Poverty can have profound negative impacts on parent, child and family health. Primary care providers are in a unique position to address child poverty. Some team-based models have integrated community support workers (CSWs) for social service system navigation assistance. The overall aim of this study is to rigorously test a poverty reduction intervention (navigation of financial supports) embedded in primary care. The primary objective is to compare parenting stress between CSW-supported, structured review of financial supports and social system navigation (intervention) and receipt of written summary of local resources (usual care).

This is a multisite pragmatic superiority randomised controlled trial with a 1:1 allocation to the CSW-supported social system navigation versus no navigation. Parent–child dyads (80 parents of children aged Do you ever have difficulty making ends meet at the end of the month?’) will be recruited during a scheduled health supervision visit from primary care practices in Kingston, Ontario. Intervention group participants will have a structured review of financial supports with a trained CSW and will meet up to 6 times over 6 months. Outcomes are measured at baseline, 6 months and 12 months after randomisation. The primary outcome is the Parenting Stress Index Fourth Edition Short Form (PSI-4-SF) total score at 6 months. Secondary outcomes include household income, food insecurity, parent mental health (depression and anxiety) and child health. An internal pilot study was used to obtain more reliable estimates of the SD of PSI-4-SF at 6 months to recalculate the sample size (if needed) and assess randomisation and completion rates. Qualitative interviews conducted 9 months after enrolment explore parent experiences with the CSW intervention.

Research ethics approval by Queen’s University Health Sciences REB. Results will be shared with the College of Family Physicians of Canada, the Ontario SPOR SUPPORT Unit and academic forums.

Connecting Families (Registered 12 October 2021 at www.clinicaltrials.gov; NCT05091957).

The commercial determinants of health (CDoH) are a rapidly growing field of research and global health priority. Despite being disproportionately affected, Indigenous Peoples’ voices and perspectives are conspicuously absent from CDoH research and policy. This article outlines the protocol for Addressing Commercial Health determinants: Indigenous Empowerment and Voices for Equity (ACHIEVE), an Aboriginal and Torres Strait Islander-led project in Australia.

ACHIEVE integrates four research streams, using a novel combination of methods. The first three streams will (i) conceptualise the CDoH using Indigenous yarning methodology, (ii) evaluate the effectiveness and cost-effectiveness of policies to reduce exposure to harmful marketing and (iii) assess the impacts of specific commercial entities on Aboriginal and Torres Strait Islander health using case studies. The final stream will consolidate findings from streams 1–3 and work with Aboriginal Community Controlled Health Organisations (ACCHOs) to co-create strategies for addressing the commercial determinants of Aboriginal and Torres Strait Islander health.

Ethical approval for streams 1–3 has been granted by Deakin University Human Research Ethics Committee. ACHIEVE is guided by a governance model that prioritises Indigenous data sovereignty, community and ACCHO partnerships, capacity building and knowledge translation. Findings will be shared with participants, ACCHOs and policymakers to maximise research impact.

This study assessed whether a previously developed Monte Carlo simulation model can be reused for evaluating various strategies to minimise time-to-treatment in southwest Netherlands for endovascular thrombectomy (EVT) in patients who had an ischaemic stroke.

Reuse of a previously developed simulation model to simulate various strategies in another region, using prospectively collected data from stroke centres and retrospective data from emergency medical services.

Data from 509 patients who had an ischaemic stroke (≥18 years) treated with EVT (2014–2018) were used.

Input for the simulation model reuse included distributions of observed time delays along the acute stroke pathway. Validation of the baseline models was based on face validity and statistical measures (patient data vs model output) using the Assessment of the Validation Status of Health Economic decision models tool. We simulated strategies for a subregion: interhospital patient transfer by helicopter, transport of the neurointerventionalist to the primary stroke centre (‘drive-the-doctor’), interhospital patient transfer to a thrombectomy-capable stroke centre (TSC) outside the region and prehospital triage using the Rapid Arterial Occlusion Evaluation (RACE) scale.

