Genitourinary syndrome of menopause (GSM) is a chronic, oestrogen-deficient condition that is frequently underdiagnosed and undertreated. Although low-dose vaginal estriol improves epithelial trophism and microbial balance, a substantial proportion of women report persistent symptoms. High-quality randomised evidence evaluating combined therapeutic strategies remains scarce. Energy-based modalities, including the erbium:YAG (Er:YAG) laser (=2940 nm), have been proposed as adjunctive treatments. This trial aims to assess the efficacy of Er:YAG laser therapy combined with vaginal estriol compared with estriol alone in postmenopausal women with GSM.

This is a single-centre, randomised, double-blind, controlled clinical trial. Postmenopausal women aged 45–70 years with vaginal pH ≥5.0 and at least one moderate GSM symptom (Visual Analogue Scale ≥4) will be eligible. Exclusion criteria include current systemic or local hormone therapy, previous vaginal energy-based treatment, abnormal cervical cytology and body mass index ≥35 kg/m². All participants will receive vaginal estriol cream (0.5 mg per dose) daily for 14 days, followed by twice-weekly administration for 16 weeks. Participants will be randomised (1:1) to receive either estriol plus sham Er:YAG laser or estriol plus active Er:YAG laser. Three laser sessions will be delivered at approximately 4-week intervals. Assessments will occur at baseline, monthly during treatment and 4 months after the final session. The primary outcome is the Vulvovaginal Health Index, with the primary endpoint defined as the change from baseline to 4 months post-treatment, reflecting sustained effect. Secondary outcomes include GSM symptom severity, vaginal microbiome composition (16S rRNA sequencing), quality of life (Menopause Rating Scale) and sexual function (Female Sexual Function Index). Data will be analysed using repeated-measures analysis of variance or appropriate non-parametric tests, with significance set at p

Ethical approval has been obtained from the Human Research Ethics Committee of UNINOVE. Written informed consent will be obtained. Findings will be disseminated via peer-reviewed journals and scientific meetings.

NCT06873971.

This study assessed the spatial distribution of HIV test non-uptake among pregnant women who attended antenatal care (ANC) in sub-Saharan Africa.

Cross-sectional study design.

Sub-Saharan Africa (SSA) region. 24 SSA countries were included in this study.

Demographic and Health Survey (DHS), 2016–2024.

82 397 women who were pregnant in the last 2 years preceding the survey.

HIV test non-uptake, which is a legacy indicator of HIV test among pregnant women.

The HIV test non-uptake among ANC attending pregnant women was 39.6% (95% CI 39.27% to 39.93%). The spatial autocorrelation test revealed that HIV testing non-uptake among pregnant women was clustered. The global Moran’s I value was 0.48 with a p value

There was a significant geographical variation in HIV test non-uptake among pregnant women attending antenatal care (ANC) in sub-Saharan Africa. Prioritising hotspot areas with high rates of HIV test non-uptake for spatially targeted interventions is essential. Policymakers, health professionals, and other stakeholders should focus on improving women’s formal education, expanding health insurance coverage, and increasing ANC contacts to ensure that each visit includes HIV screening. Moreover, special attention should be given to younger women to enhance HIV testing uptake among those attending ANC in sub-Saharan Africa.

Maternal and newborn morbidity and mortality are a global concern. Understanding the epidemiology of post-discharge complications could identify opportunities for interventions. We aimed to quantify mortality, care-seeking events and readmission among mothers and newborns in Uganda following facility-based delivery.

This prospective observational study (Apr 2022-Sep 2023) enrolled women presenting for delivery at two regional referral hospitals in Uganda. Data were collected during admission and 6 weeks after delivery by phone.

