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Abstract Background The mental health of medical students is a national and international problem increasing in both demand and acuity. Medical students face barriers to accessing mental health support that is clinically effective, timely and appropriate for their needs. This mixed methods study aimed to explore experiences of these barriers and the challenges to health service delivery aligned to the Candidacy Framework. Methods One hundred three medical students studying at The University of Sheffield completed an online survey comprising the CCAPS-34 and follow-up questions about service access and use. Semi-structured interviews with a nested sample of 20 medical students and 10 healthcare professionals explored barriers to service access and provision. A stakeholder panel of medical students and professionals met quarterly to co-produce research materials, interpret research data and identify touchpoints by pinpointing specific areas and moments of interaction between a medical student as a service user and a mental health service. Results Medical students who experienced barriers to help-seeking and accessing support scored significantly higher for psychological symptoms on the CCAPS-34. Uncertainty and fear of fitness to practice processes were important barriers present across all seven stages of candidacy. The fragmented structure of local services, along with individual factors such as perceived stigma and confidentiality concerns, limited the progression of medical students through the Candidacy Framework (a framework for understanding the different stages of a person’s journey to healthcare). Conclusion This study outlines important areas of consideration for mental health service provision and policy development to improve access to and the quality of care for medical students.

Abstract Background Without surgical repair, flexor tendon injuries do not heal and patients’ ability to bend fingers and grip objects is impaired. However, flexor tendon repair surgery also requires optimal rehabilitation. There are currently three custom-made splints used in the rehabilitation of zone I/II flexor tendon repairs, each with different assumed harm/benefit profiles: the dorsal forearm and hand-based splint (long), the Manchester short splint (short), and the relative motion flexion splint (mini). There is, however, no robust evidence as to which splint, if any, is most clinical or cost effective. The Flexor Injury Rehabilitation Splint Trial (FIRST) was designed to address this evidence gap. Methods FIRST is a parallel group, superiority, analyst-blind, multi-centre, individual participant-randomised controlled trial. Participants will be assigned 1:1:1 to receive either the long, short, or mini splint. We aim to recruit 429 participants undergoing rehabilitation following zone I/II flexor tendon repair surgery. Potential participants will initially be identified prior to surgery, in NHS hand clinics across the UK, and consented and randomised at their splint fitting appointment post-surgery. The primary outcome will be the mean post-randomisation score on the patient-reported wrist and hand evaluation measure (PRWHE), assessed at 6, 12, 26, and 52 weeks post randomisation. Secondary outcome measures include blinded grip strength and active range of movement (AROM) assessments, adverse events, adherence to the splinting protocol (measured via temperature sensors inserted into the splints), quality of life assessment, and further patient-reported outcomes. An economic evaluation will assess the cost-effectiveness of each splint, and a qualitative sub-study will evaluate participants’ preferences for, and experiences of wearing, the splints. Furthermore, a mediation analysis will determine the relationship between patient preferences, splint adherence, and splint effectiveness. Discussion FIRST will compare the three splints with respect to clinical efficacy, complications, quality of life and cost-effectiveness. FIRST is a pragmatic trial which will recruit from 26 NHS sites to allow findings to be generalisable to current clinical practice in the UK. It will also provide significant insights into patient experiences of splint wear and how adherence to splinting may impact outcomes. Trial registration ISRCTN: 10236011

