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.

Effective treatment for clinical obesity is available but is rarely offered by healthcare systems, which often treat complications without treating the underlying cause. The LightWAY trial will investigate the clinical benefits and harms as well as cost-effectiveness of an intensive weight loss intervention compared with existing weight management programmes for people with clinical obesity.

LightWAY is an investigator-initiated, international, randomised, parallel-group clinical superiority trial with blinded outcome assessment. Six hundred people seeking treatment for clinical obesity (body mass index ≥35 kg/m² with comorbidities) will be recruited in centres in the UK and Denmark and randomised 1:1 to one of two groups. The experimental group will be offered a 2-year intensive weight loss programme providing support and advice to follow a total diet replacement programme, followed by gradual transition to an energy-reduced diet in combination with increased physical activity and if needed, prescription of weight loss medication. The control group will receive usual care, typically comprising brief behavioural support for weight loss and treatment of the complications of obesity or occasionally referral to specialist weight management services. The two co-primary outcomes are cardiometabolic risk, assessed with metabolic syndrome severity Z-score, and body weight assessed at 2 years. The secondary outcomes include the Short Form-36 mental component scale, 4-metre gait speed and proportion of participants achieving ≥20% weight loss. The key adverse effects will be the proportion of participants with at least one serious adverse event, incidence of eating disorders and disproportional loss of bone mass. Incremental cost-effectiveness will be assessed over the trial period and over the lifetime through modelling.

Ethical approval was granted in the UK (August 2024, 24/SC/0211) and Denmark (December 2023, H-23065222). Findings will be disseminated through peer-reviewed journals and scientific conferences and to participants in the trial and clinicians.

NCT06321458.

Many older people experience Mild Cognitive Impairment (MCI), which may compromise the effectiveness of health promotion programmes.

We explored engagement with behaviour change among participants scoring 18-25 on the Montreal Cognitive Assessment receiving HomeHealth, a health promotion intervention supporting older adults with mild frailty to maintain independence in England ().

Of the 46 semistructured process evaluation interviews, 29 participants scored in the MCI range, purposively selected for demographic characteristics and degrees of cognitive impairment and the seven support workers.

Thematic analysis resulted in three themes: Navigating the impact of MCI; Addressing memory as a goal in the intervention; and Adapting Behaviour Change Interventions for MCI. Participants had varied opinions about whether their memory was problematic and whether anything could be done to help. Many reported not discussing memory concerns with support workers. Barriers to engagement in behaviour change included limited social support and not acknowledging memory problems. Facilitators included setting goals which increased or were linked to existing health behaviours, using reminders/prompts and actively involving family members.

Implementing these facilitators into existing and new health promotion interventions delivered to older adults, with suspected but unacknowledged MCI, could overcome the current barriers people with MCI face when trying to engage and benefit from interventions.

ISRCTN54268283

To determine burnout prevalence, associated factors and coping strategies used by nursing professionals.

Cross-sectional analytical study.

Public and private healthcare institutions in Kerala, India.

Nursing professionals in Kerala (n=349).

Burnout levels (assessed with the Burnout Assessment Tool (BAT)) and coping strategies. Log-binomial regression was performed to identify factors associated with burnout.

High burnout was reported by 36.1% of participants (126/349; 95% CI 31.1 to 41.4). Burnout prevalence was higher among nurses with an MSc (Master of Science) or higher educational qualification (adjusted prevalence ratio (APR)=1.46; 95% CI 1.04 to 2.03); those working in urban settings (APR=1.41; 95% CI 1.04 to 1.90); those who were single, divorced or separated (APR=1.58; 95% CI 1.18 to 2.12); those with travel time ≥30 min (APR=1.36; 95% CI 1.03 to 1.79); and those engaged in clinical/direct patient care duties (APR=1.75; 95% CI 1.18 to 2.59). Commonly reported coping strategies included active coping (59.6%), seeking instrumental social support (58.7%) and venting (54.4%), whereas negative strategies, such as substance use, were less frequent (22.9%).

Over one-third of the nurses in our study reported high burnout. Efforts to reduce burnout should focus on nurses with higher qualifications, those working in urban settings, those with higher travel time, those who are single/divorced/separated and those involved in clinical duties to enhance healthcare quality.

Elderly patients, defined as adults aged 65 years and above, represent a growing segment of the surgical population.1 Despite numerous advances in surgical techniques and postoperative care, elderly patients face unique physical and psychological challenges that can exacerbate their risk of poor clinical outcomes.2 The recent study by Kata et al explores...

