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.

Cancer screening appointments are an opportunity to encourage positive behavioural changes. Up to 80% of cancer screening attendees are open to discussing physical activity during cancer screening, but some say this would deter them from future screening. This study aimed to gain an in-depth understanding of individuals’ receptivity to physical activity advice at cancer screening.

Interview-based qualitative study.

The study was conducted from May 2017 to September 2018 in the UK. Participants were recruited using adverts on two university campuses, Facebook and a participant recruitment agency. To be eligible, participants had to have an upcoming cancer screening appointment within 2 weeks. There were 30 participants.

Participants recorded their receptivity to physical activity advice in the days before and after screening. Data-prompted semi-structured interviews explored these responses. Interviews were analysed using a thematic framework analysis.

Participants felt discussing physical activity at cancer screening would be relevant. However, participants experienced anxiety related to the screening process which could increase or decrease their receptivity. Participants felt if information was delivered in a judgemental way, it could negatively impact future screening participation.

Screening attendees’ receptivity could be influenced by the timing of a discussion and by their levels of anxiety throughout screening. Participants’ anxiety during screening can either reduce their ability to engage in a discussion or increase the relevance of the discussion. The communication style of the healthcare practitioner was key for why some screening attendees could be deterred from future cancer screening.

Type 2 diabetes (T2D) is a complex disease with a heterogeneous clinical presentation. Recently, five distinct clusters of T2D have been identified in the Emirati population of long-standing T2D with complications. This study aimed to validate these clusters in newly diagnosed T2D patients without any complications and determine whether severe and mild phenotypes are detectable early in the disease course.

Retrospective, cross-sectional, non-interventional study.

Primary healthcare centres in Dubai, UAE.

A total of 451 adults, including both Emiratis and expatriates, diagnosed with T2D in the last 5 years and without T2D-related complications at the time of visit, were enrolled. Patients with complications, incomplete clinical data or higher duration of T2D were excluded from the study.

Identification of distinct T2D clusters using machine learning-based clustering analysis. Five clinical variables: age at diagnosis, body mass index, glycated haemoglobin, fasting serum insulin and fasting blood glucose served as predictors. Overlap between clusters was assessed via the Silhouette Index and Bayesian probability.

Five clusters were identified, replicating prior findings: severe insulin-resistant diabetes (SIRD), severe insulin-deficient diabetes (SIDD), mild age-related diabetes (MARD), mild obesity-related diabetes (MOD) and mild early-onset diabetes (MEOD). As confirmed by a Silhouette Index and Bayesian probability of 1, 55.43% of the patients showed cluster-exclusiveness, while 44.56% of the cohort showed overlap between clusters. The highest overlap was recorded for mild forms of T2D in the order MOD>MARD>MEOD.

The study confirms that both severe and mild T2D phenotypes are present in newly diagnosed, complication-free patients, supporting the applicability of cluster-based classification early in disease. These results highlight the potential for personalised treatment strategies to optimise management and prevent complications. Future studies should investigate longitudinal outcomes and therapeutic response across clusters.

Patients who survive admission to intensive care unit (ICU) for critical illness are at high risk of developing muscle atrophy and weakness, commonly diagnosed as ICU-acquired weakness (ICUAW). The development of ICUAW is closely linked to long-term symptoms and impairments known as post-intensive care syndrome (PICS). Despite heightened recognition of impairments, there is limited research supporting effective interventions to improve muscle and physical outcomes after hospital discharge. Prior to developing and testing interventions for ICU survivors, it is imperative to understand the trajectory of muscle and physical function recovery following an ICU stay. The purpose of this study is to longitudinally investigate skeletal muscle health and physical function outcomes after ICU admission.

This protocol describes a single site, prospective, observational study in adult patients who have survived a critical illness (ie, sepsis or acute respiratory failure). Patients will participate in a battery of testing including primary outcomes: muscle power and physical function; and secondary outcomes: muscle strength, muscle size, endurance and physical activity (by accelerometry) at hospital discharge and 3, 6, and 12 months post-discharge. A subset of patients will participate in muscle biopsy and venipuncture. To examine if the trajectory of recovery predicts primary outcomes, we will perform multivariate linear regression models in 150 evaluable patients. To examine differences in molecular and cellular outcomes in plasma and muscle tissue, a control group of community-dwelling adults without history of an ICU stay will be enrolled as a comparator group. Enrolment started on 18 October 2022 with an estimated completion date of 1 August 2027.

