Miscarriage, defined in the UK as loss of pregnancy prior to 24 weeks gestation, can have long-term psychological implications. Clinical guidelines for perinatal bereavement care do not provide guidance on how best to support the mental health of women, and their partners, after miscarriage. Peer support (support from those who share common characteristics) is often sought, but there is little understanding of its access and use. We conducted a systematic review to understand the barriers to and facilitators of the implementation of peer support to improve mental health outcomes for parents after miscarriage.

Systematic review and thematic synthesis.

A comprehensive systematic search across nine databases (MEDLINE, CINAHL, APA PsycINFO, Web of Science (all databases), EMBASE, CENTRAL, LENS.org, British Nursing Index and Health Management Information Consortium) was conducted in June 2025. Grey literature was identified through website searching, contact with topic experts and a national Call for Evidence.

Qualitative and mixed-methods studies exploring motivations, experiences and preferences for peer support after miscarriage were included.

Two independent reviewers used standardised methods to search, screen, extract and code included studies. Suitable studies were evaluated using the Critical Appraisal Skills Programme Qualitative Research Checklist. Findings were extracted and subjected to a thematic synthesis.

Across nine studies included in the review, three overarching themes were developed, with seven subthemes, capturing both barriers and facilitators. ‘Engaging in relational recognition’ reflects the validation and connection that arise through experiential resonance, often heightened by the context of exclusion from broader social or clinical support. ‘Mechanisms of Communality’ describe how communality is enacted through dynamic peer interactions, including modelling and facilitating grief, benchmarking physical change and mattering through reciprocity, highlighting mutual support and shared coping. ‘Dynamics of Access’ consider factors which shape engagement, including changing needs of individuals across time and modalities of support and their effects.

These findings form the first synthesis of peer support after miscarriage and bring a nuanced service user perspective of barriers and facilitators by examining evidence from diverse studies. Peer support after miscarriage was seen to be a dynamic, relational process shaped by shared experience, mutual exchange and context-specific factors. Findings underscore key policy and practice considerations, including the use of trauma-informed, loss-sensitive approaches and consideration of intersectionality, that should be reflected when offering peer support services, with and for, those who have experienced miscarriage.

CRD42024518248.

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.

Post-COVID-19 condition (PCC) has emerged as a major public health concern. We aimed to estimate the 1-year incidence of PCC in adults with confirmed SARS-CoV-2 infection in Lombardy, Italy, comparing community-managed and hospitalised patients and to assess the prognostic value of the National Institutes of Health (NIH) Researching COVID to Enhance Recovery (RECOVER) score to support estimation of long-term PCC prevalence.

Retrospective-prospective observational cohort study enrolling patients infected between 1 March 2020 and 31 December 2022. The study visit was conducted between 16 January and 23 December 2024.

Multicentre study involving seven public hospitals and general practitioners across Lombardy.

Randomly sampled adults aged 18–70 years with confirmed SARS-CoV-2 infection. Hospitalised patients (HP) were admitted for COVID-19; general practitioner patients (GPP) were managed in the community. The total sample comprised: 1162 (546 HP, 616 GPP).

This is an observational study with no active intervention.

Primary outcome: 1-year incidence of PCC retrospectively assessed at the study visit.

Secondary outcomes: symptom profiles, long-term PCC prevalence at the study visit and predictive value of the NIH RECOVER score.

Median age was 57.1 years in HP and 42.9 years in GPP; 66.1% of HP and 47.7% of GPP were male. PCC developed in 280 patients (223 HP, 57 GPP). The 1-year cumulative incidence was 39.9% in HP (95% CI 35.9% to 44.1%) and 9.1% in GPP (95% CI 7.1% to 11.7%). The NIH RECOVER score was associated with PCC at 1 year (OR 1.18, 95% CI 1.14 to 1.21). Model-based long-term PCC prevalence was 31.8% in HP and 6.3% in GPP.

PCC remained frequent and heterogeneous, particularly among previously HP. In this cohort, the NIH RECOVER score showed prognostic value for estimating longer-term PCC burden. These findings underscore the need for structured long-term follow-up across both hospital and primary care settings.

Despite growing interest in the therapeutic potential of 3,4-methylenedioxymethamphetamine (MDMA), no targeted measure to systematically assess side effects of MDMA-assisted psychotherapy (MDMA-AP) exists.

