Video-assisted thoracoscopic surgery (VATS) lobectomy is a commonly employed surgical technique for the management of operable early stage non-small cell lung cancer (NSCLC). This procedure, however, is dependent on the patient’s ability to tolerate surgery. In light of this, stereotactic ablative radiotherapy (SABR) has emerged as a viable alternative treatment strategy for patients who are inoperable or who refuse surgery. Considering the lack of randomised controlled trials and the increased risk of bias in observational cohort studies, this study protocol proposes an emulated target trial design to investigate the causal effect of SABR, in comparison to VATS, on overall survival in operable early stage NSCLC patients.

Data on NSCLC patients will be collected from routinely collected university hospital records linked with German cancer registry data. This study protocol was developed using the target trial methodology outlined by Hernan et al. The protocol establishes specific parameters for key trial components in order to mitigate bias in the analysis of observational data and to facilitate the calculation of causal estimands. The target trial design that would be emulated is a multicentre open-label two-parallel arm superiority randomised trial. Mediators and confounding variables were determined through the use of a directed acyclic graph. The statistical analysis aims to measure the per-protocol and intention to treat effect of SABR versus VATS within 3 months of diagnosis, on survival, through the difference in restricted mean survival times, using weighted non-parametric Kaplan-Meier curves.

The Ethics Committee of the Medical Faculty of Martin Luther University Halle-Wittenberg with an approved addendum with Dnr 2023–112 has approved this study. The study uses anonymised routinely collected hospital and cancer registry data in accordance with applicable data protection regulations. Results will be disseminated through peer-reviewed publications and presentations at scientific conferences.

The interfaces between the fields of communication, education and health have been indicated by international institutions such as the WHO and the European Centre for Disease Prevention and Control. However, hegemonic scientific practices supersede dialogue between the three fields, isolating their practices. This fragmenting tendency is observed in scientific literature, which has created gaps in the dialogue and articulation between communication, education and health. Although health promotion requires both communicative and educational practices, the epistemological, historical, political, cultural and socioeconomic aspects have also engendered tensions between the fields. Communication is often seen as a mere instrument for other practices, rather than a phenomenon that (re)produces meanings and power dynamics. In opposing the reductionist and instrumentalising perspectives of knowledge fields, the primary objective of the scoping review is to map the scientific evidence on the interfaces between communication and education in health to indicate a conceptual framework that articulates communication and education practices within the context of health.

A transdisciplinary team developed this protocol based on the 2024 Joanna Briggs Institute Manual for Evidence Synthesis. The procedures required to conduct the review were guided by the frameworks proposed by Arksey and O'Malley, Levac et al and Peters et al. The study eligibility criteria were established based on the Problem, Concept and Context outlined in the research questions. Primary and secondary studies will be retrieved from nine sources, covering both conventional and grey literature. These sources include Embase, ERIC, LILACS, PubMed/MEDLINE, ScienceDirect, Scopus, Web of Science, the Brazilian Digital Library of Theses and Dissertations, and the Networked Digital Library of Theses and Dissertations. A categorised form will be used for data collection and subsequent analysis. The reporting of the review findings will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews.

The nature of the research and the use of secondary data sources do not require informed consent forms or approval from ethics committees in Brazil. The scientific findings from the review will be disseminated through peer-reviewed journals, academic conferences and other scientific communication channels.

The protocol was registered on the Open Science Framework (OSF) and is available at https://doi.org/10.17605/OSF.IO/Z3CX7.

To address whether eating disorders (ED) or insulin omission (IOM) in adult persons living with type 1 diabetes (pwT1D) are associated with impaired glycaemic control.

Cross-sectional analysis.

The French-Speaking Diabetes Society—Type 1 Diabetes Cohort (SFDT1) is an ongoing epidemiological cohort study that includes pwT1D in France who attend hospitals or private ambulatory diabetes centres.

Adult participants from the SFDT1 study, with data on ED and IOM. The current analysis was performed on data collected during the baseline visit in participants enrolled between December 2020 and March 2024.

Using the SCOFF, a self-reported questionnaire to screen for ED, and a single question on IOM to screen for IOM, we described four categories of pwT1D: no ED & no IOM, ED & no IOM, no ED & IOM and ED & IOM. We performed unadjusted and adjusted (for age, sex, diabetes duration, social vulnerability, smoking, alcohol status and insulin treatment) multinomial logistic regression models with the four categories as the outcome and glycaemic variables as explanatory variables, including continuous glucose monitoring (CGM) variables and HbA1c. No ED & no IOM was the reference outcome for all comparisons. We stratified each model by sex and fear of hypoglycaemia.

