The growing advancement of innovative stem cell technologies requires careful evaluation of their economic, clinical and societal impacts. Early economic evaluations are essential for developing new medical technologies and supporting key decisions about commercialisation and market access. This scoping review explores Early Health Technology Assessment (eHTA) approaches specifically related to human stem cell technologies. By examining how eHTA can support the commercialisation of these therapies, we aim to clarify its role in optimising resource allocation and enhancing both the clinical and societal benefits of stem cell technologies.

To explore the use of eHTA in the development of stem cell-related technologies, a scoping review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses - Scoping Review Extension guidelines. Systematic searches were conducted across scientific databases (MEDLINE, International HTA database, EconLit, PAIS Index and EconPapers), grey literature sources (Overton) and through hand-searching to identify eligible articles published from inception to 14 April 2026. No limits were imposed on language. Reviewers will independently record data from eligible studies using a standard data abstraction form. The gathered information will be synthesised both quantitatively and narratively.

Formal ethical approval is not required, as this study does not involve the collection of primary data. The findings will be shared through professional stem cell networks, published in national and international health technology assessment conference proceedings and submitted for open-access, peer-reviewed publication.

To determine burnout prevalence, associated factors and coping strategies used by nursing professionals.

Cross-sectional analytical study.

Public and private healthcare institutions in Kerala, India.

Nursing professionals in Kerala (n=349).

Burnout levels (assessed with the Burnout Assessment Tool (BAT)) and coping strategies. Log-binomial regression was performed to identify factors associated with burnout.

High burnout was reported by 36.1% of participants (126/349; 95% CI 31.1 to 41.4). Burnout prevalence was higher among nurses with an MSc (Master of Science) or higher educational qualification (adjusted prevalence ratio (APR)=1.46; 95% CI 1.04 to 2.03); those working in urban settings (APR=1.41; 95% CI 1.04 to 1.90); those who were single, divorced or separated (APR=1.58; 95% CI 1.18 to 2.12); those with travel time ≥30 min (APR=1.36; 95% CI 1.03 to 1.79); and those engaged in clinical/direct patient care duties (APR=1.75; 95% CI 1.18 to 2.59). Commonly reported coping strategies included active coping (59.6%), seeking instrumental social support (58.7%) and venting (54.4%), whereas negative strategies, such as substance use, were less frequent (22.9%).

Over one-third of the nurses in our study reported high burnout. Efforts to reduce burnout should focus on nurses with higher qualifications, those working in urban settings, those with higher travel time, those who are single/divorced/separated and those involved in clinical duties to enhance healthcare quality.

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.

This study assessed the feasibility of implementing a phase 3 field-based clinical trial protocol to evaluate paediatric praziquantel (PED-PZQ) for the treatment of Schistosoma mansoni infection in children aged 3 months to 6 years in endemic areas of Brazil, focusing on operational aspects such as recruitment logistics, documentation management, investigational product handling and protocol adherence.

Pilot and feasibility study for a phase 3 clinical trial, comprising two components: a randomised, open-label, parallel-group, two-arm trial and a single-arm trial.

Conde, Bahia, Brazil, from December 2024 to January 2025.

Two trials aim to screen 5774 participants from three rural areas in Bahia and three in Sergipe, states in northeastern Brazil, and enrol 403 children eligible for either randomisation or allocation. Trial 1 will randomise (1:1 ratio) 240 children aged 4–6 years into the PED-PZQ treatment arm or the standard praziquantel (PZQ) 1. Trial 2 will enrol 163 children aged 3 months to 3 years, all receiving PED-PZQ. Both trials are open label. Eligible participants shall meet age criteria, test positive for S. mansoni and fulfil other inclusion criteria. In the first recruiting centre, Conde (Bahia), it was estimated that 650 participants would need to be screened for trial 1 and 552 for trial 2, assuming schistosomiasis prevalence of 5% and 4%, respectively. This pilot study reports on the first 60 participants enrolled.

The primary outcome of this pilot study is the feasibility of implementing the research protocol in a real-world field setting, focusing on key aspects such as study documentation challenges, participant safety, investigational medicinal product custody chain and protocol adherence. In addition to providing preliminary data on the parasitological cure rate, secondary outcomes include the prevalence of S. mansoni infection and the reduction in S. mansoni egg count (Kato-Katz method). Furthermore, the occurrence and severity of drug-related adverse events are monitored from drug administration to day 21 post-treatment, alongside changes in renal, hepatic and cardiac functions assessed through biochemical markers.