Onset-to-groin time was the outcome.

Reuse of the original simulation model was obtained by minimal effort, implying limited adaptation. Compared with the baseline model, interhospital patient transfer by helicopter or to a TSC outside the region and prehospital routing using the RACE scale reduced mean onset-to-groin time by 16, 13 and 39 min, respectively (95% CrI for all: equal to the point estimate). ‘Drive the doctor’ reduced mean onset-to-groin time by 27 (car), 49 (ambulance) or 58 min (helicopter), each with a 95% CrI equal to the point estimate.

The original simulation model can be applied to different regions in the Netherlands. Strategies tested within the subregion resulted in promising results of ‘drive the doctor’ and prehospital patient routing using the RACE scale.

Parkinson’s disease (PD) is a neurodegenerative disorder characterised by heterogeneous motor symptoms, non-motor symptoms and rates of disease progression; phenotype and prognosis vary by individual. Although researchers have attempted to predict clinical outcomes using biomarkers and other variables, there are limited data on the development, validation and clinical utility of multivariable prediction models for individual prognostication in PD. In this protocol, we will develop a method for identifying, reviewing and appraising existing PD prognostic models in order to summarise the current literature, identify knowledge gaps and inform future research.

This scoping review will be guided by the methodological principles outlined in the Preferred Reporting Items for Systematic Review and Meta-Analysis extension for Scoping Reviews. We will include all multivariable models that predict disease progression in individuals with PD using traditional statistical methods or machine learning. We will exclude models that only report performance measures for one variable (ie, univariable models) or only provide effect estimates (eg, OR, HR). A detailed search of peer-reviewed research publications will be performed through 2025 using the following electronic databases: PubMed, EMBASE, Web of Science and Scopus. Article data will be extracted using Covidence. Two independent reviewers will screen articles by title and abstract for relevance, and a third reviewer will resolve any discrepancies. The remaining full-text articles will also be screened by two independent reviewers, and a third reviewer will resolve any discrepancies. Results from multivariable prediction models meeting inclusion criteria will be summarised using narrative synthesis and organised by clinical outcome. Models will also be appraised using Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis + Artificial Intelligence (TRIPOD+AI) and Prediction model Risk Of Bias ASsessment Tool (PROBAST) guidelines to identify deficiencies and areas of future study.

Ethical approval is not required for this scoping review. Findings will help clinicians make evidence-based decisions to improve prognostication in PD. Findings can also be used to inform the development and validation of additional multivariable clinical prediction models in PD. The results of this scoping review will be disseminated through peer-reviewed publications, research reports and presentations at relevant conferences.

Interstitial lung diseases (ILD) associated with an underlying connective tissue disease (CTD), also known as a systemic autoimmune rheumatic disease or SARD, are chronic conditions with a tendency to progress. CTD-ILDs are increasingly diagnosed and pose an important global health challenge. This systematic review aims to provide an overarching evaluation of their epidemiology and disease burden in Asia. In this review, the term CTD-ILD will be used to denote all major forms of ILD arising in the context of a SARD.

This systematic review will adhere to the standards of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, including a flow diagram to depict the process by four independent reviewers that will assess titles and abstracts against the following predetermined criteria. A systematic review of the literature search published from 2000 to 2024 will be conducted using five electronic databases including PubMed/MEDLINE, Scopus, EMBASE, Cochrane Library and Web of Science. Publications that meet the inclusion criteria of this review will be subjected to a full-text review to extract relevant data. Collated data will be analysed and organised into categories based on the expected outcome and objectives. The quality of published evidence, including heterogeneity across studies, will be checked against PRISMA checklists and assessed by Newcastle-Ottawa Scale.

Ethics approval is not applicable for this study since no original data will be collected. The findings of this review will be disseminated through a peer-reviewed publication in a scientific journal and conference communications, with the aim of contributing insights to the field by identifying research gaps and informing clinical practice.

