Global migration has steadily risen, with 16% of the UK population born abroad. Migrants (defined here as foreign-born individuals) face unique health risks, including potential higher rates and delays in diagnosis of infectious and non-communicable diseases, compounded by significant barriers to healthcare. UK Public Health guidelines recommend screening at-risk migrants, but primary care often faces significant challenges in achieving this, exacerbating health disparities. The Health Catch-UP! tool was developed as a novel digital, multidisease screening and catch-up vaccination solution to support primary care to identify at-risk adult migrants and offer individualised care. The tool has been shown to be acceptable and feasible and to increase migrant health screening in previous studies, but to facilitate use in routine care requires the development of an implementation package. This protocol describes the development and optimisation of an implementation package for Health Catch-UP! following the person-based approach (PBA), a participatory intervention development methodology, and evaluates our use of this methodological approach for migrant participants.

Through engagement with both migrants and primary healthcare professionals (approximately 80–100 participants) via participatory workshops, focus groups and think-aloud interviews, the study aims to cocreate a comprehensive Health Catch-UP! implementation package. This package will encompass healthcare professional support materials, patient resources and potential Health Catch-UP! care pathways (delivery models), developed through iterative refinement based on user feedback and behavioural theory. The study will involve three linked phases (1) planning: formation of an academic–community coalition and cocreation of guiding principles, logic model and intervention planning table, (2) intervention development: focus groups and participatory workshops to coproduce prototype implementation materials and (3) intervention optimisation: think-aloud interviews to iteratively refine the final implementation package. An embedded mixed-methods evaluation of how we used the PBA will allow shared learning from the use of this methodology within the migrant health context.

Ethics approval granted by the St George’s University Research Ethics Committee (REC reference: 2024.0191). A community celebration event will be held to recognise contributions and to demonstrate impact.

Process evaluation provides insight into how interventions are delivered across varying contexts and why interventions work in some contexts and not in others. This manuscript outlines the protocol for a process evaluation embedded in a hybrid type 1 effectiveness-implementation randomised clinical trial of incremental-start haemodialysis (HD) versus conventional HD delivered to patients starting chronic dialysis (the TwoPlus Study). The trial will simultaneously assess the effectiveness of incremental-start HD in real-world settings and the implementation strategies needed to successfully integrate this intervention into routine practice. This manuscript describes the rationale and methods used to capture how incremental-start HD is implemented across settings and the factors influencing its implementation success or failure within this trial.

We will use the Consolidated Framework for Implementation Research (CFIR) and the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) frameworks to inform process evaluation. Mixed methods include surveys conducted with treating providers (physicians) and dialysis personnel (nurses and dialysis administrators); semi-structured interviews with patient participants, caregivers of patient participants, treating providers (physicians and advanced practice practitioners), dialysis personnel (nurses, dieticians and social workers); and focus group meetings with study investigators and stakeholder partners. Data will be collected on the following implementation determinants: (a) organisational readiness to change, intervention acceptability and appropriateness; (b) inner setting characteristics underlying barriers and facilitators to the adoption of HD intervention at the enrollment centres; (c) external factors that mediate implementation; (d) adoption; (e) reach; (f) fidelity, to assess adherence to serial timed urine collection and HD treatment schedule; and (g) sustainability, to assess barriers and facilitators to maintaining intervention. Qualitative and quantitative data will be analysed iteratively and triangulated following a convergent parallel and pragmatic approach. Mixed methods analysis will use qualitative data to lend insight to quantitative findings. Process evaluation is important to understand factors influencing trial outcomes and identify potential contextual barriers and facilitators for the potential implementation of incremental-start HD into usual workflows in varied outpatient dialysis clinics and clinical practices. The process evaluation will help interpret and contextualise the trial clinical outcomes’ findings.

The study protocol was approved by the Wake Forest University School of Medicine Institutional Review Board (IRB). Findings from this study will be disseminated through peer-reviewed journals and scientific conferences.

NCT05828823.

Crohn’s disease (CD) and ulcerative colitis (UC) are chronic, inflammatory bowel diseases (IBDs) of unknown origin, affecting the gastrointestinal tract and often causing extraintestinal symptoms. Conventional treatments (eg, glucocorticosteroids, immunomodulators) and targeted advanced treatments, including anti-TNFα, antibodies to p40 subunit of IL-12/23, antibodies to p19 subunit of IL-23, anti-α4β7 integrin, Janus kinase inhibitors (JAKis) and sphingosine-1-phosphate receptor (S1PR) modulators, do not achieve sustained responses for all patients, leaving significant unmet therapeutic needs.