A total of 60 participants were recruited, and 55 provided stool samples for screening. The pilot phase demonstrated the feasibility of implementing the clinical protocol under field conditions, with successful completion of all planned procedures and minimal protocol deviations. Operational challenges were identified mainly in documentation processes, participant recruitment and investigational product management and were addressed through preventive and corrective quality assurance actions. The experience also highlighted logistical and infrastructural barriers typical of field-based trials in remote endemic areas, which informed adjustments for the subsequent phase 3 study. Preliminary parasitological results indicated an overall S. mansoni prevalence of 9.1% (5/55), with 21% in trial 1 and 2.8% in trial 2. All infected participants met the eligibility criteria, received treatment and completed follow-up. Four achieved a parasitological cure, and one case of treatment failure was observed (trial 1, PZQ group). Two mild adverse events (diarrhoea) were reported, with no serious complications or clinically significant changes in biochemical parameters.

This pilot study demonstrated the feasibility of implementing a field-based phase 3 clinical trial protocol for PED-PZQ in endemic areas of Brazil. The findings confirm that the protocol can be successfully applied in primary care settings, despite operational challenges related to recruitment, logistics and documentation. The study also provided preliminary evidence supporting the safety and effectiveness of the paediatric formulation and highlighted the need to revise prevalence assumptions to improve future screening strategies. Overall, the experience offers valuable insights to guide the large-scale phase 3 trial and supports the incorporation of PED-PZQ into national schistosomiasis control policies.

Brazilian Clinical Trials Registry; RBR-86kcy37.

Intermittent theta-burst stimulation (iTBS) is a non-invasive brain stimulation technique that has been shown to improve cognition and mood when applied to certain brain structures and regions. Despite research demonstrating that iTBS may have clinical utility in treating cognitive and mood changes, no study has yet been conducted to explore the potential to modulate the neurophysiological changes that can underpin cognitive and mood changes during the menopause transition. Cognitive and psychological symptoms are commonly reported by females experiencing the menopause transition, and it is thought that these symptoms arise due to various neurophysiological, metabolic and endocrinological changes. Despite being common, there is a lack of treatments available for managing these symptoms and a scarcity of data regarding the mechanisms by which they occur.

The aim of this 5-week randomised, sham-controlled, double-blinded pilot clinical trial (n=72) is to assess the underlying mechanisms of action of iTBS in females in the late menopause transition and the relationship with cognition and mood. Data will be analysed using Stata^TM. Normality checks will guide the choice between parametric and non-parametric tests. Generalised linear models will assess within-subject and between-subject effects across timepoints, with additional regression analyses exploring associations between biomarkers, cognition and mood. Effect sizes, CIs and relevant test statistics will be reported, with significance set at p

The study protocol has been reviewed and ethically approved by the Western Sydney University Human Research Ethics Committee (H16200; 8 November 2024). All participants will provide written informed consent prior to enrolment. Results from this trial will be disseminated via peer-reviewed publications and conference presentations, with findings shared in accordance with open science and data transparency principles.

ACTRN12625000030471, Australian New Zealand Clinical Trials Registry

It has been reported that pregnant women used more cosmetics daily than non-pregnant women. Phenoxyacetic acid is the main metabolite of phenoxyethanol, the most frequent preservative in cosmetics used in Europe, previously associated with reproductive effects (longer time to conception, endocrine disruptors in newborns and poorer verbal comprehension in children). In France, specialised platforms (PREVention ENvIronment Reproduction (PREVENIR)) in university hospital maternity wards are dedicated to evaluating environmental and occupational exposures in patients with pregnancy-related pathologies and supporting targeted prevention efforts. These platforms are composed of occupational health physicians, obstetrician-gynaecologists, midwives, occupational health nurses, and occupational health and environmental engineers. To assess the efficacy of these platforms, we developed a randomised clinical trial, the protocol for which is presented in this paper. The primary objective of the PREVENIR-G Study is to compare the change in urinary phenoxyacetic acid concentrations from baseline to 3 months postintervention between an intervention group and a control group. To date, the intervention has been integrated into routine care in certain facilities; however, its efficacy remains unproven. It is therefore essential to assess the relevance of this intervention, considering both its potential benefits and any adverse effects, such as increased stress or anxiety.