This protocol was approved by the University of Kentucky Office of Research Integrity Medical Internal Review Board (# 77407), with patients providing informed written consent. We anticipate our findings to establish recovery trajectories, improving the classification of patients who experience sustained physical disability. Improved identification of recovery trajectories of muscle and physical function enables future studies to employ an individually targeted rehabilitation approach, that is, precision medicine, with the goal of improving patient outcomes. The cellular findings will support the development of novel interventions specifically designed for detecting underlying mechanisms. We intend to disseminate findings to patients, healthcare professionals, the public and other relevant groups via conference presentations and manuscripts without publication restrictions.

NCT05537298.

There is a pressing need for effective interventions that can support healthcare workers and caregivers in the challenging yet crucial task of disclosing the HIV status to infected children and adolescents. Previously, we developed and tested a successful disclosure intervention called Sankofa in Ghana. In an ongoing 5-year follow-up study, Sankofa 2, we aim to build on the successful Sankofa trial by testing the intervention on a larger scale.

This study is a pragmatic, stepped-wedge cluster randomised trial.

It is being conducted in 12 HIV paediatric clinics in Ghana to examine the effectiveness, health benefits, cost and implementation of the Sankofa intervention. Caregiver–child dyads (n=700) will be enrolled. Evaluation of effectiveness, health benefits, cost and implementation of the Paediatric HIV disclosure intervention, Sankofa 2, is posed to offer valuable insights for scale-up and sustainability.

Ethical clearance has been obtained from the Ghana Health Service Ethics Review Committee, the University of Ghana Ethical and Protocol Review Committee, the Committee on Human Research Publication and Ethics of the Kwame Nkrumah University of Science and Technology, the Johns Hopkins Medicine Institutional Review Board and the Yale School of Medicine Human Investigation Committee. The clinical trial was registered on ClinicalTrials.gov on 5 March 2021. All caregiver participants are required to provide written informed consent and the children assent before enrolment. If either the child or caregiver says no to the study, the dyad is not eligible for the study. No study-related procedures are performed until consent is obtained. The results of the trial will be added on ClinicalTrials.gov, published in peer-reviewed journals and presented at international conferences.

NCT04791865.

We compared associations between self-reported and HearCheck screening device measures of hearing difficulty with subsequent general and domain-specific cognitive function in a population-based sample of older English adults.

Observational cohort study.

Population-based sample of older adults in wave 7 of the English Longitudinal Study of Ageing (ELSA) in 2014/15 and its Healthy Cognitive Ageing Project (HCAP) in 2018.

N=1119 adults aged ≥62 years.

Factor scores for general cognitive function and domains of memory, language, orientation and executive function were derived from the HCAP neuropsychological test battery (mean of 0 and SD of 1 for each). Hearing difficulty was assessed using a self-reported 5-point Likert-type scale and the HearCheck screening device, which administered a series of six tones in each ear.

According to the HearCheck device, 48% of participants had a mild or moderate-to-severe hearing difficulty, while 25% self-reported fair or poor hearing. In multivariable-adjusted, population-weighted linear regression models, hearing difficulty identified via HearCheck was associated with worse general cognitive function (β=–0.34 SD units; 95% CI –0.60 to –0.07 for moderate-to-severe hearing difficulty vs good hearing) as well as worse function in domains of memory, language and executive function, each with a dose-response relationship. Self-reported hearing difficulty was not associated with general or domain-specific cognitive function.

Peripheral hearing ability, as captured by the HearCheck screening device, may have stronger relevance for later-life cognitive outcomes than the broader construct of perceived hearing difficulty in one’s daily environment that is captured by a self-reported measure.

Hearing loss is highly prevalent and impacts many aspects of a person’s life, including communication, social engagement, employment, general health and well-being. Yet, many people do not access hearing healthcare and are unaware of the range of hearing healthcare options available. Barriers to hearing healthcare include poor understanding of hearing loss and its impact; poor knowledge of help-seeking for hearing healthcare options; minimal support to help decide which option is best; and stigma related to hearing loss. These barriers lead to many people not receiving the hearing healthcare they need. Guided by theories of behaviour change and implementation science, HearChoice, an online tailored decision support intervention, has been co-developed to empower adults with hearing difficulties by offering them choice and control over their own hearing healthcare. HearChoice aims to facilitate informed decisions, accessibility and uptake of hearing healthcare, including a wide range of interventions, for adults with hearing difficulties. The objectives of the trial are to evaluate the effectiveness, health economics and feasibility of HearChoice.