Overall, 7131 women delivered 7359 newborns, of whom 7129 (99%) women and 6968 (94%) newborns were discharged alive. The newborn mortality rate was 2.7% and 32% of deaths occurred post-discharge. Following discharge, 230 (3%) women and 287 (4%) newborns were readmitted. Suspected sepsis and infections were the most common reasons for readmission among mothers (62.2%) and newborns (89.9%). Caesarean delivery (OR:2·26 (1·75-2·93)) and perinatal death (OR:3·18 (2·09-4·69)) were associated with post-discharge maternal readmission. Both maternal and newborn readmission were associated with household food insecurity during pregnancy (maternal OR:1·56 (1·15-2·08); newborn OR: 1·73 (1·31-2·25)). Newborn resuscitation with oxygen was associated with maternal readmission (OR:2.24 (1.24–3·78)), newborn readmission (OR: 2·74 (1·54-4·56)) and newborn death (OR: 4·01 (1·73-8·21)). Although >99% of women had ≥1 antenatal care visit, only 511 (7%) had ≥1 routine postnatal care visit. There were no routine postnatal care visits among 211 (91·7%) readmitted mothers, 276 (96·2%) newborns and 57 (91·9%) newborns who died.

Post-discharge complications occur in a context of low routine postnatal care use. Risk-informed discharge planning, postnatal care and health education strategies may improve outcomes in mothers, newborns and their families.

Intracerebral haemorrhage (ICH) accounts for approximately 15% of all strokes in Denmark and remains associated with high mortality and morbidity. It is challenging to distinguish neoplastic from non-neoplastic causes of ICH in the acute setting, and CT findings that may aid early differentiation have not been fully characterised. Existing ICH-classification systems (SMASH-U, H-ATOMIC and CLAS-ICH) have not been directly compared for diagnostic accuracy in this setting. Identifying radiological and clinical factors associated with underlying aetiology may support faster diagnosis, reduce time to workup related to potential underlying cancer and facilitate early targeted treatment of the underlying cause of ICH.

This study is a retrospective observational cohort including all patients admitted with acute ICH to the Department of Neurology, University Hospital of Southern Denmark, Aabenraa between January 2014 and December 2024 (estimated approximately n=610). Medical records and initial non-enhanced CT scans will be reviewed. Two neurologists and two radiologists, blinded to final diagnosis, will independently extract clinical presentation, topographical and volumetric haemorrhage characteristics, and classify each case using the abovementioned ICH-classification systems. Primary analyses will assess associations between clinical and radiological features and underlying neoplastic vs non-neoplastic aetiology. Secondary analyses will compare diagnostic performance of classification systems using sensitivity, specificity and receiver operating characteristic curves. Multivariate logistic regression models will be applied with Holm correction for multiple comparisons.

The study has been submitted to the National Danish Research Ethics Committee and the Danish Data Protection Agency. As data derive from completed disease courses, no patient contact is expected. Results will be disseminated through peer-reviewed journals, conferences and scientific presentations.

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.

The Government of India launched the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) to expand access to affordable generics through private retail outlets named as Jan Aushadhi Kendras (JAKs). This study examines the association of PMBJP with out-of-pocket expenditure (OOPE), catastrophic health expenditure (CHE) and impoverishment rate (IR) attributable to medicines.

A cross-sectional observational study was conducted across nine Indian states in 2022–2023.

Outpatient (OPD) and inpatient (IPD) departments of secondary and tertiary government hospitals, private pharmacies and JAKs in 18 districts of India

A total of 10 336 patients were recruited from OPD (n=2881) and IPD (n=1009) departments of government hospitals as well as pharmacy settings (n=6446). Data on sociodemographics, disease severity, number of generic prescriptions, source of acquiring medicines and medicine-related OOPE were collected through semistructured interviews and periodic follow-ups.

Primary outcomes included mean OOPE on medicines, incidence of CHE (≥40% of non-food consumption expenditure on medicines), IR among JAK and non-JAK users were the primary outcomes of the study. Secondary outcomes comprised awareness of JAKs, generic prescribing rates in hospitals and the factors associated with OOPE, CHE and IR.

