The social determinants of health are the conditions in which people live and the systems around them that shape these conditions. Social determinants of health may affect diagnosis and treatment for people with multiple sclerosis (MS) even in countries with universal healthcare systems. This study will investigate whether a person’s age, sex and/or gender, living in a more socioeconomically deprived area and being of a minoritised ethnicity impact access to a diagnosis of MS and disease-modifying treatments (DMTs) for people living in the catchments of specialist neurology centres with a total estimated catchment population of approximately 7 million people in England and Wales.

EQUITY-MS is a multicentre retrospective cohort study using routinely collected healthcare data. Study participants are people aged 16 and above who received a new diagnosis of MS between 1 January 2018 and 31 December 2024 while living within the catchment of five specialist neurology centres (located in Leeds, Bradford, Greater Manchester, Cardiff and East London). Data will be collected from patients’ hospital records by clinical teams. The primary outcome is the length of time between MS diagnosis and prescription of any DMT. Secondary outcomes are prescriptions of a high-efficacy DMT and the duration between patient-reported symptom onset and MS diagnosis. We plan to adjust for clinical and demographic factors that could impact prescribing decisions.

The study was approved by the North West–Greater Manchester East Research Ethics Committee (National Health Service) (25/NW/0184) on 14 August 2025. Results will be published in peer-reviewed journals, and summaries will be provided to local MS societies and disseminated via the study website (https://bradfordresearch.nhs.uk/bradford-centre-for-health-data-science/equity-ms/).

Endometriosis is associated with reduced pregnancy and live birth rates in patients attempting both spontaneous and assisted conception. At present, it is unclear whether prepregnancy surgery for moderate or severe endometriosis, either in the setting of established infertility or even before a woman has begun trying to conceive, confers any benefit in terms of (a) spontaneous conception, (b) conception with assisted reproductive technology (ART), (c) live birth or (d) other obstetric outcomes.

The Endometriosis Longitudinal Fertility Study (ELFS) is a multisite prospective longitudinal cohort study, recruiting patients

The Austin Health Ethics Committee approved the ELFS protocol (HREC/65683/Austin-2020). On study completion, results of the trial will be submitted for publication in a peer-reviewed journal. Interim experiences with the ELFS App as well as relevant secondary outcomes will be presented at international conferences with additional goals for publication.

ACTRN12621000431820.

The Human Early Life Exposome (HELIX) cohort was established to assess a wide range of environmental exposures (the exposome) during early life and study the effects of the early life exposome on child and adolescent health outcomes and molecular omics signatures. Here, we describe the second follow-up of the HELIX cohort during adolescence, including measurements available and population characteristics.

HELIX is a collaborative study across six established and ongoing population-based birth cohort studies in six European countries (France, Greece, Lithuania, Norway, Spain and the United Kingdom). The cohort includes 1663 mother-child pairs recruited during pregnancy from 2003 to 2009 and followed up during childhood at 6–12 years from 2013 to 2016. This update summarises the most recent follow-up during adolescence (12–18 years) which took place from 2020 to 2022 and included 864 participants.

HELIX data have been used extensively in more than 100 publications, specifically pioneering the implementation of exposome approaches to address questions around the occurrence and effects of multiple exposures to real-life pollutant mixtures. These findings have improved our understanding of how multiple exposures co-exist and which exposures are driving the early-life exposome. Further, HELIX data have been used in exposome-wide discovery analyses to examine child health outcomes and used high-throughput omics techniques to characterise the internal exposome.

Although no additional follow-up visits are currently planned, HELIX will remain an active exposome research resource for years to come. The cohort will leverage its comprehensive database and extensive biobank to investigate complex exposure-omics-health relationships and measure additional biological markers.

Although often treated as separate social issues, youth homelessness and sex trafficking overlap as homelessness can be both a cause and a consequence of being trafficked. The primary goal of this scoping review is to understand the existing evidence on interventions for youth who have experienced homelessness and/or sex trafficking. We will identify potential differences in intervention design based on gender and Indigeneity and for youth who identify as two-spirited, lesbian, gay, bisexual, transgender and/or queer.

