisnewski, Jian Liu
A panel of hybridomas specific for different isomers of toluene diisocyanate (TDI), a cross‑linking chemical used in polyurethane production, has been previously described. These hybridomas were originally developed by researchers at the USA’s National Institute for Occupational Safety and Health (NIOSH). We sought to determine the DNA sequence encoding these TDI-specific monoclonal antibodies, enabling identification of germline gene rearrangement resulting in chemical specificity as well as production of the mAbs recombinantly. B cell receptor sequencing (BCR-seq) of hybridoma RNA readily identified productive heavy and light chain antibody sequences. The productive light chains of all 7 hybridomas showed strong identity with different genomic variable (V) and joining (J) region sequences with few changes from germline configuration. However, the productive heavy chains contained more substantial changes in their genomic V and J-region sequences consistent with antigen-driven affinity maturation, as well as N- and P- nucleotide additions comprising their complementarity-determining region 3 (CDR3). The hybridoma-defined TDI-specific mAbs were subsequently produced recombinantly in a human embryonic kidney cell line expression system, purified, and tested for their binding capacity against albumin derivatized with TDI, related diisocyanates, and control antigen. The recombinant versions of the TDI-specific mAbs demonstrated binding capacity for different isomers (2,4 and 2,6) of TDI consistent with that previously reported for the hybridoma secreted clones; one specific for 2,4-TDI, one specific for 2,6-TDI, three that bind both 2,4- and 2,6-TDI, and two that show cross-reactivity with 4,4′‑methylene diphenyl diisocyanate (MDI). None of the recombinant mAbs bound to aliphatic hexamethylene diisocyanate (HDI), its oligomer, or control antigen. Additional recombinant versions of the TDI mAbs, with identical V-regions, but different C-regions, demonstrated the dependence of antigen specificity on the V-region, but also highlighted the potential for C-region sequence to affect their detection in ELISA assays. The DNA sequences defined herein may be useful to other investigators wishing to generate recombinant TDI-specific mAbs as detection reagents for research or as standards for clinical serology tests.Urgent and emergency care (UEC) systems in England face unprecedented pressures, with record accident and emergency attendances, persistent breaches of ambulance response targets and poorer outcomes for time-sensitive conditions. National UEC recovery plans have introduced multiple innovations—such as same-day emergency care, virtual wards and specialty hubs—to manage these pressures and improve patient flow. Rural coastal areas are particularly vulnerable to excessive demand due to higher levels of deprivation, older populations with complex health needs, seasonal surges that generate unpredictable demand and challenges in attracting and retaining staff. Following the Chief Medical Officer’s 2021 Annual Report, funding research and developing bespoke solutions to manage UEC demand and address geographical disparities has been recognised as a national priority. The Elevate study responds to this priority by identifying and evaluating innovative models of UEC in rural coastal communities in England.
The Elevate study is a 30-month, mixed-methods evaluation that comprises three interlinked work packages: (1) National service mapping—outlining provision of innovative models of UEC in rural coastal areas of England. This will be developed through document review and interviews with regional and national service leaders. (2) Quantitative analysis—quasiexperimental and longitudinal approaches will use National Health Service (NHS) England’s Emergency Care Data Set and linked routine NHS datasets to evaluate the impact of UEC models on health and process outcomes. Standard and bespoke metrics will be developed and used to assess performance. (3) Qualitative case studies—up to 12 case studies of UEC models in rural coastal communities. Interviews with patients and staff and non-participant observation will explore how and why different UEC models influence patient experience, clinical outcomes, resource use and the workforce. Findings will be integrated using the Consolidated Framework for Implementation Research to identify components of UEC models that are effective, scalable and sensitive to local context,
Ethical approval for qualitative components was granted by the North of Scotland Research Ethics Committee (25/NS/0099). Dissemination will include peer-reviewed publications, policy briefs, creative media and community engagement activities to ensure findings are communicated inclusively and effectively to policymakers, health and social care practitioners and the public.
Research Registry (researchregistry11126).
Global ageing populations require accessible, non-invasive tools for early detection and monitoring of neurological chronic and neurodegenerative diseases. Current diagnostic methods face limitations including invasiveness, high costs and infrequent clinical assessments. The human voice has emerged as a promising digital biomarker, with vocal characteristics reflecting physiological and cognitive changes associated with conditions like dementia and Parkinson’s disease. While artificial intelligence (AI) and machine learning have enabled sophisticated vocal analysis, the literature remains fragmented without comprehensive synthesis. This scoping review protocol delineates a systematic approach to collate and synthesise existing research on the application of AI-driven audio biomarkers for the detection and management of neurological diseases (eg, cognitive decline, Parkinson’s disease, Alzheimer’s, dementia and depression) in older adults aged 65 years and above.
This scoping review will be conducted in accordance with the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines and the methodological framework proposed by Arksey and O’Malley, incorporating recent methodological advancements. The eligibility criteria for study selection will be formulated using the PCC (Population, Concept, Context) framework. A comprehensive literature search will be performed across several electronic databases, including PubMed/MEDLINE, Scopus, Web of Science, IEEE Xplore, Embase, Compendex, CINAHL, Scientific Information Database (SID), Magiran, IranMedex and Barakat Knowledge Network System (BKNS). The search will encompass peer-reviewed articles published in Persian and English from 1 January 2012 to 31 March 2026. Two independent reviewers will screen titles, abstracts and full texts and extract data according to the predefined PCC-based eligibility criteria. Discrepancies will be resolved through discussion or, if necessary, by consultation with a third reviewer. The results will be synthesised and presented narratively, accompanied by summary tables, charts and figures to address each research question.
The Research Ethics Committee of Tabriz University of Medical Sciences approved the protocol for this scoping review (approval number: IR.TBZMED.VCR.REC.1404.223). They concluded that since the review involves only analysis of existing literature without direct patient involvement or clinical procedures, it meets the relevant ethical standards. Results from the review will be shared through peer-reviewed journals and conference presentations to provide valuable insights for researchers, clinicians and policymakers on the use of audio-based biomarkers in older adults.
Not registered.