Publications | Newcastle Clinical Trials Unit

2022

Cheetham TD, Cole M , Abinun M, Allahabadia A , Barratt T , Davies JH , Dimitri P ,Drake A , Mohamed Z , Murray RD , Steele A , Zammitt N, Carnell S, Prichard J, Watson G, Hambleton S , Matthews JNS , Pearce SHS. Adjuvant Rituximab-Exloratory Trial in Young People with Graves Disease. The Journal of Clinical Endocrinology Metabolism 2022 Vol 107(No.3): 743-754. https://doi.org/10.1210/clinem/dgab763

Harding C, Mossop H, Homer T, Chadwick T, King W, Carnell S, Lecouturier J, Abouhajar A, Vale L, Watson G, Forbes R, Currer S, Pickard R, Eardley I, Pearce I, Thiruchelvam N, Guerrero K, Walton K, Hussain Z, Lazarowicz H, Ali A. Alternative to prophylactic antibiotics for the treatment of recurrent urinary tract infections in women: multicentre, open label, randomised, non-inferiority trial. BMJ 2022, 376, e068229.

Harding C, Chadwick T, Homer T, Lecouturier J, Mossop H, Carnell S, King W, Abouhajar A, Vale L, Watson G, Forbes R, Currer S, Pickard R, Eardley I, Pearce I, Thiruchelvam N, Guerrero K, Walton K, Hussain Z, Lazarowicz H, Ali A. Methenamine hippurate compared with antibiotic prophylaxis to prevent recurrent urinary tract infections in women: the ALTAR non-inferiority RCT. Health Technology Assessment 2022, 26(23), 1-172.

Gravestock P, Clark E, Morton M, Sharma S, Fisher H, Walker J, Wood R, Hancock H, Waugh N, Cooper A, Maier R, Marshall J, Chandler R, Bahl A, Crabb S, Jain S, Pedley I, Jones R, Staffurth J, Heer R. Using the AR-V7 biomarketr to determine treatment in metastatic castrate resistant prostate cancer, a feasibility randomised control trial, conclusions from the VARIANT trial. NIHR Open Research. doi: https://openresearch.nihr.ac.uk/articles/2-49/v1

Dunn S, Kavanagh D, Lecouturier J, Malina M, Moloney E, Oluboyede Y, Weetman C, Wong KS, Woodward L, Sheerin N. Safety and impact of eculizumab withdrawal in patients with atypical haemolytic uraemic syndrome: protocol for a multicentre, open-label, prospective, single-arm study (aHUS). BMJ Open. https://bmjopen.bmj.com/content/12/9/e054536.full

Frise MC, Holdsworth D, Sandhu M, Mellor AJ, Kasim AS, Hancock HC, Maier RH, Donnington KL, Robbins PA, Akowuah EF. Non-anemic iron deficiency predicts prolonged hospitalisation following surgical aortic valve replacement: a single-centre retrospective study. Journal of Cardiothoracic Surgery; volume 17: 157 (2022) DOI: 10.1186/s13019-022-01897-5 published 16th June.

Rennie KJ, Witham M, Bradley P, Clegg A, Connolly S, Hancock HC, Hiu S, Marsay L, McDonald C, Robertson L, Simms L, Steel AJ, Steves CJ, Storey B, Wason J, Wilson N, von Zglinicki T, Sayer AAP. MET-PREVENT: Metformin to improve physical performance in older people with sarcopenia and physical prefrailty/frailty – protocol for a double blind, randomised controlled proof of concept trial. BMJ Open 2022;12:e061823. doi:10.1136/bmjopen-2022-061823

Zaccagna F, McLean MA, Grist JT, Kaggie J, Mair R, Riemer F, Woitek R, Gill AB, Deen S, Daniels CJ, Ursprung S, Schulte RF, Allinson K, Chhabra A, Laurent MC, Locke M, Frary A, Hilborne S, Patterson I, Carmo BD, Slough R, Wilkinson I, Basu B, Wason J, Gillard JH, Matys T, Watts C, Price SJ, Santarius T, Graves MJ, Jefferies S, Brindle KM, Gallagher FA. Imaging Glioblastoma Metabolism by Using Hyperpolarized [1-$łess$sup$greater$13$łess$/sup$greater$C]Pyruvate Demonstrates Heterogeneity in Lactate Labeling: A Proof of Principle Study. Radiology: Imaging Cancer.

Mukherjee A, Wason J, Grayling MJ . When is a two-stage single-arm trial efficient? An evaluation of the impact of outcome delay. European Journal of Cancer.

Dua S, Ruiz-Garcia M, Bond S, Dowey J, Durham SR, Kimber I, Mills C, Roberts G, Skypala I, Wason J, Ewan P, Boyle RJ, Clark A. Effects of Exercise and Sleep Deprivation on Reaction Severity During Oral Peanut Challenge: A Randomized Controlled Trial. The Journal of Allergy and Clinical Immunology: In Practice

Sakata M, Toyomoto R, Yoshida K, Luo Y, Nakagami Y, Uwatoko T, Shimamoto T, Tajika A, Suga H, Hiroshi Ito, Sumi M, Muto T, Ito M, Ichikawa H, Ikegawa M, Shiraishi N, Watanabe T, Sahker E, Ogawa Y, Hollon SD, Collins LM, Watkins ER, Wason J, Noma H, Horikoshi M, Iwami T, Furukawa TA. Components of smartphone cognitive-behavioural therapy for subthreshold depression among 1093 university students: a factorial trial. Evidence Based Mental Health

Mukherjee A, Grayling MJ, Wason JMS. Adaptive Designs: Benefits and Cautions for Neurosurgery Trials. World Neurosurgery.

Busby AD, Wason J, Pratt AG, Young A, Isaacs JD, Nikiphorou E. The role of comorbidities alongside patient and disease characteristics on long-term disease activity in RA using UK inception cohort data. Rheumatology.

Li V, Leurent B, Barkhof F, Braisher M, Cafferty F, Ciccarelli O, Eshaghi A, Gray E, Nicholas JM, Parmar M, Peryer G, Robertson J, Stallard N, Wason J, Chataway J. Designing Multi-arm Multistage Adaptive Trials for Neuroprotection in Progressive Multiple Sclerosis. Neurology

Taylor GS, Shaw AC, Smith K, Wason J, McDonald TJ, Oram RA, Stevenson E, Shaw JAM, West DJ. Capturing the real-world benefit of residual $p̆beta$-cell function during clinically important time-periods in established Type 1 diabetes. Diabetic Medicine.

Zheng H, Jaki T, Wason JMS. Bayesian sample size determination using commensurate priors to leverage preexperimental data. Biometrics

Grayling MJ, Wason JMS, Villar SS. Response adaptive intervention allocation in stepped-wedge cluster randomized trials. Statistics in Medicine

Grayling MJ, McMenamin M, Chandler R, Heer R, Wason JMS. Improving power in PSA response analyses of metastatic castration-resistant prostate cancer trials. BMC Cancer

Heer R, Lewis R, Vadiveloo T, Yu G, Mariappan P, Cresswell J, McGarth J, Nabi G, Mostafid H, Lazarowicz H, Kelly J, Duncan A, Penegar S, Breackons M, Wilson L, Clark E, Feber A, Orozco-Leal G, Tangogdu Z, Taylor E, N'Dow J, Norrie J, Ramsay C, Rice S, Vale L, MacLennan G, Hall E. A ramdomized trial of PHOTOdynamic Surgery in non-muscle-invasive bladder cancer. NEJM Evid 2022; 1 (10). doi: https://doi.org/10.1056/EVIDoa2200092

2021

Wilson JA, Stocken DD, Watson GC, Fouweather T, McGlashan J, MacKenzie K, Carding P, Karagama Y, Harries M, Bell S, Khwaja S, Costello D, Wood R, Lecouturier J, O'Hara J Lansoprazole for persistent throat symptoms in secondary care: The TOPPITS RCT Health Technol Assess 2021;25(3) Published in January 2021 DOI: https://doi.org/10.3310/hta25030

Azim L, Hindmarch P, Browne G, Chadwick T, Clare E, Courtney P, Dixon L, Duffelen N, Fouweather T, Geddes JR, Goudie N, Harvey S, Helter T, Holstein EM, Martin G, Mawson P, McCaffery J, Morris R, Simon J, Smith D, Stokes PRA, Walker J, Weetman C, Wolstenhulmee F, Young AH, Watson S, McAllister Williams RH
Study protocol for a randomised placebocontrolled trial of pramipexole in addition to mood stabilisers for patients with treatment resistant bipolar depression (the PAX-BD study) BMC Psychiatry July 2021 hhtps://doi.org/10.1186/s12888-021-03322-y

White P, Gregson B, McColl E, Brennan P, Steel A, Watts P, Wood R, Bowes C, Javadpour M, Weston A, Mitra D
Emergent aneurysm treatment compared with treatment on neurological improvement in patients with ruptured poor-grade aneurysmal subarachnoid haemorrhage: the TOPSAT2 RCT NIHR Journals Library Volume 8 https://www.journalslibrary.nihr.ac.uk/eme/eme08080/#/abstract

Maier R, Kasim AS, Zacharias J, Vale L, Graham R, Walker A, Laskaski G, Deshpande R, Goodwin A, Kendall S, MurphyGJ, Zamvar V, Pessotto R, Lloyd C, Dalrymple-Hay M, Casula R, Vohra HA, Ciulli F, Caputo M, Stoica S, Baghai M, Niranjan G, Punjabi PP, Wendler O, Marsay L, Fernandez-Garcia C, Modi P, Kirmani BH, Pullan MD, Pousios D, Hancock HC, Akowuah E Minimally invasive versus conventional sternotomy for Mitral valve repair: protocol for a multicentre randomised controlled trial (UK Mini Mitral)
BMJ Open Volume 11, Issue 4 https://bmjopen.bmj.com/content/11/4/e047676

Cherlin S, Wason J.MS. 2021. Developing a predictive signature for two trial endpoints using the cross-validated risk scores method. Biostatistics. doi:10.1093/biostatistics/kxaa055.

