Although lung cancer remains the leading cause of cancer deaths in the US, recent advances in early detection and treatment have led to improvements in survival. However, there is a considerable risk of recurrence or second primary lung cancer (SPLC) following curative-intent treatment in patients with early-stage non-small cell lung cancer (NSCLC). Professional societies recommend routine surveillance with CT to optimise the detection of potential recurrence and SPLC at a localised stage. However, no definitive evidence demonstrates the effect of imaging surveillance on survival in patients with NSCLC. To close these research gaps, the Advancing Precision Lung Cancer Surveillance and Outcomes in Diverse Populations (PLuS2) study will leverage real-world electronic health records (EHRs) data to evaluate surveillance outcomes among patients with and without guideline-adherent surveillance. The overarching goal of the PLuS2 study is to assess the long-term effectiveness of surveillance strategies in real-world settings.

PLuS2 is an observational study designed to assemble a cohort of patients with incident pathologically confirmed stage I/II/IIIA NSCLC who have completed curative-intent therapy. Patients undergoing imaging surveillance will be followed from 2012 to 2026 by linking EHRs with tumour registry data in the OneFlorida+ Clinical Research Consortium. Data will be consolidated into a unified repository to achieve three primary aims: (1) Examine the utilisation and determinants of CT imaging surveillance by race/ethnicity and socioeconomic status, (2) Compare clinical endpoints, including recurrence, SPLCs and survival of patients who undergo semiannual versus annual CT imaging and (3) Use the observational data in conjunction with validated microsimulation models to simulate imaging surveillance outcomes within the US population. To our knowledge, this study represents the first attempt to integrate real-world data and microsimulation models to assess the long-term impact and effectiveness of imaging surveillance strategies.

This study involves human participants and was approved by the University of Florida Institutional Review Board (IRB), University of Florida IRB 01, under approval number IRB202300782. The results will be disseminated through publications and presentations at national and international conferences. Safety considerations encompass ensuring the confidentiality of patient information. All disseminated data will be de-identified and summarised.

Despite the important role of healthcare services in trauma recovery, many survivors of violence do not seek help. This study aims to examine rates of healthcare utilisation, including differences for physical violence versus rape, gender and physical injury (vs no injury) and obstacles to seeking care within 6 months following incidents of physical violence and rape.

The participants were randomly chosen from the National Population Registry in Norway and invited to participate in a telephone survey on violence exposure and health between June 2021 and June 2022 (N=4299, 49% women).

The sample included 1768 violence-exposed individuals. Of the women (n=749), 82.1% had experienced physical violence and 40.3% had experienced forcible rape. Of the men, most had experienced physical violence (98.6%) and a small percentage had experienced rape (3.5%).

Logistic regression models were used to investigate whether healthcare seeking differed by gender, type of violence (rape vs physical violence) and severity (physical injury). Barriers to accessing healthcare were also investigated using descriptive statistics and content analysis.

Healthcare seeking rates were low after rape (16.9%) and physical violence (24.2%), with somewhat higher rates among individuals experiencing both types of violence (39.9%). There were no statistically significant differences in the odds of healthcare utilisation between the three types of violence exposures when we controlled for gender, physical injury, violence characteristics and sociodemographic factors. Men were more likely than women to have sought healthcare (adjusted OR (aOR): 1.37, 95% CI: 1.02 to 1.85, p=0.042). Physical injury was strongly associated with greater healthcare utilisation (aOR: 6.39, 95% CI: 4.85 to 8.41, p

Few victims seek healthcare shortly after experiencing rape or physical violence. Quantitative and qualitative findings indicate that many seek healthcare exclusively for severe physical injury. These results emphasise the need to improve health services’ outreach to victims of violence, who are at heightened risk of mental health issues and chronic illnesses.

Accidental hypothermia (AH) can occur in mild-to-severe cases; however, its management is crucial in severe cases as it can cause ventricular fibrillation and lead to death. Among various rewarming therapies for AH, endovascular catheter rewarming has been the focus of recent studies as a minimally invasive alternative to invasive internal rewarming, such as extracorporeal membrane oxygenation (ECMO). However, no study has demonstrated the efficacy and safety of endovascular catheter rewarming therapy. This study aimed to validate the efficacy and safety of endovascular catheter rewarming for patients with AH.

