Acne vulgaris is a chronic inflammatory condition primarily caused by Cutibacterium acnes, which disrupts skin homeostasis, thereby triggering immune responses and sebum metabolism. Dysbiosis is an imbalance in the skin and gut microbiota identified as a significant factor contributing to acne progression. Standard therapy often relies on antibiotics, but the long-term use has increased antibiotic resistance, including in Indonesia. Consequently, alternative methods, such as probiotics and mesenchymal stromal cell secretomes, are gaining attention for immunomodulatory and regenerative properties. These novel therapies have shown promising results in modulating the skin and gut microbiota while reducing inflammation.

A phase 2 double-blind randomised controlled trial will be conducted using a parallel group design with four arms, namely: (1) standard therapy with oral probiotics and topical secretome (placebo), (2) standard therapy with oral probiotics (placebo) and topical secretome, (3) standard therapy with oral probiotics and topical secretome and (4) standard therapy with oral probiotics (placebo) and topical secretome (placebo). Sixty-four patients with mild to moderate acne vulgaris will be randomly allocated to these groups. Interventions will be administered over a period of 8 weeks, with outcomes to be measured at baseline and post-therapy. This study will be conducted at the Dermatology and Venereology Department of Bali Mandara General Hospital (RSBM). The primary outcome will be the reduction of comedones and inflammatory lesions, assessed using the Yolov8 method. Secondary outcomes will include gut and skin health parameters, such as tryptophan metabolites, collagen, pH, moisture, sebum levels and IL-6, to explore the relationship between microbiome balance, skin condition and inflammation in acne.

This study will be conducted in accordance with the ethical principles outlined in the Declaration of Helsinki and the International Conference on Harmonisation–Good Clinical Practice guidelines. Ethical approval has been granted by the Health Research Ethics Committee of Bali Mandara Regional Hospital (Approval Reference Number: 060/EA/KEPK.RSBM.DINKES/2024). All participants will provide written informed consent prior to enrolment. Data confidentiality and participant safety will be upheld throughout the trial. The results of this study will be disseminated through journals, scientific conferences and relevant academic platforms to ensure wide accessibility and to support further research and clinical application in the field of dermatology, particularly in addressing antibiotic resistance and microbiome-based acne therapies.

NCT06925386.

Epic MyChart, used as a patient portal or within Epic Healthy Planet programmes, is integrated with the Epic electronic health record system, enabling secure access to health information, communication with clinicians and self-management tools. Despite increasing portal adoption in the UK and internationally, there is fragmented and unclear evidence demonstrating impact on clinical outcomes, engagement, safety, experience, efficiency and equity. This scoping review will map existing research on Epic MyChart, identify barriers and facilitators to uptake, and explore technical and operational determinants influencing implementation.

We will conduct a scoping review guided by Arksey and O’Malley’s framework, refined by Levac et al, and report according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) and PRISMA-Equity guidelines. Eligible studies will include original research evaluating Epic MyChart or Epic Healthy Planet programmes, reporting outcomes related to patient-reported measures, clinical effectiveness, engagement, safety, efficiency or equity. Searches will cover MEDLINE, CINAHL, PsycINFO, EMBASE, Cochrane CENTRAL, Scopus, trial registries and grey literature. Two reviewers will independently screen records and extract data on study characteristics, outcomes, equity factors and implementation determinants. Quantitative findings will be synthesised narratively using synthesis without meta-analysis guidance; qualitative data will undergo thematic synthesis. Stakeholder consultations with health informatics experts, clinicians, data scientists and health system managers, alongside a patient and public involvement workshop, will support interpretation of findings. A logic model will illustrate relationships between portal features, implementation factors and outcomes. Although focused on Epic MyChart, the review will offer insights relevant to other patient portals, as many implementation and equity considerations are shared across digital health systems.

Ethical approval is not required as the review uses published data. Findings will be disseminated through peer-reviewed publication, conferences and stakeholder engagement to inform implementation of patient portals internationally.

The protocol is registered on the Open Science Framework (https://osf.io/5azdh/overview).

Global increases in armed conflict, forced displacement, pandemics and economic instability have contributed to rising levels of psychological distress worldwide, placing relevant segments of the population at increased risk of developing mental health conditions. This burden is particularly pronounced in humanitarian and low-resource settings where access to specialist mental health services is limited. Scalable, low-intensity, evidence-based psychological interventions are therefore urgently needed. In response, the WHO has developed transdiagnostic programmes, including Self-Help Plus (SH+) and Doing What Matters in Times of Stress (DWMS). Although these interventions are increasingly implemented across humanitarian and public health contexts, evidence for their effectiveness and implementation has not yet been systematically synthesised.