This online randomised controlled trial will recruit participants with hearing difficulties across Australia, with an anticipated sample size of 640. Participants will be randomised to either HearChoice (treatment) or an Australia-specific Hearing Option Grid (active control), both delivered online. Outcomes will be assessed at baseline when the interventions will be offered, at 7 days post-intervention (primary endpoint) and at 3 months post-intervention. An email reminder will be sent at 1-month post-intervention. The primary outcome is decisional conflict. Secondary outcomes include measures of readiness and self-efficacy to take action, hearing-related quality of life and empowerment, assessment of the value and impact of HearChoice, work performance and health, and feasibility measures. Primary analysis will compare outcomes between HearChoice and the active control at the primary endpoint.

The study was approved by the Curtin University Human Ethics Committee (HRE2023-0024). All participants will provide written informed consent prior to participation. A broad dissemination plan of the study findings includes peer-reviewed publications, scientific conference presentations, articles and presentations for the wider community and public written in lay and accessible language, and social media.

Australian New Zealand Clinical Trials Registry (ACTRN12624001139561).

Overweight and obesity impacts approximately 50% of pregnant women. Professional medical colleges worldwide recommend women with a higher body mass index (BMI) lose weight before conception. While diet and lifestyle interventions before pregnancy are associated with improvements in diet and modest weight loss, subsequent clinical pregnancy outcomes are poorly reported.

Our aim is to conduct a randomised controlled trial of a comprehensive lifestyle intervention for women with overweight or obesity who are planning pregnancy. We will evaluate the impact of this intervention on maternal health and well-being prior to conception; and pregnancy, birth and newborn health outcomes in a subsequent pregnancy.

Women with a BMI ≥25.0 kg/m² who plan to conceive within 2 years will be recruited.

Women randomised to the ‘Educational Control Group’ will attend a pre-conception health consultation with a research midwife, providing limited information about obesity and associated risks in pregnancy, nutrition, exercise and weight management.

Women randomised to the ‘Pre-pregnancy Lifestyle Intervention Group’ will attend a pre-conception health consultation with a research midwife, as above, and additionally consult with a research dietitian and trained health coaches throughout the 6-month intervention period. Women will also have access to a specifically designed mHealth application providing tailored content and interactive tasks delivered bi-weekly during this time.

Secondary outcomes will include a range of maternal pre-conception health outcomes; maternal and infant pregnancy and birth outcomes; diet and physical activity changes; and quality of life.

We estimate a mean birth weight z-score of 0.43 (SD 1.09) and will recruit 800 women to detect 0.4 SD difference (alpha 0.05 (two-tailed); power 80%). Analyses will be intention to treat with estimates reported as relative risks and 95% CIs.

The study protocol was approved by the Human Research and Ethics Committee of the Women’s and Children’s Hospital, Adelaide, South Australia (HREC/17/WCHN/177; 2020/HRE01445) on 17 August 2018. The first participant was recruited in June 2021, with recruitment anticipated through 2025. The study results will be disseminated in open-access international journals, scientific meetings and conferences with stakeholders.

ACTRN 12621000128897. This study has been registered at (https://www.anzctr.org.au/).

Leishmaniasis poses a significant public health problem in Kenya, where effective case management and treatment rely on accurate diagnosis. This review aims to summarise the research landscape on leishmaniasis diagnostics in Kenya and identify gaps.

This scoping review expands a previously published scoping review on leishmaniasis in Kenya to further analyse studies focusing on diagnostics. The field of diagnostics was chosen because of recent pushes for novel tools and because of the role timely diagnosis plays in disease elimination. A comprehensive search of PubMed, Embase via Embase.com, Web of Science Core Collection, the Cochrane Library, ClinicalTrials.gov, WHO ICTRP and the Pan African Clinical Trials Registry was conducted, covering studies up to 5 January 2024.

After dual, blind screening with conflict resolution by a third reviewer, 41 studies were included in the review. These studies examined a range of diagnostic tools; however most were assessed in one or few studies, and none evaluated real-time PCR. Additional gaps in the research landscape include a lack of diagnostics for cutaneous leishmaniasis and post-kala-azar dermal leishmaniasis in Kenya, outdated literature surrounding the Direct Agglutination Test and randomised trials for any diagnostic tool.

Future research should focus on solidifying the validity and reliability of diagnostic tools in the Kenyan context and updating previous work.