Our aim was to develop an MDMA-Assisted Psychotherapy Side Effects Tool (M-SET) to capture side effects over the course of MDMA-AP.

Informed by a systematic review and a review of other relevant questionnaires, we drafted a list of potential side effects. Face and content validation were obtained via a modified two-round online Delphi process involving experts in MDMA-AP and the neuropsychopharmacology of MDMA.

Twelve experts consented to participate over two rounds of Delphi panel deliberations (response rate: Round 1 = 83–92%, Round 2 = 75%). The Delphi panellists were asked to keep, discard, modify or suggest additional items. The final version of the M-SET consists of 165 items across four questionnaires that collect information at screening, baseline, the day of medication sessions and longer term follow-up.

The use of a modified Delphi technique proved a successful method to generate content for the first structured tool designed to evaluate side effects specifically associated with MDMA-AP.

The M-SET is recommended for use in both research and clinical settings. Its implementation has the potential to improve the safety of delivering MDMA-AP as well as support the development of a more systematic and robust evidence base on its safety and tolerability.

Frailty is a clinical syndrome characterised by impaired homeostatic mechanisms and reduced physiological reserve. Hospital admissions for ambulatory care sensitive conditions (ACSCs) are commonly used as indicators of quality in primary healthcare. We aimed to examine the association between frailty and the use of healthcare resources, including unplanned hospital visits due to ACSCs and non-ACSCs and visits to general practitioners (GPs) and medical specialists (MSs) in primary care. We hypothesised that frail individuals would have similar odds of hospital visits due to ACSCs and non-ACSCs.

Registry-based epidemiological study.

Data from the Danish Lolland-Falster Health Study and national health registers. Data were collected in a rural region of Denmark between February 2016 and February 2020.

10 154 randomly selected individuals aged ≥50 years participating in the Lolland-Falster Health Study with valid frailty measurements.

Hospital visits due to any diagnosis, hospital visits due to ACSCs and non-ACSCs, and visits to GPs and MSs in the primary care sector.

After adjustment for age, sex, comorbidity and socioeconomic factors, frail participants had higher odds of hospital visits due to any diagnosis (OR 1.27, 95% CI 1.02 to 1.57; p=0.03). The odds of hospital visits due to ACSCs (OR 1.42, 95% CI 0.97 to 2.08; p=0.07) and non-ACSCs (OR 1.16, 95% CI 0.91 to 1.47; p=0.22) were not significantly different. Frail individuals had higher odds of visiting their GP (OR 1.21, 95% CI 1.00 to 1.46; p=0.047) but not a medical specialist (OR 0.82, 95% CI 0.62 to 1.07; p=0.15).

Among frail individuals, the distinction between unplanned hospital visits due to ACSCs and non-ACSCs is not meaningful. This finding is consistent with the understanding of frailty as a state of reduced physiological reserve, in which minor stressors may lead to hospital care regardless of diagnostic category.

Stereotactic body radiotherapy (SBRT) delivered on an MRI-guided linear accelerator (MR-linac) enables highly conformal prostate cancer irradiation. The DESTINATION 2 trial is a federated, randomised phase II/R-IDEAL 2b study evaluating whether de-escalating the dose to prostate tissue, while maintaining a high dose to MRI-visible tumour(s) in two fractions, reduces genitourinary (GU) treatment-related adverse events (AE) without compromising disease control in men with localised prostate cancer.

200 men worldwide with localised, MRI-visible prostate cancer will be randomised 1:1 to receive either (1) prescribed uniform dose MR-linac SBRT (27 Gy in two fractions to the whole prostate and seminal vesicles with 0 mm CTV-PTV margin) or (2) de-escalated SBRT (20 Gy in two fractions to whole prostate with 0 mm CTV-PTV margin and 27 Gy in two fractions to MRI-visible tumour(s) with a 4 mm intraprostatic margin applied to the GTV. All treatments are delivered using MRI-guided adaptive Radiotherapy (MRIgRT). The primary endpoint is the absolute and relative risk reduction in acute grade 2+GU AE (CTCAE v5) within 12 weeks of completing radiotherapy. Secondary endpoints include late GU AE, acute and late gastrointestinal (GI) AE, sexual AE, patient-reported outcomes, dosimetry, technical feasibility and 2-year biochemical relapse-free survival.

