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 develop prediction models for short-term outcomes following a first acute myocardial infarction (AMI) event (index) or for past AMI events (prevalent) in a national primary care cohort.

Retrospective cohort study using logistic regression models to estimate 1-year and 5-year risks of all-cause mortality and composite cardiovascular outcomes.

Primary care practices in England contributing data to the Clinical Practice Research Datalink (CPRD) Aurum and CPRD GOLD databases between 2006 and 2019.

Patients with an incident (index) or prevalent AMI event. Models were trained on a random 80% sample of CPRD Aurum (n=1018 practices), internally validated on the remaining 20% (n=255) and externally validated using CPRD GOLD (n=248).

Discrimination assessed using sensitivity, specificity and area under the receiver operating characteristic curve (AUC). Calibration assessed using calibration plots.

In the index (prevalent) cohorts, 94 241 (64 789) patients were included in the training and internal validation sets, and 16 832 (7479) in the external validation set. For the index cohort, AUCs for 1-year [5-year] all-cause mortality were 0.802 (95% CI 0.793 to 0.812) [0.847 (0.841 to 0.853)] internally and 0.800 (0.790 to 0.810) [0.841 (0.835 to 0.847)] externally. For the primary composite outcome (stroke, heart failure and all-cause death), AUCs were 0.763 (0.756 to 0.771) [0.824 (0.818 to 0.830)] internally and 0.748 (0.739 to 0.756) [0.808 (0.801 to 0.815)] externally. Discrimination was higher in the prevalent cohort, particularly for 1-year mortality (AUC: 0.896, 95% CI 0.887 to 0.904). Models excluding treatment variables showed slightly lower but comparable performance. Calibration was acceptable across models.

These models can support clinicians in identifying patients at increased risk of short-term adverse outcomes following AMI, whether newly diagnosed or with a prior history. This can inform monitoring strategies and secondary prevention and guide patient counselling on modifiable risk factors.

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

Patient involvement in healthcare has become increasingly important, not only as an expression of respect for autonomy but also as a means of empowering individuals to safeguard their care. In blood transfusion, informed consent is a critical tool for shared decision-making. This protocol outlines a scoping review to map how transfusion consent processes and forms are used globally and to characterise their key features. We aim to identify technologies used to obtain consent, evaluate compliance with international recommendations, describe practices in special populations and examine patients’ and families’ understanding of the consent process.

Following the Joanna Briggs Institute methodology, we will search PubMed, Embase, LILACS, Web of Science and Scopus; grey literature will be explored via Google Scholar and the Open Access Theses and Dissertations platform. No language or date restrictions will be applied. Reference lists of included studies will also be screened. Two reviewers will independently screen studies and chart data; disagreements will be resolved by a third reviewer. Synthesis will be diagrammatic/tabular with structured narrative, reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses: extension for Scoping Reviews. Where data allow, findings will be stratified by clinical setting. A stakeholder consultation with two transfusion medicine experts and two patient representatives will be undertaken to validate and refine interpretations.

Only publicly available sources will be used; research ethics approval is not required. Findings will be submitted to a peer-reviewed journal and presented at scientific meetings.

10.17605/OSF.IO/NU69J.

Vitamin D deficiency during pregnancy is a global health concern, contributing to adverse maternal and fetal outcomes. Despite its importance, limited data exist on vitamin D status and its determinants among pregnant women in Ethiopia. This study aimed to assess the prevalence and determinants of vitamin D deficiency among pregnant women in their first and second trimesters in Gondar Town, Ethiopia, 2024.

A facility-based cross-sectional study was conducted at the antenatal care unit of University of Gondar Comprehensive Specialized Hospital from January to March 2024.

Eligible participants were selected using a simple random sampling technique. Sociodemographic, behavioural and clinical data were collected through structured questionnaires and medical record reviews. Serum levels of vitamin D, calcium and alkaline phosphatase were analysed using the Beckman Coulter clinical chemistry analyser. Statistical comparisons between pregnant women in the first and second trimesters were performed using the independent t-test. Determinants of vitamin D deficiency were identified using multivariate logistic regression analysis.

384 pregnant women in their first or second trimester.

The prevalence of vitamin D deficiency (90 mm Hg) (AOR 0.28, 95% CI 0.11 to 0.70), lower dietary diversity (AOR 3.17, 95% CI 1.13 to 8.89), lower fish and fish oil consumption habit (AOR 3.01, 95% CI 1.03 to 8.77; AOR 12.27, 95% CI 1.50 to 100.42) were the key predictors associated with serum vitamin D defiency.

