This study investigated perinatal depressive symptoms among pregnant and postpartum Filipino women.

Cross-sectional survey.

The Philippines.

Participants were recruited online and face-to-face from maternal care facilities.

Perinatal depressive symptoms were assessed using the Edinburgh Postnatal Depression Scale (EPDS) score, with prevalence calculated based on ≥13 cut-off, indicating clinically significant symptoms of depression. Patterns of depressive symptoms were examined by demographics, perinatal time period and other obstetric information using adjusted regression coefficients (ab) and risk ratios (aRR).

A total of 856 women participated in the study, comprising 356 pregnant and 500 postpartum women. EPDS scores were, on average, similar between pregnant (14.4) and postpartum women (14.1). Using the locally validated cut-off of ≥13 revealed that 69.1% of pregnant and 62.0% of postpartum women reported clinically significant depressive symptoms. Consistent EPDS scores and prevalence were observed across pregnancy trimesters and within 12 months postpartum and beyond. Women who received adequate prenatal care were less likely to experience antenatal (ab=–1.59, 95% CI –3.13 to –0.05) and postpartum (ab=–1.30, 95% CI –2.48 to –0.12) depressive symptoms. Postpartum EPDS scores and depressive symptom prevalence (EPDS score ≥13) were higher among 18–24-year olds (ab=1.96, 95% CI 0.30 to 3.61; aRR=1.23, 95% CI 1.03 to 1.47) and single mothers (ab=3.46, 95% CI 0.22 to 6.71; aRR=1.42, 95% CI 1.07 to 1.90), compared with older and married mothers, respectively.

At least 60% Filipino mothers experienced clinically significant perinatal depressive symptoms, which exceeds the established global average of 25%. Younger and single postpartum women were at greater risk, while pregnant and postpartum women who attended adequate prenatal visits were less likely to report depressive symptoms. Our study underscores the need for further research to uncover the true burden of poor perinatal mental health and calls for targeted early interventions and integrative public health strategies to support at-risk mothers, particularly those from socially disadvantaged backgrounds.

To examine outcomes from respiratory pathogens containment strategies focused on international travellers.

We developed a compartmental model generalisable to respiratory infectious diseases, in which international travellers interact with each other and airline/airport workers during transit. We used SARS-CoV-2 Omicron surge data (basic reproduction number (R₀): 9.5) as a case example and performed sensitivity and scenario analyses, including varying the R₀ for different respiratory pathogens.

A US high-volume airport.

Simulated international travellers and airline/airport workers.

Projection of new and imported SARS-CoV-2 infections without intervention (No Intervention); pre-travel screening for travellers who intend to travel (intended travellers) with PCR (Pre-travel PCR); or antigen testing (Pre-travel Ag); mask-wearing guidance for travellers and workers (Mask-wearing); and a Combined strategy (Pre-travel PCR & Mask-wearing).

The number of new and imported respiratory disease infections over the 90-day simulation period.

Over the 90-day simulation, the number of infected travellers entering the USA would be: 1 155 580 (27.2% of 4.2 million (M) intended travellers) with No Intervention; 709 560/4.2M (16.7%) with Pre-travel PCR; 862 330/4.2M (20.3%) with Pre-travel Ag; 1033 820/4.2M (24.4%) with Mask-wearing; and 650 480/4.2M (15.3%) with Combined. The number of new infections among airline/airport workers would be: 25 670 (73.3% of 35 000 workers) with No Intervention; 25 260 (72.2%) in Pre-travel PCR; 25 590 (73.1%) in Pre-travel Ag; 24 630 (70.4%) in Mask-wearing; and 18 770 (53.6%) in Combined. In scenario analyses, the most impactful parameters were R₀ of the respiratory pathogen and population immunity level.

A Combined strategy of pre-travel PCR testing and mask-wearing would most effectively reduce respiratory infection among international travellers and airline/airport workers, but would still allow a substantial number of infections to enter the USA, especially when the pathogen is highly transmissible.

