Professor Cindy Cooper
BSc (Pharmacology and Physiology), PhD (Neuropharmacology)
Population Health, School of Medicine and Population Health
Director, Clinical Trials Research Unit
Professor of Health Services Research and Clinical Trials
+44 114 222 0743
Full contact details
Population Health, School of Medicine and Population Health
3037
Regent Court (ScHARR)
30 Regent Street
Sheffield
S1 4DA
- Profile
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Professor Cindy Cooper is Director of Sheffield Clinical Trials Research Unit (CTRU) and Professor of Health Services Research and Clinical Trials.
After graduating in Pharmacology and Physiology from the University of Manchester and completing a PhD in neuropharmacology at the University of Nottingham, she worked at Sheffield and West Yorkshire Health Authorities. She joined ScHARR in 1996 to establish the North Trent Research Office, to provide support to local NHS organisations to develop research strategy and increase their research income. She has been involved in health services research and clinical trials for over twenty five years and has held the position of Professor of Health Services Research and Clinical Trials since January 2014.
Cindy has previously held positions on NIHR funding bodies including being a member of the Programme Grant for Applied Research Committee and the COVID Call College of Experts as well as Chair of the Yorkshire and Humber Research for Patient Benefit Committee. Cindy is Chair of three NIHR funded Project Steering Committees and a member of the UKCRC Clinical Trials Unit (CTU) Executive Group. She has extensive experience of designing and implementing evaluations of complex health interventions in large multi-centre trials and other study designs. Since 2013 she has been PI or co-applicant on 15 NIHR Health Technology Assessment, Public Health Research, Clinical Trials Unit (CTU) Efficient Trials call and Programme Grant for Applied Research grants related to trials and trials methodology to a total research cost of £12 million. She has also held CTU support and infrastructure awards to total cost of approximately £1.1 million. Cindy has published over 100 peer-reviewed research papers. The CTRU currently has a portfolio of around 20 studies, the majority being clinical trials or studies of trial methodology.
Cindy is module coordinator for the ScHARR MSc module on clinical trials research methodology and has supervised six PhD students to successful completion, one of these was an NIHR Clinical Fellowship and one a Stroke Association Fellowship.
- Research interests
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- Trials methodology, particularly pilot (external and internal) and feasibility studies
- Psycho-social aspects of long term conditions
- Health technology evaluation
- Evaluation of psychotherapeutic interventions
- Public and patient involvement in research
- Publications
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Show: Featured publications All publications
Featured publications
Journal articles
- A study of target effect sizes in randomised controlled trials published in the Health Technology Assessment journal.. Trials, 19. View this article in WRRO
- Are pilot trials useful for predicting randomisation and attrition rates in definitive studies: A review of publicly funded trials. Clinical Trials, 15(2), 189-196. View this article in WRRO
- 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. View this article in WRRO
- Use of MRI in the diagnosis of fetal brain abnormalities in utero (MERIDIAN): a multicentre, prospective cohort study. The Lancet, 389(10068), 538-546. View this article in WRRO
- The second Randomised Evaluation of the Effectiveness, cost-effectiveness and Acceptability of Computerised Therapy (REEACT-2) trial: does the provision of telephone support enhance the effectiveness of computer-delivered cognitive behaviour therapy? A randomised controlled trial.. Health Technology Assessment, 20(89), 1-64. View this article in WRRO
- Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Statistical Methods in Medical Research, 25(3), 1057-1073. View this article in WRRO
- Safety and efficacy of diaphragm pacing in patients with respiratory insufficiency due to amyotrophic lateral sclerosis (DiPALS): a multicentre, open-label, randomised controlled trial. The Lancet Neurology, 14(9), 883-892. View this article in WRRO
- 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
- Computerised cognitive behavioural therapy for the treatment of depression in people with multiple sclerosis: external pilot trial.. Trials, 12, 259. View this article in WRRO
All publications
Journal articles
- Experiences of acceptance and commitment therapy for people living with motor neuron disease (MND): a qualitative study from the perspective of people living with MND and therapists. The Cognitive Behaviour Therapist, 17.
- Effectiveness of a symptom-clinic intervention delivered by general practitioners with an extended role for people with multiple and persistent physical symptoms in England: the Multiple Symptoms Study 3 pragmatic, multicentre, parallel-group, individually randomised controlled trial. The Lancet, 403(10444), 2619-2629. View this article in WRRO
- Acceptance and Commitment Therapy plus usual care for improving quality of life in people with motor neuron disease (COMMEND): a multicentre, parallel, randomised controlled trial in the UK. The Lancet. View this article in WRRO
- Cost-effectiveness of acceptance and commitment therapy for people living with motor neuron disease, and their health-related quality of life. European Journal of Neurology. View this article in WRRO
- Aggressive Multiple Sclerosis: Clinical Phenotype and Treatment Within a Randomised Clinical Trial of Autologous Haematopoietic Stem Cell Transplantation vs High Efficacy Disease Modifying Treatment (P9-6.004). Neurology, 102(17_supplement_1).
