An affordable heart-healthy dietary approach is essential for the management of familial hypercholesterolaemia (FH); however, the optimal dietary pattern and the role of adjunctive nutrient supplementation remain uncertain. This study aims to evaluate the effects of the Brazilian Cardioprotective Diet (DICA Br), adapted from the Portfolio Diet, with or without phytosterol and/or krill oil supplementation in individuals with probable or definite FH according to the Dutch Lipid Clinic Network (Dutch MEDPED) criteria.

The DICA-FH study is a national, multicentre, randomised, factorial, parallel-group, superiority, placebo-controlled clinical trial with a 1:1:1:1 allocation ratio. Participants aged ≥16 years receiving age-appropriate lipid-lowering therapy will be randomised into four groups: (1) adapted cardioprotective diet (DICA-FH) plus phytosterol placebo and krill oil placebo; (2) DICA-FH plus phytosterol 2 g/day and krill oil placebo; (3) DICA-FH plus phytosterol placebo and krill oil 2 g/day or (4) DICA-FH plus phytosterol 2 g/day and krill oil 2 g/day. All participants will undergo whole-genome sequencing and receive appropriate genetic counselling. Primary outcomes will be means of low-density lipoprotein cholesterol and lipoprotein(a) levels after 120 days. Secondary outcomes will include additional lipid biomarkers, adherence to protocol and adverse events. The planned sample size is 300 participants. Follow-up is expected to conclude in July 2026.

This study was registered under CAAE 65549622.2.1001.0060 and received ethical approval from the Hcor Research Ethics Committee (approval number 5.805.072) and the Brazilian National Research Ethics Commission (CONEP; approval number 6.864.951). Written informed consent will be obtained from all participants prior to enrolment. The study findings will be disseminated through peer-reviewed publications, scientific conferences and channels aimed at the general public.

NCT06331195.

The DREAMSPHEN study (Dose REduction of Antipsychotics vs. Maintenance treatment in schizophrenia after Stratification based on psychotic PHENotype) aims to compare the benefits and risks of a hyperbolic tapering method for antipsychotics to the maintenance of antipsychotics in a sample of clinically stabilised patients with schizophrenia spectrum disorder.

A sample of 288 patients will be recruited from 12 centres in France. Inclusion criteria are: diagnosis of schizophrenia spectrum disorder (according to the 5th version of the Diagnostic and Statistical Manual of mental disorders, DSM-5), minimum of 3 months remission of psychotic symptoms and in treatment with antipsychotic medication (except clozapine and long-acting antipsychotic injection). First, the psychotic phenotype of the patients (cycloid psychosis vs other psychotic phenotype) will be assessed. Then, patients will be randomised either to the maintenance of treatment (MT) or to the antipsychotics dose reduction (DR) arm. DR will follow a hyperbolic schema according to Horowitz protocol. Patients will be assessed at baseline, and every 2 months until 24 months follow-up regarding social functioning, psychotic and negative symptoms, side effects of antipsychotic medication, cognitive functioning, patient satisfaction, substance and alcohol use, and quality of life. The primary outcome will be a good social functioning after 24 months defined as a score at the Personal and Social Performance Scale >70. Secondary outcome measures will include: psychotic and negative symptoms, hospitalisation for psychotic episode, antipsychotic dose, antipsychotic side effects, withdrawal symptoms, cognitive functioning, patient’s well-being and quality of life. Safety measures will include death, admissions to psychiatric hospital, psychotic relapses and severe self-harm.

The DREAMSPHEN trial aims to better identify patients with psychotic disorders who are most likely to benefit from antipsychotic tapering with an aim to inform future clinical treatment guidelines for antipsychotic treatment. DREAMSPHEN V2.0 of the 14 May 2025 has received ethical approval from Comité de protection des personnes Ile de France IV (N° 2023-509558-80-00) on 17 July 2025.

EU Clinical Trials Register – EudraCT no. 2023-509558-80-00. Clinical trials: NCT07152184. Registered on 9 August 2025.

To prospectively assess pregnancy-related care sought and obstacles and stress experienced by newly pregnant people.

The ADAPT Study, a longitudinal cohort study, followed 2015 non-pregnant participants aged 15–34 years for a year. Those with confirmed incident pregnancies were followed through their pregnancies and for 3 years.

We recruited participants from 23 reproductive and primary care facilities located in five southwestern states with different sociopolitical reproductive health contexts (restrictive, Arizona and West Texas; protective, southeastern California, Nevada and New Mexico).

334 people reported a new pregnancy within 1 year of enrolment; 324 with outcome data are included in this analysis.