The protocol of this systematic review is registered with the National Medical & Research Register (ID-24–03600-GUB) and International Prospective Register of Systematic Reviews PROSPERO (CRD420251037095).

Randomised controlled trials (RCTs) are central to generating high-quality evidence in the surgical field but face unique methodological and practical challenges, including recruitment, follow-up, blinding and ensuring patient-centred outcomes. Patient and public involvement (PPI) has emerged as a promising strategy to enhance the relevance, quality and impact of surgical research by actively involving patients throughout the whole research process. Despite growing recognition of its value, the integration and reporting of PPI in surgical RCTs remain inconsistent, and no systematic evaluation has yet addressed its application within general and abdominal surgery.

RCTs in general and abdominal surgery published since 2014 will be identified through systematic searches of the databases MEDLINE, Web of Science and CENTRAL. This systematic review and primary (meta-epidemiological) statistical analysis will assess the reporting prevalence, implementation extent and quality of PPI over time. The Guidance for Reporting Involvement of Patients and the Public 2 (GRIPP2)-SF checklist and Cochrane Risk of Bias V.2.0 tool will be used to evaluate PPI reporting and study quality. To enable a comparison between studies reporting PPI and those that do not, propensity score matching will be performed to identify non-PPI studies with similar population and design characteristics. Subsequently, regression analyses will be employed to investigate potential associations between PPI reporting and various trial characteristics, including patient recruitment and retention, outcome selection and methodological quality. The Patient Advisory Board of the Study Centre of the German Society of Surgery is actively engaged in all phases of the systematic review.

This systematic review does not require ethical approval. Results will be published in an international peer-reviewed scientific journal, as well as distributed in a lay format to the patient community and to the broader public.

CRD42024524426.

To develop survey items for a national patient registry on Long COVID using a modified Delphi process.

This study was based on a modified Delphi process involving three rounds of anonymous, online surveys to develop consensus on and prioritise survey elements to be included in a minimum dataset for use in a national patient registry in Canada. Initial Long COVID items were identified through an environmental scan of the literature.

This study focused on healthcare systems in Canada and was conducted online.

A panel of 52 experts (patients, caregivers, clinicians and researchers) participated in all three rounds of the online survey. These participants were recruited through the Long COVID Web network and word of mouth.

In total, 243 survey elements related to care, quality of life and symptoms were included in round 1 of the survey. 200 reached consensus and moved to round 2 with two additional elements being developed based on open-ended responses. In round 2, participants ranked these survey elements and 34 advanced. In round 3, 33 survey elements met the threshold of consensus with one added a priori. The 33 survey elements were then used to develop a Long COVID minimum dataset, which consists of 48 items.

The findings affirm broad consensus for collecting data related to fatigue, post-exertional malaise, cardiovascular issues, respiratory problems and cognitive issues. This highlighted the desire for quality-of-life indicators and information related to care utilisation, quality and access.

To explore perceptions regarding the approved and actual prescribed doses of protein kinase inhibitors (PKIs) in clinical practice in the European Union among medicine regulators and healthcare professionals (HCPs).

A qualitative descriptive study was conducted using semistructured interviews, continuing until thematic saturation was reached. Thematic analysis was undertaken using a combined deductive-inductive approach. Deductive main analytical themes were derived from the theoretical framework of questioning-based policy design, namely problem sensing, problem categorisation and problem decomposition. Subthemes were generated inductively and could coherently be situated within these main analytical themes.

Interviews were held online or in person at a location convenient for the interviewee, depending on the participant’s preference.

Seven medicine regulators involved in the regulation of cancer medicines—including PKIs—and 10 HCPs prescribing PKIs in clinical practice, from various countries within Europe, were included.

