Glucocorticoid (GC) bridging therapy is recommended in patients with rheumatoid arthritis commencing a disease-modifying anti-rheumatic drug (DMARD). It is not clear whether GC therapy is better administered intramuscularly or orally and at what dose level. The aim of the LEADER trial is to identify the most effective and safest way of using steroids in patients with uncontrolled RA who are starting a DMARD.

A multicentre, randomised, open-label, four-arm, parallel-group clinical trial with an internal pilot phase, economic evaluation and qualitative study of acceptability. Participants will be randomised to one of four arms: arm A, 30 mg oral prednisolone tapering over 6 weeks; arm B, 15 mg oral prednisolone tapering over 4 weeks; arm C, Intramuscularly 120 mg methylprednisolone; and arm D, Intramuscularly 80 mg methylprednisolone. Participants will be assessed at baseline (pre-GC intervention), 4, 12 and 24 weeks. The primary outcome measure is the mean DAS(CRP)–28 over 12 weeks. The primary comparison will be according to route of administration (oral vs intramuscular GC treatment) with secondary comparisons within route of administration to provide evidence of dose effectiveness. Toxicity will be measured using the Glucocorticoid Toxicity Index, a clinical outcome assessment and early morning cortisol level. LEADER will be conducted in ~30 sites delivering NHS care, recruiting a sample size of 448. Economic evaluation will compare cost-effectiveness within a trial and over a lifetime horizon from the English National Health Service perspective.

The LEADER trial received MHRA and Leicester Central Research Ethics Committee ethics approval (REC reference: 24/EM/0277, IRAS 1010280), opened to recruitment on Protocol Version 4.0 and is currently recruiting on Protocol Version 5.0. Participants will provide written informed consent in accordance with the Declaration of Helsinki and applicable regulatory requirements. Trial results will be disseminated via presentations at national and international meetings, published in open-access journals and to patients.

ISRCTN32090559.

Diabetes mellitus (DM) has a strong genetic component and is a known risk factor for several hand conditions. We aimed to examine whether DM in first-degree relatives is associated with an increased risk of hand surgical diagnoses.

A retrospective cohort study.

Data were collected from a population-based cohort in southern Sweden (Malmö Diet and Cancer Study (MDCS)). Family relationships were obtained through the Swedish Multi-Generation Register and healthcare diagnoses from the National Patient Register.

30 446 individuals (60% female) aged 45–73 years were included from the MDCS.

The primary outcome was any diagnosis within the ‘diabetic hand’ category; carpal tunnel syndrome, ulnar nerve entrapment, trigger finger, Dupuytren’s disease and thumb base osteoarthritis, identified through International Classification of Diseases, tenth revision codes. Logistic regression models were used.

In the index study population, 4 150 (14%) had ≥1 hand surgical diagnosis. In unadjusted models, DM in the index individual and first-degree relatives was associated with an increased risk of developing hand surgical diagnoses (OR 1.14, 95% CI 1.06 to 1.22). After adjusting for confounders, only DM in the index individual remained significantly associated with the diabetic hand (OR 1.23, 95% CI 1.13 to 1.33). In diagnosis-specific analyses, an association persisted between having ≥1 sibling with DM and Dupuytren’s disease (OR 1.39, 95% CI 1.09 to 1.76), and between having ≥1 child with DM and carpal tunnel syndrome (OR 1.18, 95% CI 1.00 to 1.39).

While DM in the index individual was consistently associated with a higher risk of multiple hand surgical diagnoses, DM in first-degree relatives did not significantly influence the risk after adjustments. Exceptions included an association between ≥1 sibling with DM and Dupuytren’s disease, and ≥1 child with DM and carpal tunnel syndrome. Future research should further explore potential genetic factors contributing to these conditions.

Management of cryptoglandular anal fistula is characterised by wide variation in diagnostic strategies, surgical techniques and outcome reporting, limiting comparison between studies and hindering evidence-based guideline development. This study aims to implement a standardised core outcome measurement set within a large international observational framework and to evaluate the feasibility of a scalable digitally supported model for global collaborative surgical research.

Cryptoglandular anal fistula treatment is a prospective, international, multicentre observational study comprising two components: a short-term audit capturing clinician-reported outcomes at 3 months and a long-term cohort capturing clinician- and patient-reported outcomes over twelve months. Adults undergoing surgery for primary or recurrent cryptoglandular anal fistula are eligible, excluding non-cryptoglandular aetiologies. Data are collected using secure electronic case report forms and digitally administered patient-reported outcome measures, with paper alternatives available where required. Outcomes are defined according to the Anal Fistula Core Outcome Measurement Set and include clinical and radiological healing, recurrence, complications, reintervention, development of additional fistulas, symptoms, psychological impact of treatment, continence, quality of life and additionally work productivity. The study was designed around a predefined nine-step framework, including multidisciplinary coordination, central ethical approval to support local submissions, artificial intelligence-assisted translation of study materials with native review and implementation of secure digital data capture systems. Based on previous European Society of Coloproctology studies and expected centre volumes, the audit arm aims to include approximately 1000 patients and the cohort arm 500 to 750 patients.

Central ethical approval has been obtained from the Medical Ethics Review Committee of the Maastricht University Medical Centre+ under METC 2024-0374 (audit arm) and METC 2024-0361 (cohort arm) with local approvals or waivers secured in participating countries according to national regulations. Written informed consent is obtained for cohort participation. Results will be disseminated through peer-reviewed publications and international conferences, with the aim of informing future guideline development and supporting patient-centred care in cryptoglandular anal fistula management.