Ellen Lee

Population Health, School of Medicine and Population Health

Statistician - Research Fellow

Clinical Trials Research Unit, ScHARR

e.lee@sheffield.ac.uk
+44 114 222 0805

Room 2028, Regent Court (ScHARR)

Full contact details

Ellen Lee
Population Health, School of Medicine and Population Health
Room 2028
Regent Court (ScHARR)
30 Regent Street
Sheffield
S1 4DA

Profile: I am a Medical Statistician and current NIHR Pre-doctoral Fellow. My fellowship focusses on clinical trial design, particularly statistical approaches to multiple treatment comparisons in multi arm trials. I also lead statistical support to a range of studies (particularly trials) within CTRU, spanning various therapeutic areas.

Before joining CTRU I graduated with a BSc degree in Economics and Mathematics and an MSc in Statistics with Medical Applications from The University of Sheffield. I have also worked for the NIHR Research Design Service Yorkshire and the Humber (RDS-YH) and in the Cancer Clinical Trials Centre, Sheffield.

Research interests

Clinical trials methodology
Trials with multiple treatment comparisons
Cluster randomised controlled trials and clustering in individually randomised controlled trials
Design and analysis of pilot trials
Complex interventions

Publications

Show: Featured publications All publications

Featured publications

Journal articles

Wright B, Tindall L, Scott AJ, Lee E, Biggs K, Cooper C, Bee P, Wang H-I, Gega L, Hayward E , Solaiman K et al (2022) One-session treatment compared with multisession CBT in children aged 7–16 years with specific phobias: the ASPECT non-inferiority RCT. Health Technology Assessment, 26(42).
Thornhill M, Crum A, Campbell R, Stone T, Lee E, Bradburn M, Fibisan V, Dayer M, Prendergast B, Lockhart P , Baddour L et al (2022) Temporal association between invasive procedures and infective endocarditis. Heart.
Mountain GA, Cooper CL, Wright J, Walters SJ, Lee E, Craig C, Berry K, Sprange K, Young T, Moniz-Cook E , Dening T et al (2022) The Journeying through Dementia psychosocial intervention versus usual care study: a single-blind, parallel group, phase 3 trial. The Lancet Healthy Longevity, 3(4), e276-e285.
Lee EC, Wright J, Walters SJ, Cooper CL & Mountain GA (2021) Estimating the minimum important difference in the DEMQOL instrument in people with dementia. Quality of Life Research, 30(10), 2995-3005.
Goodacre S, Thomas B, Sutton L, Burnsall M, Lee E, Bradburn M, Loban A, Waterhouse S, Simmonds R, Biggs K , Marincowitz C et al (2021) Derivation and validation of a clinical severity score for acutely ill adults with suspected COVID-19: The PRIEST observational cohort study. PLoS ONE, 16(1).