This preregistered systematic review and meta-analysis will be conducted in accordance with Cochrane Collaboration standards and reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We will include randomised controlled trials evaluating the effectiveness of SH+ or DWMS, alongside qualitative and mixed-methods studies examining their implementation among stressor-exposed individuals of any age. Outcomes will include symptoms of depression and anxiety, general distress and post-traumatic stress symptoms. Moreover, we will examine effects on well-being, psychosocial functioning, adverse events and implementation outcomes (eg, acceptability, feasibility, fidelity). We will search Cochrane CENTRAL, APA PsycNet, Web of Science Core Collection, Embase and Scopus for records published from 2016 onwards. Searches will be supplemented by hand-searching preprint repositories and citation tracking. Risk of bias will be assessed using the Revised Cochrane Risk of Bias Tool and a customised appraisal tool for studies on implementation. Quantitative data will be synthesised using random-effects multilevel meta-analyses, with meta-regression models applied to examine moderators. Bayesian meta-analyses will be conducted where appropriate as sensitivity analyses to assess the robustness of the findings. Certainty of evidence will be evaluated using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.

Ethical approval is not required. Findings will be disseminated through an open-access peer-reviewed publication, a plain-language summary, and the Open Science Framework, where all materials will be made publicly available.

CRD420251168521.

Obsessive-compulsive disorder (OCD) is characterised by obsessive thoughts and compulsive actions. These obsessive-compulsive symptoms (OCS) are subclinical manifestations that do not meet the full diagnostic criteria for OCD and are associated with anxiety, depression and lower quality of life (QoL). Medical students are vulnerable to developing OCS due to stress in medical school. This study assessed OCS prevalence and its association with the mental well-being and QoL of medical students in Egypt.

A nationwide cross-sectional study was conducted across 15 Egyptian medical schools. Using convenience sampling, 1850 students participated by completing a self-administered questionnaire that used validated scales. We assessed OCS with the Obsessive-Compulsive Inventory-Revised (OCI-R) using a screening cut-off of ≥21, QoL with the Quality-of-Life Enjoyment and Satisfaction Questionnaire (Q-LES-QSF), and anxiety and depression with the 4-item Patient Health Questionnaire (PHQ-4). Descriptive statistics and logistic regression were employed.

Clinically significant OCS prevalence among medical students was 51.1%. Significant predictors for OCS included being female (adjusted OR (AOR)=1.25), attending a private university (AOR=1.64), and having personal (AOR=2.05) or combined personal and family history of mental illness (AOR=2.69). OCS presence was associated with a lower QoL score (Q-LES-QSF: 41.00 vs 43.97) and higher psychological distress score (PHQ-4: 5.93 vs 3.57) compared with students without OCS (p

OCS are prevalent among Egyptian medical students, especially females, private university attendees and those with a personal or family history of mental illness. These symptoms are associated with higher psychological distress and a lower QoL. As OCS were identified using a screening cut-off, and given the cross-sectional design, findings should be interpreted cautiously, warranting further longitudinal investigation. Universities should consider implementing mental health support, screening and awareness programmes to address these issues.

Spinal cord injury (SCI) impairs autonomic functions, which are ranked among the highest priorities for recovery. The loss of autonomic control, including bowel, bladder, sexual and cardiovascular functions, interferes with rehabilitation and decreases health-related quality of life (HRQoL). Preliminary evidence indicates that non-invasive transcutaneous spinal cord stimulation (TCSCS) has the potential to improve autonomic stability in people with SCI. However, the optimal stimulation site for improving autonomic responses remains to be determined. This pilot randomised clinical trial aims to explore the efficacy of non-invasive mid-thoracic and lumbosacral TCSCS (proof-of-concept) for blood pressure stability (orthostatic hypotension and autonomic dysreflexia burden) alongside end-organ autonomic functions (lower urinary tract, bowel and sexual function) and HRQoL.

30 participants with chronic (>1 year) motor-complete SCI (American Spinal Injuries Association Impairment Scale A and B) at or above T6 will be enrolled in this open-label, two-arm randomised pilot clinical trial. Participants will be block randomised into either the mid-thoracic or lumbosacral TCSCS group. Participants will then undergo 8 weeks of TCSCS (3 times per week for 60 min; 24 sessions total) while in a seated position. Post-treatment effects will be recorded following the 8-week intervention and follow-up effects will be recorded 8 weeks after the end of the intervention. Primary and secondary outcomes will assess resting blood pressure, autonomic dysreflexia, orthostatic hypotension and lower urinary tract, bowel and sexual functions as well as HRQoL.

