Swansea Trials Unit

Working Closely with Researchers from the NHS and Industry

Swansea Trials Unit (STU) is part of the UK Clinical Research Collaboration (UKCRC) Registered Clinical Trials Unit (CTU) Network and receives funding from Health and Care Research Wales.

We aim to improve the health of the people of Wales and beyond by enhancing the number, progress and quality of trials in health & social care with particular reference to secondary and emergency care, notably in gastroenterology and mental health.

We offer methodological advice and support to clinical trials, both in designing new trials and in applying for grants. After successful applications, we work within trial teams to develop, initiate, conduct, manage, analyse and report funded studies.

In partnership with a large group of collaborators, we have run nearly 50 trials valued at more than £20m.

Areas of Research Focus

The Swansea Trials Unit (STU) is a service orientated UKCRC registered clinical trials unit that looks to support the technical delivery of trials and other rigorous studies across a wide range of health and social care research foci. The unit has specific recent experience supporting trials and studies related to pre-hospital care, colorectal surgery, diabetes and care of people with neurological deficits and challenges. It has specific methodological research interests in the area of patient reported outcome measures (PROMS) and the expanding use of routine data for trials.

Clinical Trials

We support the design, conduct, delivery, management, governance and reporting of clinical trials in health and social care. STU provides technical assistance in the design, development, hosting and management of data systems used for trials. STU statisticians can hone research questions providing required power/sample size calculations, analysis plans and undertaking and reporting of appropriate statistical analyses. We have experienced project managers taking on trial management functions for studies who are supported by staff knowledgeable in the regulatory requirements and approvals processes that projects must follow. The unit encourages the expanding participation of patients and members of the public as co-production partners with health and social care researchers in developing and delivering trials and studies that matter most to them.

Observational studies

STU assists clinicians and other health and social care researchers to gather data that provide detailed evidence of the current state of play across a variety of research areas of interest to them. It is hoped that such work will provide insights to inform future trials. The unit provides similar functional arrangements as for its portfolio of trials in the areas of project management, database design and use, as well as statistical and report writing expertise. During the period of the COVID-19 pandemic the unit quickly setup observational studies looking at issues affecting both health care providers and patients.

Patient reported outcome measures

Professor Hayley Hutchings is a methodological expert in the development and effective use of patient reported outcome measured (PROMS). With collaborators working in a number of clinical and social care specialities this work includes the development, validation, testing and use in research projects of new and existing PROMS.

Trials using routine data collection

Professor Alan Watkins, the senior statistician within STU, works closely with colleagues in the SAIL Databank to deliver trials utilising data they ingest from routine data collection systems collected by the NHS, Office of National Statistics and other governmental and other agencies. This work was scaled up massively during the current response to the COVID-19 pandemic. It is expected that the use of such data sources will continue to increase in the future and there are a number of staff within the Unit with direct hands-on experience of using the secure analysis research platform required by SAIL.

Research Outcomes

The Swansea Trials Unit work focuses on service led research meaning the research undertaken here is work to facilitate the work of the broad themes we have, and engage with external partners in industry and within the NHS to provide high quality support and insight into running and implementing a trial.

PROMS

Measuring patients’ health or quality of life

Patient reported outcome measures (PROMs) measure patients’ health or quality of life from their perspective using self-completed questionnaires. PROMs can be collected before and after a procedure or at regular intervals in chronic long-term conditions. PROM measurement and application is vital to provide high-quality healthcare by evaluating the performance of health care providers and guiding NHS reforms. PROMs also provide a platform to involve patients and their carers in the provision of healthcare and shaping the NHS. Professor Hayley Hutchings has secured grants as PROMs/quality of life methodological lead in excess of £6 million from funders including the National Institute for Health Research, Health and Care Research Wales, Scar Free Foundation, British Society for Audiology, Boots and Bristol Meyers Squibb/Pfizer.