To estimate the prevalence of lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH) and to identify associated sociodemographic, lifestyle and comorbidity-related factors among men aged ≥50 years in a community setting.

Community-based cross-sectional study.

Primary care and community settings in a district of southern India using multistage cluster sampling across urban and rural areas.

A total of 560 men aged ≥50 years were enrolled and completed the study. Participants were selected through multistage cluster sampling. Men with known alternative causes of LUTS (such as urinary tract infection, neurological disorders or prior prostate surgery) were excluded.

The primary outcome was the prevalence of LUTS, suggestive of BPH, defined as an International Prostate Symptom Score (IPSS) ≥8. Secondary outcomes included the distribution of individual urinary symptoms, IPSS severity categories, quality-of-life scores and factors associated with LUTS. Outcomes were analysed using survey-weighted methods accounting for clustering and sampling weights.

The survey-weighted mean (SD) IPSS score was 3.46 (2.64), with a median (IQR) of 3 (2-4). Most participants reported minimal urinary symptoms, including no incomplete emptying (82.1%), no urgency (81.4%), normal urinary stream (90.5%), and no straining (90.0%). Nocturia was common, with 43.6% waking once and 28.8% waking twice per night. Overall, 80.2% were mildly symptomatic, 10.1% moderately symptomatic and 0.4% severely symptomatic. The prevalence of LUTS suggestive of BPH was 10.32% (n=58; 95% CI 5.7 to 18.0). In survey-weighted multivariable Poisson regression, below-poverty-line status (adjusted prevalence ratio (APR) 4.13; 95% CI 1.38 to 12.41), physical inactivity (APR 2.89; 95% CI 1.81 to 4.63), diabetes mellitus (APR 2.58; 95% CI 1.26 to 5.30), cardiac disease (APR 3.27; 95% CI 1.67 to 6.41), and arthritis (APR 1.88; 95% CI 1.03 to 3.42) were independently associated with LUTS.

Approximately one in ten men aged ≥50 years had LUTS, suggestive of BPH. The findings indicate a higher prevalence of LUTS among men with socioeconomic disadvantage, physical inactivity and cardiometabolic comorbidities. Integrating symptom-based screening for LUTS into routine primary care and chronic disease follow-up may facilitate early identification and improve quality of life among older men. Further research is warranted to explore longitudinal relationships and alternative symptom thresholds in community populations.

To estimate the rate of hospitalisation, identify associated factors and assess out-of-pocket expenditure (OOPE) among adults with multimorbidity in Kerala, India.

Community-based cross-sectional study.

Two districts of Kerala, representing different geographic regions of the state.

A total of 432 adults aged ≥30 years with multimorbidity were selected using multistage cluster sampling; 52.3% were women.

Self-reported hospitalisation in the preceding 12 months and OOPE related to multimorbidity.

Hospitalisation in the past year was reported by 26.62% of participants (n=115; 95% CI 22.5% to 31.1%). Among them, the majority (n=78, 67.83%) were admitted to government hospitals, and most hospital stays lasted

One in four adults with multimorbidity in Kerala reported hospitalisation. A significant proportion of OOPE was for drugs. These findings highlight the urgent need for targeted financial protection measures, equitable resource allocation and strengthening of primary care services to reduce avoidable hospitalisations and economic burden. The increase in hospitalisation among those with insurance coverage requires careful attention from policy makers. Regulation of drug prices may be required to reduce the financial burden imposed by drugs.

Surgery and its resulting hospitalisation are associated with subsequent cognitive and functional decline. Interventions to reduce this decline have exhibited limited success. Prehabilitation is the process of enhancing capacity and reserve before an acute stressor to improve tolerance of the acute physiologic insult. Older adults requiring major surgery are an ideal population for prehabilitation. Prehabilitation exercise studies have mostly focused on physical training to improve physical outcomes after specific surgery types, and data on cognitive outcomes and in broader surgical populations are needed. Computerised cognitive training (CCT) has been shown to enhance memory, processing speed, attention and multitasking. Combining CCT with a physical exercise may be most effective in reducing cognitive and functional decline in older patients undergoing major surgery, but has yet to be evaluated.

