Risk screening for pre-eclampsia relies on accurate gestational age assessment, but routine access to ultrasound-based gestational dating remains challenging in many low- and middle-income countries. As part of the formative work for the ‘Preventing pre-eclampsia: Evaluating AspiRin Low-dose regimens following risk Screening’ (PEARLS) platform, we aim to validate and implement an artificial intelligence (AI)-based algorithm for estimation of gestational age, using blind sweeps done with a handheld ultrasound device. This study protocol outlines the accuracy cohort for AI-based gestational age estimation in participating facilities in Ghana, Kenya and South Africa.

This multicountry prospective cohort study will recruit 969 pregnant women at 13 health facilities across Kenya, Ghana and South Africa. The eligible population is pregnant women presenting for antenatal visits from 11⁺⁰ to 13⁺⁶ weeks’ gestation. Eligible women will have a gestational age assessment by a trained sonographer using fetal biometry (reference standard), followed by gestational age estimation conducted by a trained midwife using the AI-based Intelligent Ultrasound ScanNav FetalCheck system (experimental). Both conventional and AI-based gestational age scans will be conducted with the General Electric VScan Air platform. Women will return for a second visit between 14⁺⁰ and 27⁺⁶ weeks’ gestation (week of visit is randomly selected) for an assessment with both conventional and AI-based ultrasound. The primary objective is to determine the accuracy and precision of gestational age estimation using an AI ultrasound system in first and second trimesters, as compared with gestational age estimation using crown-rump length measurement by conventional ultrasound in first trimester (11⁺⁰ to 13⁺⁶ weeks’).

This study has received or sought ethics approval from the following entities: Australia: University of Melbourne, Office of Research Ethics and Integrity (Reference Number: 2024–28489-49438-3) and the Alfred Hospital Ethics Committee (Reference: Project 727/23); Ghana: Ghana Health Service Ethics Review Committee (GHS-ERC Number 002/01/24); Kenya: Kenyatta National Hospital, University of Nairobi ERC (Ref: KNH-ERC/01/MISC/20); South Africa: University of Cape Town, Faculty of Health Science, Human Research Ethics Committee (HREC Ref: 138/2024). Key findings will be disseminated to research teams to inform future scale-up of AI-based pregnancy dating and pre-eclampsia risk screening. Findings from this pilot work will be published in peer-reviewed open-access journals, conferences and meetings to maximise reach of our findings.

Colorectal cancer (CRC) is the third leading cause of new cancer cases and the second leading cause of cancer-related deaths worldwide. Current therapeutic modalities for CRC include surgical resection, intravenous chemotherapy (IVC), radiotherapy, immunotherapy, targeted therapy and their combinations. As a mainstream systemic treatment for CRC, IVC leads to widespread drug distribution but relatively low intratumoural drug accumulation. Compared with IVC, transarterial infusion chemotherapy (TAIC) involves selective arterial catheterisation to deliver chemotherapeutic agents directly to the tumour feeding vessels. Hepatic tumours receive their blood supply predominantly through branches of the hepatic artery. Hepatic artery infusion chemotherapy (HAIC) yields significantly superior outcomes compared with IVC and is currently widely employed for the treatment of primary and secondary hepatic malignancies. HAIC in combination with IVC can offer long-term durable disease control in the clinical treatment of liver cancer compared with IVC. CRC is also predominantly grown through angiogenesis. Therefore, we raise the question whether sequential IVC administered after intensive TAIC achieves better clinical efficacy than IVC alone for the treatment of unresectable CRC (uCRC). However, no prospective clinical trials have been conducted to compare the efficacy of these two strategies. This prospective study was therefore designed to fill this clinical knowledge gap.