The intensive care with endovascular catheter rewarming in accidental severe hypothermia (ICE-CRASH II) study is a multicentre, randomised study of patients with AH. This study will include patients with AH (age ≥65 years, core temperature

This study was approved by the Hokkaido University Certified Review Board (approval number: 024-00013). Written informed consent will be obtained from all the participants or their legally acceptable representatives. The results will be disseminated through publications and presentations.

Japan Registry of Clinical Trials (jRCT1012240051).

The ageing population in Europe is experiencing a significant rise in urinary incontinence (UI), which affects millions and incurs substantial healthcare costs. While conservative treatment (eg, behavioural strategies, pelvic floor exercises) can help manage UI, there is a need for evidence-based eHealth solutions to improve adherence and treatment outcomes. The KOKU Bladder project aims to co-create, develop and test an eHealth intervention to improve bladder health (BH) and UI in adults aged 50 and over.

Phase 1 will consist of the co-creation and technological development of the eHealth solution. First, a rapid review will be undertaken to identify eHealth solutions (ie, technologies and websites), including behaviour change techniques (BCTs) and elements of gamification for self-management of BH and UI in adults aged 50 and over. Also, a consultation with eight experts on BH/UI and/or BCTs will be conducted to explore recommendations for the new eHealth solution. The PROSECO framework will facilitate an assessment of the co-creation process. Phase 1 will additionally include the conduction of at least six focus groups, to be held in Kaunas (Lithuania), Catalonia (Spain) and Manchester (UK) to co-create the contents of the digital solution. Each focus group will include 10–12 community-dwelling adults aged 50+, with different physical conditions and continence status, as well as health professionals and other stakeholders. The information collected will be analysed thematically. First, we will hold three focus groups, one in each country, to find out the opinion of the participants. Once the focus groups are finished and the first version of the technological solution is created, participants will test it and provide feedback in three additional focus groups. Participants’ opinions will be taken into account to make modifications to the solution and co-create the final version. Gamification methods and the Honeycomb model for user experience will be followed in order to achieve a technological solution that is adequate for its target population.

Phase 2 will consist of a multicentre pilot study with a mixed method (quantitative and qualitative) approach to assess the feasibility and acceptability of the newly developed technological solution. At least 120 participants (40 per country) will be recruited and randomised into two groups: intervention (KOKU Bladder) and control (indirect health education). The primary outcome will be the severity of UI, according to the International Consultation on Incontinence Questionnaire-UI short form. Secondary outcomes will include quality of life (EuroQol 5-Dimension, 5-Level), life-impact related to UI (Incontinence Impact Questionnaire-7), lower urinary tract symptoms (Symptoms of Lower Urinary Tract Dysfunction Research Network Symptom Index-10 (LURN SI-10)), International Consultation Questionnaire on Incontinence Bowel Score, Patient Global Impression of Improvement; levels of physical activity and sedentary behaviour (accelerometer), as well as satisfaction with treatment (Client Satisfaction Questionnaire (CSQ-8)). The latter, together with recruitment, adherence, retention, attrition and data loss, will be used for measuring intervention feasibility and acceptability. Statistical and clinical significance, as well as effect size, will be calculated.

The project is approved by the Research Ethics Committee of IRIS-CC approved the project on 9 January 2025 (code 24/095), the Research Ethics Committee of Hospital Universitari Arnau de Vilanova of Lleida on 27 January 2025 (CEIC-3201), the Commission on Research Ethics of Lithuania on 3 March 2025 (SMTEK-31) and the Research Ethics Committee 3 of the University of Manchester on 13 August 2025 (2025-23619-43258). Participation and withdrawal will be voluntary. Informed consent will be obtained from candidates willing to join the project. Study results will be disseminated via publication of scientific articles, presentations at professional workshops, webinars and congresses, as well as through social media and lay summaries for participants and the general public.

NCT06583733.

CRD42024597624.