Patients procuring medicines exclusively from JAKs reported the lower mean OOPE (OPD: 172; IPD: 275; pharmacy: 307), compared with significantly higher spending at private pharmacies (OPD: 1085; IPD: 3165; pharmacy: 1031). After adjusting for covariates, OOPE among exclusive JAK users was significantly lower relative to private pharmacy users by 60.6%–89.3%. Furthermore, matched analysis confirmed 42% lower expenses, compared with private pharmacies. The likelihood of CHE was also significantly greater among private pharmacy users. However, utilisation of JAKs remained limited, mainly due to low awareness, perceived stock shortages and low rates of generic prescribing.

PMBJP is associated with significant reduction in OOPE and financial hardship, positioning it as an effective cost-containment intervention within India’s universal health coverage framework. Strengthening supply chains, promoting generic prescribing and integrating JAKs with public facilities would further maximise its impact.

To identify whether patients with arrhythmia, heart failure or ischaemic heart disease presenting with anxiety symptoms measured by the Hospital Anxiety and Depression Scale (HADS) have identifiable anxiety according to the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID) and, if so, which type of anxiety disorder based on the SCID.

Initial screening data from the Heart and Mind randomised clinical trial.

Patients with arrhythmia, heart failure or ischaemic heart disease were screened using HADS, and patients with a HADS-anxiety (HADS-A) score≥8 were invited to participate. Participants were interviewed by trained cardiac nurses using the SCID to determine whether they met the criteria for anxiety and, if so, the type of anxiety disorder.

Of the 7816 patients who completed the HADS questionnaire, 1803 (23%) had a HADS-A score≥8. Among these, 398 (22%) agreed to the SCID interview, and 336 (84%) met the diagnostic criteria for an anxiety disorder. The mean age was 61 years, with 40% being female. The mean HADS-A score was 11.3 (SD=2.7). The most common types of anxiety were generalised anxiety disorder (61%), panic disorder (23%) and specific phobia (8%).

The majority of individuals identified by the instrument also met the diagnostic criteria for an anxiety disorder. Generalised anxiety disorder and panic disorder were the most prevalent subtypes. Anxiety was common across the cardiac population, underscoring the need for routine assessment and targeted intervention in clinical practice.

NCT04582734.

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).

Treatment for high-risk locally advanced prostate cancer typically includes radiation or radical prostatectomy plus androgen deprivation therapy (ADT), but the optimal use of neoadjuvant and adjuvant ADT in practice remains unclear. Relugolix and enzalutamide have demonstrated strong efficacy independently in the setting of advanced disease, but their combined use in neoadjuvant/adjuvant therapy has not been studied. This trial investigates their safety and efficacy as neoadjuvant/adjuvant therapy in patients undergoing definitive local treatment.

Relugolix and Enzalutamide as Neoadjuvant/Adjuvant to Local-regional treatment in Patients with High-risk, Locally Advanced Prostate Cancer (RENAPCA) is a prospective, single-arm, open-label phase Ib trial with blinded outcome assessment. The study is conducted across four tertiary oncology centres within the United States. Eligible participants are adult men with pathologically confirmed locally advanced high-risk prostate cancer who are candidates for definitive local therapy. Patients with significant comorbidities or a life expectancy of less than 6 months are excluded. The trial includes a 3+3 dose-escalation safety lead-in cohort (up to 12 patients) to determine dose-limiting toxicities and recommended phase 2 dose, followed by a dose expansion cohort (up to 46 patients). Interventions consist of 6 months of neoadjuvant therapy with relugolix plus enzalutamide, definitive local therapy (radical prostatectomy or radiation therapy), and 18 months of adjuvant therapy with relugolix plus enzalutamide. Primary outcomes include pathologic CR rate and minimal residual disease rate. Secondary outcomes include prostate-specific antigen response, progression-free survival, objective response rate, frequency and severity of adverse events, and positive margin/pathologic downgrade rate. Exploratory objectives include patient-reported outcomes and quality of life measures. RENAPCA will assess the safety and efficacy of neoadjuvant/adjuvant relugolix+enzalutamide in high-risk, locally advanced prostate cancer to support future larger-scale studies and potentially improve treatment outcomes.