Nearly half of the pregnant women in Gondar Town exhibit vitamin D deficiency, showing a challenging public health concern. Thus, targeted interventions, such as dietary supplementation and lifestyle modifications, are urgently needed to address the problem and improve maternal and neonatal health outcomes.

The number of people living with dementia is increasing worldwide. Alzheimer’s disease (AD) is the most common type of dementia. It typically manifests itself initially with cognitive impairment in the memory domain and gradually progresses towards affecting all activities of daily living. Active music interventions, particularly singing, may improve mood, social behaviour and quality of life. However, little is known about their effects on cognition, although some studies have provided promising results. The Memory for Music (M4M) project aims to fill this gap in research by measuring the effects of learning new songs on cognitive functioning. Specifically, M4M will examine memory for new songs in non-musician adults with AD after undergoing intensive versus minimal individual musical training based on singing novel songs.

Home-dwelling adults with AD, 65 years or older, will receive 5 months of intensive intervention (2x/week) and 5 months of minimal intervention (1x/month). In a crossover design, participants will be randomised to receive either the intensive or minimal intervention first, with 2 months between the intervention periods. Participants will receive individual music lessons to learn new songs, provided by a music instructor with adequate training. The main outcomes will be measured at the beginning and end of each intervention period. General cognition will be measured with the AD Assessment Scale – Cognitive by an assessor blinded to the randomisation. Participants’ memory for music will be measured using the N400 component of electroencephalographic (EEG) event-related potentials in response to music stimuli. Additional outcomes evaluated during intervention sessions include mood and musical performance observations. With 113 participants randomised, the trial will have 80% power to detect clinically meaningful effects. Relations between mood, memory for music and cognitive abilities will be examined, with sex, age, AD stage, previous musical training and education as covariates. M4M will be conducted in close collaboration between academic researchers, service providers and service users to ensure relevance and applicability.

Dissemination of findings will apply to local, national and international levels. The study has been approved by the Regional Committees for Medical and Health Research Ethics in Norway (reference number 759936) and by Mautalén Salud e Investigación, CECOM in Argentina (register code 14412).

Clinicaltrials.gov, NCT06611878.

To evaluate medication adherence, available social support and types of accessible support among patients with drug-sensitive tuberculosis (DS-TB). Coping mechanism(s) in TB management and associations between accessible support(s) and medication adherence were also explored.

Prospective questionnaire-guided cross-sectional study.

The WHO-certified TB directly observed therapy (DOT) clinic of two tertiary hospitals in Ibadan, southwest Nigeria.

Adult patients with DS-TB attending the TB-DOT clinic of the hospitals.

Primary outcomes were level of adherence to TB regimens, available social support and type(s) of accessible support. Secondary outcomes were coping mechanisms in TB management, as well as associations between accessible support(s) and medication adherence.

Overall, 152 (89.4%) had optimal adherence. Available social supports were ranked as family (168; 98.8%) >healthcare providers (166; 97.6%) >government (119; 70.0%) >non-governmental organisation (NGO) (118; 69.4%) >religious affiliations (81; 47.6%) >friends (65; 38.2%) >patient association (3; 1.8%). Emotional (168; 98.8%) and financial (137; 80.6%) supports were mostly accessible from family, while drug support (118; 69.4%) was largely received from NGO. Seeking emotional support from family or friends (159; 93.5%) was the most effective coping mechanism. Medication adherence was higher among patients who received health information (p=0.02) and drug support (p=0.03) from the NGO. There was no difference in medication adherence of patients with or without emotional (p=0.20) and financial support (p=0.53) from family, as well as from friends (p=0.31 and p>0.99, respectively).

Nearly ninety per cent of DS-TB patients had optimal adherence. Family was the most available source of social support for TB management, with one hundred and approximately eighty-two per cent respectively citing emotional and financial support as most accessible from the family. Emotional support from family or friends was the most effective coping mechanism in TB management. There is generally a need for initiation and implementation of an expanded social support system for DS-TB patients as a critical step towards achieving the WHO End-TB strategy milestone target.

To explore existing evidence for the provision of support for return to work (RTW) in long COVID (LC) patients and the barriers and facilitators to taking up this support.

