http://bura.brunel.ac.uk/handle/2438/8617 2026-05-23T02:33:25Z 2026-05-23T02:33:25Z Johnson, EE Vale, L Kenny, R Meader, N Wallace, S Bugge, C Thakar, B Dwyer, L Spencer, S Igualada-Martinez, P Guerrero, K http://bura.brunel.ac.uk/handle/2438/33323 2026-05-21T02:01:00Z 2025-05-01T00:00:00Z

Title: Non-surgical interventions for pelvic organ prolapse in women: a component network meta-analysis and cost-effectiveness analysis - Protocol (version 1.1) Authors: Johnson, EE; Vale, L; Kenny, R; Meader, N; Wallace, S; Bugge, C; Thakar, B; Dwyer, L; Spencer, S; Igualada-Martinez, P; Guerrero, K Abstract: Background: Pelvic organ prolapse (POP) is the descent of a woman's womb, bladder or rectum into the vagina. Up to 1 in 10 women have POP, which can be caused by childbirth, obesity, surgical removal of the womb or ageing. Women with POP have emphasised that the condition is life-altering due to symptoms, such as incontinence, that affect daily activities, quality of life, body image and mental health. Surgery for POP is twice as common as incontinence surgery, costing the NHS £45 million per year. The National Institute for Health and Care Excellence (NICE) recommends women try non-surgical treatments for POP (e.g. pelvic floor exercises or pessaries) before surgery. However, in our two patient and public involvement workshops women with POP told us that after clinical guidance they remain unsure what non-surgical treatments are available, and which work best. As the number of people with POP is predicted to increase due to an ageing population, it is important to know which non-surgical treatments work and are value for money. This will allow women to make informed choices about their care and the NHS can make best use of its resources. We are applying for funding to carry out this research. Methods: In a workshop, women with POP from different ethnic and socioeconomic backgrounds discussed what research questions were most relevant to them. They wanted to know what available treatments (from the NHS and elsewhere) were most effective. A statistical method called 'component network meta-analysis' will bring together data from all relevant existing clinical studies to compare treatments and find out how well they work (e.g. do they reduce the severity of prolapse and improve quality of life?). We will use these data to see which non-surgical treatments make best use of NHS resources. This means we will have the best available evidence to inform women, clinicians and policy makers about which non-surgical treatments are best. Patient and public involvement: Patient and public involvement has been central to developing the proposed work. We openly advertised for and recruited two patient co-applicants to help control and influence decision making during the development of this proposed research project. We also involved women with lived experiences of POP, including our patient co-applicants, in a survey and two workshops that have significantly shaped our aims, objectives and helped identify our key outcomes. If funded, we will recruit up to 10 women to an advisory group to provide different perspectives that will help shape the research whilst it is being planned and undertaken. We will provide contributors with training in key methods (e.g. systematic review) designed for lay audiences, so they are better able to shape the work. We will engage the group in all aspects of the work, regularly meeting and sharing progress updates. We will work with the group to discuss their experience of care and how this should determine the health economic analyses. Group members will help us interpret findings and to develop key messages for dissemination that will maximise their public reach. How the findings will be shared: We will share our findings as journal articles and at academic conferences. As identified by workshop discussions, research findings will be shared on appropriate media platforms (e.g. BBC Radio). We will further explore best approaches to share research findings with our planned patient advisory group. Description: Plain English Summary: Research question: What are the most effective and cost-effective non-surgical interventions for treating pelvic organ prolapse in women? Background: Pelvic organ prolapse (POP) is the descent of the female pelvic organs into the vagina. The condition is common, with a UK-based survey finding that 8.4% of women reported a vaginal bulge or lump. The prevalence of POP increases with age and so, given our ageing population, will be an increasing issue for women and the NHS. Current National Institute for Health and Care Excellence (NICE) guidelines for POP recommend non-surgical treatments, e.g. pelvic floor muscle training (PFMT) and pessaries, as first-line treatment. There is currently limited evidence comparing how effective these non-surgical interventions for POP are nor is these enough evidence on their value for money for the NHS. Uncertainty remains surrounding the effectiveness and cost-effectiveness of these interventions, which this work addresses. Aims and objectives: This work will answer 3 research questions: What are the most effective non-surgical interventions for managing POP in women? What are women's preferences for these interventions? Which of these interventions is the most cost-effective from an NHS perspective? Methods: We will conduct a component network meta-analysis (CNMA) of clinical effectiveness according to a pre-defined protocol. A CNMA is the most appropriate and robust method for synthesising data surrounding the potentially heterogenous and complex non-surgical interventions used to treat POP and will provide the best available evidence for decision making. To explore women's preferences for different ways care can be provided and its outcomes we will conduct a discrete choice experiment. The results of this and the CNMA will be incorporated into an economic evaluation model to assess cost-effectiveness. The project will be governed and the conduct further influenced by patient co-applicants and an advisory group of up to 10 women with a lived experience of POP. They will build on the patient involvement embedded into this application to further refine and establish the methods for the CNMA and the health economics. Timeline for delivery: We will deliver this work over 14 months. The CNMA will be conducted between months 1 and 10, with the DCE running between months 4 and 11. The structure of the economic model and additional model requirements will be identified between months 4 and 9, with the integration of the CNMA into the final model occurring in months 11 and 12. The public advisory group will convene in month 1 and formally meet 4 times across the course of the project, as well as meeting to formally discuss and feed into methods across the course of the work. Anticipated impact and dissemination: Our outputs include a detailed final report, at least two peer-reviewed academic journal articles, and conference presentations at relevant societal and methods-focused meetings. We will also feed the results of the project into guidelines produced by NICE, the European Association of Urology and the International Consultation on Incontinence to ensure our work directly impacts on clinical practice. Our work with women with POP has already identified wider platforms to publicly share our work (e.g. radio and podcasts). We will continue to work with our PPIE co-applicants and advisory group to identify public-facing dissemination options and to co-produce dissemination materials.