Types of pregnancy care sought (‘Have you looked into where or how you could get (prenatal care, abortion care or adoption services)?’) and care-seeking stress (‘How stressful was it to find (prenatal, abortion or adoption) care for this pregnancy?’).

Most participants (83%, 270/324) sought prenatal care; 43% (138/324) sought abortion care; and 5% (17/324) sought adoption services. Overall, 17%, 29% and 23%, respectively, reported that care-seeking was extremely/quite a bit stressful. Abortion care-seeking was associated with significantly more stress than seeking prenatal care in the ordinal (adjusted odds ratio (aOR 1.70, 95% CI 1.10 to 2.62) but not logistic (aOR 1.33, 95% CI 0.74 to 2.38) model. Adoption care-seeking stress did not differ from prenatal care-seeking stress in either model. Participants who experienced any type of abortion care-seeking obstacle and those recruited in a state with a restrictive policy environment (aOR 2.72, 95% CI 1.09 to 6.80) reported more care-seeking stress than their counterparts.

People who seek pregnancy care often experience some care-seeking stress, regardless of the type of care they seek. Findings point to the need to reduce the burden of the pregnancy care-seeking process across all types of pregnancy care.

NCT03888404.

The dynamic physiological and hormonal changes through the menopause transition predispose women to an increased risk of chronic diseases including cardiovascular disease, metabolic disease, depression and dementia. The underlying mechanisms remain unclear, yet it is thought that chronic systemic inflammation and changes to lifestyle behaviours play important roles. The LIfestyle risk Factors for chronic disease across the stagEs of reproductive ageing (LIFE study) is a cross-sectional study aimed to characterise how hormonal and lifestyle (physical activity, diet and sleep) differences across pre, peri and postmenopause influence chronic systemic inflammation, visceral adiposity, cognitive function and sleep health.

Women aged between 40 and 65 years were recruited and classified into pre, peri or postmenopausal groups. Body composition measures and blood samples were collected. Sleep and physical activity were objectively measured using activPAL4 and ActiGraph GT9X link accelerometer over 7 days. Participants were also provided with a sleep diary. Physical function was assessed using the Short Physical Performance Battery. Cognitive function was evaluated using Addenbrooke’s Cognitive Examination-III and Cambridge Neuropsychological Test Automated Battery. Participants completed a series of questionnaires: Depression, Anxiety and Stress Scale-21, RuSATED, Berlin Questionnaire, Insomnia Severity Index, Activities-specific Balance Confidence Scale and the Australian Eating Survey.

Ethical approval was received from the relevant University Human Research Ethics Committee (ethics approval number #S221718) prior to the commencement of the research project. Data collection is ongoing and expected to be completed by April 2026. Results are expected to be available from July 2026. Findings will be disseminated in national and international conferences and in peer-reviewed journals and expected to inform how differences in lifestyle behaviours across menopause influence chronic systemic inflammation, visceral adiposity and cognitive function. Understanding and characterising the links between lifestyle behaviours and menopausal symptoms will inform targeted strategies to improve long-term well-being, heart, brain and metabolic health.

People with severe mental illness (SMI) engage in less physical activity (PA) and more sedentary behaviour (SB) than the general population, contributing to poorer physical health outcomes in this population. Therefore, the aim of this study was to evaluate the feasibility of a multi-component behaviour change intervention called Walking fOR Health (WORtH), delivered by community mental health teams, aimed at increasing PA and reducing SB compared with a one-off education session in people with SMI.

Feasibility randomised controlled trial (RCT).

Study recruitment and intervention delivery took place within four community mental health teams in the UK and Ireland.

Eligible participants had a diagnosis of a SMI and no contraindications to participating in physical activity. Fifty-four participants (25 male, 29 female; mean age 51.6 years) were recruited.

Participants were randomised to the 13-week WORtH intervention, comprising education, activity tracking and health coaching or an education-only control.

Feasibility outcomes included recruitment, retention, adherence and acceptability. Clinical outcomes included device-measured (Axivity AX3) and self-reported PA and SB, body anthropometry, physical function and mental well-being.

This feasibility study met 90% target recruitment and 94% of participants provided follow-up data. Adherence to allocated intervention and engagement with all core intervention components was >80%. Qualitative feedback indicated high levels of satisfaction. Valid device-measured moderate-vigorous PA (MVPA), the intended primary outcome for a definitive trial, was obtained from 90% of participants at baseline and 75% of participants at post-intervention. Point estimates indicated a mean increase of 8.6 min/day of MVPA in the intervention group (baseline 54.7 min/day (95% CI 39.5 to 70.0); follow-up 63.3 min/day (95% CI 50.1 to 76.4)) and of 1.0 min/day in the control group (baseline 42.1 min/day (95% CI 24.6 to 59.6); follow-up 43.1 min/day (95% CI 29.6 to 56.5)).

