Subjective well-being, a measurement of quality of life, varies systematically across racialised groups. However, the use of inconsistent subjective well-being measures across academic disciplines results in conflicting subjective well-being findings for people racialised as Black or African American in the USA. The aim of this scoping review is to provide a comprehensive overview of how subjective well-being is measured for people racialised as Black or African American in the USA and to examine how subjective well-being reports differ between people racialised as Black and white in the nation.

This scoping review will use the Joanna Briggs Institute methodology and report findings according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines. A predefined search strategy was used on 17 April 2024 to search PubMed (includes MEDLINE), APA PsycINFO (ProQuest), Sociological Abstracts (ProQuest), EconLit (EBSCOhost) and Scopus for studies published in English. Articles will be included if they specify Black or African American population, subjective well-being, and include populations within the USA. Data will be extracted and presented quantitatively and qualitatively in tabular and/or figure form to describe the characteristics and conclusions of included studies, grouped by subjective well-being component and measure. Analysis will identify methodological inconsistencies and research gaps.

This study does not require review by our institution’s review board as primary data will not be collected in this study. The findings of this scoping review will be disseminated through peer-reviewed publications, conference presentations, and condensed summaries for key partners in the field.

10.17605/OSF.IO/M9GA8.

Dance is an artistic and social form of exercise and has been shown to be effective across the lifespan. Intergenerational dance programmes can have beneficial effects in reducing discrimination and fostering communities. Previous intergenerational dance programmes included small sample sizes or were not designed to target physical outcomes. There is a need for well-designed community-based intergenerational dance programmes to target the needs of older adults (OAs) and adolescents addressing physical activity, ageism and loneliness.

The aim of this study was to co-design and refine the content of an intergenerational dance programme with OAs and adolescents using the ‘six steps in quality intervention development framework’ (6SQuID). The objectives were to complete steps 1–4 of the 6SQuID framework and run a short pilot study with OAs.

A proof-of-concept pilot study.

The programme took place in a local community centre.

12 participants were recruited (n=5 adolescents; n=7 OAs). Adolescents were aged between 14 and 16 years. OAs were aged 60 years and older.

The intervention was led by a physiotherapist and dance teacher and comprised of intergenerational practice and social dance.

Outcome measures focused on physical activity, well-being, ageism and mobility. Accelerometers were used to establish programme intensity. Focus groups were conducted to explore the opinions of participants. Qualitative data were analysed using Thematic Analysis.

Six OAs and four adolescents completed the programme. The average age of OAs was 72.8±6.69 years and the adolescents were aged 14–16 years. The intensity of the classes was driven by participants, with some achieving vigorous intensity, and most achieving light-moderate intensity. This accounted for an average of 28.36 (±11.02) min of the class. The outcome measures were found to be meaningful for participants; however, more challenging balance measures were suggested by both cohorts. The social dance was enjoyable, especially when the music was tailored to participants’ preferences. Meeting with other age groups was valued, and it was suggested that more time should be given to icebreakers and socialising.

Intergenerational dance may be a promising way of improving well-being, intergenerational connections and achieving moderate-intensity activity. The process of designing an evidence-based intervention in this paper can be used to guide researchers and practitioners in designing an intergenerational arts-based programme.

To improve social determinants of health, healthcare organisations can support societal and economic goals in their role as anchor institutions (large organisations with an important presence and ties to a place). In England, the National Health Service (NHS) Long Term Plan highlighted the role of the NHS as an Anchor. Despite a clear policy mandate on this, less is known about specific indicators to measure and benchmark anchor performance. A set of metrics was developed to quantify anchor activity using the Greater Manchester (GM) region in England as a case study.

Descriptive cross-sectional study.

Data were received on employment and procurement for the financial year 2022/2023 from NHS trusts located in GM.

Performance against two anchor metrics, local spending and employment, was assessed. ‘Local’ was defined as the Integrated Care Board (ICB) footprint in which the trusts are located. The proportion of procurement spend to the local economy was derived from procurement data. Employment data was aggregated by ethnicity codes and deprivation levels and compared with ICB-level ethnicity and deprivation profiles using the Index of Multiple Deprivation based on 2021 Census data.

The included trusts employed 65 597 residents of GM and spent £389 million on local procurement, demonstrating their importance as anchor organisations. Considerable variation was observed between trusts in local spending, ranging from 6.4% (95% CI 6.4% to 6.41%) to 52.7% (95% CI 52.69% to 52.72%) (with the mean at 21%). The percentage of locally employed staff ranged from 82.7% (95% CI 81.45% to 83.90%) to 89.5% (95% CI 89.12% to 89.95%). All trusts demonstrate strong workforce representation from minoritised ethnic groups, but most employed a lower proportion of staff from the most deprived areas than expected based on the local population profile.