Aims: Scoliosis is a lateral curvature of the spine with associated rotation, often causing distress due to appearance. For some curves, there is good evidence to support the use of a spinal brace, worn for 20 to 24 hours a day to minimize the curve, making it as straight as possible during growth, preventing progression. Compliance can be poor due to appearance and comfort. A night-time brace, worn for eight to 12 hours, can achieve higher levels of curve correction while patients are supine, and could be preferable for patients, but evidence of efficacy is limited. This is the protocol for a randomized controlled trial of ‘full-time bracing’ versus ‘night-time bracing’ in adolescent idiopathic scoliosis (AIS). Methods: UK paediatric spine clinics will recruit 780 participants aged ten to 15 years-old with AIS, Risser stage 0, 1, or 2, and curve size (Cobb angle) 20° to 40° with apex at or below T7. Patients are randomly allocated 1:1, to either full-time or night-time bracing. A qualitative sub-study will explore communication and experiences of families in terms of bracing and research. Patient and Public Involvement & Engagement informed study design and will assist with aspects of trial delivery and dissemination. Discussion: The primary outcome is ‘treatment failure’ (Cobb angle progression to 50° or more before skeletal maturity); skeletal maturity is at Risser stage 4 in females and 5 in males, or ‘treatment success’ (Cobb angle less than 50° at skeletal maturity). The comparison is on a non-inferiority basis (non-inferiority margin 11%). Participants are followed up every six months while in brace, and at one and two years after skeletal maturity. Secondary outcomes include the Scoliosis Research Society 22 questionnaire and measures of quality of life, psychological effects of bracing, adherence, anxiety and depression, sleep, satisfaction, and educational attainment. All data will be collected through the British Spine Registry. Cite this article: Bone Jt Open 2023;4(11):873–880.

Some text in this abstract has been reproduced from Lindsay J, Din S, Hawkey C, Hind D, Irving P, Lobo A, et al. OFR-9 An RCT of autologous stem-cell transplantation in treatment refractory Crohn’s disease (low-intensity therapy evaluation): ASTIClite. Gut 2021;70(Suppl. 4):A4. Background Treatment-refractory Crohn’s disease is characterised by chronic symptoms, poor quality of life and high costs to the NHS, and through days of work lost by patients. A previous trial of autologous haematopoietic stem cell transplant (HSCT) failed its end point of medication-free clinical remission for 3 months with no evidence of disease activity, and reported high toxicity. Subsequent studies suggest that HSCT achieves complete mucosal healing in 50% of patients, and that toxicity likely relates to the cyclophosphamide dose. Objectives The primary objective was to assess the efficacy of HSCTlite (HSCT with low-dose cyclophosphamide) compared with standard care for inducing regression of intestinal ulceration in patients with refractory Crohn’s disease at week 48. Secondary objectives included the assessment of disease activity, quality of life and regimen safety. Mechanistic objectives included immune reconstitution after HSCTlite. Design Two-arm, parallel-group randomised controlled trial with a 2 : 1 (intervention : control) allocation ratio. Setting Nine NHS trusts (eight trusts were recruitment sites; one trust was a treatment-only site). Participants Adults with treatment-refractory Crohn’s disease, for whom surgery was inappropriate or who had declined surgery. Interventions The intervention treatment was HSCTlite using cyclophosphamide, and the control was any current available treatment for Crohn’s disease, apart from stem cell transplantation. Main outcomes The primary outcome was treatment success at week 48 [mucosal healing (Simple Endoscopic Score for Crohn’s Disease ulcer subscore of 0) without surgery or death], assessed by central readers blinded to allocation and timing of assessment. Key secondary outcomes were clinical remission, Simple Endoscopic Score for Crohn’s Disease scores at week 48, change in Crohn’s Disease Activity Index scores and safety. Results The trial was halted owing to Suspected unexpected serious adverse events that took place after randomising 23 patients (HSCTlite arm, n = 13; usual-care arm, n = 10). Ten out of the 13 patients randomised to the HSCTlite arm received the intervention and nine (one death) reached the 48-week follow-up. In the usual-care arm 9 out of the 10 patients randomised reached