A rapid review reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The study was preregistered in PROSPERO (ID: CRD42023478126).

Searches were completed in June 2024 across major databases including MEDLINE, Embase, PsycINFO, evidence-based medicine reviews, Web of Science and Google Scholar.

Included studies focused on people with LC (PwLC) symptoms lasting over 12 weeks and addressed either: (1) non-workplace- or workplace-based support for RTW and/or (2) barriers and facilitators to RTW in this population.

A quality assessment was conducted using the JBI Systematic Reviews critical appraisal tool. The data were summarised in tabular format and a narrative synthesis.

Twenty-five studies were included. While many studies demonstrated rigorous methodologies and low risk of bias levels, some had high and medium risk levels. Non-workplace-based support was mostly measured quantitatively and included interdisciplinary healthcare programmes, clinical interventions and rehabilitation programmes focusing on pacing and breathing strategies. Compensation and insurance schemes were important funders of these interventions.

Workplace-based support was mostly measured qualitatively. Barriers to the provision of support at organisational level included lack of understanding of LC symptoms, insufficient workplace guidance and educational gaps among managers. Individual barriers included threat of income loss, remote working and disconnection from the workplace. Facilitators for support included recognition and validation of LC and its symptoms, and eligibility for disability benefits associated with work.

RTW is an important outcome of health-related absence and should be systematically recorded in studies of PwLC. The heterogeneity and unpredictability of LC symptoms create challenges for supporting working age populations. Further research is crucial to better understand the specific RTW needs for PwLC and address potential barriers and facilitators to workplace-based support, particularly through interventions, organisational practices and employ-led policies that enable sustained RTW. Consistent guidelines on LC’s definition and disability status may facilitate the provision of support and the development of interventions.

CRD42023478126.

Self-harm and suicide are common among prison inmates, but less is known about these phenomena in those with psychosis.

The aim of this study was to examine self-harm behaviour in New South Wales (NSW) prisons in Australia among inmates diagnosed with psychosis. This study also examined self-harm-related alerts applied by Corrective Services to assist staff with the management of the security and well-being of inmates.

A retrospective case-control data-linkage study was conducted using administrative data collections in NSW, Australia.

The study included all individuals diagnosed with psychosis and incarcerated between 2001 and 2020 in NSW as cases and an age and sex matched control group with no such diagnosis with a record of incarceration in the same time period.

The primary outcome measure was self-harm among the cases and controls. The secondary outcome measure was the application of alerts by Corrective Services in relation to self-harm incidents.

Multivariate regression analysis was used to examine predictors of self-harm in prison. Prisoners with psychosis (n=14 900) were more likely to self-harm than controls (n=2713), with 15.0% versus 3.6% engaging in self-harm (highest odds of self-harm observed in those with schizophrenia and related psychoses, aOR=4.84, 95% CI: 3.93 to 5.98). Those of Aboriginal heritage had an increased risk of self-harm (aOR=1.58, 95% CI: 1.43 to 1.75). Factors associated with a lower risk of self-harm were male sex and older age (≥25 years) at the time of their first incarceration. 35.6% of those released from prison with a prior psychosis diagnosis had at least one alert applied during incarceration compared with 10.1% of prisoners without a diagnosis of psychosis. Overall, 35 individuals with psychosis and 1 individual from the control group died while in prison between 2001 and 2020. 17 prison suicides were recorded from the study population; all occurred in the psychosis group.

Given the heightened risk of self-harm in those with histories of psychosis, consideration should be given to sharing mental health information between agencies to improve the care and management of this group during incarceration. Prison alerts may be a useful tool to help staff manage inmates’ well-being if used appropriately.

Cancer has impacted patients’ quality of life (QoL). Qigong, a type of mind-body exercise, has been adopted by some patients with cancer to improve their QoL. However, various lengthy questionnaires were used to assess Qigong’s effects which made data synthesis difficult. Therefore, a simplified Qigong QoL Questionnaire (3Q instrument) has been developed to assess cancer patients’ QoL when they practise Qigong. This study aims to validate this instrument and contribute to the standardisation and simplification of the outcome measures for the studies on Qigong.