2025-05-01T00:00:00Z Mansell, SK Olsen, O Gowing, F Muwaffak, Z Kilbride, C Hilton, S Main, E Schievano, S Mandal, S http://bura.brunel.ac.uk/handle/2438/33322 2026-05-20T02:00:59Z 2025-07-29T00:00:00Z

Title: 3DPiPPIN: 3D printing of positive airway pressure (PAP) therapy interfaces: a single site feasibility study Authors: Mansell, SK; Olsen, O; Gowing, F; Muwaffak, Z; Kilbride, C; Hilton, S; Main, E; Schievano, S; Mandal, S Abstract: Sleep-disordered breathing (SDB) affects 14% of the population. Positive airway pressure (PAP) therapy is standard, but commercially available interfaces may be ineffective due to poor fit. Three-dimensional (3D) printing can customise PAP therapy interfaces. Is it feasible to manufacture and use 3D-printed customised oronasal PAP interfaces in clinical practice? Do customised interfaces improve patient comfort and reduce side effects compared to off-the-shelf interfaces? A single-site feasibility study involving 10 healthy and 10 patient participants was undertaken. A 3D facial scan was used to 3D print a mould, injected with medical-grade silicone to create a oronasal customised interface. Participants underwent a 10-minute trial with both off-the-shelf and customised interfaces. Comfort (Visual Analogue Scale), skin reactions, and interface leak (L/min) were measured. Patient participants used the customised interface for five nights at home, with data collected on Apnoea Hypopnoea Index (AHI), interface leak, and PAP therapy concordance. The study recruited 20 participants. Customised oronasal interfaces showed a failure rate in manufacturing (23.75% 3D printing, 50%: silicone injection). Adverse reactions were 10% in the patient study. Comfort scores were similar between interfaces. Interface leak was lower with customised interfaces after five nights. AHI was reduced with customised interfaces, but with a trend towards decreased PAP therapy concordance. The study demonstrated 3D-printed customised oronasal PAP interfaces can be manufactured, with potential benefits of reduced interface leak and AHI. Improvements in manufacturing processes are needed to reduce failure rates. Further research via a randomised controlled trial with a longer duration is warranted. Description: Data Availability statement: The data generated and/or analysed during the current study are not publicly available due to data protection and intellectual property protection.