All publications

Journal articles

Lee MJ, Lee E, Bradburn M, Hind D, Strong EB, Din F, Wysocki AP, Lund J, Moffatt C, Morton J , Senapati A et al (2024) Research and practice priorities in pilonidal sinus disease: a consensus from the PITSTOP study. Colorectal Disease. View this article in WRRO
Lee MJ, Lee E, Bradburn M, Hind D, Strong EB, Din F, Wysocki AP, Lund J, Moffatt C, Morton J , Senapati A et al (2024) Classification and stratification in pilonidal sinus disease: findings from the PITSTOP cohort. Colorectal Disease. View this article in WRRO
Brown SR, Hind D, Strong E, Bradburn M, Din F, Lee E, Lund J, Moffatt C, Morton J, Senapati A , Jones H et al (2024) Real-world practice and outcomes in pilonidal surgery: pilonidal sinus treatment studying the options (PITSTOP) cohort. British Journal of Surgery, 111(3). View this article in WRRO
Jones G, Bailey L, Beeken RJ, Brady S, Cooper C, Copeland RJ, Crosland S, Dawson S, Faires M, Gilbody S , Haynes H et al (2024) Supporting physical activity through co-production in people with severe mental ill health (SPACES): protocol for a randomised controlled feasibility trial. Pilot and Feasibility Studies, 10(1). View this article in WRRO
Lindsay JO, Hind D, Swaby E, Berntsson H, Bradburn M, Bannur U, Byrne J, Clarke C, Desoysa L, Dickins B , Din S et al (2024) Safety and efficacy of autologous haematopoietic stem-cell transplantation with low-dose cyclophosphamide mobilisation and reduced intensity conditioning versus standard of care in refractory Crohn’s disease (ASTIClite): an open-label, multicentre, randomised controlled trial. The Lancet Gastroenterology and Hepatology. View this article in WRRO
Wright B, Tindall L, Scott AJ, Lee E, Biggs K, Cooper C, Bee P, Wang H-I, Gega L, Hayward E , Solaiman K et al (2022) One-session treatment compared with multisession CBT in children aged 7–16 years with specific phobias: the ASPECT non-inferiority RCT. Health Technology Assessment, 26(42).
Thornhill M, Crum A, Campbell R, Stone T, Lee E, Bradburn M, Fibisan V, Dayer M, Prendergast B, Lockhart P , Baddour L et al (2022) Temporal association between invasive procedures and infective endocarditis. Heart.
Wang H-I, Wright B, Tindall L, Cooper C, Biggs K, Lee E, Teare MD, Gega L, Scott AJ, Hayward E , Solaiman K et al (2022) Cost and effectiveness of one session treatment (OST) for children and young people with specific phobias compared to multi-session cognitive behavioural therapy (CBT): results from a randomised controlled trial. BMC Psychiatry, 22.
Mountain G, Wright J, Cooper CL, Lee E, Sprange K, Beresford-Dent J, Young T, Walters S, Berry K, Dening T , Loban A et al (2022) An intervention to promote self-management, independence and self-efficacy in people with early-stage dementia: the Journeying through Dementia RCT.. Health Technol Assess, 26(24), 1-152.
Mountain GA, Cooper CL, Wright J, Walters SJ, Lee E, Craig C, Berry K, Sprange K, Young T, Moniz-Cook E , Dening T et al (2022) The Journeying through Dementia psychosocial intervention versus usual care study: a single-blind, parallel group, phase 3 trial. The Lancet Healthy Longevity, 3(4), e276-e285.
Lee EC, Wright J, Walters SJ, Cooper CL & Mountain GA (2021) Estimating the minimum important difference in the DEMQOL instrument in people with dementia. Quality of Life Research, 30(10), 2995-3005.
Thomas B, Goodacre S, Lee E, Sutton L, Bursnall M, Loban A, Waterhouse S, Simmonds R, Biggs K, Marincowitz C , Schutter J et al (2021) Prognostic accuracy of emergency department triage tools for adults with suspected COVID-19: the PRIEST observational cohort study.. Emerg Med J.
Gould RL, Wetherell JL, Kimona K, Serfaty MA, Jones R, Graham CD, Lawrence V, Livingston G, Wilkinson P, Walters K , Le Novere M et al (2021) Acceptance and commitment therapy for late-life treatment-resistant generalised anxiety disorder: a feasibility study.. Age Ageing.