the 48-week follow-up (one ineligible). The primary outcome was available for 7 out of 10 HSCTlite patients (including the patient who died) and six out of nine usual-care patients. Absence of endoscopic ulceration without surgery or death was reported in three out of seven (43%) HSCTlite patients, compared with zero out of six (0%) usual-care patients. Centrally read Simple Endoscopic Score for Crohn’s Disease scores [mean (standard deviation)] were 10.8 (6.3) and 10.0 (6.1) at baseline, compared with 2.8 (2.9) and 18.7 (9.1) at week 48, in the HSCT and usual-care arms, respectively. Clinical remission (Crohn’s Disease Activity Index scores of 18.5 kg/m2). Have received a diagnosis of CD using colonoscopy, histology and/or radiology. Have had a disease duration of at least 6 months. Have a disease distribution accessible to endoscopic assessment (jejuno-ileal, ileo-caecal or colonic). Have had active clinical CD activity with impaired quality of life at any time within 3 months prior to randomisation into the trial, as assessed by a gastroenterology clinician. Be refractory or intolerant to azathioprine, mercaptopurine or methotrexate. Be refractory or intolerant to at least two classes of biologic therapy [currently anti-tumour necrosis factor (TNF) therapy, vedolizumab (Entyvio, Takeda UK Limited, London, UK) or ustekinumab (Stelara, Janssen Pharmaceuticals, New Brunswick, NJ, USA)] despite dose optimisation. Be considered unsuitable for surgery or have had surgery declined. Have endoscopic evidence of active disease in screening [Simple Endoscopic Score for Crohn’s Disease (SES-CD) ulcer size subscore of ≥ 2 in at least one segment]. SES-CD will be used as standard for patients with disease in the ileum and/or colon. Should the disease be only proximal to the ileum, the SES-CD would still be used to score the relevant bowel segment. Have undergone a satisfactory European Society for Blood and Marrow Transplantation. Autoimmune Disease Working Party-recommended screening assessment prior to HSCT. Be willing to discontinue all immunosuppressant medication after randomisation if allocated to the HSCT arm. Be, in the opinion of the Trial Management Group (TMG), fit enough to undergo treatment. Participants were ineligible if any of the following conditions were met: Have received a diagnosis of ulcerative colitis or indeterminate colitis. Have no evidence of active CD on screening endoscopic assessment. Have strictures that prevent assessment for endoscopic active disease. Have undrained perianal fistulae (patients with previous perianal disease or perianal disease adequately drained with a seton in situ were eligible). Presence of undrained perianal sepsis on screening pelvic [magnetic resonance imaging (MRI) scan, or computerised tomography (CT) scan if MRI was contraindicated]. Have evidence of intra-abdominal sepsis on abdominal MRI (or CT scan if MRI scan was contraindicated). Have an active or latent mycobacterial infection. Have had prior exposure to hepatitis B virus, hepatitis C virus or human immunodeficiency virus (HIV). Have evidence of an enteric or systemic infection. Be pregnant or breastfeeding, or planning pregnancy within the study duration. The possibility of current pregnancy was to be ruled out with a pregnancy test at the screening assessment. Be unwilling to use adequate contraception (if appropriate) until at least 12 months after the last dose of study drug. Have a contraindication to the use of cyclophosphamide, fludarabine, filgrastim or rabbit anti-thymocyte globulin (Thymoglobulin, Sanofi UK, Reading, UK). Have a significant medical comorbidity that precludes HSCT, as adjudicated by the TMG. Have significant psychiatric comorbidity. Have significant language barriers likely to affect their understanding of the study or their ability to complete outcome questionnaires. Be participating in another interventional clinical trial. Be considered medically unfit for HSCT as defined by any of the following criteria – Renal: creatinine clearance of 6.7 kPa. Forced expiratory volume or forced vital capacity of 1.0 × 109/l for two consecutive days. Participants randomised to the usual-care arm continued with conventional, biologic or nutritional therapy for the management of CD, until the primary end point was assessed. Follow-up Participants were followed up at 8, 14, 24, 32, 40 and 48 weeks. Day 0 of the follow up was the date of stem cell reinfusion for HSCT arm