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.

To contribute to the development of a people-centred global framework for collaborative action on tuberculosis (TB) and comorbidities, a rapid qualitative study on the perspectives of people with lived experience of TB and its associated comorbidities was undertaken.

From August to October 2021, TB survivors from high-burden countries, who encountered at least one comorbidity during TB treatment, were interviewed to explore their healthcare experiences and priorities. Thematic analysis drew on a healthcare acceptability model.

Participants (n=24, 13 women) were treated for drug-susceptible (n=13) or drug-resistant (n=11) TB between 2015 and 2021. They faced diverse comorbidities (mental health and substance use disorders, diabetes, Hepatitis C, lupus and HIV); half of whom reported more than one comorbidity, and all faced socioeconomic hardships. TB diagnosis and treatment exacerbated participants’ comorbidities and, in the absence of integrated support, precipitated mental health challenges. Four healthcare priorities for addressing TB-associated comorbidities were identified: (1) disclosure and early identification of comorbidities, (2) timely and affordable access to care for comorbidities, (3) tailored counselling and peer support and (4) coordinated and consolidated care for TB and comorbidities.

The syndemic manifestation of comorbidities in people affected by TB calls for a people-centred approach to care that facilitates building of trust with multiple care providers, timely linkages to non-TB programmes, access to integrated diagnosis and treatment, allaying intersecting stigmas and self-shame, and care coordination approaches that correspond to people’s needs and preferences. These healthcare priorities were included in the WHO’s Framework for collaborative action on TB and comorbidities.

Routine childhood immunisation is vital to preventing life-threatening illness; however, global coverage of routine childhood immunisations has fallen in recent years, leaving over 14 million children globally without protection. This study aimed to identify shared and context-specific drivers of routine childhood immunisation dropout in select sites in Mozambique and Malawi through a secondary analysis of qualitative data.

We conducted a secondary inductive thematic analysis on qualitative data from a community-based participatory research study. Co-creation workshops, guided by a human-centred design approach, were held to develop context-specific solutions in each study site. Data for this analysis were collected between February 2020 and March 2021 in Mozambique and between July 2022 and February 2023 in Malawi.

Zambezia, Mozambique and Lilongwe and Mzimba North Districts, Malawi.

Participants included caregivers of partially (n=60) and fully vaccinated (n=22) children aged 25–34 months, healthcare workers (n=12), community healthcare workers (n=30), Expanded Programme on Immunisation staff (n=11) and community representatives (n=14). Caregivers were identified through vaccination registers and with support from health workers, community leaders and health volunteers.

We identified four key contextual and health system differences between Malawi and Mozambique affecting dropout: the composition of the immunisation workforce, the state of the vaccine ecosystem, vaccination card policies and vaccination outreach models. Common challenges across both countries included gender roles that burdened mothers, limited vaccine information, negative health worker interactions, pandemic-related disruptions and stockouts. Common solutions generated through co-creation workshops included improving health worker–caregiver communication, vaccine education and immunisation outreach resources. Solutions in Mozambique emphasised strengthening the community health worker (CHW) role in immunisation, while in Malawi, whose CHW workforce already administers vaccines, solution ideas focused on improving CHW data management.

Our analysis highlights the opportunity for scalable solutions to identified common immunisation barriers, including tailored vaccine education that addresses caregiver knowledge gaps, improved caregiver–health worker communication, improved outreach models and addressing gender dynamics and vaccine stockouts.

Overuse of CT scans is associated with multiple harms, such as an increased risk of cancer development, particularly in children. However, the rate of CT scan use is high and unwarranted worldwide.

This study aimed to identify the patterns and reported indications for head CT scans ordered for non-traumatic paediatric cases in Palestine.

This was a retrospective, cross-sectional study based on a desk review.

The study was carried out from June 2024 to September 2024 in five hospitals located in five major Palestinian governorates in the West Bank.

The study included records of children aged 14 or younger, presenting with non-traumatic complaints and having undergone head CT between January 2020 and September 2024. A total of 3715 patient records were explored, of which 2977 were included in the final analysis; 1764 (59.3%) males and 1213 (40.7%) females.

A pilot review of 100 records was conducted, and the data collection spreadsheet included demographic and clinical characteristics, presentations, reported reasons for CT requests, CT results, and information on lumbar puncture (LP) performance.

