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.

Heart failure (HF) is associated with complex symptoms and frequent hospitalisation that reduce patients’ quality of life (QoL). This study aims to assess the association between angiotensin receptor-neprilysin inhibitor (ARNI) use and changes in QoL and disease-related outcomes among patients with HF in Jordan.

Prospective observational cohort study.

The study was conducted among patients with HF attending the outpatient cardiology clinics at Jordan University Hospital, a tertiary care centre in Amman, Jordan. Patients either initiated on ARNI or receiving angiotensin-converting enzyme inhibitor (ACEI)/angiotensin receptor blocker (ARB) were included in the study at a 1:2 ratio. All participants were followed up for up to 1 year after recruitment. The study period was from 4 February 2024 to 29 May 2025.

Data on QoL, New York Heart Association (NYHA) functional class and left ventricular ejection fraction (LVEF) were collected at baseline and after 3 months of treatment. Hospitalisation data were collected for the preceding year and the year following participants’ recruitment. Medication adherence and ARNI side effects were assessed after 3-month of follow-up period.

A total of 227 patients with HF were included; 74 were initiated on ARNI, and 153 were receiving ACEIs/ARBs. At baseline, significantly lower QoL scores and LVEF were observed in the ARNI group compared with the ACEIs/ARBs group. After 3-month, the ARNI group showed improvements in all QoL scores, NYHA functional class and LVEF (p

ARNI use was associated with favourable QoL, NYHA class, and LVEF as well as lower hospitalisation rates among patients with HF in Jordan. The safety profile was consistent with previous studies.

Paediatric kidney transplantation, while life-saving, presents significant academic challenges for children. Frequent hospitalisations, medical treatments and the psychosocial impact of chronic illness can severely disrupt educational trajectories. This study aimed to explore the post-transplant academic experiences of children from the perspective of their parents.

A qualitative phenomenological study. Data were collected through in-depth, semistructured interviews and analysed using inductive thematic analysis.

The study was conducted in Lahore, Pakistan, with participants recruited from the registry of the Punjab Human Organ Transplantation Authority (PHOTA).

Thirteen parents of children who had undergone a kidney transplant and were enrolled in a formal school.

Five major themes emerged from the analysis: (1) academic disruption and coping, detailing declines in performance and motivation alongside efforts to maintain engagement; (2) cognitive fatigue and emotional strain, encompassing reduced focus, memory difficulties and psychological distress; (3) school attendance, participation and support, highlighting frequent absenteeism, limited engagement in activities, and the critical role of institutional flexibility; (4) social identity and peer exclusion, revealing fears of stigma, self-isolation and misunderstanding from peers and (5) navigating the future, reflecting parental anxieties about long-term educational and career prospects alongside adaptive hope. The findings underscore that formal support systems in schools and healthcare settings are currently underdeveloped to meet these children’s complex needs.

This study illuminates the profound and multifaceted academic challenges faced by children after kidney transplantation. The results emphasise that a transplant is not merely a medical event but a life-altering experience with significant educational consequences. There is a critical need for integrated, targeted interventions that provide robust psychological support, flexible educational policies and comprehensive school reintegration programmes to ensure these children can achieve their full academic and personal potential.

The study evaluated the feasibility and efficacy of a non-immersive virtual reality (VR) system on upper extremity (UE) recovery in ischaemic stroke patients in comparison to a conventional physiotherapy.

An open-label, parallel-group, randomised controlled trial randomly assigned the participants to two groups, VR intervention or conventional physiotherapy.

Two tertiary stroke care centres in South India participated in the study.

Sixty first-ever ischaemic stroke patients (1–6 months of stroke onset) having spasticity grades of 1 or 1+ as per Modified Ashworth scale and Brunnstrom recovery stages of 3, 4 or 5 in the UE were included in the intention-to-treat analysis.

High-intensity non-immersive VR-based comprehensive rehabilitation gaming system with a duration of 12 weeks (3 days/week) was compared with equally intensive conventional physiotherapy.

The feasibility outcome was the compliance with the treatment. The primary efficacy outcome was the improvement in the motor function assessed by the Fugl-Meyer assessment (FMA) and Wolf motor function test (WMFT). The secondary outcomes included the performance in activities of daily living by the Barthel index (BI) and the quality of life by the 36-item short form health survey (SF-36).