The results of this study support the feasibility of the WORtH intervention in adults with SMI, and findings will be used to optimise the design of a definitive RCT.

NCT04134871.

Worldwide, billions of children and young people live in areas affected by war. Suicide remains one of the three leading causes of death worldwide among people aged 15–29 years. However, little is known about the effect of war on suicidal behaviours in this group. This review aims to assess suicides, suicide attempts and suicidal ideation among children and young people exposed to war or armed conflict.

A scoping review of studies was conducted using Web of Science, PubMed, Embase and PsycINFO databases from their inception to 18 November 2025, without any restrictions on geographical location. We included only observational studies with full-text, peer-reviewed English articles reporting any suicides, suicide attempts and suicidal ideation of children and young people aged 0–24 years exposed to war. The quality of the included articles was assessed using the Quality Assessment with Diverse Studies. The protocol of the review was registered with the Open Science Framework on 29 March 2022 (https://osf.io/7kszh/).

Of the 3229 articles retrieved, 37 studies were eligible for review, providing data from 24 countries and covering a period of almost a hundred years (1921–2025). Most studies (>20) focused on conflicts ongoing during or until the 2000s, whereas only three focused on World War II. The reported outcomes were suicides (n=9), suicide attempts (n=15) and suicidal ideation (n=21). Included studies spanned six continents, from Latin America (n=5, Colombia only) to Europe (n=10). We assessed the suicide rates during and after wars. There was some evidence of a decrease in suicide rates during war, but no clear trend in suicide rates post-war was observed. The prevalence rates of suicide attempts and suicidal ideation varied widely, without uniformity in the definitions used. War-related trauma, mental health problems, substance abuse and exposure to suicide or suicide attempts were identified as risk factors, while protective factors included family and social support.

There is a need for more methodologically consistent and rigorous research on suicidal thoughts and behaviours in children and young people exposed to war or armed conflicts. Future research should identify mediator/moderating factors influencing suicidal behaviours and their links to mental health.

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 synthesise evidence on the association between any diagnosed or self-reported mental health problems prior to pregnancy (pre-existing mental health problems) and birth outcomes including preterm birth (PTB), low birth weight (LBW), small for gestational age (SGA), neonatal unit (NNU) admission and mode of birth (instrumental birth, planned or unplanned caesarean section).

Systematic searches were conducted in MEDLINE, CINAHL, Embase and PsycINFO in December 2024 for studies examining the association between any pre-existing mental health problems and PTB, LBW, SGA, NNU admission and mode of birth. Only articles published in English were included with no restriction on year of publication. Two reviewers independently screened studies and extracted data. Study quality was assessed using the Newcastle-Ottawa Scale and Joanna Briggs Institute checklists. Random-effects meta-analyses were conducted to pool crude and adjusted ORs (aORs) and risk ratios (aRR) with 95% CIs. ORs and RRs were analysed separately. Between-study heterogeneity was quantified using the I² statistic.

Of 15 467 records screened, 33 studies met the inclusion criteria. Women with any pre-existing mental health problems had higher odds and risks of adverse birth outcomes, including PTB (aOR 1.41, 95% CI 1.27 to 1.56) (aRR 1.36, 95% CI 1.21 to 1.51), LBW (aOR 1.28, 95% CI 1.22 to 1.33) (aRR 1.32, 95% CI 1.04 to 1.68), SGA (aOR 1.27, 95% CI 1.07 to 1.51) (aRR 1.34, 95% CI 1.19 to 1.51) and NNU admission (aOR 1.44, 95% CI 1.19 to 1.74). Adjusted estimates were based on multivariable models that commonly controlled for maternal age, parity and socio-demographic factors. No consistent associations were observed between pre-existing mental health problems and mode of birth.

Pre-existing mental health problems were associated with increased risks and odds of several adverse birth outcomes. These findings highlight the importance of early identification and targeted support for women with mental health problems before pregnancy to strengthen preconception and maternity care planning.

CRD42023485834.

A clinical prediction model (IMPROVE) for ipsilateral ischaemic stroke risk in symptomatic patients with carotid disease was recently developed with good performance. We aim to evaluate the model-based cost-effectiveness of IMPROVE-based triage versus triage in care-as-usual (CAU) for optimal medical treatment (OMT) alone or carotid endarterectomy plus OMT.