This is a federated trial design in which each centre operates independently with its own sponsor, ethics committee approval and regulatory oversight. Each centre is responsible for obtaining and maintaining local ethics approval in accordance with their national and institutional requirements. The UK centre (The Royal Marsden NHS Foundation Trust) has received ethical approval from the East of England–Cambridge South Research Ethics Committee (REC reference: 24/EE/0163; IRAS: 338368). Results will be disseminated via peer-reviewed publications and conference presentations.

NCT06638541.

Diabetes is a chronic disease characterised by elevated blood sugar levels, which can lead to damage across various body systems. Bangladesh has the second highest number of adults with diabetes in South Asia and faces a significant economic burden from this condition. The objective of this study was to investigate the economic burden of diabetes and its associated factors among patients with diabetes registered at a tertiary-level diabetes hospital in the Rajshahi region of Bangladesh.

This was a cross-sectional hospital-based study.

Primary data were collected from patients with diabetes at a tertiary-level diabetes hospital in Bangladesh.

The study recruited 400 patientswith diabetes, who were randomly selected. The economic burden was assessed using the Catastrophic Health Expenditure (CHE) threshold of ≥10% of household income. Descriptive statistics, 2 tests, t-tests, linear regression and binary logistic regression were employed for analysis, with statistical significance set at p

The proportion of diabetes-related burden among patients with diabetes was 50.7%. 95.8% of patients had type 2 diabetes, and over half (52.5%) were overweight or obese. Treatment costs were significantly associated with diabetes duration, insulin use and age (35–55 vs ≥56 years). The economic burden was strongly associated with lower income levels (poor income and middle income vs high income) and longer diabetes duration. Participants not adhering to a healthy diet had 43% lower odds of experiencing economic burden than those following a healthy diet.

Approximately half of the patients experienced catastrophic health expenditure due to diabetes, indicating a substantial economic burden in the Rajshahi region of Bangladesh. This burden was significantly higher among lower-income and middle-income groups and patients with longer disease duration, and treatment-related factors such as insulin use were associated with greater financial strain. These findings emphasise the need for targeted financial protection strategies, including subsidised care and preventive interventions.

To develop and user-test a patient decision aid for people diagnosed with degenerative cervical myelopathy and who are considering surgery.

Mixed-methods study describing the development of a patient decision aid.

A draft decision aid was developed by a multidisciplinary steering group (including study authors with degenerative cervical myelopathy, health professionals and researchers) informed by the best available evidence, authorship consensus and existing patient decision aids.

Patient-participants and health professional-participants who manage people with degenerative cervical myelopathy were recruited through social media and the steering group’s research and practice network. Quantitative questionnaires were used to gather baseline data, descriptive feedback, refine the decision aid and assess its acceptability. Qualitative semi-structured interviews were conducted online to gather feedback on the decision aid and were analysed using reflexive thematic analysis.

We conducted 32 interviews: 19 patient-participants and 13 health professional-participants who manage people with degenerative cervical myelopathy (neurosurgeons, neurologists, physiotherapists, orthopaedic surgeons, general practitioners, rehabilitation and pain specialists and consultant occupational physicians and chiropractors). Participants were from 10 countries (Australia, Canada, Cyprus, Germany, Ireland, New Zealand, Sweden, Switzerland, United Kingdom and USA). Most participants rated the decision aid’s acceptability as good-to-excellent and agreed with most aspects of the decision aid (eg, defining degenerative cervical myelopathy, management recommendations, potential benefits and harms, questions to consider asking a health professional).

Our patient decision aid was rated as an acceptable tool by both health professional-participants who treat degenerative cervical myelopathy and patient-participants with lived experience of degenerative cervical myelopathy. This decision aid can be used by clinicians and people with degenerative cervical myelopathy to help with shared decision making following a diagnosis of degenerative cervical myelopathy. A study testing the potential benefits of this decision aid in a clinical setting is recommended.

To synthesise the prevalence and patterns of dementia-relevant structural brain MRI abnormalities in adults with suspected or confirmed dementia in low- and middle-income countries (LMICs), and to summarise MRI protocols and the incremental diagnostic contribution of MRI beyond cognitive screening.