The treatment compliance was similar in two groups (p=0.19). Both groups improved in motor performance, activities of daily living and quality of life. However, there were no significant differences in the FMA (p=0.58), WMFT (functional ability scale, p=0.33; performance time, p=0.44), BI (p=0.84) and SF-36 (physical, p=0.87; mental, p=0.99) scores between the groups.

The non-immersive VR system was feasible, effective and safe; however, it was not found to be superior to conventional physiotherapy. The trial was stopped early and did not reach its proposed sample size and hence, the findings are to be interpreted cautiously.

Clinical trial registry India: CTRI/2021/11/038339 (https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=NTc1OTI=&Enc=&userName=CTRI/2021/11/038339).

Cutaneous vascular anomalies and scars can cause significant physical and psychosocial difficulties for children, but can be ameliorated with pulsed dye laser (PDL) and neodymium-doped yttrium aluminium garnet (Nd:YAG) laser treatment. Given that multiple rounds of treatment are often required, and that the procedures are painful, achieving adequate analgesia is imperative in this setting. Paediatric procedural pain management guidelines suggest that multimodal non-pharmacological and pharmacological analgesia should be used for such procedures; however, the place of topical anaesthetic (TA) within this paradigm has not been adequately studied.

This feasibility and pilot trial will investigate the feasibility of performing a randomised, placebo-controlled trial assessing pain intensity in children receiving TA in conjunction with other multimodal analgesic methods for laser procedures. The primary objective of the trial will be to assess feasibility, and secondary objectives will be to assess pain intensity, acceptability of trial procedures to participating families and their clinical team, to assess the laser treatment response, and obtain data necessary for full-scale trial sample size calculations.

The trial will include 50 children aged 0–18 years old who are undergoing awake PDL and/or Nd:YAG laser treatment for scars or vascular anomalies. Patients will be randomised in a 1:1 ratio to receive either TA cream (lidocaine 2.5%/prilocaine 2.5% (Numit 5% cream, Ego Pharmaceuticals, Braeside, VIC, Australia)) or a placebo, along with our unit’s standard multimodal analgesic agents for laser treatment (including paracetamol, ibuprofen or oxycodone and intraprocedural sucrose solution or intranasal fentanyl). Investigators, participants and their caregivers, and clinicians will be blinded to participant allocation.

The primary outcome of the trial will be trial feasibility based on pre-specified criteria. The secondary outcome of pain intensity will be assessed by observer, caregiver and self-reported measures, and the secondary outcome of trial method acceptability with a Theoretical Framework of Acceptability questionnaire. The assessment of laser treatment response will be assessed with lesion-specific evaluation tools. Feasibility and acceptability data will be summarised using descriptive statistics. The association between treatment groups and pain scores, treatment groups and laser treatment response will be investigated using a univariable linear regression model, with the effect estimate reported as mean difference and 95% CI.

This trial has undergone ethical review and has been granted approval by the Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee (ref HREC/23/QCHQ/91002) and the Griffith University Human Research Ethics Committee (ref 2023/308). The protocol has been prospectively registered in the Australian and New Zealand Clinical Trials Registry (ACTRN12623000494639). Results of this trial may be presented at scientific meetings and will be published in a peer-reviewed journal. Participating families that have indicated an interest in trial results will receive a plain-language summary of the trial results by email.

ACTRN12623000494639.

To evaluate the efficacy of melatonin, a neurohormone regulating the sleep–wake cycle, in preventing delirium within 5 days of hospitalisation among older adult patients (≥65 years) admitted to general medical wards.

Single-centre, double-blinded, randomised, placebo-controlled trial.

General medical wards of a tertiary hospital in Oman.

Patients aged ≥65 years admitted within 24 hours to general medical wards were screened. Key exclusion criteria included prevalent delirium, use of vasopressors, non-invasive ventilation, intensive or high-dependency unit admission and aphasia.

Participants were randomly assigned to receive either 5 mg or 8 mg of melatonin or a placebo nightly for up to 5 days during hospitalisation or until discharge, whichever occurred first.

The primary outcome was the incidence of delirium within 5 days, assessed using the 3-Minute Diagnostic Confusion Assessment Method. Secondary outcomes included delirium treatment, average sleep duration or sleep maintained, 28-day mortality and 28-day readmission. Analyses followed the intention-to-treat (ITT) principle, with per-protocol (PP) analyses conducted for robustness.

