Welcome to The Royal Devon Research Repository

The Royal Devon Research Repository contains research outputs from staff at the Royal Devon University Healthcare NHS Foundation Trust.

You can browse items by Title, Author, Subject or Community/Collection, or use the search function to find specific topics.

The repository contains details of published, peer-reviewed journal articles, reviews, book chapters, conference abstracts and posters. Full-text of journal articles have been included where publisher's permissions allow.

If you are a member of Royal Devon University Healthcare NHS Foundation Trust and you'd like to submit an item to the repository, please fill in this online form. If you have a list of publications you'd like to submit, please e-mail the repository admin team: rde-tr.ResearchRepository@nhs.net.

For more information or help, please contact The Royal Devon Research Repository admin team:
Email: rde-tr.ResearchRepository@nhs.net
Telephone: Exeter Health Library, 01392 406800

Recent Submissions

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    Long-Term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Adults and Adolescents with Cystic Fibrosis and at Least One F508del Allele: A Phase 3, Open-Label Extension Study
    (Wolters Kluwer, 2025-04-10) Daines, C. L.; Polineni, D.; Tullis, E.; Costa, S.; Linnemann, R. W.; Mall, M. A.; McKone, E. F.; Quon, B. S.; Ringshausen, F. C.; Selvadurai, H.; Taylor-Cousar, J. L.; Withers, N. J.; Sawicki, G. S.; Lee, T.; Ahluwalia, N.; Morlando Geiger, J.; Jennings, M.; Tan, Y. V.; Waltz, D.; Ramsey, B.; Griese, M.; Withers, Nicholas J.
    RATIONALE: Clinical and real-world studies show elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) is efficacious and safe in people with cystic fibrosis (CF) ≥12 years of age with at least one F508del allele. OBJECTIVES: Given the potential for life-long ELX/TEZ/IVA use, long-term safety and efficacy of ELX/TEZ/IVA was assessed. METHODS: In this phase 3, open-label, single-arm extension study, participants with F508del-minimal function genotypes (from 24-week parent study 445-102 [n = 399]) or with the F508del-F508del genotype (from 4-week parent study 445-103 [n = 107]) received ELX/TEZ/IVA (ELX 200 mg once daily, TEZ 100 mg once daily, and IVA 150 mg every 12 hours) over 192 weeks. MEASUREMENTS AND MAIN RESULTS: Primary endpoint was safety and tolerability. Mean exposure to ELX/TEZ/IVA was 172.6 weeks. Most participants had adverse events classified as mild (12.8%) or moderate (60.7%) in severity. Eighteen participants (3.6%) had adverse events that led to treatment discontinuation. After starting ELX/TEZ/IVA, participants had consistent increases in percent predicted FEV(1) (ppFEV(1)), Cystic Fibrosis Questionnaire-Revised respiratory domain score, and body mass index, with decreases in sweat chloride concentration and pulmonary exacerbations rates; these improvements were maintained through 192 weeks. The mean annualized rate of change in ppFEV(1) was 0.02 percentage points (95% CI, -0.14 to 0.19) after initiation of ELX/TEZ/IVA. CONCLUSIONS: During this 192-week open label extension study, the longest clinical study of a CFTR modulator to date, ELX/TEZ/IVA remained generally safe and well-tolerated. Participants had sustained improvements in lung function, respiratory symptoms, CFTR function, pulmonary exacerbation rates, and nutritional status. The estimated annualized rate of change in ppFEV(1) suggests no evidence of pulmonary function loss across the study population over the 4-year treatment period. These results confirm the favorable long-term safety profile and durable disease-modifying clinical benefits of ELX/TEZ/IVA in adolescents and adults with CF. This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives License 4.0 (http://creativecommons.org/licenses/by-nc-nd/4.0/). Clinical trial registration available at www. CLINICALTRIALS: gov, ID: NCT03525574.
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    Answer to the letter to the editor of X. Zhang, et al. concerning AI versus the spinal surgeons in the management of controversial spinal surgery scenarios" by Mehmet, S. et al. (Eur spine J [2025]: doi.org/10.1007/s00586-025-08825-w)"
    (Springer Nature, 2025-05-28) Mehmet, S.; Elmarawany, M. N.; Harding, I.; Bowey, A. J.; Andrews, J.; Chan, D.; Jayasuriya, R.; Srinivas, S.; Tomlinson, J.; Bayley, E.; Grevitt, M. P.; James, S.; Jones, A.; McCarthy, M. J. H.; Chan, Daniel
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    Long-term outcomes of Grammont style reverse shoulder arthroplasty at a minimum of 10-year follow-up: A survival analysis
    (SAGE, 2025-04-18) Donoghue, S. J.; Williams, M. G.; Burden, E. G.; East, J.; Batten, T. J.; Pearce, E.; Evans, J. P.; Smith, C. D.; Orthopaedics; Donoghue, Sophie J; Williams, Mark G; Burden, Eleanor G; East, Jamie; Pearce, Eleanor; Evans, Jonathan P; Smith, Christopher D