This is a prospective, multicentre, randomised, open-label clinical trial. The uCRC is defined as inability to achieve an R0 resection owing to locally advanced CRC with clinical T4 disease confirmed by MRI or CT and/or synchronous liver metastases. This study only includes microsatellite stable or proficient mismatch repair uCRC. A total of 50 eligible patients will be randomly assigned to either the IVC group or the TAIC group. Patients in the IVC group will receive FOLFOX (fluorouracil, leucovorin, oxaliplatin)-based IVC every 2 weeks for a total duration of 8 weeks. Patients in the TAIC group will receive FOLFOX-based TAIC at week 0 and week 4 and receive FOLFOX-based IVC at week 2 and week 6. For patients with colorectal liver metastases, cetuximab or bevacizumab will be administered according to the RAS and BRAF status and the primary tumour site. The primary endpoint is the objective response rate. This study is scheduled to commence on 10 January 2026, and complete follow-up on 31 December 2027. The first subject was enrolled on 20 March 2026. To date, one subject in the IVC group and six subjects in the TAIC group have been enrolled.

The present study protocol has been approved by the Medical Ethics Committee of Guang’anmen Hospital, China Academy of Chinese Medical Sciences (ethical approval number 2025-268 KY). On completion of the study, data cleaning and analysis will be performed, and the results will be disseminated at academic conferences and in international peer-reviewed journals. This trial has been registered at ClinicalTrials.gov. The statistical analysis plan will be finalised and approved before the database lock. The final version is retained in the study documentation and will be made available to support the transparency and interpretation of the study results.

NCT07333053.

To develop and internally validate a clinical prediction model estimating the probability of emergency caesarean delivery among low-risk pregnancies using routinely available intrapartum variables. The model is intended to support clinicians in recommending transfer decisions in rural obstetric settings without onsite caesarean capacity.

Retrospective cohort study with multivariable logistic regression and internal validation using bootstrap resampling.

Province-wide birth registry in Ontario, Canada.

Singleton, hospital births from low-risk pregnancies between 1 April 2012 and 31 March 2020, captured in the Better Outcomes Registry and Network Ontario. Exclusions included previous caesarean, major comorbidities and other high-risk conditions.

Emergency caesarean delivery during labour.

Among 611 644 low-risk pregnancies, 66 482 (10.9%) resulted in emergency caesarean delivery. Key predictors included abnormal fetal health surveillance, nulliparity, gestational hypertension, polyhydramnios area under the receiver operating characteristic curve (AUC) and oxytocin augmentation. The optimism-corrected AUC was 0.86, indicating strong discrimination. Calibration was generally good, though the model underestimated caesarean risk in patients first admitted to level I hospitals.

This study presents a proof-of-concept prototype with strong discrimination, though calibration of the full model was suboptimal in level I hospitals, the intended setting for application. While not clinically deployable in its current form, the model lays the groundwork for a translational pathway that will require local recalibration, external validation and contextual adaptation before implementation. Threshold-based clinical utility (eg, positive/negative predictive value or net benefit) was not assessed and will be evaluated during external validation and local recalibration.

Chronic pain is a leading public health problem, impacting over 1.5 billion people worldwide. Standard-of-care includes pharmaceutical medication, surgery and physical therapy, yet many patients experience continued symptoms. Investigation into lifestyle-based approaches such as dietary interventions has increased in recent years, including intermittent fasting, due to known impacts on inflammation and neurotransmitters.

This systematic review and meta-analysis will be conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The literature search will include the PubMed/MEDLINE, Embase (Ovid), Web of Science (Core Collection) and LILACS (VHL) databases. The Google Scholar, ClinicalTrials.gov, PROSPERO, Open Science Forum and MedRXiv platforms will also be searched. Randomised, controlled trials investigating the impact of intermittent fasting interventions in adult humans with any chronic pain condition will be included. The primary outcomes will be self-reported pain or function and the secondary outcome will be rescue medication use. Study screening, data extraction and risk of bias assessment will be conducted independently in duplicate. The Cochrane Risk of Bias-2 tool will be used to assess bias at the study level, and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) guidelines will be used to assess bias at the outcome level. The meta-analysis will use random effects, with heterogeneity assessed using the I² statistic. For studies that report rescue medication use, we will analyse the impact of intermittent fasting on pain or function, adjusting for rescue medication use, using established methods. Subgroup and sensitivity analyses will be conducted to explore heterogeneity.