The study was terminated early due to futility. At termination, a total of 115 participants were recruited, 109 of whom were included in the ITT analyses: 55 in the melatonin group (5 mg or 8 mg) and 54 in the placebo group. The overall incidence of delirium by day 5 was 2.75%, 3.64% in the melatonin group and 1.85% in the placebo group (p=1.000). No statistically significant differences were found in the average sleep duration (p=0.136), 28-day mortality (3.64% vs 1.85%, p=1.000) or 28-day readmission (21.82% vs 20.37%, p=0.853). PP analyses and subgroup sensitivity yielded similar findings.

In this trial, melatonin did not significantly reduce the incidence of delirium. The lower-than-expected numbers of outcome events and resultant early termination for futility limited the study’s power. As a result, the study findings should be interpreted with caution, and further research is necessary before definitive recommendations can be made.

NCT06509191.

Some intensive care unit (ICU) patients develop an extremely deep and sustained immunosuppression that increases the risk of secondary infections and can ultimately compromise survival. Thanks to an easily accessible and simplified immune monitoring to identify immunological failure, a personalised immune restoration approach is now feasible. Among the different therapeutic strategies in this field, interferon gamma (IFN-) is probably the most interesting drug to reduce the burden of secondary infections in the ICU.

This is a two parallel group multicentre blinded add-on randomised trial comparing immunorestoration by subcutaneous injection of IFN- to standard of care in targeted ICU patients. The study will be performed in 23 ICUs in France. Patients hospitalised in the ICU for a week, with multiple organ failure defined by a sequential organ failure assessment score ≥6 during this first week, will be enrolled. If within 96 hours after inclusion, these patients express immunosuppressed features defined by a low absolute lymphocyte count (x10⁹/L) and low expression of human leucocyte antigen-DR (HLA-DR) on monocytes (13 500 antibodies bound per cell and an absolute lymphocyte count >1200 x10⁹/L) at day 10, healthcare costs at day 90 and rate of serious adverse reactions and suspected unexpected serious adverse reaction at day 90. We plan to randomise 326 patients.

The study will be implemented in accordance with European regulations and was independently reviewed and approved by the French Ethics Committee Comité de Protection des Personnes Ile de France III (EUCT number: 2024-516780-93-00). The results will be reported in international peer-reviewed journals and presented at international and national conferences.

NCT06774235.

Heart failure (HF) remains a major global health challenge, particularly in low-resource settings where access to comprehensive cardiac rehabilitation (CR) is limited. Yoga, a culturally contextualised mind-body intervention, holds promise as an adjunctive therapy in CR. The Yoga-EndOmics study aims to evaluate the effects of Yoga-based cardiac rehabilitation (Yoga-CaRe) on gene expression, endothelial function, vascular biomarkers and clinical outcomes in systolic HF, providing mechanistic insights into its potential integration into conventional cardiac rehabilitation.

This is a prospective, randomised, open-label, blinded-endpoint (PROBE) mechanistic trial enrolling 78 patients with HF with reduced ejection fraction (HFrEF). Participants will be randomised in a 1:1 ratio to receive either a structured Yoga-CaRe intervention or enhanced standard care for 3 months. The Yoga-CaRe group will attend 20 supervised sessions with guided home practice involving tailored asanas, pranayama and meditation. Primary outcomes are changes in endothelial-dependent flow-mediated dilation (FMD) and functional exercise capacity at 3 months. Secondary outcomes include changes in arterial compliance and stiffness, circulating biomarkers of endothelial dysfunction, oxidative stress and inflammation, and immediate changes in global gene expression profiles in peripheral blood mononuclear cells following the Yoga-CaRe intervention. Data will be analysed using analysis of covariance (ANCOVA) for between-group comparisons and significant analysis of microarray (SAM) for global gene expression profiles.

The study has received ethical clearance from the Institutional Ethics Committee of the SDM College of Medical Sciences and Hospital, India (SDMIEC/2025/1072) and is registered with the Clinical Trials Registry of India. Findings will be disseminated through peer-reviewed journals, scientific conferences and stakeholder engagement platforms to inform future integrative strategies in HF management.