We will use the scoping review framework originally developed by Arskey and O’Malley and later refined by Peters et al. Ongoing consultation will mainly occur through a Lived Experience Expert Committee, which consists of eight survivors of youth homelessness and sex trafficking, chaired by two survivors. This review was registered with the Open Science Framework and will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines. We will search for articles published between 2015 and 2026 in MEDLINE (Ovid), PsycINFO (Ovid), Cumulative Index to Nursing and Allied Health Literature (EBSCO), Social Work Abstracts (Ovid) and Applied Social Sciences Index and Abstracts (Proquest). We will include both published and unpublished literature from high-income countries that report on interventions or programmes supporting social, economic or post-traumatic growth for young people aged 16–29 who have experienced homelessness or been involved in the sex industry. Data will be extracted using Covidence software and charted using a piloted data-charting table. Data will be analysed both quantitatively and qualitatively. Frequency counts will be produced for each data extraction category. We will apply basic qualitative content analysis to map the various types of interventions and identify characteristics of the articles, such as data on subpopulations.

This scoping review does not involve human participants and therefore does not require approval from an institutional ethics board. However, we are dedicated to ongoing reflexivity, authentic partnerships with lived experience experts, fair compensation and efforts to reduce the risk of retraumatisation. The scoping review will inform the development of an intervention for youth who have experienced homelessness and sex trafficking and will be codesigned with lived experts. We will also disseminate our findings in peer-reviewed journals and through conference presentations.

To investigate the impact of decentralisation on communication, trust and professional relationships in the context of clinical trials and to identify practical strategies to support coordination and oversight in decentralised clinical trials (DCTs).

Qualitative interview study using semi-structured interviews and thematic analysis.

International decentralised and hybrid clinical trials conducted across multiple therapeutic areas and healthcare contexts.

Thirty-one stakeholders involved in the design and delivery of DCTs, including investigators, trial managers, administrators, industry personnel and service vendors.

Participants were purposively sampled from a series of DCT case studies. Semi-structured interviews were conducted via videoconferencing, audio-recorded and transcribed verbatim. Data were analysed using a thematic framework approach to identify themes relevant to communication, coordination and trial oversight. Reporting followed the Standards for Reporting Qualitative Research guidelines.

Three interrelated themes were identified. First, DCTs operate as complex networks of formal and informal connections through which information, responsibilities and decisions flow. Second, effective communication and trust-building were viewed as central to participant safety, protocol adherence and collaboration, but were more difficult to establish in remote trial contexts. Third, unclear roles and responsibilities contributed to communication delays, coordination challenges and increased operational risk. Participants highlighted the value of proactively clarifying responsibilities and communication pathways during trial set-up and delivery. A social network perspective was identified as a useful heuristic tool for understanding these dynamics.

DCTs place increased demands on communication, coordination and relationship-building across distributed teams. Proactively clarifying roles, responsibilities and communication pathways may support more effective trial delivery and oversight. Although focused on DCTs, these findings are relevant to other digitally mediated and multi-stakeholder models of health research delivery.

N/A

Drowning remains a substantial global health challenge, and research in this area predominantly relies on observational study designs due to ethical, practical and administrative limitations. Although the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement is available, adherence within the drowning research community has been inconsistent and frequently incomplete. Consequently, essential methodological components and drowning-specific factors are often under-reported or inconsistently described, impeding quality, reproducibility, critical appraisal and evidence synthesis.

This protocol outlines the development of an extension to the STROBE statement, specifically for reporting observational studies in drowning epidemiology (STROBE-D). The proposed extension aims to provide structured guidance for authors, reviewers and editors, thereby enhancing the clarity, transparency and comparability of reporting practices.

The development of the STROBE-D statement will follow established recommendations and methodological frameworks for guideline creation. The process will include a scoping review and initial draft preparation, a two-round modified Delphi process using surveys with multidisciplinary and international expert participation, an expert consensus meeting to finalise the content and manuscript, public comment with interest-holder involvement and a final revision before submission for peer review.

The Committee on Health Research Ethics in the Region Zealand of Denmark waived the need for ethical approval as this is a consensus study (EMN-2025-09099). Findings will be disseminated through open access peer-reviewed publications, targeted communication through professional networks, conferences and social media platforms. The STROBE-D statement will serve as an extension to the STROBE statement, specifically tailored to observational studies in drowning epidemiology to improve consistency and transparency. Simultaneous publications of the original STROBE-D statement and the accompanying explanation and elaboration paper will be pursued in line with existing best practices.

Bloodstream infections (BSIs) are a major cause of morbidity and mortality worldwide. Although recent clinical trials have increasingly adopted patient-centred outcome measures, patient-informed selection of outcome measures remains limited in infectious disease research. Greater deliberate engagement and partnership with patients and families are required to ensure that outcomes reflect priorities that are meaningful to those with lived experience. Our study aims to incorporate patient-informed perspectives into outcome selection for BSI clinical trials.