Grayling MJ, Bigirumurame T, Cherlin S, Ouma L, Zheng H, Wason JMS. 2021. Innovative trial approaches in immune-mediated inflammatory diseases: current use and future potential. BMC Rheumatology. doi.org/10.1186/s41927-021-00192-5

Vergis N [et al. including Cherlin S]. Multi-arm Trial of Inflammatory Signal Inhibitors (MATIS) for hospitalised patients with mild or moderate COVID-19 pneumonia: a structured summary of a study protocol for a randomised controlled trial. Trials. doi.org/10.1186/s13063-021-05190-z

Grahame V, Dixon L, Honey E, Rogan L, Fletcher-Watson S, Garland D, Glod M, Goodwin J, Le Couteur A, Rob P, Rodgers J, Grayson Z, Mackie L, Heron S, Iverson R, Walls E, Kasim AS, Kernohan A, Vale L, Kharatikoopaei E, Mathis A, Weetman C, Wolstenhulme F, Wood R, Probert H, Riby D, Thompson S, Webb EI
A clinical and cost-effectiveness trial of a parent group intervention to manage challenging restricted and repetitive behaviours in young children with autism spectrum disorder: study protocol for a randomised controlled trial (MRB) BMC Trials 01 Aprill 2021 https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05175-y#Abs1

Forbes S, Flatt AJ, Bennett D, Clarkson R, Pimkova M, Birtles L, Pernet A, Wood RC, Burling K, Barker P, Counter C, Lumb A, Choudhary P, Rutter MK, Rosenthal M, Sutherland A, Casey J, Johnson P, Shaw JAM. The impact of islet mass, number ot transplants, and time between transplants on graft function in a national islet transplant program. American Journal of Transplantation 26 July 2021. DOI: 10.1111/ajt.16785

Lambert HJ, Sharma S, Matthews JNS. I-KID study protocol: evaluation of efficacy, outcomes and safety of a new infant haemodialysis and ultrafiltration machine in clinical use: a randomised clinical investigation using a cluster stepped-wedge design. BMJ Paediatrics Open 2021;0:e001224. doi:10.1136/ bmjpo-2021-001224

Wood CL, Morrison N, Cole M, Donaldson M, Dunger DB, Wood R, Pearce SHS, Cheetham TD. Initial response of young people with Thyrotoxicosis to block and replace or dose titration thionamide. European Thyroid Journal.0:e210043. doi: 10.1530/ETJ-21-0043

Bywater T, Berry V, Blower S, Bursnall M, Cox E, Mason-Jones A, McGilloway S, McKendrick K, Mitchell S, Pickett K, Richardson G, Solaiman K, Teare MD, Walker S, Whittaker K. A proportionate, universal parenting programme to enhance social-emotional well-being in infants and toddlers in England: the E-SEE Steps RCT. Public Health Research.

Wang HI, Debenham Wright B, Bursnall M, Cooper C, Kingsley E, Le Couteur A, Teare D, Biggs K, McKendrick K, Gomez de la Cuesta G, Chater T, Barr A, Solaiman K, Packham A, Marshall D, Varley D, Nekooi R, Gilbody S, Parrott S. Cost-utility analysis of LEGO based therapy for school children and young people with autism spectrum disorder: results from a randomised controlled trial. BMJ Open.

Foo O, Hiu S, Teare D, Syed AA, Razvi S. A global country-level analysis of the relationship between obesity and COVID-19 cases and mortality. Diabetes Obes Metab 2021; DOI:10.1111/dom.14523.

Rayner F, Anderson AE, Baker KF, Buckley CD, Dyke B, Fenton S, Filer A, Goodyear CS, Hilkens CMU, Hiu S, Kerrigan S, Kurowska-Stolarska M, Matthews F, McInnes I, Ng W-F, Pratt AG, Prichard J, Raza K, Siebert S, Stocken S, Teare MD, Young S, Isaacs JD. BIOlogical Factors that Limit sustAined Remission in rhEumatoid arthritis (the BIO-FLARE study): Protocol for a non-randomised longitudinal cohort study. BMC Rheumatol 2021; 5:22.

Blower SL, Berry VL, Bursnall MC, Cohen J, Gridley N, Loban A, Mandefield L, Mason-Jones AJ, McGilloway S, McKendrick KL, Mitchell SB, Pickett KE, Richardson GA, Teare MD, Tracey LC, Walker SM, Whittaker KA, Wright J, Bywater TJ. Enhancing Social-Emotional outcomes in Early years (E-SEE): Randomized pilot study of incredible years infant and toddler programs. J Child Fam Stud 2021; 30:1933-49.

Lesseur C, Ferreiro-Iglesias A, Mckay JD, Bossé Y, Gaborieau V, Landi MT, hristiani DC, aporaso NC, Bojesen SE, Amos CI, Shete S, Liu G, Rennert G, Albanes D, Aldrich MC, Tardon A, Chen C, Triantafillos L, Field JK, Teare MD, Kiemeney LA, Diergaarde B, Ferris RL, Zienolddiny S, Lam S, Olshan AF, Weissler MC, Lacko M, Risch A, Bickeboller H, Ness AR, Thomas S, Le Marchand L, Schabath MB, Wunsch-Filho V, Tajara EH, Andrew AS, Clifford GM, Lazarus P, Grankvist K, Johansson M, Arnold S, Melander O, Brunnstrom H, Boccia S, Cadoni G, Timens W, Obeidat M, Xiao X, Houlston RS, Hung RJ, Brennan P. Genome-wide association meta-analysis identifies pleiotropic risk loci for aerodigestive squamous cell cancers. PLoS Genet 2021; 17:e1009254.

Liu G, Brenner H, Chen C, Christiani D, Field JK, Hung R, Jie Z, Le Marchand L, Ryan B, Schabath MB, Schwartz AG, Shete S, Shiraishi K, Tardon A, Teare MD, Yang P, Zhang ZF, Xu W. A reply to 'Lung cancer outcomes: Are BMI and race clinically relevant?'. Lung Cancer 2021; doi:10.1016/j.lungcan.2021.02.019.

Jiang M, Fares AF, Shepshelovich D, Yang P, Christiani D, Zhang J, Shiraishi K, Ryan BM, Chen C, Schwartz AG, Tardon A, Shete S, Schabath MB, Teare MD, Le Marchand L, Zhang ZF, Field JK, Brenner H, Diao N, Xie J, Kohno T, Harris CC, Wenzlaff AS, Fernandez-Tardon G, Ye Y, Taylor F, Wilkens LR, Davies M, Liu Y, Barnett MJ, Goodman GE, Morgenstern H, Holleczek B, Thomas S, Brown MC, Hung RJ, Xu W, Liu G. The relationship between body-mass index and overall survival in non-small cell lung cancer by sex, smoking status, and race: A pooled analysis of 20,937 International lung Cancer consortium (ILCCO) patients. Lung Cancer 2021; 152:58-65.

Grayling MJ, Bigirumurame T, Cherlin S, Ouma L, Zheng H, Wason J. Innovative trial approaches in immune-mediated inflammatory diseases: Current use and future potential. BMC Rheumatol 2021;

Castellucci LC, Almeida L, Cherlin S, Fakiola M, Francis RW, Carvalho EM, Santos da Hora A, do Lago TS, Figueiredo AB, Cavalcanti CM, Alves NS, Morais KLP, Teixeira-Carvalho A, Dutra WO, Gollob KJ, Cordell HJ, Blackwell JM. A genome-wide association study identifies SERPINB10, CRLF3, STX7, LAMP3, IFNG-AS1, and KRT80 as risk loci contributing to cutaneous leishmaniasis in Brazil. Clin Infect Dis 2021; 72:e515-25.

Wagnild JM, Akowuah E, Maier RH, Hancock HC, Kasim A. Impact of Prehabilitation on Objectively Measured Physical Activity Levels in Elective Surgery Patients: A Systematic Review. 2021. Sep 7;11(9):e049202. doi: 10.1136/bmjopen-2021-049202.