As this project involves analysis of publicly available data, no ethical oversight was or is required. The results of this review will be disseminated by publication in a peer-reviewed journal.

CRD #420261395061.

IgG4-related disease is a chronic fibroinflammatory disease with multiorgan involvement. Glucocorticoids and/or immunosuppressants as well as rituximab are both first-line treatments in remission induction therapy. However, relapse is common during the maintenance period, particularly in patients with re-elevation of serum IgG4 level. This study aims to evaluate whether adding mycophenolate mofetil (MMF) during the maintenance phase for such patients can reduce the risk of disease flare.

This study is a multicentre, randomised, double-blind, placebo-controlled study. A total of 108 eligible patients with re-elevation of serum IgG4 level during maintenance therapy will be included in this study and randomised in a 1:1 ratio to receive add-on MMF 0.5 g one time per day or placebo for 52 weeks. The primary outcome is the proportion of patients experiencing relapse at week 52. Secondary outcomes include time-to-relapse, changes in disease activity and serum IgG4 level, stratified relapse rate according to the elevation level of IgG4. Analyses will follow the intention-to-treat principle.

The study has been approved by the Ethics Committee of Peking Union Medical College Hospital, Chinese Academy of Medical Sciences (approval no. K3231). Written informed consent will be obtained from all participants before enrolment. Findings will be disseminated through peer-reviewed journals and conference presentations.

NCT05974683.

To synthesise barriers and facilitators to reducing sedentary behaviour among stroke survivors and map them to the Theoretical Domains Framework (TDF).

A scoping review conducted following Joanna Briggs Institute (JBI) methodology and reported in accordance with Preferred Reporting Items for Systematic Review and Meta-Analysis, Scoping Review extension (PRISMA-ScR) guidelines.

Nine electronic databases (PubMed, CINAHL, MEDLINE, Embase, PsycINFO, Web of Science, Cochrane Library, CNKI and WanFang) were searched from inception to May 2025. Grey literature was identified through Google Scholar and ProQuest. Updated research was conducted in July 2026.

Studies focusing on barriers and/or facilitators to sedentary behaviour among stroke survivors were included, with no restrictions on study design.

Two reviewers independently screened studies, extracted data and mapped identified barriers and facilitators to the Theoretical Domains Framework. Frequencies of domains were calculated to summarise distribution patterns.

49 studies were included. A total of 32 barriers and 17 facilitators were identified and mapped to 12 TDF domains. Barriers were reported more frequently than facilitators. The most frequently represented domains included Skills, Environmental Context and Resources, Beliefs about Capabilities, Beliefs about Consequences, Social Influences, Knowledge and Emotion. Common barriers included stroke-related physical and functional limitations, fatigue, inadequate knowledge, low self-efficacy, fear of falling, limited social support and environmental constraints. Key facilitators included sedentary behaviour education, higher self-efficacy, supportive social and physical environments, inpatient rehabilitation and behaviour change strategies that promoted more active lifestyles.

Barriers to reducing sedentary behaviour among stroke survivors include limited knowledge, low motivation, insufficient social support, negative emotions and beliefs and physical limitations. Facilitators include social support, positive beliefs and supportive environmental conditions. Future interventions should comprehensively address these multilevel factors to develop more tailored and feasible behaviour change strategies.

This study was registered with the Open Science Framework website (osf.io/ma8qp).

Home-based primary care has been suggested to reduce emergency department visits among vulnerable older adults but how it should be organised to achieve this effect is unclear. This study aimed to increase the understanding of how older adults receiving home-based primary care and their family caregivers’ experience care during the period prior to an emergency department visit and to identify components of home-based primary care delivery that could help reduce such visits.

Qualitative study using semi-structured interviews with older adults receiving home-based primary care who had recently visited the emergency department, along with their family caregivers. Interviews were analysed using inductive thematic analysis.

Interviews were conducted in the homes of informants receiving home-based primary care in Region Stockholm, Sweden, 2022–2023.

Fourteen adults aged ≥65 years receiving home-based primary care who had visited an emergency department within the past 3 months were interviewed; seven interviews also included a family member.