Migrants and refugees with low language proficiency (LLP) in the dominant language of their host country have a higher risk of suffering from certain mental health disorders compared with non-migrant populations. They are also more likely to experience a lack of access to mental healthcare due to language-related and culture-related barriers. As part of the MentalHealth4All project, a digital multilingual communication and information platform was developed to promote access to mental healthcare for LLP migrants and refugees across Europe. This paper describes the study protocol for evaluating the platform in practice, among both health and/or social care providers (HSCPs) and LLP migrants and refugees.

We will conduct a pretest–post-test cross-national survey study to evaluate the platform’s effect evaluation (primary objective) and process evaluation (secondary objective). The primary outcomes (measured at T0, T2 and T3) are four dimensions of access to mental healthcare services: availability, approachability, acceptability and appropriateness of mental healthcare. Secondary outcomes (measured at T2) are: actual usage of the platform (ie, tracking data), perceived ease of use, usefulness of content, comprehensibility of information, attractiveness of content and emotional support. Participants will be recruited from nine European countries: Belgium, Germany, Italy, Lithuania, the Netherlands, Poland, Slovakia, Spain and the UK. Using convenience sampling through professional networks/organisations and key figures, we aim to include at least 52 HSCPs (ie, 6–10 per country) and 260 LLP migrants (ie, 30–35 per country). After completing a pretest questionnaire (T0), participants will be requested to use the platform, and HSCPs will participate in an additional personalised training (T1). Next, participants will fill out a post-test questionnaire (T2) and will be requested to participate in a second post-test questionnaire (T3, about 6–8 weeks after T2) to answer additional questions on their experiences through a brief phone interview (T3 is optional for migrants/refugees).

For all nine countries, the ethical review board of the participating university (hospital) has assessed and approved the protocol. If successful, the MentalHealth4All platform will be made publicly available to help improve access to mental healthcare services, as well as HSCPs’ cultural competencies in delivering such services, for any LLP migrants and refugees across Europe (and beyond). Findings will also be disseminated through peer-reviewed journals and conferences.

The ‘MHealth4All project’ was prospectively registered on Open Science Framework, DOI: 10.17605/OSF.IO/U4XSM.

Regular physical exercise has well-known health benefits and is generally considered safe for adults with congenital heart disease (ACHD). However, many individuals with ACHD remain insufficiently physically active. This study explored the barriers and needs related to physical exercise as experienced by people with ACHD to inform the development of tailored strategies that support and promote increased physical activity.

Qualitative study using semistructured interviews conducted between March and May 2023. The interview guide was based on the Fear Avoidance Model, Tampa Scale for Kinesiophobia Heart and European Society of Cardiology guidelines on sports cardiology and exercise for cardiovascular diseases. Interviews were coded and thematically analysed to identify specific physical exercise barriers and needs.

Data saturation was reached after interviewing 19 individuals living with ACHD (median age 46 years (range 24–75), 10 women). Thematic analysis identified four main barriers: (1) physical symptoms and negative past experiences, (2) alienation from peers, (3) perceived decline in physical fitness over time and (4) lack of knowledge about personal physical boundaries. Two needs were identified: (1) personalised, disease-specific exercise information and advice and (2) structured support and guidance from healthcare professionals.

People with ACHD face multiple barriers to engaging in physical exercise. There is a clear need for specific, personalised exercise advice from healthcare providers and the development of long-term programmes and interventions to overcome relevant barriers.

Perinatal care continuity across the full continuum is essential for optimising maternal and infant health; however, a stark gap occurs post partum, with less than one half of Indian mothers receiving postpartum care due to significant logistical and sociocultural barriers, particularly for periurban and rural residents. To overcome these barriers and reduce women’s postpartum isolation, our international team of maternal and infant health clinicians and researchers developed and pilot-tested a culturally-tailored mobile interactive education and support group intervention, Kushal Maa (‘informed-mother’), confirming feasibility and acceptability and preliminary effectiveness. The current study seeks to estimate the effectiveness of the Kushal Maa intervention compared with standard care on maternal and neonatal health-related behaviours and health, characterise the mechanisms of intervention impact and evaluate the cost-effectiveness of the Kushal Maa intervention in improving postpartum maternal and neonatal health compared with the standard of care.