We included 1113 participants, 51% males, median (IQR) age 38 (29–50) years, diabetes duration 21 (12–32) years. Prevalences were as follows: no ED & no IOM: 68% (n=758), ED & no IOM: 11% (n=124), no ED & IOM: 16% (n=177) and ED & IOM: 5% (n=54). With the fully adjusted model, and compared with the group no ED & no IOM, time in range (OR (95% CI) 0.5 (0.4 to 0.7)) and time below range (0.5 (0.3 to 0.8)) were inversely associated with ED & IOM. Moreover, time in range (0.4 (0.4 to 0.5)) was associated with IOM & no ED. Time above range (2.2 (1.6 to 2.9)), Glycaemic Risk Index (1.8 (1.3 to 2.5)), glucose monitoring indicator (2.2 (1.7 to 2.9)) and HbA1c (2.0 (1.5 to 2.5)) were directly associated with ED & IOM. We did not observe associations between CGM variables and ED & no IOM. Most associations were valid in both men and women. The associations were stronger in participants with a fear of hypoglycaemia. However, the associations remained even in people with a fear of hypoglycaemia.

Both ED and IOM are frequent in pwT1D, and IOM seems to be associated with impaired glycaemic control. As our analysis was cross-sectional, we cannot infer causality and cannot know whether IOM was a result of glycaemic control or the inverse (reverse causality). Our results suggest that IOM should be systematically screened in clinical practice. Further research is needed to better identify and care for EDs, with or without IOM, in T1D.

NCT04657783.

Shift work is associated with disrupted sleep, circadian misalignment and increased risks of adverse health, performance and safety outcomes. Although recommendations for shift workers typically focus on obtaining one long sleep period, many shift workers divide sleep into two episodes, referred to as biphasic sleep. Biphasic sleep may help mitigate sleep loss-related impairments, yet its prevalence, characteristics and potential benefits for shift working populations remain unclear. Existing reviews have examined sleep duration, mental health, or the consequences of shift work broadly, but none have specifically mapped evidence comparing biphasic and monophasic sleep between shifts. This scoping review will identify and summarise the available literature on biphasic sleep among adult shift workers. In addition, we will describe the outcomes and subsequently highlight any possible gaps to inform future research.

This review will follow the Joanna Briggs Institute methodology for scoping reviews and be reported in accordance with the preferred reporting items for systematic reviews and meta-analyses extension for scoping reviews guidelines. Biphasic sleep is defined as two distinct sleep episodes within a 24-hour period between work shifts, including two similarly timed sleep periods or one longer sleep combined with a shorter nap. A comprehensive search will be conducted in April 2026 in MEDLINE, Embase, PsycINFO, Web of Science and CENTRAL using controlled vocabulary (eg, Medical Subject Headings) and free-text terms related to shift work and split sleep. Peer-reviewed primary research examining biphasic sleep among adult shift workers will be included, and studies focusing solely on naps during work hours will be excluded. Two reviewers will independently screen titles/abstracts and full texts, with discrepancies resolved through discussion or by consulting a third reviewer. Data will be extracted using a standardised template including study characteristics, sleep parameters and reported outcomes. Results will be summarised descriptively and presented in tables and evidence maps. No statistical synthesis will be performed.

This scoping review will synthesise data from articles published in peer-reviewed journals. As no primary data will be collected and no human participants will be involved, the review is exempted from formal ethical approval. Findings will be disseminated in terms of a peer-reviewed publication and will inform future systematic reviews on sleep strategies among shift workers.

This project is registered with the Open Science Framework accessible at 10.17605/OSF.IO/WY7KJ.

Malnutrition is a highly prevalent chronic condition that contributes to higher morbidity and mortality in patients with multiple comorbidities. While positive effects of nutritional therapy in the in-hospital setting have recently been demonstrated, the benefits of long-term nutritional therapy after hospital discharge remain uncertain. Herein, we outline the design and rationale of the EFFORTII trial, the largest nutritional trial to date to assess the effects of continued nutritional support after hospital discharge in medical patients, with particular attention to key design decisions regarding nutritional strategy, patient selection criteria and study endpoints.