This research protocol has been approved by the Institutional Review Board of the University of Oklahoma Health Sciences Center (7 March 2024). The study is based on voluntary participation with informed written consent.

NCT06130995.

Angina with no obstructive coronary artery disease (ANOCA) affects millions and is frequently under-recognised because diagnostic pathways and risk tools predominantly target obstructive coronary artery disease (CAD). This protocol describes shared methods for two machine-learning (ML) studies: (1) differentiating ANOCA from stable angina with obstructive CAD and (2) predicting long-term mortality among patients with ANOCA and obstructive CAD.

We will develop and cross-site validate ML classification models using a multicentre retrospective cohort drawn from the Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease registry and institutional datasets from the University of Ottawa Heart Institute and the University Health Network. Eligible participants are adults (≥18 years) undergoing initial cardiac catheterisation for chest pain/anginal equivalents since 1995, excluding prior revascularisation, major structural heart disease and predefined non-anginal indications. Outcomes are (1) ANOCA (0% to

Model development will use nested cross-validation with stratified k-fold inner-loop tuning and leave-one-site-out cross-validation for repeated external validation. Candidate predictors will be harmonised across sites, filtered for missingness and refined using expert/directed acyclic graph-guided selection plus Boruta and Least Absolute Shrinkage and Selection Operator. Preprocessing includes appropriate encoding, missing-data imputation (multivariate imputation by chained equations) and feature scaling. Algorithms will include elastic-net logistic regression, random forest, LightGBM and multilayer perceptron models; hyperparameters will be optimised via Bayesian optimisation. Performance and threshold tuning will be reported. Explainability and subgroup fairness will be assessed using SHapley Additive exPlanations. Final models will be deployed as a web-based clinical risk calculator.

Ethics approval has been obtained from the University of Calgary and the University Health Network (#24-5916). Analyses will use deidentified data in secure environments; only aggregate results will be reported. Findings will be disseminated via peer-reviewed publications, conferences and a web-based calculator.

Settings with insufficient human resources struggle to provide timely eye care services and information to the population. mHealth (mobile healthcare) is a promising solution; however, evidence on the effectiveness of interactive voice response (IVR) and real-time phone-based education remains scarce, despite their potential to be scalable and cost-effective. This study aims to implement the Virtual Baithak, an interactive mHealth platform, to improve eye-health literacy among older adults residing in rural India. The objectives are to (1) Develop and validate the Virtual Baithak for improving vision health and (2) Determine its effectiveness, feasibility and acceptability among the older adults.

This 3-armed, parallel, randomised controlled trial of 14 months duration will enrol 381 older adults (aged 60 years and above). Participants will be blinded and randomly (computer-generated) assigned to either of the three groups based on the intervention for eye-health education they receive: both IVR and group calls moderated by a healthcare professional, only IVR and usual care. The two intervention arms will receive the information weekly over a 3-month period through the Virtual Baithak platform, which will be designed for this study using a participatory research approach to develop the content. The primary study outcomes are digital health literacy and vision health knowledge scores, measured at baseline and 14 months. The secondary outcomes include m-health technology acceptance and usage practices. A mixed-method process evaluation will be conducted to assess the intervention feasibility and implementation, including in-depth interviews with participants. The qualitative data will be thematically analysed to explore factors that promote or restrain the implementation. The inferential statistical quantitative analysis will be performed using linear mixed models.

The study has been approved by the ‘Institute Ethics Committee,’ PGIMER, Chandigarh, India (PGI/IEC/2022/EIC000282 dated 18 February 2022). The results will be disseminated via presentations and/or publications at the national and international levels.

CTRI/2023/02/049383, dated 1 February 2023.

Healthcare quality improvement increasingly relies on patient experience data, yet traditional survey modes face declining response rates and rising costs. Mobile web surveys have emerged as a promising alternative for improving response rates. The primary aim of this study was to investigate the effectiveness of mobile web surveys in improving response rates in South Korea’s Patient Experience Assessment. We also aimed to assess the impact of a mixed-mode approach integrating mobile web and follow-up telephone surveys across different demographic groups.