- Exploring the barriers to, and importance of, participant diversity in early-phase clinical trials: an interview-based qualitative study of professionals and patient and public representatives. BMJ Open, 14(3). View this article in WRRO
- Recording harms in randomised controlled trials of behaviour change interventions: a qualitative study of UK clinical trials units and NIHR trial investigators. Trials, 25(1), 163.
- 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
- Recording harms in randomised controlled trials of behaviour change interventions: a scoping review and map of the evidence. Journal of Clinical Epidemiology, 111275-111275.
- Efficacy and safety of autologous haematopoietic stem cell transplantation versus alemtuzumab, ocrelizumab, ofatumumab or cladribine in relapsing remitting multiple sclerosis (StarMS): protocol for a randomised controlled trial. BMJ Open, 14(2). View this article in WRRO
- The evolution of entry criteria in clinical trials of autologous haematopoietic stem cell transplantation for relapsing remitting multiple sclerosis to reflect changing clinical practice. Journal of the Neurological Sciences, 455, 121832-121832.
- O08 Mesenchymal stromal cells infusions in children with recessive dystrophic epidermolysis bullosa (MissionEB): a randomized controlled trial. British Journal of Dermatology, 189(3), e42-e43.
- Interventions to increase physical activity and reduce sedentary behaviour in severe mental ill health: How effective are they?’- A systematic review. Mental Health and Physical Activity, 100547-100547.
- I-SOCIALISE: Results from a cluster randomised controlled trial investigating the social competence and isolation of children with autism taking part in LEGO® based therapy (‘Play Brick Therapy’) clubs in school environments. Autism.
- 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).
- PROMoting the use of studies within a trial (PROMETHEUS): results and experiences from a large programme to evaluate the routine embedding of recruitment and retention strategies within randomised controlled trials routinely. Research Methods in Medicine & Health Sciences.
- The alleviating specific phobias in children trial: challenges and solutions to implementing a randomized controlled trial in clinical services. Frontiers in Child and Adolescent Psychiatry, 1.
- Comparison of amitriptyline supplemented with pregabalin, pregabalin supplemented with amitriptyline, and duloxetine supplemented with pregabalin for the treatment of diabetic peripheral neuropathic pain (OPTION-DM): a multicentre, double-blind, randomised crossover trial. The Lancet, 400(10353), 680-690. View this article in WRRO
- 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.
- Staff training to improve participant recruitment into surgical randomised controlled trials: A feasibility study within a trial (SWAT) across four host trials simultaneously. Research Methods in Medicine & Health Sciences.
- The PROMoting the USE of SWATs (PROMETHEUS) programme: Lessons learnt and future developments for SWATs. Research Methods in Medicine & Health Sciences. View this article in WRRO
- An intervention to promote self-management, independence and self-efficacy in people with early-stage dementia : the Journeying through Dementia RCT. Health Technology Assessment, 26(24), 1-151.
- Learning from COVID-19 related trial adaptations to inform efficient trial design—a sequential mixed methods study. BMC Medical Research Methodology, 22(1). View this article in WRRO
- 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. View this article in WRRO
- Understanding the current nutritional management for people with amyotrophic lateral sclerosis - a mapping review. Clinical Nutrition ESPEN. View this article in WRRO
- 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, 12(1).
- Patient, carer and healthcare professional perspectives on increasing calorie intake in Amyotrophic Lateral Sclerosis. Chronic Illness. View this article in WRRO
- Adjusting for bias in the mean for primary and secondary outcomes when trials are in sequence. Pharmaceutical Statistics. View this article in WRRO
- The implementation of Journeying through Dementia : strategies to run a successful pragmatic multicenter trial of a complex intervention. Brain and Behavior.
- Estimating the minimum important difference in the DEMQOL instrument in people with dementia.. Qual Life Res.
- 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
- Adverse event recording failed to reflect potential harms: A review of trial protocols of behavioural, lifestyle and psychological therapy interventions.. Journal of Clinical Epidemiology.
- Assessing fidelity of a community based psychosocial intervention for people with mild dementia within a large randomised controlled trial. BMC Geriatrics, 21(1).
- Journeying through dementia randomised controlled trial of a psychosocial intervention for people living with early dementia: embedded qualitative study with participants, carers and interventionists. Clinical Interventions in Aging, 16, 231-244.