It is feasible to quantify aspects of anchor activity using routine NHS data, and meaningful variation exists across trusts, even within a single health system. GM provides a useful case study, but further work is needed to embed anchor metrics in routine reporting and to extend measurement to other domains such as estates and sustainability.

Risk reduction training for UK care home staff is limited, not standardised and challenging to implement. Virtual reality (VR) is an immersive, engaging method of education delivery that is being adopted in health and social care. VR may be an effective education tool in care homes, but this research has yet to be conducted.

The VR-CARE project aims to create a new VR risk reduction training programme for care homes that combines hand hygiene and falls prevention modules, and to evaluate this through a pilot trial to inform a future randomised controlled trial (RCT).

There are two research phases with patient and public involvement and engagement (PPIE) activities embedded throughout. Care home stakeholders are collaborating to design the training and toolkit, oversee methods, review resources for accessibility, support recruitment and ensure the project meets the needs of the workforce and positively impacts resident care.

In phase 1, we will use a mixed-methods and user-centred design approach to develop the VR training and an accompanying implementation toolkit needed to deliver it. The training will be developed and tested by 15 care home staff across three rounds to identify and inform changes that maximise usability and acceptability. We will conduct up to 20 interviews with staff from VR companies and care homes to support toolkit development.

Phase 2 is a mixed-methods pilot cluster RCT, with a waitlist control and process evaluation with up to 80 unregistered staff members from six North England care homes, to develop the measures and methods to inform a future trial. The process evaluation will generate knowledge about VR as a training mechanism in care homes. This phase will focus on the practicality of using VR, broader impacts (eg, on residents), contextual considerations and how it might be scaled up.

The University of Manchester Proportionate University Research Ethics Committee has approved phase 1 (Reference: 2025-24416-44642). We will obtain further approval before commencing phase 2.

Outputs will include user-friendly and acceptable VR risk reduction training for care homes, accompanied by an implementation toolkit adaptable for other VR training in social care settings. Materials (eg, training overviews, infographics and videos) will be developed to support uptake. Findings will be presented at conferences and published in journals. Lay summaries will be co-created with our PPIE group, and additional dissemination methods will be co-developed to broaden reach.

To understand how public health practitioners (PHPs) are using parental guidance on talking to children in their work with parents. In 2021, evidence-based guidance was produced for parents of young children to facilitate these conversations, but it is unclear how this guidance is being promoted to parents or used by PHPs.

Qualitative study, consisting of in-depth, semistructured interviews.

Local authority, National Health Service or other healthy weight service providers in the UK.

Participants were PHPs working on children’s healthier lifestyles programmes in the UK as part of the UK’s National Child Measurement Programme (NCMP). Invitations to participate were distributed via the Department of Health and Social Care and regional and national networks.

24 participants were interviewed. Practice varied between organisations with the guidance being used in NCMP letters to parents, in follow-up phone calls with parents and in training NCMP staff and other health or education professionals. Participants valued the evidence-based guidance and its compassionate tone, feeling it gave them and parents, confidence in addressing a sensitive topic. Some felt it was too lengthy for parents with learning disabilities or low literacy levels. Others identified a need for similar guidance for older children. Though helpful, participants acknowledged the guidance was only one small part of a necessary systems-wide approach to promoting healthy weight.

The guidance is a useful tool but needs systematic promotion to increase use and effectiveness. Further work is warranted to develop adapted versions for other populations.

Palliative care supports the physical, emotional, social and spiritual needs of people with serious life-limiting illness. Future research must align with the priorities of people approaching the end of their lives, and those close to them.

To undertake a refresh of the James Lind Alliance Palliative and End of Life Care Priority Setting Partnership, to identify and prioritise areas for future research.

The James Lind Alliance process was applied, between May 2023 and February 2025. An initial online survey collected areas for future research from participants. These were synthesised into a long list of questions and shortlisted through a second online survey. Final ranking of priorities was achieved using an adapted Nominal Group Technique within a prioritisation workshop.

People living with serious life-limiting illnesses, carers, friends and family members supporting them, bereaved people, health and social care professionals, volunteers working in palliative and end-of-life care and members of the public.