This study is approved by The University of British Columbia’s Clinical Research Ethics Board (UBC CREB H22-00365), and by Health Canada for Investigational Testing Authorisations (ITA) for Class II medical devices used in this trial (ITA#346875 TESCoN; ITA#381 154 SCONE). The findings will be disseminated through peer-reviewed publications, conferences, seminars and SCI community outreach.

NCT05369520.

Obesity and related cardiometabolic comorbidities, including hypertension, dyslipidaemia, diabetes, metabolic dysfunction-associated steatotic liver disease and atherosclerotic cardiovascular disease, are increasingly prevalent among individuals with inflammatory bowel disease (IBD). These conditions influence disease activity, therapeutic response, surgical outcomes and overall quality of life, yet evidence remains fragmented. The Modulate Obesity and relateD metabolic complIcations For Yielding improvements in IBD outcomes (MODIFY-IBD) initiative aims to synthesise evidence and generate consensus recommendations to guide practice and future research in this area. This study describes a protocol for a structured evidence synthesis and Research ANd Development/University of California, Los Angeles (RAND/UCLA) Appropriateness Method (RUAM) consensus process.

We will conduct three systematic reviews and a structured evidence synthesis organised into three domains: (1) the impact of obesity on IBD outcomes, (2) the burden of cardiometabolic complications in IBD and (3) the management of overweight, obesity and cardiometabolic comorbidities in IBD. A multidisciplinary international panel of gastroenterologists, surgeons, endocrinologists, hepatologists, cardiologists and dietitians will assess each statement using the RAND/UCLA appropriateness method. Panellists will rate the appropriateness of each statement (only those that fall within their area of expertise) on a 1–9 scale (1–3=inappropriate, 4–6=uncertain and 7–9=appropriate), with medians rounded up (eg, 6.5=appropriate). Agreement will be assessed using the RAND Disagreement Index (DI

This study will not involve direct patient participation, as it is based on evidence synthesis and expert consensus; therefore, formal research ethics committee approval will not be required. Patient representatives will contribute to the consensus process to provide contextual perspectives but no identifiable data will be collected.

Findings will be disseminated through publication in peer-reviewed journals, presentation at major gastroenterology and IBD conferences and communication with professional societies. A lay summary and patient-friendly infographic will also be developed to facilitate translation of recommendations into clinical practice.

CRD420251178843: a systematic review of the impact of obesity on inflammatory bowel disease outcomes.

CRD420251178799: a systematic review of cardiometabolic complications in inflammatory bowel disease.

CRD420251174653: management of overweight, obesity and cardiometabolic comorbidities in inflammatory bowel disease: a systematic review.

Tuberculosis (TB) stigma is a critical barrier to timely diagnosis and treatment, yet few studies have quantified community-level TB stigma or its variability across geographic contexts. This study describes methods for capturing community-level TB stigma and examines stigma variability and correlations with community-level sociodemographic and TB-related factors across urban, periurban and rural communities.

Ecological study.

93 demarcated study communities in Buffalo City Metropolitan Health District, Eastern Cape, South Africa.

3869 heads of household, age ≥18 years, were surveyed in a geographically clustered random sample of households across the 93 study communities.

Validated scales were used to measure perceived TB stigma. Community levels of TB stigma were generated by aggregating individual responses within each study community.

Median community TB stigma scores varied significantly by community location: compared with urban communities, rural communities had lower TB stigma scores (beta=–0.235; 95% CI –0.362 to –0.108) while periurban communities had higher scores (beta=0.136; 95% CI 0.017 to 0.254). Community TB stigma was positively associated with community HIV stigma, with the strongest associations in urban (beta=0.977 (95% CI 0.634 to 1.321) and rural (beta=0.816 (95% CI 0.186 to 1.446) communities. No associations were observed between TB stigma and TB prevalence, TB knowledge or household demographics after adjusting for community location.

TB stigma varied meaningfully across communities and was associated with urbanicity and HIV stigma. Stigma is a complex social process and there may be many other factors shaping TB stigma at the community level. Future research and stigma-reduction interventions should consider local contexts and community-level determinants beyond individual demographics, TB knowledge or community TB burden.

To evaluate the value of linked electronic health records (EHRs) for measuring stroke care quality in England before and after the COVID-19 pandemic, focusing on metrics not routinely captured: stroke incidence, dispensing of secondary prevention medications and a proxy of disability—time spent at home after stroke (‘home-time’).

Prospective cohort study using national linked datasets.

England-wide health data linkage including the Sentinel Stroke National Audit Programme (SSNAP), primary and secondary care, dispensed medications and mortality records, accessed via National Health Service (NHS) England’s Secure Data Environment.

425 675 adults with a first stroke between 1 January 2020 and 31 December 2023; data were available for 304 210 in primary care, 279 825 in hospital admissions, 220 470 in SSNAP and 59 465 in death records.

