Muscle-invasive bladder cancer (MIBC) is an aggressive type of cancer. About 50% of patients will die from the disease within 5 years despite radical treatment. This implies that in many patients, the disease has already spread at the time of radical treatment, even though imaging shows no signs of metastasis. We hypothesise that the standard local staging method, transurethral resection of the bladder tumour (TURBT), is partly responsible for tumour cell spread. Furthermore, TURBT (and re-TURBT in many patients) contributes to a significant delay to definitive therapy. The aim of this randomised study is to determine whether multiparametric MRI (mpMRI) of the bladder, in combination with a single outpatient bladder tumour biopsy for histological confirmation, is a safer, faster, less costly and, therefore, more cost-effective diagnostic pathway than TURBT to detect or rule out MIBC.

BladParadigm is a two-arm multicentre randomised controlled trial (RCT) conducted in the Netherlands. Over a 3-year period, patients with clinically suspected MIBC without evidence of metastases will be recruited and randomised 1:1 to either TURBT or 3-Tesla mpMRI with same-day outpatient bladder biopsy. The Vesical Imaging Reporting and Data System (VI-RADS) will be used to standardise mpMRI reporting. Patients will undergo definitive treatment based on the results of the TURBT or mpMRI. The study is powered to demonstrate that the mpMRI-based strategy is at least non-inferior to standard TURBT in patients treated with radical cystectomy alone, assuming a relative hazard of 0.55. The required sample size is 360 patients (180 TURBT, 180 mpMRI). The primary outcome is 2-year progression-free survival. Progression will be assessed by imaging, according to the current standard of care. Secondary outcome measures are time to definitive treatment, quality of life (EuroQol 5D-5L), healthcare costs and cost-effectiveness.

This study has received ethical approval from the Medical Ethical Committee Oost-Nederland (NL83685.091.23). All participants will provide written informed consent prior to inclusion. Findings of this study will be disseminated through peer-reviewed, open-access publications, presentations at scientific conferences and stakeholder briefings.

NCT05779631.

Diabetes is one of the most common long-term health conditions worldwide, placing a huge economic burden on health services. Diabetes self-management education and support programmes can support people with diabetes to manage their condition; however, uptake of face-to-face services remains low. Digital self-management tools are becoming increasingly available. MyWay Diabetes is a digital platform that offers a comprehensive self-management and education programme accessible through a mobile app and website and allows patients to access their personal healthcare records. Following successful implementation in Scotland, MyWay Diabetes is now being rolled out in three geographical areas in England. We plan to undertake three qualitative studies, as part of a larger mixed-methods research programme, to assess whether MyWay Diabetes is acceptable across diverse patient groups and healthcare professionals and gather views of patients who do not currently use the digital service.

We will conduct three online focus group studies. (1) One focus group with healthcare professionals (n=6–10) to understand their perceptions of implementing MyWay Diabetes in their local regions. (2) Up to four focus groups with existing users of MyWay Diabetes (n=24–40) across the three geographical areas in England to explore their acceptability of the platform. (3) Up to three focus groups with people living with diabetes who do not currently use MyWay Diabetes (n=18–30). Data will be collected using online videoconferencing and analysed thematically using template analysis.

Ethical approval was granted by South Central – Berkshire Research Ethics Committee (ref: 25/SC/0125) and The University of Manchester Proportionate Research Ethics Committee (ref: 2025-23064-42006). Study results will be disseminated through peer-reviewed journals, conference presentations, MyWay Digital Health platforms and national bodies. The evidence from this broader mixed-methods evaluation will inform decisions for platform improvement and regional and national commissioning across the National Health Service in England.