Prescription digital therapeutics (PDTx) represent an emerging frontier in healthcare, leveraging software-based solutions to treat or manage specific medical conditions. However, despite rising interest and encouraging evidence of clinical benefits, the policy landscape remains fragmented. Jurisdictions vary widely in their regulatory approaches, reimbursement pathways and processes for clinical integration, thus creating uncertainties for developers, payers and healthcare providers. This protocol outlines an eDelphi study to develop and validate a comprehensive policy maturity framework guiding systematic assessment of national or regional readiness for PDTx adoption.

We will conduct an e-Delphi study with up to three rounds to refine and validate a PDTx policy maturity framework. Experts will be recruited purposively from six stakeholder groups (regulators, healthcare providers, payers/health economists, developers, researchers and patient advocates), prioritising Europe while seeking variation across health system types and levels of economic development; a small number of non-European experts may be invited to broaden perspectives. An optional pilot round will gather initial feedback on the prototype framework, followed by iterative rounds to assess and revise domains, scoring criteria and maturity thresholds. A 5-point Likert scale (from ‘strongly disagree’ to ‘strongly agree’) will collect quantitative data, while open-text prompts will capture qualitative insights. Consensus will be defined as ≥70% agreement and/or an IQR ≤1 for critical items. Quantitative summaries and thematic analysis will guide iterative revisions of the model. This Delphi protocol aims to produce a consensus-driven framework that captures the essential elements of PDTx policy development and implementation. If validated, the framework can serve as a reference for policymakers, industry leaders, healthcare providers and researchers seeking to benchmark or advance the adoption of PDTx within health systems.

Ethical approval for this study was obtained from the Ethics Committee of the Faculty of Medicine of the University of Porto (reference: 320/CEFMUP/2025). Panellists will provide electronic informed consent, and data will be kept confidential. The finalised framework will be disseminated via peer-reviewed publications, conference presentations and policy briefs targeting stakeholders involved in digital health governance.

To evaluate the feasibility of conducting a full-scale randomised controlled trial to assess the clinical and cost-effectiveness of the MAINTAIN intervention, designed to support recovery and independence following a fall among people living with dementia.

Pilot cluster randomised controlled trial (c-RCT).

Community-based healthcare services across six UK sites representing primary and secondary care settings.

31 participant-carer dyads were recruited. Eligibility criteria included a diagnosis of dementia and a recent fall. Exclusion criteria included severe comorbidity precluding participation. The consent rate was 84%, and retention at follow-up was 81%.

The MAINTAIN intervention comprised tailored, home-based therapy sessions delivered by trained professionals, focusing on functional recovery, confidence and re-engagement in daily activities, compared with usual care. The intervention was delivered over 12 weeks with booster sessions up to week 24, with the full trial period lasting 28 weeks.

Feasibility outcomes included recruitment and retention rates, intervention adherence and data completeness for outcome and economic measures. Exploratory outcomes assessed functional performance and quality of life. Feasibility outcomes were assessed at baseline, 12 weeks and 28 weeks.

Recruitment occurred over an 8-month period (September 2023–April 2024) across six UK sites. Most intervention participants (89%) attended at least 60% of planned sessions. Completion rates for outcome and economic data were high, indicating strong acceptability and feasibility of both the intervention and trial procedures.

The pilot c-RCT demonstrated that recruitment, retention and intervention delivery were feasible and well accepted. Findings support progression to a definitive trial to evaluate the effectiveness and cost-effectiveness of the MAINTAIN intervention.

ISRCTN16413728 (International Standard Randomised Controlled Trial Number registry).

The Happy Healthy Active Children (HHAC) initiative is a multicomponent community-based initiative aimed at promoting physical activity, food literacy and nature literacy among children in early childhood kindergarten and primary school settings. Developed in collaboration between Activity Experts and Community Stakeholders, HHAC integrates thematic activities (Play, Nature, Food) across kindergartens, schools and the broader community. The initiative responds to growing concerns about declining physical activity levels, insufficient contact with nature and poor dietary habits in childhood, factors known to influence long-term health and well-being. This protocol outlines the design, implementation and planned evaluation of the HHAC initiative.