CTRI/2023/12/060758

In chronic kidney disease (CKD), anaemia develops and evolves as kidney dysfunction progresses. The treatment of anaemia is described in clinical practice guidelines (CPGs), which are designed to report the most relevant evidence for clinical practice in disease management. This study will analyse CPGs for transparency, methodological quality and quality of recommendations for their implementation over time, and also compare recommendations for the treatment of anaemia outlined in these documents.

CPGs will be identified by conducting a systematic search of the data sources CINAHL, Embase, MEDLINE, Scielo, Scopus, ProQuest, Trip Database, Virtual Health Library, Web of Science, and guidelines on websites, published between January 2009 and December 2025. Three reviewers will, independently, evaluate the methodological quality of the guidelines using the Appraisal of Guidelines for REsearch and Evaluation II (AGREE-II) tool and the quality of recommendations using the AGREE – Recommendations Excellence tool. The treatment recommendations for anaemia in CKD will be summarised and compared. Results will be presented in tables and descriptive statistics will be compiled for all domains of the tools.

This is a literature-based study and, therefore, no ethical approval will be required. Results of the study can be submitted for publication in high-impact, peer-reviewed scientific journals, and also presented at national and international conferences.

CRD42024629656.

Metabolic bariatric surgery (MBS) can lead to substantial fat-free mass loss (FFML) due to malnutrition, decreased protein intake and insufficient physical activity. Disproportional FFML has been associated with an increased risk for adverse health outcomes. Resistance training (RT) combined with protein intake contributes to maintenance and increase of fat-free mass (FFM) in healthy individuals. However, it is unclear whether RT and protein supplementation can prevent FFML after MBS.

In the EffectiveNess of pRotein supplementatIon Combined witH resistance Exercise training to counteract Disproportional fat-free mass loss following metabolic bariatric surgery (ENRICHED) randomised controlled trial, 400 patients scheduled to undergo MBS will be randomised in a 1:1 ratio to the ENRICHED perioperative care programme (intervention group) or the standard perioperative care programme of the Dutch Obesity Clinic (control group). The study is currently recruiting participants at two centres in the Netherlands: Nieuwegein and Amsterdam. The postoperative standard programme consists of 13 group sessions spread over a period of 18 months. As part of the ENRICHED programme, RT and protein supplementation will be added 3 weeks after MBS. Additional whole-body RT consists of home-based training sessions two to three times a week, and supervised RT sessions of 45–60 min once weekly, performed at 60–75% of one-repetition maximum (1-RM). Protein supplementation will start by adding 20 g of whey protein to the daily intake. The supplementation will be gradually increased with 20 g every 4 weeks until a total of 60 g whey protein a day is reached. After 12 weeks of protein supplementation, the focus shifts towards incorporating protein-rich food products into the daily dietary intake. The primary endpoint is the prevalence of disproportional FFM loss, defined as FFML/total weight loss ≥30%, at 3 months post-MBS. Secondary endpoints are differences in body composition, muscle strength and function, cardiorespiratory fitness, (cardio)metabolic health, health-related quality of life, gastrointestinal discomfort, cost-effectiveness of the intervention and treatment satisfaction. Outcomes will be assessed preoperatively and at 3, 6 and 12 months postoperatively.

The study protocol V.2.0 was approved by the Medical Research Ethics Committee Oost-Nederland (NL-OMON57119) on 9 April 2025. All participants will provide written informed consent prior to enrolment. Study findings will be disseminated through peer-reviewed publications and conference presentations. Insights gained in this study will provide evidence for a patient-tailored intervention that could be implemented in clinical practice.

NCT07156552.

Telerehabilitation (TR) programmes are increasingly recognised for their feasibility and potential benefits, such as eliminating travel time, reducing costs and providing a more comfortable rehabilitation experience at home. However, the comparative efficacy of remote physiotherapy compared with traditional in-person sessions for individuals with Parkinson’s disease (PD) remains uncertain. This study aims to evaluate the effects of TR compared with in-person physiotherapy in individuals with PD, focusing on both motor and non-motor outcomes.