A dataset of 678 patients with carotid disease and a recent ipsilateral ischaemic stroke, transient ischaemic attack or amaurosis fugax from four cohort studies informed a decision-analytic model. Stratification of patients for carotid endarterectomy was based on ≥50% carotid stenosis (CAU arm) or a range of 3-year ipsilateral ischaemic stroke risk thresholds (IMPROVE arm). The threshold resulting in the lowest number of ipsilateral strokes and perioperative strokes and deaths was selected as the optimal threshold. Patients with

IMPROVE-based triage reduced ipsilateral ischaemic strokes and perioperative strokes and deaths by 34.5% (CAU: 4.3%, IMPROVE: 2.8%) over 3 years. Revascularisations decreased by 20% with IMPROVE, while Quality-Adjusted Life Years slightly increased. Procedural stroke occurred in 1.8% of patients in CAU versus 1.4% of patients for IMPROVE. Societal costs decreased on average by 1441/patient for IMPROVE versus CAU for a 3-year time horizon (lifetime cost reduction: 6101/patient). Subgroup analyses identified IMPROVE as the superior strategy for 50–69% and 70–99% stenosis (3-year and lifetime horizon) and

In this modelling analysis, triage of symptomatic patients with carotid disease with the IMPROVE model can lead to the prevention of one-third of ipsilateral ischaemic strokes and perioperative strokes and deaths, while also reducing societal costs. These findings should be validated in a clinical trial.

To assess determinants of human papillomavirus (HPV) vaccine non-uptake among adolescent girls in Ethiopia.

Community-based cross-sectional study.

Ethiopia.

A weighted sample of 5341 adolescent girls.

A secondary analysis was conducted using the 2024 Ethiopian National Immunization Evaluation Survey dataset. A two-stage stratified sampling technique was used to select 467 enumeration areas (EAs). Within each EA, 30 households with adolescent girls aged 15–18 were systematically selected. Data were collected using a semi-structured questionnaire. Mixed-effects logistic regression was used to identify individual-level and/or household-level, and community-level determinants. Associations were presented using adjusted ORs with 95% CIs and statistical significance was set at p

Individual and household-level determinants of HPV vaccine non-uptake include age 17–18 years (adjusted OR (AOR)=1.41; 95% CI 1.16 to 1.72), illiteracy (AOR=3.03; 95% CI 2.14 to 4.28), not currently attending school (AOR=2.84; 95% CI 2.24 to 3.60), poor knowledge (AOR=8.91; 95% CI 6.63 to 11.99), unfavourable attitude (AOR=4.24; 95% CI 3.34 to 5.37) and living in the poorest households (AOR=1.48; 95% CI 1.04 to 2.10). Community-level determinants were urban residence (AOR=1.40; 95% CI 1.01 to 1.95); and living in Addis Ababa (AOR=2.73; 95% CI 1.29 to 5.74), Afar (AOR=4.73; 95% CI 2.08 to 10.77), Dire Dawa (AOR=2.69; 95% CI 1.21 to 5.98), Harari (AOR=2.09; 95% CI 1.05 to 4.14) and Somali (AOR=3.68; 95% CI 1.61 to 8.38).

The determinants of HPV vaccine non-uptake were older age (17–18), illiteracy, school non-attendance, poor knowledge, unfavourable attitude, living in the poorest households, urban residence and living in Addis Ababa, Afar, Dire Dawa, Harari and Somali. The findings call for improved health literacy, knowledge and attitude through health extension programmes and targeted outreach in underserved urban and pastoralist settings.

The Chronic Disease Self-Management Program (CDSMP) is a widely used peer-led patient education intervention that imparts disease knowledge and self-management skills to people with chronic diseases. While the CDSMP was developed to be accessible to people with diverse chronic diseases, chronic disease self-management needs and beliefs can vary by clinical or cultural populations. Questions remain regarding the range of populations it has been adapted for and the methods that have been used to make these modifications. This scoping review explores the following research questions: For which clinical and cultural populations has the CDSMP been adapted? Which methods, frameworks and/or processes have been used to inform CDSMP adaptations?

We are conducting a scoping review with guidance from the JBI Manual for Evidence Synthesis and Arksey and O’Malley’s framework. Search results were retrieved on 30 October 30 and 4 November 2025 from the following databases: Medline (Ovid) 1946–2025, Embase (Elsevier) 1974–2025, CINAHL Complete (Ebscohost) 1937–2025, Cochrane CENTRAL (Wiley) 1898–2025, Web of Science Core Collection (Clarivate) 1900–2025, Sociological Abstracts (ProQuest) 1952–2025, Dissertations and Theses Global (ProQuest) 1861–2025 and Dimensions (Digital Science) coverage varies. Conference abstracts were excluded from Embase, Web of Science, Sociological Abstracts and Dimensions. Additionally, chapter, edited book, monograph, reference work and research chapters were excluded in Dimensions.