Goodacre S, Thomas B, Sutton L, Burnsall M, Lee E, Bradburn M, Loban A, Waterhouse S, Simmonds R, Biggs K , Marincowitz C et al (2021) Derivation and validation of a clinical severity score for acutely ill adults with suspected COVID-19: The PRIEST observational cohort study. PLoS ONE, 16(1).
Mallallah F, Packham A, Lee E & Hind D (2021) Is hyperpolarised gas magnetic resonance imaging a valid and reliable tool to detect lung health in cystic fibrosis patients? a cosmin systematic review. Journal of Cystic Fibrosis. View this article in WRRO
Goodacre S, Thomas B, Lee E, Sutton L, Loban A, Waterhouse S, Simmonds R, Biggs K, Marincowitz C, Schutter J , Connelly S et al (2020) Post-exertion oxygen saturation as a prognostic factor for adverse outcome in patients attending the emergency department with suspected COVID-19: a substudy of the PRIEST observational cohort study. Emergency Medicine Journal. View this article in WRRO
Goodacre S, Thomas B, Lee E, Sutton L, Loban A, Waterhouse S, Simmonds R, Biggs K, Marincowitz C, Schutter J , Connelly S et al (2020) Characterisation of 22445 patients attending UK emergency departments with suspected COVID-19 infection : observational cohort study. PLoS ONE, 15(11). View this article in WRRO
Lee MJ, Drake TM, Sayers AE, Walsh CJ, Davies MM, Fearnhead NS, Abercrombie J, Acheson A, Alderson D, Anderson I , Bach S et al (2020) Outcomes of obstructed abdominal wall hernia: results from the UK national small bowel obstruction audit. BJS Open, 4(5), 924-934. View this article in WRRO
Bradburn MJ, Lee EC, White DA, Hind D, Waugh NR, Cooke DD, Hopkins D, Mansell P & Heller SR (2020) Treatment effects may remain the same even when trial participants differed from the target population. Journal of Clinical Epidemiology. View this article in WRRO
Ponte C, Serafim AS, Monti S, Fernandes E, Lee E, Singh S, Piper J, Hutchings A, McNally E, Diamantopoulos AP , Dasgupta B et al (2020) Early variation of ultrasound halo sign with treatment and relation with clinical features in patients with giant cell arteritis. Rheumatology. View this article in WRRO
Snowden JA, Hawkey C, Hind D, Swaby L, Mellor K, Emsley R, Mandefield L, Lee E, Badoglio M, Polge E , Labopin M et al (2019) Autologous stem cell transplantation in refractory Crohn’s disease – low intensity therapy evaluation (ASTIClite): study protocols for a multicentre, randomised controlled trial and observational follow up study. BMC Gastroenterology, 19(1). View this article in WRRO
Drake TM, Lee MJ, Sayers AE, Abercrombie J, Acheson A, Alderson D, Anderson I, Bradburn M, Davies M, Hamady Z , Hind D et al (2019) Outcomes following small bowel obstruction due to malignancy in the national audit of small bowel obstruction. European Journal of Surgical Oncology, 45(12), 2319-2324. View this article in WRRO
Tomkow LJ, Kang CP, Farrington RL, Wiggans RE, Wilson RJ, Pushkar P, Tickell-Painter MC, Lee AR, Whitehouse ER, Mahmood NG , Lawton KM et al (2019) Healthcare access for asylum seekers and refugees in England : a mixed methods study exploring service users’ and health care professionals’ awareness. European Journal of Public Health. View this article in WRRO
Wright J, Foster A, Cooper C, Sprange K, Walters S, Berry K, Moniz-Cook E, Loban A, Young TA, Craig C , Dening T et al (2019) Study protocol for a randomised controlled trial assessing the clinical and cost-effectiveness of the Journeying through Dementia (JtD) intervention compared to usual care. BMJ Open, 9(9). View this article in WRRO
Wright BD, Cooper C, Scott AJ, Tindall L, Ali S, Bee P, Biggs K, Breckman T, Davis TE, Gega L , Hargate RJ et al (2018) Clinical and cost-effectiveness of one-session treatment (OST) versus multisession cognitive-behavioural therapy (CBT) for specific phobias in children: Protocol for a non-inferiority randomised controlled trial. BMJ Open, 8(8). View this article in WRRO
