Tuberculosis is the leading cause of death globally from a single infectious agent. Early diagnosis is critical to reducing morbimortality. In cases of negative smear microscopy or limited sputum production, bronchoalveolar lavage (BAL) samples offer an alternative for diagnosis. Culture, the gold standard, requires a high bacterial load, extensive infrastructure and is time-consuming. Xpert MTB/RIF provides faster results with a higher cost. Previous systematic reviews present substantial limitations, including significant heterogeneity. Therefore, the diagnostic utility of Xpert MTB/RIF using BAL samples in adults with negative or scant sputum for pulmonary tuberculosis (PTB) needs to be reassessed.

A systematic search of MEDLINE, Embase, LILACS and Web of Science will be conducted without language or publication date restriction. Cross-sectional diagnostic studies of negative or sputum-scarce adults with presumptive PTB who underwent bronchoscopy to obtain samples for Xpert MTB/RIF and culture will be included. Screening and data extraction will be performed independently. Methodological quality will be assessed using the QUADAS-2 tool. A bivariate hierarchical random-effects model will synthesise sensitivity and specificity. Meta-analysis will be performed using Meta-DiSc 2.0. Heterogeneity will be assessed using I² and Cochrane thresholds. Subgroup analyses will be performed based on study design, population differences, country, culture method and risk of bias. Publication bias will be investigated using a funnel plot. The certainty of evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation approach. There was no patient or public involvement in the development of the systematic review protocol.

Ethical approval is not required as this study will use publicly available data. Findings will be disseminated through peer-reviewed publication.

CRD42025639440.

Knee osteoarthritis (OA) causes pain, reduced function and disability and may require total knee replacement (TKR). Although TKR is effective, up to 20% of patients remain dissatisfied, partly due to poor preoperative function and unrealistic expectations. Long waiting times for surgery may worsen patients’ function, yet preoperative physiotherapy is rarely offered. Prehabilitation—exercise and education before surgery—could improve postoperative recovery, but current evidence is limited. This trial investigates whether adding prehabilitation to standard care before TKR improves postoperative patient-reported joint awareness, enablement and knee function.

This multicentre, randomised controlled parallel-group trial is planned to be conducted within two specialised orthopaedic outpatient rehabilitation units in the southeast healthcare region of Sweden. Eligible patients (40–85 years, awaiting unilateral TKR) are randomised 1:1, stratified by age (≤67, >67 years), to either 8 weeks of prehabilitation—comprising two times per week supervised exercise therapy (strength, range of motion and balance) and education—in addition to standard care, or to standard care alone. Standard care consists of self-care, a single standardised preoperative education session and standardised postoperative rehabilitation. Assessments are conducted at baseline, post-intervention, 1 week pre-surgery and 6, 12 and 52 weeks post-surgery. A total of 110 patients will be recruited to the trial. Primary outcomes are joint awareness (Forgotten Joint Score-12) and patient enablement (modified Patient Enablement Instrument-2). Secondary outcomes are patient satisfaction (5-category Likert scale), the Knee injury and Osteoarthritis Outcome Score, the EuroQol 5 Dimension 3 Level questionnaire, the International Physical Activity Questionnaire—short form, objective function and accelerometer-based physical activity. Analyses will follow intention-to-treat and per-protocol principles. Between-group and within-group differences will be tested using t-tests or non-parametric equivalents, and linear mixed models or generalised linear models. Multiple linear regression and logistic regression will be used to analyse predictor variables for the primary outcomes. Sensitivity analyses will be performed to quantify the magnitude of missing data from patients lost to follow-up.

The trial has received ethical approval from the Swedish Ethical Review Authority (reg. no.2023-05120-01) and complies with the Declaration of Helsinki. Signed informed consent is collected for all patients before entering the trial. Results will be submitted for publication in a peer-reviewed journal and presented at international/national conferences. The findings may improve future clinical guidelines and care pathways for patients undergoing TKR.

NCT06290336.