This prospective, multi-centre observational study will follow a cohort of 240 patients across multiple study centres within NHS trusts in the UK who are initiating or switching biologics, specifically anti-TNFα and anti-α4β7 integrin for UC, and anti-TNFα, antibodies to p40 subunit of IL-12/2 and JAKi for CD. Through comprehensive profiling of immunological, transcriptional, microbiome, genetic and proteomic markers at baseline, week 12, and week 52, this study aims to uncover non-invasive biomarkers that predict response to these drug classes, ultimately advancing personalised medicine in IBD.

Ethical approval for the Nottingham/AstraZeneca study was granted by the West of Scotland Research Ethics Committee. Recruitment began in December 2022 and is currently ongoing at 10 NHS Trust sites across the UK. Study findings will be disseminated by publication in peer-reviewed journals and presentations at relevant national and international conferences.

Internationally, the vision of a ‘Digital Trustworthy Evidence Ecosystem’ is being pursued with clinical practice guidelines (CPGs) as one element of such a system. Consequently, CPGs and CPG repositories need to be digitalised.

The objective of this prospective, before-after study is to evaluate the impact of digitalising a quality-assured CPG registry using the international data format standard ‘Fast Healthcare Interoperability Resources’ (FHIR). This includes the architecture of the registry, the format of individual guidelines and application programming interfaces to import and export CPG content. The study is guided by a scoping review.

The primary outcome is the usability of the digitalised CPG registry and CPG content for different user groups comprising CPG developers, CPG administrators, health care professionals and patients—including at the point of care in in- and outpatient settings—and technical professionals as users of CPG content in digital applications.

For the before-after comparison, semi-quantitative (surveys) and qualitative (focus groups) methods are applied. All user groups will be involved in a baseline analysis to assess user expectations and technical requirements. According to the results, the digitalised guideline registry will be implemented. The intervention comprises the testing of the digitalised registry with guideline content by all user groups. Analysis of outcomes will include formative and summative evaluation. Final results and further research needs will be discussed in a World Café with all stakeholders.

The Ethics Committee of the Berlin chamber of physicians, in accordance with its code of conduct §15 section 1 (Eth-KB-24-11) confirmed that no ethical approval is needed for this study. The study is registered in the German Clinical Trials Registry (No: DRKS00034111). Results will be presented at national and international conferences, published in peer-reviewed journals and on the website of the funding institution.

German Clinical Trials Registry (No: DRKS00034111).

Our study aims to investigate the associations between sexual minority stressors, resilience factors and substance misuse outcomes, using an intersectional framework to examine heterogeneities across sexual minority populations (SMPs) in the United States of America (USA). We hypothesised that stressors would be positively associated with substance use, and that resilience factors would be negatively associated, with these associations varying across intersectional strata.

The current study employed a secondary data analysis strategy to analyse cross-sectional data using Bayesian hierarchical modelling and Multilevel Analysis of Individual Heterogeneity and Discriminatory Accuracy (MAIHDA).

Data were obtained from the Generation Study Wave 1 (data collected from 2016 to 2018), a nationally representative cohort of SMPs in the USA.

The study included 1518 participants aged 18–59. Combinations of education, birth sex, sexual orientation, income and race/ethnicity defined intersectional strata. Participants were selected based on self-reported demographic and behavioural data.

Primary outcomes were the risks of alcohol use and drug use, measured using validated scales (AUDIT (Alcohol Use Disorders Identification Test) and DUDIT (Drug Use Disorders Identification Test)). Explanatory variables included resilience factors (social support, life satisfaction, social well-being and community connectedness) and sexual minority stressors (everyday discrimination, perceived stigma, healthcare stereotype threat and internalised homophobia).

In descriptive analyses, group differences on psychosocial scales were small to modest, with higher everyday discrimination in lower-income and Black participants. In Bayesian regressions, everyday discrimination was the strongest positive correlate of both alcohol and drug use, whereas perceived stigma was inversely associated. In MAIHDA models, demographic factors were associated with higher AUDIT among males and those with college-or-more education, and with higher DUDIT among low-income participants; relative to bisexual participants, gay (AUDIT) and lesbian (DUDIT) groups had lower scores. The strata-level variance component was small in null models and approached zero after adjusting for demographics and psychosocial factors, indicating that disparities are primarily driven by differential exposure to these factors rather than unexplained heterogeneity between strata.

While minority stressors and resilience factors are salient predictors of substance use among SMPs, their effects are consistent across diverse intersectional identities. The application of MAIHDA demonstrates that substance use disparities are better explained by the main effects of demographics and psychosocial experiences than by the unique combination of identities. This highlights the importance of universal interventions in reducing discrimination and enhancing resilience across the entire SMP population.