The mean age of patients was 4.3 years (SD±3.3), with 59.3% aged 3 to 11 years, and 47.7% presenting to hospitals in northern governorates. The most commonly reported presentation was fever and convulsion (8.2%), followed by convulsions (7.7%), and a combination of fever, headache and vomiting (6.5%). Only 12.9% of the CT scans yielded positive findings, including dilated ventricles (19.3%), sinusitis (18.8%), brain oedema (12.9%), and brain mass (11.1%). Most CT scans were requested to check for contraindications to LP, with only 4.1% having a positive CT finding indicating a contraindication. At the multivariate level, a positive CT result was associated with being a neonate, having a past medical condition, ordering CT to check for contraindication to LP and presenting with convulsions.

CT scans were found to be overused without justification, particularly for ruling out contraindications to LP. The development of clear and specific national guidelines is recommended. This process can be supported through training, decision support tools, alternative management pathways and specialist consultations to ensure compliance. Additionally, enhancing reporting quality and using health information systems are vital for monitoring and improving radiological safety.

Over 777 million COVID-19 infections have occurred globally, with data suggesting that 10%–20% of those infected develop Long COVID. Fatigue is one of the most common and disabling symptoms of Long COVID. We aim to assess the feasibility and safety of a new, remotely delivered, multimodal rehabilitation intervention, paced to prevent post-exertional malaise (PEM), to support the conduct of a future, definitive randomised trial.

We will conduct a randomised, two-arm feasibility trial (COVIDEx intervention vs usual care). Sixty participants with Long COVID will be recruited and randomised prior to giving informed consent under a modified Zelen design using 1:1 allocation with random permuted blocks via central randomisation to receive either the COVIDEx intervention or usual care. The 50-minute, remotely delivered, COVIDEx intervention will occur twice weekly for 8 weeks. All participants will wear a non-invasive device throughout their entire study participation, to track heart rate, blood oxygen saturation, steps, sleep and monitor PEM. The primary feasibility objectives will be recruitment rates, intervention fidelity, adherence, acceptability (intervention and design), retention, blinding success and outcome completeness. Secondary objectives will include refined estimates for the standard deviation and correlation between baseline and follow-up measurements of fatigue. Feasibility and clinical outcomes will be collected at baseline, 4, 8, 12 and 24 weeks. Qualitative interviews with participants and physiotherapists will explore intervention acceptability and barriers/facilitators.

Ethical approval for this study was obtained by the Western University Health Sciences Research Ethics Board (REB# 123902). Dissemination plans include sharing of trial findings at conferences and through open access publications and patient/community channels.

NCT06156176

Taking multiple medicines can be appropriate but has the potential to be problematic. The Implementing Stimulating Innovation in the Management of Polypharmacy and Adherence THrough the Years (iSIMPATHY) project used the 7-Steps person-centred approach for medication reviews, supporting patients and clinicians to define and achieve realistic goals for drug treatment, and helping enable patients to lead healthy and active lives.

To assess the impact of pharmacist-led comprehensive person-centred medication reviews using the 7-Steps methodology.

iSIMPATHY sought to transform the approach to optimisation of medicinces through the delivery of person-centred medication reviews for people taking multiple medicines in primary care, hospital and outpatient clinics. The reviews were conducted by embedding a single approach for polypharmacy management, building on key recommendations from SIMPATHY.

Interventions made were graded, with 82% being classified as clinically significant and 4% potentially preventing major organ failure, adverse drug reactions or incidents of similar clinical importance. The average number of medications reduced from 12 to 11, with 92% of the reviews resulting in more appropriate medication use, thereby decreasing the likelihood of medication-related harm. Inappropriate medicines were stopped, reduced or altered to improve appropriateness. There were significant healthcare resource utilisation benefits as indicated by a positive return on investment for both medication and healthcare costs with a quality-adjusted life year gain of 7.4 per 100 patients.

Pharmacist-led, person-centred medication review using the 7-Steps approach was delivered across jurisdictions and healthcare settings, with positive impacts on the number and appropriateness of medicines, clinical interventions and cost savings outweighing expenditure on the service. The approach is scalable by means of the tools and resources developed over the duration of the project.

Cystic fibrosis-related diabetes (CFRD) is one of the most clinically impactful comorbidities associated with cystic fibrosis (CF). Current recommended management with insulin therapy is challenging due to variable daily insulin requirements and adds to the significant burden of self-management. This study aims to determine if hybrid closed-loop insulin delivery can improve glucose outcomes compared with standard insulin therapy with continuous glucose monitoring (CGM) in young people (≥16 years) and adults with CFRD.