Wilson N, Biggs K, Bowden S, Brown J, Dimairo M, Flight L, Hall J, Hockaday A, Jaki T, Lowe R, Murphy C, Pallmann P, Pilling MA, Snowdon C, Sydes MR, Villar SS, Weir CJ, Welburn J, Yap C, Maier R, Hancock HC, Wason JMS. Costs and staffing resource requirements for adaptive clinical trials: quantitative and qualitative results from the Costing Adaptive Trials project. BMC Med. 2021 Oct 26;19(1):251. doi: 10.1186/s12916-021-02124-z.

Vergis N, Phillips R, Cornelius V, Katsarou A, Youngstein T, Cook L, Willicombe M, Pilay C, Shturova T, Almonte M, Charania A, Turner R, Kon OM, Cooke G, Thursz M, Cherlin S, Wason J, Milojkovic D, Innes AJ, Cooper N. Multi-arm Trial of Inflammatory Signal Inhibitors (MATIS) for hospitalised patients with mild or moderate COVID-19 pneumonia: A structured summary of a study protocol for a randomised controlled trial. Trials 2021; 22:270.

Egle M, Hilal S, Tuladhar AM, Pirpamer L, HoferE, Duering M, Wason J, Morris RG, Dichgans M, Schmidt R, Tozer D, Chen C, de Leeuw FE, Markus HS. Prediction of dementia using diffusion tensor MRI measures: the OPTIMAL collaboration. Journal of Neurology, Neurosurgery & Psychiatry.

Busby AD, Wason J, Pratt AG, Young A, Isaacs JD, Nikiphorou E. Predictors of poor function in RA based on two prospective UK inception cohorts. Do comorbidities matter?. Rheumatology 2021; DOI:10.1093/rheumatology/keab598

Grayling MJ, Bigirumurame T, Cherlin S, Ouma L, Zheng H, Wason J. Innovative trial approaches in immune-mediated inflammatory diseases: Current use and future potential. BMC Rheumatol 2021; 5:21.

Collins A, Lendrem D, Wason J, Tarn J, Howard-Tripp N, Bodewes I, Versnel MA, Gottenberg JE, Seror R, Mariette X, Ng WF. Revisiting the JOQUER trial: Stratification of primary Sjögren's syndrome and the clinical and interferon response to hydroxychloroquine. Rheumatol Int 2021; 41:1593-1600.

Kunzmann K, Grayling MJ, Lee KM, Robertson DS, Rufibach K, Wason JMS. A review of Bayesian perspectives on sample size derivation for confirmatory trials. Am Stat 2021; DOI:10.1080/00031305.2021.1901782

Ouma LO, Grayling MJ, Zheng H, Wason J. Treatment allocation strategies for umbrella trials in the presence of multiple biomarkers: A comparison of methods. Pharm Stat 2021; doi:10.1002/pst.2119

Lee KM, Brown LC, Jaki T, Stallard N, Wason J. Statistical consideration when adding new arms to ongoing clinical trials: The potentials and the caveats. Trials 2021; 22:203.

2020

Cormack S, Ashfaq M, Panahi P, Das R, Steel AJ, Chadwick T, Bryant A, Egred M, Konstantinos S, Spredopoulos I. Effect of ciclosporin on safety, lymphocyte kinetics and left ventricular remodeling in acute myocardial infarction (CAPRI Trial). British Journal Clinical Pharmacology - 2020. https://dx.doi.org/10.1111/bcp.14252.

Maguire A, Clarkson JE, Douglas GVA, Ryan V, Homer T, Marshman Z, McColl E, Wilson N, Vale L, Robertson M, Abouhajar A, Holmes RD, Freeman R, Chadwick B, Deery C, Wong F, Innes NPT. Best practice prevention alone or with conventional or biological caries management for 3-7-year-olds: The FICTION three-arm RCT. Health Technology Assessment Volume: 1, Published in January 2020.

Innes NP, Clarkson JE, Douglas GVA, Ryan V, Wilson N, Homer T, Marshman Z, McColl E, Vale L, Robertson M, Abouhajar A, Holmes RD, Freeman R, Chadwick B, Deery C, Wong F, Maguire A. Child caries management: a randomized controlled trial in dental practice. Journal of Dental Research 2020. 99(1), 36-43.

Freeman R, Maguire A, Ryan V, Wilson N, Innes N, Clarkson J, McColl E, Marshman Z, Robertson M, Abouhajar A, Chadwick B, Deery C, Wong F, Douglas G. The FICTION trial: child oral health related quality of life and dental anxiety across 3 treatment strategies for managing caries in young children. Community Dentistry Oral Epidemiology 2020.

Rennie KJ, O'Hara J, Rousseau N, Stocken DD, Howel D, Ternent L, Drinnan M, Bray A, Rooshenas L, Hamilton DW, Steel A, Fourweather T, Hynes AM, Holstein EM, Oluboyede Y, Abouhajar A, Wilson JA, Carrie S. Nasal Airway Obstruction Study (NAIROS): A phase III, open-label, mixed-methods, multicentre randomised controlled trial of septoplasty versus medical management of a septal deviation with nasel obstruction. BMC Trials- February 2020. https://doi.org/10.1186/s13063-020-4081-1.

Snowden C, Lynch E, Avery L, Haighton C, Howel D, Mamasoula V, Gilvarry E, McColl E, Prentis J, Gerrand C, Steel A, Goudie N, Howe N, Kaner E. Preoperative behavioral intervention to reduce drinking before elective orthopedic surgery: The PRE-OP BIRDS feasibility RCT Health Technology Assessment Volume: 24, Issue: 12, Published in March 2020.

Price CI, Shaw L, Islam S, Javanbakht M, Watkins A, McMeekin P, Snooks H, Flynn D, Francis R, Lakey R, Sutcliffe L, McClelland G, Lally J, Exley C, Rodgers H, Russell I, Vale L, Ford GA. Effect of an Enhanced Paramedic Acute Stroke Treatment Assessment on Thrombolysis Delivery During Emergency Stroke Care: A Cluster Randomized Clinica Trial - PASTA. JAMA Neurology Published 13 April 2020.

Cherlin S, Wason JMS. Developing and testing high-efficacy patient subgroups within a clinical trial using risk scores. Statistics in Medicine: 2020. https://doi.org/10.1002/sim.8665

Goulao B, Carnell S, Shen J, MacLennan G, Norrie J, Cook J, McColl E, Breckons M, Vale L, Whybrow P, Rapley T, Forbes R, Currer S, Forrest M, Wilkinson J, Andrich D, Mundy A, N'Dow J, Payne S, Watkin N, Pickard R. Surgical Treatment for Recurrent Bulbar Urethral Stricture: A Randomised Open-Label Superiority Trial of Open Urethroplasty versus Ednoscopic Urethrotomy (The OPEN Trial). European Urology 202. epub ahead of print.

Witham MD, Anderson E, Carroll C, Dark PM, Down K, Hall AS, Knee J, Maier RH, Mountain GA, Nestor G, Oliva L, Prowse SR, Tortice A, Wason J, Rochester L. Developing a roadmap to improve trial delivery for underserved groups: results from a UK multi-stakeholder process. Trials 21, 694 (2020). https://doi.org?10.1186/s13063-020-04613-7

Maier R, Bawamia B, Bennaceur K, Dunn S, Marsay L, Amoah R, Kasim A, Filby A, Austin D, Hancock H*, Spyridopoulos I*. Telomerase activation to reverse immunosenescence in elderly patients with acute coronary syndrome: Protocol for a randomised pilot trial. JMIR Res Protoc 2020: 9 (9): e19456, DOI: 10.2196/19456, PMID: 32965237.

Liew AYL, Holmes-Truscott E, Flatt AJS, Bennett D, Crookston R, Pimkova M, Birtles L, Casey J, Pernet A, Wood RC, Choudhary P, Forbes S, Rutter MK, Rosenthal, Johnson P, Shaw JAM, Speight J. Characterization of pre-transplant psychosocial burden in an integrated national islet transplant programme. Islets Accepted April 2020, Published online 20/08/2020 https://doi.org/10.1080/19382014.2020.1736740

Flatt AJS, Little SA, Speight J, Leelarathna L, Walkinshaw E, Tan HK, Bowes A, Lubina-Solomon A, Holmes-Truscott E, Chadwick TJ, Wood RC, McDonald TJ, Kerr D, Flanagan D, Brooks A, Heller SR, Evans ML, Shaw JAM. Predictors of recurrent severe hypoglycemia in adults with type 1 diabetes and impaired awareness of hypoglycemia during the HypoCOMPaSS study. Diabetes Care Jan 2020 https://dio.org/10.2337/dc19-0630

Wood CL, Cole M, Donaldson M, Dunger, Wood R, Matthews JNS, Pearce SHS, Cheetham TD. Randomised trial of block and replace versus dose titration in young people with thyrotoxicosis. European Journal of Endocrinology online publication 01/09/2020 https://dx.doi.org/10.1530/EJE-20-0617.