This is a randomised, single-blind clinical trial with a mixed-methods approach. A total of 22 individuals diagnosed with PD will be randomly assigned to one of two groups. The experimental group will receive TR, consisting of remote physiotherapy sessions conducted once a week for 1 hour over a 4-month period. The control group will receive the same interventions in person. Interventions will include global muscle strengthening exercises, balance training, gait and motor coordination exercises, and cognitive training. The primary outcome will be motor function, measured using part III of the Movement Disorder Society–Unified Parkinson’s Disease Rating Scale. Secondary outcomes will include cognition (Montreal Cognitive Assessment), gait (Functional Gait Assessment), mobility (Timed Up and Go Test) and quality of life (Parkinson’s Disease Questionnaire). Data will be analysed using repeated measures analysis of variance to compare outcomes between groups across four assessment points (baseline, midpoint, postintervention and 2 months follow-up). Additionally, a qualitative phase will explore participants’ perceptions and experiences regarding TR and in-person interventions, with assessments carried out 2 months after the completion of the 24-week interventions, through semistructured interviews that will be analysed using Bardin’s Content Analysis technique.

This protocol was approved by the Research Ethics Committee of the Federal University of Rio Grande do Norte (approval number: 5.553.701). All participants will provide written informed consent before inclusion. Results will be disseminated through peer-reviewed publications, scientific conferences and communication with participants and healthcare professionals.

RBR-6h5knrj.

Since 2018, WHO has endorsed the use of whole-genome sequencing (WGS) of Mycobacterium tuberculosis complex isolates to detect drug-resistant tuberculosis (DR-TB). This endorsement was based on the assumption that a faster and more detailed description of the resistance profile would improve treatment prescription for DR-TB by healthcare providers, and hence the treatment outcomes of patients. Nonetheless, this assumption has not been tested in routine clinical practice and different scenarios. In Brazil, WGS is not routinely used for the diagnosis of DR-TB, having been carried out in only a few centres for research purposes. With this trial, we will evaluate whether a WGS-based drug-resistance report improves treatment adequacy in patients with pulmonary DR-TB, compared with the current standard-of-care diagnostic methods used in the state of São Paulo, Brazil.

We will conduct a non-randomised controlled clinical trial with two arms to compare the intervention group (ie, individuals receiving a WGS-based report) with a historical control group (i.e., individuals who received resistance diagnostics based on the standard of care of conventional genotyping and phenotyping techniques). The primary outcome will be the proportion of patients whose treatment scheme was adequate based on complete resistance profile determined by WGS and/or phenotypic drug-susceptibility testing (pDST). Other secondary outcomes will also be considered. The target sample size is 88 eligible patients per group. The intervention group will be prospectively recruited over 18 months and the control group will be composed of patients diagnosed with pulmonary DR-TB up to 2 years before the start of the trial. To ensure comparability, isolates from the control group will undergo WGS retrospectively, and pDST will be performed retrospectively in both groups. This clinical trial will take place in six medical centres for the treatment of DR-TB in the state of São Paulo. This study is intended to support the implementation of the WGS in the routine diagnosis of DR-TB in the state of São Paulo.

Ethical approval was obtained from the Human Research Committee of the Institute of Biomedical Sciences, University of São Paulo, Brazil (CAAE: 79497924.1.1001.5467). Study results will be published in peer-reviewed journals and disseminated to policymakers and stakeholders.

U1111-1308-4669.

To assess maternal medical conditions, physical and surgical ailments, contraceptive use and barriers to its use, maternal mental health, neonatal health, breastfeeding practices and available social support in the postpartum period.

A prospective cohort study.

A large tertiary care centre.

12 245 women who delivered after 22 weeks gestation in the year 2022.

Three pre-specified exposures, namely mode of delivery, presence of significant risk factors and preterm delivery within the cohort, were used to identify potential groups of women who would need additional support.

The primary outcome was the number of unscheduled visits by the mother or child and the indications for these visits.

The secondary outcomes in mothers included unhealed wound sites, anaemia, increase in body mass index (BMI) by >3, persistent high blood pressure, pain in the abdomen or pelvis, urinary or bowel problems, musculoskeletal pain, abnormal maternal mental health, breast-related issues and barriers to breastfeeding, contraceptive use and sexual activity.

