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Volume 20 Supplement 1

Meeting abstracts from the 5th International Clinical Trials Methodology Conference (ICTMC 2019)

Meeting abstracts

The publication charge for this supplement was not funded by any sponsorship.

Brighton, UK06-09 October 2019

The following abstracts have been omitted from this publication as they have previously been published elsewhere. These abstracts can be accessed in full here: https://ictmc2019.com/abstracts/

P-1 Early phase and adaptive design clinical trials in rheumatoid arthritis: a systematic review of early phase trials

Mr Tim Pickles1,2 , Prof Robin Christensen3 , Prof Lai-Shan Tam4 , Dr Lee S. Simon5 , Prof Ernest H. Choy2
1Centre for Trials Research, Cardiff, United Kingdom, 2Cardiff Regional Experimental Arthritis Treatment and Evaluation Centre, Cardiff, United Kingdom, 3Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark, 4Department of Medicine & Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, China, 5 SDG LLC, Cambridge, USA

P-4 A review of software availability for adaptive clinical trials
Dr Michael Grayling1 , Dr Graham Wheeler2
1Newcastle University, Newcastle upon Tyne, United Kingdom, 2Cancer Research UK & UCL Cancer Trials Centre, University College London, London, United Kingdom Introduction: The increasing expense of the drug

P-11 Development of a group structured education programme to support safe EXercise in people with Type One Diabetes: The EXTOD Education programme
Dr Parth Narendran1,2, Prof Sheila Greenfield3 , Mrs Jacqui Troughton4 , Dr Yvonne Doherty5 , Miss Niamh Quann6 , Mrs Catherine Thompson7 , Dr Ian Litchfield3 , Prof Robert Andrews7,8
1Department of Diabetes, University Hospitals Birmingham NHS Foundation Trust, United Kingdom, 2 Institute of Immunology and Immunotherapy, University of Birmingham, United Kingdom, 3 Institute of Applied Health Research, University of Birmingham, United Kingdom, 4 Leicester Diabetes Centre, University Hospitals Leicester, United Kingdom, 5Department of Psychological Medicine, York Teaching Hospitals NHS Foundation Trust, United Kingdom, 6 Leicester Clinical Trials Unit, University of Leicester, United Kingdom, 7Department of Diabetes, United Kingdom, 8University of Exeter Medical School, United Kingdom

P-15 SKIP (Supporting Kids with diabetes In Physical activity): Feasibility of a randomised controlled trial of a digital intervention for 9-12 year olds with type 1 diabetes mellitus.
Dr Holly Blake1,6, Dr Emily Knox1 , Dr Tabitha Randell3 , Dr Paul Leighton2 , Dr Boliang Guo2 , Dr James Greening4 , Dr E.Bethan Davies2,5, Ms Lori Amor5 , Prof. Cris Glazebrook2
1 School of Health Sciences, University of Nottingham, Nottingham, United Kingdom, 2 School of Medicine, University of Nottingham, Nottingham, United Kingdom, 3Nottingham Children's Hospital, Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom, 4 Leicester Royal Infirmary, University Hospitals of Leicester NHS Trust, Leicester, United Kingdom, 5NIHR MindTech MedTech Co-operative, Institute of Mental Health, University of Nottingham, Nottingham, United Kingdom, 6NIHR Nottingham Biomedical Research Centre, Nottingham, United Kingdom

P-31 A systematic mixed methods evidence synthesis and economic modelling of a complex intervention: The EMPoWER study of effectiveness, cost-effectiveness and feasibility of powered mobility for under5s
Dr Niina Kolehmainen1,2, Ms Jennifer McAnuff1,3, Dr Louise Tanner1 , Prof Dawn Craig1 , Ms Fiona Beyer1 , Prof Jane Noyes4 , Ms Dor Wilson1 , Ms Lorna Tuersley4 , Ms Aimee Grayston3 , Prof Rhiannon Tudor Edwards4 , Dr Nathan Bray4
1Newcastle University, Newcastle Upon Tyne, United Kingdom, 2Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, United Kingdom, 3 Leeds Community NHS Healthcare Trust, Leeds, United Kingdom, 4Bangor University, Bangor, United Kingdom

P-78 Methods used in the selection of instruments for outcomes included in Core Outcome Sets
Dr Sarah L Gorst1 , Dr Cecilia A C Prinsen2 , Mr Maximilian Salcher3 , Prof Paula R Williamson1 , Dr Caroline B Terwee2
1University Of Liverpool, Liverpool, United Kingdom, 2VU University medical center, Amsterdam, The Netherlands, 3 London School of Economics and Political Science, London, United Kingdom