O'Brien JT, McKeith IG, Thomas AJ, Bamford c, Vale L, Hill S, Allan L, Finch T, McNally R, Hayes L, Surendransthan A, Kane JPM, Dunn S, Bentley A, Barker S, Mason J, Burn D, Taylor JP. Introduction of a Management Toolkit for Lewy Body Dementia: A Pilot Cluster - Randomised Trial. wiley Online Library September 2020 http://dx.doi.org/10.1002/mds.28282

Kachuri L, Johansson M, Rashkin SR, Graff RE, Bossé Y, Manem V, Caporaso NE, Landi MT, Christiani DC, Vineis P, Liu G, Scelo G, Zaridze D, Shete SS, Albanes D, Aldrich MC, Tardon A, Rennert G, Chen C, Goodman GE, Doherty JA, Bickeboller H, Field JK, Davies MP, Teare MD, Kiemeney LA, Bojesen SE, Haugen A, Zienolddiny S, Lam S, Le Marchand L, Cheng I, Schabath MB, Duell EJ, Andrew AS, Manjer J, Lazarus P, Arnold S, Mckay JD, Emami NC, Warkentin MT, Brhane Y, Obeidat M, Martin RM, Relton C, Davey-Smith G, Haycock PC, Amos CI, Brennan P, Witte JS, Hung RJ. Immune-mediated genetic pathways resulting in pulmonary function impairment increase lung cancer susceptibility. Nat Commun 2020; 11:27.

Cherlin S, Lewis MJ, Plant D, Nair N, Goldmann K, Tzanis E, Barnes MR, McKeigue P, Barrett JH, Pitzalis C, Barton A, MATURA Consortium, Cordell HJ. Investigation of genetically regulated gene expression and response to treatment in rheumatoid arthritis highlights an association between IL18RAP expression and treatment response. Ann Rheum Dis 2021; 79:1446-52.

Castellucci LC, Almeida L, Cherlin C, Fakiola M, Carvalho E, Figueiredo AB, Cavalcanti CM, Alves NS, Dutra WO, Gollob KJ, Cordell HJ, Blackwell JM. A genome-wide association study highlights a regulatory role for IFNG-AS1 contributing to cutaneous leishmaniasis in Brazil. bioRxiv 2020; doi:10.1101/2020.01.13.903989.

Fonagy P, Yakeley J, Gardner T, Simes E, McMurran M, Moran P, Crawford M, Frater A, Barrett B, Cameron A, Wason J, Pilling S, Butler S, Bateman A. Mentalization for Offending Adult Males (MOAM): Study protocol for a randomized controlled trial to evaluate mentalization-based treatment for antisocial personality disorder in male offenders on community probation. Trials 2020; 21:1001

Ward M, Grayling M, Wason J, Welton NJ, Haji-Ali AL, Jalal H, Thom H. PSU4 Value of information for adaptive trials: Proof of concept study in multi-arm multi-stage trials of interventions for the prevention of surgical site infections. Value Health 2020; 23:S738.

Witham MD, Anderson E, Carroll CB, Dark PM, Down K, Hall AS, Knee J, Maher ER, Maier RH, Mountain GA, Nestor G, O'Brien JT, Oliva L, Wason J, Rochester L. Ensuring that COVID-19 research is inclusive: Guidance from the NIHR INCLUDE project. BMJ Open 2020; 10:e043634

Lin C-J, Wason JMS. Efficient analysis of time-to-event endpoints when the event involves a continuous variable crossing a threshold. J Stat Plan Infer 2020; 208:119-29

Wason JMS, Robertson DS. Controlling type I error rates in multi-arm clinical trials: A case for the false discovery rate. Pharm Stat 2020.

McMenamin M, Grayling MJ, Berglind A, Wason JMS. Increasing power in the analysis of responder endpoints in rheumatology: a software tutorial. medRxiv 2020

Stallard N, Hampson L, Benda N, Brannath W, Burnett T, Friede T, Kimani PK, Koenig F, Krisam J, Mozgunov P, Posch M, Wason J, Wassmer G, Whitehead J, Williamson SF, Zohar S, Jaki T. Efficient adaptive designs for clinical trials of interventions for COVID-19. Stat Biopharm Res 2020; 12:483-97.

Lee KM, Wason J. Including non-concurrent control patients in the analysis of platform trials: Is it worth it? BMC Med Res Methodol 2020; 20:165

Dimairo M, Pallmann P, Wason J, Todd S, Jaki T, Julious SA, Mander AP, Weir CJ, Koenig F, Walton MK, Nicholl JP, Coates E, Biggs K, Hamasaki T, Proschan MA, Scott JA, Ando Y, Hind D, Altman DG. The Adaptive designs CONSORT Extension (ACE) statement: A checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design. BMJ 2020; 369:m115

Robertson DS, Wason JMS, Bretz F. Graphical approaches for the control of generalised error rates. Stat Med 2020.

Wason J, McMenamin M, Dodd S. Analysis of responder-based endpoints: improving power through utilising continuous components. Trials 2020; 21:427.

Zheng H, Wason JMS. Borrowing of information across patient subgroups in a basket trial based on distributional discrepancy. Biostatistics 2020

Fonagy P, Butler S, Cottrell D, Scott S, Pilling S, Eisler I, Fuggle P, Kraam A, Byford S, Wason J, Smith JA, Anokhina A, Ellison R, Simes E, Ganguli P, Allison E, Goodyer IM. Multisystemic therapy versus management as usual in the treatment of adolescent antisocial behaviour (START): 5-year follow-up of a pragmatic, randomised, controlled, superiority trial. Lancet Psychiat 2020; 7:P420-30

Wang J, Patel A, Wason JMS, Newcombe PJ. Two-stage sparse regression screening to detect biomarker-treatment interactions in randomized clinical trials. arXiv 2020; arXiv:2004.12028

Brown S, Nixon J, Ransom M, Gilberts R, Dewhirst N, McGinnis E, Longo R, Game F, Bojke C, Chadwick P, Chandrasekar A, Chetter I, Collier H, Fernandez C, Homer-Vanniasinkam S, Jude E, Leigh R, Lomas R, Vowden P, Wason J, Sharples L, Russell D. Multiple Interventions for Diabetic Foot Ulcer Treatment Trial (MIDFUT): Study protocol for a randomised controlled trial. BMJ Open 2020; 10:e035947.

Khan MH, Khan MS, Ansari ZN, Siddiqi TJ, Khan SU, Riaz IB, Asad Z, Mandrola J, Wason J, Warraich HJ, Stone GW, Bhatt DL, Kapadia SR, Kalra A. Prevalence of multiplicity and appropriate adjustments among cardiovascular randomized clinical trials published in major medical journals. JAMA Netw Open 2020; 3:e203082.

Witham MD, Wason J, Dodds R, Sayer AA. Developing a composite outcome measure for frailty prevention trials - Rationale, derivation and sample size comparison with other candidate measures. BMC Geriatrics 2020; 20:113.

Amin Al Olama A, Wason JMS, Tuladhar AM, van Leijsen EMC, Koini M, Hofer E, Morris RG, Schmidt R, de Leeuw F-E, Markus HS. Simple MRI score aids prediction of dementia in cerebral small vessel disease. Neurology 2020; 94:e1294-302.

Grayling MJ, Wason JMS (2020). A web application for the design of multi-arm clinical trials. BMC Cancer 2020; 20:80

Gallagher FA, Woitek R, McLean MA, Gill AB, Manzano Garcia R, Provenzano E, Riemer F, Kaggie J, Chhabra A, Ursprung S, Grist JT, Daniels CJ, Zaccagna F, Laurent M-C, Locke M, Hilborne S, Frary A, Torheim T, Boursnell C, Schiller A, Patterson I, Slough R, Carmo B, Kane J, Biggs H, Harrison E, Deen SS, Patterson A, Lanz T, Kingsbury Z, Ross M, Basu B, Baird R, Lomas DJ, Sala E, Wason J, Rueda OM, Chin S-F, Wilkinson IB, Graves MJ, Abraham JE, Gilbert FJ, Caldas C, Brindle KM. Imaging breast cancer using hyperpolarized carbon-13 MRI. P Natl Acad Sci USA 2020; 117(4):2092-2098

2019

Hancock HC, Maier R, Kasim AS, Goodwin A, Owens WA, Mason JM, Murphy GJ, Kirmani B, Akowuah EA. Mini-sternotomy versus conventional sternotomy for aortic valve replacement: results from the MAVRIC randomised controlled trial. Journal of the American College of Cardiology (JACC). 2019; 73(19): 2487-2492

Yiannakou Y, Etherson K, Close H, Kasim A, Mercer-Jones M, Plusa S, Maier R, Green S, Cundall S, Knowles C and Mason J. A randomised double-blinded Sham-controlled cross-over trial of tined-lead sacral nerve stimulation testing for chronic constipation. European Journal of Gastroenterology & Hepatology 2019;31(6): 653-660. DOI: 19.1097/MEG.0000000000001379.