Only 2% of women and children were lost to follow-up. Nine women and 75 babies died. The majority of infant deaths were related to serious congenital diseases. Unscheduled visits to the health facility were seen in 44% of the cohort, most commonly for upper respiratory infections and fever in the mother and baby. 41 mothers and 741 infants needed admission to hospital. Hospitalisation was more common in those with risk factors or preterm delivery. High blood pressure was seen in 3 to 4% and anaemia in 4% of the cohort. Wound infection was seen in 3 to 4% and urinary incontinence in 2% of women. Wound infection was more common with instrumental delivery. Bowel incontinence was rare. A fourth of the cohort had musculoskeletal pain, especially back pain, which was more common after caesarean delivery. Only 5.5% of the cohort had unsatisfactory mental health, and these women were more likely to have abnormal mental health scores with the NICE Questionnaire at screening. The family APGAR of the cohort was 9/10, and 95% belonged to the middle-income group. 2.6% of neonates had delayed milestones, and this was more common in the group with risk factors and preterm delivery.

Healthcare utilisation was mainly for minor complaints. Re-admissions were rare, as intrapartum and immediate postpartum care were optimal. Women who delivered by caesarean section or delivered a preterm child needed additional support in the postpartum phase. NICE Questionnaire is a quick and easy screening tool to identify unsatisfactory mental health and should be used before discharge, postnatally, even in busy settings. The implementation of formal telephonic support 24 hours a day in birthing facilities should be explored in the future. Holistic postnatal care of mother and child during the immunisation of the baby would be the best opportunity to improve the quality and coverage of care in the postnatal phase.

CTRI/2022/03/041343.

Our study investigated the age-adjusted incidence rates of non-fatal overdoses by HIV status and sex, and examined trends over time.

We used data from the Comparative Outcomes and Service Utilization Trends study, a population-based cohort study that includes clinical and administrative health data on virtually all people with HIV (PWH) and a 10% random sample of people without HIV in the province.

British Columbia, Canada.

Between April 2012 and March 2020, 11 050 PWH (81.8% male) and 473 952 people without HIV (50.3% male) who were 19 years and older contributed 68 035 and 3 285 824 person years (PY) of follow-up, respectively.

The primary outcome was age-adjusted incidence rates of non-fatal overdose events stratified by sex and HIV status. Trends over time were also assessed.

Age-adjusted non-fatal overdose incidence rates among males with and without HIV were 36.4 and 3.12 per 1000 PY, respectively (incidence rate ratio (IRR) = 11.7, 95% CI 10.9 to 12.5). For females with and without HIV, the age-adjusted incidence rates were 61.4 and 2.33 per 1000 PY, respectively (IRR=26.3, 95% CI 24.0 to 28.7). Between 2013 and 2019 (calendar years with full-year data), the age-adjusted non-fatal overdose rate increased significantly among males and females without HIV but not among PWH.

We observed a significantly higher non-fatal overdose rate among PWH compared to people without HIV. The rate was highest among females with HIV. These findings underline the need for policies and programmes oriented towards PWH to mitigate overdoses, especially for females.

This systematic review aims to examine the association between maternal psychological distress (specifically perceived stress, clinical anxiety and depressive symptoms), measured exclusively during pregnancy, and child neurodevelopmental outcomes assessed within the first 3 years of life (0–36 months), including cognitive, language, socioemotional and behavioural development.

The review was conducted in line with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and registered on PROSPERO (CRD42024599742). It focused exclusively on studies assessing maternal distress during the prenatal period and its impact on cognitive, language, socioemotional and behavioural outcomes in infancy and toddlerhood.

A comprehensive search of six databases, PubMed, Web of Science, Cochrane Library, Embase, EBSCOhost and PsycINFO, was conducted up to 10 April 2025, using structured combinations of keywords related to maternal stress and child development.

: Studies were included if they assessed psychological distress during pregnancy with validated tools and evaluated neurodevelopmental outcomes in children aged 0–36 months using standardised measures. Excluded were studies measuring distress only postnatally, animal models, non-original articles and studies without neurodevelopmental endpoints.

Data were extracted and reviewed independently by two authors using predefined criteria, with a third reviewer resolving disagreements. Methodological quality was assessed using the Cochrane Risk of Bias in Non-randomised Studies of Exposures tool for non-randomised studies and Cohort Studies. Given study heterogeneity, a structured narrative synthesis with standardised effect summaries was used.

44 studies met the inclusion criteria. Across these, small, correlational associations linked higher maternal distress during pregnancy with modest differences in cognitive and language scores and with elevated risks of behavioural and socioemotional difficulties. Children exposed to higher distress more often showed attention problems, greater negative emotionality, lower verbal ability and weaker emotion regulation, with effects frequently attenuated after adjustment and selective attrition.

