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Understanding LUng Cancer risk factors and their Impact Assessment (LUCIA): protocol for multicentre observational cohort study

Por: Idoyaga-Uribarrena · J. E. · Garcia-Echeberria · L. · Lecumberri · I. · Azkona · E. · Jimenez · U. · Sainz-Camin · M. · Nunez-Benjumea · F. J. · Luque-Romero · L. G. · Ernst · B. · Guiot · J. · Stonans · I. · Krams · A. · Macia · I. · Garin-Muga · A. · Gut · I. G. · Gut · M. · Orcajo-L
Introduction

Lung cancer (LC) is the leading cause of cancer-related mortality worldwide, primarily due to diagnosis at advanced stages. Although low-dose computed tomography (LDCT) screening reduces lung cancer mortality in high-risk populations, current screening programmes are largely restricted to individuals defined by age and smoking history. This approach excludes never-smokers and individuals with non-smoking-related risk factors, limiting the equity, efficiency and scalability of lung cancer screening. The LUng Cancer risk factors and their Impact Assessment (LUCIA) project aims to overcome these limitations by developing personalised lung cancer risk prediction models and evaluating novel non-invasive technologies for early detection within a risk-adapted screening strategy.

Methods and analysis

LUCIA is a multicentre, observational, longitudinal cohort study that will recruit approximately 4000 participants across four European regions: Andalusia and the Basque Country (Spain), Liège (Belgium) and Riga (Latvia). The study population includes smokers, never-smokers and reduced smokers with low-to-moderate lung cancer risk. All participants will initially enter phase 1 (wide population screening) and may transition to phase 2 (precision screening) or phase 3 (diagnosis) based on LDCT findings, results from non-invasive screening devices and artificial intelligence-based risk prediction models. Participants will be followed up for 24 months, with assessments at baseline and at 6, 12 and 24 months. Data collection includes sociodemographic characteristics, medical history, environmental and occupational exposures, lifestyle factors, spirometry, multi-omics profiles and outputs from novel non-invasive devices, including a breath analyser, spectrometry-on-card and a skin-applied volatile organic compound sensing patch. The study will develop and validate integrated lung cancer risk prediction models and evaluate the diagnostic performance of these technologies to support population stratification and personalised screening.

Ethics and dissemination

The study will be conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines and applicable national and European regulations. Ethical approval has been obtained from the relevant ethics committees in all participating countries. Written informed consent will be obtained from all participants. Study findings will be disseminated through peer-reviewed open-access publications, scientific conferences and communication with public health stakeholders.

Trial registration number

ClinicalTrials.gov, NCT06473870.

Effects of rehabilitation and behavior change interventions on physical capacity and physical activity behavior following lumbar surgery for degenerative disease: A systematic review and meta-analysis

by José Manuel García-Moreno, Tyler Adams, Amber Beynon, Janine Vlaar Olthuis, Stephan U. Dombrowski, Richelle Witherspoon, Niels Wedderkopp, Jeffrey J. Hébert

Background

Rehabilitation and behavior change interventions are commonly used after lumbar surgery to improve recovery, but their effects on physical capacity and physical activity remain unclear. This study aimed to investigate the effectiveness of rehabilitation and behavior change interventions on physical capacity and physical activity behavior in patients following lumbar surgery for degenerative disease.

Methods

EMBASE, MEDLINE, PsycINFO, and CENTRAL were searched from inception to September 2025 and reference lists were hand-searched. Randomized controlled trials assessing rehabilitation or behavior change interventions on physical capacity or physical activity behavior in adults with lumbar degenerative disc disease who underwent lumbar surgery were included. Review author pairs independently extracted data and assessed included studies. Risk of bias was assessed with the Cochrane tool, and study quality with the Grading of Recommendations Assessment, Development and Evaluation classification. Results were pooled using random-effects models and reported as standardized mean differences (SMD) with 95% confidence intervals (CI).

Results

Exercise was more effective than minimal or usual care in improving trunk extension endurance in the immediate term (SMD, 1.54; 95% CI, 0.93–2.16). Supervised exercise outperformed self-directed exercise in improving trunk extension endurance in the immediate term (SMD, 1.28; 95% CI, 0.75–1.81). Psychologically informed rehabilitation was more effective than minimal or usual care in increasing physical activity levels in the intermediate term (SMD, 0.26; 95% CI, 0.02–0.49), but not in the immediate term (SMD, 0.17; 95% CI, −0.14 to 0.49). Physical activity advice did not increase physical activity levels compared to minimal or usual care in the immediate term (SMD, 0.21; 95% CI, −0.13 to 0.55). Prehabilitation was more effective than minimal or usual care in increasing physical activity levels in the intermediate term (SMD, 0.28; 95% CI, 0.03–0.53). Certainty of evidence ranged from low to moderate.

