Nikki Totton

BSc, MSc

Population Health, School of Medicine and Population Health

PhD Student

Ntotton1@sheffield.ac.uk

Room 1.03, The Innovation Centre

Full contact details

Nikki Totton
Population Health, School of Medicine and Population Health
Room 1.03
The Innovation Centre
217 Portobello
Sheffield
S1 4DP

Profile

After completing a BSc in Mathematics and an MSc in Statistics and Management Science at the University of the West of England, Bristol, I began my career as a clinical trial statistician. Firstly, at Bangor University before moving over to The University of Sheffield. I have a range of experience designing and analysing clinical trials as well as other study designs. I also work ad-hoc for the Research Design Service where I offer general study design advice as well as specific statistical aspects such as sample size calculations.

I started an ESRC White Rose funded doctoral fellowship with an MA in Social Research followed by the PhD project which started in October 2021.

Qualifications

BSc in Mathematics (University of the West of England)
MSc in Statistics and Management Science (University of the West of England)
MA in Social Research (University of Sheffield)

Research interests

PhD Title: How can benefit-risk methods be used when setting the non-inferiority margin within non-inferiority clinical trials to account for the benefit of a secondary outcome of importance?

My PhD project combines my research interests of non-inferiority clinical trials and benefit-risk assessment. Other research interests of mine are pilot and feasibility studies as well as the importance of including patients and the public within research and the difficulties surrounding this.

Current Projects:

AWARE-IBD: Putting people with inflammatory bowel disease (IBD) in control of their care.
BASIS: Bracing Adolescent Idiopathic Scoliosis
BRAINS: Benefit-Risk Assessment to Inform Non-Inferiority and Superiority Study Designs
INITIAL: Involving patients and the public In sTatistIcal Analysis pLans.