HHAC is carried out within the long-term strategic initiative Tingbjerg Changing Diabetes. Following the Supersetting approach, HHAC addresses inequity in health by mobilising resources across local settings (kindergartens, schools and the local community arenas) and population groups (children, parents, staff and other community members) to develop and implement contextually relevant activities promoting outdoor play, cooking and nature experiences. Activities are evaluated using a within-subject design in kindergartens, while in schools a quasi-experimental design with matched control groups is applied. Data is collected at baseline and follow-up through accelerometry, validated questionnaires and structured observations. Primary outcomes include physical activity levels, food literacy and nature literacy. Analyses apply linear mixed-effects models to account for repeated measures and clustering at the institutional level. The evaluation also investigates implementation processes and context-mechanism configurations through a comprehensive realist evaluation. This includes developing a programme theory, conducting interviews with children, parents, staff and other local stakeholders and participant observations aiming to explore experiences and the mechanisms through which the activities contribute to changes in behaviour and well-being. All data will be analysed and condensed for a model for transferability.

Findings will be disseminated through peer-reviewed journals, conference presentations and public engagement activities targeting educators, policymakers and health professionals. The intervention materials will also be made freely available to support broader implementation. The study procedures were registered and approved by The Capital Region’s centre for data reviews ‘Videnscenter for Dataanmeldelser’ (Reference: P-2023–14277). All procedures were carried out under relevant regulations and guidelines. Written information about the study was given to all school principals, teachers and parents/guardians before the start of the study, and written informed consent is obtained from all legal guardians of all participants in their native language prior to child enrolment.

Treatment advancements in chronic myeloid leukaemia (CML) have made the disease manageable but carry significant risk of side effects. Bridging information gaps between patients and physicians through shared decision-making (SDM) is increasingly favoured, yet understanding treatment complexities remains a challenge. This study sought to identify decisional and informational needs of both patients and physicians in CML care.

A qualitative study using semi-structured interviews was conducted to investigate the opinions, attitudes and preferences of both patients with chronic myeloid leukaemia and physicians.

Patients and physicians were recruited through the Dutch CMyLife platform, an initiative of haematologists, patients and patient organisations. They were provided with the participant information and invited to participate if interested.

A total of 15 interviews (n=10 patients, n=5 physicians) were conducted between April and October 2023.

A pre-defined interview guide was developed based on the Decisional Needs Assessment questionnaire. Interview transcripts were thematically analysed.

Eight themes and 28 sub-themes were observed, highlighting patient needs, treatment choices and informational preferences. Patients emphasised the importance of understanding medication options and side effects, while physicians stressed the necessity of delivering up-to-date and comprehensible information. Almost all participants had experienced professionals making the treatment decision, without patient involvement, especially when initiating treatment. Some patients expressed too little information and missed partnership with professionals at treatment onset. Peer support, decision-making dynamics and the role of caregivers were also significant considerations.

Both shared and distinct perspectives on CML treatment decision-making between patients and physicians were revealed, underscoring the complexity of decisional needs in CML management. The findings emphasise the importance of patient-centred care, SDM and tailored communication strategies to optimise patient outcomes and satisfaction. Improved communication and evidence-based decision-making tools can significantly impact patient well-being. Further research and interventions are necessary to address the challenges in decision-making processes in CML care.

The digital transformation of healthcare has created an urgent need for primary care physicians (PCPs) to acquire competencies in digital health. However, the structure and scope of postgraduate training programmes remain poorly defined and unevenly implemented worldwide, and no scoping review has yet synthesised the evidence. This review aims to map existing postgraduate digital health training programmes for PCPs, including their content, structure and delivery approaches.

This scoping review will follow the Joanna Briggs Institute methodology and adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist. A systematic search will be conducted across five databases (PubMed, Scopus, Cochrane Library, ScienceDirect and Web of Science) and relevant grey literature, covering publications from January 2019 to June 2025. Studies describing postgraduate digital health training programmes for PCPs will be eligible for inclusion. Data will be extracted and synthesised descriptively and thematically using an inductive approach.