This study is an unblinded, randomised clinical superiority trial with two parallel groups (intervention vs no intervention) in four university maternity hospitals in France. We will include 300 pregnant women (aged 18 years or older) who are under 24 weeks of gestation (150 per group) referred to the participating PREVENIR platforms for management. The intervention will consist of clinical prevention management through the PREVENIR platforms, involving a consultation with an environmental health expert for an assessment of environmental and occupational exposures. During the consultation, targeted prevention messages will be provided based on identified exposures. The no intervention comparator will be a waiting-list control group. At the inclusion visit, patients will receive urine collection vials for samples to be collected at baseline and again at 3 months. Urine samples will be collected twice in a single day, on three separate days, during the collection week at home. In the week following the urine collection period, only participants in the intervention group will engage with the PREVENIR platforms. The primary outcome will be the difference in the urinary phenoxyacetic acid concentration between baseline and 3 months postintervention, compared between the intervention and control groups.

The study has been approved by the hospital ethics committee (CCP Ouest 2, no. 2023-A00941-44). All participants will provide written informed consent. Results will be shared through presentations and publications.

NCT06642818

To describe diagnostic and management characteristics of acute rheumatic fever (ARF) among participants in the ‘Searching for a Technology-Driven Acute Rheumatic Fever Test’ study, in order to answer clinical questions and determine epidemiological and practice differences in different settings.

Multisite, prospective cohort study.

One hospital in northern Australia and two hospitals in New Zealand, 2018–2021.

143 episodes of definite, probable or possible ARF among 141 participants (median age 10 years, range 5–23; 98% Indigenous).

Participant characteristics, clinical, biochemical and echocardiographic data were explored using descriptive data. Associations with length of stay were determined using multivariable regression analysis.

ARF presentations were heterogeneous with the most common ARF ‘phenotype’ in 19% of cases being carditis with joint manifestations (polyarthritis, monarthritis or polyarthralgia), fever and PR prolongation. The total proportion of children with carditis was 61%. Australian compared with New Zealand participants more commonly had ARF recurrence (22% vs 0%), underlying RHD (48% vs 0%), possible/probable ARF (23% vs 9%) and were underweight (64% vs 16%). Erythrocyte sedimentation rate (ESR) provided an incremental diagnostic yield of 21% compared with C reactive protein. No instances of RHD were diagnosed among participants in New Zealand. Positive throat Group A Streptococcus culture was more common in New Zealand than in Australian participants (69% vs 3%). Children often required prolonged hospitalisation, with median hospital length-of-stay being 7 days (range 2–66). Significant predictors for length of stay in a multivariable regression model were valve disease (adjusted OR (aOR) 1.56, 95% CI 1.23 to 1.98, p

This study provides new knowledge on ARF characteristics and management and highlights international variation in diagnostic and management practice. Differing approaches need to be aligned. Meanwhile, locally specific information can help guide patient expectations after ARF diagnosis.

Chronic limb-threatening ischaemia (CLTI) represents a severe and debilitating condition characterised by inadequate blood supply to the extremities, leading to acute and persistent pain, ulceration and a heightened risk of limb loss. Patients with CLTI often experience chronic pain that significantly impairs their quality of life. The pain experienced by patients with CLTI can be complex and challenging to manage, requiring a refined approach to balance analgesic efficacy with potential adverse pharmacological effects and pre-existing, competing comorbidities. This systematic review protocol aims to explore, critically assess and compare the effectiveness and safety of different pharmacological and locoregional analgesic approaches for managing pain occurring secondary to CLTI.

The methods will be performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Five electronic databases will be searched. At least two reviewers will perform study screening, data extraction and quality assessments. Any disagreements will be arbitrated by an additional independent reviewer. Randomised studies, observational cohort studies and case series consisting of four or more patients will be included. Grey literature will be excluded. The primary outcome will be the effectiveness of analgesia. Secondary outcomes will include adverse effects of analgesia and functional outcomes. Where the data allow, appropriate quantitative synthesis methods will be pursued.

This systematic review will not involve primary data collection; thus, no ethical approval is required. The results will be disseminated in a peer-reviewed publication and presented at conferences.

CRD42024561800