- Delivery of nutritional management services to people with amyotrophic lateral sclerosis (ALS).. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration, 22(5-6), 350-359. View this article in WRRO
- Cost-effectiveness of out-of-hospital continuous positive airway pressure for acute respiratory failure: decision analytic modelling using data from a feasibility trial.. BMC Emerg Med, 21(1), 13.
- The diagnostic accuracy of pre-hospital assessment of acute respiratory failure. British Paramedic Journal, 5(3), 15-22. View this article in WRRO
- Self-managed, computerised word finding therapy as an add-on to usual care for chronic aphasia post-stroke : an economic evaluation. Clinical Rehabilitation. View this article in WRRO
- Factors associated with adherence to self-managed aphasia therapy practice on a computer—a mixed methods study alongside a randomized controlled trial. Frontiers in Neurology, 11. View this article in WRRO
- Interventions to promote oral nutritional behaviours in people living with neurodegenerative disorders of the motor system : a systematic review. Clinical Nutrition, 39(8), 2547-2556. View this article in WRRO
- Is a definitive trial of prehospital continuous positive airway pressure versus standard oxygen therapy for acute respiratory failure indicated? The ACUTE pilot randomised controlled trial. BMJ Open, 10(7). View this article in WRRO
- What Is the health and well-being burden for parents living with a child with ADHD in the United Kingdom?. Journal of Attention Disorders. View this article in WRRO
- Computerised speech and language therapy or attention control added to usual care for people with long-term post-stroke aphasia : the Big CACTUS three-arm RCT. Health Technology Assessment, 24(19), 1-176. View this article in WRRO
- Challenges in the design, planning and implementation of trials evaluating group interventions. Trials, 21. View this article in WRRO
- Health care professionals’ views on psychological factors affecting nutritional behaviour in people with motor neuron disease : a thematic analysis. British Journal of Health Psychology, 24(4), 953-969. View this article in WRRO
- Using telehealth in motor neuron disease to increase access to specialist multidisciplinary care : a UK-based pilot and feasibility study. BMJ Open, 9(10). View this article in WRRO
- Self-managed, computerised speech and language therapy for patients with chronic aphasia post-stroke compared with usual care or attention control (Big CACTUS) : a multicentre, single-blinded, randomised controlled trial. The Lancet Neurology, 18(9), 821-833. View this article in WRRO
- Behavioural activation therapy for post-stroke depression : the BEADS feasibility RCT. Health Technology Assessment, 23(47), 1-176. View this article in WRRO
- MRI in the diagnosis of fetal developmental brain abnormalities : the MERIDIAN diagnostic accuracy study. Health Technology Assessment, 23(49), 1-144. View this article in WRRO
- 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
- Investigating SOcial Competence and Isolation in children with Autism taking part in LEGO-based therapy clubs In School Environments (I-SOCIALISE) : study protocol. BMJ Open, 9(5). View this article in WRRO
- Multicentre, double-blind, crossover trial to identify the Optimal Pathway for TreatIng neurOpathic paiN in Diabetes Mellitus (OPTION-DM): study protocol for a randomised controlled trial. Trials, 19(1), 578-578. View this article in WRRO
- A study of target effect sizes in randomised controlled trials published in the Health Technology Assessment journal.. Trials, 19. View this article in WRRO
- 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
- The ACUTE (Ambulance CPAP: Use, Treatment effect and economics) feasibility study: a pilot randomised controlled trial of prehospital CPAP for acute respiratory failure. Pilot and Feasibility Studies, 4(1). View this article in WRRO
- Open-label, cluster randomised controlled trial and economic evaluation of a brief letter from a GP on unscheduled medical contacts associated with the start of the school year: The PLEASANT trial. BMJ Open, 8(4). View this article in WRRO
- 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
- Are pilot trials useful for predicting randomisation and attrition rates in definitive studies: A review of publicly funded trials. Clinical Trials, 15(2), 189-196. View this article in WRRO
- MRI for Fetal Developmental Brain Abnormalities: Perspectives From the Pregnant Patient. Qualitative Health Research, 28(8), 1295-1307.
- The TiM system: developing a novel telehealth service to improve access to specialist care in motor neurone disease using user-centered design. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration, 19(5-6), 351-361. View this article in WRRO
- Use of MRI in the Diagnosis of Fetal Brain Abnormalities in Utero (MERIDIAN). Obstetric Anesthesia Digest, 37(4), 202-203.
- Can more appropriate support and services be provided for people who attend the emergency department frequently? National Health Service staff views. Emergency Medicine Journal. View this article in WRRO
- Use of MRI in the Diagnosis of Fetal Brain Abnormalities in Utero (MERIDIAN). Obstetrical & Gynecological Survey, 72(6), 323-325.