Annual stroke incidence; first-year medication dispensing rates for antiplatelets, anticoagulants, antihypertensives and lipid-lowering agents (with a 1-month washout period) and home-time at 180 days post stroke.

Stroke ascertainment was highest when combining all sources, with 10.8% of non-fatal ischaemic strokes recorded exclusively in primary care and 19.4% of fatal strokes identified solely through death records. Standardised annual stroke incidence rose from 227.6 (95% CI 226.1 to 229.0) to 244.8 (95% CI 243.4 to 246.3) per 100 000 over the study period including the COVID-19 pandemic. During the COVID-19 lockdown, non-fatal stroke recordings decreased while stroke-related deaths rose, indicating that recording quality was sensitive to shifts in healthcare-seeking behaviour during the pandemic. Among people with ischaemic stroke, 89.1% received an antiplatelet or anticoagulant, 44.5% an antihypertensive and 80.5% a lipid-lowering therapy. For haemorrhagic stroke, these proportions were: for anticoagulants 13.5%, antiplatelets 13.2%, antihypertensives 46.6% and lipid lowering 41.1%. Medication dispensing for stroke prevention declined with increasing age and comorbidity, but varied little by ethnicity, region or pandemic period. Mean home-time within 180 days of stroke was 166.6 (95% CI 166.4 to 166) days, decreasing with greater age (141.4 days for 90 years or older (95% CI 140.7 to 142.1)), deprivation (166.4 days (95% CI 166.1 to 166.6) for most deprived quintile) and stroke severity (137.4 days for National Institutes of Health Stroke Scale (NIHSS) score on arrival over 22 (95% CI 135.8 to 139.1)) and increasing with years from the COVID-19 pandemic 2023 (169.3 days (95% CI 169.0 to 169.5) vs 2020 164.4 days (95% CI 164.1 to 164.7)).

Standardised stroke incidence increased significantly over the study period, highlighting a growing public health burden that persisted despite disruptions due to the pandemic although variation in case ascertainment and stroke coding practices was observed. While secondary prevention coverage for antiplatelets and lipids was high, lower rates of dispensing of antihypertensives, particularly in older and comorbid populations, potentially signal a target for improvement. Home-time represents a sensitive, person-centred outcome that exposes disparities linked to socioeconomic deprivation and clinical severity that can be used to enhance routine stroke audits. These findings justify the expansion of linked EHR infrastructure and the modernisation of governance frameworks to enable the longitudinal evaluation of care quality beyond the COVID-19 era.

Rare skeletal disorders (RSDs) cause lifelong functional impairment, chronic pain and reduced quality of life. Evidence-based rehabilitation strategies remain underdeveloped, particularly for adolescents and young adults. We previously demonstrated preliminary feasibility of a 5-day adapted sailing intervention but observed benefit attenuation at 3-month follow-up. This pilot trial evaluates feasibility, acceptability and safety of intensive adapted sailing therapy followed by home-based telerehabilitation maintenance versus telerehabilitation alone.

This is a prospective, randomised, assessor-blinded, parallel two-arm pilot feasibility trial. 24 participants aged 12–30 years with confirmed RSDs will randomise with a 1:1 allocation ratio to: (1) 5-day adapted sailing therapy followed by 3-month telerehabilitation (n=12) or (2) 3-month telerehabilitation alone (n=12). Primary outcomes assess feasibility through recruitment efficiency (≥80% eligible patients enrolled), intervention adherence (≥75% sessions completed), participant retention (≥80% at 6-month follow-up), and safety (zero serious adverse events attributable to interventions). Secondary outcomes include sensor-based motor function (balance, gait, upper extremity mobility via inertial measurement units) and patient-reported outcomes (health-related quality of life, functional capacity, kinesiophobia, pain), measured at baseline, 3-month and 6-month follow-up. Exploratory analyses will estimate preliminary between-group effect sizes. Statistical analysis uses intention-to-treat principles with linear mixed-effects models.

The study received approval from the Area Vasta Emilia Centro Ethics Committee (363/2025/Sper/IOR) on 7 July 2025. The study is ongoing, and data collection is expected to be completed by March 2026. Results will be disseminated through peer-reviewed open-access publications, conference presentations, patient organisation partnerships and plain-language summaries.

NCT07102875.

Perinatal depression is a common, yet understudied, mental health disorder among women and contributes to poor engagement in prevention of mother-to-child transmission (PMTCT) of HIV in sub-Saharan Africa. Male partners are positioned to provide critical forms of social and economic support during pregnancy and postpartum, and also may contribute to women’s stress, depression and anxiety through intimate partner violence and withholding of social support. Despite the critical role of men in pregnancy outcomes and HIV prevention, few interventions have engaged men around women’s depressive symptoms, nutrition and health, and engagement in PMTCT. We will conduct a pilot trial of Mphatso, a couple-based intervention based on problem-solving therapy with couple relationship skills to reduce depressive symptoms in perinatal women, improve food insecurity and prevent HIV transmission to the infant.