As this study is based on a review of publicly available literature, ethical approval is not required. The findings will be disseminated through a peer-reviewed publication and conference presentations and will inform future curriculum development and policy in digital health education for PCPs. The results may also inform national curriculum reforms and accreditation standards, supporting more consistent and competency-based digital health education globally.

This scoping review protocol has been registered with the Open Science Framework.

Studies have demonstrated the positive impact of falls prevention interventions for high-risk older adults who have experienced a severe fall. However, uptake and adherence rates remain low. The purpose of this study is to assess the capabilities, opportunities and motivations of older adults following a fall with subsequent presentation to the emergency department and direct discharge home in relation to falls prevention measures.

This study, conducted as part of the ‘Sentinel fall presenting to the emergency department’ project at the Carl von Ossietzky University Oldenburg in Germany, involved a participatory research team (PRT). It was a qualitative study based on focus group interviews undertaken between June and October 2022, analysed in accordance with qualitative content analysis following Kuckartz. The Theoretical Domains Framework forms the basis of the deductive category system. PRT members collaborated as co-researchers in conducting and analysing the focus groups.

12 focus groups were conducted (N=52). The participants were older adults (≥60 years) who had received outpatient care in an emergency department following a fall (N=41) and their relatives (N=11).

Interviewees indicated that both knowledge of available support options and the ability to self-evaluate are important following a fall. Additionally, health circumstances, such as limitations resulting from fall-related consequences, influence the adoption of falls prevention measures. Social influences, as well as environmental context and resources, were also discussed, reflecting participants’ preferences for intervention design, such as having a central point of contact and specific courses on fall training. Moreover, the fall event itself may strengthen the perceived need for preventive measures, whereas a fear of falling can lead to reduced or modified activity levels.

To improve the engagement of older adults in falls prevention interventions following a fall, the establishment of a central point of contact could be considered. Individual tailored interventions, including psychological support as well as specific fall training, are needed.

DRKS00025949.

Students enrolling in higher education often adopt lifestyles linked to worse mental health, potentially contributing to the peak age onset of mental health problems in early adulthood. However, extensive research is limited by focusing on single lifestyle behaviours, including single time points, within limited cultural contexts, and focusing on a limited set of mental health symptoms.

The UNIversity students’ LIFEstyle behaviours and Mental health cohort (UNILIFE-M) is a prospective worldwide cohort study aiming to investigate the associations between students’ lifestyle behaviours and mental health symptoms during their college years. The UNILIFE-M will gather self-reported data through an online survey on mental health symptoms (ie, depression, anxiety, mania, sleep problems, substance abuse, inattention/hyperactivity and obsessive/compulsive thoughts/behaviours) and lifestyle behaviours (ie, diet, physical activity, substance use, stress management, social support, restorative sleep, environment and sedentary behaviour) over 3.5 years. Participants of 69 universities from 28 countries (300 per site) will be assessed at university admission in the 2023 and/or the 2024 academic year and followed up for 1, 2 and 3.5 years.

The study was first approved at a national level in Brazil (CAE:63025822.8.1001.5346). Study sites outside Brazil obtained additional ethics approval from their institutions using the main approval. Results from the UNILIFE-M cohort will be disseminated through scientific publications, presentations at scientific meetings, press releases, the general media and social media.

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.

To evaluate the impact of public–private mix (PPM) models for tuberculosis (TB) on health, process and system outcomes, adopting the WHO’s definition of PPM, which is a strategic partnership between national TB programmes and healthcare providers, both public and private, to deliver high-quality TB diagnosis and treatment.

Systematic review without meta-analysis using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines.

EMBASE, MEDLINE, Health Management Information Consortium, Social Sciences Citation Index, Science Citation Index, Emerging Sources Citation Index, CENTRAL, Database of Disability and Inclusion Information Resources, WHO Library Database and 3ie.