Gastric outlet obstruction syndrome (GOOS) is a clinically significant condition often associated with advanced malignancies, particularly gastric and pancreatic cancers. Management strategies focus on symptom relief, nutritional improvement and quality of life enhancement. Surgical gastrojejunostomy (GJ), especially laparoscopic GJ, is commonly recommended for patients with good functional status and life expectancy exceeding 2 months. The modified Devine partial stomach-partitioning gastrojejunostomy (PSPG) was introduced to address functional limitations of conventional GJ, including duodenogastric reflux and afferent loop syndrome. However, PSPG has not been widely adopted, and its role in malignant GOOS remains unclear.

This systematic review aims to synthesise the available evidence on the application, functional outcomes and oncological implications of the modified Devine technique in malignant GOOS.

This review follows Preferred Reporting Items for Systematic Review and Meta-Analysis guidelines. The PICO framework was employed to define eligibility criteria, focusing on studies examining PSPG for malignant GOOS as palliative surgery or a bridge to resection. Literature searches were conducted across Medline, EMBASE, Cochrane Library, ClinicalTrials.gov and grey literature sources using a prospectively registered search strategy, between August and October 2025, following protocol submission. Two independent reviewers will screen articles, extract data and assess quality using the Newcastle-Ottawa Scale where applicable. Data will be synthesised narratively.

As this study is a systematic review of published literature, formal ethical approval was not strictly required. In accordance with institutional policy, the protocol was submitted to the Institutional Review Board of Hospital Prof. Doutor Fernando Fonseca, which confirmed that the study met criteria for ethical exemption. Findings will be disseminated through peer-reviewed publication.

This study is registered in PROSPERO (CRD42024593540). Search strategy is registered in searchRxiv https://doi.org/10.1079/searchRxiv.2025.00838.

PROSPERO CRD42024593540

https://doi.org/10.1079/searchRxiv.2025.00838.

Cancer is the leading cause of death and morbidity among children and adolescents worldwide. Functionality-based interventions are relevant among children and adolescents with an oncological diagnosis, whence studies summarising evidence on this topic are needed. This systematic review will summarise evidence on the effect of interventions to improve functionality indicators among paediatric patients diagnosed with cancer.

This protocol will follow Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA)-Protocols reporting guidelines. The systematic review will be conducted according to the Cochrane Handbook and PRISMA 2020. Studies will be searched in MEDLINE (PubMed), Embase, Web of Science, CENTRAL, LILACS and PEDro. Additional searches will include Google Scholar, reference lists of included studies, relevant reviews and trial registries. Studies will be included if they implement a functionality-based intervention. They must evaluate effects among paediatric patients with an oncological diagnosis. Secondary outcomes will include health-related quality of life. There will be no limits to language or year of publication, and articles published in peer-reviewed journals will be accepted. Only randomised controlled trials will be included. Risk of bias will be assessed using the Cochrane Risk of Bias Tool 2. Two independent reviewers will select studies, extract data and assess risk of bias. A narrative synthesis and meta-analysis will be conducted if studies are clinically and methodologically homogeneous. Statistical heterogeneity will be assessed using Higgins’ inconsistency test (I^²). Meta-analysis may estimate combined effects using random-effects and the inverse variance method. The R statistical software will be used. The certainty of evidence will be evaluated for each outcome using the Grading of Recommendations Assessment, Development and Evaluation system.

This study used data from previously published studies, thus waiving submission to an Ethics Committee. Scientific dissemination strategies will include publication in peer-reviewed journals, conference presentations and workshops for the public.

CRD42024462833.

In rural sub-Saharan Africa (sSA), the burden of antimicrobial resistance (AMR) remains high. As AMR continues to rise, there is a strong need for practical, implementable surveillance to monitor and mitigate risks, as well as inform timely, evidence-based clinical decision-making. Emerging evidence points to possible community-level drivers, such as transmission between human, animal and environmental reservoirs as contributing factors, yet microbiological surveillance or opportunities for wastewater-based surveillance are often limited and insufficient in these settings. Therefore, alternative sustainable and affordable approaches are needed. We intend to build on the demonstrated potential of metagenomic profiling of pooled faecal material, which accurately predicted population-level AMR prevalence in invasive Enterobacterales infections.

