The length of hospital stay for patients with physical illnesses is longer for those with mental health comorbidity, particularly in the presence of severe physical multimorbidity. Integrating psychosocial risk screening at hospital admission, with a subsequent care pathway, could address psychosomatic and social care needs early and reduce length of stay. However, implementation may be hindered by organisational factors such as increased staff workload and timely integration into existing processes. In addition, patient factors such as low acceptance of screening and follow-up may affect uptake. This pilot study aims to assess the feasibility of implementing this integrated approach to screening and follow-up in preparation for a confirmatory trial.

The present study is a single centre, randomised feasibility study conducted on a pilot ward. Patients will be enrolled and assigned to the intervention or the control group. Only the intervention group will receive tablet-based psychosocial risk screening conducted by ward physicians or medical students in their practical year. If the psychosomatic screening is positive and the patient agrees, he or she is referred to the psychosomatic consultation service. If the social service screening is positive, the patient will be seen by a social worker. The main objective of this study is to assess the feasibility of conducting a full-sized confirmatory trial. An informed consent rate of 30% of eligible patients is set as the feasibility criterion. A study period of 4 months is planned for the feasibility study. The feasibility study will be analysed using descriptive statistics.

The study protocol was approved by the Ethics Committee of the Medical Faculty of Heidelberg University (S-301/2024) on 24 May 2024. The results of this feasibility study will be published in a peer-reviewed journal.

NCT06651164.

Non-communicable diseases (NCDs) currently contribute to over 50% of the global disease burden. Digital tools bear the potential to mitigate the risk of NCDs by facilitating personalised, preventive healthcare. It is therefore pertinent to examine the specific components that contribute to the success or constrain the impact of digital health interventions (DHIs), with particular attention to the sustainability of their long-term effects. Additionally, it is important to provide an up-to-date perspective on emerging interventions and technologies that have not yet been comprehensively addressed in the literature. This protocol defines the methodology for an umbrella review to synthesise the available high-quality evidence from systematic reviews and meta-analyses regarding effectiveness of DHIs in influencing the primary prevention of NCDs.

Using a rigorous search strategy, the subsequent databases will be searched in December 2025: MEDLINE, Web of Science, CINAHL, Embase, Scopus and Epistemonikos. Following the Joanna Briggs Institute (JBI) methodology, the selected literature will be screened based on predefined inclusion criteria. This includes systematic reviews and meta-analyses published within the last 5 years, without restrictions on country or language, that evaluate the effectiveness of any DHI aimed at the primary prevention of NCDs. Suitable full-text articles will be extracted by four researchers and independently assessed for methodological quality by two researchers using the AMSTAR-2 (A Measurement Tool to Assess Systematic Reviews) tool. The results will be presented in a summary table aligned with the review question and subquestions, accompanied by a narrative synthesis that explores the findings and their relevance to the research aims.

Ethical approval is not required as no primary data will be collected. The findings of this umbrella review will be published in a peer-reviewed journal and presented at academic conferences.

CRD420251139744.

To characterise the reporting practices of sequential multiple assignment randomised trials (SMARTs) in human health research.

Scoping review of protocol and primary analysis papers describing SMARTs published between January 2009 and February 2024.

SMARTs are innovative trial designs that allow for multiple stages of randomisation to treatment, with randomization potentially based on a patient’s response(s) to previous treatment(s). They are uniquely designed to develop sequential adaptive interventions (dynamic treatment regimes (DTRs)) to support personalized clinical decision-making over time. Previous reviews have identified inconsistencies in how the design, implementation and results of SMARTs have been reported in published studies. A comprehensive assessment of SMART reporting practices is lacking and necessary for developing standardised SMART-specific reporting guidelines.

We systematically searched multiple databases for SMART-related protocol and primary analysis papers published between January 2009 and February 2024. Title, abstract and full-text screenings were performed by pairs of reviewers, with disagreements resolved by consensus. Data extraction included study characteristics, design elements and analytical approaches for embedded or tailored DTRs. Results were synthesised qualitatively and presented descriptively.

From 5486 screened studies, 103 (59 protocol papers, 16 primary analysis papers, 14 protocol papers with corresponding primary analysis papers) met the inclusion criteria. Most studies targeted adults (62.7% protocols, 62.5% primary analyses, 42.9% protocol+primary analyses) and were primarily conducted in the USA. Behavioural and mental health constituted the most frequent therapeutic domain. While intervention descriptions and re-randomisation criteria were consistently reported, operational characteristics such as blinding (protocols: 64.4%, primary analyses: 62.5%, protocols+primary analyses: 71.4%) and randomisation details (protocols: 55.9%, primary analyses: 37.5%, protocols+primary analyses: 50.0%) were inconsistently documented. Only 46.7% of primary analyses evaluated embedded DTRs, and none explored deeply tailored DTRs.

Despite the increased adoption of SMART designs, substantial reporting variability persists. Most primary analyses underuse the capability of SMARTs to generate data for developing DTRs. SMART-specific standardised reporting guidelines can help accelerate the scientific and clinical impact of SMARTs.

Intermittent theta-burst stimulation (iTBS) is a non-invasive brain stimulation technique that has been shown to improve cognition and mood when applied to certain brain structures and regions. Despite research demonstrating that iTBS may have clinical utility in treating cognitive and mood changes, no study has yet been conducted to explore the potential to modulate the neurophysiological changes that can underpin cognitive and mood changes during the menopause transition. Cognitive and psychological symptoms are commonly reported by females experiencing the menopause transition, and it is thought that these symptoms arise due to various neurophysiological, metabolic and endocrinological changes. Despite being common, there is a lack of treatments available for managing these symptoms and a scarcity of data regarding the mechanisms by which they occur.