An overarching theme, Trust as a prerequisite for timely emergency assessments in home-based primary care, describes how patient trust–in home-based primary care in general and in specific individual healthcare professionals–seems important in reducing emergency department visits, especially when patients experience symptoms of uncertain urgency or gradual onset. Four subthemes describe how primary care may build trust: through (1) access to care, (2) medical competence, (3) respect and relationship and (4) coordination and teamwork.

Trust in both home-based primary care in general and in individual healthcare professionals is crucial in reducing emergency department visits among older adults receiving home-based primary care. Trust may be strengthened by accessible and competent care, familiarity with both general practitioners and the responsible nurse and working as a collaborative team.

Single-arm trials (SATs) with objective performance criteria (OPCs) or performance goals (PGs) are increasingly used for regulatory approval of medical devices and other interventions. However, the comparability of study design characteristics between SAT and their external comparator sources remains unclear. This scoping review aimed to evaluate the comparability of study design characteristics between SATs and their matched OPC/PG sources.

Scoping review.

PubMed, Embase, the Cochrane Library and four Chinese databases—China National Knowledge Infrastructure, Wanfang Data, CQVIP and SinoMed—were searched from inception to 30 April 2026.

We included SATs that used one or more OPCs or PGs as external comparators to evaluate safety and/or effectiveness endpoints and reported specific numerical values of OPCs or PGs.

Two reviewers independently screened the retrieved records and extracted data using a standardised form. For each included SAT, we retrieved the cited OPC/PG sources and extracted study design characteristics data (age, sex, health conditions, outcome definitions and measurement time points) for comparison. Age and sex were compared using summary t-tests and ² tests; health conditions were assessed by two clinicians based on eligibility criteria and baseline characteristics. Results were stratified by OPC versus PG.

A total of 1243 records were identified, and 133 SATs were included. Most studies used PGs (84, 63.2%); 34 (25.6%) claimed to use OPCs, and 15 (11.3%) could not be classified. Of the 60 age comparisons available from 41 studies, 30 showed statistically significant differences; of the 82 sex comparisons available from 59 studies, 60 showed significant differences. Health conditions, outcome definitions and time points were assessed descriptively in a subset of studies, and discrepancies were also observed.

Suboptimal comparability of study design characteristics was observed between SATs and their OPC/PG sources, which might influence the treatment effect estimates. Greater attention to the comparability of study design characteristics in SATs with OPC/PGs may improve the validity of evidence.

During pregnancy, physiological and psychological factors influence eating behaviour and food preferences. Food cravings are common in pregnancy and contribute to excessive gestational weight gain (GWG). Excessive GWG is present across all body mass index (BMI) categories and is associated with adverse outcomes. Outside of pregnancy, highly palatable food cues activate brain regions involved in reward and attention, which may influence eating behaviour and behavioural responses. However, brain and behavioural responses to food cues across pregnancy, and their association with psychological and metabolic factors, remain poorly understood. This study aims to investigate spatiotemporal brain responses to visual food cues across individuals with different BMI categories and their associations with behavioural, psychological and metabolic outcomes during pregnancy.

This is a prospective observational cohort study conducted at the Lausanne University Hospital, Switzerland. 94 pregnant individuals (47 healthy normal weight and 47 with overweight/obesity) will be assessed at 12–16 and 31–36 weeks of gestational age from November 2024 to September 2026. Data collected for the primary outcomes include electroencephalography-based brain responses to validated visual food cues varying in fat and carbohydrate content, behavioural responses to the same cues using a gamified smartphone Go/NoGo task. Secondary validated outcomes include heart rate variability (Actiheart), body composition (InBody S10), glycated haemoglobin (Afinion), cardiorespiratory fitness (The Chester step test), snack intake, eating behaviour (Intuitive Eating Scale-2, Three-Factor Eating Questionnaire-Revised), food cravings (Food Craving Questionnaire-state), mood and depressive symptoms (Edinburgh Postnatal Depression Scale). Statistical analyses include group comparisons, longitudinal analyses and regression models adjusted for potential sociodemographic/medical confounders.