Publications

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Featured publications

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All publications

Journal articles

Totton N, Waddingham E, Owen R, Julious S, Hughes D & Cook J (2024) A proposal for using benefit-risk methods to improve the prominence of adverse event results when reporting trials. Trials, 25. View this article in WRRO
Goulão B, Morris TP, Blazeby J, Gamble C, Gillies K, Laidlaw L, Ramsay C, Soulsby I, Stewart D & Totton N (2023) Involving patients and the public In sTatistIcal Analysis pLans (INITIAL): a delphi survey. PLOS ONE, 18(12). View this article in WRRO
Bolt R, Hyslop MC, Herbert E, Papaioannou DE, Totton N, Wilson MJ, Clarkson J, Evans C, Ireland N, Kettle J , Marshman Z et al (2023) The MAGIC trial: a pragmatic, multicentre, parallel, noninferiority, randomised trial of melatonin versus midazolam in the premedication of anxious children attending for elective surgery under general anaesthesia. British Journal of Anaesthesia, S0007-0912(23)00565.
Sheldon EM, Lillington G, Simpson K, Gibson K, Chambers L, D'Afflitto M, Greig N, Stearn T, Hind D, Ainley R , Winsor G et al (2022) Development of an inflammatory bowel disease (IBD) Patient‐Reported Experience Measure (PREM): A patient‐led consensus work and ‘think aloud’ study for a quality improvement programme. Health Expectations. View this article in WRRO
Bevan A, Hoo ZH, Totton N, Girling C, Davids IR, Whelan P, Antrobus S, Ainsworth J, Buchan I, Anderson A , Bourke S et al (2022) Corrigendum to “Using a learning health system to understand the mismatch between medicines supply and actual medicines use among adults with cystic fibrosis” [J Cyst Fibros (2022), 21/2, 323-331]. Journal of Cystic Fibrosis.
Totton N, Bradburn M, Hoo ZH, Lewis J, Hind D, Girling C, Shepherd E, Nightingale J, Daniels T, Dewar J , Dawson S et al (2021) Prospectively predicting Pseudomonas aeruginosa infection/s using routine data from the UK cystic fibrosis register. Health Science Reports, 4(4). View this article in WRRO
Bevan A, Hoo ZH, Totton N, Girling C, Davids IR, Whelan P, Antrobus S, Ainsworth J, Buchan I, Anderson A , Bourke S et al (2021) Using a learning health system to understand the mismatch between medicines supply and actual medicines use among adults with cystic fibrosis. Journal of Cystic Fibrosis. View this article in WRRO
Hoo ZH, Totton N, Waterhouse S, Lewis J, Girling C, Bradburn M, Arden MA, Whelan P, Ainsworth J, Dawson S , Millward S et al (2021) Real-world adherence among adults with cystic fibrosis is low – a retrospective analysis of the CFHealthHub digital learning health system. Chest. View this article in WRRO
Ali A, Tabassum D, Baig SS, Moyle B, Redgrave J, Nichols S, McGregor G, Evans K, Totton N, Cooper C & Majid A (2021) Effect of exercise interventions on health-related quality of life after stroke and transient ischemic attack: a systematic review and meta-analysis. Stroke. View this article in WRRO
Totton N, Julious S, Hughes D, Cook J, Biggs K, Coates L, Cook A, Hewitt C & Day S (2021) Utilising benefit-risk assessments within clinical trials—a protocol for the BRAINS project. Trials, 22. View this article in WRRO
Coates E, Amiel S, Baird W, Benaissa M, Brennan A, Campbell M, Chadwick P, Chater T, Choudhary P, Cooke D , Cooper C et al (2021) Protocol for a cluster randomised controlled trial of the DAFNEplus (Dose Adjustment for Normal Eating) intervention compared with 5x1 DAFNE : a lifelong approach to promote effective self-management in adults with type 1 diabetes. BMJ Open, 11(1). View this article in WRRO
Rees CJ, Brand A, Ngu WS, Stokes C, Hoare Z, Totton N, Bhandari P, Sharp L, Bastable A, Rutter MD , Verma AM et al (2020) BowelScope: Accuracy of Detection Using Endocuff Optimisation of Mucosal Abnormalities (the B-ADENOMA Study): a multicentre, randomised controlled flexible sigmoidoscopy trial. Gut, 69(11), 1959-1965.
Walters SJ, Jacques RM, dos Anjos Henriques-Cadby IB, Candlish J, Totton N & Xian MTS (2019) Correction to: Sample size estimation for randomised controlled trials with repeated assessment of patient-reported outcomes: what correlation between baseline and follow-up outcomes should we assume?. Trials, 20(1).
Walters SJ, Jacques RM, dos Anjos Henriques-Cadby IB, Candlish J, Totton N & Xian MTS (2019) Sample size estimation for randomised controlled trials with repeated assessment of patient-reported outcomes : what correlation between baseline and follow-up outcomes should we assume?. Trials, 20(1). View this article in WRRO
Ngu WS, Bevan R, Tsiamoulos ZP, Bassett P, Hoare Z, Rutter MD, Clifford G, Totton N, Lee TJ, Ramadas A , Silcock JG et al (2019) Improved adenoma detection with Endocuff Vision: the ADENOMA randomised controlled trial. Gut, 68(2), 280-288.
Roberts JL, Pritchard AW, Williams M, Totton N, Morrison V, DIn NU & Williams NH (2018) Mixed methods process evaluation of an enhanced community-based rehabilitation intervention for elderly patients with hip fracture. BMJ Open, 8(8). View this article in WRRO
Ngu W, Walls M, Bhandari P, Stokes C, Totton N, Hoare Z, Bastable L & Rees C (2018) The B-ADENOMA study: Bowelscope – Accuracy of detection using endocuff optimisation of mucosal abnormalities: Study protocol for randomised controlled trial. Endoscopy International Open, 06(07), E872-E877. View this article in WRRO
Williams NH, Mawdesley K, Roberts JL, Din NU, Totton N, Charles JM, Hoare Z & Edwards RT (2018) Hip fracture in the elderly multidisciplinary rehabilitation (FEMuR) feasibility study: Testing the use of routinely collected data for future health economic evaluations. Pilot and Feasibility Studies, 4(1). View this article in WRRO
Morrison V, Spencer LH, Totton N, Pye K, Yeo ST, Butterworth C, Hall L, Whitaker R, Edwards RT, Timmis LJ , Hoare Z et al (2018) Trial of Optimal Personalised Care After Treatment - Gynaecological Cancer (TOPCAT-G): A randomized feasibility trial. International Journal of Gynecological Cancer, 28(2), 401-411. View this article in WRRO
Pye K, Totton N, Stuart N, Whitaker R, Morrison V, Edwards RT, Yeo ST, Timmis LJ, Butterworth C, Hall L , Rai T et al (2016) Trial of Optimal Personalised Care After Treatment for Gynaecological cancer (TOPCAT-G): a study protocol for a randomised feasibility trial. Pilot and Feasibility Studies, 2(1). View this article in WRRO
Williams NH, Roberts JL, Din NU, Totton N, Charles JM, Hawkes CA, Morrison V, Hoare Z, Williams M, Pritchard AW , Alexander S et al (2016) Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR): a phase II randomised feasibility study of a multidisciplinary rehabilitation package following hip fracture. BMJ Open, 6(10). View this article in WRRO
Totton N, Lin J, Julious S, Chowdhury M & Brand A () A review of sample sizes for UK pilot and feasibility studies on the ISRCTN registry from 2013 to 2020. Pilot and Feasibility Studies, 9(1).
Swaby L, Perry DC, Walker K, Hind D, Mills A, Jayasuriya R, Totton N, Desoysa L, Chatters R, Young B , Sherratt F et al () Bracing Adolescent Idiopathic Scoliosis (BASIS) study – night-time versus full-time bracing in adolescent idiopathic scoliosis: study protocol for a multicentre, randomized controlled trial. Bone & Joint Open, 4(11), 873-880.
Totton N, Julious SA, Coates E, Hughes DA, Cook JA, Biggs K, Hewitt C, Day S & Cook A () Appropriate design and reporting of superiority, equivalence and non-inferiority clinical trials incorporating a benefit–risk assessment: the BRAINS study including expert workshop. Health Technology Assessment, 1-58.
Coates E, Wickramasekera N, Barr A, Shackley P, Lee M, Hind D, Probert C, Sebastian S, Totton N, Blackwell S , Bedford H et al () Patient preferences and current practice for adults with steroid-resistant ulcerative colitis: POPSTER mixed-methods study. Health Technology Assessment, 26(41), 1-118.
Williams NH, Roberts JL, Din NU, Charles JM, Totton N, Williams M, Mawdesley K, Hawkes CA, Morrison V, Lemmey A , Edwards RT et al () Developing a multidisciplinary rehabilitation package following hip fracture and testing in a randomised feasibility study: Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR). Health Technology Assessment, 21(44), 1-528. View this article in WRRO