The COgnitive and Physical Exercise to improve Outcomes after Surgery (COPE-iOS) study is a randomised, controlled, participant and assessor blinded clinical trial testing the hypothesis that a pragmatic programme combining CCT and physical exercise throughout the perioperative (ie, preoperative and postoperative) period will improve long-term cognitive and disability outcomes in older surgical patients at high risk for decline. The trial aims to randomise 250 patients who undergo major surgery for a treatment period of approximately 1 month prior to surgery and 3 months after surgery, with a follow-up period of 12 months after surgery. The primary outcome is global cognition at 3 months after surgery. Key secondary outcomes include global cognition at 12 months after surgery and disability in activities of daily living and depression at 3 and 12 months after surgery.

Trial protocol has been approved by Vanderbilt Human Research Protections Programme (#202496) and an independent Data Safety Monitoring Board. Results will be presented at scientific conferences and submitted for publication.

ClinicalTrials.gov Registry NCT04889417.

This project, in adult surgical patients, will evaluate whether the creation of a customised checklist, driven by a clinical decision support tool, is able to improve anaesthesia providers’ adherence to consensus guidelines and standardised practice recommendations for the prevention of postoperative nausea and vomiting (PONV).

The intervention will be evaluated using a sequential, repeated crossover design at the institutional level, with designated washout, control and intervention periods. The surgical case will serve as the unit of analysis. The primary outcome is adherence to appropriate PONV prophylaxis administration guidelines. Secondary outcomes include the incidence of PONV and length of stay in the postanaesthesia care unit (PACU).

This protocol and statistical analysis plan provide an outline of the study design, primary and secondary end points and analytic approach. The Advancing Strategies to Optimise the PerIopeRativE Management of PostOperative Nausea and Vomiting trial has received approval from the Vanderbilt University Institutional Review Board (IRB: 250773). The results will be disseminated through peer-reviewed publications and presentations at national conferences. Findings from this trial will inform best practices for timely antiemetic prophylaxis, with the goal of reducing PONV incidence and shortening PACU stay.

NCT07152249.

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.

To investigate associations between adventurous play, outdoor play and screen time and mental health (MH) in British preschool-aged children.

Cross-sectional.

A nationally representative sample of caregivers of 2–4 years old (n=1066) in England, Scotland and Wales (Britain), recruited through an online research data and analytics group (YouGov UK).

Caregivers of 1018 children provided valid complete-case data (age 2: n=298 (29%), age 3: n=365 (36%), age 4: n=355 (35%); female n=481 (47%); white: n=878 (81%)).

Four outcomes, derived from parent-report questionnaires: internalising and externalising scores (using the Strengths and Difficulties Questionnaire) and positive and negative affect scores (using the Positive and Negative Affect Schedule for Children-P). Linear regression was used to explore associations between the three exposures (time (in hours per week) a child spent: (1) playing adventurously; and engaging in (2) educational screen time and (3) recreational screen time) and the four outcomes; interactions between play and screen time variables were also tested. Models were adjusted for child and parental demographic variables.

For each additional hour per week a child engaged in adventurous play, they had lower internalising scores (–0.02 (–0.03 to –0.01)) and higher positive affect scores (0.04 (0.02 to 0.05)). More hours per day (vs

In British preschoolers, adventurous play is associated with better MH outcomes, whereas higher educational screen time was associated with poorer MH, indicating that adventurous play may benefit preschoolers’ MH or that preschoolers with better mental health are more likely to engage in adventurous play. Adventurous play may also offset possible negative associations with screen time.

To estimate the prevalence and identify the determinants of assistive device usage in daily life among older adults in India.

Cross-sectional analysis of nationally representative survey data.

India

A total of 66 316 adults aged ≥45 years with complete information on assistive device use from Wave 1 of the Longitudinal Ageing Study in India, 2017–2018.

The primary outcome was self-reported use of any assistive device, including visual, hearing, mobility or other assistive devices. There were no predefined secondary outcome measures. Sociodemographic and health-related variables were analysed as covariates to assess factors associated with assistive device use.