Conclusions

For adults with lumbar degenerative disease who underwent lumbar surgery, exercise, especially supervised programs, improved trunk extension endurance in the immediate term. Psychologically informed rehabilitation and prehabilitation increased physical activity levels in the intermediate term, while physical activity advice showed no benefit. Findings are limited by low certainty of evidence and high risk of bias.

Feasibility of implementing a non-invasive self-sampling method for saliva specimens that can be used for the diagnosis of respiratory infections among paediatric patients in the Tshwane District, South Africa: a study protocol

Por: Nxele · S. · Dlangalala · T. · Gxekwa · N. V. · Ramatsokotla · S. · Musekiwa · A. · Kgatle · M. M. · Hatchett · D. B. · Shin · A. · Tu · W.-c. · Robertson · I. H. · Su · X. · Berthier · E. · Thongpang · S. · Theberge · A. B. · Mashamba-Thompson · T. P.
Introduction

Effective community-based disease management is essential for public health. In low- and middle-income countries, sustainable strategies for timely diagnosis and treatment are a research priority. This study aims to assess the feasibility of a non-invasive saliva self-sampling method, paired with digitally linked molecular point-of-care diagnostics, for detecting respiratory infections among paediatric patients in the Tshwane District, South Africa.

Methods and analysis

A field study will be conducted at Steve Biko Academic Hospital to compare saliva collection using the CandyCollect lollipop device and standard mouth swabs. The spiral groove of the lollipop device captures pathogens, which are stored in DNA/RNA preservation media and later analysed using quantitative PCR and commercially available rapid antigen tests. The multiplex respiratory pathogen panel, based on TaqMan real-time PCR technology, targets key paediatric pathogens including Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, respiratory syncytial virus (RSV) and influenza A/B. Nucleic acids will be extracted using standard viral extraction kits and analysed following manufacturer protocols. Internal controls will be included in each qPCR run, and samples with CT values below defined thresholds will be considered positive. Rapid antigen tests will detect common pathogens such as influenza A/B, RSV and SARS-CoV-2 for comparative analysis. User experience and acceptability will be assessed via child-friendly and caregiver surveys following sample collection. The study will be implemented in two phases: diagnostic performance evaluation and user feedback assessment. The protocol is aligned with the Standard Protocol Items: Recommendations for Interventional Trials 2013 checklist.

Ethics and dissemination

Ethical approval has been granted by the University of Pretoria (509/2023) and the Gauteng Department of Health (GP_202406_032). The study is registered in the Pan African Clinical Trial Registry (PACTR202411743094783). Findings will be disseminated through peer-reviewed journals, conferences and stakeholder briefings. The study complies with South Africa’s Protection of Personal Information Act. Data collection is scheduled from November 2024 to February 2025, with project completion expected within 1 year.

Trial registration number

Pan African Clinical Trial Registry (PACTR202411743094783).

Hospital discharge planning in cardiac care: study protocol for a mixed-methods study on the implementation, influencing factors and quality of care in Germany

Por: Imhof · L. · Bartels · R. · Blum · K. · Blume · K. S. · Fleischer · S. · Gottschalk · S. · Heber · R. · Horenkamp-Sonntag · D. · Meyer · G. · Remppis · B. A. · Schneider · U. · Schreyoegg · J. · Winter · V.
Introduction

Discharge planning (DP) is essential to ensure continuity of care during patient transitions between inpatient and outpatient settings. Although DP has been legally required for all hospitals in Germany since 2017, several studies show considerable variation in its implementation, likely due to differences in structural characteristics and organisational processes. Both quality and efficiency-enhancing DP processes are particularly important in the context of cardiovascular disease, which is the leading cause of mortality and a major contributor to healthcare costs in Germany. The ‘Ready to Discharge’ (R2D) project investigates the implementation status, influencing factors and outcomes of DP in cardiac units of German hospitals. By integrating quantitative and qualitative data, we aim to identify best practices and provide actionable recommendations for improving DP processes.

Methods and analysis

A mixed-methods study design will be used. Quantitative analyses will be based on primary data from hospital and patient surveys combined with secondary data from health insurance claims and hospital quality reports. Key outcome measures will include healthcare utilisation outcomes (eg, readmissions, emergency department visits), patient health status outcomes (eg, patient satisfaction, self-rated health) and medication-related outcomes (eg, medication adherence). Qualitative interviews with healthcare professionals will enrich the findings by providing insights into barriers and facilitators to DP.

Ethics and dissemination

This study was approved by the Ethics Committee of Bergische University of Wuppertal and the German Federal Office for Social Security. Informed consent will be obtained for all primary data collections. Hospital managing directors will be informed prior to the hospital survey and will be able to withdraw consent. Patients can withdraw their consent at any time. Secondary data will be analysed in pseudonymised form to ensure patient confidentiality. Results will be disseminated through workshops, regional and international conferences and peer-reviewed publications.

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