Programmes based on early childhood development (ECD) services play a vital role in improving child health and developmental outcomes. Across many countries, these programmes target children under 5 years of age—including those who are healthy, at risk or with developmental disorders—and are implemented in governmental and non-governmental organisations in both the health and non-health sectors globally. This protocol outlines a scoping review designed to systematically map and synthesise existing evidence on the components, implementation strategies and delivery mechanisms of ECD services worldwide. The review aims to inform the development of optimised and comprehensive interventions that support holistic child development.

This review will be conducted by Arksey and O’Malley’s framework and its recent advances. Several databases, including PubMed/MEDLINE, Scopus, Science Direct and Web of Science, Scientific Information Database, Magiran, IranMedex and Barakat knowledge network system, will be initially searched for studies up to December 2024. All searches will be done for published or unpublished articles/reports without time and language restrictions. Two researchers will independently carry out screening of the included studies and extraction of data. Any discrepancies will be resolved by consensus. In case no initial consensus is reached, a third researcher will be consulted to make a decision. The findings will be synthesised through the content-analysis method.

The findings of this review may offer a novel perspective for developing a comprehensive package of ECD services within the Iranian health system. Furthermore, it provides a detailed roadmap for researchers and stakeholders aiming to enhance child health and prevent developmental disorders. This study received ethical approval from Tabriz University of Medical Sciences (ID: IR.TBZMED.REC.1404.139), with no ethical concerns as it involves no patient participation or interventions.

Radiological imaging is a central facet of the multidisciplinary evaluation of suspected child physical abuse. Current guidelines for the imaging of suspected child physical abuse are often unclear, incomplete and highly variable regarding recommendations on critical questions, thereby risking clinical heterogeneity, unstructured decision-making and missed diagnoses. We, therefore, aim to develop and report an evidence-based and consensus-derived international guideline for the radiological investigation of index and contact children in the context of suspected physical abuse and to ascertain areas of scientific uncertainty to inform future research priorities.

The international guidelines for the imaging investigation of suspected child physical abuse (IGISPA) consensus group includes formal representation from 127 recognised experts across 14 subspecialties, six continents and 32 national and/or international organisations. Participants will be divided into five longitudinal subgroups (indications for imaging, skeletal imaging, visceral imaging, neuroimaging and postmortem imaging) with three cross-cutting themes (radiography, genetics and adaptations for low- and lower-middle-income countries). Each subgroup will develop preliminary consensus statements via integration of current evidence-based guidelines, systematic literature review and the clinical expertise of a multinational group of experts. Statements will then undergo anonymised voting in a modified e-Delphi process and iterative revision until consensus (≥80% agreement) is achieved. Final statements will undergo both internal and external peer review prior to endorsement.

As an anonymous survey of consenting healthcare professionals, this study did not require ethical approval. Experts provided written informed consent to participate prior to commencement of the modified Delphi process. The IGISPA consensus statement and any subsequent guidance will be published open access in peer-reviewed medical journals.

Poor chest health is the leading cause of early mortality in children with cerebral palsy (CP). It is also the most common reason to seek healthcare, accruing significant costs and reducing quality-of-life for children and families. Clinical trials examining chest health interventions in CP are characterised by inconsistent outcome measures, limiting the capacity for evidence synthesis to inform clinical application. The study aims to develop a core outcome set (COS) and related measurement instruments to assess, monitor and evaluate chest health in children with CP, both in research and routine clinical practice. The COS will reflect the views of children, young people, parent/carers, clinicians and researchers, emphasising under-represented groups in research and those at risk of poorer chest health.

A 3-phase methodology will be conducted in line with the Core Outcome Measures in Effectiveness Trials (COMET) Initiative. (1) Candidate outcomes will be identified through a qualitative evidence synthesis and interviews with key stakeholders. Findings will be mapped to COMET-taxonomy, generating a list of candidate outcomes. (2) An international e-Delphi survey will invite stakeholders to rate the importance of each outcome, followed by a consensus meeting to ratify the COS. (3) A structured review, guided by health measurement taxonomy, will evaluate relevant instruments, with a final meeting to agree on recommended measures for each COS domain.

Ethical approval was provided by the University of Plymouth Research Ethics Committee for the qualitative interview study (ID5116), e-Delphi study and consensus meeting (ID5636). Study findings will be published open access in a peer-reviewed journal and presented at relevant national and international conferences.

COMET registration: 2590 (https://www.comet-initiative.org/Studies/Details/2590)

CRD42024562735.