Inclusion criteria encompass any study type reporting on adaptations to the CDSMP and include people of any age diagnosed with any chronic disease, and specifically asthma, arthritis, cancer, cardiovascular disease, diabetes, heart disease, hypertension or stroke, who are attending the CDSMP in any type of health setting. Data will be extracted and organised into categories and subthemes in tabular form. To extract information on adaptations, we will use an adapted version of the Framework for Reporting Adaptations and Modifications.

This study does not involve the participation of human subjects. Thus, we do not have approval from an Institutional Review Board. Review findings will be disseminated through a peer-reviewed journal and at conferences. This protocol is registered with Open Science Framework (https://doi.org/10.17605/OSF.IO/27KTF).

Effective management of type 2 diabetes mellitus (T2DM) in older adults requires interventions that address both metabolic control and functional capacity. Exercise improves insulin sensitivity, glucose uptake and cardiometabolic health, while high-protein diets support muscle mass preservation, satiety and glycaemic regulation. Evidence suggests that integrating structured exercise with a high-protein diet may provide additive benefits; however, research evaluating this combined approach in older adults with T2DM, particularly in low-resource settings, is limited. This study aims to determine whether a 12-week multimodal exercise programme combined with a high-protein diet improves glycaemic control and broader health outcomes compared with exercise alone.

In this randomised controlled trial (RCT), 140 adults aged ≥60 years with T2DM will be allocated 1:1 to an experimental group (multimodal exercise with high-protein diet, n=70) or a control group (multimodal exercise alone, n=70). All participants will engage in three supervised exercise sessions per week for 12 weeks. Additionally, the experimental group will follow a high-protein diet that provides approximately 30% of total energy from protein, with a 500-kcal daily energy deficit. The primary outcome is glycaemic control, measured by Glycated haemoglobin (HbA1c). Secondary outcomes include anthropometric measures, fasting blood glucose, lipid profile, functional capacity (6-minute walk test) and health-related quality of life Short Form-36 Health Survey (SF-36). All outcomes will be assessed at baseline, postintervention (week 12) and follow-up (week 24). Participants, outcome assessors and statisticians will remain blinded. Intervention fidelity, adherence and safety will be systematically monitored, and final results will be analysed using SPSS (v.26.0). The study will follow ethical standards and comply with Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and Consolidated Standards of Reporting Trials (CONSORT) guidelines.

The protocol has been approved by the Institutional Review Board of the Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (Approval No.: PTR-JUST/IRB/2025/09/192404) and registered with the Clinical Trials Registry of India. Findings will be disseminated via peer-reviewed journals, conference presentations and structured knowledge-sharing sessions to inform clinical practice in diabetes management.

Trial registration number: CTRI/2025/08/092509

Scabies is a common skin condition and poses a substantial disease burden in resource-poor tropical settings. The Rohingya refugee camps in Cox’s Bazar, Bangladesh represent one of the world’s largest and most protracted humanitarian crises. Using 3 years of data from 2021 to 2023, this study analysed the seasonality of scabies and examined its association with climatic factors.

This is a retrospective observational study conducted in the Rohingya refugee camps and adjacent host communities in Ukhiya and Teknaf, Cox’s Bazar. All patients clinically diagnosed with scabies and who received treatment at 35 International Organization for Migration (IOM)-supported health facilities between 1 January 2021 and 31 December 2023 were included. Climate data, including daily mean, minimum and maximum temperature and total and maximum rainfall, were obtained from the Bangladesh Meteorological Department. Seasonal–Trend decomposition using LOESS (locally estimated scatterplot smoothing) (STL) was applied. Associations between climatic variables and the decomposed seasonal component of scabies cases and corresponding attack rate, as well as overall scabies case counts and overall attack rate, were assessed using Pearson’s correlation tests.

A total of 323 106 new scabies cases were reported from IOM-supported health facilities between January 2021 and December 2023. Children aged under 5 years and 6–18 years accounted for the highest proportion of cases (32.08% and 38.95%, respectively). The average monthly number of scabies cases was highest in November (12 625) and lowest in May (5862). Case numbers increased from November to February (high season), with a peak between October and November, and declined between April and June (low season). An inverse relationship was observed between temperature and scabies incidence, with higher case numbers during cooler months and lower numbers during warmer months. Pearson’s correlation analysis demonstrated a strong and significant negative correlation between the seasonal components of both scabies cases and attack rate and temperature variables, including maximum (cases: r=–0.492, p=0.002; attack rate: r=–0.484, p=0.003), minimum (cases: r=–0.506, p=0.002; attack rate: r=–0.489, p=0.002) and mean temperature (cases: r=–0.525, p=0.001; attack rate: r=–0.511, p=0.001). No significant association was observed between the seasonal component of scabies cases or attack rate and humidity or rainfall.

