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.

To develop survey items for a national patient registry on Long COVID using a modified Delphi process.

This study was based on a modified Delphi process involving three rounds of anonymous, online surveys to develop consensus on and prioritise survey elements to be included in a minimum dataset for use in a national patient registry in Canada. Initial Long COVID items were identified through an environmental scan of the literature.

This study focused on healthcare systems in Canada and was conducted online.

A panel of 52 experts (patients, caregivers, clinicians and researchers) participated in all three rounds of the online survey. These participants were recruited through the Long COVID Web network and word of mouth.

In total, 243 survey elements related to care, quality of life and symptoms were included in round 1 of the survey. 200 reached consensus and moved to round 2 with two additional elements being developed based on open-ended responses. In round 2, participants ranked these survey elements and 34 advanced. In round 3, 33 survey elements met the threshold of consensus with one added a priori. The 33 survey elements were then used to develop a Long COVID minimum dataset, which consists of 48 items.

The findings affirm broad consensus for collecting data related to fatigue, post-exertional malaise, cardiovascular issues, respiratory problems and cognitive issues. This highlighted the desire for quality-of-life indicators and information related to care utilisation, quality and access.

This project explores the feasibility of setting up a neuropsychiatric de-identified database (DiD) and a Research Register (RR) to collect, analyse, monitor and systematically report clinical data for people with intellectual disabilities (PwIDs) and epilepsy.

A multicentre project designed to collect de-identified data from clinical records at three adult ID specialist services in England and Wales and to develop an RR of PwID and epilepsy. Patients added to the DiD will be identified from patient clinic lists, clinic letters, in-house databases and electronic systems. Patients to be added to the RR will also be identified through attendance for regular review at clinic appointments. The collected data will be entered into the Research Electronic Data Capture (REDCap) database. Personal details of PwID and their consultees will also be collected from participants who consent to be on the RR. Around 600 PwID and epilepsy (200 per site) will be added to the DiD at the three sites, while around 45–60 participants (15–20 per site) are anticipated to be added to the RR. Data analysis will involve using descriptive statistics to summarise feasibility outcomes, such as screening and recruitment rates, as well as the completeness of the collected data. The characteristics of the participants (demographic, ID classification, clinical, epilepsy history and antiseizure medication) will be summarised descriptively. Progression will be assessed using the Red/Amber/Green stop-go criteria to determine if a national register should be created.

Ethical approval (24/NW/0210) has been obtained from the Northwest-Haydock Research Ethics Committee and the University of Plymouth Faculty Research Ethics and Integrity Committee (reference no. 5284). The project is funded by Jazz Pharmaceuticals as an independent investigator-initiated support grant and, as such, has received independent peer review.

NCT06780501.

Childhood cancer treatment can cause subfertility in adulthood. Ovarian or testicular tissue preservation is a rapidly evolving field with significant potential benefits. However, the establishment of patient-centred reproductive survivorship pathways remains a challenge in clinical settings due to a lack of robust evidence to inform its development. Patient and public involvement and engagement (PPIE) consultation may help ensure that future studies align with patient needs and that tailored survivorship care pathways are developed for young people with preserved fertility tissue.

This PPIE consultation aimed to identify priority areas for future research that would support the development of a tailored survivorship care pathway for childhood cancer survivors who have preserved tissue for future fertility.

Recruitment occurred through national networks, including collaborations with advocacy groups such as Candlelighters and clinical networks. Data were collected via telephone or online unstructured interviews, with some supplementary email exchanges. Thematic analysis was used to identify emergent themes. The Guidance for Reporting Involvement of Patients and the Public (GRIPP)-2 guidelines were used to help guide PPIE.

An online focus group and/or a one-to-one interview with e-mail interactions.

In total, 12 unique participants took part in a focus group and/or interview. Participants included parents of children who had stored tissue, young adult cancer survivors with stored tissue and five clinicians from the leading National Health Service (NHS) centres in the UK.

Six key themes emerged that highlighted unmet needs and priority areas for research: (1) Lack of communication and information; (2) unmet needs in follow-up care; (3) emotional impact and psychological support; (4) importance of patient and parental involvement; (5) desire for information and education; and (6) long-term concerns and support. Parents, young adults and healthcare clinicians found talking about fertility issues difficult. They noted that consistency of care, education resources and access to emotional support were important areas where improvements could be made. We used thematic analysis to help identify patterns in the data, and we used the Guidance for Reporting Involvement of Patients and the Public (GRIPP)-2 reporting guidelines for PPIE work.

PPIE provided valuable insights into the experiences of childhood cancer survivors with preserved fertility tissue, their parents and clinicians, highlighting priority areas to guide future research and ensure it addresses the concerns of care recipients. Our findings suggest that childhood cancer survivors who preserve tissue for future fertility need personalised follow-up care with information and psychological support. A larger sample of participants, studied using a qualitative research design, is needed to capture the full range of experiences, needs and preferences and to ensure that care is inclusive and relevant to the wider population.