A randomised experimental design was employed to compare response rates as well as contact and cooperation rates among survey modes. A total of 4800 patients from four general hospitals were randomly allocated to telephone, mobile web or mixed-mode survey, with 1600 patients per mode. Each mode allowed five contact attempts through calls or mobile survey links. The mixed-mode survey included follow-up calls for mobile non-respondents.

The survey was conducted between October and November 2022 among patients discharged from four general hospitals in South Korea.

A total of 4800 patients aged 19 years or older who were hospitalised for more than 1 day and discharged within 2–56 days from four general hospitals were included in this study. Exclusion criteria included patients in day clinics, palliative care, paediatrics and neuropsychiatry, as well as those without personal information consent forms during hospital admission.

The primary outcome measure was the response rate for each survey mode. Secondary outcome measures included the contact rate and the cooperation rate.

The mobile web survey yielded an overall higher response rate (32.5%) than the telephone survey (22.4%), with the mixed-mode survey achieving the highest response rate (39.3%). Decomposing response rates revealed that while contact rates were comparable for both telephone and mobile web surveys, the cooperation rate was considerably higher for the mobile web survey (73.2%) compared with the telephone survey (52.2%). Substantial gender-age subgroup differences were found.

Adopting mobile web surveys for patient experience assessments, which aligns with the public’s preference for information and communication technologies, could significantly improve response rates in patient experience surveys.

KCT0011374 (post-results).

To assess and compare the diagnostic accuracy of non-ophthalmologist-led diabetic retinopathy screening (DRS) at health and wellness centres (HWCs) and offline artificial intelligence (AI)-assisted community-based screening, using specialist grading as the reference standard in India.

Pragmatic diagnostic accuracy study in primary healthcare settings. The settings included HWCs and community-based screening sites in rural Block Boothgarh, Mohali District, Punjab, India. A total of 600 people with diabetes aged ≥30 years were enrolled across three screening models: (1) non-ophthalmologist-led DRS at the HWC, (2) AI-assisted smartphone-based DRS in the community and (3) standard referral-based care. Retinal images were captured using non-mydriatic fundus cameras and independently graded by two masked human graders; a senior retina specialist resolved any disagreements. The AI was assessed for its ability to detect diabetic retinopathy (DR) and referable diabetic retinopathy (RDR). Diagnostic performance metrics were reported.

The non-ophthalmologist-led model demonstrated 86.4% sensitivity (95% CI 65.1% to 97.1%) and 94.3% specificity (95% CI 88.5% to 97.7%) for DR detection, with an ungradability rate of 8%. For RDR, sensitivity reached 95.8% (95% CI 78.9% to 99.9%) and specificity was 93.1% (95% CI 88.0% to 96.5%). The offline AI-assisted model achieved 93.3% sensitivity (95% CI 68.1% to 99.8%) and 85.1% specificity (95% CI 76.9% to 91.2%) for RDR, but with a higher ungradability rate (38%), mainly due to cataracts and poor image quality. Both approaches effectively identified referable cases; however, the non-ophthalmologist-led model demonstrated greater accuracy and operational feasibility.

This study demonstrates that non-ophthalmologist-led DRS at HWCs can enhance access to primary care. Offline AI-enabled screening demonstrates potential for community use but is currently limited by image quality and binary classification outputs. Integrating both approaches may strengthen DRS coverage in resource-limited settings.

CTRI/2022/10/046283.

Psychedelic-assisted therapy shows promise for treating various mental health conditions; however, its reliance on intensive psychological preparation limits its broader application. Digital health interventions have the potential to address this limitation by providing structured, accessible and scalable preparation solutions. This randomised controlled feasibility trial aims to evaluate the feasibility and preliminary efficacy of the Digital Intervention for Psychedelic Preparation (DIPP), a 21-day mobile-accessible programme designed to prepare individuals for psychedelic experiences.