We will conduct a prospective, parallel block-randomised controlled trial with a 1:1 allocation ratio among 2100 pregnant women across three geographically diverse Indian states. Inclusion criteria for women: aged 18+years of age at enrolment, in the last trimester of pregnancy (30–33 weeks of gestation), with any parity, carrying single or multiple gestation (1-2), with knowledge of site-specific local language and had access to a mobile phone. Participants will be block-randomised in groups of 15. Intervention participants will receive 28 tailored education and support sessions weekly via audio/video conference facilitated by trained moderators (four prenatal and 24 weekly postpartum sessions through 6 months) and will be engaged in WhatsApp groups for health education videos and peer discussion via text chat. Control participants receive the standard of care. Data will be collected at four points: 30–33 weeks of pregnancy (enrolment), 6 weeks, 3 months and 6 months postpartum (endline). Investigators, outcome assessors and data analysts will be blinded to group allocation. Primary outcomes will be measured at 6 weeks, 3 months and 6 months post partum and include: postpartum depression (using Edinburgh Postnatal Depression Scale), exclusive breastfeeding and met need for postpartum family planning. Secondary outcomes include other maternal and child health knowledge, outcomes and maternal and newborn healthcare use indicators. We will use intention-to-treat analysis. Mixed-effects models will account for clustering due to the group-oriented delivery of the intervention and repeated measures.

This study has been approved by the Health Ministry Screening Committee, Government of India and approved by ethics boards at the Post-Graduate Institute for Medical Education and Research, Chandigarh (Ref:001208, IEC-06/2022–2471), Maharashtra University of Health Sciences (Ref: MUHS/EC/06/2024), Sangath (Ref: AB_2022_81) and the University of California, San Francisco (Ref: 21–35730). All research activities will be performed in accordance with the Declaration of Helsinki. On completion, findings will be disseminated to stakeholders through diverse strategies. Results will be published in academic journals and presented at conferences.

ClinicalTrials.gov: NCT05268588 Clinical Trials Registry – India: CTRI/2022/07/043889.

Neoadjuvant (chemo)radiotherapy (n(C)RT) followed by resection with total mesorectal excision (TME) constitutes the standard treatment for patients with locally advanced rectal cancer of the middle and lower third. However, n(C)RT has demonstrated no significant impact on overall survival but is associated with adverse effects, including impaired sphincter and sexual function. We hypothesise that omitting n(C)RT in selected patients with a clear circumferential resection margin (CRM) >1 mm as determined through preoperative MRI is not inferior regarding local recurrence rate within 3 years after surgery. That treatment approach may show fewer adverse effects and be more cost-effective.

Selective neoadjuvant therapy of rectal cancer patients (SELREC) is a randomised controlled, parallel-group, open, multicentre, non-inferiority trial. The experimental intervention involves performing TME surgery without n(C)RT. In contrast, the control intervention adheres to German S3-guidelines, incorporating neoadjuvant radiotherapy (nRT) with a dosage of 5x5 Gy or a total of 50.4 Gy. Additionally, if applicable, concomitant chemotherapy (CT) based on 5-fluorouracil is administered, followed by TME surgery within less than 12 weeks. Adjuvant treatment according to guidelines is allowed depending on the (y)pTNM stage.

The inclusion criteria for this study encompass adult patients with primary adenocarcinoma of the rectum in whom the main tumour mass is located less than 12 cm away from the anal verge, as assessed via proctoscopy. Additionally, eligible participants are required to have a preoperative tumour stage determined by MRI of either T1 or T2 with lymph node involvement (N1) or T3 with no lymph node involvement (N0) or with lymph node involvement (N1) and no distant metastases (M0). The assessment of a clear CRM >1 mm, based on MRI, is another prerequisite for inclusion. A total of 1074 patients in approximately 35 centres are planned to be allocated to the trial.

The primary endpoint of the trial is local recurrence within 3 years after surgery. The primary estimand is based on the full analysis set using a logistic mixed model (margin 3%). The first secondary endpoint is no/minor low anterior resection syndrome (LARS) score at 2 years after surgery, and further secondary endpoints include survival outcomes and quality of life. Safety analysis involves describing the frequencies of major intervention-specific complications, such as the acute toxicity of n(C)RT according to CTCAE and perioperative morbidity and mortality according to Clavien-Dindo criteria.