participants and day 49, post randomisation, for usual-care arm participants to align the timelines in both groups. Main outcome measures The primary outcome was treatment success at week 48, defined as mucosal healing [no endoscopic ulceration (SES-CD ulcer subscore of zero, assessed by central readers blind to allocation and time of assessment)] without surgery or death. Key secondary outcomes included clinical remission using the Crohn’s Disease Activity Index (CDAI), the Harvey–Bradshaw Index and patient-reported outcomes; SES-CD at week 48; change in CDAI SES-CD between baseline and week 48; assessment of safety through reports of AEs and SAEs; patient-reported quality of life; and healthcare resource use. Mechanistic outcomes included analysis of re-engraftment. Results The trial was halted because of unexpected SAEs after 23 patients (HSCT arm, n = 13; usual-care arm, n = 10) had been randomised. Patients had advanced disease [mean (standard deviation) CD duration 13.8 (7) years, mean CDAI at baseline 337.5 (182.4)], with 20 (91%) having undergone at least one resection and nine (41%) having a stoma (these figures are calculated based on the 22 participants in the intention-to-treat population, as opposed to the 23 participants randomised). Of the 13 participants randomised to receive HSCTlite, three withdrew before transplantation, 12 reached mobilisation, and 10 went on to receive stem cell reinfusion. Of the 10 usual-care arm participants, eight received medications specifically to treat CD (including biologic therapies and corticosteroids), one underwent surgery for CD (small bowel resection) and one withdrew. All patients contributed to the safety analysis, and 10 patients who completed HSCT and nine patients receiving usual care contributed to the efficacy analyses. The primary outcome using central reading was available for 7 out of 10 HSCT and six out of nine usual-care patients at week 48. Absence of endoscopic ulceration without surgery or death (at 48 weeks) was reported in three out of seven (43%) HSCT patients, compared with zero out of six (0%) usual-care patients. Centrally read SES-CD scores [mean (SD)] were 10.8 (6.3) and 10.0 (6.1) at baseline, compared with 2.8 (2.9) and 18.7 (9.1) at week 48, in the HSCT and usual-care arms, respectively. Centrally read change in SES-CD fell by 6.4 (4.3) in HSCT patients, whereas it increased by 7.5 (3.5) in usual-care patients. Clinical remission (CDAI

Introduction Ovarian hyperstimulation syndrome (OHSS) is the most significant short-term complication of pharmacological ovarian stimulation. Symptoms range from mild abdominal discomfort to rare complications such as renal failure, thromboembolism and respiratory distress syndrome.Currently, clinical practice typically involves monitoring the patient until the condition becomes severe, at which point they are admitted to hospital, where drainage of ascitic fluid (paracentesis) may take place. Preliminary studies have indicated that earlier outpatient paracentesis may reduce the progression of OHSS and prevent hospitalisation in women.Methods and analysis This UK, multicentre, pragmatic, two-arm, parallel-group, adaptive (group sequential with one interim analysis), open-label, superiority, confirmatory, group sequential, individually randomised controlled trial, with internal pilot will assess the clinical and cost-effectiveness and safety of outpatient paracentesis versus conservative management (usual care) for moderate or severe OHSS. 224 women from 20 National Health Service and private fertility units will be randomised (1:1) and followed up for up to 13.5 months. The primary outcome is the rate of OHSS related hospital admission of at least 24 hours within 28 days postrandomisation. The primary analysis will be an intention to treat with difference in hospitalisation rates as measure of treatment effect. Secondary outcomes include time to resolution of symptoms, patient satisfaction, adverse events and cost-effectiveness. A qualitative substudy will facilitate the feasibility of recruitment. Participant recruitment commenced in June 2022.Ethics and dissemination London—Southeast Research Ethics Committee approved the protocol (reference: 22/LO/0015). Findings will be submitted to peer-reviewed journals and abstracts to relevant national and international conferences, as well as being disseminated to trial participants and patient groups.Trial registration number ISRCTN71978064.