The study will recruit 40 non-treatment-seeking adults without a clinical diagnosis, randomly assigning them to one of two conditions: (1) DIPP-MEDITATE, which combines daily guided meditation with background music or (2) DIPP-MUSIC, which provides the same background music without guided meditation. Both groups will complete the 21-day digital intervention remotely. Following the intervention, participants will attend an in-person supervised psilocybin session, receiving a standardised 25 mg dose. Primary outcomes focus on feasibility metrics including recruitment efficiency, participant retention and adherence to the intervention protocol. Secondary outcomes assess subjective feasibility, acceptability and preliminary efficacy, specifically evaluating psychedelic preparedness, the quality of the psychedelic experience and changes in wellbeing, with follow-up assessments at 2 weeks, and at 3, 6 and 9 months post-session. Exploratory measures include neuroimaging, physiological, cognitive and psychological assessments, as well as voice note experience sampling through a chatbot (referred to as ‘DIPP-bot’) to monitor inner speech, thought and emotional states during the intervention and follow-up periods.

Approved by UCL Research Ethics Committee (ID: 19113/003), this study follows the Declaration of Helsinki. Results will be published in peer-reviewed journals and presented at conferences. Confidentiality will be maintained throughout.

NCT06815653.

Adolescent tobacco use (ATU) is a global public health concern, causing significant morbidity and premature death. This study aimed to assess trends in the prevalence of ATU in Indonesia between 2009 and 2019 and to identify factors contributing to the observed changes.

This study performed secondary data analysis of three consecutive waves (2009, 2014, and 2019) of the Indonesian Global Youth Tobacco Survey (IGYTS). Weighted prevalence estimates and complex survey data analysed using multivariate logistic regression were established across the three-wave surveys. A pooled IGYTS data set was explored to determine the risk factors of the ATU. A multivariate decomposition analysis (MDA) was used to determine factors contributing to the prevalence change in male adolescents over the last two surveys.

The prevalence of ATUs was 21.1% (38.2% in males; 6.4% in females), 18.6% (32.7% in males; 3.9% in females) and 19.8% (36.8% in males; 3.5% in females) for the three consecutive surveys, respectively. Being older adolescents, male, exposed to SHS (secondhand smoke) at home, tobacco industry promotion, not knowledgeable of the dangers of tobacco smoke and SHS, and against banning smoking in public places were associated with ATU consistently across the surveys. In addition, inadequate anti-cigarette media and not being knowledgeable of the difficulty of quitting smoking were also identified as risk factors in the pooled data. MDA showed that 88.94% of the explained change was due to differences in the composition of explanatory variables between the last two surveys.

This study suggests that social influence and tobacco industry promotion significantly impact ATU in Indonesia. Governments should emphasise these factors in their tobacco control interventions.

Patients in intensive care units (ICUs) and their families face existential physical, psychosocial and spiritual distress. Integrating palliative care (PC) into ICU care may benefit patients, relatives and ICU clinicians. Prior PC studies have shown a reduction in ICU length of stay (LOS) and distressing symptoms without altering overall mortality. A shorter ICU LOS may alleviate the burden for patients and relatives and help optimise the use of limited intensive care resources. PC in the ICU, however, remains underused, partly due to limited access and knowledge of ICU clinicians. Also, robust data regarding the effectiveness and cost-effectiveness of PC treatment in the ICU are scarce. We established the ‘enhancing palliative care in ICUs’ (EPIC) study to implement a system-based harmonised practice model across European ICUs. The aim is to investigate if early integration of PC via telemedicine, clinician education and bedside tools is effective and cost-effective, ultimately benefiting patients, relatives and ICU clinicians.

This multicentre, controlled, cluster-randomised, non-blinded stepped-wedge design trial with crossover phase aims to recruit around 2,000 patients from five European countries. All adult patients admitted to participating ICUs—with an ICU LOS exceeding 72 hours, where cancer is not the primary cause of critical illness, and who are not expected to die within the next 24 hours—are screened for the need for specialised PC based on the attending physician’s judgement. This judgement is triggered by the presence of one or more of the following: (1) significant disagreement among ICU team members and/or relatives about the appropriateness of current ICU treatment, (2) considerations of limiting life-sustaining therapy or (3) the anticipation that a specialised PC consultation may benefit the patient, their relatives or the ICU team. Patients identified as needing specialised PC and their relatives are then enrolled after obtaining written informed consent.