Regulators highlighted insufficient attention to optimal dose finding, yielding approved doses often based on outdated maximum tolerated dose concepts, leading to uncertainties in efficacy and safety. HCPs reported using alternative dosing strategies in clinical practice to improve tolerability and quality of life (QoL) but noted a lack of robust evidence to guide such adjustments and faced legal constraints to deviate from the approved dose. Participants emphasised the need for improved pre-approval and post-approval dose optimisation to improve safety, enhance QoL and bridge gaps between trial data and real-world patient diversity.

Collaborative efforts involving multistakeholders including HCPs, regulators, pharmaceutical companies, insurers, governments and patient representatives are essential to advance dose optimisation and improve patient-centric outcomes, with further research needed to understand these stakeholders’ perspectives.

A ‘7-1-7’ timeliness metric, developed for hastening the response to infectious disease outbreaks/pandemics, was adapted to improve screening and managing household contacts (HHCs) of pulmonary tuberculosis (TB) patients. The feasibility, enablers, challenges and utility of implementing this modified metric through TB Champions (TB survivors) for HHC management were assessed.

This was an explanatory mixed-methods study with a cohort design (quantitative) followed by a descriptive design with focus group discussions (qualitative).

The study was conducted within routine programmatic settings in public health facilities in six districts from three states of India.

In total, 595 drug-susceptible index pulmonary TB patients registered for treatment in the selected health facilities, and their listed 2108 HHCs were included in the study between December 2022 and August 2023. All 17 TB Champions involved in implementation participated in the focus group discussions.

The primary outcome measures were the percentage of eligible participants receiving the desired service within the ‘7-1-7’ timeliness metric and challenges in achieving the timeliness metrics.

In 89% of 595 index patients, their HHCs were line-listed within 7 days of initiating anti-TB treatment (‘First-7’). In 90% of 2108 HHCs, screening outcomes were ascertained within 1 day of line-listing (‘Next-1’). In 42% of 2073 HHCs eligible for further evaluation, anti-TB treatment, TB preventive treatment (TPT) or a decision to not receive medication were made within 7 days of screening (‘Second-7’). Barriers to TPT uptake included lack of money and daily wage losses for travelling to clinics, reluctance of asymptomatic contacts to take medication and fear of adverse events. TB Champions felt timeliness metrics improved performance in the systematic and timely management of HHCs.

TB Champions found ‘7-1-7’ timeliness metrics were feasible and useful, and national TB programmes should consider their operationalisation.

Although there are some drugs to control Parkinson’s disease (PD), they have several side effects and cannot control the inflammation and oxidative stress, the leading causes of PD progression. On the other hand, there is a growing interest in herbal medicine as a safe and cheap adjunctive therapy to prevent PD progression. In this regard, limited human studies investigated the effect of saffron, a rich source of antioxidants, on PD. Nevertheless, due to low sample size, saffron dosage and study duration, they could not completely affirm the efficacy of saffron on PD. Therefore, this triple-blind randomised controlled clinical trial aimed to investigate this subject in human patients with a proper sample size, saffron dosage and duration study.

In this parallel, randomised, triple-blind controlled clinical trial, 92 patients with PD will be randomised into two groups to receive either (1) a daily tablet containing 100 mg/d saffron for 12 weeks or (2) placebo tablets for the same duration. The following variables will be assessed before and after the intervention, as the outcomes of interest: serum values of C-reactive protein, total antioxidant capacity, malondialdehyde, glutathione, zonulin, the activity of catalase enzyme, PD stage, symptoms of PD (motor symptoms, non-motor symptoms), quality of life, mental health, sleep quality, cognitive status, anthropometric indices, blood pressure, gastrointestinal symptoms, appetite and fatigue. The intention-to-treat approach will be used for patients who were lost to follow-up. Additionally, to adjust for the potential confounders, a one-way analysis of covariance will be performed.