1032 and 626 responses were received to survey 1 and 2, respectively. 20 people with lived and professional experience attended the prioritisation workshop. An updated list of 24 priorities for palliative and end-of-life care research was produced.

The priorities reflect the range of issues shaping end-of-life experiences and serve as a call to action for researchers and funders.

Mobile health (mHealth) technologies have become increasingly popular for monitoring mental health symptoms and lifestyle behaviours, and are largely reported to be feasible and acceptable to users. However, to date, the efficacy of such technologies to improve perinatal mental health outcomes has been mixed. Within the perinatal context, much of this work has been done in the context of postpartum depression, stemming from electronic health records as well as cohort studies. There is, however, a dearth of studies focusing on depression in pregnancy, and machine learning-based clinical decision support systems remain underexplored. The HappyMums application has been developed to meet this need, and its use across Europe will be tested in this study.

A total of 1000 pregnant people currently suffering from, or at risk of, antenatal depression will be recruited across six countries. All participants will be between 13 and 28 weeks’ gestation and will be given access to the new purposefully developed HappyMums mobile application, to use from enrolment until 2 months postpartum. The application leverages passively collected data from smartphone sensors relating to physical activity and behaviour, as well as requiring active engagement from the user to complete mental health questionnaires and ‘game-like’ activities. Digital data types will be combined with traditional mental health measurement methods, such as standardised questionnaires and interviews, to develop novel predictive models capable of identifying mental health trajectories in women at risk of developing antenatal depression and to test the app’s utility for use as personalised risk prediction and depression identification tool. The primary outcome of this study is to determine what proportion of users will continue to use the mobile application and engage with its tasks and activities at least weekly, while secondary exploratory outcomes include assessing usability of the app and testing the predictive ability of a novel machine learning-based model. These outcomes will, for the first time, be assessed by integrating active as well as passive data.

Ethical approval has been granted by local research ethics committees in each recruiting centre. At King’s College London (leading the clinical study), the study was reviewed by the East of England—Essex Research Ethics Committee and granted favourable opinion (REC reference 24/EE/0129). All other sites collecting participant data have the study approved for local delivery. Findings relating to the primary and secondary outcomes will be submitted for publication in open access, peer-reviewed journals, as well as presentations at conferences as symposia or posters. Findings will be made available to a non-specialist audience through open access digital mental health magazines and promotion on social media.

NCT06578845.

Fetal alcohol spectrum disorder (FASD) is a diagnostic term that describes the neurodevelopmental and physical effects resulting from prenatal exposure to alcohol. Individuals living with FASD can experience lifelong challenges, yet with a diagnosis and sufficient support for the individual and their whānau (families), people can live fulfilling lives. Currently, little is known of the prevalence and impact in Aotearoa, New Zealand (NZ). Our aim is to identify the prevalence and understand the needs of young people living with FASD and other neurodevelopmental disorders in Youth Justice (YJ) residences in Aotearoa, NZ. One study will investigate the prevalence of FASD in this setting. The outcomes of both studies may demonstrate barriers and enablers, as well as strengths and gaps in YJ services of Aotearoa, NZ. The outcomes of both studies may guide reinforcing of current best practices as well as highlight necessary and novel initiatives together providing best support for the children and adolescents and their whānau as well as staff across YJ residences.

Extensive consultation with Māori and Pacific Advisory groups, researchers and experts in FASD and justice settings, individuals living with FASD and YJ staff together informed the development of this study.

Children and adolescents (hereafter young people) aged 10 to 18 years and currently residing in YJ residences are eligible for participation and assessment for FASD through assenting and consenting to provide personal and social histories and completed physical and neuropsychological assessments. The comprehensive FASD histories, screening and assessment will be conducted by a neuropsychologist and paediatrician employing standardised assessment practices and instruments. The team will also collect information from health, education and care and protection records; from the young people themselves; and from their family and staff. The study will reference Whakakotahitanga, the newly released (2024) guidelines for screening and diagnosing FASD in Aotearoa, NZ while also acknowledging the differences imposed under constraints of funding research including, for example, time and money. An individualised report will be prepared for each young person and their whānau. Study data will be analysed with descriptive statistics as appropriate. Our findings will be considered by the Māori and Pasifika advisory groups for framing and culturally secure translation, disseminated with all participating young people, translated to YJ services and staff, government and community neurodiversity sectors. Outcomes will be made available through community hubs, conferences, reports and peer-reviewed journal publications.