Aspray TJ, Chadwick T, Francis RM, McColl E, Stamp E, Prentice A, von Wilamowitz-Moellendorff A, Scoenmakers I. Randomized controlled trial of Vitamin D supplementation in older people to optimize bone health. American Journal of Clinical Nutrition 2019;109(1): 207-217

Cole M, Hynes AM, Howel D, Hall L, Abinum M, Allahabadia A, Barrett T, Boelaert K, Drake AJ, Dimitri P, Kirk J, Zammitt N, Pearce S, Cheetman T. Adjuvant rituximab, a potential treatment for the young patient with Graves' hyperthyroidism (RiGD): Study protocol for a single-arm, single-stage, phase II trial. BMJ Open 2019; 9 (1), e024705

Adams N, Skelton D, Bailey C, Howel D, Coe D, Lampitt R, Wilkinson J, Fouweather T, de John LD, Gawler S, Deary V, Gray J, Waterman H, Parry SW. Visually Impaired Older people's Exercise programme for falls prevenTion (VIOLET): a feasibility study. NIHR Journals Library 2019 https://www.journalslibrary.nihr.ac.uk/phr/phr07040/

Price CI, Shaw L, Dodd P, Exley C, Plynmn D, Francis R, Islam S, Javanbakht M, Lakey R, Lally J, McClelland G, McMeekin P, Rodgers H, Snooks H, Sutcliffe L, Tyrell P, Vale L, Watkins A, Ford GA. Paramedic Acute Stroke Treatment Assessment (PASTA): Study protocol for a randomised controlled trial. BioMed Central Ltd. 2019;20(1), [121]
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-3144-z

Dutta P, Funaton W, Mossop H, Ryan V, Jones R, Forbes R, Sen S, Pearson J, Griffin SM, Smith JA, Ward C, Forrest IA, Simpson AJ. Randomised, double-blind, placebo-controlled pilot trial of omeprazole in idiopathic pulmonary fibrosis. Thorax 2019. http://thorax.bmj.com/cgi/content/full/thoraxjnl-2018-212102

Giles EL, McGeechan GJ, Coulton S, Deluca P, Drummond C, Howel D, Kaner E, McColl E, McGovern R, Scott S, Stamp E, Sumnall T, Todd L, Vale L, Albani V, Boniface S, Ferguson J, Gilvarry E, Hendrie N, Howe N, Mossop H, Ramsay A, Stanley G, Newbury-Birch D. Brief alcohol intervention for risky drinking in young people aged 14 15 years in secondary schools: the SIPS JR-HIGH RCT. Brief alcohol intervention for risky drinking in young people aged 14 15 years in secondary schools: the SIPS JR-HIGH RCT. Public Health Research 2019; 9 https://doi.org/10.3310/phr07090

Sniehotta FF, Evans EH, Sainsbury K, Adamson A, Batterham A, Becker F, Brown H, Dombrowski SU, Jackson D, Howel D, Ladha K, McColl E, Olivier P, Rothman AJ, Steel A, Vale L, Viiera R, White M, Wright P, Araujo-Soares V. Behavioural intervention for weight loss maintenance versus standard weight advice in adults with obesity: A randomised controlled trial in the UK. PLoS Medicine 2019;16(5), e1002793

Rodgers H, Bosomworth H, Krebs HI, van Wijck F, Howel D, Wilson N, Aird L, Alvarado N, Andole S, Cohen DL, Dawson J, Fernandez-Garcia C, Finch T, Ford GA, Francis R, Hogg S, Hughes N, Price CI, Ternent L, Turner DL, Vale L, Wilkes S, Shaw L. Robot assisted training for the upper limb after stroke (RATULS): a multicentre randomised controlled trial. The Lancet 2019;394 (10192), 51-62

Schaeffer EM, Fisher H, Oluboyede Y, Chadwick T, Abdel-Fattah M, Brennand C, Fader M, Harrison S, Hilton P, Larcombe J, Little P, McClurg, D McColl E, N'Dow J, Ternent L, Thiruchelvam N, Timoney A, Vale L, Walton K, Von Wilamowitz-Moellendorff A, Wilkinson J, Wood R, Pickard R. Continuous Low-Dose Antibiotic Prophylaxis for Adults with Repeated Urinary Tract Infections (AnTIC): A Randomised, Open-Label Trial. Journal of Urology 2019;202(2), Page 191

Clark E, Morton M, Sharma S, Fisher H, Howel D, Walker J, Hancock H, Maier R, Marshall J, Bahl A, Crabb S, Jain S, Pedley I, Jones R, Staffurth J, Heer R. Prostate cancer androgen receptor splice variant 7 biomarker study - A multicentre randomised feasibility trial of biomarker-guided personalised treatment in patients with advanced prostate cancer (the VARIANT trial) study protocol. BMJ Open 2019, 9(12), e034708

Papamalis FE, Kalyva E, Teare MD, Meier PS. The role of personality functioning in drug misuse treatment engagement. Addiction 2019; 115:726-39.

Pilbery R, Teare MD. PP14 Soiled airway tracheal intubation and the effectiveness of decontamination (SATIATED) by paramedics: A randomised controlled manikin study. Emerg Med J 2019; 36:e7

Shepshelovich D, Xu W, Lu L, Fares A, Yang P, Christiani D, Zhang J, Shiraishi K, Ryan BM, Chen C, Schwartz AG, Tardon A, Wu X, Schabath MB, Teare MD, Le Marchand L, Zhang ZF, Field JK, Brenner H, Diao N, Xie J, Kohno T, Harris CC, Wenzlaff AS, Fernandez-Tardon G, Ye Y, Taylor F, Wilkens LR, Davies M, Liu Y, Barnett MJ, Goodman GE, Morgenstern H, Holleczek B, Brown MC, Liu G, Hung RJ. Body mass index (BMI), BMI change, and overall survival in patients with SCLC and NSCLC: A pooled analysis of the International Lung Cancer Consortium. J Thorac Oncol 2019; 14:1594-607.

Palmer J, Lloyd A, Steele L, Fotheringham J, Teare D, Iqbal J, Grech ED. Differential risk of ST-segment elevation myocardial infarction in male and female smokers. J Am Col Cardiol 2019; 73:3259-66.

Varley D, Wright B, Cooper C, Marshall D, Biggs K, Ali S, Chater T, Coates E, Gilbody S, de la Cuesta GG, Kingsley E, Le Couteur A, McKelvey A, Shephard N, Teare D. Investigating SOcial Competence and Isolation in children with Autism taking part in LEGO-based therapy clubs In School Environments. (I-SOCIALISE): Study protocol.

Dai J, Li Z, Amos CI, Hung RJ, Tardon A, Andrew AS, Chen C, Christiani DC, Albanes D, van der Heijden EHFM, Duell EJ, Rennert G, Mckay JD, Yuan JM, Field JK, Manjer J, Grankvist K, Le Marchand L, Teare MD, Schabath MB, Aldrich MC, Tsao MS, Lazarus P, Lam S, Bojesen SE, Arnold S, Wu X, Haugen A, Janout V, Johansson M, Brhane Y, Fernandez-Somoano A, Kiemeney LA, Davies MPA, Zienolddiny S, Hu Z, Shen H. Systematic analyses of regulatory variants in DNase I hypersensitive sites identified two novel lung cancer susceptibility loci. Carcinogenesis 2019; 40(3):432-440.

Zhu Y, Wei Y, Zhang R, Dong X, Shen S, Zhao Y, Bai J, Albanes D, Caporaso NE, Landi MT, Zhu B, Chanock SJ, Gu F, Lam S, Tsao M-S, Shepherd FA, Tardon A, Fernandez-Somoano A, Fernandez-Tardon G, Chen C, Barnett MJ, Doherty J, Bojesen SE, Brennan P, Mckay JD, Carreras-Torres R, Muley T, Risch A, Wichmann H-E, Bickeboeller H, Rosenberger A, Rennert G, Saliba W, Arnold SM, Field JK, Davies MPA, Marcus MW, Wu X, Ye Y, Le Marchand L, Wilkens LR, Melander O, Manjer J, Brunnstrom H, Hung RJ, Liu G, Brhane Y, Kachuri L, Andrew AS, Duell EJ, Kiemeney LA, van der Heijden EHFM, Haugen A, Zienolddiny S, Skaug V, Grankvist K, Johansson M, Woll PJ, Cox A, Taylor F, Teare DM, Lazarus P, Schabath MB, Aldrich MC, Houlston RS, McLaughlin J, Stevens VL, Shen H, Hu Z, Dai J, Amos CI, Han Y, Zhu D, Goodman GE, Chen F, David C Christiani. Elevated platelet count appears to be causally associated with increased risk of lung cancer: A Mendelian randomization analysis. Cancer Epidemiol Biomarkers Prev 2019; 28:935-42.

Pilbery R, Teare MD. 1 Soiled airway tracheal intubation and the effectiveness of decontamination (SATIATED) by paramedics: A randomised controlled manikin study. BMJ Open 2019; 9.