A total of 173 patients with cancer practising Qigong in Australia and China will be recruited to evaluate QoL using the 3Q instrument and Functional Assessment of Cancer Therapy–General (FACT-G) questionnaire. SPSS Statistics V.29 software will be used for data analyses. Exploratory factor analysis will be conducted to identify the factor structures of the 3Q instrument. The internal consistency of the 3Q instrument will be evaluated by Cronbach’s alpha. Test–retest reliabilities will be confirmed by intraclass correlations. Content validity will be assessed by the Spearman’s correlation coefficient. Construct validity will be established through confirmatory factor analysis. Criterion validity will be assessed against FACT-G, and Spearman’s correlation coefficient will be adopted to calculate their correlations.

This study has been approved by the RMIT University Human Research Ethics Committee (HREC26229). The findings from the present study will be submitted to peer-reviewed journals for publication and/or presented at conferences.

Patients living with chronic obstructive pulmonary disease (COPD) experience periods of disease stability and exacerbations (ECOPD). COPD imposes a negative and impactful extrapulmonary impairment and commonly overlaps with multimorbidity, particularly cardiovascular disease. Pulmonary rehabilitation (PR) aims to improve physical activity (PA) and quality of life, while behavioural change interventions (BCIs) aim to promote lifestyle changes and autonomy. However, after ECOPD, a variety of barriers often delay patient referral to PR. This study aims to assess the effects of a BCI for patients after ECOPD, focusing on cardiovascular health, PA and functionality. Additionally, the study will assess 6-month sustainability of PA and conduct a cost-utility analysis comparing a non-intervention group in the Unified Health System.

This randomised clinical trial will assess patients with ECOPD over 12 weeks using a BCI based on self-determination theory to increase daily steps. First, the cardiovascular and functional profile will be evaluated. Afterwards, the patients will receive an accelerometer to monitor the PA level. After 7 days, questionnaires will be applied on quality of life, symptoms and motivational levels for PA. Patients will be randomised into control group or intervention groups, both will receive educational booklets and IG will also receive an educational interview. PA will be tracked using activPAL accelerometer at weeks 1, 4 and 12, and follow-up at 6 months. Data analysis will include unpaired Student’s t-test or Mann-Whitney test for group comparison, and a linear mixed model to assess intervention effects over time. Economic evaluation, using STATA (V.14), will involve correlation analysis, and p

This study has been approved by the Federal University of São Carlos’ Ethics Committee, Irmandade Santa Casa de Misericórdia de São Carlos and Base Hospital of São José do Rio Preto. All procedures will be conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines and applicable regulatory requirements. All results will be presented in peer-reviewed medical journals and international conferences.

Brazilian Registry of Clinical Trials under the registration number RBR-6m9pwb7.

Radiological imaging is a central facet of the multidisciplinary evaluation of suspected child physical abuse. Current guidelines for the imaging of suspected child physical abuse are often unclear, incomplete and highly variable regarding recommendations on critical questions, thereby risking clinical heterogeneity, unstructured decision-making and missed diagnoses. We, therefore, aim to develop and report an evidence-based and consensus-derived international guideline for the radiological investigation of index and contact children in the context of suspected physical abuse and to ascertain areas of scientific uncertainty to inform future research priorities.

The international guidelines for the imaging investigation of suspected child physical abuse (IGISPA) consensus group includes formal representation from 127 recognised experts across 14 subspecialties, six continents and 32 national and/or international organisations. Participants will be divided into five longitudinal subgroups (indications for imaging, skeletal imaging, visceral imaging, neuroimaging and postmortem imaging) with three cross-cutting themes (radiography, genetics and adaptations for low- and lower-middle-income countries). Each subgroup will develop preliminary consensus statements via integration of current evidence-based guidelines, systematic literature review and the clinical expertise of a multinational group of experts. Statements will then undergo anonymised voting in a modified e-Delphi process and iterative revision until consensus (≥80% agreement) is achieved. Final statements will undergo both internal and external peer review prior to endorsement.

As an anonymous survey of consenting healthcare professionals, this study did not require ethical approval. Experts provided written informed consent to participate prior to commencement of the modified Delphi process. The IGISPA consensus statement and any subsequent guidance will be published open access in peer-reviewed medical journals.

The Puerto Rico Department of Health (PRDH) seeks to identify dengue epidemics as early as possible with high specificity.

Development and prospective application of an early warning system for dengue epidemics using routine historical surveillance data. A weekly intercept-only negative binomial regression model was fitted using historical probable and confirmed dengue data. A range of threshold definitions was explored using three model-estimated percentiles of weekly dengue case counts.