Vector control is imperative for eliminating leishmaniasis as a public health problem in Kenya. As elimination efforts expand in East Africa, it is crucial to understand the current research landscape. To address that need and identify gaps, a scoping review was conducted to characterise the landscape of leishmaniasis vector research in Kenya.

Building on a previously published scoping review by this team, we updated database searches in PubMed, Embase via Embase.com, Web of Science Core Collection, the Cochrane Library, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform (ICTRP) and the Pan African Clinical Trials Registry to incorporate literature up to 4 January 2024 and focused on vector-related papers. Studies classified as ‘prevention’ in the original scoping review were included due to overlapping definitions.

A total of 95 studies were included in the analysis. Although a wide range of sandfly species have been documented, most of the research is outdated, having taken place 20–40 years ago. Existing studies are mostly epidemiological with little focus on basic and clinical research. There are also no studies on post-kala-azar dermal leishmaniasis despite its potential contribution to the disease transmission cycle. The geographical scope of the research is largely limited to traditional transmission foci with little attention to new disease hotspots such as North Eastern Kenya.

These research gaps need to be addressed to better inform the country’s leishmaniasis prevention and vector control strategy.

Stroke is a leading cause of disability and mortality worldwide, with upper limb dysfunction being among its most common effects. Compression therapy has recently gained growing interest as an adjunct to other rehabilitation interventions for managing upper limb dysfunction among stroke survivors. However, the evidence for its effectiveness remains inconsistent and equivocal. Therefore, this systematic review aims to assess the effectiveness of compression therapy in managing upper limb dysfunction in patients with stroke.

A systematic search of databases (PubMed, Scopus, Web of Science, CINAHL, Cochrane Library, Embase, PEDro, OTseeker, ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform) will be conducted to identify peer-reviewed studies and relevant grey literature on compression therapy on upper limb dysfunction after stroke. Two reviewers will independently screen, select and extract data, with discrepancies resolved through discussion or involvement of a third reviewer. Outcomes of interest include clinical measures of upper limb function, activity, participation and safety (ie, adverse effects). Risk of bias will be assessed using the Cochrane RoB 2 for randomised studies, the Risk Of Bias In Non-randomised Studies of Interventions for non-randomised studies. The certainty of evidence across types of compression therapy and outcomes will be evaluated using the Grading of Recommendations, Assessment, Development and Evaluation approach. Data will be narratively synthesised, and a meta-analysis will be performed if feasible. The review will be reported following the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines and will be conducted from September 2025 to December 2025.

This systematic review does not require ethical approval as only secondary data will be used. This review will synthesise the body of evidence on the effectiveness of compression therapy in managing poststroke upper limb dysfunction. Results will then be disseminated through a peer-reviewed publication to inform research and clinical practice.

CRD42024625815.

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.

There are substantial barriers to initiate advance care planning (ACP) for persons with chronic-progressive disease in primary care settings. Some challenges may be disease-specific, such as communicating in case of cognitive impairment. This study assessed and compared the initiation of ACP in primary care with persons with dementia, Parkinson’s disease, cancer, organ failure and stroke.

Longitudinal study linking data from a database of Dutch general practices’ electronic health records with national administrative databases managed by Statistics Netherlands.

Data from general practice records of 199 034 community-dwelling persons with chronic-progressive disease diagnosed between 2008 and 2016.

Incidence rate ratio (IRR) of recorded ACP planning conversations per 1000 person-years in persons with a diagnosis of dementia, Parkinson’s disease, organ failure, cancer or stroke, compared with persons without the particular diagnosis. Poisson regression and competing risk analysis were performed, adjusted for age, gender, migration background, living situation, frailty index and income, also for disease subsamples.

In adjusted analyses, the rate of first ACP conversation for persons with organ failure was the lowest (IRR 0.70 (95% CI 0.68 to 0.73)). Persons with cancer had the highest rate (IRR 1.75 (95% CI 1.68 to 1.83)). Within the subsample of persons with organ failure, the subsample of persons with dementia and the subsample of stroke, a comorbid diagnosis of cancer increased the probability of ACP. Further, for those with organ failure or cancer, comorbid dementia decreased the probability of ACP.

Considering the complexity of initiating ACP for persons with organ failure or dementia, general practitioners should prioritise offering it to them and their family caregivers. Policy initiatives should stimulate the implementation of ACP for people with chronic-progressive disease.