SELREC is financially supported by the German Federal Ministry of Education and Research.

This trial has been prospectively registered in the German Clinical Trials Register.

Previously, the study had been approved by the responsible ethics committee of Heidelberg and the local ethics committees of the collaborating institutions before patient enrolment. Any protocol deviation that has an impact on relevant parameters such as study design, endpoints or patient safety will be reported to the responsible ethics committees.

The results will be published in a peer-reviewed scientific journal and on institutional websites.

German Clinical Trials Register DRKS00030567.

Treating modifiable risk factors of dementia may prevent or delay dementia cases by up to 40%. The ‘Strategic Multimodal Intervention in at-risk Elderly Indians for Prevention of Dementia (SMRUTHI INDIA)’ study will be conducted to establish a trial-ready cohort of elderly Indians who are at high risk of developing dementia.

The main aim of the study is to create and study a cohort of individuals at high risk of dementia in rural India, where we can do multiple intervention trials. The study uses the ‘Cohort Multiple Randomised Controlled Trial’ (cmRCT) design, which combines a cohort study with in-built provisions to do multiple randomised controlled trials. A large rural cohort of size 10 000 (four zones of India, through established Indian Council of Medical Research - Model Rural Health Research Units) will be followed systematically with yearly neuropsychological evaluation for 5 years (the current funding supports first 3000 participants). The study also proposes to design a multimodal ‘care bundle’ for the prevention of dementia, which is culturally tailored and context-specific to the Indian population. This intervention will undergo testing for feasibility in the hospital setting at the central coordinating site through a pilot randomised controlled trial (6 months, 30 participants). In parallel, the care bundle will be culturally and linguistically adapted and pilot-tested in 20 participants in each zone. The final curated care bundle (first intervention that is planned) will then be tested for efficacy in phase 2 of the SMRUTHI INDIA cmRCT cohort.

The study has received ethical clearance at the central coordinating site and at each of the four clinical sites by the Institute Research Committee of each site. The outcomes of the study will be disseminated to various target audiences, including research participants, general public, scientific community and policy makers through national and international conferences and events, social media, various community engagement activities and publication in peer-reviewed journals.

The study protocol is registered in the Clinical Trial Registry of India (CTRI/2024/01/061172).

This systematic review investigates the effectiveness of different communication strategies to increase COVID-19 vaccine uptake and willingness.

Systematic review and meta-analysis of randomised controlled trials (RCTs), following recommendations from the Cochrane Handbook and reporting according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guideline.

We searched the following databases until 27 July 2022: Cochrane COVID-19 Study Register, PsycINFO, CINAHL, Web of Science Core Collection and WHO COVID-19 Global literature.

We included RCTs investigating, any population, communication-based interventions to increase COVID-19 vaccine uptake and comparing these with no intervention (with or without placebo), another communication strategy or another type of intervention.

Screening, data extraction and bias assessment, using the Cochrane ROB 1.0 tool, were conducted by two authors independently. We performed meta-analyses if studies were homogeneous using the Review Manager (RevMan 5) software, synthesised the remaining results narratively and assessed the certainty in the evidence using the Grading of Recommendations Assessment, Development, and Evaluation approach.

We identified 49 studies reporting on the predefined four categories of communication interventions. Evidence from our meta-analyses shows that COVID-19 vaccine uptake may increase when education and information strategies are applied (risk ratio (RR) 1.23, 95% CI 1.17 to 1.28; high-certainty evidence) or social norms are communicated (RR 1.28, 95% CI 1.23 to 1.33; high-certainty evidence) compared with no intervention. The different communication strategies mostly have little to no impact on vaccine intention; however, there may be a slight increase in vaccine confidence when gain framing is applied compared with no intervention.

Overall, we found that education and information-based interventions or social norm-framing strategies are most effective compared with no intervention given. Our findings show that some of the investigated communication strategies might influence policy decision-making, and our results could be useful for future pandemics as well.

PROSPERO (CRD42021296618).

This study aimed to investigate the association between the type and severity of disabilities and depression among adolescents aged 15–17 years living in underdeveloped areas of Indonesia.

Cross-sectional study.

Data were derived from the 2018 Indonesia Basic Health Research, a nationally representative data of Indonesia.