Dengue is endemic in Puerto Rico with irregular occurrence of large epidemics with substantial impact on health burden and health systems. Probable and confirmed dengue data are routinely collected from all hospitals and private clinics.

A total of 86 282 confirmed or probable dengue virus cases were reported from 1 January 1986 to 30 June 2024, with an annual mean of 2212 cases (median: 1533; range: 40–10 356).

The model was fitted retrospectively to mimic real-time epidemic detection and assessed based on sensitivity and specificity of epidemic detection.

The 75th percentile threshold aligned best with historical epidemic classifications, balancing false alarms and missed detections. This model provides a robust method for defining thresholds, accounting for skewed data, using all historical data and improving on traditional methods like endemic channels.

In March 2024, PRDH declared a public health emergency due to an early, out-of-season surge in cases that exceeded the epidemic alert threshold developed in this study. This real-time application highlights the value of these thresholds to support dengue epidemic detection and public health response. Integrating thresholds with other tools and strategies can enhance epidemic preparedness and management.

This study aimed to determine the association between diabetes mellitus (DM) medication use and glycaemic control.

This was a retrospective diabetes registry-based cohort study.

Singapore.

Patients aged 18 and above with incident DM in the SingHealth Diabetes Registry from 2013 to 2020 were included. The entire study period included a 1 year baseline period, a 1 year observation period and a 3 month outcome period.

Drug use was measured using the proportion of days covered (PDC), and the changes in glycated haemoglobin (HbA1c) between the outcome and baseline periods were assessed. The associations between baseline HbA1c and PDC ≥0.80 and between PDC and change in HbA1c were analysed using logistic regression and the Kruskal–Wallis test, respectively.

Of 184 646 unique patients in the registry from 2013 to 2020, 36 314 met the inclusion and exclusion criteria and were included in the analysis. The median PDC for any DM drug, oral DM drugs and insulin during the observation period was 20.3%, 16.8% and 0%, respectively. Those who had good glycaemic control at baseline were less likely to receive DM drugs and those with poor baseline glycaemic control or missing baseline HbA1c were more likely to be consistent users (PDC >80%) (px 10^-16).

The relationship between DM drug use and glycaemic control is complex and non-monotonic. Higher PDC for any DM drug and oral DM drugs during the observation period was significantly associated with clinically relevant HbA1c improvements.

Patient engagement (PE), or a patient’s participation in their healthcare, is an important component of comprehensive healthcare delivery, yet there is not an existing, publicly available, measurement tool to assess PE capacity and behaviours. We sought to develop a survey to measure PE capacity and behaviours for use in ambulatory healthcare clinics.

Measure development and psychometric evaluation.

A total of 1180 adults in the USA from 2022 to 2024, including 1050 individuals who had indicated they had seen a healthcare provider in the prior 12 months who were recruited nationally via social media across three separate samples; 8 patient advisors and healthcare providers recruited from a large, midwestern US Academic Medical Center; and 122 patients recruited from five participating ambulatory clinics in the Midwestern USA.

An initial survey was developed based on a concept mapping approach with a Project Advisory Board composed of patients, researchers and clinicians. Social media was then used to recruit 540 participants nationally (Sample 1) to complete the initial, 101-item version of the survey to generate data for factor analysis. We conducted exploratory and confirmatory factor analyses to assess model and item fit to inform item reduction, and subsequently conducted cognitive interviews with eight additional participants (patient advisors and providers; Sample 2), who read survey items aloud, shared their thoughts and selected a response. The survey was revised and shortened based on these results. Next, a test–retest survey, also administered nationally via another round of social media recruitment, was administered two times to a separate sample (n=155; Sample 3), 2 weeks apart. We further revised the survey to remove items with low temporal stability based on these results. For clinic administration, research staff approached patients (n=122; Sample 4) in waiting rooms in one of five ambulatory clinics to complete the survey electronically or on paper to determine feasibility of in-clinic survey completion. We engaged in further item reduction based on provider feedback about survey length and fielded a final revised and shortened survey nationally via a final round of social media recruitment (n=355; Sample 5) to obtain psychometric data on this final version.

Cronbach’s alphas, intraclass correlations (ICCs), Comparative Fit Index (CFI), root mean square error of approximation (RMSEA), standardised root mean squared residual (SRMR).