We included all primary studies examining PPM models delivering TB services in urban health sectors in least-developed, low-income and lower–middle-income countries and territories.

17 reviewers were involved in data extraction in COVIDENCE using a prepiloted template. All extractions were completed by a single reviewer and checked by a second reviewer. Quality appraisal was carried out using the mixed-methods appraisal tool, covering mixed-methods, qualitative and quantitative study designs. Narrative synthesis was carried out by tabulating and summarising studies according to PPM models and reported in line with the synthesis without meta-analysis guidelines.

Of the 57 included studies, covering quantitative (n=41), qualitative (n=6) and mixed-method (n=10) designs, the majority were from Southeast Asia (n=37). PPM models had overall positive results on TB treatment outcomes, access and coverage and value for money. They are linked with improved TB health workers’ skills and service delivery. Most outcomes tended to favour interface models, although with considerable heterogeneity. Inconsistent implementation of national TB guidelines, uncoordinated referrals and lack of trust among partners were identified as areas of improvement. Evidence was lacking on the involvement of informal providers within PPM models.

PPM models can be effective and cost-effective for TB care in urban low- and middle-income countries contexts, particularly when levels of mistrust between public and private sectors are addressed through principles of equal partnership. The evidence indicates that this may be more achievable when an interface organisation manages the partnership.

CRD42021289509.

The predictive value of carotid-femoral pulse wave velocity (cfPWV) for cardiovascular (CV) events in individuals with blood pressure (BP) 120–159/80–99 mm Hg, where more accurate risk stratification has the greatest clinical effect, is unknown. This study aims to determine whether cfPWV improves the prediction of CV events beyond traditional risk factors in individuals with moderate BP.

A systematic review and meta-analysis.

PubMed and EMBASE were searched through April 2023.

We included prospective, population-based cohort studies with ≥1 year follow-up that directly measured cfPWV as an index of arterial stiffness and reported incident CV disease (CVD), atherosclerotic CVD (ASCVD), coronary heart disease, stroke or all-cause mortality outcomes.

Individual participant data from 11 cohorts (n=15 987) were harmonised and analysed using two-stage random-effects meta-analysis. Incremental predictive and clinical utility analyses compared 10-year risk models with and without cfPWV.

There were 1279 first atherosclerotic CV events over a median follow-up of 9.9 years. A 1-SD increase in log_e(cfPWV) was associated with a 1.21-fold (95% CI 1.08 to 1.36) increase in risk of ASCVD. Adding cfPWV to traditional risk factors improved ASCVD prediction: change in discrimination (C-index): 0.0048 (95% CI 0.0002 to 0.0094), p=0.041. In hypothetical populations of 100 000 individuals with moderate BP, cfPWV-guided treatment could reduce event rates by 2.7% and 3.1% under European and US guidelines, respectively.

Adding cfPWV to traditional CV risk factors may improve the prediction and classification of first CV events in individuals with moderate BP. Additional screening with cfPWV could enhance risk stratification for antihypertensive treatment initiations.

The ‘time-limited trial’ for patients with critical illness is a collaborative plan made by clinicians, patients and families to use life-sustaining therapies for a defined duration. After this period, the patient’s response to therapy informs decisions about continuing recovery-focused care or transitioning to comfort-focused care. The promise of time-limited trials to help navigate the uncertain limits and benefits of life-sustaining therapies has been extensively discussed in the palliative and critical care literature, leading to their dissemination into clinical practice. However, we have little evidence to guide clinicians in how to conduct time-limited trials, leading to substantial variation in how and why they are currently used. The overall purpose of this study is to characterise the features of an optimal time-limited trial through a rich understanding of how they are currently shaping critical care delivery.

We are conducting an observational, multicentre, focused ethnography of time-limited trials in patients with acute respiratory failure receiving invasive mechanical ventilation in six intensive care units (ICUs) within five hospitals across the US. Study participants include patients, their surrogate decision makers and ICU clinicians. We are pursuing two complementary analyses of this rich data set using the open-ended, inductive approach of constructivist grounded theory and, in parallel, the structured, deductive methods of systems engineering. This cross-disciplinary, tailored approach intentionally preserves the tension between time-limited trials’ conceptual formulation and their heterogeneous, real-world use.