We will employ a two-arm pilot randomised controlled trial in the Zomba district of Malawi to assess the feasibility and acceptability of Mphatso (meaning ‘gift’ or the child) and explore health impacts on depressive symptoms, PMTCT engagement and food insecurity. We will enrol 60 pregnant women in the second or third trimester who are living with HIV and meet criteria for probable depression based on the Edinburgh Postnatal Depression Scale and their male partners. Couples will be randomised to receive either five sessions of Mphatso (problem-management skills plus health education and relationship skills) or enhanced usual care. Feasibility and acceptability outcomes will include session attendance rates, satisfaction levels and retention at 3 months and 6 months postpartum. Exploratory analyses using regression models including time and treatment arm will be conducted to explore effects on the mothers’ and fathers’ depressive symptoms, adherence to PMTCT (antiretroviral therapy, nevirapine use, HIV testing and exclusive breastfeeding) and food insecurity.

The pilot trial has been approved by the University of California, San Francisco (Human Research Protection Program (HRPP); Protocol Number 23-40685), and the study has also been approved by the National Health Sciences Research Committee in Malawi (NHSRC; Protocol Number 24/05/4431). Results will be disseminated to study participants, health officials, policymakers, community leaders and care providers, as well as through presentations at conferences and publications in peer-reviewed journals.

NCT06659315.

To study the association between job demands and distress among working adults and to test whether perceived supervisor support moderates this relationship.

Mixed-effects analysis of repeated measures from a population-based cohort study, estimating overall (combined within-person and between-person) associations.

The Netherlands Longitudinal Study on Hearing (NL-SH), an ongoing Dutch cohort with nationwide recruitment and follow-up including four measurement waves.

A total of 989 employed individuals (≥12 hours/week) with 1858 observations had complete data on distress, job demands, supervisor support and covariates.

The dependent variable was distress, measured using the 16-item distress subscale (range 0–32) of the Four-Dimensional Symptom Questionnaire. Job demands and supervisor support were assessed with subscales from the Job Content Questionnaire. Multilevel linear models were used to estimate main and interaction effects, adjusted for age, sex, educational level, hearing impairment, contract type and chronic diseases.

Higher job demands were associated with greater distress (B=0.22, 95% CI (0.17 to 0.27)). Higher supervisor support was associated with lower distress (B=–0.26, 95% CI (–0.38 to –0.15)). The interaction between job demands and supervisor support was statistically significant (B=-0.02, 95% CI (-0.04 to 0.001), p=0.042). Stratified analyses showed that the association between job demands and distress was stronger among employees with low supervisor support (B=0.27, p

Job demands and supervisor support were independently associated with distress. Supervisor support appeared to buffer the impact of job demands, as the association between job demands and distress was stronger among employees reporting low levels of supervisor support. These findings underscore the importance of strengthening supportive supervisor practices, alongside addressing excessive job demands, as integral components of workplace mental health strategies.

To explore healthcare professionals’ experiences with medication errors (MEs) in terms of types and factors that contribute to them.

A mixed-methods study was conducted to explore the MEs experiences of healthcare professionals. Quantitative data were collected through a cross-sectional, self-administered questionnaire, whereas qualitative data were collected via face-to-face semi-structured interviews.

The study was conducted at Diwan Polyclinic in Muscat, a primary and secondary healthcare institute.

The study population included healthcare workers who were practising (not retired) and actively involved in patient care and the medication-use cycle, either by prescribing, dispensing or administering medication. The total number of participants was 83 (55 females and 28 males) healthcare professionals, comprising doctors (38), nurses (32), pharmacists and assistant pharmacists (13). Omani participants accounted for 72%, whereas non-Omani participants accounted for 28%. Six of 83 healthcare professionals were purposefully selected to provide additional qualitative insights into their experiences with MEs and the measures they use to reduce them.

None.

The primary outcomes focused on identifying types, causes and effects of MEs, and the secondary outcomes aimed to explore the emotional and professional implications on healthcare workers as well as suggested strategies to minimise MEs.

A total of 83 participants (55 females and 28 males) were included, with 72% Omani and 28% non-Omani. Of these, 44 participants (53%) encountered MEs during their practice at Diwan Polyclinic. The most common type of MEs was prescribing errors (51%), followed by dispensing errors (39%) and administering errors (10%). Incorrect dosing was the most typical cause of prescribing errors.