P-79 Developing Core Outcome Sets: what is the definition of a unique trial outcome?
Dr Amber Elizabeth Young1 , Dr Sara T Brookes2 , Dr Kerry Avery1 , Dr Anna Davies1 , Prof Chris Metcalfe3 , Prof Jane Blazeby1
1Bristol Centre for Surgical Research, Bristol Medical School, Population Health Sciences, University of Bristol, Bristol, United Kingdom, 2 Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK, 3Bristol Randomised Trials Collaboration, Population Health Sciences, University of Bristol, Bristol, UK

P-91 Parental experiences of being approached to join multiple neonatal clinical trials: a qualitative study, ‘PARENT’
Dr Judy Richards2 , Dr Judith Rankin3 , Prof. Edmund Juszczak4 , Prof Jon Stewart Dorling1 , Prof. William McGuire5 , Prof. Nicholas Embleton3
1 IWK Health Centre, Halifax, Canada, 2Department of Sociology, Newcastle University, Newcastle Upon Tyne, UK, 3 Institute of Health & Society, Newcastle University, Newcastle Upon Tyne, UK, 4NPEU Clinical Trials Unit. University of Oxford, Oxford, UK, 5Centre for Reviews and Dissemination & Hull York Medical School, University of York, York, UK

P-106 Parents’ prioritised outcomes for trials investigating treatments for paediatric severe infection: a qualitative synthesis
Dr Kerry Woolfall1 , Dr Caitlin O'Hara1 , Dr Elizabeth Deja1 , Ms Ruth Canter4 , Mr Imran Khan5 , Dr Paul Mouncey4 , Ms Anjali Carter6 , Ms Nicola Jones6 , Mr Jason Watkins6 , Dr Mark.D Lyttle7 , Dr Lyvonne Tume8 , Dr Rachel Agbeko9 , Dr Shane Tibby10, Dr John Pappachan11, Dr Kentigern Thorburn12, Prof Kathy Rowan4 , Prof Mark Peters3 , Prof David Inwald2
1University Of Liverpool, United Kingdom, 2Paediatric Intensive Care Unit, St Mary’s Hospital, United Kingdom, 3Respiratory, Critical Care and Anaesthesia Unit, University College London Great Ormond Street, Institute of Child Health, NIHR Biomedical Research Centre, , 4Clinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), United Kingdom, 5Centre of Primary Care and Public Health, Queen Mary University of London, United Kingdom, 6Patient and Public Involvement partner, United Kingdom, 7Emergency Department, Bristol Royal Hospital for Children, United Kingdom, 8 Faculty of Health and Applied Sciences, University of the West of England, United Kingdom, 9Department of Paediatric Intensive Care, Great North Children’s Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust and Institute of Cellular Medicine Newcastle University, United Kingdom, 10Paediatric intensive Care, Evelina London Children’s Hospital, St Thomas' Hospital, United Kingdom, 11Southampton Children’s Hospital, United Kingdom, 12Paediatric Intensive Care Unit, Alder Hey Children’s Hospital, United Kingdom

P-114 How qualitative methodologies can be used to address the top 10 research priorities for trial recruitment identified within the PRioRiTy study
Ms Marita Hennessy1 , Dr Andrew Hunter1 , Dr Patricia Healy1 , Dr Sandra Galvin1 , Dr Catherine Houghton1
1NUI Galway, Galway, Ireland

P-116 Identification and comparison of key criteria for allocating funding from external peer reviews, applicant feedback and applicant guidance.
Dr Kathryn Fackrell1 , Dr Katie Meadmore1 , Dr Alejandra Recio Saucedo1 , Ms Abby Bull1 , Dr Simon Fraser1,2, Ms Amanda Blatch-Jones1
1National Institute for Health Research Evaluation, Trials and Studies Coordinating Centre, University of Southampton, Southampton, United Kingdom, 2 School of Primary Care and Population Sciences, Faculty of Medicine, University of Southampton, Southampton, United Kingdom

P-117 Understanding stakeholder expectations about the peer review process
Dr Kathryn Fackrell1 , Ms Abby Bull1 , Dr Alejandra Recio Saucedo1 , Dr Katie Meadmore1 , Dr Simon Fraser1,2, Ms Amanda Blatch-Jones1
1National Institute for Health Research (NIHR) Evaluation, Trials and Studies Coordinating Centre (NETSCC), University of Southampton, Southampton, United Kingdom, 2 School of Primary Care and Population Sciences, Faculty of Medicine, University of Southampton, Southampton, United Kingdom