This study was confirmed by the Ethics Committee of Isfahan University of Medical Sciences with the code of IR.MUI.PHANUT.REC.1402.072. Written informed consent to participate will be obtained from all participants. Final findings will be presented in future publications and scientific congresses.

IRCT20121216011763N61; Pre-results.

Distal radius fractures are the most common fractures seen in the emergency department in children in the USA. However, no established or standardised guidelines exist for the optimal management of completely displaced fractures in younger children. The proposed multicentre randomised trial will compare functional outcomes between children treated with fracture reduction under sedation versus children treated with simple immobilisation.

Participants aged 4–10 years presenting to the emergency department with 100% dorsally translated metaphyseal fractures of the radius less than 5 cm from the distal radial physis will be recruited for the study. Those patients with open fractures, other ipsilateral arm fractures (excluding ulna), pathologic fractures, bone diseases, or neuromuscular or metabolic conditions will be excluded. Participants who agree to enrol in the trial will be randomly assigned via a minimal sufficient balance algorithm to either sedated reduction or in situ immobilisation. A sample size of 167 participants per arm will provide at least 90% power to detect a difference in the primary outcome of Patient-Reported Outcomes Measurement Information System Upper Extremity computer adaptive test scores of 4 points at 1 year from treatment. Primary analyses will employ a linear mixed model to estimate the treatment effect at 1 year. Secondary outcomes include additional measures of perceived pain, complications, radiographic angulation, satisfaction and additional procedures (revisions, refractures, reductions and reoperations).

Ethical approval was obtained from the following local Institutional Review Boards: Advarra, serving as the single Institutional Review Board, approved the study (Pro00062090) in April 2022. The Hospital for Sick Children (Toronto, ON, Canada) did not rely on Advarra and received separate approval from their local Research Ethics Board (REB; REB number: 1000079992) on 19 July 2023. Results will be disseminated through publication in peer-reviewed journals and presentations at international conference meetings.

NCT05131685.

Diabetes mellitus is a significant global health challenge, requiring innovative strategies to improve management and mitigate complications. Digital health technologies offer promising solutions to enhance diabetes self-care by providing real-time feedback, improving communication and supporting data-driven decision-making. Despite the increasing adoption of digital self-care interventions, there is a lack of comprehensive synthesis of evidence on their impact, accessibility and integration into healthcare systems. This scoping review aims to map existing research on digital self-care solutions for diabetes management, identify knowledge gaps and highlight best practices and key factors influencing adoption.

The review will follow Arksey and O’Malley’s framework and adhere to Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines. A systematic search will be conducted in Medline, Scopus, Embase, CINAHL and Google Scholar, focusing on studies published from January 2004 to December 2024 in English, French, Arabic, Portuguese, Spanish, Italian, Czech, Slovak and Chinese. Studies reporting on digital self-care solutions for diabetes management will be included, covering experimental and quasi-experimental study designs. Data extraction will cover study and participant characteristics, digital solution features, and barriers and facilitators to adoption. Ethical and equity considerations will also be analysed using established frameworks. Two reviewers will independently screen studies, with discrepancies resolved by a third reviewer.

This scoping review will provide a comprehensive understanding of digital self-care solutions for diabetes management, offering insights to inform future research and enhance self-care practices globally. Findings will be disseminated through peer-reviewed publications, conferences and interest holder engagements to inform clinical practice and policy development. As this study involves the review of existing literature, ethical approval is not required.

To describe the features and rates of emergency department (ED) presentations identified as related to violence against women (VAW) and of confirmed cases of family domestic violence (FDV) inpatient admissions and to compare these across geographic locations in New South Wales (NSW) Australia.

A retrospective data linkage study.

Routinely collected public hospital data from approximately 180 designated public hospital EDs in NSW, Australia.

Cases were included if female, aged ≥15 years, presenting to any NSW ED between 2015 and 2022 and with one or more criteria indicating VAW, leading to 21 219 cases being included.