Pollard DJ, Brennan A, Dixon S, Waugh N, Elliott J, Heller S, Lee E, Campbell M, Basarir H & White D (2018) Cost-effectiveness of insulin pumps compared with multiple daily injections both provided with structured education for adults with type 1 diabetes: a health economic analysis of the Relative Effectiveness of Pumps over Structured Education (REPOSE) randomised controlled trial. BMJ Open, 8(4). View this article in WRRO
Chatters R, Newbould L, Sprange K, Hind D, Mountain G, Shortland K, Powell L, Gossage-Worrall R, Chater T, Keetharuth , Lee E et al (2018) Recruitment of older adults to three preventative lifestyle improvement studies. Trials, 19. View this article in WRRO
Mountain G, Windle G, Hind D, Walters S, Keertharuth A, Chatters R, Sprange K, Craig C, Cook S, Lee E , Chater T et al (2017) A preventative lifestyle intervention for older adults (lifestyle matters): a randomised controlled trial. Age And Ageing, 46(4), 627-634.
Hind D, Parkin J, Whitworth V, Rex S, Young T, Hampson L, Sheehan J, Maguire C, Cantrill H, Scott E , Epps H et al (2017) Aquatic therapy for children with Duchenne muscular dystrophy: a pilot feasibility randomised controlled trial and mixed-methods process evaluation. HEALTH TECHNOLOGY ASSESSMENT, 21(27). View this article in WRRO
Heller S, White D, Lee E, Lawton J, Pollard D, Waugh N, Amiel S, Barnard K, Beckwith A, Brennan A , Campbell M et al (2017) A cluster randomised trial, cost-effectiveness analysis and psychosocial evaluation of insulin pump therapy compared with multiple injections during flexible intensive insulin therapy for type 1 diabetes: the REPOSE Trial. Health Technology Assessment, 21(20), 1-278.
Heller S, Amiel S, Campbell M, Choudhary P, Cooper C, Dimairo M, Elliott J, Hammond P, Lee E, Lindsay R , Waugh N et al (2017) Relative effectiveness of insulin pump treatment over multiple daily injections and structured education during flexible intensive insulin treatment for type 1 diabetes: cluster randomised trial (REPOSE). BMJ, 356, ---.
Hind D, Parkin J, Whitworth V, Rex S, Young T, Hampson L, Sheehan J, Maguire C, Cantrill H, Scott E , Epps H et al (2017) Aquatic therapy for boys with Duchenne muscular dystrophy (DMD): an external pilot randomised controlled trial. Pilot and Feasibility Studies, 3, 16-16. View this article in WRRO
Luqmani R, Lee E, Singh S, Gillett M, Schmidt WA, Bradburn M, Dasgupta B, Diamantopoulos AP, Forrester-Barker W, Hamilton W , Masters S et al (2016) The Role of Ultrasound Compared to Biopsy of Temporal Arteries in the Diagnosis and Treatment of Giant Cell Arteritis (TABUL): a diagnostic accuracy and cost-effectiveness study. Health Technology Assessment, 20(90), 1-238.
Flight L, Allison A, Dimairo M, Lee E, Mandefield L & Walters SJ (2016) Recommendations for the analysis of individually randomised controlled trials with clustering in one arm – a case of continuous outcomes. BMC Medical Research Methodology, 16.
Hind D, Kaklamanou D, Beever DA, Webster R, Lee E, Barkham M & Cooper C (2016) The assessment of depression in people with multiple sclerosis: a systematic review of psychometric validation studies. BMC Psychiatry, 16. View this article in WRRO
Rafiq MK, Lee E, Bradburn M, McDermott CJ & Shaw PJ (2016) Creatine kinase enzyme level correlates positively with serum creatinine and lean body mass, and is a prognostic factor for survival in amyotrophic lateral sclerosis. European Journal of Neurology, 23(6), 1071-1078.
Lawton J, Kirkham J, Rankin D, White DA, Elliott J, Jaap A, Smithson WH, Heller S, Gianfrancesco C, Gordon V , Greaves L et al (2016) Who gains clinical benefit from using insulin pump therapy? A qualitative study of the perceptions and views of health professionals involved in the Relative Effectiveness of Pumps over MDI and Structured Education (REPOSE) trial. Diabetic Medicine, 33(2), 243-251.
Rafiq MK, Lee E, Bradburn M, McDermott CJ & Shaw PJ (2015) Effect of lipid profile on prognosis in the patients with amyotrophic lateral sclerosis: Insights from the olesoxime clinical trial. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration, 16(7-8), 478-484. View this article in WRRO