Systematic review and meta-analysis.

PubMed, EMBASE, Web of Science and PsycINFO (January 1990–27 January 2025), plus reference list screening and targeted manual searches.

Observational or diagnostic-accuracy studies from World Bank-defined LMICs including adults (≥50 years) with suspected or confirmed dementia who underwent brain MRI as part of diagnostic evaluation.

Two reviewers independently screened, extracted data and assessed risk of bias using ROBINS-I. Random-effects models pooled prevalence of dementia-relevant MRI abnormalities; diagnostic-accuracy outcomes were synthesised narratively due to heterogeneous reference standards and incomplete reporting.

39 LMIC studies were included; 23 studies (2513 participants) contributed to the meta-analysis. Dementia-relevant MRI abnormalities (defined as ≥1 clinically relevant structural abnormality per study definition) were present in 1248/2513 participants. The pooled prevalence of dementia-relevant MRI abnormalities was 58% (95% CI 43% to 72%), with substantial heterogeneity (I²=95%) and a wide prediction interval (8–96%), indicating marked between-study variability; this estimate should be interpreted as a descriptive summary of study-level proportions rather than a precise population parameter.

Brain MRI frequently demonstrates dementia-relevant pathology in LMIC clinical cohorts, usually with mixed neurodegenerative-vascular patterns. Structured visual ratings may add aetiologic specificity beyond cognitive screening, but pooled estimates should be interpreted as summaries of heterogeneous study-level findings rather than precise population parameters, given high heterogeneity and risk of bias.

CRD42024510241.

Colchicine has been shown to reduce cardiovascular events and may improve outcomes in arteriovenous fistulas used for haemodialysis due to antiproliferative effects. However, it is often avoided in patients receiving dialysis. Therefore, a large trial assessing the potential benefits of colchicine in dialysis patients cannot begin without further data on feasibility. The primary objective of this study is to assess the feasibility of carrying out future trials of colchicine in dialysis patients.

This is an open-label, single centre, single arm study with 100 participants. The primary outcome is feasibility and the decision to progress to a full-scale trial. This will be based on the consent rate and the colchicine discontinuation rate. Secondary objectives are testing the feasibility of data collection procedures relating to quality-of-life measures, vascular access interventions and safety. Other secondary objectives are to assess the utility of the electronic health record for collecting trial data and to explore patients’ and healthcare providers’ experiences and attitudes towards colchicine and a feasibility study.

The study has Research Ethics Committee approval (Wales REC 6; 24/WA/0277). It is intended that the results of the study will be reported in peer-reviewed scientific journals.

ISRCTN91308625.

Exercise therapy is the most recommended treatment for chronic low back pain (LBP), with evidence supporting modest effects, likely due to the heterogeneity of patient presentations. Evidence suggests that matching individuals to the most appropriate exercise type could improve outcomes. Systematic reviews also emphasise that effective exercise interventions should be patient centred, target paraspinal muscle health and be of sufficient duration. This study addresses these gaps using a targeted care approach to identify a homogenous sample that is more likely to respond to our interventions. The inclusion of a sample with predominant nociceptive pain profile will be performed with the integration of the Pain and Disability Drivers Management Model (PDDM) and the Lumbar Spine Instability Questionnaire (LSIQ). The primary aim of this two-arm randomised controlled trial is to compare the effectiveness of motor control plus isolated lumbar extension exercises (MC+ILEX, arm 1) to free-weight resistance training (arm 2) in reducing LBP-related disability. Secondary aims include examining whether changes in multifidus composition mediate disability improvements comparing intervention effects on muscle size and quality, strength, mobility, pain, quality of life, sleep, physical activity and satisfaction; exploring baseline LSIQ scores and sex/gender as moderators of treatment response; and investigating participants’ perceptions and experiences of exercise therapy.