The age-standardised rate of VAW ED presentations per year and confirmed FDV inpatient admissions within metropolitan and non-metropolitan areas in NSW, Australia.

Women presenting with VAW were more likely to be aged 25–44 years (n=9705, 45.7%), with almost 20% of presentations from women who identified as Indigenous (n=4153, 19.6%). Indigenous presentations were greater in non-metropolitan areas (n=2675, 30.9%) compared with metropolitan areas (n=1478, 11.8%). Indigenous women in NSW represent only 4.2% of the estimated residential population. VAW presentation rates by age group varied over time, a gradual increase being seen in the 65–84 year-old age group who experienced 45 VAW presentations per year in 2015 to 79 presentations per year in 2022 with an annual rate of change of 7.3%.

VAW accounts for a substantial burden of ED presentations across NSW; the greatest impact on women aged 25–44 years and Indigenous women, particularly in non-metropolitan areas. Rising presentations among older women further highlight the need for strengthened ED screening and referral pathways and for targeted resource allocation to address inequities in family, domestic and sexual violence.

This project aims to comprehensively examine the incidence of suicidality, individual and population characteristics, and health pathways, for a cohort of Australian veterans using linked administrative data.

The cohort will comprise veterans who are clients of the Department of Veterans’ Affairs (DVA) residing in Queensland between 1 January 2017 and 31 December 2022. People currently serving in the Australian Defence Force, Australian Federal Police personnel, other DVA clients who are not veterans (eg, eligible dependents), and clients currently known to DVA who have requested that their data not be disclosed for research will be excluded. This cohort will be linked to DVA administrative data, the Queensland Hospital Admitted Patients Data Collection (QHAPDC), Queensland Hospital Non-Admitted Patients Data Collection, Emergency Data Collection (EDC), Consumer Integrated Mental Health and Addiction Application (CIMHAA), Queensland Death Register, National Death Index, Medicare Benefits Schedule, Centrelink (Data Over Multiple Individual Occurrences) database and Pharmaceutical Benefits Scheme. These data will be linked for a period of at least 1-year preindex and postindex contact with DVA, such that the entire study period is expected to encompass at least 1 January 2016 to 31 December 2023.

This study received ethical approval from the Departments of Defence and Veterans’ Affairs Human Research Ethics Committee (HREC; Project ID: 556-23), and the Australian Institute of Health and Welfare HREC (Project ID: EO2024/1/1461). This project also received Public Health Act approval (File reference: PHA 556-23). The project was ratified by the University of Queensland HREC (Project ID: 2024/HE002153). The findings of this project will be disseminated via a publicly available report, presentations and peer-reviewed publications.

Visual perception and visual-motor integration skills are key predictors of handwriting. Children with cerebral palsy often experience difficulties in these areas, which can negatively affect handwriting. Interventions targeting these skills may improve handwriting outcomes in this population.

This single-blind (data analyst blinded), three-arm randomised controlled trial will include 30 children with spastic cerebral palsy. Participants will be randomly allocated to one of three groups: (1) a computerised visual-motor integration training group, (2) a computerised visual perception training group or (3) a control group. Randomisation will be performed using a stratified permuted block design based on cerebral palsy subtype (hemiplegia, diplegia and quadriplegia). Each intervention group will receive 20 individual sessions (two times per week for 10 weeks) using validated computerised games. The primary outcome is handwriting performance, assessed by the Persian Handwriting Assessment Tool. Secondary outcomes include visual-motor integration, assessed by the Beery–Buktenica Developmental Test of Visual–Motor Integration, and visual perception, assessed by the Test of Visual–Perceptual Skills–Revised.

This study was approved by the Ethics Committee of Tehran University of Medical Sciences. Written informed consent will be obtained from parents. Participation is voluntary, free and confidential. Control group participants may receive the intervention after the trial. Results will be published in peer-reviewed journals and shared with relevant stakeholders.

IRCT20230219057447N1.