This study identified a distinct seasonal pattern of scabies, with higher caseloads and attack rate during late autumn and winter (October to February) and lower caseloads and attack rate during summer months (April to June). Temperature showed a strong negative association with the seasonal component of scabies burden. These findings may inform the timing of public health strategies, including mass drug administration, intensified case management and social and behavioural change communication, in humanitarian settings.

To explore the feasibility of a novel multimodal executive function intervention in school-aged children with complex congenital heart disease (cCHD).

Single-centre, single-blinded, randomised-controlled 8-week multimodal personalised executive function intervention (E-Fit) study. Outcomes were measured throughout the intervention, post-intervention (T1) and at 4-month follow-up (T2).

Tertiary care centre between May 2022 and May 2024.

Children 10 to 12 years (M=11.0, SD=0.9) with cCHD without a genetic diagnosis with infant open-heart surgery and reported difficulties (T-scores ≥60) on any of the summary scales of the parent- or teacher-reported Behavior Rating Inventory for Executive Function (BRIEF).

Children with cCHD were randomly assigned to one of two groups: the intervention or the control group. The 8-week intervention was multimodal including three modalities: (1) computerised executive function (EF) training 3x20 min/week with CogniFit; (2) a weekly, remote standardised 1:1 individual EF strategy coaching; (3) analogue games played at convenience. The control group completed activity logs.

Acceptability: Acceptance and Feasibility Scale (AFS) and coach-rated engagement during coaching sessions. Demand: Number of completed computerised training, strategy coaching and analogue game sessions. Implementation: E-Fit Fidelity Measurement System, assessing adherence to core components. Practicality: Retention rate. Integration: AFS integration items. Exploratory efficacy: BRIEF, neuropsychological EF testing and psychosocial variables at baseline, post-intervention (8 weeks) and at 4-month follow-up.

We recruited 42 participants (N_female=20). Acceptability: The intervention was acceptable, with moderate observed engagement. Demand: median number of computerised training sessions completed was 16 of 24 sessions (67%, (IQR; 6 to 19)), all children attended all scheduled coaching sessions, analogue games were played in total a median of 9 times (IQR 4 to 14). Implementation: Coaching sessions could be implemented by the coaches as intended. Practicality: Overall retention rate was 90%. Integration: E-Fit was well integrable into the home setting. Exploratory efficacy favoured the intervention group with improvements in the parent-rated Behavioral Regulation Index of the BRIEF (adjusted Hedge’s (g_A1) = –0.408 to –0.903) and in social responsiveness (g_A1 = –0.427 to –0.521) at T1 and at T2.

E-Fit is a feasible intervention suggesting EF and social responsiveness improvements in children with cCHD. Motivational strategies to improve adherence to computerised training should be refined before a full-scale efficacy trial.

NCT05198583.

Infections are a leading cause of non-relapse mortality following chimeric antigen receptor T-cell therapy (CAR-T) and bispecific antibody (BsAb) therapies. However, infection data from clinical trials are often incomplete, lack pathogen-level detail and rarely capture late infectious complications. This CAR-T treatment in Lymphoma: Analysis of Risk of Infection following Therapy (CLARITY) study aims to generate real-world, longitudinal infection data with extended follow-up to characterise infection timing, including late events and inform risk prediction in patients with lymphoma and myeloma receiving novel immunotherapies.

CLARITY is a multicentre observational cohort study across six Australian centres enrolling adults treated with CAR-T or BsAb therapies. A co-designed REDCap (Research Electronic Data Capture) instrument captures infections classified as microbiologically defined, clinically defined or fever of unknown origin, using internationally standardised definitions. Patients were enrolled between 2019 and 2023, with at least 2 years follow-up per patient, allowing time-updated data on immunosuppressive exposures, haematological recovery and prophylaxis. Multivariable regression and landmark analyses will estimate infection incidence and identify dynamic risk factors over time. Incidence rate ratios will assess prophylaxis effectiveness. Data integrity is supported by central adjudication and site-level audits.

The study has received a waiver of consent (HREC/PMCC/89002) and was co-designed by haematology and infectious diseases investigators. Findings will be disseminated through peer-reviewed publications, scientific meetings and national guideline committees to inform infection prevention and late effects surveillance in immunotherapy-treated populations.