- Change in diagnostic confidence brought about by using in utero MRI for fetal structural brain pathology: Analysis of the MERIDIAN cohort. Clinical Radiology. View this article in WRRO
- 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. View this article in WRRO
- 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. View this article in WRRO
- Telephone-supported computerised cognitive–behavioural therapy: REEACT-2 large-scale pragmatic randomised controlled trial. The British Journal of Psychiatry, 210(5), 362-367. View this article in WRRO
- Staff experiences of closing out a clinical trial involving withdrawal of treatment: qualitative study. Trials, 18. View this article in WRRO
- Informing efficient randomised controlled trials: Exploration of challenges in developing progression criteria for internal pilot studies. BMJ Open, 7(e013537). View this article in WRRO
- Use of MRI in the diagnosis of fetal brain abnormalities in utero (MERIDIAN): a multicentre, prospective cohort study. The Lancet, 389(10068), 538-546. View this article in WRRO
- PLEASANT: Preventing and Lessening Exacerbations of Asthma in School-age children Associated with a New Term - a cluster randomised controlled trial and economic evaluation.. Health Technology Assessment, 20(93), 1-154. View this article in WRRO
- The second Randomised Evaluation of the Effectiveness, cost-effectiveness and Acceptability of Computerised Therapy (REEACT-2) trial: does the provision of telephone support enhance the effectiveness of computer-delivered cognitive behaviour therapy? A randomised controlled trial.. Health Technology Assessment, 20(89), 1-64. View this article in WRRO
- The impact of ADHD on the health and well-being of ADHD children and their siblings. European Child & Adolescent Psychiatry, 25(11), 1217-1231. View this article in WRRO
- Behavioural Activation Therapy for Depression after Stroke (BEADS): a study protocol for a feasibility randomised controlled pilot trial of a psychological intervention for post-stroke depression. Pilot and Feasibility Studies, 2(1). View this article in WRRO
- The assessment of depression in people with multiple sclerosis: a systematic review of psychometric validation studies. BMC Psychiatry, 16. View this article in WRRO
- Patterns of multimorbidity and their association with health outcomes within Yorkshire, England: Baseline results from the Yorkshire Health Study. BMC Public Health, 16(649). View this article in WRRO
- DiPALS: Diaphragm Pacing in patients with Amyotrophic Lateral Sclerosis - a randomised controlled trial.. Health Technol Assess, 20(45), 1-186. View this article in WRRO
- Cohort Profile: The Yorkshire Health Study.. Int J Epidemiol, 45(3), 707-712. View this article in WRRO
- Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Statistical Methods in Medical Research, 25(3), 1057-1073. View this article in WRRO
- Using technology to improve access to specialist care in amyotrophic lateral sclerosis: A systematic review. Amyotrophic Lateral Sclerosis && Frontotemporal Degeneration, 17(5-6), 313-324. View this article in WRRO
- 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.
- Clinical and cost effectiveness of computer treatment for aphasia post stroke (Big CACTUS): study protocol for a randomised controlled trial. Trials, 16(1). View this article in WRRO
- A randomised controlled trial of computerised cognitive behaviour therapy for the treatment of depression in primary care: the Randomised Evaluation of the Effectiveness and Acceptability of Computerised Therapy (REEACT) trial. Health Technology Assessment, 19(101), 1-174. View this article in WRRO
- Uncovering the emotional aspects of working on a clinical trial: a qualitative study of the experiences and views of staff involved in a type 1 diabetes trial. Trials, 16(1). View this article in WRRO
- Safety and efficacy of diaphragm pacing in patients with respiratory insufficiency due to amyotrophic lateral sclerosis (DiPALS): a multicentre, open-label, randomised controlled trial. The Lancet Neurology, 14(9), 883-892. View this article in WRRO
- 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
- Use of home visits increases data completion and retention in studies involving family members. Trials, 16(S2).
- ‘Fish out of water’: a cross-sectional study on the interaction between social and neighbourhood effects on weight management behaviours. International Journal of Obesity, 39(3), 535-541. View this article in WRRO
- Examining the impact of 11 long-standing health conditions on health-related quality of life using the EQ-5D in a general population sample. European Journal of Health Economics, 16(2), 141-151. View this article in WRRO
- Putting Life in Years (PLINY): a pilot randomised controlled trial and mixed-methods process evaluation of telephone friendship groups for community living older adults. Public Health Research, 2(7).