Harrison R, Ward K, Lee E, Razaghi H, Horne C & Bishop NJ (2015) Acute bone response to whole body vibration in healthy pre-pubertal boys. Journal of Musculoskeletal Neuronal Interactions, 15(2), 112-122. View this article in WRRO
Cooper CL, Hind D, Duncan R, Walters S, Lartey A, Lee E & Bradburn M (2015) A rapid review indicated higher recruitment rates in treatment trials than in prevention trials. Journal of Clinical Epidemiology, 68(3), 347-354. View this article in WRRO
Lee EC, Whitehead AL, Jacques RM & Julious SA (2014) The statistical interpretation of pilot trials: should significance thresholds be reconsidered?. BMC Med Res Methodol, 14, 41.
Baxter SK, Baird WO, Thompson S, Bianchi SM, Walters SJ, Lee E, Ahmedzai SH, Proctor A, Shaw PJ & McDermott CJ (2013) The impact on the family carer of motor neurone disease and intervention with noninvasive ventilation.. J Palliat Med, 16(12), 1602-1609.
Baxter SK, Baird WO, Thompson S, Bianchi SM, Walters SJ, Lee E, Ahmedzai SH, Proctor A, Shaw PJ & McDermott CJ (2013) Use of non-invasive ventilation at end of life.. Palliat Med, 27(9), 878.
Baxter SK, Baird WO, Thompson S, Bianchi SM, Walters SJ, Lee E, Ahmedzai SH, Proctor A, Shaw PJ & McDermott CJ (2013) The use of non-invasive ventilation at end of life in patients with motor neurone disease: a qualitative exploration of family carer and health professional experiences.. Palliat Med, 27(6), 516-523. View this article in WRRO
Baxter SK, Baird WO, Thompson S, Bianchi SM, Walters SJ, Lee E, Ahmedzai SH, Proctor A, Shaw PJ & McDermott CJ (2013) The initiation of non-invasive ventilation for patients with motor neuron disease: patient and carer perceptions of obstacles and outcomes.. Amyotroph Lateral Scler Frontotemporal Degener, 14(2), 105-110.
Banks J, Lee E, Lee MJ & Brown SR () Decision regret following surgical management of pilonidal disease. Colorectal Disease.
Brown S, Hind D, Strong E, Bradburn M, Din FVN, Lee E, Lee MJ, Lund J, Moffatt C, Morton J , Senapati A et al () Treatment options for patients with pilonidal sinus disease: PITSTOP, a mixed-methods evaluation. Health Technology Assessment, 1-113.
Lindsay JO, Hind D, Swaby L, Berntsson H, Bradburn M, Bannur C U, Byrne J, Clarke C, Desoysa L, Din S , Emsley R et al () Autologous stem cell transplantation with low-dose cyclophosphamide to improve mucosal healing in adults with refractory Crohn’s disease: the ASTIClite RCT. Efficacy and Mechanism Evaluation, 1-106.
Tew GA, Bailey L, Beeken RJ, Cooper C, Copeland R, Brady S, Heron P, Hill A, Lee E, Spanakis P , Stubbs B et al () Physical Activity in Adults with Schizophrenia and Bipolar Disorder: A Large Cross-Sectional Survey Exploring Patterns, Preferences, Barriers, and Motivating Factors. International Journal of Environmental Research and Public Health, 20(3), 2548-2548.
Han O, Tan HW, Julious S, Sutton L, Jacques R, Lee E, Lewis J & Walters S () A descriptive study of samples sizes used in agreement studies published in the PubMed repository. BMC Medical Research Methodology, 22(1).
Wright B, Tindall L, Scott AJ, Lee E, Cooper C, Biggs K, Bee P, Wang H, Gega L, Hayward E , Solaiman K et al () One session treatment (OST) is equivalent to multi‐session cognitive behavioral therapy (CBT) in children with specific phobias (ASPECT): results from a national non‐inferiority randomized controlled trial. Journal of Child Psychology and Psychiatry.
Goodacre S, Thomas B, Lee E, Sutton L, Loban A, Waterhouse S, Simmonds R, Biggs K, Marincowitz C, Schutter J , Connelly S et al () Characterisation of 22446 patients attending UK emergency departments with suspected COVID-19 infection: Observational cohort study. View this article in WRRO
Brown S, Hind D, Beal E, Graham C, Wilkinson C, Lund J, Senapati A, Morton J, Moffatt C, Lee M , Shaw PV et al () The PITSTOP Study: PIlonidal sinus Treatment: STudying the OPtions - Protocol.