In the qualitative part of the study, the interviewed participants implemented these measures to reduce MEs: 1) double-checking the prescribed medicines, patients ‘names and identity before dispensing and administering drugs, 2) patient education on polypharmacy and 3) alerting prescribing doctors to errors in their prescriptions or orders. Several measures have been suggested to mitigate MEs, including better communication among health professionals and between them and patients, focusing on staff well-being and development and innovative built-in modules and programmes in electronic medical records for drug verification.

The most common type of MEs was prescribing errors. Focusing on better communication and staff well-being, as well as the innovative development of electronic medical records, will help minimise MEs.

Live attenuated vaccines (LAVs) are recommended during moderate corticosteroid therapy (

To test the safety and immunogenicity of LAVs in NS in children on moderate dose corticosteroid therapy (1.5 mg/kg alternate day dose with maximum 40 mg alternate day dose; early arm) vs those off corticosteroid therapy for 4 weeks (standard arm), we are conducting a single-centre, open-label, non-inferiority RCT at a tertiary care centre in South India (VACCINES trial: Vaccines in Children on Corticosteroids for NEphrotic Syndrome). Eligible children (after inclusion and exclusion criteria) will be enrolled after obtaining written informed consent (from a legally accepted representative/parents) as well as assent for children aged >12 years. Two doses of measles, mumps, rubella (MMR) and/or varicella vaccines will be administered 12 weeks apart, after the initial assessment of seroprotection. Immunological assessment of humoral and cellular immunity will be evaluated in eligible participants. Randomisation into the standard and early arms will be performed during the last 2 weeks of alternate-day therapy (stratified into first episode and relapse patients). Seroconversion assessments will be made at 4, 12, 16 and 52 weeks into the study. The primary objective is to compare the proportion of participants who demonstrate seroconversion after 4 weeks of the first intervention. The secondary outcomes are the antibody geometric mean titres and adverse event profiles including serious events. With a non-inferiority margin of 15% (assuming 86% seroconversion in healthy controls), power of 85% and an alpha error of 5%, 100 patients (including 10% attrition) will be randomised (1:1). Comparisons with 50 healthy children will also be made. The occurrence of three serious adverse events directly attributable to the intervention constitutes a stopping rule. An interim analysis after recruitment of 50% is planned to be presented to an institutional Data Safety Monitoring Board. The first patient was enrolled on 30 June 2025, and enrolment is expected to be completed by February 2028.

The trial has been approved by the Institutional Review Board (IRB) of the Christian Medical College, Vellore (IRB min 2411130, dated 20 November 2024). Results will be published in a peer-reviewed journal and may be presented at medical conferences.

Clinical Trials Registry – India, CTRI/2025/01/078854 (Jan 16, 2025).

In sub-Saharan Africa, young women face disproportionate challenges transitioning from school to employment, with high rates of those not in education, employment or training (NEET). Structural barriers—including unequal gender norms, early marriage and unpaid labour—limit their economic participation. The Campaign for Female Education (CAMFED) Livelihoods programme supports young women’s transition from school to independent adulthood through mentoring, life skills, business and agricultural training and access to financial resources.

This study will evaluate the impact, process and mechanisms of change, and cost-benefit of CAMFED Livelihoods programme in Tanzania and Zimbabwe (2024–2027), focusing on outcomes related to economic activity, empowerment, leadership, mental health, subjective well-being and sexual and reproductive health among adolescent and young women (aged 15–24 years).

We will conduct a mixed-method, longitudinal evaluation across five districts in Tanzania and three districts in Zimbabwe. The quantitative component includes a pre-post cohort with a comparison group in Tanzania (n=1520) and a single-cohort design in Zimbabwe (n=500), with data collected at baseline, midline and endline. Primary outcomes are NEET status and leadership, complemented by measures of well-being, empowerment and health. The qualitative component will explore mechanisms of change and programme delivery. A cost-benefit analysis will estimate social and economic returns using a provider perspective. Youth researchers will be engaged to enhance participatory learning.

We have received ethics approvals from the London School of Hygiene and Tropical Medicine (31266), the National Health Research Ethics Committee (6732) in Tanzania and the Medical Research Council of Zimbabwe (MRCZ/A/3239) in Zimbabwe. Results of this study will be published in peer-reviewed academic journals and shared with policymakers, study participants and the other stakeholders in Tanzania and Zimbabwe.

To investigate how patients with sarcoma present prior to diagnosis—through a general practitioner (GP) or another healthcare professional (HCP)—and describe presenting symptoms.

International observational cohort study.

Data were obtained from the longitudinal ‘QUality of life and Experiences of Sarcoma Trajectories’ (QUEST) cohort study, conducted across the Netherlands, the United Kingdom (UK), Australia and New Zealand.