- SABRE: a multicentre randomised control trial of nebulised hypertonic saline in infants hospitalised with acute bronchiolitis. Thorax, 69(12), 1105-1112. View this article in WRRO
- Cognitive behavioural therapy for the treatment of depression in people with multiple sclerosis: a systematic review and meta-analysis.. BMC Psychiatry, 14, 5. View this article in WRRO
- Perceptions and experiences of using automated bolus advisors amongst people with type 1 diabetes: A longitudinal qualitative investigation. Diabetes Research and Clinical Practice, 106(3), 443-450. View this article in WRRO
- Prediction of unsuccessful treatment in patients with severe acute asthma. Emergency Medicine Journal, 31(e1), e40-e45.
- The Relative Effectiveness of Pumps Over MDI and Structured Education (REPOSE): study protocol for a cluster randomised controlled trial. BMJ Open, 4(9), e006204-e006204. View this article in WRRO
- Conducting qualitative research within Clinical Trials Units: avoiding potential pitfalls.. Contemp Clin Trials, 38(2), 338-343. View this article in WRRO
- Examining the incremental impact of long-standing health conditions on subjective well-being alongside the EQ-5D. Health and Quality of Life Outcomes, 12(1). View this article in WRRO
- 'Putting Life in Years' (PLINY) telephone friendship groups research study: pilot randomised controlled trial.. Trials, 15, 141. View this article in WRRO
- Exploring the impact of patient and public involvement in a cancer research setting.. Qual Health Res, 24(1), 46-54. View this article in WRRO
- A randomised controlled trial and cost-effectiveness evaluation of 'booster' interventions to sustain increases in physical activity in middle-aged adults in deprived urban neighbourhoods.. Health Technol Assess, 18(13), 1-210.
- Comparison of recruitment yield in prevention and therapy trials. Trials, 14(S1).
- The role of clinical trials units in maximising qualitative research with RCTS. Trials, 14(S1).
- Preventing and lessening exacerbations of asthma in school-age children associated with a new term (PLEASANT): Study protocol for a cluster randomised control trial. Trials, 14(1). View this article in WRRO
- Credibility and the 'professionalized' lay expert: reflections on the dilemmas and opportunities of public involvement in health research.. Health (London), 16(6), 602-618. View this article in WRRO
- Computer therapy compared with usual care for people with long-standing aphasia poststroke: a pilot randomized controlled trial.. Stroke, 43(7), 1904-1911.
- Cognitive behavioural intervention for adults with anxiety complications of asthma: Prospective randomised trial. Respiratory Medicine, 106(6), 802-810.
- Coping strategies used by Pakistani parents living in the United Kingdom and caring for a severely disabled child.. Disabil Rehabil, 34(18), 1540-1549.
- Protocol for diaphragm pacing in patients with respiratory muscle weakness due to motor neurone disease (DiPALS): a randomised controlled trial.. BMC Neurol, 12, 74. View this article in WRRO
- The Authors' reply.. Heart, 98(2), 170-171.
- Very early diagnosis of chest pain by point-of-care testing: comparison of the diagnostic efficiency of a panel of cardiac biomarkers compared with troponin measurement alone in the RATPAC trial.. Heart, 98(4), 312-318.
- Interhospital variation in the RATPAC trial (Randomised Assessment of Treatment using Panel Assay of Cardiac markers).. Emerg Med J, 29(3), 233-238.
- Computerised cognitive behavioural therapy for the treatment of depression in people with multiple sclerosis: external pilot trial.. Trials, 12, 259. View this article in WRRO
- Rehabilitation of older patients: day hospital compared with rehabilitation at home. Clinical outcomes. AGE AGEING, 40(5), 557-562.
- Cost-effectiveness of point-of-care biomarker assessment for suspected myocardial infarction: the randomized assessment of treatment using panel Assay of cardiac markers (RATPAC) trial.. Acad Emerg Med, 18(5), 488-495.
- "Booster" interventions to sustain increases in physical activity in middle-aged adults in deprived urban neighbourhoods: internal pilot and feasibility study.. BMC Public Health, 11, 129. View this article in WRRO
- South Yorkshire Cohort: a 'cohort trials facility' study of health and weight - protocol for the recruitment phase.. BMC Public Health, 11, 640. View this article in WRRO
- Can the impact of public involvement on research be evaluated? A mixed methods study. Health Expectations.
- Evaluating the impact of service user involvement on research: a prospective case study. International Journal of Consumer Studies, 35(6), 609-615.
- The Randomised Assessment of Treatment using Panel Assay of Cardiac Markers (RATPAC) trial: a randomised controlled trial of point-of-care cardiac markers in the emergency department.. Heart, 97(3), 190-196.
- Critical perspectives on 'consumer involvement' in health research Epistemological dissonance and the know-do gap. J SOCIOL, 46(1), 63-82. View this article in WRRO
- Principles of Design of Access with Evidence Development Approaches A Consensus Statement from the Banff Summit. PHARMACOECONOMICS, 28(2), 109-111.