All participants will provide written informed consent. The Human Research Ethics Committee of the Canton de Vaud approved the study protocol (CER-VD 2023-01462). Findings will be disseminated through peer-reviewed publications, (inter)national conferences and shared with healthcare professionals and stakeholders to inform strategies for improving maternal health.

The diagnostic and therapeutic landscape for high-risk localised prostate cancer and synchronous metastatic hormone-sensitive prostate cancer (mHSPC) is rapidly evolving, driven by advances in imaging, risk stratification and systemic therapies, including the advent of precision medicine. High-quality real-world data integrating clinical, imaging, molecular, quality-of-life information and outcome data remain scarce. The PROspective Prostate Cancer Infrastructure (ProPCI) is a nationwide, multicentre observational cohort designed to collect comprehensive longitudinal data and biomaterials to support real-world evidence generation, facilitate biomarker discovery and enable future cohort multiple randomised controlled trials (cmRCTs).

ProPCI includes adult men with high-risk localised prostate cancer or synchronous mHSPC across hospitals in the Netherlands. Clinical data are extracted from electronic health records using a standardised protocol and linked to national registries and healthcare use datasets. Patient-reported outcome measures are collected at baseline and regular intervals using validated instruments. Serial blood samples are biobanked for circulating tumour DNA and other molecular analyses. Outcomes include diagnostic and treatment patterns, Prostate-specific antigen kinetics, time to castration-resistant prostate cancer, radiological and clinical progression, health-related quality of life trajectories and healthcare use, including expenditure and exploratory biomarker associations. Statistical methods include descriptive analyses, time-to-event models, mixed-effects models and biomarker-outcome correlates.

Ethical approval has been obtained from the Committee on Research Involving Human Subjects (CMO) of Radboudumc. Written informed consent will be obtained from every participating patient and covers: (1) extraction and linkage of clinical, imaging, pathology and registry data, (2) future contact for potential cmRCT participation; and optional components (3) quality-of-life questionnaires, (4) collection of additional blood samples and (5) use of biomaterials for genomic testing. Results will be disseminated through peer-reviewed publications.

NCT07560748.

This study assessed the feasibility of both the delivery and evaluation of ‘enhanced’ (behaviourally informed) text message reminders containing links to existing co-designed resources supporting decision-making for people with severe mental illness (SMI) regarding attendance of cervical screening.

A pilot randomised controlled trial (RCT).

13 General Practice (GP) practices in London were recruited.

GP practices identified people with SMI aged 24–64 years who were overdue cervical screening. Target sample size was 120 participants (60 per arm) based on existing guidance for pilot trials.

In March 2025, participants were randomised (1:1) to receive either the enhanced (intervention) or the standard (control) SMS reminder.

18 weeks later, feasibility outcomes were collected (primary outcomes) and data analysis for a definitive RCT was rehearsed (secondary outcome).

Of the 150 participants across 13 GP practices that were randomised (n=75 per arm), 132 (88%) texts delivered (intervention n=64/75 (85%), control n=68/75 (91%)). 10 practices (76.9%) provided follow-up data for 102 participants (intervention n=50, control n=52). Five participants (intervention n=4, control n=1) attended screening within the trial period. Participant survey response rate was low (9/132 (7%), intervention n=5, control n=4). Both SMS messages were low cost, with the intervention SMS a 50% higher cost to deliver (7.5p vs 5p per SMS). Primary feasibility measures of recruitment rate of GP practices (27%), retention of GP practices (77%) and participants (100%), SMS delivery (88%) and data completeness (64%) indicated viability, although survey response rate (7%) did not.

Achieving adequate recruitment and retention, data completeness and comparable groups is viable with some amendments, although an alternative method is required to assess fidelity. Behaviourally informed SMS reminders are feasible to deliver to people with SMI, although it is uncertain if the extra resources are accessed and used. With changes to data collection, a definitive trial could be feasible. Given the low observed cervical screening attendance, additional intervention is needed for this group.

ISRCTN12558681.