2025-07-29T00:00:00Z Lauwereins, L D'Hoore, A Coeckelberghs, E Wolthuis, A Bislenghi, G Haustermans, K Rasschaert, G Dekervel, J Debrun, L Castro, EM Devoogdt, N De Groef, A Vanderheyden, H Geraerts, I Abasbassi, M Arnold, D Baert, E Barros, A Bianchi, F Bogaert, M Bulens, P Butt, Y Christensen, P Cihan, G Costiff, H Crispin, B Cucalon, C Cyr, M-P Debets, S Debleu, C Depaifve, Y Desnouck, S Devriendt, S Driesen, N Ferreira, RE Basany, EE Gambacorta, N Gärtner-Tschacher, N Geboes, K Gürsen, C Hoile, E Houben, B Igualada-Martinez, P Johannessen, H Joye, I Juul, T Kalkdijk, J Khera, A Kinross, J Sorensen, GK Komen, N Kossler, T Lefevre, J Lescrauwaet, L Leupe, T Majgaard, M Marinello, F Menconi, C Moretto, R Mørkved, S Nijs, A Stafne, SN Österlund, P Papaconstantinou, I Pape, E Pattyn, P Peters, F Pletinckx, P Poncelet, D Remue, C Ribas, Y Röder, F Roels, S Roenen, J Scalafani, F Sjövall, A Spaas, M Spinelli, A Stellamans, K Tambeur, V Tanis, P Tonarelli, N Trevor, J Van den Broeck, S van den Eynde, M Van Geluwe, B Van Herpe, F Van Ooteghem, G Van Reijn, D Vandessel, I Vanneste, H Vermeulen, H Thaysen, HV Weiss, L Bowel Diary Research group http://bura.brunel.ac.uk/handle/2438/33273 2026-05-14T02:01:23Z 2026-03-23T00:00:00Z

Title: Development of S.Tool: An electronic diary for assessing bowel symptoms after rectal cancer surgery Authors: Lauwereins, L; D'Hoore, A; Coeckelberghs, E; Wolthuis, A; Bislenghi, G; Haustermans, K; Rasschaert, G; Dekervel, J; Debrun, L; Castro, EM; Devoogdt, N; De Groef, A; Vanderheyden, H; Geraerts, I; Abasbassi, M; Arnold, D; Baert, E; Barros, A; Bianchi, F; Bogaert, M; Bulens, P; Butt, Y; Christensen, P; Cihan, G; Costiff, H; Crispin, B; Cucalon, C; Cyr, M-P; Debets, S; Debleu, C; Depaifve, Y; Desnouck, S; Devriendt, S; Driesen, N; Ferreira, RE; Basany, EE; Gambacorta, N; Gärtner-Tschacher, N; Geboes, K; Gürsen, C; Hoile, E; Houben, B; Igualada-Martinez, P; Johannessen, H; Joye, I; Juul, T; Kalkdijk, J; Khera, A; Kinross, J; Sorensen, GK; Komen, N; Kossler, T; Lefevre, J; Lescrauwaet, L; Leupe, T; Majgaard, M; Marinello, F; Menconi, C; Moretto, R; Mørkved, S; Nijs, A; Stafne, SN; Österlund, P; Papaconstantinou, I; Pape, E; Pattyn, P; Peters, F; Pletinckx, P; Poncelet, D; Remue, C; Ribas, Y; Röder, F; Roels, S; Roenen, J; Scalafani, F; Sjövall, A; Spaas, M; Spinelli, A; Stellamans, K; Tambeur, V; Tanis, P; Tonarelli, N; Trevor, J; Van den Broeck, S; van den Eynde, M; Van Geluwe, B; Van Herpe, F; Van Ooteghem, G; Van Reijn, D; Vandessel, I; Vanneste, H; Vermeulen, H; Thaysen, HV; Weiss, L; Bowel Diary Research group Abstract: Introduction: Rectal cancer treatment has improved survival, but postoperative bowel dysfunction, known as Low Anterior Resection Syndrome (LARS), significantly impacts Quality of Life. However, current assessment tools lack granularity to assess all LARS symptoms. Therefore, this study developed a mobile application (S.Tool), designed to be patient-friendly and easy to interpret, tailored to monitor LARS. Materials and methods: This study followed eight phases: 1) literature review, 2) internal expert group, 3) pre-Delphi patient focus group, 4) international Delphi Survey (conducted in two rounds in Dutch and English with five stakeholder-groups including colorectal surgeons, radiation and medical oncologists, pelvic floor physiotherapists, colorectal clinical nurse specialists and patients), 5) post-Delphi patient focus group, 6) consensus meeting, 7) forward-backward translation, and 8) development of the application. Descriptive statistics, percentages and median (range), were used to present the data. Results: A total of 122 participants, including 22 patients, participated in the international Delphi survey. Of these, 103 (84%) completed the first round and 97 (80%) the second round. After the Delphi rounds, 25 items were included in the bowel diary, 10 excluded and 8 discussed in the consensus meeting. Based on feedback from the post-Delphi patient focus group, the consensus meeting decided to include 6 of the 8 discussed items, resulting in 31 items. These guided the development of the S.Tool application. Conclusion: The S.Tool application is an innovative, multidisciplinary bowel diary for assessment and follow-up of patients with LARS. It generates visual summaries shareable with healthcare professionals to support clinical decision-making and personalized care. Description: Data availability: All data generated or analyzed during this study are included in this article. Further inquiries can be directed to the corresponding authors.; Supplementary data are available online at: https://www.sciencedirect.com/science/article/pii/S0748798326003744?via%3Dihub#appsec1 .; Acknowledgements: The authors are grateful to the patients who participated in the focus groups, the participants of the Delphi Survey (both patients and healthcare staff) and the scientific committee for their contributions to data acquisition.