Conference proceedings papers

Bradburn M, Lee E, White D, Hind D & Heller S (2019) Do RCTs reflect patient populations and does it matter? Considerations and a case study. Trials, Vol. 20(Supplement 1) (pp 124-124). Brighton, UK, 6 October 2019 - 9 October 2019. View this article in WRRO
Thompson B, Mountain G, Thomas B, Lee E & Crawford B (2019) An exploratory study of the limitations of outcome measures used in a randomised controlled trial of a complex intervention in dementia. Trials, Vol. 20(Supplement 1) (pp 118-118). Brighton, UK, 6 October 2019 - 9 October 2019. View this article in WRRO
Luqmani RA, Lee E, Singh S, Gillett M, Schmidt W, Bradburn M, Dasgupta B, Diamantopoulos AP, Forrester-Barker W, Hamilton W , Masters S et al (2016) ULTRASOUND COMPARED WITH BIOPSY IN THE DIAGNOSIS OF SUSPECTED GIANT CELL ARTERITIS. RHEUMATOLOGY, Vol. 55 (pp 37-37)
Luqmani RA, Lee E, Singh S, Gillett M, Schmidt WA, Bradburn M, Dasgupta B, Diamantopoulos AP, Forrester-Barker W, Hamilton W , Masters S et al (2016) INTERRATER AND INTRARATER ANALYSIS OF ULTRASOUND AND HISTOLOGICAL FINDINGS IN PATIENTS WITH SUSPECTED GIANT CELL ARTERITIS. RHEUMATOLOGY, Vol. 55 (pp 171-171)
Walters S & Lee E (2015) Analysis and reporting of trials which randomise couples to therapy based interventions: how should we do it?. Trials, Vol. 16(S2)
Rafiq M, Lee E, Bradburn M, McDermott C & Shaw P (2015) Elevated creatine kinase is associated with a better prognosis in patients with amyotrophic lateral sclerosis. EUROPEAN JOURNAL OF NEUROLOGY, Vol. 22 (pp 741-741) View this article in WRRO
Rafiq M, Lee E, Bradburn M, McDermott C & Shaw P (2013) Elevated creatine kinase suggests better prognosis in patients with amyotrophic lateral sclerosis.. J Neurol Neurosurg Psychiatry, Vol. 84(11) (pp e2). England
Rafiq M, Lee E & Bradburn M (2013) Effect of lipid profile on prognosis in the patients with amyotrophic lateral sclerosis.. J Neurol Neurosurg Psychiatry, Vol. 84(11) (pp e2). England

Posters

Beal E, Hind D, Bradburn M, Lee E, Howard A, Shackley P, Lee M & Brown S (2018) #20 Design and rationale of the PIlonidal sinus Treatment - STudying the OPtions (PITSTOP) study: a multicentre cohort, nested mixed-methods case study and discrete choice experiment (poster presentation).
Walters S, Lee E, Flight L, Mandefield L, Dimario M & Allison A (2015) Analysis and reporting of individually randomised controlled trials with clustering in one arm only: how should we do it?.

Preprints

Han O, Tan HW, Julious S, Sutton L, Jacques R, Lee E, Lewis J & Walters S (2022) Review of samples sizes used in agreement studies published in the PubMed database, Research Square.
Goodacre S, Thomas B, Sutton L, Bursnall M, Lee E, Bradburn M, Loban A, Waterhouse S, Simmonds R, Biggs K , Marincowitz C et al () Derivation and validation of a clinical severity score for acutely ill adults with suspected COVID-19: The PRIEST observational cohort study, Cold Spring Harbor Laboratory.
Thomas B, Goodacre S, Lee E, Sutton L, Loban A, Waterhouse S, Simmonds R, Biggs K, Marincowitz C, Schutter J , Connelly S et al () Prognostic accuracy of emergency department triage tools for adults with suspected COVID-19: The PRIEST observational cohort study, Cold Spring Harbor Laboratory.
Biggs K, Thomas B, Goodacre S, Lee E, Sutton L, Bursnall M, Loban A, Waterhouse S, Simmonds R, Marincowitz C , Schutter J et al () Prognostic accuracy of emergency department triage tools for children with suspected COVID-19: The PRIEST observational cohort study, Cold Spring Harbor Laboratory.