To evaluate temporal trends in the epidemiology of hip osteoarthritis (OA) in the USA from 1990 to 2019, with stratification by sex and geographic region.

Cross-sectional time-series analysis using secondary data from the Global Burden of Disease (GBD) study.

US population-based analysis, stratified by the four US Census Bureau regions: Northeast, Midwest, South and West.

De-identified, aggregate population-level data representing all adults in the USA from 1990 to 2019, drawn from the GBD database.

Age-standardised rates per 100 000 population for years lived with disability (YLDs), prevalence and incidence of hip OA. Outcomes were stratified by sex and region. Statistical significance was defined as p

Between 1990 and 2019, hip OA in the USA increased by 23.91% in YLDs, 24.67% in prevalence and 25.22% in incidence. In 2019, the mean YLDs were 28.30 in women versus 25.48 in men; prevalence was 49.55 versus 41.08; and incidence was 919.29 versus 818.10 (all p

There has been a substantial rise in the burden of hip OA in the USA over the past three decades. Women and residents of the Northeastern USA are disproportionately affected. These findings underscore the need for targeted public health strategies that account for geographic and sex-based disparities in hip OA burden.

The COVID-19 pandemic led to major disruptions in society across many spheres, including healthcare, the economy and social behaviours. While early predictions warned of an increased risk of suicide during and after the COVID-19 pandemic, rates of suicide deaths remained stable or decreased over that period for most countries. In contrast, the prevalence of suicidal ideation doubled and suicide attempts slightly increased during the COVID-19 pandemic in the adult general population worldwide, accompanied by a higher prevalence of major depressive disorder and anxiety disorders. While these data can tell us what happened, they cannot tell us why. Qualitative suicide research seeks to understand experiences of individuals with suicide-related thoughts and behaviours, provides an in-depth exploration of their lives and interactions with others and centres their views and unique context. There is little qualitative research focusing on suicidality during the pandemic. This study will use a qualitative approach to explore the extent and impact of the COVID-19 pandemic on Canadians who experienced suicidality and review their experiences of accessing mental healthcare to identify key components in supporting safety and recovery.

This study will involve approximately 100 semistructured interviews with participants across four Canadian provinces and will explore experiences with suicide-related thoughts and behaviours during the COVID-19 pandemic. Transcripts will be analysed through qualitative analysis informed by constructivist grounded theory.

The study was approved by the Research Ethics Board of the Centre for Addiction and Mental Health, Toronto Academic Health Sciences Network (for JZ: CAMH REB No 104-2022). In addition to traditional peer-reviewed presentations and publications, a report will make study findings accessible to policy makers, media and the public.

Mental health issues such as depression and anxiety are highly and disproportionally prevalent among university students. Beyond the academic rigour, stressors imposed by a new environment result in them being vulnerable to the onset and manifestation of mental health symptomatology. Leveraging smartphones and wearables for digital phenotyping capabilities is an innovative approach for monitoring and intervening in the mental health conditions of university students. This provides a unique opportunity to collect and identify digital and behavioural biomarkers, subsequently enabling the development of predictive models to identify university students at risk.

This study—Brightline—will employ an observational study design over a 6-month period, recruiting 500 students from a major public university in Singapore. Passive data collection will occur continuously throughout the monitoring period through a wearable device (Fitbit Charge 6) and smartphone sensors via the Brightline app, which uses a digital phenotyping data collection platform. Active data collection will consist of self-report questionnaires to be completed at the beginning of the study and follow-up assessments at 1, 3 and 6 months after. The passive and active data collected will be analysed to identify the digital biomarkers associated with depression, anxiety, stress, loneliness and affect among university students. Predictive models of these mental health issues will also be developed.

This study was approved by the Nanyang Technological University Institutional Review Board (IRB-2023-894). Findings from this study will be published in peer-reviewed journals and presented at academic conferences.

NCT06770075.