The study has received ethical approval from the Southern Health and Disability Ethics Committee (2024 Full 20065). Locality ethical approval has been granted from Oranga Tamariki (Ministry of Children), and a privacy impact evaluation has been undertaken. The findings will be shared through peer-reviewed publication, local and national conferences and with key agencies including Oranga Tamariki.

Vaccines are our best defence against infectious diseases, yet uptake of childhood immunisation programmes has consistently declined in the UK, with growing concerns around socioeconomic inequalities. Liverpool, in particular, demonstrated some of the lowest uptake rates in England since 2019. In response, the Health Equity Liverpool Project (HELP) implemented a hyper-localised community-led initiative between September 2023 and June 2024 to tackle vaccine hesitancy. Activities included outreach events and school-based engagement across nine sites within Liverpool. Despite promising qualitative evidence, the intervention’s impact on childhood vaccine uptake has not yet been quantified. We aim to evaluate the population level impact of the HELP intervention on the uptake of five childhood vaccines (first and second doses of the measles, mumps and rubella vaccine (MMR1, MMR2), 6-in-1 vaccine (diphtheria, tetanus, pertussis, polio, haemophilus influenzae type b and hepatitis B), pneumococcal conjugate vaccine booster dose (PCV) and rotavirus vaccine) using synthetic control methods.

We will analyse publicly available quarterly vaccine uptake data (between April 2019 and March 2025) from the Cover of Vaccination Evaluated Rapidly programme for general practices (GPs) in England. The intervention group will be defined as practices located within a 1 km radius of the intervention sites. A synthetic control group will be constructed using non-intervention GPs matched on pre-intervention vaccine uptake, and linked demographic, socioeconomic and healthcare capacity covariates. Primary outcomes are the uptake of MMR1 and MMR2 vaccines. Secondary outcomes include the uptake of 6-in-1, PCV and rotavirus vaccines. Average treatment effects will be estimated as the post-intervention difference in uptake between intervention and synthetic control groups. Sensitivity analyses will examine spillover effects, alternative spatial definitions of exposure, the biasing effect of concurrent interventions and the feasibility of analysis at small area neighbourhood level.

This study will be conducted as part of the ReCITE project, which has received ethical approval from the Liverpool School of Tropical Medicine Research Ethics Committee (Reference: 24–018) and is funded by the UK Arts and Humanities Research Council (Project Number: AH/Z505341/1). Findings will be shared with the project funder and submitted for publication in a peer-reviewed journal.

Falls are a significant health concern and associated with cancer survivorship. Falls can result in negative psychosocial consequences for cancer survivors and economic sequelae for healthcare delivery. There are cancer-specific fall risk factors relevant to cancer survivors which can contribute to increased fall risk. However, fall prevention may not be addressed in standard care for cancer survivors. This review aims to synthesise the findings from published research to explore the intervention characteristics and the effectiveness of fall prevention interventions on the incidence of falls and risk factors for falls in cancer survivors.

This systematic review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A systematic search in CINAHL Ultimate, PubMed, Scopus, Embase and supplementary search Google Scholar will be conducted in November 2025. We will include randomised controlled and controlled trials that describe the characteristics of the programme and report falls or risk factors for falls as outcomes. Title, abstract and full-text screening will be performed independently by two reviewers. The Tool for the assEssment of Study qualiTy and reporting in EXercise (TESTEX), Risk Of Bias instrument for Use in SysTematic reviews-for Randomised Controlled Trials (ROBUST-RCT) and Grading of Recommendations Assessment, Development and Evaluations (GRADE) tools will be used to assess the quality and certainty of evidence. We will provide a summary of the intervention characteristics and perform a meta-analysis or narrative synthesis of the findings as appropriate.

Ethics approval is not required for this systematic review as we will include papers published in peer-reviewed journals and original data will not be collected. The findings of this systematic review will be disseminated in a peer-reviewed publication and presented at relevant conferences.

ID 1240723.

Outcome from large vessel occlusion stroke can be significantly improved by time-critical thrombectomy but treatment is only available in regional comprehensive stroke centres (CSCs). Many patients are first admitted to a local primary stroke centre (PSC) and require transfer to a CSC, which delays treatment and decreases the chance of a good outcome. Access to thrombectomy might be improved if eligible patients could be identified in the prehospital setting and selectively redirected to a CSC. This study is evaluating a new specialist prehospital redirection pathway intended to facilitate access to thrombectomy.