    BACKGROUND: Reverse shoulder arthroplasty (RSA) is an established and successful treatment for rotator cuff tear arthropathy. Despite increased popularity, there is a paucity of long-term survivorship data and patient-reported outcome measures. This study aimed to establish the survival at a minimum 10-year follow-up for a Grammont-style reverse shoulder prosthesis. METHODS: A single centre, retrospective case series of 101 primary RSAs in 86 patients, performed between 1999 and 2012 was conducted. The primary outcome measure was all-cause revision. Implant survivorship analysis using the Kaplan-Meier method was conducted. Deaths were censored. Secondary outcomes included up-to-date Oxford Shoulder Score (OSS) in surviving patients, historic OSS scores over time and radiological outcomes. RESULTS: Mean age was 76 years (SD ± 7.29) at time of surgery. The 10-year implant survival was 93.2% (95% confidence interval [CI] 87.8-98.6). The mean OSS was 33 (range 17-48, 95% CI 29.1-36.9) with a minimum of 10-year follow-up (n = 21). Radiographic review showed scapular notching in 79% of implants over 10 years old, but no radiolucency around humeral implants. CONCLUSIONS: The rate of RSA survivorship is high at 93.2% at 10 years. Most patients died with their primary implant in-situ. Functional outcome scores were less predictable over time.
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    OCT-Derived Biomarkers in Optic Disc Pit Maculopathy Are Associated with Age, Visual Function, and Natural History
    (Karger, 2025-04-04) Bloch, E.; Flores-Sánchez, B. C.; Georgiadis, O.; Ramsden, C. M.; da Cruz, L.; West of England Eye Unit; Ramsden, Conor M.
    INTRODUCTION: Optic disc pit maculopathy (ODP-M) describes the variable intra- (IRF) and/or subretinal fluid (SRF) accumulation complicating a congenital optic disc anomaly that is primarily observed in young adults. This study aimed to explore the morphological variance in ODP-M, in order to measure associations between demographic and functional characteristics and investigate the natural course of the disease. METHODS: A single-centre, retrospective, observational study was performed. Subjects with ODP-M were identified through electronic notes review. Demographic characteristics, visual acuity, and anatomical features were analysed with respect to a predefined OCT-based sub-categorisation: type 1a: IRF only; type 1b: IRF + outer lamellar hole (OLH) +/- SRF; type 2: SRF +/- IRF (no OLH). RESULTS: Fifty eyes (50 subjects) were sub-categorised according to fluid distribution into type 1a (34%), type 1b (28%), and type 2 ODP-M (38%). Those with type 2 were found to be significantly younger than those with types 1a/b ODP-M (p < 0.001) and accounted for 93% of cases occurring in subjects ≤20 years old. The presence of OLH (i.e., type 1b) was noted to be independently associated with worse final VA (p = 0.013) and higher likelihood of proceeding to surgery (p = 0.002). CONCLUSION: There appears to be an age-related variation in ODP-M morphology, indicating the possibility of separate pathoanatomical processes, with distinct clinical courses and potentially different optimal management strategies. Sub-categorisation of ODP-M according to the reported structural features may help guide management of this rare condition.
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    AI versus the spinal surgeons in the management of controversial spinal surgery scenarios
    (Springer Nature, 2025-04-03) Mehmet, S.; Elmarawany, M. N.; Harding, I.; Bowey, A. J.; Andrews, J.; Chan, D.; Jayasuriya, R.; Srinivas, S.; Tomlinson, J.; Bayley, E.; Grevitt, M. P.; James, S.; Jones, A.; McCarthy, M. J. H.; Chan, Daniel
    AIMS: The use of artificial intelligence (AI) in spinal surgery is expanding, yet its ability to match the diagnostic and treatment planning accuracy of human surgeons remains unclear. This study aims to compare the performance of AI models-ChatGPT-3.5, ChatGPT-4, and Google Bard-with that of experienced spinal surgeons in controversial spinal scenarios. METHODS: A questionnaire comprising 54 questions was presented to ten spinal surgeons on two occasions, four weeks apart, to assess consistency. The same questionnaire was also presented to ChatGPT-3.5, ChatGPT-4, and Google Bard, each generating five responses per question. Responses were analyzed for consistency and agreement with human surgeons using Kappa values. Thematic analysis of AI responses identified common themes and evaluated the depth and accuracy of AI recommendations. RESULTS: Test-retest reliability among surgeons showed Kappa values from 0.535 to 1.00, indicating moderate to perfect reliability. Inter-rater agreement between surgeons and AI models was generally low, with nonsignificant p-values. Fair agreements were observed between surgeons' second occasion responses and ChatGPT-3.5 (Kappa = 0.24) and ChatGPT-4 (Kappa = 0.27). AI responses were detailed and structured, while surgeons provided more concise answers. CONCLUSIONS: AI large language models are not yet suitable for complex spinal surgery decisions but hold potential for preliminary information gathering and emergency triage. Legal, ethical, and accuracy issues must be addressed before AI can be reliably integrated into clinical practice.
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