The Leeds Teaching Hospitals Repository contains research, organisational learning and information generated by LTH staff and colleagues and departments.

Recent Submissions

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    Validity and Psychometric Properties of 3 and 4 Visual Analog Scale in Participants With Psoriatic Arthritis Treated With Guselkumab.
    (2026) Tillett, W.; Coates, L.C.; Vis, M.; Zimmermann, M.; Lozenski, K.; Rampakakis, E.; Soriano, E.R.; Merola, J.F.; Sharaf, M.; Nash, P.; Helliwell, P.S.; Helliwell, Philip
    Objective. To evaluate the validity of the 3-item visual analog scale (3VAS) and 4-item VAS (4VAS) and determine the minimal clinically important difference (MCID) and minimal detectable change (MDC) for each measure using data from 3 phase III randomized clinical trials of guselkumab in psoriatic arthritis (PsA). Methods. Pooled data (1405 participants) from the DISCOVER-1, DISCOVER-2, and COSMOS studies were used. 3VAS/4VAS MCID and MDC were estimated using established formulas. Receiver-operating characteristic curve analysis was used to identify 3VAS/4VAS thresholds for low, moderate, and high disease activity. Criterion validity was assessed by correlating 3VAS/4VAS with other PsA measures. Mixed models evaluated the association between changes from baseline in 3VAS/4VAS at week 8 of guselkumab treatment with the total PsA-modified Sharp-van der Heijde (SvdH) score through week 100. Results. 3VAS/4VAS showed moderate-to-strong correlation with all outcome measures assessed, with coefficients ranging from 0.56/0.62 for Health Assessment Questionnaire-Disability Index to 0.92/0.94 for patient global assessment. MCID was 0.9 for both 3VAS (range 0.7-1.3 depending on method used) and 4VAS (0.6-1.3); MDC was 3.1 and 3.0, respectively. 3VAS cutoffs for low, moderate, and high disease activity were 2.1, 3.3, and 4.8, respectively, and 2.1, 3.4, and 5.0 for 4VAS. Change in 4VAS at week 8 of guselkumab treatment significantly associated with change in SvdH score through week 100 (P = 0.04). Conclusion. These analyses support the validity of 3VAS/4VAS as multidimensional measures of PsA disease activity. 4VAS may be preferred owing to its greater face validity and separate measurements of the 2 cardinal aspects of PsA (joint/skin disease) and pain.
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    Embedding routine enquiry about domestic violence and abuse within multiple sclerosis care.
    (2026) Hutchison, K.; Morgan, L.; Venkatachalam, S.; Ford, H.; Morgan, Lucy; Ford, Helen; Nursing
    Recent evidence suggests that people with multiple sclerosis (MS) are exposed to a variety of forms of violence and abuse, including domestic violence and abuse. This reflects the increased risk of DVA found among disabled people. Those who experience DVA are more likely to approach healthcare professionals (HCPs) due to the physical or psychological consequences of DVA. Hence, MS HCPs may encounter patients experiencing DVA, and they could play an important role in identifying and responding to DVA if facilitated to do so. This article presents findings and reflections from a feasibility study on implementing DVA routine enquiry within MS care at an NHS trust. It reflects on why and how routine enquiry questions were amended to meet the needs of patients with MS, and how MS HCPs have created safe spaces for asking these questions..
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    Dinutuximab Beta Added to Temozolomide-Based Chemotherapy for Children With Relapsed and Refractory Neuroblastoma: Results of the ITCC-SIOPEN BEACON Immuno Phase II Trial.
    (2026) Gray, J.C.; Weston, R.; Owens, C.; Canete, A.; Gambart, M.; De Wilde, B.; Nysom, K.; van Eijkelenburg, N.; Ladenstein, R.; Castellano, A.; Gerber, N.U.; Marshall, L.V.; Barone, G.; Rubio-San-Simon, A.; Ng, A.; Vaidya, S.; Gallego, S.; Makin, G.; Burke, G.A.A.; McCarthy, A.; Murphy, D.; Zwaan, C.M.; Lopez-Almaraz, R.; Jannier, S.; Thebaud, E.; Corradini, N.; Yeomanson, D.; Howell, L.; Tweddle, D.A.; Elliott, M.; Hobin, D.; Valteau-Couanet, D.; Schleiermacher, G.; Chastagner, P.; Defachelles, A.S.; Brichard, B.; George, S.; Chesler, L.; Laidler, J.; Firth, C.; Holt, G.; Moroz, V.; Pearson, A.D.J.; Gates, S.; Wheatley, K.; Kearns, P.; Moreno, L.; Elliott, Mark
    PURPOSE - Outcomes for children with relapsed and refractory high-risk neuroblastoma (RR-HR-NBL) remain dismal. Here, we investigate addition of the anti-GD2 monoclonal antibody, dinutuximab beta (dB), to temozolomide (T)-based chemotherapy.MATERIALS AND METHODS - Patients with RR-HR-NBL were randomly assigned in a 1:2 ratio to receive chemotherapy alone or chemotherapy with dB, given concurrently as a 7-day infusion (10 mg/m2/24 h). The trial had a factorial design, with some patients also randomly assigned between chemotherapy regimens (T v T-topotecan [TTo]). Crossover to dB with To/cyclophosphamide was allowed for patients randomly assigned to chemotherapy alone with disease progression (PD). The primary outcome was best objective response (complete or partial) rate (overall response rate [ORR]) during six cycles of