A total of 106 participants will be recruited through primary and secondary care and randomised (1:1) to receive either MC+ILEX or free-weight resistance training. Both groups will complete 48 exercise sessions over 16 weeks. The primary outcome will be disability at 16 weeks, measured by the Oswestry Disability Index. Secondary outcomes include multifidus muscle composition and size, lumbar and gluteal muscle strength, hip range of motion, pain, physical and mental function, satisfaction and recovery, health-related quality of life, sleep quality and physical activity levels. Linear mixed-effects models will be used to assess primary and secondary outcomes. Regression analyses will explore whether baseline LSIQ scores moderate treatment effects on multifidus composition and other outcomes. A subsample of participants will undergo semistructured interviews before and after the intervention to explore their illness perceptions, illness mindsets, perceptions of exercise therapy, as well as their experiences and satisfaction with the two exercise interventions. Reflexive thematic analysis will be used to analyse qualitative data.

This study received ethics approval from the Central Ethics Research Committee of the Quebec Minister of Health and Social Services (CCER-25-26-14). Results will be submitted to peer-reviewed journals and scientific meetings.

ISRCTN14864451.

Cancer is the leading cause of death and morbidity among children and adolescents worldwide. Functionality-based interventions are relevant among children and adolescents with an oncological diagnosis, whence studies summarising evidence on this topic are needed. This systematic review will summarise evidence on the effect of interventions to improve functionality indicators among paediatric patients diagnosed with cancer.

This protocol will follow Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA)-Protocols reporting guidelines. The systematic review will be conducted according to the Cochrane Handbook and PRISMA 2020. Studies will be searched in MEDLINE (PubMed), Embase, Web of Science, CENTRAL, LILACS and PEDro. Additional searches will include Google Scholar, reference lists of included studies, relevant reviews and trial registries. Studies will be included if they implement a functionality-based intervention. They must evaluate effects among paediatric patients with an oncological diagnosis. Secondary outcomes will include health-related quality of life. There will be no limits to language or year of publication, and articles published in peer-reviewed journals will be accepted. Only randomised controlled trials will be included. Risk of bias will be assessed using the Cochrane Risk of Bias Tool 2. Two independent reviewers will select studies, extract data and assess risk of bias. A narrative synthesis and meta-analysis will be conducted if studies are clinically and methodologically homogeneous. Statistical heterogeneity will be assessed using Higgins’ inconsistency test (I^²). Meta-analysis may estimate combined effects using random-effects and the inverse variance method. The R statistical software will be used. The certainty of evidence will be evaluated for each outcome using the Grading of Recommendations Assessment, Development and Evaluation system.

This study used data from previously published studies, thus waiving submission to an Ethics Committee. Scientific dissemination strategies will include publication in peer-reviewed journals, conference presentations and workshops for the public.

CRD42024462833.

Unplanned hospital readmissions within 30 days of discharge measure the quality of healthcare. This study aims to identify the characteristics of patients at higher risk of readmission.

Retrospective cohort study.

North-east Italy (Marca Trevigiana Local Health Authority).

The study examined a total of 39 467 index admissions from hospital discharges (SDO) in the 890 000-inhabitant area during 2022.

Readmission rates and 95% CIs were computed by risk factor, age and type of admission (surgical or medical). A logistic mixed-effects model was used to estimate readmission OR, adjusting for potential confounders.

A total of 2197 readmissions occurred within 30 days of the index admission, resulting in an overall rate of 30-day readmissions of 6.7% (CI 6.4% to 7.0%). The median time to readmission was 11 days (IQR 5 to 20). In the multivariate analysis, after adjusting for age and sex, the following clinical conditions were associated with a higher risk of readmission: alcohol-related disease (OR=2.06, CI 1.36 to 3.13), metastatic cancer (OR=1.98, CI 1.57 to 2.50), epilepsy (OR=1.93, CI 1.36 to 2.75), dialysis or end-stage kidney disease (OR=1.92, CI 1.39 to 2.66), chronic obstructive pulmonary disease (OR=1.88, CI 1.49 to 2.36), stoma (OR=1.72, CI 1.22 to 2.44), transplant (OR=1.62, CI 1.03 to 2.55), being bedridden (OR=1.57, CI 1.28 to 1.93), anaemia (OR=1.57, CI 1.35 to 1.83), urinary tract infection (OR=1.54, CI 1.30 to 1.83), pneumonia (OR=1.52, CI 1.31 to 1.75), dementia (OR=1.49, CI 1.24 to 1.79), diabetes (OR=1.37, CI 1.17 to 1.61) and transfusion (OR=1.34, CI 1.03 to 1.73).

Several chronic and acute conditions at index admission significantly increased the risk of readmission. Strengthening transitional care, outpatient services and palliative care could mitigate readmissions.