The prevalence of assistive device use was 38.61% (95% CI: 37.73% to 39.50%). Use increased with age, from 34.48% among adults aged 45–59 years to 52.07% among those aged ≥75 years (adjusted prevalence ratios (aPR) 1.30; 95% CI: 1.25 to 1.35). Prevalence was higher among men (40.94%) than women (37.51%) (aPR 1.06; 95% CI: 1.03 to 1.09), among individuals with education above primary level (54.28%) compared with those with up to primary education (28.35%) (aPR 1.42; 95% CI: 1.36 to 1.48), and among urban residents (53.88%) vs rural residents (31.16%) (aPR 1.18; 95% CI: 1.14 to 1.22). A clear socioeconomic gradient was observed, with prevalence increasing from 27.65% in the poorest to 50.66% in the richest wealth quintile (aPR 1.32; 95% CI: 1.25 to 1.39). Assistive device use was higher among participants with chronic conditions (47.30%) than those without (28.16%) (aPR 1.15; 95% CI: 1.11 to 1.19) and was markedly higher among those with a prior eye or vision diagnosis (64.93%) compared with those without (14.61%) (aPR 3.94; 95% CI: 3.78 to 4.11). Among users, spectacles or contact lenses were most common (89.26%), followed by walking sticks or walkers (11.62%) and dentures (6.15%). State-level prevalence varied widely, ranging from 71.27% in Goa to 13.44% in Arunachal Pradesh.

Assistive device use was reported by less than half of Indian adults aged ≥45 years. The findings reveal clear socioeconomic and geographic inequities in access to assistive devices, with substantially lower use among older adults with less education, those in poorer wealth quintiles and rural residents. These disparities highlight the need for equity-focused interventions that improve accessibility to assistive devices, particularly for socially and economically disadvantaged groups and individuals with chronic conditions.

Obesity affects over a quarter of the UK population and can lead to serious health issues. NHS Specialist Weight Management Services (WMS) offer treatments including lifestyle advice, psychological support and medications, but access and availability vary by region. Although around 4 million people could be eligible for NHS Specialist WMS annually, capacity is limited to 35 000, severely limiting overall access for those who need it. While digital technology has started to be used in WMS, more evidence is needed to confirm its long-term effectiveness, acceptability and cost-effectiveness. This study explores the use of Gro Health W8Buddy, a digital platform and app providing remote Specialist WMS. It aims to determine the long-term health benefits of remote WMS pathway Gro Health W8Buddy compared with standard NHS WMS delivered in hospitals, and to improve patients access to services.

The study is a real-world evaluation with observational data collection. We will recruit 450 study participants from four NHS specialist WMS who will choose either standard NHS WMS or the digital pathway Gro Health W8Buddy. Participants are being given the option to choose their pathway to generate real-world evidence. We will measure and analyse health outcomes including weight loss, time taken to be treated and cost-effectiveness, at 18 months and follow up at 24 months for later analysis (outside of this core funding). We will gather experiential data from patients and healthcare professionals through surveys, observation and interviews.

Ethical approval has been obtained from NHS Health Research Authority (HRA) and Health and Care Research Wales (HCRW) (Supplementary Figure 3) (REC reference: 25/EM/0147). Our findings will be disseminated through academic publications, conference presentations and stakeholder engagement.

ISRCTN89168871; Pre-results.

Accurate identification of adverse events after colonoscopy is essential for quality assurance in colorectal cancer (CRC) screening. Review of medical records is labour intensive as adverse events are infrequent. The object of this study was to investigate the accuracy of claims data in identifying adverse events after colonoscopy in CRC screening.

Cross-sectional, retrospective.

Males and females aged 50–74 years were randomised to once-only sigmoidoscopy or biennial faecal immunochemical test in a CRC screening trial at two screening centres in Norway. Participants in the present study underwent follow-up colonoscopy from 2012 to April 2020 after initial positive screening test. We reviewed medical records for adverse events within 30 days following 11 205 colonoscopies.

The primary outcome of the study was to assess the sensitivity of claims data from the Norwegian Patient Registry to identify lower gastrointestinal bleeding using emergency contact International Statistical Classification of Diseases and Related Health Problems 10th Revision diagnostic code sets under two definitions: a stringent definition (codes explicitly identifying bleeding) and a broad definition (including suggestive codes). Secondary outcome measures included the sensitivity to identify perforation using a stringent and a broad definition. Additionally, we assessed whether incorporating procedure codes and non-emergency contacts improved accuracy.

87 cases of lower gastrointestinal bleeding and eight perforations were confirmed. Sensitivity for bleeding differed between the centres (p

Use of claims data underestimated adverse event rates following colonoscopy. Difference in coding practice across hospitals underscores the need for standardised reporting in screening programmes.

NCT01538550.