The complex intervention consists of (a) a blended-learning programme to foster knowledge and attitude about PC among ICU clinicians, (b) bedside tools, including a checklist to identify patients in need of PC and a factsheet and (c) standardised telemedical consultations from trained EPIC interventionists. Patient and relative follow-up is conducted 3 months post-ICU discharge. Outcomes include clinical measures (including ICU LOS (primary outcome), severity of critical illness, invasive treatments and health-related quality of life), economic endpoints (resource use, costs, cost–consequence situation, cost-effectiveness), ICU clinician burnout and distress, and patient and family perception about the quality of symptom management, care and communication. Endpoint analyses will employ generalised linear mixed models, accounting for the clustered data structure and stepped wedge design.

EPIC complies with the Declaration of Helsinki and has been approved by all local ethics committees. A decision-making structure is established to ensure trial procedures are carried out according to Good Clinical Practice. Study findings will be published in peer-reviewed journals and communicated to participants, healthcare professionals and the public. Sets of anonymised study data will be made available following Findable, Accessible, Interoperable, and Reusable principles.

NCT06605079.

Cannabis-based medicine may alleviate breathlessness. This study will investigate whether dronabinol, a synthetic form of ⁹-tetrahydrocannabinol (⁹-THC), reduces breathlessness in patients with severe and very severe chronic obstructive pulmonary disease (sCOPD) compared to placebo.

This single-centre, randomised, double-blinded, placebo-controlled, crossover trial will enrol 30 patients with sCOPD and persistent breathlessness despite optimal treatment. Patients will be recruited from a pulmonary outpatient clinic in Denmark over 24 months. Eligible patients (aged ≥18 years) will receive either dronabinol or placebo for 4 weeks, followed by a 2-week washout, before crossing over to the other treatment for 4 weeks. Exclusion criteria include ongoing infection, substance abuse and significant comorbidities. Primary outcome is breathing discomfort or unpleasantness measured using the 0–10 Numerical Rating Scale. Secondary outcomes include lung function (forced expiratory volume in one second), hair cortisol concentrations, functional tests, plasma THC blood concentrations and questionnaires assessing breathlessness, activity, quality of life, anxiety and depression. Continuous monitoring of vital signs, activity and sleep will be performed using a Garmin Venu 3 smartwatch. Data will be entered into electronic case report forms and monitored by the Good Clinical Practice (GCP) unit in Odense.

This will be the largest randomised, double-blinded, crossover trial to investigate dronabinol in patients with COPD and will provide new knowledge on the efficacy and safety.

Written informed consents will be obtained from study patients. The study has been approved by the Danish Medicines Agency (case number: 2023010659) and the medical research ethics committees (case number: 2301456). It is registered in the European Union Clinical Trials Registry (2024-513593-22-00) and ClinicalTrials.gov (NCT06473701). The trial follows the Declaration of Helsinki II and International Council for Harmonisation-GCP guidelines. Findings will be disseminated in peer-reviewed publications.

The European Union Clinical Trials Registry (2024-513593-22-00) and ClinicalTrials.gov (NCT06473701).

Paternal incarceration represents a significant stressor that disrupts family cohesion, undermines paternal identity and adversely affects children’s psychosocial well-being. While family-focused programmes show promise in improving outcomes for incarcerated parents and their children, culturally attuned prison-based parenting interventions remain underdeveloped and scarce, particularly in Asian contexts. To address this gap, a local parenting intervention grounded in the Double ABCX model of family resilience, the ‘Be My Hero’ programme, was designed for incarcerated fathers in Hong Kong, China.