We will undertake an exploratory sequential mixed methods study nested with the currently running international BALANCE+ trial of Gram-negative BSI (NCT06537609). All study materials will be co-developed and piloted with patient partners. Phase I will consist of virtual focus groups with past patient and family member participants of the BALANCE+ trial from intensive care and ward settings (total of 24–40 participants), using purposive sampling to maximise variation across demographic characteristics. Data will be audio-recorded and transcribed verbatim and analysed thematically using dual independent coding and consensus methods. Phase II will encompass development and administration of a survey (total ~100 respondents) to rank and prioritise outcomes identified in phase I, with responses descriptively summarised and integrated with qualitative findings. In phase III, virtual meetings with relevant parties including patients/families and investigators/study team members in the infectious disease field will be held to generate consensus-based recommendations and inform implementations with BALANCE+ and future trials.

Ethics approval has been obtained from the University of Calgary for all study activities and participating BALANCE+ sites to enable recruitment. Study findings will be disseminated through peer-reviewed publications, community engagement, conference presentations and integration into ongoing and future trials.

Diabetes mellitus is a global epidemic affecting hundreds of millions of people worldwide. The diabetic foot is among the most serious complications, and it is estimated that between 15 and 25% of patients with diabetes mellitus develop ulcers during their lifetime. The costs for the treatments of foot ulcerations are enormous, and thus prevention and early personalised treatments are a priority. Many traditional clinical and metabolic analyses have been performed, but these should now be supported by modern specific multi-instrumental measurements.

This is a no-profit, multicentre national study aimed at the prevention of complications in the diabetic foot. It is an interventional clinical trial, without medications or medical devices, involving two populations of patients with diabetes mellitus type-2. A first population has no previous history of foot ulceration but has a moderate ulcerative risk (International Working Group on the Diabetic Foot (IWGDF) grade 2); this will receive state-of-the-art clinical assessments and metabolic analyses in one centre, together with thorough biomechanical and functional analyses in a second centre and advanced biological and biochemical analyses in a third centre. A second population is affected by diabetic foot, had foot ulcers (IWGDF grade 3) but these must have been resolved for at least 6 months; in the centre in which they are recruited, they will receive state-of-the-art clinical assessments and metabolic analyses, together with advanced biological and biochemical analyses. Internationally established scores will be used in the three centres. Comparison of all these measurements between the two populations is performed at baseline (T0) and at 12-month follow-up (T1). Biomechanical analyses include multi-segment foot kinematics with stereophotogrammetry, plantar pressure with instrumented platforms and also 3D reconstructions of foot bones, tissues and calcifications from most modern CT scans in weight-bearing.

The primary objective is to compare the clinical and metabolic condition together with the biological and biochemical biomarkers in the two populations. Secondary objectives are (a) creation of a database for reference on metabolic conditions and structural and dynamic alterations of the diabetic foot in correlation with risk of ulceration; (b) comparison of the measurements at T0 and T1 of all the measurements; and (c) analysis of possible correlation between biomechanical parameters and the onset of ulceration in the first population. In other words, possible novel biomechanical and biochemical based biomarkers for the risks of ulceration are searched.

The present study wants to contribute in a possible future limitation of the incidence of foot ulcerations in patients with diabetes mellitus, through careful screenings, risk stratifications and thorough monitoring. The study finally combines traditional assessments with modern multi-instrumental measuring techniques being supported by a multidisciplinary investigative approach.

The present study protocol has been recently approved by the local ethical committees (‘Comitato Etico di Area Vasta Emilia Centro – AVEC’, and ‘Comitato Etico della Romagna – CEROM’). Written informed consent will be collected for all the participants. Findings of this study will be disseminated through peer-reviewed publications and conference presentations, as always and frequently done by the present authors.

Clinical study ‘Strategie multifattoriali per la prevenzione dei rischi di ulcerazione in pazienti affetti da piede diabetico’, prot. DARE-DiaFoot, promoted by Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Ortopedico Rizzoli:

Clinical study ‘Strategie multifattoriali per la prevenzione dei rischi di ulcerazione in pazienti affetti da piede diabetico’, prot. DARE-DiaFoot, promoted by Istituto Ortopedico Rizzoli, CET-CEROM, Reg. sperimentazioni n. 3875, Prot. 851/2025 I.5/5, local Principal Investigator Luca Dalla Paola, UO Piede Diabetico, Maria Cecilia Hosp, Cotignola (Ravenna)

NCT07021222.

Adolescent obesity is increasing worldwide, and a minority of adolescents are meeting recommended physical activity (PA) and dietary guidelines, particularly among adolescents from low socioeconomic areas. There are limited studies qualitatively investigating the engagement in healthy lifestyle behaviours in this population. Therefore, this study aimed to gain a greater understanding of perceived barriers and facilitators of healthy lifestyle behaviours, specifically PA and dietary behaviours, in this under-represented population.