Associated Collaborative and Industry Partners

Collaboration is central to our work, and our wide range of partners include:

Swansea Bay University Health Board
Hywel Dda University Health Board
Welsh Ambulance Service Trust
Cardiff and Vale University Health Board
Cardiff University
Wales Cancer Industry Forum (WCIF)
Health and Care Economics Cymru
Diabetes Research Unit Cymru
PRIME Centre Wales
SAIL Databank

Associated Research Projects

Randomised trial of clinical and cost effectiveness of Administration of Prehospital fascia Iliaca compartment block (FICB) for emergency hip fracture care Delivery (RAPID2)
FASAR
LIothyrONiNe Sulphate use in hypothyroid subjects homozygous for the Thr92Ala Deiodinase 2 ploymorphism on L-thyroxine alone - a phase 2b, crossover, double blind, randomised controlled trial (LIONNS-D2)
Phase two prospective observational single blind multi-site performance evaluation trial of serum Raman spectroscopy and supervised machine learning classification in a FIT-positive bowel screening population (COLOSPECT)
Brief Intervention with Cyclophosphamide in patients with Colorectal Cancer who completed treatment (BICCC)
A mixed-methods scoping study of sun safety policies in primary schools in Wales (Sunproofed)
How the Sun Sees You (SunView)
Sun Safety Conversations about Healthy Attitudes to Tanning (SunChat)
Enabling research activity across Wales (Enabling Research)
Evaluating a technique to prevent parastomal hernias and improve symptoms and quality of life for those with stomas: A multi-centre feasibility randomised trial (ExPeCT)
Ustekinumab in adolescents with recent-onset type 1 diabetes (USTEKID)
Group-based positive psychotherapy for people living with Acquired Brain Injury: A feasibility study (PP4TBI)
Eye Movement Desensitisation and Reprocessing (EMDR) for symptoms of Post-Traumatic Stress Disorder (PTSD) in adults with intellectual disabilities (TRAUMA-AID)
GPs in EDs: Realist evaluation of GP-ED models (GPs in EDs)
What works to improve SafeTy, pAtient experience, outcomes and costs reLated to deLayed ambulance handovers at Emergency Departments? A whole system approach (STALLED)
The impact of cessation of screening for diabetic eye disease on people with diabetes during the COVID-19 pandemic (DESW COVID)
Hughes Abdominal Repair Trial – a multi-centre pragmatic randomised trial of wall closure technique to reduce incidence of incisional hernias (HART)
Extending the Hughes Abdominal Repair Trial: Long-term Follow-Ups by Routine Data (HART FU)
Development of Co-produced guidance for the care of Patients with blunt Chest wall Trauma: a mixed methods study (CO-PACT)
Enhanced epidermal antigen specific immunotherapy trial - Type 1 Diabetes (EE-ASI)

Associated Sub-Theme Publications

Battle C, Cole E, Carter K, Baker E. Clinical prediction models for the management of blunt chest trauma in the emergency department: a systematic review. BMC Emerg Med 24, 189 (2024) DOI: 10.1186

Alzghaibi H, Hutchings HA. The Impact of Leadership and Management on the Implementation of Electronic Health Record Systems in the Primary Healthcare Centers. Healthcare 2024, 12(20), 2013 DOI: 10.3390

Bashir M, Jubouri M, Surkhi AO, Williams IM, Davidovic LB, Koncar I, Stelzmueller M-E, Hoksbergen AWJ, Jongkind V, Zacà S, Mansour W, Sirignano P, D'Oria M, Tolva S, Van Herzeele I, Klincheva M, Atanasov Z, Bartoli S, Bellosta R, Chisci E, Guagliano A, Teraa M, Ivak P,

Recicarova S, Pellenc Q, Heijmen R, Pfister K, Piffaretti G, Hutchings HA, Holland G, Bailey D, Thielmann M, Jakob HG, Uncomplicated Type B Aortic Dissection - A European Multicentre Cross-Sectional Evaluation. Ann Vascular Surgery (Sept 2024) Annals of Vascular Surgery, Sept 2024

Kingston MR, Davies J, Snooks H, Porter A, Hutchings H. Patient Perspectives on the Acceptability of Emergency Admission Risk Prediction: A Focus Group Study. Ann Public Health Reports, 8(1):336-343 (2024) DOI: 10.36959/856/544