This study examined social determinants and structural barriers to lung cancer outcomes in Kern and Fresno counties, California, and co-developed a multilevel intervention strategy informed by community perspectives.

Engaging stakeholders through group model building (GMB) to elicit their knowledge to build a system dynamics (SD) simulation model for intervention strategy design.

We identified and trained four community members from two community-based organisations in Central Valley, California, to help recruit GMB participants. 14 community members representing patient advocacy organisations, cancer survivors, clinicians, caregivers, public health professionals, medical interpreters, housing, agriculture, sanitation, healthcare payer organisations and local policymaking sectors were recruited.

The GMB protocol consisted of two in-person and four virtual workshops from 22 August to 11 November 2024. The SD simulation model was built with iSee System’s Stella Architect SD modelling software (V.4.0).

The 181 variables suggested by the GMB workshop participants were categorised into 3 themes and 13 subthemes, which shaped the system boundary and model structure. 7 of the 16 intervention scenarios tested showed a cumulative reduction in the at-risk population and increases in screening, diagnoses, treatment and cancer-free survival. Participants selected a multilevel strategy focused on expanding public health and insurance education and advocating for air pollution-related screening within existing protocols.

Community engagement is essential for understanding lung cancer disparities and designing practical multilevel interventions. Scenario testing enables informed planning to improve long-term population health outcomes.

Dental implants are a widely accepted solution for tooth replacement, but standardised outcome assessment, particularly patient-reported outcomes, remains limited. Moreover, international variability in implantology practices underscores the need for consistent and comprehensive evaluation tools. This study aims to develop and validate the DEntal implaNt Set (DENS), a standardised tool to capture clinician and patient perspectives on peri-implant health and restorative treatment outcomes.

This prospective multicentre cohort study aims to include 1000 patients aged 18–75 years from 30 dental practices in the Netherlands and Spain. The DENS was developed by an international multidisciplinary team through structured iterative working sessions, grounded in the mandatory outcome domains of the Implant Dentistry Core Outcome Set and Measurement (ID-COSM) framework and informed by expert consultation with the ID-COSM authors. Patient-reported outcome measure (PROM) items were adapted from validated instruments and subjected to forward-backward translation into Dutch, English and Spanish. Data are collected at six time points from pre-implant placement to 12-month follow-up. Clinical outcomes and PROMs are assessed via the digital. Descriptive analyses and psychometric testing of the DENS instrument are planned at the end of the data collection phase.

Ethical approval was granted by committees in the Netherlands (Erasmus University Medical Center: MEC-2023-0688; Anna Hospital Eindhoven: 2024.076; Anna Hospital Geldrop: MEC-24.008; St. Antonius Hospital: R&D/Z24.070/DENS; University Medical Center Groningen: METc 2024/389) and Spain (CEI-SL 2024/122). Participants provide informed consent, and no procedures exceed standard clinical care. All data are pseudo-anonymised. Findings will be shared through publications, conferences and professional networks. The DENS tool will be made available for clinical practice and research purposes to promote standardised, evidence-based practice in implant dentistry.

NCT07337057.

Life expectancy for people with type 1 diabetes has increased due to improved treatment of diabetes and its comorbidities, allowing many to reach old age. Still, we lack knowledge of how individuals with type 1 diabetes age. On one hand, those who reach older age can be considered survivors, but on the other hand their long-standing diabetes might still exhibit negative impacts on their health and functional ability. Healthy ageing is the WHO’s priority for this decade. The focus has shifted from chronological age to functional ability, which reflects the ability of individuals to perform meaningful activities. Functional ability is shaped by intrinsic capacity, the environment and their interaction. Intrinsic capacity encompasses five main domains: cognition, vitality, sensory function, locomotion and psychological domain. This observational study aims to assess how this vulnerable group of individuals with type 1 diabetes age and to identify factors that contribute to their healthy ageing, intrinsic capacity and its domains.