Retroperitoneal sarcomas (RPS) are rare and often large malignancies that frequently require extensive surgery for complete tumour removal. Resections of the colorectum are part of the standard resection, this way contributing to complication rates, including anastomotic leakage or obstruction. Surgical strategies for stoma formation and colorectal reconstruction remain poorly defined. The Colorectal Resections and Postoperative Quality of Life in Retroperitoneal Sarcoma Patients Across German-Speaking Sarcoma Centres (COLOSARC-Q) study aims to explore surgical procedures and health-related quality of life (HRQoL) in patients undergoing colorectal procedures during RPS surgery.

COLOSARC-Q is a prospective, multicentre, non-interventional study and will recruit 120 patients with primary RPS who undergo colorectal resection as part of sarcoma surgery in a sarcoma referral centre in Germany or Switzerland. HRQoL is assessed using standardised questionnaires (EORTC QLQ-C30, QLQ-CR29) as well as semi-structured interviews by psycho-oncology services and patient advocates. Data will be collected via an electronic Case Report Form, encompassing demographic, clinical, surgical and outcome-related information. All data will be centrally analysed. For the assessment of quality of life, a qualitative analysis with content and context analysis, as well as evaluation of the questionnaires according to a standardised scoring system, is planned. The primary aim is to evaluate surgical techniques for bowel resection and reconstruction and their influence on the further course of disease. Secondary endpoints assess postoperative complications as well as tumour-, patient- and treatment-related factors.

Ethical approval was granted by the Ethics Committee II of the University of Heidelberg (approval number 2024-562; 13 June 2024). The data protection review was approved by the data protection officer of the University of Heidelberg. Participation of other centres in the study requires local ethical approval. All patients will be required to sign an informed consent form. Results of primary and secondary endpoints will be published.

NCT06943612; German Clinical Trials Registry (DRKS00034135).

A growing number of individuals born with congenital heart disease (CHD) are surviving well into adulthood, and a successful transition from paediatric to adult healthcare is essential for their long-term health. However, discontinuity in care is prevalent.1 Parents play an important role in the transition process and may impact transition-related outcomes,2 but their experiences and...

The prevalence of depression and mood disorders has been steadily rising in Australian youth, with a concomitant increase in antidepressant pharmacotherapy prescription rates. Yet, the tolerability and efficacy of antidepressant drugs in youth remain poor. Pharmacogenetic (PGx) testing, or the personalised and guided treatment of medication based on genetic data, has been suggested to improve the effectiveness and tolerability of antidepressants. However, limited studies have evaluated the utility of antidepressant PGx-guided treatment in adolescent and young adult populations. Thus, this pilot randomised controlled trial (RCT), the GENE-YD Study, will evaluate the feasibility for a large-scale RCT assessing the effect of PGx-guided antidepressant prescription vs treatment as usual in youth with major depressive disorder (MDD).

Eighty young people between 16 and 24 years of age and in the early stages of pharmacotherapy treatment for MDD will be recruited. Following initial screening, participants will be randomised on a 1:1 ratio to either the intervention or control study group. Participants in the intervention condition will have their treatment tailored based on their PGx profile. Participants randomised into the control group will have their prescription based on current best practice recommendations, or treatment as usual. Individuals will be assessed at drug prescription baseline and again 6 and 12 weeks following drug prescription. The primary outcome of the study will be to evaluate the feasibility and acceptability of the GENE-YD protocol. Specifically, this study will explore participation recruitment strategies and attrition to the study protocols to guide the recruitment processes of a large-scale RCT, along with participating satisfaction in overall study protocols. Secondary outcomes will inform the utility and variability of specific measures (eg, depression rating scales, quality of life measures and medication adherence scales) that may be scaled up for use in a future full-scale trial.

Ethics approval was granted by the Department of Health, Western Australia’s Human Research Ethics Committee (RGS0000006822) and recognised by the University of Western Australia’s Human Research Ethics Committee (2024/ET000685). All participants will be required to provide written informed consent. Results will be published in international peer-reviewed journals.

ACTRN12624000760572.

The Maharashtra Anaemia Study 3 (MAS 3) aims to (1) Investigate the nutritional, environmental, and economic impacts on haemoglobin concentration/anaemia, (2) Identify the underlying micronutrient causes of anaemia and (3) Investigate the association between anaemia and physical and cognitive development of Indian children during their first 18 years of life. This paper introduces the MAS 3 cohort, which consists of data collected from the participants in the prospective Pune Maternal Nutrition Study from the antenatal period to children at 18 years of age (1996–2014) in the Maharashtra state, India.