We used information collected from 4811 adolescents aged 15–17 living in underdeveloped areas of Indonesia.

The primary outcome was depression, based on the conditions experienced by respondents during the last 2 weeks.

The analysis showed that 5.65% of adolescents aged 15–17 years living in underdeveloped areas of Indonesia had depressive symptoms. Adolescents with severe physical and psychological disabilities were most at risk, exhibiting significantly higher odds of developing depression (aOR=12.09, 95% CI: 5.41 to 27.03, p0.001). Other significant predictors included female adolescents (aOR=2.18, 95% CI: 1.51 to 3.14, p0.001) and those who had a non-communicable disease (aOR=3.50, 95% CI: 1.00 to 12.18, p=0.049).

These findings highlight the critical need for targeted depression interventions and collaborative efforts to support vulnerable adolescents in underdeveloped areas of Indonesia, particularly those with disabilities, girls and those with non-communicable diseases. Efforts to engage healthcare providers, educators and policymakers to improve access to mental health resources will enhance the overall well-being of vulnerable populations.

This study assessed the health-related quality of life (HRQoL) and its relationship with clinical factors and comorbidities in people with type 2 diabetes mellitus (T2DM) treated in primary care settings.

Cross-sectional study design: This study assessed the HRQoL using a 36-item Short Form Survey (SF-36) tool in eight domains. The HRQoL scores ranged from 0% to 100% for each domain, with higher scores indicating better HRQoL. Linear regression was used to assess the association of HRQoL domain scores with clinical covariates and comorbidities.

A countrywide study was conducted on individuals with established T2DM (N=635) attending primary healthcare services for various conditions across nine federal states of Austria from 2021 to 2023.

A total of 635 individuals, aged above 50 years and diagnosed with T2DM, were recruited by the attending physician to evaluate their HRQoL in relation to T2DM and its associated comorbidities.

The mean SF-36 scores for physical functioning (69±28), role-physical (62±42), mental health (72±20), role-emotional (73±41), social functioning (79±25), bodily pain (67±28) and vitality (55±22) were satisfactory, except for general health (41±10). Age and body mass were inversely associated with physical, mental and social HRQoL (p

Our analysis showed that advanced age, obesity, depression, cardiovascular disease, chronic lung diseases and multimorbidity were associated with poor HRQoL of individuals with T2DM at the primary care level. These findings highlight the need for strengthening holistic management in primary care to address the diverse physical, social and emotional needs of individuals with T2DM.

Regular physical activity (PA) and good motor performance are essential for children’s physical and mental health. However, historical trends suggest that levels of PA and motor performance in children and adolescents are at a low point. The relationships between PA, motor performance, health and their respective determinants, as well as their individual development throughout childhood and adolescence, are not yet fully understood. Therefore, continuous monitoring of PA, motor performance and health is needed to identify vulnerable subpopulations and provide data for policy-makers and health promotion professionals. The Motorik Monitoring 2.0-Study aims to analyse the developmental, historical and periodic trends in motor performance and PA, as well as the underlying determinants, in children and adolescents in Germany.

A representative sample of children and adolescents aged 4–17 years is drawn across 195 sample points in Germany. The assessment, carried out by test instructors, includes (1) a PA questionnaire covering different settings, including determinants, (2) anthropometric measures, (3) fine and gross motor performance tests focusing on coordination, flexibility, strength and endurance, (4) 24 hours device-based measured physical behaviour by accelerometry for 1 week and (5) a health interview focusing on health behaviour, physical and mental health as well as socioeconomic status. In addition, external data may be linked to the study using geographical information systems (eg, area deprivation, access to sports facilities). Analyses will be conducted using mixed-effects models to account for the nationwide structure of the study.

Ethical approval was obtained from the Ethics Committee of the Karlsruhe Institute of Technology. Results will be published in open-access scientific journals and disseminated at congresses for scientists, policy-makers and stakeholders.

The study was registered in the NFDI4health database (https://csh.nfdi4health.de/resource/1034). The NFDI4health database is a central platform of the National Research Data Infrastructure for Personal Health Data. It is used to collect, manage and provide health data for scientific research and facilitates access to high-quality data for epidemiological and clinical studies.