The FinnDiane LifeOne Study is a prospective observational cohort study. We aim to recruit a minimum of 300 individuals with type 1 diabetes from the FinnDiane Study, aged >65 and a minimum of 100 matched controls without insulin-dependent diabetes. The cohort will be comprehensively characterised, including clinical assessment, laboratory tests, questionnaires and a geriatric assessment of different aspects of functioning ability, with 5 years intervals. We will compare the individuals with type 1 diabetes to their matched controls. For those with type 1 diabetes, we will further assess which factors from the FinnDiane baseline and trajectories during follow-up predict healthy ageing in above 65-year-olds.

The LifeOne Study protocol is approved by the Ethics Committee of HUS Helsinki University Hospital (HUS/4387/2023) and the study adheres to the Declaration of Helsinki. Written informed consent is obtained from each participant. Findings will be published in international peer-reviewed journals with an open access choice.

NCT07289204.

Studies have shown promising results using bone graft as a carrier for local administration of antibiotics to reduce the risk of prosthetic joint infection (PJI). The objective of this clinical trial is to determine if tobramycin and vancomycin-impregnated bone graft is safe and effective in reducing the rate of PJI after total hip arthroplasty (THA).

This study is an international, randomised, double-blinded, placebo-controlled clinical drug trial. Patients scheduled for THA (n=1100) requiring bone grafting (excluding revisions due to an ongoing infection) are randomised in a 1:1 ratio to prophylactic treatment with tobramycin and vancomycin or placebo-impregnated bone graft.

The primary outcome is the time to reoperation due to infection or diagnosis of PJI, expressed as a relative risk difference between the two groups. A risk reduction of at least 50% is considered clinically relevant. Secondary outcomes are time to and reason for reoperation and implant revision, type of micro-organism and antibiotic susceptibility pattern within 2 and 5 years after surgery. Safety outcomes are the number of adverse events and revision rate due to aseptic loosening. The primary analysis will be performed using proportional hazard models.

The study has been approved under the Clinical Trial Regulation No 536/2014 (EU CT; 2024-510921-25-00). Results will be published in open-access peer-reviewed journals and disseminated to patient organisations and the media, and de-identified individual participant data will be curated and shared on reasonable request in accordance with the Findability, Accessibility, Interoperability and Reuse principles, subject to the laws and regulations governing data protection in each participating country.

NCT05169229.

Whiplash-associated disorders (WADs) are the most common and costly consequence of road traffic injury (RTI). Providing early and effective treatment is a healthcare priority; however, current guideline-based care which focuses on education and physiotherapy-led exercise does not routinely address the psychosocial effects of trauma, and access to early integrated treatment is limited. This study aims to evaluate the feasibility of delivering and evaluating recovery, information, support and empowerment (RISE), a co-designed short message service-based intervention integrating psychosocial and exercise/activity support for individuals with acute whiplash injury who are at risk of poor recovery in a randomised feasibility trial. Secondary aims are to explore preliminary changes in candidate clinical outcomes and opportunities for intervention personalisation and future implementation.

This mixed-methods randomised controlled feasibility trial with a nested process evaluation will recruit 50 participants (>18 years) with WAD grade II/III who are identified at medium to high risk of poor recovery and within 12 weeks of RTI from Queensland emergency departments and the community. Participants will be randomised in a 1:1 ratio to receive either the RISE intervention (tailored, daily messaging+optional brief clinician support session/s) or an active control (general health-related text messages plus access to an online resource, My Whiplash Navigator). Feasibility outcomes, including recruitment and retention rates, data collection (including wearable-derived and economic data) and intervention uptake will be descriptively summarised and evaluated against pre-defined traffic light progression criteria. Acceptability will be examined using validated questionnaires and purpose-built items, qualitative interviews with intervention participants and focus groups with patients, clinicians and funders. Secondary aims will be addressed through preliminary estimates of between-group differences in patient-reported outcomes with 95% CIs and exploratory analysis of multimodal data (eg, wearable-derived physiological data, intervention engagement metrics) using a large language model where possible to inform future personalisation and implementation planning.

This trial is approved by the Townsville Hospital Human Research Ethics Committee (HREC/QTHS/121395) and ratified by the Human Research Ethics Committee at The University of Queensland, which is the study sponsor (2025/HE002491). Results will be published in peer-reviewed journals and presented at conferences and professional meetings.