This open-label, multicentre, randomised, two-arm, single-period parallel design study aims to randomise 114 young people (≥16 years) and adults with CFRD. Following a 2–3 weeks’ run-in period, during which time participants use a masked CGM, participants with time in target glucose range (3.9–10.0 mmol/L) 10.0 mmol/L), mean glucose and HbA1c. Other secondary efficacy outcomes include glucose and insulin metrics, change in forced expiratory volume in 1 s and body mass index. Safety, utility, participant experiences and participant-reported outcome measures will also be evaluated. The trial is funded by the National Institute for Health and Care Research.

Ethics approval has been obtained from East of England–Cambridge South Research Ethics Committee. Results will be disseminated by peer-reviewed publications and conference presentations, and findings will be shared with people living with CF, healthcare providers and relevant stakeholders.

NCT05562492.

The aim of this study is to explore the perceptions, attitudes and previous experiences of Sultan Qaboos University (SQU) students towards artificial intelligence (AI) mental health chatbots.

The study was conducted as an exploratory qualitative study, involving focus group discussions (FGDs).

The study was conducted at SQU. All FGDs were conducted via Google Meet.

A total of 60 students were recruited through convenience sampling. Both male and female students from different colleges were enrolled in the study. 10 FGDs were conducted.

The interview findings revealed that most students were open to using AI mental health chatbots, with many already having used similar applications. Participants listed several benefits that such applications could have, including increased availability, reduced stigma and behaviour tracking. The participants also raised some concerns about such applications, including data security, cultural sensitivity and various ethical issues.

The future of AI chatbots for mental health is promising, as they have the potential to enhance mental healthcare services. Now that we know the disadvantages and limitations that may be associated with the use of such apps, it would be easier to design suitable apps that can properly triage mental health issues and provide supportive mental health.

Intermittent physiological monitoring and early warning scores (EWS) are limited in their ability to detect deteriorating patients in a timely manner. Wearable physiological sensors allow continuous remote monitoring and may be more timely and accurate in the identification of those at risk, compared with manual collection. This study aims to determine if wearable physiological sensors can be used for the early detection of postoperative deterioration, while being acceptable to patients and healthcare staff.

This is a prospective observational cohort study that will recruit adults undergoing major surgery in Benin, India, Ghana, Guatemala, Mexico, Nigeria, Rwanda and the UK. Participants will wear wearable physiological chest and limb sensors before, during and after surgery for up to 10 days or until discharge. In this ‘shadow-mode’ study, continuous physiological observations collected using the devices will not be made available to clinical teams. No changes in participant care will result. Standard of care clinical data will be collected contemporaneously. Continuous sensor data will be used to design algorithms to predict deterioration and specific complications in this population. Usability and feasibility testing, through focus groups, interviews and questionnaires, will be undertaken with healthcare professionals and people undergoing surgery.

Our stakeholder panel are directly involved in all aspects of this study, which will be conducted in accordance with the principles of the International Conference on Harmonisation Tripartite Guideline for Good Clinical Practice (ICH GCP) in addition to the principles of the ethics committee(s)/Institutional Review Boards (IRBs) who have reviewed and approved this study. Artificial intelligence (AI) prediction models will be reported in accordance with the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis+Artificial Intelligence (TRIPOD+AI) and Developmental and Exploratory Clinical Investigations of DEcision support systems driven by Artificial Intelligence (DECIDE-AI) reporting guidelines frameworks.

NCT06565559.

A scoping review on the association between ID and frailty was published in 2016,1 which found that frailty may affect people with ID at a young age and is associated with negative outcomes. The authors of the paper discussed here sought to update the...

Cancer remains a major public health concern worldwide. Patient navigation, developed in the 1990s to address disparities in cancer outcomes, aims to guide patients through the complex healthcare system and improve access to timely, quality care. Despite its proven benefits, little is known about the implementation or impact of patient navigation programmes in African settings.

This scoping review aims to map the current evidence on components, procedures, outcomes and impact, as well as barriers and challenges to implementation of patient navigation programmes in cancer care across Africa.