- What is a pilot or feasibility study? A review of current practice and editorial policy.. BMC Med Res Methodol, 10, 67. View this article in WRRO
- Continuing the multiple sclerosis risk sharing scheme is unjustified.. BMJ, 340, c1786.
- A randomised controlled trial and cost-effectiveness evaluation of "booster" interventions to sustain increases in physical activity in middle-aged adults in deprived urban neighbourhoods.. BMC Public Health, 10, 3. View this article in WRRO
- The acceptability of computerised cognitive behavioural therapy for the treatment of depression in people with chronic physical disease: a qualitative study of people with multiple sclerosis.. Psychol Health, 25(6), 699-712.
- Health and use of health services: a comparison between Gypsies and Travellers and other ethnic groups.. Ethn Health, 14(4), 359-377.
- Health researchers' attitudes towards public involvement in health research.. Health Expect, 12(2), 209-220. View this article in WRRO
- Rehabilitation of older patients: day hospital compared with rehabilitation at home. A randomised controlled trial.. Health Technol Assess, 13(39), 1-iv.
- The Multiple Sclerosis Risk Sharing Scheme Monitoring Study--early results and lessons for the future.. BMC Neurol, 9, 1. View this article in WRRO
- Perceptions of the causes of childhood disability among Pakistani families living in the UK.. Health Soc Care Community, 16(6), 606-613.
- Involving consumers successfully in NHS research: a national survey.. Health Expect, 10(4), 380-391. View this article in WRRO
- Multiple sclerosis and retention of employment: Experience within the risk sharing scheme. JOURNAL OF NEUROLOGY NEUROSURGERY AND PSYCHIATRY, 78(9), 1033-1033.
- Health-related beliefs and experiences of Gypsies and Travellers: a qualitative study.. J Epidemiol Community Health, 61(3), 205-210.
- Health status of Gypsies and Travellers in England.. J Epidemiol Community Health, 61(3), 198-204.
- Anxiety and panic fear in adults with asthma: prevalence in primary care.. BMC Fam Pract, 8, 62. View this article in WRRO
- Principles and indicators of successful consumer involvement in NHS research: results of a Delphi study and subgroup analysis.. Health Policy, 75(3), 280-297. View this article in WRRO
- The health status of gypsy travellers in England. EUR J PUBLIC HEALTH, 14(4), 13-13.
- What does it mean to involve consumers successfully in NHS research? A consensus study.. Health Expect, 7(3), 209-220. View this article in WRRO
- The effects of smoking on birthweight-for-gestational-age curves in teenage and adult primigravidae. Public Health, 117(1), 31-35.
- Breast-feeding knowledge and attitudes of teenage mothers in Liverpool. Journal of Human Nutrition and Dietetics, 15(1), 33-37.
- Consumer involvement in health research: a review and research agenda.. Health Policy, 61(2), 213-236. View this article in WRRO
- Quality of referrals to gynaecologists: Towards consensus. Journal of Clinical Governance, 10(4), 177-181.
- Consumer involvement in health research: Fact or fiction?. British Journal of Clinical Governance, 7(2), 92-103. View this article in WRRO
- MEASUREMENT OF CATECHOLAMINES, INDOLEAMINES, THYROTROPIN-RELEASING-HORMONE AND SUBSTANCE-P IN RAT AND HUMAN SPINAL-CORD USING A COMMON EXTRACTION METHOD. JOURNAL OF NEUROSCIENCE METHODS, 1(22), 31-39.
- Time to STEP UP: methods and findings from the development of guidance to help researchers design inclusive clinical trials. BMC Medical Research Methodology, 24(1).
- Recommendations on recording harms in randomised controlled trials of behaviour change interventions. BMJ, e077418-e077418.
- Effective interventions to increase representation of under-served groups in randomised trials in UK and Ireland: a scoping literature review. NIHR Open Research, 4, 12-12.
- Trial Forge Guidance 4: a guideline for reporting the results of randomised Studies Within A Trial (SWATs). Trials, 25(1).
- Implementation successes and lessons learnt from a randomised controlled trial of a complex school-based intervention. Research Methods in Medicine & Health Sciences.
- Undertaking Studies Within A Trial to evaluate recruitment and retention strategies for randomised controlled trials: lessons learnt from the PROMETHEUS research programme. Health Technology Assessment, 1-114.
- Identifying the Active Ingredients of a Computerized Speech and Language Therapy Intervention for Poststroke Aphasia: Multiple Methods Investigation Alongside a Randomized Controlled Trial. JMIR Rehabilitation and Assistive Technologies, 10, e47542-e47542.