Among 572 patients, 487 (85.1%) started their diagnostic trajectory at the GP (subcohort 1) and 85 (14.9%) with another HCP (subcohort 2)—mainly medical specialists treating unrelated conditions (36/85; 42.4%). Soft tissue sarcoma patients most often reported swelling, whereas bone sarcoma patients reported unexplained pain. Notably, 31/85 (36.5%) of subcohort 2 were asymptomatic. Reasons for delaying GP visits included assuming symptoms were minor and expecting them to resolve. Patients sought care when, among others, symptoms persisted and worsened.

Most patients first consulted a GP, underlining the role of primary care in sarcoma diagnosis internationally. Due to rarity and nonspecific symptoms, faster diagnosis remains challenging, requiring improvements in both primary and specialist care.

NCT03441906; Results.

To estimate the contribution of ultraprocessed foods (UPF) to total energy intake and to macronutrient and micronutrient intakes among very old people aged 85 years in the Newcastle 85+ Study.

Cross-sectional observational analysis of baseline dietary and demographic data from the Newcastle 85+ cohort.

Community-dwelling and institutionalised adults in Newcastle on Tyne and North Tyneside, UK, recruited through general practice registered between June 2006 and October 2007.

Eight hundred participants (62% female) aged 85 years at baseline, with two complete non-consecutive 24-hour dietary recalls.

The primary outcome was the contribution of UPF (Nova group 4) to total energy intake, macronutrient intakes, expressed as percentage of total energy for carbohydrate, protein, total fat, saturated fat and added sugars, as grams per day for fibre and to micronutrient intakes (vitamins A, B, B₁₂, C, D, E and folate) and minerals (calcium, potassium, magnesium, zinc, selenium, phosphorus, iron and sodium). All evaluated across sex, education and socioeconomic status, adjusted tertiles of UPF intake.

Among the 800 participants included in the analysis, UPF contributed 56% of total energy intake, surpassing that from unprocessed foods (27%). Total energy intake did not differ across tertiles of UPF consumption (lowest vs highest tertile: 1759.5 kcal/day (95% CI 1684.6 to 1834.4) vs 1740.0 kcal/day (1667.3 to 1812.7)). Higher UPF intake was associated with a higher proportion of energy from carbohydrates and added sugars, and a lower proportion from protein and saturated fat. Intakes of several micronutrients were lower in the highest versus the lowest UPF tertile, including vitamin C (59.9 mg/day (49.8 to 70.0) vs 94.0 mg/day (83.7 to 104.4)) and potassium (2455.9 mg/day (2334.1 to 2577.6) vs 2786.3 mg/day (2660.8 to 2911.8)). By contrast, calcium from fortified foods increased across tertiles (6.3 mg/day (3.7 to 8.9) to 15.4 mg/day (12.9 to 17.9)).

This study highlights the potential role of UPF in the diets of very old people: higher UPF intake was not associated with higher energy intakes often observed in younger populations. Some UPF, particularly fortified products, may contribute to meeting micronutrient requirements in very old people where dietary inadequacies are common. Further research is needed to confirm these findings and to inform dietary guidance for very old people.

To examine HIV care attrition patterns and risk factors among adolescent girls and young women (AGYW) enrolled in prevention of mother-to-child transmission of HIV (PMTCT) services in Tanzania.

Prospective cohort study.

The study was conducted in three regions of Tanzania: Kagera, Tabora and Dar es Salaam across 543 public and private health facilities.

A total of 10 147 pregnant and postpartum AGYW living with HIV attending PMTCT services between 1 January 2018 and 31 December 2020 were included in this study and followed prospectively until they were censored at the last appointment date or 31 December 2023, whichever was earlier.

The primary outcome was time to HIV care attrition, defined as death, discontinuation of antiretroviral treatment (ART) or loss to follow-up (LTFU). LTFU was defined as failure to attend a scheduled clinic appointment and being absent from care for ≥90 consecutive days following a missed appointment among non-transfers. Kaplan-Meier analyses were used to estimate time to first attrition. The Anderson-Gill proportional hazard model estimated the risk factors for repeated care interruptions, adjusted for baseline characteristics and stratified by ART status at PMTCT enrolment.