This study has been reviewed and approved by the University of Wisconsin Institutional Review Board (IRB) as the single IRB (ID: 2022-1681; initial approval date 23 January 2023). Our findings will be disseminated through peer-reviewed publication, conference presentations, and summaries for the public.

NCT06042621.

We aim to use an agent-based model to accurately predict the spread of COVID-19 within multiple US state prisons.

We developed a semistochastic transmission model of COVID-19.

Five regional state-owned prisons within North Carolina.

Several thousand incarcerated individuals.

We measured (1) the observed and simulated average daily infection rate of COVID-19 for each prison studied in 30-day intervals, (2) the observed and simulated average daily recovery rate from COVID-19 for each prison studied in 30-day intervals, (3) the mean absolute percentage error (MAPE) of each prison’s summary statistics and the simulated results and (4) the parameter estimates of key predictors used in the model.

The COVID-19 pandemic disparately affected incarcerated populations in the USA, with severe morbidity and infection rates across the country. In response, many predictive models were developed to help mitigate risk. However, these models did not feature the systemic factors of prisons, such as vaccination rates, populations and capacities (to determine overcrowding) and design and were not generalisable to other prisons.

An agent-based model that used geospatial contact networks and compartmental transmission dynamics was built to create predictive microsimulations that simulated COVID-19 outbreaks within five North Carolinian regional prisons between July 2020 and June 2021. The model used the characteristics of an outbreak’s initial case size, a given facility’s capacity and its incarcerated vaccination rate as additional parameters alongside traditional susceptible-exposed-infected-recovered transmission dynamics. By fitting the model to each prison’s data using approximate Bayesian computation methods, we derived parameter estimates that reasonably modelled real-world results. These individualised estimates were then averaged to produce generalised parameter estimates for North Carolina state prisons overall.

Our model had a mean average MAPE score of 23.0 across all facilities, meaning that it reasonably forecasted facilities’ average daily positive and recovery rates of COVID-19. Our model estimated an average incarcerated vaccination rate of 54% across all prisons (with a 95% CI of ±0.12). In addition, the prisons of this study were estimated to be operating at 90% of their capacity on average (95% CI ±0.16). Given the high levels of COVID-19 observed in these prisons, which averaged over one-third positive tests on respective 1-day maxima, we conclude that vaccination levels were not sufficient in curbing COVID-19 outbreaks, and high occupancy levels likely exacerbated the spread of COVID-19 within prisons.

In addition, data gaps in facilities without recorded daily testing resulted in poor spread predictions, demonstrating how important consistent data release practices are in incarcerated settings for accurate tracking and prediction of outbreaks.

The findings of this study better quantify how spatial contact networks and facility-level characteristics unique to congregate living facilities can be used to predict infectious disease spread. Our approach also highlights the need for increased vaccination efforts and potential capacity reductions to mitigate COVID-19 transmission in prisons.

Many patients receive oral anticoagulation for reduced stroke risk in atrial fibrillation or as treatment or prevention of venous thromboembolism. Oral factor Xa inhibitors (oral FXaI, eg, apixaban, edoxaban or rivaroxaban) are commonly prescribed for this indication. Dabigatran, an oral direct thrombin inhibitor, is similarly approved. In vitro and animal model evidence suggests that dabigatran also has direct effects on Staphylococcus aureus virulence and infection. Observational data have shown that dabigatran users are less likely to develop S. aureus bacteremia (SAB), and a small randomised controlled trial showed that dabigatran has anti-S. aureus effects when compared with low molecular weight heparins during bloodstream infection. We seek to answer whether dabigatran is superior to the oral FXaIs in achieving better SAB outcomes among patients who independently require oral anticoagulation. We report the intervention-specific protocol, embedded in an adaptive platform trial.