To determine the prevalence of malaria co-infection among patients with irritable bowel syndrome (IBS) in Yemen and to evaluate the association of systemic inflammatory biomarkers (neutrophil-to-lymphocyte ratio (NLR), mean platelet volume (MPV) and platelet-to-lymphocyte ratio (PLR)) with this co-infection.

Multicentre, cross-sectional observational study conducted between April and December 2024.

Primary and secondary healthcare facilities across 21 governorates in Yemen.

142 consecutive adult patients (aged 18–70 years) diagnosed with IBS according to the Rome IV criteria.

The primary outcome was the prevalence of malaria infection, confirmed by a rapid diagnostic test . Secondary outcomes included differences in NLR, MPV and PLR between groups, assessed using independent t-tests, and the diagnostic performance of these biomarkers evaluated by receiver operating characteristic curve analysis with AUC calculation. Multivariate binary logistic regression was used to identify independent predictors of malaria co-infection, adjusting for potential confounders.

The mean age was 42.3 years (SD 11.7) with an equal gender distribution. The prevalence of malaria co-infection was 45.1% (64/142). Patients with malaria positivity had significantly higher NLR (mean difference 0.56, 95% CI 0.40 to 0.72; p

Nearly half of the Yemeni patients with IBS in this study had malaria co-infection, with the highest burden in diarrhoea-predominant and mixed subtypes. Elevated NLR and PLR were strongly associated with co-infection, suggesting these readily available biomarkers could aid targeted screening in resource-limited, endemic settings.

Leprosy is a chronic disease caused by the bacillus Mycobacterium leprae and remains a public health concern in endemic countries. Early diagnosis is fundamental to prevent transmission and irreversible disabilities. Histopathological identification of acid-fast bacilli in tissue specimens is traditionally considered the laboratory reference standard; however, its sensitivity is limited, particularly in paucibacillary forms. Immunohistochemistry (IHC) has been proposed as an adjunctive diagnostic tool for detecting M. leprae antigens in tissue samples, but its diagnostic accuracy has not been systematically synthesised. This protocol outlines a systematic review aimed at evaluating the sensitivity and specificity of IHC in the laboratory diagnosis of leprosy.

This systematic review of diagnostic test accuracy studies will include analytical observational studies and clinical trials evaluating IHC in human subjects with suspected leprosy. The reference standard will be defined as the identification of acid-fast bacilli in skin biopsy specimens from patients with compatible clinical presentation using conventional staining methods (eg, Fite-Faraco), with the exclusion of alternative mycobacterial infections when applicable. Searches will be conducted in PubMed/MEDLINE (Medical Literature Analysis and Retrieval System Online), Embase, Scopus, Web of Science and BVS/LILACS (Biblioteca Virtual em Saúde/Latin American and Caribbean Health Sciences Literature), as well as grey literature sources, at 31 May 2026. Two independent reviewers will perform study selection, data extraction using a standardised Microsoft Excel form and risk of bias assessment using the Quality Assessment of Diagnostic Accuracy Studies-2. Sensitivity and specificity estimates will be calculated. If appropriate, a bivariate random-effects meta-analysis will be conducted using RevMan (Review Manager) and Stata.

Ethical approval is not required because this study will use publicly available data. The results will be submitted to a peer-reviewed journal and presented at scientific conferences.

Bilateral deep brain stimulation (DBS) of the subthalamic nucleus (STN) is a well-accepted treatment for advanced Parkinson’s disease (PD). Currently, programming of the DBS is done in a trial-and-error manner and it can take up to 12 months to reach optimal stimulation parameters. Technological advances in electrode design and implantable pulse generator capabilities lead to an almost infinite number of stimulation options. To explore the potential benefit of all these technological advances, a conventional trial-and-error approach is no longer sufficient. Consequently, there is a clear need for a more computational approach to programming DBS systems. This pilot study is a prospective trial to prove the feasibility of programming bilateral STN-DBS for PD in a computational fashion based on patient anatomy, electrode position and brain connectivity. In this study, we aim to assess the safety, practical feasibility and technical feasibility of a computational approach for programming newly implanted STN-DBS patients with PD. This computational approach will be based on a patient-specific DBS setting regarding sweet spots and structural connectivity of the STN. The results of this pilot study will be used to develop a computational approach for DBS programming to use in a future randomised clinical trial.