treatment. Progression-free (PFS), overall survival (OS), and safety were secondary outcomes.RESULTS - Sixty-five patients were randomly assigned to chemotherapy alone (3 T, 19 TTo) or with dB (6 dBT, 37 dBTTo). The median age was 4 years; 28 and 37 patients had refractory and relapsed diseases, respectively. Baseline characteristics were balanced between arms. The ORR was 30.2% (13 of 43) and 18.2% (4 of 22) in dB and non-dB arms, the median PFS was 11.1 months (95% CI, 4.3 to 15.5) for dB patients and 3.8 months (95% CI, 1.9 to 7.9) for non-dB patients, respectively. The median OS was 25.7 months (95% CI, 11.4 to not reached [NR]) for dB patients and 17.1 months (95% CI, 7.6 to 54.6) for non-dB patients (upper 95% CI, NR in dB arm). Thirteen of 22 patients in the non-dB arm crossed over to dB with cyclophosphamide/To because of PD. Neurotoxicity was more common in the dB arm (grade 1 and 2: 26% v 9%, grade 3: 2.3% v 4.5%), but other toxicities were similar.CONCLUSION - Within a randomized phase II setting, results observed with addition of dB to T-based chemotherapy in RR-HR-NB warrant further evaluation.
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    Chest pain: what primary care nurses need to know.
    (2026) Collins, A.; Buelu, S.; Warriner, D.; Warriner, David
    Primary care clinicians are likely to encounter patients experiencing chest pain. This could be caused by a wide range of factors, less serious musculoskeletal issues and life-threatening heart problems. This article provides an overview of chest pain assessment, triage and onward referral for primary care nurses, discussing cardiac conditions such as acute coronary syndrome, angina and aortic dissection, as well as non-cardiac causes of chest pain. A systematic method of physical assessment and investigation is described, including the benefits and limitations of electrocardiogram use in primary care. The article emphasises that early detection of warning signs and an individualised approach to care are essential for managing chest pain in primary care settings.
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    A wound dressing with copper and silver nanoparticles versus ionic silver hydrofibre dressing for the treatment of diabetic foot ulcers: a randomised clinical trial.
    (2026) Roosimaa, M.; Ilumets, H.; Kaha, T.; Kubo, A.-L.; Valkna, A.; Sihtmae, M.; Kadaja, M.; Russell, D.A.; Bondarenko, O.; Vasiliev, G.; Russell, David
    Objective: The objective of this trial was to compare the clinical performance and safety of a novel wound dressing containing silver and copper nanoparticles (Nanordica; Nanordica Medical OU, Estonia) (Ag/Cu) with the ionic silver-based dressing Aquacel Ag+ Extra (Convatec Group, UK) (Ag+) for the treatment of infected diabetic foot ulcers (DFUs). Method(s): This study was a single-blinded, randomised, active-controlled pilot trial involving patients with infected DFUs who were randomly assigned to receive either the Ag/Cu or Ag+ dressing. Patients were treated over a one-week active phase with dressing changes every other day, followed by a two-week follow-up phase using a non-antibacterial dressing. Efficacy was measured by wound area size (WAS) reduction, bacterial load control and quality of life (QoL) scores. Safety outcomes were based on adverse events and blood Ag levels. Result(s): The experimental cohort included 30 patients. Consistently better results were observed in nearly all efficacy and safety endpoints for patients treated with the Ag/Cu dressing compared with those treated with the Ag+ dressing. Although WAS decreased in both groups, the WAS in the Ag/Cu dressing group had already decreased by 31% after the first dressing change. By the end of the active phase, the WAS had decreased by 43% in the Ag/Cu dressing group, compared with a 13% reduction in the Ag+ dressing group. The mean total bacterial load in the wound bed did not change significantly in the Ag/Cu dressing group but increased in the Ag+ dressing group. The QoL score increased more in the Ag/Cu dressing group, but this difference did not reach statistical significance. Conclusion(s): The findings of this clinical study indicated that the Ag/Cu dressing is a safe and effective way to treat infected DFUs, demonstrating faster WAS reduction, enhanced bacterial control, and higher QoL scores compared with traditional Ag+ dressings. Declaration of interest: This research was supported by grants from the Development Fund of the National Institute of Chemical Physics and Biophysics, the Estonian Connected Health Cluster, Enterprise Estonia, the European Innovation Council (EIC) Accelerator (Project 190199469 - NANOWOUND), and by the European Union and the Ministry of Education and Research via project TEM-TA55. The funding bodies had no role in the design of the study, data collection, analysis, interpretation, or manuscript preparation. MR, A-LK, AV, MK, OB and GV are employees of Nanordica Medical, Tallinn, Estonia, the company developing the wound dressing studied in this research. The remaining authors have no conflicts of interest.

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