Hung RJ, Spitz MR, Houlston RS, Schwartz AG, Field JK, Ying J, Li Y, Han Y, Ji X, Chen W, Wu X, Gorlov IP, Na J, de Andrade M, Liu G, Brhane Y, Diao N, Wenzlaff A, Davies MPA, Liloglou T, Timofeeva M, Muley T, Rennert H, Saliba W, Ryan BM, Bowman E, Barros-Dios JM, Pérez-Ríos M, Morgenstern H, Zienolddiny S, Skaug V, Ugolini D, Bonassi S, van der Heijden EHFM, Tardon A, Bojesen SE, Landi MT, Johansson M, Bickeboller H, Arnold S, Le Marchand L, Melander O, Andrew A, Grankvist K, Caporaso N, Teare MD, Schabath MB, Aldrich MC, Kiemeney LA, Wichmann HE, Lazarus P, Mayordomo J, Neri M, Haugen A, Zhang ZF, Ruano-Ravina A, Brenner H, Harris CC, Orlow I, Rennert G, Risch A, Brennan P, Christiani DC, Amos CI, Yang P, Gorlova OY. Lung cancer risk in never-smokers of European descent is associated With genetic variation in the 5p15.33 TERT-CLPTM1Ll region. J Thorac Oncol 2019; 14:1360-9.

Li Y, Xiao X, Bossé Y, Gorlova O, Gorlov I, Han Y, Byun J, Leighl N, Johansen JS, Barnett M, Chen C, Goodman G, Cox A, Taylor F, Woll P, Wichmann HE, Manz J, Muley T, Risch A, Rosenberger A, Han J, Siminovitch K, Arnold SM, Haura EB, Bolca C, Holcatova I, Janout V, Kontic M, Lissowska J, Mukeria A, Ognjanovic S, Orlowski TM, Scelo G, Swiatkowska B, Zaridze D, Bakke P, Skaug V, Zienolddiny S, Duell EJ, Butler LM, Houlston R, Artigas MS, Grankvist K, Shepherd FA, Marcus MW, Brunnstrom H, Manjer J, Melander O, Muller DC, Overvad K, Trichopoulou A, Tumino R, Liu G, Bojesen SE, Wu X, Le Marchand L, Albanes D, Bickeboller H, Aldrich MC, Bush WS, Tardon A, Rennert G, Teare MD, Field JK, Kiemeney LA, Lazarus P, Haugen A, Lam S, Schabath MB, Andrew AS, Bertazzi PA, Pesatori AC, Christiani DC, Caporaso N, Johansson M, Mckay JD, Brennan P, Hung RJ, Amos CI. Genetic interaction analysis among oncogenesis-related genes revealed novel genes and networks in lung cancer development. Oncotarget 2019; 10:1760-74.

Candlish J, Teare MD, Cowen J, Bywater T. Statistical design and analysis in trials of proportionate interventions: A systematic review. Trials 2019; 20:151.

Jiang X, Finucane HK, Schumacher FR, Schmit SL, Tyrer JP, Han Y, Michailidou K, Lesseur C, Kuchenbaecker KB, Dennis J, Conti DV, Casey G, Gaudet MM, Huyghe JR, Albanes D, Aldrich MC, Andrew AS, Andrulis IL, Anton-Culver H, Antoniou AC, Antonenkova NN, Arnold SM, Aronson KJ, Arun BK, Bandera EV, Barkardottir RB, Barnes DR, Batra J, Beckmann MW, Benitez J, Benlloch S, Berchuck A, Berndt SI, Bickeboller H, Bien SA, Blomqvist C, Boccia S, Bogdanova NV, Bojesen SE, Bolla MK, Brauch H, Brenner H, Brenton JD, Brook MN, Brunet J, Brunnstrom H, Buchanan DD, Burwinkel B, Butzow R, Cadoni G, Caldés T, Caligo MA, Campbell I, Campbell PT, Cancel-Tassin G, Cannon-Albright L, Campa D, Caporaso N, Carvalho AL, Chan AT, Chang-Claude J, Chanock SJ, Chen C, Christiani DC, Claes KBM, Claessens F, Clements J, Collée JM, Correa MC, Couch FJ, Cox A, Cunningham JM, Cybulski C, Czene K, Daly MB, deFazio A, Devilee P, Diez O, Gago-Dominguez M, Donovan JL, Dörk T, Duell EJ, Dunning AM, Dwek M, Eccles DM, Edlund CK, Edwards DRV, Ellberg C, Evans DG, Fasching PA, Ferris RL, Liloglou T, Figueiredo JC, Fletcher O, Fortner RT, Fostira F, Franceschi S, Friedman E, Gallinger SJ, Ganz PA, Garber J, García-Sáenz JA, Gayther SA, Giles GG, Godwin AK, Goldberg MS, Goldgar DE, Goode EL, Goodman MT, Goodman G, Grankvist K, Greene MH, Gronberg H, Gronwald J, Guénel P, Håkansson N, Hall P, Hamann U, Hamdy FC, Hamilton RJ, Hampe J, Haugen A, Heitz F, Herrero R, Hillemanns P, Hoffmeister M, Høgdall E, Hong YC, Hopper JL, Houlston R, Hulick PJ, Hunter DJ, Huntsman DG, Idos G, Imyanitov EN, Ingles SA, Isaacs C, Jakubowska A, James P, Jenkins MA, Johansson M, John EM, Joshi AD, Kaneva R, Karlan BY, Kelemen LE, Kühl T, Khaw KT, Khusnutdinova E, Kibel AS, Kiemeney LA, Kim J, Kjaer SK, Knight JA, Kogevinas M, Kote-Jarai Z, Koutros S, Kristensen VN, Kupryjanczyk J, Lacko M, Lam S, Lambrechts D, Landi MT, Lazarus P, Le ND, Lee E, Lejbkowicz F, Lenz HJ, Leslie G, Lessel D, Lester J, Levine DA, Li L, Li CI, Lindblom A, Lindor NM, Liu G, Loupakis F, Lubiński J, Maehle L, Maier C, Mannermaa A, Le Marchand L, Margolin S, May T, McGuffog L, Meindl A, Middha P, Miller A, Milne RL, MacInnis RJ, Modugno F, Montagna M, Moreno V, Moysich KB, Mucci L, Muir K, Mulligan AM, Nathanson KL, Neal DE, Ness AR, Neuhausen SL, Nevanlinna H, Newcomb PA, Newcomb LF, Nielsen FC, Nikitina-Zake L, Nordestgaard BG, Nussbaum RL, Offit K, Olah E, Olama AAA, Olopade OI, Olshan AF, Olsson H, Osorio A, Pandha H, Park JY, Pashayan N, Parsons MT, Pejovic T, Penney KL, Peters WHM, Phelan CM, Phipps AI, Plaseska-Karanfilska D, Pring M, Prokofyeva D, Radice P, Stefansson K, Ramus SJ, Raskin L, Rennert G, Rennert HS, Van Rensburg EJ, Riggan MJ, Risch HA, Risch A, Roobol MJ, Rosenstein BS, Rossing MA, De Ruyck K, Saloustros E, Sandler DP, Sawyer EJ, Schabath MB, Schleutker J, Schmidt MK, Setiawan VW, Shen H, Siegel EM, Sieh W, Singer CF, Slattery ML, Sorensen K D, Southey MC, Spurdle AB, Stanford JL, Stevens VL, Stintzing S, Stone J, Sundfeldt K, Sutphen R, Swerdlow AJ, Tajara EH, Tangen CM, Tardon A, Taylor JA, Teare MD, Teixeira MR, Terry MB, Terry KL, Thibodeau SN, Thomassen M, Bjørge L, Tischkowitz M, Toland AE, Torres D, Townsend PA, Travis RC, Tung N, Tworoger SS, Ulrich CM, Usmani N, Vachon CM, Van Nieuwenhuysen E, Vega A, Aguado-Barrera ME, Wang Q, Webb PM, Weinberg CR, Weinstein S, Weissler MC, Weitzel JN, West CML, White E, Whittemore AS, Wichmann HE, Wiklund F. Shared heritability and functional enrichment across six solid cancers. Nat Commun 2019; 10:431.

Razvi S, Arnott B, Teare D, Hiu S, O'Brien N, Pearce SH. Multinational survey of treatment practices of clinicians managing subclinical hypothyroidism in older people in 2019. Eur Thyroid J 2020; doi:10.1159/000509228.

Heaps S, Nye T, Boys R, Williams T, Cherlin S, Embley M. Generalizing rate heterogeneity across sites in statistical phylogenetics. Stat Model 2019

McMenamin M, Barrett JK, Berglind A, Wason JMS. Sample size estimation using a latent variable model for mixed outcome co-primary, multiple primary and composite endpoints. arXiv 2019; arXiv:1912.05258

Michiels S, Wason J. Overestimated treatment effects in randomised phase II trials: What's up doctor? Eur J Cancer 2019; 123:116-127.