We aim to validate this metagenomic pooled approach on additional populations, and to evaluate whether AMR patterns could be similarly predicted from surveillance of community One Health reservoirs. We will assemble existing data from hospital-based microbiology diagnostic laboratories in rural Burkina Faso and Kenya, and determine to what extent community-level metagenomic data, and/or faecal material of patients on hospital admission, can predict AMR in clinical isolates. We will perform community-level surveys in eight clusters per country, randomly selecting 15 households per cluster. We will systematically sample suspected environmental AMR exposure sites in and around households (soil, drinking water, latrines, chicken faeces) and collect data on community-level antibiotic use, hygiene practices, contact with domestic animals and sanitary facilities. Samples and data will be collected twice: during the dry and during the rainy season.

In addition to evaluating the accuracy of predicting resistance in clinical isolates, we will quantify community-level exposure risks. We will conduct metagenomic profiling on pooled DNA extracts from human stool samples (hospital and community-level) and from household environments. Bayesian statistical models will quantify relationships between AMR gene abundance in the environment and in human stool, and invasive bacteria identified among clinical patients, accounting for geography and seasonality. A cost-utility analysis will determine under what circumstances the use of pooled metagenomic data to inform empirical antibiotic policies would represent an efficient use of resources.

The proposed surveillance protocol is developed in partnership with local communities and local and international researchers and has received ethical approval in Kenya and Burkina Faso. It will assess whether intermittent, pooled-sample metagenomics provides a viable, low-cost and practical approach for population-level AMR surveillance in settings that—like many in rural sSA—lack systematic microbiological diagnostics and where sewage systems for wastewater-based surveillance are absent. By providing an alternative to routine microbiological-based surveillance where this proves challenging to implement, this approach may help improve treatment outcomes, contribute to equity and public health. Findings will be disseminated through peer-reviewed publications and academic conferences and will contribute to the recently proposed WHO AMR surveillance strategy, which combines survey-based approaches with routine AMR surveillance.

The current German treatment guideline for chronic ischaemic heart disease (IHD) recommends that general practitioners (GPs) deliver brief advice on physical activity (PA) to patients with IHD. Such advice consists of at least three elements (ie, 3As): (1) assessing the PA level, (2) advising on PA and (3) assisting with recommendations. This study examined the extent to which individuals with self-reported IHD in Germany reported the receipt of such advice.

Cross-sectional population-based face-to-face survey (from June 2023 to August 2024).

Households across Germany.

1004 individuals aged 35+ years with self-reported IHD and GP contact.

Primary outcome: self-reported proportions of receipt of GP-delivered PA advice according to the 3As. Main secondary outcome: associations between person characteristics and the likelihood of receiving PA advice.

Among individuals with self-reported IHD, 36.4% (95% CI 33.4% to 39.4%) received all 3As of PA advice, 42.1% (95% CI 39.1% to 45.2%) received one or two elements, 9.9% (95% CI 8.1% to 11.8%) received no advice at all and 3.8% (95% CI 2.7% to 5.1%) were advised to avoid PA (7.9% did not remember/refused to answer). Women (vs men) were more likely to receive no advice (OR=1.74, 95% CI 1.11% to 2.72%), while middle (vs younger) aged individuals (OR=0.46, 95% CI 0.22% to 0.99%), those with PA levels of 1–149 min/week (vs no PA; OR=0.16, 95% CI 0.08% to 0.31%) and of 150+ min/week (vs no PA; OR=0.13, 95% CI 0.07% to 0.23%) and those with higher (vs lower) education (OR=0.39, 95% CI 0.20% to 0.76%) were less likely to receive no advice. Individuals living in urban (vs rural) areas (OR=0.65, 95% CI 0.46% to 0.88%) and those with PA levels of 1–149 min/week (vs no PA; OR=0.59, 95% CI 0.37% to 0.95%) and of 150+ min/week (vs no PA; OR=0.55, 95% CI 0.36% to 0.84%) were less likely to receive only one or two (vs all) of the 3As. Of those who received at least one element of advice (n=788), 72.5% reported they were more active afterwards, with a higher proportion when all 3As (vs only some elements) were provided (86.8% vs 59.6%).