Maternal psychological distress during pregnancy is a context-sensitive correlate, not a proven cause, of early neurodevelopmental differences across cognitive, emotional and behavioural domains.

To examine the relationship between catastrophic thinking and postural stability in individuals with chronic non-specific neck pain (CNSNP); to assess the moderating role of pain duration and intensity; and to investigate the mediating role of fear-avoidance beliefs.

Cross-sectional observational study.

Outpatient musculoskeletal and pain rehabilitation clinics.

Eighty-six adults aged 18–65 years with CNSNP (mean age: 45.3±10.5 years) were recruited via purposive sampling.

Primary outcomes included postural stability parameters—centre of pressure path length, sway velocity, range of movement in the anterior-posterior and mediolateral directions, and sway area—measured using computerised posturography. Catastrophic thinking was assessed using the Pain Catastrophizing Scale (PCS). Secondary measures included the Neck Disability Index (NDI) to evaluate disability, the Visual Analogue Scale (VAS) to measure pain intensity, the Fear-Avoidance Beliefs Questionnaire (FABQ) to assess fear-related beliefs, and the Short Form-36 (SF-36) Health Survey to evaluate quality of life. Pain duration and intensity were analysed as moderating variables, and fear-avoidance beliefs were examined as a potential mediator.

Moderate positive correlations were found between PCS scores and COP path length (r=0.41, p=0.014), sway velocity (r=0.38, p=0.022) and sway area (r=0.43, p=0.011). Participants with high PCS scores demonstrated significantly worse postural stability than those with low PCS scores. Pain duration (β=0.35, p=0.004) and intensity (β=0.42, p=0.006) significantly moderated this relationship. Fear-avoidance beliefs were statistically identified as a partial mediator of the association between catastrophic thinking and postural stability (indirect effect=0.22; 95% CI 0.10 to 0.35).

Catastrophic thinking is linked to reduced postural stability in individuals with chronic non-specific neck pain, with pain characteristics and fear-avoidance beliefs potentially influencing this association. These results underscore the importance of psychological factors in balance and support the need for further longitudinal research to inform comprehensive management strategies.

To investigate the occurrence of depression and mental health disorders other than depression among Brazilian people with intellectual disabilities, analysing data from a national household survey.

Cross-sectional epidemiological study using data from the 2019 National Health Survey (PNS).

Brazil, nationwide data collection in urban and rural private households.

272 499 individuals, among whom 1.2% (n=3198) reported intellectual disabilities.

Self-reported depression and mental health disorders other than depression (anxiety, panic, schizophrenia, bipolar disorder, psychosis or obsessive–compulsive disorder (OCD)), either isolated or comorbid.

Among people with intellectual disabilities, 43.2% reported at least one mental health disorder versus 13.7% without disabilities. In adults aged 0–59 years, intellectual disability was associated with higher odds of depression (adjusted OR (aOR) 3.25, 95% CI 1.76 to 6.00), mental health disorders other than depression (aOR 12.23, 95% CI 7.52 to 19.90) and depression associated with other mental health disorders (aOR 14.34, 95% CI 7.92 to 25.96). In older adults (≥60 years), risks also remained elevated: depression (aOR 1.71, 95% CI 1.04 to 2.79), mental health disorders other than depression (aOR 4.33, 95% CI 2.09 to 8.94) and depression associated with other mental health disorders (aOR 2.98, 95% CI 1.49 to 5.95). Women with intellectual disabilities were more likely to report depression and multimorbidity, while men more often reported non-depressive disorders. Poorer self-perceived health was consistently linked to worse outcomes across age groups.

Mental health disorders and their comorbidities are significantly more prevalent among people with intellectual disabilities in Brazil. These findings highlight the urgent need for inclusive, equitable and specialised mental healthcare policies.

Severe aorto-iliac steno-occlusive atherosclerotic disease is a major cause of morbidity and amputation in patients with peripheral arterial disease. While both open surgical and endovascular revascularisation are standard treatments in this patient group, there is no high-quality randomised evidence to determine which approach offers superior clinical and cost-effectiveness, leading to uncertainty and poor outcomes after intervention.