2026-03-23T00:00:00Z Jenkins, TO Edwards, GD Patel, S Canavan, J Kon, S Barker, RE Jones, S Walsh, JA Ingram, K Nolan, CM Man, WD-C http://bura.brunel.ac.uk/handle/2438/33231 2026-05-07T13:37:30Z 2026-01-23T00:00:00Z

Title: The minimal important deterioration of the incremental shuttle walk test in chronic obstructive pulmonary disease: a prospective cohort study Authors: Jenkins, TO; Edwards, GD; Patel, S; Canavan, J; Kon, S; Barker, RE; Jones, S; Walsh, JA; Ingram, K; Nolan, CM; Man, WD-C Abstract: Introduction: The incremental shuttle walk test (ISWT) is a standardized field walking test used to assess cardiorespiratory fitness, particularly in individuals with chronic cardiorespiratory conditions like chronic obstructive pulmonary disease (COPD), bronchiectasis, and idiopathic pulmonary fibrosis.1–3 It has been widely adopted as a validated measure of exercise tolerance in pulmonary rehabilitation. The minimum important difference (MID)—sometimes called the Minimal Clinically Important Difference—is the smallest change in an outcome that patients or their clinicians perceive as beneficial (or harmful). The MID is useful for evaluating the effectiveness (or not) of clinical interventions, and for epidemiological research, but can also be used to evaluate decline over time, especially in progressive conditions. To date, the minimum important improvement for the ISWT in COPD cohorts undergoing pulmonary rehabilitation has been established as between 35.0 m and 36.1 m using distribution- and anchor-based methods.1 However, the minimum important decline of the ISWT has not been established, and it is plausible that patients with COPD may perceive decline in a different way to improvement. The aims of this study were to describe the change in ISWT over 1 year in people with COPD and to estimate the minimum important decline of the ISWT using distribution- and anchor-based methods. Description: Supplementary material: Supplementary data is available at Annals of the American Thoracic Society online at: https://academic.oup.com/annalsats/article/23/4/637/8435331#supplementary-data .

2026-01-23T00:00:00Z