Only one-third of individuals with self-reported IHD in Germany received comprehensive PA advice. Specific person characteristics, such as female gender and lower education, were associated with lower proportions of received PA advice. Efforts are needed to improve GP-led PA guidance, particularly for underserved groups.

German Clinical Trials Register (DRKS00031304).

Active self-management by patients following acute coronary syndrome (ACS) can reduce recurrent events. Patient education for transitioning from hospital to home promotes effective self-management but can be limited in the acute setting due to time and resource pressures. Patients from ethnic minority and immigrant backgrounds face additional language, cultural and health literacy barriers to receiving patient education. Self-administered virtual patient education presents an innovative solution to these challenges. This study aims to evaluate a co-adapted, virtual avatar nurse-guided, discharge education application (app) for Chinese-speaking patients following ACS.

This multicentre, assessor-blinded, randomised controlled trial will recruit 98 Chinese-speaking inpatients following ACS with evaluation at 1 and 3 months postdischarge. Control participants in the control group will receive the usual ward-based patient discharge education. Intervention participants will additionally receive the education app installed on their devices before hospital discharge with unlimited access during the study period. Cultural relevance and linguistic accuracy for this Chinese version of an existing app were ensured through co-adaptation with Chinese-speaking consumers; the primary outcome will be coronary heart disease (CHD) knowledge, and secondary outcomes will include knowledge, attitudes and beliefs regarding heart attack symptoms and responses, CHD self-management behaviours, utilisation of healthcare services and quality of life. A process evaluation will be conducted alongside the trial to assess the acceptability and feasibility of the app. Between-group comparisons will be made using 95% CIs, accounting for baseline differences using linear mixed effects or mixed effects logistic regression models.

The Western Sydney Local Health District Human Research Ethics Committee has approved this study protocol (26 February 2024, amendment number 2) (2024/STE00147), with site-specific authorisations obtained from each participating hospital. The results will be disseminated through peer-reviewed journal articles and presentations at scientific conferences.

ACTRN12624000408583.

High costs of screening and diagnostic tests remain a major barrier to timely tuberculosis (TB) identification in resource-limited settings. Evidence on the cost-effectiveness of scalable screening algorithms is limited. Start4All is a research project aimed at developing and evaluating algorithmic approaches to TB screening and diagnosis, with the goal of optimising technical and allocative efficiency when expanding diagnostic coverage to primary healthcare and community settings.

Five screening and diagnostic tests will be evaluated: a capillary blood-based assay (C-reactive protein (CRP)), sputum-based rapid molecular tests (PCR; individual and pooled Xpert MTB/RIF Ultra assay (Xpert Ultra, Cepheid®, California, USA)), a lateral-flow urine-based test for lipoarabinomannan (LF-LAM), and digital chest X-rays with artificial intelligence-based computer-aided detection (CXR-CAD). A microbiological reference standard of positive culture using the mycobacteria growth indicator tube will be used to confirm TB disease.

We will compare the cost and effectiveness of concurrent and sequential positive serial combinations (screening algorithms) of CRP, CXR-CAD, LF-LAM, individual and pooled Xpert Ultra. Diagnostic performance will be estimated using sensitivity, specificity, predictive values and proportions of positive results, with Bayesian inference used to derive these estimates. The analysis will include adults (15 years and older) only and will be stratified by HIV status and level of care, including facility and community-based case finding. Effectiveness will be assessed based on the number of people with TB detected. Cost analysis will be conducted from the provider perspective, incorporating commodity and implementation costs. A decision tree model will be developed to assess the cost per number of persons with confirmed TB detected across all countries. Probabilistic sensitivity analysis will be conducted to account for uncertainty in model parameters, incorporating willingness-to-pay and willingness-to-accept thresholds.

WHO ethical review committee approval ERC.0003921. Data will be available on reasonable request to the principal investigator of the consortium.

NCT05845112.

Recent research indicates that around 8% of older people living in prison have signs or symptoms of dementia or mild cognitive impairment (MCI), yet the care they receive is not equivalent to care in the community and this means their needs may not be met. We co-developed an intervention specifically for older people living in prison with dementia/MCI (Dementia and Mild Cognitive Impairment in prison care pathway and training package–DECISION). To date, this has not been implemented or evaluated. This paper presents our protocol for a study to assess the feasibility and acceptability of DECISION.