This study is a multicentre cluster randomised controlled trial with included health economic and process evaluations. Clusters are ambulance stations (or teams) which are work bases for ambulance practitioners. Intervention allocated ambulance practitioners use the Specialist PrE-hospital rEDirection for ischaemic stroke thrombectomY (‘SPEEDY’) pathway which comprises initiation according to specific criteria followed by contact with CSC staff who undertake a remote assessment to select patients for direct CSC admission. Control allocated ambulance practitioners continue to provide standard care which comprises admission to a local PSC and transfer to a CSC for thrombectomy if required. A co-primary outcome of thrombectomy treatment rate and time from stroke symptom onset to thrombectomy treatment will evaluate the impact of the pathway. Secondary outcomes include key aspects of emergency care including prehospital/hospital time intervals, receipt of other treatments including thrombolysis, and performance characteristics of the pathway. A broad population of all ambulance practitioner suspected and confirmed stroke patients across participating regions is being enrolled with a consent waiver. Data about SPEEDY pathway delivery are captured onto a study case record form, but all other data are obtained from routine healthcare records. Powered on a ‘primary analysis population’ (ischaemic stroke patients with pathway initiation criteria), 894 participants will detect an 8.4% difference in rate and data from 564 thrombectomy procedures will detect a 30 minute difference in time to treatment. The full study population is estimated to be approximately 80 000. Regression modelling will be used to examine primary and secondary outcomes in several analysis populations. The economic analyses will include cost-effectiveness and cost–utility analyses, and calculation of willingness to pay at a range of accepted threshold values. The process evaluation involves semi-structured interviews with professionals and patient/family members to explore views and experiences about the SPEEDY pathway.

This study has ethical, Health Research Authority and participating NHS Trust approvals.

Dissemination of study results will include presentations at national and international conferences and events, publication in peer-reviewed journals, and plain English summaries for patient/public engagement activities.

ISRCTN77453332.

Musculoskeletal pain is a global issue affecting millions of individuals. Healthcare provider gender bias (HCP-GB) in pain management or treatment may have implications. This study aimed to systematically (1) identify and map the scientific and grey literature as it relates to HCP-GB in the assessment, diagnosis and management of musculoskeletal pain, and (2) identify current gaps that necessitate further research.

This scoping review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR).

The following databases were searched: PubMed (National Library of Medicine), Embase (Elsevier), Scopus (Elsevier), CINAHL Complete (Ovid), Academic Search Complete (EBSCOhost), Pre-Prints Database (National Library of Medicine) and Rehabilitation Reference Center from inception to August 2022 and updated in May 2025. Relevant grey literature was identified.

All screening was performed by two reviewers during title/abstract screening and full-text screening stages. Articles published in English, Spanish and German were included if they involved participants with musculoskeletal pain and examined HCP-GB as the dependent variable.

Two reviewers independently extracted data from the bibliometric, study characteristics and pain science variables. Results were descriptively mapped, and the frequency of concepts, population and characteristics was narratively reported.

21 full-text articles were included. All articles were published in North America and Europe. A total of 3694 healthcare providers from various specialty areas were examined. A majority of studies (57.1%; n=12) measured HCP-GB using written case vignettes, 33.3% (n=7) used case vignettes plus virtual human pictures/videos, and 9.5% (n=2) used real patients. The influence of patients’ sex in HCP pain assessment was reported in 28.5% (n=6) of the articles, while 42.9% (n=9) reported gender bias regarding HCP non-pharmacological treatment recommendations. Male patients were more likely to receive exercise recommendations for back pain and laboratory testing, whereas female patients received more psychological treatment recommendations and counselling from their HCP.

While there appears to be inconsistent use of the terms sex and gender, the literature informing this review suggests an existence of gender bias in the management of patients with musculoskeletal pain. Future research should be more purposeful in the use of sex/gender-related terms and consider exploring the impact of implicit bias training to rectify potential gender biases present in HCP.

To understand how reductions in resource allocation affect food safety services in England.

This longitudinal ecological study analysed secondary observational data.

England, data at the local authority level.

Ecological study, without human participants.

The primary outcome measures were the number of staff, represented by the number of full-time equivalents per capita, number of interventions per establishment, and proportion of hygiene-compliant establishments.

A £1 decrease in food safety expenditure per capita was associated with a 2% (–3.3 to –0.7) decrease in staffing levels and a 1.6% (–3.2 to –0.1) decrease in the number of interventions achieved per establishment. A one-unit reduction in staff was associated with a 42.2% (–80.5 to –11.9) decrease in the number of interventions achieved. No evidence of an association was found between expenditure or staff levels and the proportion of compliant establishments.