The aim of this 5-week randomised, sham-controlled, double-blinded pilot clinical trial (n=72) is to assess the underlying mechanisms of action of iTBS in females in the late menopause transition and the relationship with cognition and mood. Data will be analysed using Stata^TM. Normality checks will guide the choice between parametric and non-parametric tests. Generalised linear models will assess within-subject and between-subject effects across timepoints, with additional regression analyses exploring associations between biomarkers, cognition and mood. Effect sizes, CIs and relevant test statistics will be reported, with significance set at p

The study protocol has been reviewed and ethically approved by the Western Sydney University Human Research Ethics Committee (H16200; 8 November 2024). All participants will provide written informed consent prior to enrolment. Results from this trial will be disseminated via peer-reviewed publications and conference presentations, with findings shared in accordance with open science and data transparency principles.

ACTRN12625000030471, Australian New Zealand Clinical Trials Registry

This study aims to assess the feasibility of respondent-driven sampling (RDS) to recruit participants with recent abortion experiences in humanitarian contexts, and describe the composition of the study sample generated with this sampling method.

This was a three-phase mixed-methods community-engaged research study employing an exploratory and explanatory sequential approach. We conducted in-depth interviews, focus group discussions, an interviewer-administered questionnaire on abortion experiences and a health facility assessment.

Bidibidi Refugee Settlement, Uganda and Kakuma Refugee Camp, Kenya from November 2021 to December 2022.

Using RDS, we recruited 600 participants in Kakuma and 601 participants in Bidibidi with recent abortion experiences. In Kakuma, participants were primarily from Burundi, the Democratic Republic of the Congo and South Sudan; participants in Bidibidi were primarily from South Sudan. Most participants in both sites had completed at least some primary school and were not employed.

RDS recruitment dynamics: convergence and bottlenecks on key sociodemographic variables, recruitment and population homophily, reciprocity of social ties, success and experiences recruiting.

There were minor violations of RDS assumptions, particularly regarding assumptions of reciprocity of ties and seed composition independent of sample. In addition, there was a strong tendency of participants to recruit those from the same home country and living within the same camp zone. However, sample proportions for age, home country, marital status, zone of residence and student status reached equilibrium (stabilised) by around 500 participants at each site, and we were able to quickly attain the study sample size.

While the true representativeness of our sample remains unknown, RDS is a practical and effective recruitment method in humanitarian contexts for sensitive topics, particularly for research questions in which no data or sampling frames exist. However, attention to representativeness and community engagement is essential to optimising its application and ensuring success.

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.

Delirium is a critical and complex neuropsychiatric syndrome that significantly affects older adults in general hospital wards. Although multicomponent interventions have been shown to be effective in preventing delirium, the consistent implementation remains a challenge. Also, to manage the complex pathway of patients from admission to discharge in hospital, the involvement of the nursing staff is essential. Developing a nurse-led clinical pathway for delirium prevention could provide a structured approach to improving care quality. For intervention development taking account of the complexity of the clinical environment, the UK Medical Research Council framework is frequently used. A core element of this framework is mapping a programme theory that explains how, for whom and in what circumstances an intervention may work. The realist review methodology is well suited to uncovering the underlying mechanisms, contexts and outcomes of interventions, translating these into a programme theory.

The aim of this realist review is to develop a programme theory for a nurse-led clinical pathway to prevent delirium in older adults aged 65 years or older in general hospital wards and to identify strategies to support its effective implementation.

The realist review is based on the methodical framework developed by Pawson et al and further adapted by Rycroft-Malone et al and the reporting will follow the Realist And MEta-narrative Evidence Syntheses: Evolving Standards guidelines. The process comprises four steps: (1) defining the review scope; (2) systematically searching for and appraising the evidence; (3) extracting and synthesising findings and (4) developing a narrative synthesis. Interest holders, including clinical and academic experts, will be actively involved as an expert reference group to inform and refine the programme theory. The final programme theory will be presented in Context-Mechanism-Outcome configurations and the Implementation Research Logic Model.

Since no data are collected as part of the review, ethical approval is not required. Findings will be disseminated through academic conferences and publication in a peer-reviewed journal.

This protocol has been registered at Open Science Framework (https://doi.org/10.17605/OSF.IO/7EPTF).

Perinatal complications involving conflicts between maternal and fetal health interests present a unique challenge to health economic evaluations. No comprehensive synthesis exists of how such studies account for dual-patient outcomes. We aim to develop a scoping review protocol to map and critically examine the methodologies in this understudied area.

The scoping review will be conducted under the Joanna Briggs Institute (JBI) framework. It will include health economic studies, such as cost-effectiveness, cost utility and decision analysis studies, focusing on clinical conditions during pregnancy where maternal and fetal interests conflict. Cost analysis without effectiveness assessment will be excluded. Using comprehensive search strategies in Medline (Ovid), EMBASE (Elsevier) and Cochrane Library (Wiley), two independent reviewers will screen and identify relevant studies via abstract and full-text review. We will perform data extraction following an adapted form from the Consolidated Health Economic Evaluation Reporting Standards checklist, which includes the content details, such as the type of study, population, intervention, comparator, probability, utility, duration, cost, model types and uncertainty measurements. As we try to explore the impact of the health economic studies in clinical practice, we will include citation metrics of each study and whether the study was cited by practice guidelines and clinical trials in the data extraction. We will also apply the JBI Checklist for Economic Evaluations to assess the reporting completeness in each article. Results will be tabulated by clinical theme and synthesised narratively to highlight patterns in valuation approaches, gaps in current methods and impact on clinical guidelines.

This study does not require ethical approval as it involves secondary analysis of published data. Findings will be disseminated through peer-reviewed publications, conference presentations and stakeholder engagement activities.

CRD42024557324