The Effect of Continued Nutritional Support at Hospital Discharge on Mortality, Frailty, Functional Outcomes and Recovery (EFFORTII) is an investigator-initiated, non-commercial randomised controlled trial designed to evaluate whether ongoing, individualised nutritional therapy after hospital discharge—targeted to meet specific energy and protein requirements—offers a cost-effective approach to lowering mortality, minimising complications and maintaining functional status compared with standard care. Eligible participants are adult, chronically ill medical inpatients at risk of malnutrition. Patients in the intervention group receive individualised nutritional therapy delivered by an experienced dietitian through a combination of telemedicine and in-person consultations. The intervention aims to meet personalised nutritional targets, supported by a trained dietitian. Control group patients receive nutritional counselling at discharge, but no structured nutritional management during follow-up. We designed the trial as an event-driven trial with a target of 247 mortality events (primary endpoint), which will be assessed over approximately 5 years until event-driven endpoint is met. The minimum total sample size is at least 802 participants, based on the assumed treatment HR of 0.70. The main trial is enrolling patients across multiple sites in Switzerland. During the trial, additional sites in Spain joined the study, and their data will be analysed using a patient-level pooled approach.

This study involves human participants and was first granted ethical approval by the Ethics Committee Northwest- and Central Switzerland and then by all participating local ethics committees. Written informed consent will be obtained from all participants. Findings will be disseminated in peer-reviewed journals and academic conferences.

NCT04926597.

Current expert consensus statements generally suggest cardiovascular risk assessment, including atrial fibrillation (AF) screening, on detection of covert brain infarctions (CBIs). However, evidence to guide management of CBI remains limited. In the absence of randomised clinical trials specifically targeting CBI populations, observational studies comparing individuals with and without CBI can provide insights into the prevalence and burden of cardiovascular risk factors.

We aimed to compare the burden of atherosclerosis and cardiovascular risk factors in participants with CBI to those without, and to explore the yield of AF screening in individuals with CBI.

A prospective population-based birth cohort study including men and women born in 1950 and resident in Akershus County, Norway.

The two hospitals serving the population of Akershus county, Norway.

Participants included in the Akershus Cardiac Examination (ACE) 1950 study who also underwent a subsequent MRI examination were eligible for this study.

Cardiovascular risk assessment was performed at study inclusion (2012–2015). Carotid ultrasound was used to quantify atherosclerosis through a carotid plaque score, and CHA₂DS₂-VA and Systematic COronary Risk Evaluation 2 (SCORE2) scores were calculated to estimate cardiovascular risk. Brain MRI was performed in a randomly selected, blood pressure-stratified subset of participants (2016–2024). CBI was defined as focal lesions consistent with ischaemia in the absence of clinical stroke. Participants with CBI were offered 72-hour ambulatory ECG monitoring for AF detection.

MRI was performed in 414 of 3706 (11%) participants in the ACE 1950 Study. The mean age at the time of the MRI examination was 70.2±2.3 years, and 165 (41%) were women. CBI was identified in 54 participants (13%), of whom 45 (83%) completed 72-hour ambulatory ECG monitoring. There were no differences in mean carotid plaque score, SCORE2 or CHA₂DS₂-VA score between participants with CBI compared with those with normal MRI findings. AF was detected in one (2%) participant with CBI.

In this community-based cohort of individuals in late midlife, individuals with CBI did not have an increased cardiovascular risk compared with those without, as indicated by SCORE2, CHA₂DS₂-VA score, age-appropriate carotid plaque burden and a low prevalence of AF.

URL: https://www.clinicaltrials.gov. Unique identifier: NCT01555411.

Food retail outlets in sports and recreation facilities often fail to support healthy eating, despite aligning with healthy lifestyles and goals of local governments (LGs) that often own or manage them. LGs face barriers to implementing facility changes including inadequate staffing, training and incentives. The Promoting CHANGE initiative was co-designed to support LGs in improving and sustaining healthier food and drink offerings in these settings.

A 3-year, type 2 effectiveness-implementation hybrid cluster randomised controlled trial will evaluate the Promoting CHANGE capacity-building and support package in three Intervention and four Control LGs in Victoria, Australia (August 2023–July 2026). The co-designed initiative includes human resource support, training, tools, technical assistance, community-of-practice groups, feedback based on food outlet audit and sales data and small grant incentives. Using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) evaluation framework, the trial’s co-primary outcomes are the percentage of least healthiest food and drinks (1) displayed (implementation) and (2) sold weekly (effectiveness). Key secondary outcomes are effectiveness (sales and revenue); facility-level adoption, implementation, maintenance of healthy changes; cost-effectiveness (within-trial modelled economic evaluation). Findings will provide evidence of the initiative’s effectiveness and scalability, informing recommendations for advancing healthier food environments in over 6000 community-based food outlets across 500 Australian LGs, with implications globally.