ACTRN12626000506392; date registered: 23 April 2026; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=390706&isReview=true

The COVID-19 pandemic had profound effects on mental health worldwide. Within Canada, the province of Québec experienced high increases in mental health distress and implemented particularly strict public health measures. These unique characteristics motivate the examination of the local experience of the COVID-19 pandemic. This study aimed to examine changes in incidence rates of diagnosed anxiety and depressive disorders in Québec, Canada before and after the COVID-19 pandemic.

Analyses drew on administrative health records from the Québec Integrated Chronic Disease Surveillance System from January 2010 to March 2022 (147 months).

The setting for analyses was the province of Québec, Canada.

The analytical sample covered January 2010 to March 2022 (147 months) for all individuals aged 15 years and older (men and women) eligible for the Québec public health insurance plan.

Interrupted time series methods were used to estimate counterfactual trends of monthly incidence rates of diagnosed anxiety and depressive disorders under conditions with and without the impact of the COVID-19 pandemic. Analyses adjusted for local public health policies, including the enactment of the Cannabis Act (2018) and major provincial health system reforms (2015). As we drew on count data, we used generalised linear modelling techniques with Poisson distribution to estimate predicted and counterfactual incidence rates of diagnosed anxiety and depressive disorders over time. We report regression results as the incidence rate ratio (IRR) with 95% CIs.

Following the onset of the COVID-19 pandemic, monthly incidence rates of diagnosed anxiety disorders were 4.9% higher (IRR: 1.049, 95% CI 0.955 to 1.153), but there was insufficient evidence of a statistically significant change; there was a statistically significant increase in the slope by 1% (IRR: 1.010, 95% CI 1.00 to 1.018). For diagnosed depressive disorders, monthly incidence rates were rather 3.6% lower (IRR: 0.965; 95% CI 0.904 to 1.030), although not statistically significant; there was a statistically significant increase in the slope by 1.4% (IRR: 1.014; 95% CI 1.008 to 1.020). Results from the counterfactual trends suggest that incidence rates of diagnosed anxiety disorders would have been lower (observed rates are higher), while incidence rates of depressive disorders would have been higher (observed rates are lower) had the COVID-19 pandemic not occurred.

Findings encourage further consideration of the indirect consequences of public health crises and related responses on population mental health. They also highlight the need to examine dynamics in local jurisdictions and support reflection on policy investments in mental health protection and promotion.

Distressing sensory experiences (DSEs) are commonly reported by children and young people accessing Child and Adolescent Mental Health Services (CAMHS) in the UK. Despite their prevalence, evidence-based tailored interventions for this population are scarce. The ChUSE trial aims to address this gap by evaluating the feasibility and acceptability of a novel brief talking therapy for children aged 8–16 years and an accompanying parent coaching programme.

A single-blind, two-arm randomised controlled feasibility trial will be conducted across three National Health Service trusts in Greater Manchester, UK. Sixty young people under the care of CAMHS experiencing DSEs and their parents/caregivers will be randomised 1:1 to receive either treatment as usual (TAU) or TAU plus the ChUSE intervention. The intervention involves four child therapy sessions and three optional parent sessions. Primary feasibility outcomes include recruitment and retention rates, treatment adherence and intervention safety. Secondary objectives assess the feasibility of data collection procedures and gather qualitative insights into trial acceptability and the influence of the intervention on young people’s well-being.

The ChUSE Trial has received ethical approval through the Health Research Authority following review by the West Midlands – South Birmingham Research Ethics Committee specialising in paediatric research (ID 327343). The feasibility trial addresses a significant clinical gap in CAMHS provision and will also capture information as to current TAU practices, contributing novel data to guide future service provision as TAU is currently understood to be heterogeneous. The information gathered through this trial will inform the design of a definitive trial evaluating the clinical effectiveness and cost-consequences of an early, age-appropriate intervention for DSEs. Findings and translational outputs will be shared through scientific and public forums to reach a variety of audiences.

ISRCTN12245618.