- Play brick therapy to aid the social skills of children and young people with autism spectrum disorder: the I-SOCIALISE cluster RCT. Public Health Research, 1-137.
- A randomised controlled trial of acceptance and commitment therapy plus usual care compared to usual care alone for improving psychological health in people with motor neuron disease (COMMEND): study protocol. BMC Neurology, 22(1).
- Optimal pharmacotherapy pathway in adults with diabetic peripheral neuropathic pain: the OPTION-DM RCT. Health Technology Assessment, 26(39), 1-100.
- 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), 1-174.
- The nutritional management of people living with Amyotrophic Lateral Sclerosis (ALS): A national survey of dietitians. Journal of Human Nutrition and Dietetics.
- Prehospital continuous positive airway pressure for acute respiratory failure: the ACUTE feasibility RCT. Health Technology Assessment, 25(7), 1-92.
- Computerised cognitive behaviour therapy (cCBT) as treatment for depression in primary care (REEACT trial): large scale pragmatic randomised controlled trial. BMJ, i195-i195.
- Computerised cognitive behaviour therapy (cCBT) as treatment for depression in primary care (REEACT trial): large scale pragmatic randomised controlled trial. BMJ, h5627-h5627. View this article in WRRO
- An Investigation of the Shortcomings of the CONSORT 2010 Statement for the Reporting of Group Sequential Randomised Controlled Trials: A Methodological Systematic Review. PLOS ONE, 10(11), e0141104-e0141104. View this article in WRRO
- Needs and preferences for psychological interventions of people with motor neuron disease. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration. View this article in WRRO
- Saline in Acute Bronchiolitis RCT and Economic evaluation: hypertonic saline in acute bronchiolitis – randomised controlled trial and systematic review. Health Technology Assessment, 19(66), 1-130. View this article in WRRO
- A 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.
Chapters
- Background to Sample Size Calculations, Handbook of Statistical Methods for Randomized Controlled Trials (pp. 243-274). Chapman and Hall/CRC
- Evaluating the impact of public involvement on research, Critical Perspectives on User Involvement (pp. 217-223).
- Should we? Could we? Measuring involvement, Critical Perspectives on User Involvement (pp. 209-216).
Conference proceedings papers
- Pre-hospital CPAP for acute respiratory failure : the ACUTE feasibility and pilot randomised controlled trial. British Paramedic Journal, Vol. 4(3) (pp 53-54). Cardiff, Wales, 24 September 2019 - 24 September 2019. View this article in WRRO
- Staff training to improve participant recruitment into surgical randomised controlled trials: a feasibility study embedded within four randomised controlled trials. TRIALS, Vol. 20
- PROMoting THE USE of SWATs (PROMETHEUS): Routinely embedding recruitment and retention interventions within randomised trials. TRIALS, Vol. 20
- Identifying barriers and enablers of adherence to self-directed aphasia computer therapy: a patient and carer perspective. INTERNATIONAL JOURNAL OF STROKE, Vol. 12 (pp 23-23)
- Behavioural activation therapy for depression after stroke (BEADS): a feasibility randomised controlled pilot trial of a psychological intervention for post-stroke depression. INTERNATIONAL JOURNAL OF STROKE, Vol. 12 (pp 15-15)
- Staff experiences of closing out a clinical trial involving withdrawal of treatment : qualitative study. Trials, Vol. 18(Suppl 1) (pp 91-91). Liverpool, UK, 7 May 2017 - 10 May 2017. View this article in WRRO
- Staff experiences of closing out a clinical trial involving withdrawal of treatment: qualitative study. TRIALS, Vol. 18
- Quantifying effect sizes in clinical trials. TRIALS, Vol. 18
- Defining and measuring the components of a complex neuro-rehabilitation intervention for aphasia. INTERNATIONAL JOURNAL OF STROKE, Vol. 11 (pp S19-S19)
- LATE-BREAKING ABSTRACT: PLEASANT: Preventing and lessening exacerbations of asthma in school-age children associated with a new term. 1.6 General Practice and Primary Care
- Investigation of the shortcomings of the consort 2010 statement for the reporting of group sequential randomised controlled trials. Trials, Vol. 16(S2) View this article in WRRO
- Differential reporting of group sequential RCTs: shortcomings ofthe CONSORT 2010 statement. CPS 11: Group Sequential Methods and Interim Analysis. ARLINGTON, VIRGINIA, USA, 17 May 2015 - 20 May 2015.