Recruitment of 2466 married non-pregnant women, and their husbands, took place between June 1994 and April 1996 in six villages, approximately 50 km from Pune city in India. Women were followed up monthly to identify those who became pregnant. A total of 797 pregnant women were followed up for data collection at or near gestational week 18 and 28, with further data collection for women and children occurring within 72 hours of delivery, for both live and stillbirths. Of the 797 women, 710 were included in the MAS 3 cohort, and long-term follow-up of children occurred at 6 years, 12 years and 18 years of age.

In the MAS 3 cohort, most mothers (73%) were aged between 18 and 25 years at the time of their final prepregnancy visit (baseline), and half (55%) belonged to families of middle-upper socioeconomic status (SES). At the children’s baseline (birth) visit, children had a mean birth weight of 2630 g (SD: 376), with one third (31%) of low birth weight. At the 6-year, 12-year and 18-year follow-up visits, data were available for 706 (99%), 689 (97%) and 694 (98%) children.

MAS 3 will be used to address a number of research objectives, including (1) Trends of haemoglobin and anaemia-related micronutrients from age 6 to 18 years, (2) Micronutrient causes of anaemia during childhood, (3) Prevalence and risk factors for maternal anaemia and childhood anaemia, (4) Impact of maternal anaemia on immediate birth outcomes and (5) Intergenerational risk factors associated with anaemia.

To examine trends in preconception and pregnancy cardiometabolic risk factors and conditions, pregnancy and birth complications, obstetric interventions, and the impact of COVID-19, and to forecast future disease burden.

A multi-centre retrospective cohort study.

A large hospital network with three maternity hospitals serving ethnically diverse populations in Melbourne, Australia.

Pregnant women who gave birth between 2016 and 2022.

Trends in cardiometabolic conditions, birth complications and obstetric interventions.

Over 7 years, 63 232 women were included, of whom 40% were nulliparous, and 60.9% were born overseas from 167 countries. From 2016–2022, maternal age (30.2–31.3 years), obesity (21.0%–26.2%), gestational diabetes mellitus (GDM) (15.9%–28.1%) and caesarean delivery (28.5%–37.6%) increased, while average gestational weight gain, premature births and special care admissions declined from 12.6–11.6 kg, 6.3%–4.9% and 24.2%–14.1%, respectively; and was statistically significant (p

Prepregnancy and pregnancy cardiometabolic risk factors and conditions, pregnancy and birth complications, and obstetric interventions increased markedly over 7 years. Despite this, offspring complications, including special care admissions, stillbirths and prematurity, decreased, while pregnancy complications peaked during COVID-19. GDM is forecasted to increase to 43.0% by 2028, posing an unsustainable health and economic burden that necessitates urgent public health initiatives.

Relational continuity of care (RCC) refers to the sustained therapeutic relationship between a patient and a clinician, which fosters trust, enhances communication and facilitates the accumulation of knowledge about the patient. RCC is associated with enhanced patient outcomes, reduced hospital admissions, lower mortality rates, decreased healthcare costs and improved patient experience. Despite these benefits, reorganisations within the NHS and workforce challenges have led to an increased reliance on multidisciplinary and part-time working, resulting in fragmented care and a decline in RCC. Our study aims to explore who needs RCC, under what circumstances, to what extent and why, with the goal of informing optimal implementation strategies.

We will conduct a realist review to develop an evidence-based programme theory explaining the mechanisms underlying RCC, the populations that benefit most, the contextual factors influencing RCC and effective care models. Following Pawson’s five iterative stages, we will: (1) Locate existing theories, (2) Search for relevant evidence, (3) Select appropriate articles, (4) Extract and organise data and (5) Synthesise findings to draw conclusions. A stakeholder advisory group, comprising policymakers, healthcare professionals, public contributors and patients, will be engaged throughout the process. We will adhere to Realist And Meta-narrative Evidence Synthesis: Evolving Standards (RAMESES) for realist reviews to ensure methodological rigor.

Our findings will inform practical, evidence-based recommendations for optimising RCC within general practice. Outputs will include peer-reviewed publications, conference presentations, plain English summaries, social media infographics, a short video and end-of-study events. Collaborations with stakeholders and public involvement will ensure both accessibility and impact. Ethical approval is not required for this review.