Tatovic D, Marwaha A, Taylor P, Hanna SJ, Carter K, Cheung WY, Luzio S, Dunseath G, Hutchings HA, Holland G, Hiles S, Fegan G, Williams E, Yang JHM, Domingo-Vila C, Pollock E, Wadud M, Ward-Hartstonge K, Marques-Jones S, Bowen-Morris J, Stenson R, Levings MK, Gregory JW, Tree TIM, Dayan C, USTEKID Study Group. Ustekinumab for type 1 diabetes in adolescents: a multicenter, double-blind, randomized, phase 2 trial. Nature Medicine (2024) DOI: 10.1038

Abbott RA, Tod D, Lanyon K, Driscoll T, Prathap S, Watkins A, Peconi J. Are Welsh primary schools Sunproofed? Results of a national survey, part 2: sun protection practices in primary schools in Wales. Clinical and Experimental Dermatology, llae218 (2024) DOI: 10.1093/ced/llae218

Tur Porres G, Lanyon K, Abbott R, Lewis H, Marchant E, Peconi J. Exploring perceptions of and attitudes towards tanning with school children, parents/carers and educators in Wales: A mixed methods study protocol for the SunChat study. (PLoS ONE 19(6): e0295719, 2024) DOI: 10.1371

Battle C, O’Neill M, Barnett J, Hutchings H, Uzzell B, Toghill H, O’Neill C. Patient and clinician perceptions of blunt chest trauma management and recovery: a qualitative study. Disability and Rehabilitation (2024) DOI: 10.1080

Hutchings HA, Rahman M, Carter K, Islam S, O'Neill C, Roberts S, John A, Fegan G, Dave U, Hawkes N, Ahmed F, Hasan M, Azad AK, Rahman MM, Kibria MG, Rahman MM, Mia T, Akhter M, Williams JG. Did the COVID-19 pandemic affect levels of burnout, anxiety and depression among doctors and nurses in Bangladesh? A cross-sectional survey study. BMJ Open (2024;14:e079350)
DOI: 10.1136

Fisher Z, Field S, Fitzsimmons D, Hutchings H, Carter K, Tod D, Gracey F, Knight A, Kemp AH. Group-based positive psychotherapy for people living with acquired brain injury: a protocol for a feasibility study. Pilot Feasibility Stud 10, 38 (2024) DOI: 10.1186

Fegan G, Tod D, Downing A, Elmusharaf N, Pepper C, Fegan C. Social deprivation independently impacts clinical outcomes in patients with chronic lymphocytic leukemia. Haematologica (2024) DOI: 10.3324

Hutchings HA, Cochrane M, Battle C. Study to evaluate the readability and visual appearance of online resources for blunt chest trauma: an evaluation of online resources using mixed methods. BMJ Open (2024) DOI: 10.1136

Ali SR, Dobbs TD, Tarafdar A, Strafford H, Fonferko-Shadrach B, Lacey AS, Pickrell WO, Hutchings HA, Whitaker IS. Natural language processing to automate a web-based model of care and modernize skin cancer multidisciplinary team meetings. British Journal of Surgery, Volume 111, Issue 1 (2024) DOI: 10.1093

Toader A-M, Campbell MK, Quint JK, Robling M, Sydes MR, Thorn J, Wright-Hughes A, Yu L-M, Abbott TEF, Bond S, Caskey FJ, Clout M, Collinson M, Copsey B, Davies G, Driscoll T, Gamble C, Griffin XL, Hamborg T, Harris J, Harrison DA, Harji D, Henderson EJ, Logan P, Love SB, Magee LA, O’Brien A, Pufulete M, Ramnarayan P, Saratzis A, Smith J, Solis-Trapala I, Stubbs C, Farrin A, Williamson P. Using healthcare systems data for outcomes in clinical trials: issues to consider at the design stage. Trials 25, 94 (2024) DOI: 10.1186

Peconi J, Lanyon K, Tod D, Driscoll T, Prathap S, Watkins A, Abbott RA. Are Welsh primary schools Sunproofed? Results of a national survey Part 1: Scoping the landscape of sun safety policies in Wales. Clinical and Experimental Dermatology (2024) DOI: 10.1093

Ali SR, Dobbs TD, Jovic M, Strafford H, Lacey AS, Williams N, Pickrell WO, Hutchings HA, Whitaker IS. Revisiting basal cell carcinoma clinical margins: Leveraging natural language processing and multivariate analysis with updated Royal College of Pathologists histological reporting standards. Journal of Plastic, Reconstructive & Aesthetic Surgery (2024) DOI: 10.1016