The S. aureus Network Adaptive Platform (SNAP) trial [NCT05137119] is a pragmatic, randomised, multicentre adaptive platform trial that compares different SAB therapies for 90-day mortality rates. For this intervention (‘Dabi-SNAP’), patients receiving therapy with an oral FXaI will be randomised to continue as usual or to change to dabigatran as of the next scheduled dose. All subjects will receive standard of care antibiotics and/or antibiotics allocated through other active domains in the platform. As the choice of anticoagulant may not demonstrate large differences in mortality, a ranked composite of death and adverse outcomes (Desirability of Outcome Ranking, or DOOR) was chosen as the primary outcome.

The study is conditionally approved by the research ethics board of the McGill University Health Centre: identifier 2025-10900. Trial results will be published open access in a peer-reviewed journal and presented at a global infectious disease conference. The trial is registered at clinicaltrials.gov with the identifier NCT06650501.

NCT0665050.

There is limited evidence regarding the outcomes and impacts of Patient and public involvement (PPI) in research, mainly based on narrative studies. Existing frameworks for supporting and evaluating PPI often require adaptation to specific contexts, and comprehensive instruments are needed. From an international perspective, strengthening the scientific foundation that underpins PPI is crucial to generate stronger evidence to understand which approaches work best, in which contexts, and with what effects.

To promote PPI implementation in German health research, this project aims to (1) Establish an evaluation framework, (2) Develop a modular evaluation tool in the form of a questionnaire and (3) Pilot and psychometrically validate the tool.

A three-phase mixed methods approach will be employed, integrating qualitative and quantitative data. First, we will explore with researchers, research partners and other stakeholders in health services research what contributes to meaningful and successful PPI through a web-based survey and focus groups. Findings are discussed in a codesign workshop in which participants agree on an evaluation framework based on a LOGIC model. Second, items from international instruments that evaluate PPI are deductively assigned to the evaluation framework. Further items are developed based on the focus groups from phase 1. Cognitive pretests and qualitative review will be conducted with researchers and patients in order to refine the item pool and develop the evaluation tool. Third, the evaluation tool with modules for researchers and patients will be piloted in a web-based survey. Data analysis will include thematic analysis for qualitative data and descriptive and psychometric analyses for quantitative data. A participatory research team will provide ongoing support throughout all project phases.

Ethical approval has been obtained from the Local Ethics Committee of the Centre for Psychosocial Medicine, University Medical Centre Hamburg-Eppendorf (LPEK-0889). The study will follow the principles of the Helsinki Declaration and good scientific practice. Results will be disseminated at national and international conferences, public symposiums and in peer-reviewed journals, contributing to the internationally developing field of PPI in research and addressing relevant research gaps.

To evaluate the available virtual reality (VR) applications for treating perinatal mental health disorders, focusing on their effectiveness in reducing symptoms such as anxiety and depression, which are common during the perinatal period.

Rapid scoping review adhering to the Joanna Briggs Institute guidelines and Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Review (PRISMA-ScR), with adjustments based on the Cochrane Rapid Reviews guidelines.

Medline, PsychInfo, Embase, Evidence-Based Medicine (EBM) Reviews using Ovid and Web of Science were searched through 20 February 2024.

Studies were included if they were written in English or French, provided details on the VR technology, described the assessment of perinatal mood disorders and specified the outcomes measured and the methodological approach used. Review and editorial articles were excluded as well as abstracts and posters.

One reviewer extracted study characteristics (eg, design, participants, VR components, outcomes) and a second reviewer verified accuracy; study quality was assessed using the National Institute of Health (NIH) Quality Assessment of Controlled Intervention Studies tool, and findings were synthesised narratively and in tabular form.

A total of 425 records were identified. After removing duplicates, 308 records were screened by title and abstract. Of these, 74 full texts were assessed for eligibility, resulting in 10 studies being included for data extraction. These final studies were primarily conducted in high-income countries from 2019 to 2024. 8 of 10 (80%) were randomised controlled trials, employing VR through head-mounted displays. Studies predominantly targeted non-severe cases of anxiety and depression, with VR environments ranging from nature scenes to therapeutic content. Results suggest a positive impact of VR interventions on reducing anxiety and depression levels among participants.