The EVOCC trial is a national, multicentre, parallel-group, superiority randomised controlled trial comparing open surgery to endovascular revascularisation in patients with symptomatic severe aorto-iliac occlusive disease. A total of 628 participants across 30 NHS sites in the UK will be randomised 1:1 to receive either open surgery or endovascular (minimally invasive) intervention. The primary outcome is amputation-free survival, defined as time to first event (major lower limb amputation or death). Secondary outcomes include mortality, cardiovascular events, hospital readmissions, re-interventions and quality-of-life measures. An internal pilot phase (10 sites, 6-month duration) will assess recruitment feasibility. A QuinteT Recruitment Intervention is integrated into the trial to optimise recruitment.

The trial has received ethical approval from a UK Research Ethics Committee (REC reference: 23/SW/0065; trial registration reference: ISRCTN14591444). Informed consent will be obtained from all participants.

The EVOCC trial is the first RCT assessing the clinical and cost-effectiveness of open vs endovascular revascularisation for severe aorto-iliac disease worldwide. The results will provide robust evidence to inform clinical practice and healthcare policies globally. Results will be disseminated via patient groups, online lay summaries, a trial website, social media, presentations in conferences, a formal scientific publication in a medical journal and direct communications with policymakers across borders.

ISRCTN14591444.

Diabetic foot ulcers (DFUs) are highly prevalent and recurrent complications of diabetes mellitus that have significant health and cost implications. Self-care is critical for preventing or delaying DFU and promoting healing, yet adherence to self-care recommendations is low. Interventions using motivational interviewing (MI) have been effective in supporting behaviour change and emotional adjustment, but evidence for DFU is scarce. This study will assess the acceptability, feasibility and preliminary efficacy of an MI-guided programme, Healing DFU through Empowerment and Active Listening (HEALing), and its integration in usual wound care practice.

This single-arm pilot study adopts a mixed-methods approach to assess the feasibility and acceptability of the HEALing intervention. HEALing is a practical, low-intensity, clinic-integrated personalised self-care support intervention, comprising three 30 min face-to-face sessions delivered over 6 weeks by trained wound care nurses, aiming to enhance self-care behaviours and support emotional adjustment in patients with DFU. Data will be collected from a battery of questionnaire-based surveys with patients (n=30), and in-depth individual interviews with both patients (n=30) and wound care nurse facilitators (n=10) from nurse-led wound clinics in a large primary care sector in Singapore.

The primary feasibility outcomes will include enrolment, retention (≥80%), data completion (≥80% of surveys) and participant satisfaction. Secondary outcomes will include self-report measures of illness perceptions, foot care confidence, diabetes distress, foot self-care behaviour, DFU knowledge, autonomy support and health-related quality of life, taken at baseline and post-intervention. Post-intervention interviews with patients and wound care nurse facilitators will be conducted to collect feedback on the programme and its implementation feasibility.

The study protocol has been approved by the local ethics committee, and written informed consent will be obtained from all participants. Findings will be disseminated through the first author’s PhD thesis, peer-reviewed journals, national and international conferences and public events.

NCT06540170; Pre-results.

This systematic review aims to: (1) evaluate how behavioural and psychological factors have been incorporated into cardiovascular disease (CVD) risk prediction models; (2) assess their impact on model performance metrics such as area under the curve (AUC) and net reclassification index (NRI); and (3) identify which specific variables are most consistently associated with predictive improvements. This protocol is reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses protocols (PRISMA-P) 2015, and the systematic review will follow the Cochrane Handbook and report findings based on PRISMA 2020.

A systematic review protocol developed in accordance with the (PRISMA-P) 2015 guidelines.

Systematic searches will be carried out in PubMed, Scopus, Web of Science and Google Scholar, limited to studies published from 2019 to 2024.

Peer-reviewed original studies involving adult populations (≥18 years) at risk of CVD, incorporating at least one behavioural or psychological variable into a CVD risk prediction model. Studies must report model performance metrics such as AUC or NRI. Studies focusing solely on biochemical or demographic factors, paediatric populations, or non-CVD outcomes will be excluded.

Two independent reviewers will screen eligible studies, extract data and assess study quality using the Newcastle-Ottawa Scale and Quality in Prognostic Studies tool. A narrative synthesis will be performed, with meta-analysis conducted if feasible.

Ethical approval is not required for this study. Findings will be disseminated through peer-reviewed publication and conference presentations.

CRD420251014218.