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).

To assess the prevalence and determinants of essential newborn care (ENC) practices among Ethiopian mothers using the 2023 Performance Monitoring for Action (PMA) dataset.

A cross-sectional analysis of the nationally representative 2023 PMA Ethiopia survey.

A total of 1933 mothers with complete data on ENC practices were included.

Ethiopia, using a multi-stage stratified cluster sample.

ENC, defined as the adoption of at least four of five WHO-recommended practices: immediate drying, delayed bathing, skin-to-skin contact, clean cord care and early initiation of breastfeeding.

Overall, 32.1% (95% CI 28.1% to 36.0%) of mothers practised at least four ENC components. Coverage was highest for immediate drying (95.4%) and delayed bathing (87.3%), but lower for skin-to-skin contact (53.6%) and clean cord care (64.5%). Health facility delivery showed a strong association with higher ENC practice (adjusted OR (AOR)=106.00; 95% CI 46.14 to 243.54). Mothers who were spouses, rather than household heads, had higher odds of practising ENC (AOR=2.88; 95% CI 1.20 to 6.89) and those mothers with parity two or three had higher odds of practising ENC compared with first-time mothers (AOR=2.00; 95% CI 1.33 to 3.02 and AOR=3.39; 95% CI 1.76 to 6.53, respectively). Lack of postnatal care attendance was negatively associated with ENC (AOR=0.56; 95% CI 0.37 to 0.85). Regional disparities were observed, with mothers in the Southern Nations, Nationalities and Peoples’ region being significantly less likely to practise ENC compared with those in Addis Ababa (AOR=0.31; 95% CI 0.15 to 0.64). All results are based on weighted data to ensure national representativeness.

The prevalence of ENC practices remains low in Ethiopia. Health facility delivery, maternal role in the household, parity and region of residence were significant predictors of ENC practice. Strengthening facility-based delivery, promoting maternal empowerment and addressing regional disparities are essential to improving newborn health outcomes in the country and achieving Sustainable Development Goal 3.

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

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

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

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

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

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

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

Brazilian Clinical Trials Registry; RBR-86kcy37.

Mobile health (mHealth) technologies have become increasingly popular for monitoring mental health symptoms and lifestyle behaviours, and are largely reported to be feasible and acceptable to users. However, to date, the efficacy of such technologies to improve perinatal mental health outcomes has been mixed. Within the perinatal context, much of this work has been done in the context of postpartum depression, stemming from electronic health records as well as cohort studies. There is, however, a dearth of studies focusing on depression in pregnancy, and machine learning-based clinical decision support systems remain underexplored. The HappyMums application has been developed to meet this need, and its use across Europe will be tested in this study.

A total of 1000 pregnant people currently suffering from, or at risk of, antenatal depression will be recruited across six countries. All participants will be between 13 and 28 weeks’ gestation and will be given access to the new purposefully developed HappyMums mobile application, to use from enrolment until 2 months postpartum. The application leverages passively collected data from smartphone sensors relating to physical activity and behaviour, as well as requiring active engagement from the user to complete mental health questionnaires and ‘game-like’ activities. Digital data types will be combined with traditional mental health measurement methods, such as standardised questionnaires and interviews, to develop novel predictive models capable of identifying mental health trajectories in women at risk of developing antenatal depression and to test the app’s utility for use as personalised risk prediction and depression identification tool. The primary outcome of this study is to determine what proportion of users will continue to use the mobile application and engage with its tasks and activities at least weekly, while secondary exploratory outcomes include assessing usability of the app and testing the predictive ability of a novel machine learning-based model. These outcomes will, for the first time, be assessed by integrating active as well as passive data.

Ethical approval has been granted by local research ethics committees in each recruiting centre. At King’s College London (leading the clinical study), the study was reviewed by the East of England—Essex Research Ethics Committee and granted favourable opinion (REC reference 24/EE/0129). All other sites collecting participant data have the study approved for local delivery. Findings relating to the primary and secondary outcomes will be submitted for publication in open access, peer-reviewed journals, as well as presentations at conferences as symposia or posters. Findings will be made available to a non-specialist audience through open access digital mental health magazines and promotion on social media.

NCT06578845.