This study has received approval from the Deakin University Human Research Ethics Committee (reference number HEAG-H 92_2023). The results will be published in scientific peer-reviewed journals along with plain language summaries for participants.

ACTRN12621001120864.

A neglected area of patient safety research is how the characteristics of mental health staff and teams may influence incidents, specifically, through unintended and harmful consequences of clinical care. While the research literature into patient safety has increased, there is still a need to further consider safety on mental health wards, for example, the role of the staff team in containment and conflict. This review aims to explore the question, ‘How do staff and team characteristics relate to safety incidents in adult inpatient mental health settings?’.

The review will follow Whittemore and Knafl’s integrative review framework. CINAHL, Cochrane, Embase, MEDLINE, PsycINFO, Web of Science will be searched. Literature published after 1999, that includes extractable quantitative, qualitative and mixed methods data exploring the relationship between staff and team characteristics on incidents in adult inpatient mental health settings, will be suitable for inclusion. The Mixed Methods Appraisal Tool will be used for quality appraisal and data analysis and will comprise data reduction, display and comparison.

No new data or access to participants will be involved in this review. As such, ethical review will not be required. Dissemination will include publication in peer-reviewed journals and presentations at national and international conferences.

This review has been registered on PROSPERO (ref. CRD420251119981; https://www.crd.york.ac.uk/PROSPERO/view/CRD420251119981).

Immune checkpoint inhibitors (ICIs) have revolutionised cancer treatment through targeted disruption of the physiological pathways that maintain tissue tolerance, but which are co-opted by cancers to evade immunosurveillance. Thus, the resultant T-cell activity often causes immune-related adverse events including immune checkpoint inhibitor-induced inflammatory arthritis (ICI-IA). ICI-IA results in functional impairment that frequently persists, even after ICI discontinuation, with substantial quality-of-life impacts for cancer survivors.

A high-quality body of evidence to guide ICI-IA management remains an unmet need. Pharmacological treatment may be prolonged, typically begins with non-specific immunosuppression, including systemic steroids, and is usually only rationalised to more targeted therapy in resistant cases. Moreover, retrospective data suggest the high dose glucocorticoids sometimes used in new-onset ICI-IA may be associated with worse cancer outcomes.

Tumour necrosis factor (TNF) inhibition strategies are well established with excellent efficacy and safety profiles in ‘spontaneous’ inflammatory arthritides including rheumatoid and psoriatic arthritis. Mechanistic evidence from ex vivo and murine studies also supports the utility of anti-TNF therapy for steroid-refractory cases of ICI-IA. Although good clinical responses have been reported in this setting, the REACT trial (REmission induction of Arthritis caused by Cancer ImmunoTherapy) aims to provide randomised and robust clinical evidence for deploying targeted therapy earlier in ICI-IA management. It will test whether up-front anti-TNF therapy can more effectively and quickly control symptoms, reduce glucocorticoid exposure, prevent early ICI discontinuation and increase the frequency of drug-free ICI-IA remission.

REACT is a prospective, multicentre, open-label, superiority, two-arm, randomised controlled clinical trial to guide initial therapy for patients with ICI-IA. The trial will compare the current standard of care (initial prednisolone; Arm A) with the anti-TNF drug, adalimumab without glucocorticoids (Arm B).

The primary outcome is glucocorticoid-free arthritis remission rate at 24 weeks where remission is defined as: (i) No use of systemic or intra-articular glucocorticoids (except when used for adrenal insufficiency) within 4 weeks prior to assessment at 24 weeks; and (ii) absence of synovitis on clinical examination.

The protocol was approved by East Midlands—Leicester South Research Ethics Committee on 31-Oct-2024 (Ref: 24/EM/0202). Participants are required to provide written informed consent. The results of this trial will be disseminated through national and international presentations and peer-reviewed publications.

ISRCTN18217497.