The iDBS trial will be a prospective randomised feasibility study carried out at the Radboud university medical center. A total of 24 patients with PD eligible for bilateral STN-DBS surgery implanted with Boston Scientific Cartesia leads will be included. Patients will be randomised to receive either (1) computational DBS programming (n=12) or (2) conventional DBS programming based on monopolar review (n=12). The primary endpoints are safety (occurrence of stimulation-induced side effects, duration of induced side effects (temporary or permanent), severity of the stimulation-induced side effects) and technical feasibility (time from surgery to DBS initiation, time from surgery to reaching optimal DBS stimulation settings) of the computational workflow.

Ethical approval for this study has been granted by the Medical Ethical Committee region Arnhem-Nijmegen, the Netherlands (2024–17453). This study will be conducted in accordance with the Declaration of Helsinki and all applicable European and Dutch law. All participants will have to provide written informed consent. Results of the study will be submitted for publication in peer-reviewed journals and conferences.

The study is registered in the OMON-registry (NL87334.091.24, NL-OMON57446).

Anaemia is highly prevalent among the indigenous population globally. Several interventions have been used to prevent and manage nutritional anaemia, including dietary measures, health education, oral iron supplements, food fortification and intravenous iron therapy. This protocol describes a systematic review and meta-analysis to assess the effectiveness of interventions for the prevention and treatment of nutritional anaemia in indigenous populations worldwide.

The review will include randomised controlled trials, quasi-experimental studies and observational studies evaluating interventions, including but not limited to iron and folic acid supplementation, dietary modifications, food fortification, deworming and health education. A robust search strategy will be developed, and six electronic bibliographic databases and Google Scholar will be searched from 2000 to 2025. Two reviewers will independently screen the identified studies, extract data, conduct a critical appraisal and evaluate quality using the Joanna Briggs Institute tool. Based on the level of heterogeneity, a meta-analysis will be conducted using either a fixed-effect or random-effects model, with pooled estimates, and 95% CIs. The I² statistic will be used to evaluate heterogeneity. When meta-analysis is not feasible, narrative synthesis will be conducted. The impact of the intervention type and delivery model will be investigated using subgroup analysis.

This systematic review has been registered with PROSPERO. Ethical approval is not required as the study does not collect primary data from participants. The findings will be communicated via peer-reviewed journal articles and presentations at national and international conferences.

CRD420251120554.

Up to 30% of individuals with depression develop persistent depressive disorder (PDD), an often disabling and difficult to treat condition. The Cognitive Behavioural Analysis System of Psychotherapy (CBASP) is the only psychotherapy developed specifically for treating individuals with PDD. While several randomised controlled trials (RCTs) have demonstrated its efficacy in outpatient settings, evidence for its use in inpatient settings remains limited. Pilot studies of CBASP inpatient programmes in Germany have shown promising feasibility and effectiveness; however, no RCTs to date have systematically evaluated their outcomes. This study represents the first RCT to compare the short- and long-term efficacy and safety of CBASP with Behavioural Activation (BA), a first-line psychotherapy for depression, within an intensive multimodal inpatient setting.

In this prospective, multicentre, rater-blinded RCT with an active control group, we aim to recruit 396 adults (aged 18–70 years) with treatment-resistant PDD at eight German university hospitals. Participants will be randomly assigned to receive either (1) CBASP or (2) BA within an intensive treatment programme consisting of 10 weeks acute treatment in an inpatient and/or day clinic setting, followed by 6 weeks of outpatient continuation treatment. Primary and secondary outcome assessments will be conducted at multiple time points: baseline (T0), treatment onset (T1), after 5 and 10 weeks of acute treatment (T2, T3), at the end of continuation treatment (T4, week 16) and every 2 months up to week 64 (T5, naturalistic follow-up).

The primary outcome measure will be the change in depression severity, as assessed by the Hamilton Depression Rating Scale (24-item version), after 16 weeks of treatment (from T0 to T4). Secondary outcomes will include response, remission, deterioration and relapse rates, self-reported depression and anxiety symptoms and additional psychological variables. A cost-benefit analysis will evaluate the health-economic benefits of both interventions. Additionally, this RCT will explore personalised treatment selection and mechanisms of change, including potential moderators and mediators of treatment effects. The findings from this trial are expected to provide clinicians with evidence-based guidance on choosing CBASP versus BA for inpatients with treatment-resistant PDD.

This study has received ethical approval from the ethics committees of all participating university hospitals. All participants will provide written informed consent before enrolment. Study findings will be published in peer-reviewed journals and presented at national and international conferences. We have involved people with lived experience from the earliest pilots onward, using their feedback to refine our study design. Ongoing consultation at conferences and public events has further ensured that our research remains grounded in patient perspectives.

NCT04996433.