In 2022, the WHO conditionally recommended the use of treatment decision algorithms (TDAs) for treatment decision-making in children

Within the Decide-TB project (PACT ID: PACTR202407866544155, 23 July 2024), we aim to generate an individual-participant dataset (IPD) from prospective TB diagnostic accuracy cohorts (RaPaed-TB, UMOYA and two cohorts from TB-Speed). Using the IPD, we aim to: (1) assess the diagnostic accuracy of published TDAs using a set of consensus case definitions produced by the National Institute of Health as reference standard (confirmed and unconfirmed vs unlikely TB); (2) evaluate the added value of novel tools (including biomarkers and artificial intelligence-interpreted radiology) in the existing TDAs; (3) generate an artificial population, modelling the target population of children eligible for WHO-endorsed TDAs presenting at primary and secondary healthcare levels and assess the diagnostic accuracy of published TDAs and (4) identify clinical predictors of radiological disease severity in children from the study population of children with presumptive TB.

This study will externally validate the first data-driven WHO TDAs in a large, well-characterised and diverse paediatric IPD derived from four large paediatric cohorts of children investigated for TB. The study has received ethical clearance for sharing secondary deidentified data from the ethics committees of the parent studies (RaPaed-TB, UMOYA and TB Speed) and as the aims of this study were part of the parent studies’ protocols, a separate approval was not necessary. Study findings will be published in peer-reviewed journals and disseminated at local, regional and international scientific meetings and conferences. This database will serve as a catalyst for the assessment of the inclusion of novel tools and the generation of an artificial population to simulate the impact of novel diagnostic pathways for TB in children at lower levels of healthcare. TDAs have the potential to close the diagnostic gap in childhood TB. Further finetuning of the currently available algorithms will facilitate this and improve access to care.

Perioperative adverse events increase morbidity and mortality. The rate and severity of complications and the risk for subsequent mortality are increased after high-risk procedures and in elevated-risk patients. Over the past decades, a multitude of prognostic studies identified perioperative risk factors at the population level. However, to allow for the advancement of precision surgery strategies, improved risk prediction on the individual patient level is warranted. Comprehensive, consecutive, multisource, structured, high-quality patient-related and procedure-related data sets, together with thorough follow-up and combined with state-of-the-art machine-learning analyses, are needed to facilitate precise prediction of perioperative complications. Therefore, we designed and currently conduct the Heidelberg Perioperative Deep Data study (HeiPoDD). Here, we report the rationale and design of the HeiPoDD study.

HeiPoDD is a prospective, single-centre, exploratory cohort study aiming to build up a large-scale deep-data base and corresponding biomaterial collection. 1040 adult patients planned for elective high-risk, non-cardiac surgery for any indication at Heidelberg University Hospital, Germany will be included. The obtained study-specific data set includes clinical data, lab values, genome- and proteome analysis as well as plasma, serum and peripheral blood mononuclear cells (PBMC) collected before and at days 1, 3 and 7 postsurgery. Urine samples are collected before and at day 1 postsurgery. Structured follow-up for perioperative complications such as redo-surgery, length of intensive care stay or length of hospital stay is conducted at days 30, 90 and 1 year postsurgery and for disease progression and survival after 3 and 5 years postsurgery. All study data will be transferred to the HeiPoDD registry to allow merging with all available routine clinical data from the hospital information system including imaging studies as well as haemodynamic and respiratory biosignals. Biomaterials will be stored in the HeiPoDD biomaterial bank to allow further analyses.

The trial protocol and amendments were approved by the ethics committee of the University of Heidelberg (S-758/2021). The protocol is registered with the German Clinical Trial Register (DRKS00024625). Participating patients’ data will be recorded only in pseudonymised form. After completion of the study, data collected during the study will be kept on file for up to 30 years. Biomedical samples collected during the study and entered into the biobank will be held for the same amount of time. The findings will be disseminated in peer-reviewed academic journals.