Grayling MJ, Mander AP, Wason JMS. Two-stage adaptive designs for three-treatment bioequivalence studies. Stat Biopharm Res 2019; 11:360-74.

Wilson DT, Walwyn REA, Wason JMS, Brown J, Farrin AJ. Bayesian design and analysis of external pilot trials for complex interventions. arXiv 2019; arXiv:1908.05955

Lee KM, Wason J, Stallard N. To add or not to add a new treatment arm to a multiarm study: A decision-theoretic framework. Stat Med 2019; 38:3305-21.

Pennington M, Ring H, Howlett J, Smith C, Redley M, Murphy C, Hook R, Platt A, Gilbert N, Jones E, Kelly J, Pullen A, Mander A, Donaldson C, Rowe S, Wason J, Irvine F. The impact of an epilepsy nurse competency framework on the costs of supporting adults with epilepsy and intellectual disability: Findings from the EpAID study. J Intell Disabil Res 2019; 63:1391-400

McClure ME, Wason J, Gopaluni S, Tieu J, Smith RM, Jayne DR, Jones RB. Evaluation of PR3-ANCA status after rituximab for ANCA-associated vasculitis. J Clin Rheumatol 2019; 25:217-23

Dua S, Ruiz-Garcia M, Bond S, Durham SR, Kimber I, Mills C, Roberts G, Skypala I, Wason J, Ewan P, Boyle R, Clark A. Effect of sleep deprivation and exercise on reaction threshold in peanut-allergic adults: A randomised controlled study. J Allergy Clin Immun 2019; 144:1584-94.e2.

Grayling MJ, Wason JMS, Mander AP. Exact group sequential designs for two-arm experiments with Poisson distributed outcome variables. Commun Stat Theory

Clearkin L, Ramasamy B, Wason J, Tiew S. Anti-VEGF intervention in neovascular AMD: Benefits and risks restated as natural frequencies. BMJ Open Ophthal 2019; 4:e000257

Wason J. Design of Multi-Arm, Multi-Stage Trials in Oncology. In Textbook of Clinical Trials in Oncology: A Statistical Perspective.

Grayling MJ, Mander AP, Wason JMS. Admissible multiarm stepped‐wedge cluster randomized trial designs. Stat Med 2019; 38:1103-19.

Lee KM, Wason J. Design of experiments for a confirmatory trial of precision medicine. J Stat Plan Infer 2019; 199:179-187

McMenamin M, Barrett JK, Berglind A, Wason JMS. Employing latent variable models to improve efficiency in composite endpoint analysis. arXiv 2019; arXiv:1902.07037

Robertson DS, Wason JMS. Familywise error control in multi-armed response-adaptive trials. Biometrics 2019; 75:885-94

Wason JMS, Brocklehurst P, Yap C. When to keep it simple - Adaptive designs are not always useful. BMC Medicine 2019; 17:152

Antoniou M, Kolamunnage-Dona R, Wason J, Bathia R, Billingham C, Bliss JM, Brown LC, Gillman A, Paul J, Jorgensen AL. Biomarker-guided trials: Challenges in practice. Contemp Clin Trials Commun 2019; 16:100493.

2018

Wright SE, Thomas K, Watson G, Baker C, Bryant A, Chadwick T, Shen J, Wood R, Wilkinson J, Mansfield L, Stafford V, Wade C, Furneval J, Henderson A, Hugill K, Howard P, Roy A, Bonner S, Baudouin S. Intensive versus standard physical rehabilitation therapy in the critically ill (EPICC): A multicentre, parallel-group, randomised controlled trial. Thorax 2018, 73(3), 213-221. https://doi.org/10.1136/thoraxjnl-2016-209858

Howe N, Giles E, Newbury-Birch D, McColl E. Systematic review of participants’ attitudes towards data sharing: a thematic synthesis. Journal of Health Services Research & Policy 2018, 23(2), 123-133. https://doi.org/10.1177/1355819617751555

Homer T, Shen J, Vale L, McColl E, Tincello DG, Hilton P & on behalf of the INVESTIGATE-I studies group. Pilot and Feasibility Studies 2018, 4(1), [67]. https://doi.org/10.1186/s40814-018-0255-y

Carnell, S.C.; Perry, J.D.; Borthwick, L.; Vollmer, D.; Biboy, J.; Facchini, M.; Bragonzi, A.; Silipo, A.; Vergunst, A.C.; Vollmer, W.; Khan, A.C.M.; De Soyza, A. Targeting the Bacterial Cytoskeleton of the Burkholderia cepacia Complex for Antimicrobial Development: A Cautionary Tale. Int. J. Mol. Sci. 2018;19, 1604 https://doi.org/10.3390/ijms19061604

Pickard R, Chadwick T, Oluboyede Y, Brennand C, von Wiliamowitz-Moellendorff A, McClurg D, Wilkinson J, Ternent L, Fisher H, Walton K, McColl E, Vale L, Wood R, Adbel-Fattah M, Hilton P, Fader M, Harrison S, Larcombe J, Little P, Timoney A, N'Dow J, Armstrong H, Morris N, Walker K, Thiruchelvam N. Continuous low-dose antibiotic prophylaxis to prevent urinary tract infection in adults who perform clean intermittent self-catheterisation: The AnTIC RCT. Health Technology Assessment 2018;22(24), 1-102. https://doi.org/10.3310/hta22240

Kunadian V, Chan D, Ali H, Wilkinson N, Howe N, McColl E, Thornton J, Von Wilamowitz-Moellendorff A, Holstein E-M, Burns G, Fisher A, Stocken D, De Soyza A. Antiplatelet therapy in the primary prevention of cardiovascular disease in patients with chronic obstructive pulmonary disease: protocol of a randomised controlled proof-of-concept trial (APPLE COPD-ICON 2). BMJ Open 2018;8:e020713. doi:10.1136/ bmjopen-2017-020713

Brass D, Fouweather T, Stocken D, Macdonald C, Wilkinson J, Lloyd J, Farr P, Reynolds N and Hampton P. An observer‐blinded randomized controlled pilot trial comparing localized immersion psoralen–ultraviolet A with localized narrowband ultraviolet B for the treatment of palmar hand eczema. Br J Dermatol 2018;179, 63-71. doi:10.1111/bjd.16238

Danilenko M, Stamp E, Stocken DD, Husain A, Zangarini M, Cranston A, Stones R, Sinclair N, Hodgson K, Bowett S, Roblin D, Traversa S, Plummer R, Veal G, Langtry J, Ashworth A, Burn J, Rajan N. . Targeting Tropomyosin Receptor Kinase in Cutaneous CYLD Defective Tumors With Pegcantratinib: The TRAC Randomized Clinical Trial. JAMA Dermatol. 2018;154(8):913–921. doi:10.1001/jamadermatol.2018.1610

Snowden C, Lynch E, Avery L, Gerrand C, Gilvarry E, Goudie N, Haighton C, Hall L, Howe N, Howel D, McColl E, Prentis J, Stamp E & Kaner E. Preoperative Behavioural Intervention versus standard care to Reduce Drinking before elective orthopaedic Surgery (PRE-OP BIRDS): protocol for a multicentre pilot randomised controlled trial. Pilot and Feasibility Studies 2018;4, [140]

Fisher H, Oluboyede Y, Chadwick T, Abdel-Fattah M, Brennard C, Fader M, Harrison S, Hilton P, Larcombe J, Little P, McClurg D, McColl E, N'Dow J, Ternent L, Thiruchelvam N, Timoney A, Vale L, Walton K, von Wilamowitz-Moellendorff A, Wilkinson J, Wood R, Pickard R. Continuous low-dose antibiotic prophylaxis for adults with repeated urinary tract infections (AnTIC): a randomised, open-label trial. The Lancet Infectios Diseases. 2018;18 (9), 957-968

Pinder E, Rostron AJ, Hellyer TP, Ruchaud-Sparagano M-H, Scott J, Macfarlane JG, Wiscombe S, Widdrington JD, Roy AI, Linnett VC, Baudouin SV, Wright SE, Chadwick T, Fouweather T, Juss JK, Chilvers ER, Bowett SA, Parker J, McAuley DF, Morris AC, Simpson AJ. Randomised controlled trial of GM-CSF in critically ill patients with impaired Neutrophil phagocytosis.Thorax 2018;73:918-925.