Endometriosis is a chronic, oestrogen-dependent condition with a wide range of symptoms and comorbidities that significantly affect physical, emotional and psychological well-being, as well as quality of life. Women with endometriosis often face complex treatment decisions with no universally accepted gold-standard therapy. Shared decision-making, supported by patient decision aids (PtDAs), can enhance patient knowledge and promote informed preferences and decisions. Digital PtDAs, in particular, offer potential for personalised, interactive and accessible decision support. Their characteristics, development process and evaluation in endometriosis care remain underexplored. The objective of this scoping review is to map the existing literature on digital PtDAs developed for women of reproductive age (18–49) with endometriosis, across a range of healthcare and digital health contexts.

This scoping review will follow the Joanna Briggs Institute (JBI) methodology for scoping reviews. A comprehensive three-step search, developed with an information specialist, will be conducted across MEDLINE (PubMed), CINAHL, Embase, Web of Science, Cochrane databases and grey literature sources. Citations will be imported into Rayyan for screening. Two independent reviewers will conduct study selection, data extraction and analysis. Data will be summarised using tables and descriptive content analysis to identify key features, development processes and evaluation methods of digital PtDAs. The review will be reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines.

This review started off in July 2025, and the anticipated end date is November 2025. We plan to disseminate this research through publications, presentations at relevant national and international conferences and meetings with relevant stakeholders. This scoping review protocol has been registered at Open Science Framework (osf.io/fp86m). As this scoping review will use data from published and publicly available sources, research ethics approval is not required.

The Windrush Generation describes a group of individuals who migrated, primarily from the Caribbean to the UK between 1948 and 1971, many of whom are now entering older age. Now entering later life, many face ongoing health inequalities shaped by systemic racism and cultural marginalisation. Despite a growing number of ethnic minority residents in UK care homes, little is known about the lived experiences of Black African Caribbean people in these settings, particularly at the end of life.

This qualitative study explores the experiences of Black African Caribbean care home residents and their families, focusing on how race, identity and marginalisation shape care. Guided by the Silences Framework, semistructured interviews will be conducted with up to 16 participants across diverse care home settings. Data will be analysed thematically, with attention to under-represented narratives. A Patient and Public Involvement group of African Caribbean community members has codeveloped the study and will support analysis and dissemination to ensure cultural relevance.

Ethical approval has been secured (REC: 24/WM/0151; protocol number: RG_21087; IRAS project ID: 302629), and the study will follow rigorous consent and capacity procedures, including caregiver affirmation and UBACC assessment where needed. Given the sensitive, potentially distressing focus on racism, marginalisation and end-of-life experiences, the research will be conducted by an experienced clinician-researcher using a reflexive, ethically grounded approach that safeguards both participants and researcher. Interviews will be held in private, accessible settings with appropriate advocacy, safeguarding concerns will follow care home and national protocols, and all data will be securely stored, anonymised and managed under General Data Protection Regulation and university governance, with the University of Birmingham as sponsor and data controller.

A significant proportion of adults in England and Wales report experiencing childhood trauma, which is often associated with poor health and negative social outcomes including a significant increase in the risk of poor mental health outcomes in adulthood. This proposed scoping review adopts a broad definition of childhood trauma and applies both a salutogenic framework and ecological systems theory to explore how protective factors at five ecological levels can support mental well-being. The review will also examine how protective factors vary across different population groups and contexts.

The scoping review will follow the Joanna Briggs Institute (JBI) protocol for scoping reviews. The databases that will be searched are Embase, PubMed, Web of Science, PsycINFO, CINAHL and Medline. Studies will be included if they include protective factors and involve adults aged 18 and over who have experienced childhood trauma, whether self-identified, retrospectively self-reported or measured using a validated instrument. Studies will be excluded if they focus on participants under the age of 18.

All search results will be uploaded to Covidence, duplicates removed, and titles/abstracts screened by at least two reviewers based on inclusion criteria. Full texts of potentially relevant sources will be imported into EndNote 21. Reasons for exclusions will be documented and disagreements resolved through discussion or a third reviewer. The full process will be reported using a Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram. Data will be extracted by at least two reviewers using a tool developed by the team based on the JBI guidance. A best-fit framework analysis will be used, using a matrix developed by the researchers including the four salutogenic domains and the five levels of the ecological framework.

Formal ethical approval is not necessary for this scoping review as it does not involve the collection of primary data. The outcomes of this study will be disseminated through peer-reviewed journal articles, conference/seminar presentations, and developed into resources for stakeholders and collaborators.

Open Science Framework (DOI 10.17605/OSF.IO/CJRUY).