The final PE Capacity Survey (PECS) includes six domains across two scales: ‘engagement behaviours’ (ie, preparing for appointments, ensuring understanding, adhering to care) and ‘engagement capacity’ (ie, healthcare navigation resources, resilience, relationship with provider). The PECS is 18 questions, can be completed during a clinic visit in less than 10 minutes, and produces scores which demonstrate acceptable internal consistency reliability (α=0.72 engagement behaviours, 0.76 engagement capacity), indicating items are measuring the same overarching construct. The scales also had high test–retest reliability (ICC=0.82 behaviours, 0.86 capacity), indicating stability of response over time, and expected dimensionality with high fit indices for the final scales (behaviours: CFI=0.97; RMSEA=0.07; SRMR=0.05; capacity: CFI=0.99; RMSEA=0.06; SRMR=0.06), indicating initial evidence of construct validity.

The PECS is the first known measure to assess patients’ capacity for engagement and represents a step toward informing interventions and care plans that acknowledge a patient’s engagement capacity and supporting engagement behaviours. Future work should be done to validate the measure in other languages and patient populations, and to assess criterion-related validity of the measure against patient outcomes.

To explore patient perspectives on using a digital adherence technology (DAT) for tuberculosis (TB) treatment, specifically, the TB Treatment Support Tools (TB-TST) intervention, which integrates a mobile app designed to enhance patient-centred support, monitoring and communication, alongside a drug metabolite test.

Qualitative study conducted as part of a pragmatic randomised controlled trial.

Four public reference hospitals in Argentina. All patients in the intervention group were invited to participate; 33 patients in the intervention group and five treatment supporters were included.

Data collection and analysis: semistructured interviews were conducted. The normalisation process theory guided analysis to understand factors that enable or hinder the intervention’s integration into routine practice for TB treatment medication adherence.

Patients identified medication reminders, educational messages and direct communication with treatment supporters (TSs) as the most helpful components of the intervention. Many reported using the app to ask TSs questions they felt uncomfortable raising with physicians in person. Initially, many patients did not fully understand the purpose and use of the metabolite test. Over time, their understanding of the app improved, though some continued to misinterpret the test results. Motivation to adhere to TB treatment was primarily driven by a desire to protect family members and resume normal daily activities. Reported barriers to app use included time constraints due to work, technical issues, limited internet connectivity and the burden of medication side effects. While the intervention was generally perceived as supportive and user-friendly, patients suggested improvements such as faster response times from TSs, expanded availability and better technical reliability and internet access.

These findings highlight the importance of tailoring digital adherence interventions to meet the diverse needs of patients and reinforce the pivotal role of the TS as a trusted and accessible source of guidance throughout TB treatment.

NCT04221789; https://clinicaltrials.gov/ct2/show/NCT04221789.

Postoperative pulmonary complications (PPCs) represent a significant cause of postoperative morbidity and even mortality. However, there is a lack of consensus regarding this composite endpoint, the definition of the individual components, classification and optimal outcome measures. This study aims to refine the PPCs composite framework by evaluating its construct validity, assessing the necessity and risks of a composite measure and exploring the feasibility of differentiating severity categories.

A Delphi consensus process will be conducted, engaging an international multidisciplinary group of 30–40 panellists, including clinicians, researchers, patients, public representatives and health economists. Through iterative rounds, the study will seek agreement on the individual components of the PPCs composite. Additionally, consensus will establish a framework for a composite outcome measure based on a standardised severity classification, appropriate timeframes and weighted grading of PPCs.

Consensus, defined by ≥75% concurrence in multiple choice questions or on Likert–scale statements, will be evaluated from round 2 onwards. Delphi rounds will be continued until all statements have reached stability of responses evaluated by ² tests or the Kruskal-Wallis test.

The study will be conducted in strict compliance with the principles of the Declaration of Helsinki and will adhere to ACCORD guidance for reporting. Ethics approval has been obtained for this study from the University of Wolverhampton, UK (SOABE/202425/staff/3). Informed consent will be obtained from all panellists before the commencement of the Delphi process. The results of the study will be published in a peer–reviewed journal with the authorship assigned in accordance with ICMJE requirements.

NCT06916598 (clinicaltrials.gov).