Eight semistructured qualitative focus groups with 35 adolescents aged 13–15 years old were conducted across four European countries (Spain, the Netherlands, Greece, UK) following the Theory of Planned Behaviour framework which states that individual behavioural intentions are grounded on attitudes, subjective norms and perceived behavioural control. Discussions were centred on adolescents’ PA and healthy eating behaviours and were thematically analysed.

Regarding attitudes, adolescents understood the importance of healthy lifestyle behaviours but often failed to engage in them. Concerning subjective norms, friends and peers were perceived as barriers to PA, except during physical education (PE) classes. Positive relationships between pupils and teachers facilitated PA, and family influence primarily affected dietary behaviours. Regarding perceived behavioural control, the school structures including lack of space and time, as well as limited healthy food options in canteens and the COVID-19 pandemic were barriers to healthy lifestyle behaviours, while mandatory PE classes and school clubs facilitated PA.

In conclusion, despite adolescents recognising the significance of healthy lifestyle behaviours they often fail to engage in them. Their healthy lifestyle behaviours were influenced by their friends, families and teachers. The school structure and the COVID-19 pandemic were considered barriers to healthy lifestyle behaviours among adolescents.

NCT05002049.

To evaluate the feasibility, safety and acceptability of arm crank ergometry cardiopulmonary exercise testing (CPETarm) in patients with chronic limb threatening ischaemia (CLTI).

Prospective feasibility single-arm cohort study.

A tertiary vascular surgery referral centre in Greater Manchester, UK.

Adult inpatients admitted with CLTI and scheduled for non-elective vascular intervention.

Participants underwent bedside CPETarm using an incremental ramp protocol. Cardiopulmonary parameters measured included peak oxygen uptake, anaerobic threshold (AT), ventilatory equivalent for carbon dioxide at AT, peak work rate, oxygen pulse, maximum heart rate and respiratory exchange ratio.

Primary outcomes were feasibility domains including eligibility, recruitment, test completion, safety, practicality, implementation and patient acceptability. Secondary outcomes included the ability to obtain clinically relevant CPET variables for perioperative risk stratification.

60 patients underwent CPETarm. 74% of CLTI inpatients met eligibility criteria and 71% of eligible patients consented to testing. CPETarm was completed to volitional exhaustion by 95% of participants, with anaerobic threshold identified in 68%. No major adverse events occurred during testing or within 24 hours post-test. 90% of CPETarm assessments were completed within 48 hours of the decision to proceed with intervention, without delaying surgery. The procedure was well tolerated and acceptable to patients.

CPETarm is a feasible, safe and acceptable method for preoperative assessment in patients with CLTI who are unsuitable for conventional lower-limb CPET. Further research is required to establish modality-specific thresholds, evaluate prognostic value for postoperative outcomes and evaluate integration into perioperative care pathways.

NCT06404229.

Microbiome composition across multiple body sites, including the vagina, gut, urinary tract and semen, has been implicated in reproductive health and infertility. Vaginal dysbiosis and reduced Lactobacillus abundance have previously been associated with poorer outcomes in assisted reproductive technologies, yet few studies have simultaneously characterised microbiomes of both partners or compared infertile couples with healthy population controls. The BIOME study, a prospective cohort study, aims to characterise multisite microbiomes in infertile and healthy Danish couples and examine their association with long-term fertility outcomes.

The BIOME study is a multicentre, prospective observational cohort study including 100 couples undergoing fertility treatment following ≥12 months of unsuccessful pregnancy attempts and 100 healthy control couples. Participants provide biological samples from multiple body sites (vaginal swab or semen, faeces, urine and blood) prior to initiation of fertility treatment. Samples will undergo microbial sequencing, quantitative PCR, culture-based analyses, proteomics, metabolomics and microRNA profiling. Questionnaire data, clinical information and electronic medical record data will be collected. Participants will be followed for 5 years after sample collection to assess fertility outcomes. No intervention, randomisation or blinding is performed. Recruitment is planned over 24 months.

The study has been approved by the Danish Ethics Committee (#SJ-1033), and all participants provide written informed consent. Data are processed according to the General Data Protection Regulation and the Danish Data Protection Act, with pseudonymisation and restricted-access procedures. Results will be disseminated through peer-reviewed publications and scientific conferences. Sequencing data will be deposited in a public repository (eg, European Nucleotide Archive) with personal identifiers removed, and curated metadata will be available on reasonable request.