PRELUCA is a randomised, intervention, non-inferiority study designed to use real-time, longitudinal circulating tumour DNA (ctDNA) measurements to evaluate the efficacy of immunotherapy in patients with advanced non-small cell lung cancer (NSCLC). The primary outcome is overall survival between the two groups: the standard of care group (computer tomography scan evaluation) and intervention group (ctDNA evaluation).

The inclusion and exclusion criteria align with European Society for Medical Oncology treatment guidelines and permit broad inclusion of NSCLC patients, ensuring ‘real-world’ representativeness. The study uses a tumour-informed method, using baseline next generation sequencing analyses to design patient-specific droplet digital PCR assays, which are run with collected blood samples 1 week prior to the intended treatment, enabling real-time evaluation via ctDNA Response Evaluation Criteria in Solid Tumours.

Inclusion began in July 2023 and patients are now being actively included in five locations across Denmark. Approval by The Committee on Health Research Ethics of Region Zealand was gained on 4 May 2023.

NCT05889247.

Group A Streptococcus (Strep A) causes a wide spectrum of diseases, ranging from pharyngitis and impetigo to severe invasive infections and immune-mediated conditions such as acute rheumatic fever, rheumatic heart disease and acute post-streptococcal glomerulonephritis. Contemporary data on the global burden of Strep A diseases are lacking. The proposed study aims to use administrative data from numerous jurisdictions to estimate age-specific incidence or prevalence of Strep A diseases, with an emphasis on severe clinical endpoints. Depending on the availability of data, a secondary objective will be to estimate the economic burden of Strep A diseases.

This population-based descriptive study will use routine health data obtained from different low-income and middle-income and high-income countries through international research collaborations to estimate the country-level and global burden of Strep A diseases. Data will be primarily obtained and collated from hospital or national health laboratory databases for individuals across all age groups, along with emergency department, primary care and microbiological datasets where available. Strep A disease endpoints will be identified using International Classification of Diseases 10th Revision or other relevant coding systems and microbiological diagnosis. Age-specific incidence and prevalence rates will be computed using population denominators, and country-level age-adjusted rates will be applied to standard global reference populations to estimate the number of cases globally.

Ethical approval to conduct this study was obtained from the Human Research Ethics Committee at the University of Western Australia (reference: #2024/ET000401) and governance approval was obtained from The Kids Research Institute Australia. The findings from this study will be published in peer-reviewed journals and presented at Strep A Vaccine Global Consortium collaborative meetings.

Concentration of care and collaborations between hospitals increasingly reorganise oncological care into Comprehensive Cancer Networks (CCNs), aiming to improve care outcomes and reduce costs. This study aims to evaluate the effect of four CCNs on healthcare cost and outcomes for patients with colon or pancreatic cancer.

We performed a retrospective cohort study based on claims data in the Netherlands. Data included patient characteristics, health insurance claims and healthcare activities. All costs were indexed to Euro 2023. We performed propensity score matching per CCN and applied regression models with a difference-in-difference design, adjusting for non-linear trends before the start of a CCN.

The study was conducted within the Dutch healthcare system, analysing claims data representative of hospital-based cancer care.

A total of 92 309 patients with colon cancer and 25 630 patients with pancreatic cancer were included. Patients were identified through health insurance claims between January 2013 and June 2021.

Implementation of four CCNs, which included structured collaboration between healthcare organisations. Follow-up duration was 2 years post-diagnosis.

Primary outcomes included 2-year oncological healthcare costs and 2-year mortality rate. Secondary outcomes involved care process indicators: referral rates and double diagnostics (an identical diagnostic activity performed within 4 weeks after referral to a secondary hospital).

For colon cancer, one CCN showed a significant decrease in 2-year oncological costs (–1899). One CCN showed a significant decrease in referrals (–3.6%) and one a significant increase (+4.4%). No significant effect on 2-year mortality and double diagnostic activities was found. For pancreatic cancer, one CCN showed a significant decrease in 2-year oncological costs (–3747) and one CCN showed a significant increase in double diagnostic activities (+8.6%). No significant effect on referrals and 2-year mortality was found.

CCNs do not consistently reduce costs or affect referral patterns or redundant diagnostics. No impact on mortality was found. Additional insights into determinants of CCN success are required before broad implementation is warranted.