Studying VR appears to be a promising avenue for developing options to manage perinatal mental health. The immersive nature of VR may provide opportunities for emotional relief and support during this critical period through engaging experiences which can reduce symptoms of anxiety and depression. However, the body of research remains limited, indicating a need for further studies to explore the long-term benefits and potential integration of VR into perinatal healthcare practices. The promising results from initial studies encourage continued exploration and development within this innovative therapeutic field.

https://doi.org/10.17605/OSF.IO/VFZC7.

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

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

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

U1111-1308-4669.

Crohn’s disease (CD) and ulcerative colitis (UC) are chronic, inflammatory bowel diseases (IBDs) of unknown origin, affecting the gastrointestinal tract and often causing extraintestinal symptoms. Conventional treatments (eg, glucocorticosteroids, immunomodulators) and targeted advanced treatments, including anti-TNFα, antibodies to p40 subunit of IL-12/23, antibodies to p19 subunit of IL-23, anti-α4β7 integrin, Janus kinase inhibitors (JAKis) and sphingosine-1-phosphate receptor (S1PR) modulators, do not achieve sustained responses for all patients, leaving significant unmet therapeutic needs.

This prospective, multi-centre observational study will follow a cohort of 240 patients across multiple study centres within NHS trusts in the UK who are initiating or switching biologics, specifically anti-TNFα and anti-α4β7 integrin for UC, and anti-TNFα, antibodies to p40 subunit of IL-12/2 and JAKi for CD. Through comprehensive profiling of immunological, transcriptional, microbiome, genetic and proteomic markers at baseline, week 12, and week 52, this study aims to uncover non-invasive biomarkers that predict response to these drug classes, ultimately advancing personalised medicine in IBD.

Ethical approval for the Nottingham/AstraZeneca study was granted by the West of Scotland Research Ethics Committee. Recruitment began in December 2022 and is currently ongoing at 10 NHS Trust sites across the UK. Study findings will be disseminated by publication in peer-reviewed journals and presentations at relevant national and international conferences.

Tobacco use is the most significant modifiable risk factor for adverse health outcomes, and early research indicates there are also significant harms associated with vaping. National targets aim to reduce smoking and vaping during pregnancy for Aboriginal and Torres Strait Islander people. While most Aboriginal and Torres Strait Islander people want to quit, cessation is frequently attempted without support, increasing the chance of relapse. Group-based smoking cessation programmes increase quit success by 50%–130% in the general population; however, they have never been evaluated in Aboriginal and/or Torres Strait Islander communities.

The Gulibaa study is an Indigenous-led and community-embedded project that will co-design, implement and evaluate a group-based model of care to support Aboriginal and Torres Strait Islander women to be smoke- and vape-free. Staff of Health Services in New South Wales, Australia, will receive training to deliver a face-to-face group-based smoking and vaping cessation intervention. Aboriginal and/or Torres Strait Islander people who identify as a woman or non-binary, are pregnant or of reproductive age (16 to 49 years), currently smoke or vape at least once per day and are willing to attend the programme are eligible to participate. Up to 500 participants will be recruited. A mixed method evaluation approach will be implemented guided by the RE-AIM framework. Outcomes will include intervention reach, intervention effectiveness (determined primarily by self-reported 7-day point prevalence abstinence at 6 months follow-up), acceptability and feasibility of the intervention, programme fidelity and maintenance and cost effectiveness.

Embedding culturally safe support to quit during pregnancy can result in improved outcomes for both mother and child and immediately improve intergenerational health and well-being. Ethics approval has been provided by the Aboriginal Health and Medical Research Council and the University of Newcastle. Study findings will be disseminated to Aboriginal and Torres Strait Islander communities in ways that are meaningful to them, as well as through Aboriginal health services, key national bodies, relevant state and federal government departments.

ACTRN12625001050448.