Heart failure (HF) is a debilitating condition associated with high morbidity, mortality and healthcare resource use. Frailty in HF patients is associated with poorer outcomes, including increased morbidity, mortality and reduced quality of life (QoL). Nutritional disorders, such as malnutrition, are common in patients with HF and contribute to functional decline and increased mortality. The Meta-Analysis Global Group in Chronic HF (MAGGIC) risk score was developed to predict 1-year and 3-year hospitalization and mortality in patients with HF. This study aims to assess the added value of frailty, QoL and nutritional status to the MAGGIC risk score.

This prospective cohort study, conducted at a tertiary public hospital in southern Brazil, will include 316 patients with chronic HF who are followed up at the HF Outpatient Clinic. Frailty will be assessed using the Fried scale, health-related QoL will be assessed using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and nutritional status will be assessed using the Mini Nutritional Assessment. These variables will be incorporated into the MAGGIC risk score. Continuous variables with a normal distribution will be described as mean±SD, skewed variables as median±IQR and categorical variables as absolute and relative frequencies. Survival analysis will be performed using the Kaplan-Meier method with log-rank test comparisons. The prognostic value of frailty, its components, the MLHFQ score and nutritional status will be assessed by Cox regression, which will be adjusted for the MAGGIC risk score. Net Reclassification Improvement and Integrated Discrimination Improvement will assess the accuracy of the MAGGIC score when including frailty, MLHFQ and nutritional status. A p value

This study adheres to the Declaration of Helsinki and was approved by the Institutional Committee for Scientific Ethics and Research (No 20220558) and the Brazilian Government Registry (No 66474223200005327). The data will be available on reasonable request from the corresponding author. The results will be disseminated via peer-reviewed manuscripts and shown at national and international conferences.

Novel diagnostics, particularly point-of-care (POC) tests, play a crucial role in the early detection and management of infectious diseases, especially in resource-limited settings. Ensuring test performance and quality while minimising the risk of human error becomes more relevant when shifting testing tasks from highly controlled settings like centralised laboratories to people with minimal training. Applying usability and human factors engineering principles can reduce the challenges related to human errors. Despite existing frameworks and tools, the practical application of usability guidelines remains variable across different settings.

This scoping review protocol outlines a systematic investigation of current practices in assessing the usability of novel diagnostics, particularly POC tests for infectious diseases intended for use in low-income and middle-income countries. The review will analyse original research studies of all designs and product dossiers that report on the usability evaluation or validation of a diagnostic test for an infectious disease. A qualitative synthesis of the data extracted from the articles will be conducted. We will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols and the Joanna Briggs Institute guidelines for this scoping review.

No ethical approval is required because individual patient data will not be included. The findings will be disseminated through publication in a peer-reviewed journal.

The COVID-19 pandemic dramatically affected schools. However, there are insufficient data on the chronic physical and mental health consequences of the pandemic in school workers.

To determine the prevalence and the functional and mental health impact of pandemic-related chronic health symptoms among school workers towards the end of the COVID-19 pandemic.

Cross-sectional analysis of health questionnaires and serology testing data (nucleocapsid, N antibodies) collected between January and April 2023, within a cohort of school workers.

Three large school districts (Vancouver, Richmond, Delta) in the Vancouver metropolitan area, Canada (representing 186 elementary and secondary schools in total).

Active school staff employed in these three school districts.

COVID-19 infection history by self-reported viral and/or nucleocapsid antibody testing.

Self-reported, new-onset pandemic-related chronic health symptoms that started within the past year, lasting at least 3 months, after a positive viral test among those with a known infection.

Of 1128 school staff enrolled from 185/186 (99.5%) schools, 1086 (96.3%) and 998 (88.5%) staff completed health questionnaires and serology testing, respectively. The N-seroprevalence adjusted for clustering by school and test sensitivity and specificity was 84.7% (95% Credible Interval (95% CrI): 79.2% to 91.8%) compared with 85.4% (95% CrI: 81.6% to 90.3%) in a community-matched sample of blood donors. Overall, 31.1% (95% CI: 28.4% to 34.0%) staff reported new-onset chronic symptoms. These symptoms were more frequently reported in staff with viral test-confirmed infections (38.0% (95% CI: 34.3% to 41.9%)) compared with those with positive serology who were unaware that they had COVID-19 (14.3% (95% CI: 7.6% to 23.6%); p

The pandemic had major health impacts on school workers. To our knowledge, this study is among the first to concurrently quantify a broad range of chronic physical and mental health impacts, highlighting the need for further research and targeted health programmes to address this significant burden.