A concurrent mixed-methods design will be used to evaluate the intervention. A convenience sample of 20–30 incarcerated fathers of children aged 3–11 will be recruited from three correctional facilities. Quantitative measures assessing paternal competence, father–child attachment, communication and resilience will be collected preintervention and postintervention. Qualitative data will be triangulated through semistructured interviews with participants, their children and social workers, supplemented by session logs documenting perceived shifts in paternal identity and programme feasibility. The intervention is expected to mitigate disruptions in paternal identity and strengthen father–child bonds. This may, in turn, reduce intergenerational disadvantage and improve overall family well-being.

This study has received ethical approval from The University of Hong Kong. Informed consent and assent will be obtained from the participants, their children and current guardians. Findings will be disseminated through peer-reviewed journals or conferences to inform correctional rehabilitation practices, encouraging the integration of family-focused and resilience-based approaches. Stakeholders, including practitioners and policymakers, may adopt similar interventions to promote healthier re-entry outcomes and reduce intergenerational disadvantage.

Temporary childbirth migration (TCM), where women return to their natal homes for pregnancy, delivery or postpartum for a limited duration, is a long-standing sociocultural practice in India. While often motivated by familial support and traditional norms, its implications for maternal and child health and health system engagement remain poorly understood. This study aims to quantify the impact of TCM on maternal and newborn outcomes and to explore how continuity of perinatal care and social support mediate these relationships.

We are conducting a three-site, community-based, prospective cohort study across the Health and Demographic Surveillance System sites of Vadu (Maharashtra), Sevagram (Maharashtra) and DEESHA (Delhi). A total of 3000 pregnant women will be enrolled in pregnancy (

This study has been approved by the Ethics committees at the KEM Hospital Research Centre Pune (KEMHRC/RVM/EC/1931), Society for Applied Studies (SAS/ERC/TCM Study/2024), Mahatma Gandhi Institute of Medical Sciences (MGIMS/lEC/COMMED/8412023) and University of California San Francisco (22-36484). All research activities are conducted in accordance with Indian Council of Medical Research Guidelines for biomedical research and the Declaration of Helsinki. On study completion, findings will be disseminated to diverse local, national and global stakeholders and published in academic journals.

CTRI/2024/02/062881.

To examine bronchopulmonary dysplasia (BPD) epidemiological data in Chinese very preterm infants and compare agreement between four diagnostic definitions and their predictive accuracy for discharge outcomes.

Observational epidemiologic study of a multicentre cohort of the Chinese Neonatal Network (CHNN).

Tertiary neonatal intensive care units participating in the CHNN.

42 664 preterm infants born at

BPD was diagnosed using four definitions: Shennan 1988, the National Institute of Child Health and Human Development (NICHD) 2001 and 2018, and the Neonatal Research Network (NRN) 2019 definitions. BPD prevalence and severity were examined. Agreement was assessed using kappa statistics. Predictive accuracy for discharge outcomes was evaluated using c-statistics from multivariable generalised estimating equation models.

Among 42 664 infants (mean gestational age, 29.0 weeks; 43.1% females), BPD prevalence varied significantly: Shennan 1988: 37.0%, NICHD 2001: 51.1%, NICHD 2018: 37.0%, NRN 2019: 37.0%. NICHD 2001 and 2018 definitions classified more infants as severe BPD (16.4% and 10.1%, respectively), while NRN 2019 classified more as grade 2 (moderate; 15.0%). Shennan 1988 showed good agreement with NICHD 2018 (=1.0) and Jensen 2019 (=1.0). Shennan 1988 (c-statistic range: 0.921–0.974), NICHD 2018 (0.948-0.978) and NRN 2019 (0.949-0.982) demonstrated higher discriminative accuracy for discharge outcomes than NICHD 2001 (0.854–0.925).

This study found a high prevalence of BPD among very preterm infants in China, varying by definitions. The Shennan 1988, NICHD 2018 and NRN 2019 definitions showed good agreement and better predictive accuracy for outcomes at discharge compared with NICHD 2001. These definitions could be prioritised for clinical use in our population.