This scoping review will follow Arksey and O’Malley’s scoping review framework, as further developed by Levac et al. A systematic search will be conducted across PubMed, African Journals Online and Google Scholar to identify relevant studies published from database inception to the date of the final search, using a combination of relevant keywords and MeSH terms. Eligible studies must be reported in English, have been carried out in Africa, involved patients diagnosed with cancer or navigating the cancer care continuum, and report on the description, implementation or evaluation of patient navigation programmes. Screening will be managed with Rayyan and carried out through a two-stage process: screening by titles and abstracts, then by full-text screening based on the prespecified inclusion and exclusion criteria. Data will be extracted into a structured Excel spreadsheet and synthesised using qualitative content analysis to identify programme characteristics, outcomes, barriers and implementation challenges.

This scoping review does not require ethical approval. Our findings will be published in a peer-reviewed, open-access journal on completion.

Sepsis and antibiotic resistance constitute a deadly synergy, causing the loss of millions of lives across the world, with their economic and developmental consequences posing a threat to global prosperity. Their impact is disproportionately felt in resource-limited settings and among vulnerable populations, especially children. A key challenge is prompt diagnosis and timely commencement of appropriate antibiotic therapies. These challenges are compounded in low-income and middle-income countries by a lack of comprehensive epidemiological data, with Nigeria being one such country for which it is lacking. Kaduna is the third largest state in Nigeria, with over 10 million inhabitants, of whom more than half are children under 14 years old. While bacterial sepsis and antimicrobial resistance (AMR) are recognised as a growing problem in the state, there are huge gaps in the current understanding of their aetiology. This project employs a cross-sectional design to investigate the clinical and haematological markers of paediatric sepsis, alongside determining the bacterial cause and prevalence of AMR at four high-turnover hospitals in Kaduna State, Nigeria. Further, whole-genome sequencing of isolated bacterial pathogens will be performed to determine the genetic features of resistance. This project represents the largest surveillance study of paediatric sepsis in Kaduna to date. Additionally, we aim to use the clinical, haematological, microbiological and genomic data to derive predictive models for sepsis causes, treatment strategies and patient outcomes.

This is a hospital-based, cross-sectional study that will recruit up to 461 children with bacterial sepsis who were admitted at the two teaching and two general hospitals in Kaduna State, Nigeria. Children presenting with features of fever, subnormal temperature and body weakness would be recruited into the study and have their blood samples collected. The blood samples will be used for culture, complete blood count, HIV and malaria testing. Accordingly, we will capture clinical presentation, haematological characteristics, causative pathogen from blood culture and patient outcomes. Nutritional status, known congenital immunosuppressive diseases, HIV infection and malaria infection will also be determined and documented. The bacterial isolates will be phenotypically characterised for AMR and genotypically following whole genome sequencing. Known and potential confounders to the outcomes of bacterial sepsis would be assessed in all participants, and adjustment for confounding would be performed using logistic regression and/or stratification±Mantel-Haenszel estimator where applicable.

Ethical approvals were granted by the University of Birmingham (ERN_2115-Jun2024), the Ahmadu Bello University Teaching Hospital (ABUTHZ/HREC/H45/2023), Barau Dikko Teaching Hospital, Kaduna (NHREC/30/11/21A) and the Kaduna State Ministry of Health (MOH/AD M/744/VOL.1/1110018). The study will be conducted using the international guidelines for good clinical practice and based on the principles of the Declaration of Helsinki. The results will be disseminated via oral and poster presentations in scientific conferences and published in peer-reviewed journal articles.

Telemedicine use has risen significantly since the COVID-19 pandemic. Evidence suggests that the quality of care in telemedicine could be as good as in-person care, but this is likely context-dependent. Expert guidelines have declared the appropriate medical conditions, but often without empirical evidence that grapples with the fundamental information limitations facing telemedicine. We draw on the task-technology fit theory and empirical evidence around human communication to examine how the medical and social contexts affect the efficiency and clinical quality of primary care.

We will use a population-based dataset from the Canadian province of British Columbia (BC) to inform a quasi-experimental study using propensity score matching (PSM). The treatment group will consist of telemedicine visits from April to December 2022. We will use PSM to create a control group of matched, in-person visits in the same period. We will then use cluster-robust linear regression to identify how specific medical conditions and social contexts are associated with higher rates of prescription, follow-up with primary care providers, emergency department visits and acute care admissions. We plan for the study to take place from 1 August 2025 to 1 August 2026.

The Research Ethics BC has granted approval for this study (H21-02244-A006). Our findings will be shared with patients, healthcare providers and policymakers and disseminated through conference presentations and peer-reviewed publications.