This is a non-randomised, realist-informed mixed-methods feasibility study with integrated process evaluation, which will take place in two prisons in England. The intervention was codeveloped with experts with lived experience. Participants will include older people living in prison, staff working in prison and peer supporters. We will assess the feasibility and acceptability of the intervention (eg, numbers eligible; rates of recruitment and retention), and the evaluation design (eg, completion rates of standardised outcome measures). Methods will include semistructured, realist-informed interviews; an audit to assess implementation fidelity; focused ethnography; training questionnaires; and collection of resource use data. We will refine the DECISION programme theory using realist-informed methods to examine and refine how contexts and mechanisms interact to produce the intervention’s outcomes.

This study received a favourable ethical opinion from the Wales REC 3 Research Ethics Committee in January 2025 (reference number 24/WA/0323). HMPPS National Research Committee approval was also granted in January 2025 (reference number 2024-1451). Findings will be disseminated through a range of avenues, including stakeholder engagement events, open-access papers, conference presentations, evidence briefings for commissioners, providers and practitioners, and newsletters for service users.

To describe disability severity transitions in the ageing population in Switzerland using an overall functioning score to define four disability severity states (no, mild, moderate and severe) and death, and to investigate the association of multimorbidity and further predictors with these transitions.

Secondary analysis of the Swiss version of the Survey of Health, Ageing and Retirement in Europe (SHARE).

Switzerland.

Community-dwelling population aged 50+ with at least two interviews in SHARE (N=3505).

Not applicable.

Primary outcome measures are the disability severity as assessed by a previously developed overall functioning score, and death status as assessed by the SHARE end-of-life interview. Transition analysis between disability severity states and death was conducted using multistate Markov models. The association between predictor variables and transition intensities was quantified using the proportional hazards assumption. Two distinct operationalisations of multimorbidity (count, burden) were used and analysed according to two separate models (A, B).

The findings for both models were similar: Estimated HRs for transition intensities suggest that being multimorbid or having a higher disease burden score increases the risk of transitioning to higher disability severity states and death for most transitions (HRs between 0.90 and 2.34 for model A compared with not being multimorbid; HRs between 0.95 and 1.46 for model B for a one-point increase in the disease burden score). In addition, most transitions to higher disability severity states and death are more likely for higher age (HRs between 1.00 and 1.14 for model A, and between 1.00 and 1.15 for model B for a 1 year increase in age), and transitions to death are less likely for women, compared with men (HRs between 0.34 and 0.88 for model A, and between 0.38 and 0.71 for model B).

This study is a first attempt to understand disability severity transitions in the older population in Switzerland. Although we believe that such an approach is suitable to inform resource allocation to LTC, rehabilitation and prevention, more detailed information on contextual factors will be important to consider for future research. Moreover, our study contributes to the discussion on how to operationalise multimorbidity in healthy ageing research.

This project, in adult surgical patients, will evaluate whether the creation of a customised checklist, driven by a clinical decision support tool, is able to improve anaesthesia providers’ adherence to consensus guidelines and standardised practice recommendations for the prevention of postoperative nausea and vomiting (PONV).

The intervention will be evaluated using a sequential, repeated crossover design at the institutional level, with designated washout, control and intervention periods. The surgical case will serve as the unit of analysis. The primary outcome is adherence to appropriate PONV prophylaxis administration guidelines. Secondary outcomes include the incidence of PONV and length of stay in the postanaesthesia care unit (PACU).

This protocol and statistical analysis plan provide an outline of the study design, primary and secondary end points and analytic approach. The Advancing Strategies to Optimise the PerIopeRativE Management of PostOperative Nausea and Vomiting trial has received approval from the Vanderbilt University Institutional Review Board (IRB: 250773). The results will be disseminated through peer-reviewed publications and presentations at national conferences. Findings from this trial will inform best practices for timely antiemetic prophylaxis, with the goal of reducing PONV incidence and shortening PACU stay.

NCT07152249.