Spending reductions negatively affected the capacity of food safety teams to provide key services. Reductions in food safety expenditure significantly affected food hygiene staff levels and service provision. This finding raises concerns about the capacity of food safety teams to operate and the potential for increased public risk of gastrointestinal infections.

Leprosy remains a significant public health challenge in many low and middle-income countries, including India. People affected by leprosy face multifaceted challenges: physical, psychological, social and economic. In response, donors support self-help groups (SHGs) to improve health, social integration and economic circumstances for marginalised people, including those with leprosy. This study aims to assess the sustainability of SHGs in India after the withdrawal of donor support by examining whether they remain functional and exploring the key factors, barriers and facilitators that influence their long-term social and economic viability.

To examine the functionality of SHGs after withdrawal of donor support, and to explore the factors, barriers and facilitators influencing their long-term social and economic sustainability.

Using qualitative methods, we conducted semistructured interviews with 40 key informants associated with five SHGs formed under the Self-Help Community Development Project implemented in an endemic state of India and funded by The Leprosy Mission Trust India.

It was an exploratory qualitative study using interviews with SHG members and key informants, situated within the self-help community-based project.

While some SHGs demonstrated resilience and adaptability, others faced challenges such as internal discord, loss of members to migration and lack of access to government schemes. Thematic analysis revealed key drivers and barriers to sustainability and realising the benefits of SHGs, highlighting variations in leadership, governance, economic performance and social engagement across groups.

SHGs are often sustained after the funding and managerial donor support have been withdrawn. The findings emphasise the importance of strong leadership, community support and external facilitation in sustaining SHGs and enhancing their impact on marginalised populations. This study contributes to understanding the role of SHGs in addressing the socioeconomic challenges faced by individuals affected by leprosy and offers insights for improving their long-term viability.

Establishing comparability between measured outcomes in clinical trials poses a significant obstacle for systematic reviewers. Core outcome sets (COSs) were developed to address this issue. The macular degeneration (MD) COS is designed to standardise outcome measurement across clinical trials for MD. This study investigates the uptake of the MD COS in standardising outcome measurement across clinical trials.

Cross-sectional analysis

We conducted a search on ClinicalTrials.gov to locate MD clinical trials that were registered 5 years prior to COS publication through the search date of 26 June 2023 and obtained a pool of 2152 registered studies. After applying various inclusion and exclusion criteria, we analysed 159 trials. We then analysed the COS uptake using an interrupted time series analysis (ITSA) and performed performed analyses of variance (ANOVAs) and Pearson correlations to evaluate associations between trial characteristics and outcome measurement.

ITSA showed no significant change in uptake following the MD COS (2016): mean percentage of completion of the COS increased by 0.24% per month before publication (p=0.27) and by 0.07% per month after publication (p=0.62), indicating no meaningful post-publication slope change in COS use. For context, visual acuity was most commonly measured, while several patient-reported and disutility domains were infrequently captured.

No discernible patterns in COS usage for MD trials were observed. We recommend further collaboration between regulators and COS developers to help with COS uptake. Additionally, we suggest that further studies analyse adherence to COSs in respect to regulatory recommendations.

Etrasimod is an oral, once-daily, selective sphingosine 1-phosphate_1,4,5 receptor modulator for the treatment of moderately to severely active ulcerative colitis (UC). While etrasimod demonstrated efficacy in randomised controlled trials, understanding its effectiveness in an observational setting is crucial.

EFFECT-UC is a prospective, multinational, non-interventional study to evaluate the real-world effectiveness of etrasimod in adults with moderately to severely active UC. The study consists of a 52-week treatment period and a 28-day safety follow-up period and aims to enrol ~300 patients per cohort. Eligible patients (18–64 years) are advanced therapy naïve or experienced and are initiating etrasimod in a real-world clinical setting. Treatment will be guided independently by the clinician’s judgement. Patient-reported outcomes will be collected electronically throughout the study and daily for the first 2 weeks. Exploratory data, including faecal calprotectin, endoscopy and intestinal ultrasound, will be collected at predefined visits or during standard care. Primary endpoints are symptomatic remission at week 12 and week 52. Secondary endpoints include patient-reported outcome 2 (combined rectal bleeding and stool frequency subscores) response at week 12 and week 52 and corticosteroid-free symptomatic remission at week 52.

Ethics approval was obtained for all sites. Recruitment is underway for cohort 1, comprising patients from the UK, Germany and Canada. Interim results for this cohort are expected in 2026 and final results in 2028; these will be submitted for publication in peer-reviewed journals and presented at appropriate congresses.

NCT06294925.