Forbes R, Ali A, Abouhajar A, Brennard C, Brown H, Carnell S, Chadwick T, Eardley I, Lecouturier J, Mossop H, Pearce I, Pickard R, Thiruchelvam N, Walton K, Wilkinson J, Harding C. Alternatives to prophylactic Antibiotics for the treatment of Recurrent urinary tract infection in women (ALTAR): Study protocol for a multicentre, pragmatic, patient-randomised, non-inferiority trial. Trials: 2018; 19 (1), [616] https://doi.org/10.1186/s13063-018-2998-4

Adams N, Skelton DA, Howel D, Bailey C, Lampitt R, Fouweather T, Gray J, Coe D, Wilkinson J, Gawler S, de Jong L, Waterman H, Deary V, Clarke M & Parry SW. Feasibility of trial procedures for a randomised controlled trial of a community based group exercise intervention for falls prevention for visually impaired older people: the VIOLET study. BMC Geriatrics 2018;18, [307]

Bourke JP, Watson G, Muntoni F, Spinty S, Roper H, Guglieri M, Speed C, McColl E, Chikermane A, Jayawant S, Admani S, Willis T, Wilkinson J, Bryant A, Chadwick T, Wood R, Bushby K. Randomised placebo-controlled trial of combination ACE inhibitor and beta-blocker therapy to prevent cardiomyopathy in children with Duchenne muscular dystrophy? (DMD Heart Protection Study): A protocol study BMJ Open 2018;8 (12):e022572. doi: 10.1136/bmjopen-2018-022572

2016-2017

During 2016/17 core and affiliate NCTU staff have contributed directly to 21 high-quality peer-reviewed clinical trial publications, of which 18 relate to NIHR funded trials.

Harrison D.A., Ferrando-Vivas P., Wright S.E., McColl E., Heyland D.K., Rowan K.M. Psychometric assessment of the Family Satisfaction in the Intensive Care Unit questionnaire in the United Kingdom. Journal of Critical Care. Apr-17; 38: 346-350

McPherson S., Wilkinson N., Tiniakos D., Wilkinson J., Burt A.D., McColl E., Stocken D.D., Steen N., Barnes J., Goudie N., Stewart S., Bury Y., Mann D., Anstee Q.M., Day C.P. A randomised controlled trial of losartan as an anti-fibrotic agent in non-alcoholic steatohepatitis. PLoS ONE. Apr-17; 12:4 e0175717

Deave T., Hawkins A., Kumar A., Hayes M., Cooper N., Watson M., Ablewhite J., Coupland C., Sutton A., Majsak-Newman G., McDaid L., Goodenough T., Beckett K., McColl E., Reading R., Kendrick D. Evaluating implementation of a fire-prevention injury prevention briefing in children's centres: Cluster randomised controlled trial. PLoS ONE. Mar-17; 12:3 e0172584

Nankivell M., Langley R.E., Barton R., Faivre-Finn C., Wilson P., McColl E., Moore B., Brisbane I., Ardron D., Sydes B., Stephens R., Parmar M., Mulvenna P. How do the QUARTZ trial results inform future research for patients with brain metastases from non-small cell lung cancer? Translational Cancer Research. Mar-17; 6: S446-S447

Ali K., Zahra D., Mccoll E., Salih V., Tredwin C. Impact of early clinical exposure on the learning experience of undergraduate dental students. European Journal of Dental Education. 2017; DOI: 10.1111/eje.12260

Bell G.M., Anderson A.E., Diboll J., Reece R., Eltherington O., Harry R.A., Fouweather T., MacDonald C., Chadwick T., McColl E., Dunn J., Dickinson A.M., Hilkens C.M.U., Isaacs J.D. Autologous tolerogenic dendritic cells for rheumatoid and inflammatory arthritis. Annals of the Rheumatic Diseases. Jan-17; 76:1 227-234

Armstrong N., Shaw E., McColl E., Tincello D.G., Hilton P. Trial participation as avoidance strategy: a qualitative study. Health Expectations. Dec-16; 19:6 1346-1354

Giles E.L., Coulton S., Deluca P., Drummond C., Howel D., Kaner E., McColl E., McGovern R., Scott S., Stamp E., Sumnall H., Tate L., Todd L., Vale L., Albani V., Boniface S., Ferguson J., Frankham J., Gilvarry E., Hendrie N., Howe N., McGeechan G.J., Stanley G., Newbury-Birch D. Multicentre individual randomised controlled trial of screening and brief alcohol intervention to prevent risky drinking in young people aged 14-15 in a high school setting (SIPS JR-HIGH): Study protocol. BMJ Open. Dec-16; 6-12 e012474

Hilton P., Buckley B.S., McColl E., Howel D., Tincello D.G., Brennand C. Understanding variations in patient screening and recruitment in a multicentre pilot randomised controlled trial: A vignette-based study. Trials. Oct-16; 7:1 522

Mulvenna P., Nankivell M., Barton R., Faivre-Finn C., Wilson P., McColl E., Moore B., Brisbane I., Ardron D., Holt T., Morgan S., Lee C., Waite K., Bayman N., Pugh C., Sydes B., Stephens R., Parmar M.K., Langley R.E. Dexamethasone and supportive care with or without whole brain radiotherapy in treating patients with non-small cell lung cancer with brain metastases unsuitable for resection or stereotactic radiotherapy (QUARTZ): results from a phase 3, non-inferiority, randomised trial. The Lancet. Oct-16; 388:1005 2204-2014

Echevarria C., Steer J., Heslop-Marshall K., Stenton S.C., Hickey P.M., Hughes R., Wijesinghe M., Harrison R.N., Steen N., Simpson A.J., Gibson G.J., Bourke S.C. The PEARL score predicts 90-day readmission or death after hospitalisation for acute exacerbation of COPD. Thorax. Aug-17; 72:8 686-693

Pennington L., Lombardo E., Steen N., Miller N. Acoustic changes in the speech of children with cerebral palsy following an intensive program of dysarthria therapy. International Journal of Language and Communication Disorders. 2017; DOI: 10.1111/1460-6984.12336

Hansen C.K., Christensen A., Rodgers H., Havsteen I., Kruuse C., Nybing J., Kaasbøl M.-A., Christensen H. CT and MRI-based door-needle-times for acute stroke patients a quasi-randomized clinical trial. Clinical Neurology and Neurosurgery. Aug-17; 159: 42-49

Rodgers H., Shaw L., Bosomworth H., Aird L., Alvarado N., Andole S., Cohen D.L., Dawson J., Eyre J., Finch T., Ford G.A., Hislop J., Hogg S., Howel D., Hughes N., Krebs H.I., Price C., Rochester L., Stamp E.,Ternent L., Turner D., Vale L., Warburton E., van Wijck F., Wilkes S. Robot Assisted Training for the Upper Limb after Stroke (RATULS): Study protocol for a randomised controlled trial. Trials. Jul-17; 18:1 340

Moore S.A., Da Silva R., Balaam M., Brkic L., Jackson D., Jamieson D., Ploetz T., Rodgers H., Shaw L., van Wijck F., Price C. Wristband Accelerometers to motiVate arm Exercise after Stroke (WAVES): Study protocol for a pilot randomized controlled trial. Trials. Oct-16; 17:1 508

Payne B., Chadwick T.J., Blamire A., Anderson K.N., Parikh J., Qian J., Hynes A.M., Wilkinson J., Price D.A., the Efficacy of Switch to Lopinavir/Ritonavir in Improving Cognitive Function in Efavirenz-treated Patients (SLICE) study team. Does efavirenz replacement improve neurological function in treated HIV infection? HIV Medicine. Oct-17; 18:9 690-695

Fisher A., Andreasson A., Chrysos A., Lally J., Mamasoula C., Exley C., Wilkinson J., Qian J., Watson G., Lewington O., Chadwick T., McColl E., Pearce M., Mann K., McMeekin N., Vale L., Tsui S., Yonan N., Simon A., Marczin N., Mascaro J., Dark J. An observational study of Donor Ex vivo lung perfusion in UK lung transplantation: DEVELOP-UK. Health Technology Assessment. Nov-16; 20:85 276

Akowuah, E., Goodwin, A.T., Owens, W.A., Hancock, H.C., Maier, R., Kasim, A.K., Mellor, A., Khan, K., Murphy, G. & Mason, J.M. (2017). Manubrium-limited ministernotomy versus conventional sternotomy for aortic valve replacement (MAVRIC): study protocol for a randomized controlled trial. Trials 18: 46.

Cox, J., Hancock, H., Maier, R., Spratt, J., Lee, C.M. & Mason, J.M. (2017). Multidetector CT improving surgical outcomes in breast cancer (MISO-BC): A randomised controlled trial. The Breast 32: 217-224.

Rees, C.J., Rajasekhar, P.T., Wilson, A., Close, H., Rutter, M.D., Saunders, B.P., East, J.E., Maier, R.H., Moorghen, M., Muhammad, U., Hancock, H.C., Jayaprakash, A., MacDonald, C., Ramadas, A., Dhar, A. & Mason, J.M. (2017). Narrow band imaging optical diagnosis of small colorectal polyps in routine clinical practice: the Detect Inspect Characterise Resect and Discard 2 (DISCARD 2) study. Gut 66(5): 887-895.

Akowuah, E., Hancock, H., Maier, R., Kasim, A., Zacharias, J., Deshpande, R., Birdi, I., Vale, L., Livesey, S., Stewart, M. & Murphy, G. (2016). Minimally invasive thoracoscopically-guided right minithoracotomy versus conventional sternotomy for mitral valve repair: a multicentre randomised controlled trial (UK Mini Mitral). NIHR Journals Library . https://www.journalslibrary.nihr.ac.uk/programmes/hta/14192110#/