A total of 3259 attrition events were observed, of which 79% occurred within the first year, with the median time to first attrition of 4 months (IQR: 1–8), 96.3% were due to LTFU. Over two-thirds of first-year attrition occurred among AGYW newly started on ART at PMTCT enrolment, who had more than twice the attrition rate of those already on ART (28.6 vs 11.2 per 100-person-years). Of AGYW lost to follow-up, 44.8% returned to care and 20.9% experienced subsequent attrition. Among AGYW new on ART, attrition was higher in those enrolled late in their third trimester (adjusted HR (aHR) 1.20; 95% CI 1.01 to 1.42) versus those in the first trimester and lower during the postpartum period (aHR 0.58; 95% CI 0.43 to 0.79). In AGYW already on ART, attrition rate was higher among adolescents 18–19 years (aHR 1.37; 95% CI 1.13 to 1.66) and those enrolled late; during the second (aHR 1.41; 95% CI 1.16 to 1.72) and third trimesters (aHR 1.57; 95% CI 1.23 to 2.00) or post partum (aHR 1.36; 95% CI 1.09 to 1.70) compared with the first trimester. AGYW with early-stage HIV, on second-line regimens and attending facilities with fewer AGYW, had a lower attrition rate in contrast to comparison groups.

AGYW newly started on ART at PMTCT enrolment are more likely to have early and recurring dropout. Given the cyclical nature of HIV care engagement, tailored and repeated interventions are needed to support continuous retention and re-engagement for pregnant and postpartum AGYW with HIV.

Visual impairment is reported to affect 40%–50% of children with cerebral palsy (CP). Vision difficulties in the context of rehabilitation are often under-recognised, under-treated and therefore under-studied, pointing to an urgent need for the development of evidence-based vision interventions for infants and toddlers with cerebral vision impairment (CVI). We present the protocol of a multisite pragmatic pilot randomised controlled trial (RCT) of feasibility, acceptability and preliminary efficacy of an early vision-awareness and parent-directed environmental enrichment programme for infants with or at risk of CP under 7 months corrected age (CA) with vision impairment.

The main objective is to determine the feasibility and acceptability of the Vision Intervention for Seeing Impaired Babies: Learning through Enrichment (VISIBLE) intervention. We will estimate the preliminary effects of the programme on infants’ visual functions and early development, as compared with standard community-based care (SCC).

A two-group RCT will be conducted. Infants at 3–6 months at entry, with severe visual impairment and at high risk of CP, will be enrolled and randomised (n=16 per group) to receive the VISIBLE intervention compared to SCC. Randomisation will be completed through an independent automated process (Research Electronic Data Capture). VISIBLE intervention will be delivered by a therapist through home visits (90–120 min) once every 2 weeks. Completion of 10 visits (80% of the intervention target dose) within 6 months is required for adherence to the VISIBLE trial. Outcome will be assessed at 12 months CA. Visual function will be evaluated with the Infant Battery for Vision, motor outcomes with the Peabody Developmental Motor Scales, Second Edition. Developmental quotients, infant quality of life, parent well-being and parent-infant relationship will be also monitored through standardised tools.

The enrolling sites have historically demonstrated rapid and effective translation of successful evidence-based interventions into routine clinical practice, as well as the dissemination of the findings through local, national and international scientific meetings.

ACTRN12618000932268.

To explore existing qualitative research on patients’ experiences from the onset of symptoms to the diagnosis of sarcoma, with the purpose of identifying patient-perceived barriers at both patient and healthcare system levels and to highlight opportunities for improvement.

Systematic review of qualitative studies using thematic synthesis.

We systematically searched Medline [Ovid], Embase [Ovid], PsycINFO [EBSCOhost] and CINAHL [EBSCOhost] from database inception to 11 April 2025 for qualitative studies reporting sarcoma patients’ experiences during their diagnostic trajectory. The final search was conducted on 11 April 2025. All articles were screened against predefined inclusion and exclusion criteria and methodological quality was appraised using the Critical Appraisal Skills Programme qualitative checklist. Six studies conducted in Australia, the Netherlands and the UK were included. Data were analysed using a thematic synthesis approach guided by Thomas and Harden (2008). Confidence in the synthesised findings was assessed using the Grading of Recommendations Assessment, Development and Evaluation - Confidence in the Evidence from Reviews of Qualitative Research (GRADE-CERqual) approach.

Four overarching themes emerged: patients’ experience and interpretation of symptoms, diagnostic pathways, healthcare system factors, and reflections and recommendations. Key contributors to delayed diagnosis were symptom normalisation, misattribution by both patients and healthcare professionals, limited continuity of care and communication challenges. These findings were consistent across multiple countries, indicating relevance and validity in many settings. Patients emphasised the importance of disease awareness, persistence of patients and coordinated care.

Diagnostic delays in sarcoma are influenced by both patient and healthcare systemic factors. Addressing these factors requires increased disease awareness among healthcare professionals and the public, improved coordination within the healthcare system, and targeted research to guide future interventions. This review provides cross-country insights into barriers to early sarcoma diagnosis, informing future priorities in clinical practice and research.

CRD420251030726.