Conference proceedings papers

Coates E, Barr A, Totton N, Hind D, Shackley P, Blackwell S, Dames N, Bedford H, Lee M, Sebastian S , Probert C et al (2021) P97 Management of steroid resistant ulcerative colitis – a national survey of UK practice. Posters
Wildman M, Totton NV & Hoo Z (2020) NOBODY LEFT BEHIND: THE UK NATIONAL EQUITY INDICATOR USING REAL TIME DATA FROM THE CFHEALTHHUB DIGITAL LEARNING HEALTH SYSTEM TO UNDERSTAND THE REACH OF SELF-CARE SUPPORT ACROSS ADULT CENTRES. PEDIATRIC PULMONOLOGY, Vol. 55 (pp S319-S319)
Totton N, Julious S, Hughes D & Cook J (2019) MRC-NIHR Methodology guideline development on utilising benefit-risk assessments within clinical trials. Trials, Vol. 20(Supplement 1) (pp 93-93). Brighton, UK, 6 October 2019 - 9 October 2019. View this article in WRRO
Walls M, Brand A, Ngu WS, Stokes C, Sharp L, Hoare Z, Totton N, Bastable A, Bhandari P & Rees C (2019) OTU-01 The B-ADENOMA trial: a multicentre, randomised controlled trial of adenoma detection with endocuff vision. Endoscopy

Posters

Hoo ZH, Totton N, Waterhouse S, Hind D, Girling C, Bradburn M, Shepherd E, Nightingale JA, Daniels TV, Dewar J , Saini G et al (2019) ePS5.05 Understanding objective adherence to preventative inhaled therapies at a centre level for quality improvement - a CFHealthHub (CFHH) improvement collaborative study.

Presentations

Meeting abstracts from the 4th International Clinical Trials Methodology Conference (ICTMC) and the 38th Annual Meeting of the Society for Clinical Trials.

Preprints

Totton N, Julious S, Walters S & Coates E (2023) A review of UK publicly funded non-inferiority trials: Is the design more inferior than it should be?, Research Square Platform LLC.
Totton N, Julious S, Hughes D, Cook J, Biggs K, Coates L, Cook A, Hewitt C & Day S () Utilising Benefit-Risk Assessments within Clinical Trials – A Protocol for the BRAINS project.
Totton N, Julious S, Hughes D, Cook J, Biggs K, Coates L, Cook A, Hewitt C & Day S () Utilising Benefit-Risk Assessments within Clinical Trials – A Protocol for the BRAINS project.
Totton N, Julious S, Hughes D, Cook J, Biggs K, Coates L, Cook A, Hewitt C & Day S () Utilising Benefit-Risk Assessments within Clinical Trials – A Protocol for the BRAINS project.

Teaching activities

I have previous tutored on HAR6036 – Application of Statistics in the Medical and Health Sciences, HAR6045 – Further Statistics for Health Science Researchers and Critical Numbers.

I have supervised Masters projects as well as ran Research Attachment projects for the Intercalated Medical Students.

Professional activities and memberships: I am a member of the RSS Local Group for Sheffield, as well as on the steering committee for the NIHR Statistics Group, leading the benefit-risk working group.