T.D. Dobbs, M. Ottenhof and J.A.G. Gibson Whitaker IS, Hutchings HA. The Patient-Reported Outcome Measures In Skin Cancer Reconstruction (PROMISCR) study: Anglicisation and initial validation of the FACE-Q Skin Cancer Module in a UK cohort, Journal of Plastic, Reconstructive & Aesthetic Surgery, https://doi.org/10.1016/j.bjps.2020.09.005

https://doi.org/10.1016/j.bjps.2020.09.005

Richards D A, Bazeley P, Borglin G, Craig P, Emsley R, Frost J, Hill J, Horwood J, Hutchings H A , Jinks C, Montgomery A, Moore G, Plano Clark V L,Tonkin- Crine S, Wade J, Warren F C, Wyke S, Young B, O’Cathain A. Integrating quantitative and qualitative data and findings when undertaking randomised controlled trials. BM J Open 2019, published online 27 November 2019.

DOI: dx.doi.org/10.1136/bmjopen-2019-032081

Hounsome N, Kassahun MM, Ngari M, Berkley JA, Kivaya E, Njuguna P, Fegan G, Tamiru A, Kelemework A, Amberbir T, Clarke A, Lang T, Newport MJ, McKay A, Enquoselassie F, Davey G. Cost-effectiveness and social outcomes of a community-based treatment for podoconiosis lymphoedema in the East Gojjam zone, Ethiopia. PLoS Negl Trop Dis. 2019 Oct;13(10):e0007780. doi: 10.1371/journal.pntd.0007780. eCollection 2019 Oct. PubMed PMID: 31644556

10.1371/journal.pntd.0007780

Rapport F, Clement C, Seagrove AC, Alrubaiy L, Hutchings HA, Williams JG. Patient views about the impact of ulcerative colitis and its management with drug treatment and surgery: a nested qualitative study within the CONSTRUCT trial. BMC Gastroenterology 2019, Article number 166. Published online 15 October 2019.

DOI:10.1186/s12876-019-1085-y

Lynch TR, Hempel RJ, Whalley B, Byford S, Chamba R, Clarke P, Clarke S, Kingdon DG, O’Mahen H, Remington B, Rushbrook SC, Shearer J, Stanton M, Swales M, Watkins A, Russell IT. Refractory depression – mechanisms and efficacy of radically open dialectical behaviour therapy (RefraMED): findings of a randomised trial on benefits and harms. Br J Psychiatry. 2019 Jul 18:1-9. doi: 10.1192/bjp.2019.53. [Epub ahead of print] PubMed PMID: 31317843.

10.1192/bjp.2019.53

Gibson JA, Dobbs TD, Griffiths R, Song J, Akbari A, Whitaker S, Watkins A, Langan S, Hutchings HA, Lyons RA, Whitaker IS. The Association of Smoking and Socioeconomic status on Cutaneous Malignant Melanoma; a population based, data linkage, case-control study. British Journal of Dermatology 2019. DOI:10.1111/bjd.18526. Published online 17 September 2019.

DOI:10.1111/bjd.18526

Battle C, Hutchings H A, Driscoll T, O’Neill C, Groves S, Watkins A, Lecky F E, Jones S, Gagg J, Body R, Abbott Z, Evans P A. A multicentre randomised feasibility STUdy evaluating the impact of a prognostic model for Management of BLunt chest wall trauma patients: STUMBL Trial.BMJ Open, Published: July 26, 2019

http://dx.doi.org/10.1136/bmjopen-2019-029187

Bandsma R.h.J, Voskuijl W., Chimwezi E., Fegan G., Briend A., Thitiri J., Ngari M., Mwalekwa L., Bandika V., Ali R., Hamid F., Owor B., Mturi N., Potani I., Allubha B., Kobold A.C.M., Bartels R.H., Versloot C.J., Feenstra M., A. van den Brink D., F. van Rheenen P., Kerac M., Bourdon C., Berkley J.A.A reduced-carbohydrate and lactose-free formulation for stabilization among hospitalized children with severe acute malnutrition: A double-blind, randomized controlled trial, Plos Medicine, Published: February 26, 2019

https://doi.org/10.1371/journal.pmed.1002747