- Methodological, planning and implementation challenges for rcts evaluating group interventions. Trials, Vol. 14(Suppl 1) (pp O124-O124)
- The acceptability of cognitive behavioural therapy software for the treatment of depression in people with multiple sclerosis. J EPIDEMIOL COMMUN H, Vol. 62 (pp A12-A13)
- How appropriate is cognitive behavioural therapy computer software for the treatment of depression in people with multiple sclerosis?. MULTIPLE SCLEROSIS JOURNAL, Vol. 14 (pp S263-S264)
- The multiple sclerosis monitoring study: Progress to date. JOURNAL OF NEUROLOGY NEUROSURGERY AND PSYCHIATRY, Vol. 75(8) (pp 1214-1214)
Posters
- View this article in WRRO Challenges in the design, planning and implementation of trials evaluating group interventions.
Other
Preprints
- Identifying the Active Ingredients of a Computerized Speech and Language Therapy Intervention for Poststroke Aphasia: Multiple Methods Investigation Alongside a Randomized Controlled Trial (Preprint), JMIR Publications Inc..
- Cost-effectiveness of Out-of-Hospital Continuous Positive Airway Pressure for Acute Respiratory Failure: Decision analytic modelling using data from a feasibility trial, Research Square Platform LLC.
- Cost-effectiveness of Out-of-Hospital Continuous Positive Airway Pressure for Acute Respiratory Failure: Decision analytic modelling using data from a feasibility trial, Research Square Platform LLC.
- Teaching interests
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I am co-ordinator for the Randomised Controlled Trials in Health and Social Care module of the MSc in Clinical Research.
I am interested in supervising research students in areas such as RCT methodology, evaluation of health technologies, particularly psychotherapeutic interventions and psychosocial aspects of chronic conditions.
- Professional activities and memberships
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- Director of the Clinical Trials Research Unit
- Chair of University Health Research Governance Committee 2011 - 2019
- Member of the NIHR CTU Directors Executive Group 2015 -
- Trial Management Group member for Journeying through Dementia, CACTUS, ACUTE, ASPECT, I-Socialise and OPTION DM trials
- Member of the York Trials Unit Strategic Advisory Group
- Member of the UKCRC CTU Directors Meeting
- Member of the NIHR Clinical Trials Unit Standing Advisory Committee 2016 -
- Member of the Sheffield Teaching Hospital Foundation Trust Research Innovation and Education Committee 2016-2019
- Member of the Programme Grant for Applied Research Assessment Panel D 2017 -
- Chair of the Trial Steering Committee for the York University lead, HTA Funded:-ACTIVE (articular type C pilon fracture Trial Internal vs External Fixation) Trial. 2017 -
- Chair of the Trial Steering Committee for the York University lead, NIHR Programme Grant Funde: MODS (Multi-morbidity in OLder Adults with Depression Study) 2019 -
Current Projects
- CACTUS (Clinical and cost effectiveness of aphasia computer therapy compared with usual stimulation or attention control long term post stroke. HTA 2013-2018. £1.7 million.
- OPTION DM Optimal Pathway for TreatIng neurOpathic paiN in Diabetes Mellitus (OPTION-DM) trial. HTA Project: 15/35/03. £2.9 million 01/06/2016 to: 31/08/2019 .
- The ACUTE (Ambulance CPAP: Use, Treatment effect and Economics) feasibility study: A pilot randomised controlled trial of prehospital CPAP for acute respiratory failure. HTA: 15/08/40, 2016-1019. £378,285
- ASPECT A non inferiority randomised controlled trial comparing the clinical and cost effectiveness of single session treatment with multi-session CBT in children with specific phobias. HTA 15/38/04 . 2016-2020.£1.4 million
- NIHR CTU Support Funding £350,000 per annum
- Journeying through Dementia is a large-scale research study that aims to find out whether attending a 12-week community programme has a positive impact on the quality of life for people who are living with the early stages of dementia.
- The COMMEND project (NIHR HTA 16/81/010) includes two phases. Phase 1 will adapt ACT for people with MND and test the acceptability and feasibility of the adapted ACT intervention and whether it is possible to conduct a larger study.
- High CALS. A programme to develop and evaluate a complex intervention to achieve a high calorie diet in ALS (HighCALS) 42 months 02/04/2018 - 01/03/2024. NIHR PGfAR £1,871,107.00 (IA 6% - £112,266.42. CI - C McDermott
- MSS 3. NIHR HS&DR Funded RCT - MSS3: Multiple Symptoms Study 3: pragmatic trial of a community based clinic for patients with persistent (medically unexplained) physical symptoms. Co-I.UoS allocation - £898,732.57.
- MATTS. Major Trauma Triage Tool Study. NIHR HTA funded. CI- Dr Gordon Fuller
- I-SOCIALISE Investigating SOcial Competence and Isolation in children with Autism taking part in LEGO-based therapy clubs In School Environments (I-SOCIALISE), NIHR PHR Funded