P-123 The value of qualitative methods in interpreting trial outcomes to inform clinical practice: understanding UPSTREAM trial participants treatment decision making for lower urinary tract symptoms
Dr Jeremy Horwood1 , Ms Clare Clement1 , Dr Cynthia Ochieng2 , Dr Amanda Lewis1 , Prof Christopher Chapple3 , Prof Paul Abrams4 , Prof Marcus J. Drake4 , Dr Lucy E. Selman1
1University Of Bristol, Bristol, United Kingdom, 2Cardiff University, Cardiff, United Kingdom , 3 Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom , 4North Bristol NHS Trust, Bristol, United Kingdom

P-130 Lessons learned from a phase II feasibility trial of Aspirin vs placebo for venous leg ulcers
Mrs Helen Tilbrook1 , Dr Rhian Gabe1 , Mrs Liz Cook1 , Prof Robert Hinchliffe2
1York Trials Unit, University of York, York, United Kingdom, 2University of Bristol, Bristol, United Kingdom

P-169 Decision-making practices used by UK and international health related funding organisations
Dr Katie Meadmore1 , Dr Kathryn Fackrell1 , Dr Alejandra Recio Saucedo1 , Ms Abby Bull1 , Dr Simon Fraser1,2, Ms Amanda Blatch-Jones1
1National Institute for Health Research Evaluation, Trials and Studies Coordinating Centre, University of Southampton, Southampton, United Kingdom, 2 School of Primary Care and Population Sciences, Faculty of Medicine, University of Southampton, Southampton, UK

P-170 Peer Review and Decision-Making in Research Funding Allocation: What are the alternatives?
Ms Amanda Jane Blatch-Jones1 , Dr Kathryn Fackrell1 , Dr Katie Meadmore1 , Dr Alex Recio Saucedo1 , Ms Abby Bull1 , Dr Simon Fraser1,2
1NIHR Evaluation Trials and Studies Coordinating Centre, Southampton, United Kingdom, 2 School of Primary Care and Population Sciences, Faculty of Medicine, University of Southampton, Southampton, United Kingdom

P-191 Baseline testing in cluster randomised controlled trials: should this be done?
Ms Jaime E Bolzern1 , Mr Alex Mitchell2 , Prof. David J Torgerson2
1Hull York Medical School, United Kingdom, 2York Trials Unit, Department of Health Sciences, University of York, United Kingdom

P-196 Improving Kaplan–Meier plots in medical research: results of the KMunicate study
Dr Tim P Morris1 , Dr Christopher I Jarvis2 , Mr William Cragg3 , Dr Patrick P J Phillips4 , Dr Babak ChoodariOskooei1 , Mr Matthew R Sydes1
1MRC Clinical Trials Unit At UCL, London, United Kingdom, 2Department of Infectious Disease Epidemiology, LSHTM, London, UK, 3Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, London, UK, 4Division of Pulmonary and Critical Care Medicine, University of California San Francisco, San Francisco, USA

P-206 Multiple imputation of missing data in clinical trials with longitudinal data: the BEEP trial as a case study
Dr Elaine Nicholls1,2, Dr Emma Healey1 , Dr Melanie Holden1,2, Mrs Stephanie Tooth2 , Ms Lorraine Watson1 , Prof. Elaine Hay1 , Prof. Nadine Foster1,2
1Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, United Kingdom, 2Keele Clinical Trials Unit, School of Primary, Community and Social Care, Keele University, United Kingdom

P-226 A realist synthesis of decision-making approaches to grant funding allocation
Dr Alejandra Recio Saucedo1 , Dr Katie Meadmore1 , Dr Kathryn Fackrell1 , Ms Abby Bull1 , Dr Simon Fraser1,2, Ms Amanda Blatch-Jones1
1National Institute for Health Research (NIHR) Evaluation, Trials And Studies Coordinating Centre, University Of Southampton, Southampton, United Kingdom, 2 School of Primary Care and Population Sciences, Faculty of Medicine, University of Southampton, Southampton, United Kingdom

P-301 Implications on sample size and power when using multi-state models to analyse pressure ulcer prevention trials
Miss Isabelle Louise Smith1 , Prof Linda Sharples2 , Prof Jane Nixon1
1CTRU, University of Leeds, United Kingdom, 2 London School of Hygiene and Tropical Medicine, United Kingdom

P-307 BiomArker-guided Duration of Antibiotic treatment in hospitalised PaTients with suspected Sepsis: the ADAPT-Sepsis Trial.
Prof Paul Dark1,2 , Mr Jonathan Guck3 , Miss Nicola McGowan3
1 Salford Royal Foundation Trust, Salford, United Kingdom, 2University of Manchester, Manchester, United Kingdom, 3Warwick Clinical Trials Unit, Coventry, United Kingdom

PS1C - O3 Developing items into questions for a new modular resource-use questionnaire
Miss Kirsty Garfield1,2, Dr Joanna Thorn1,2, Dr Sian Noble1,2, Dr Samantha Husbands 1,2, Prof. Will Hollingworth1,2
1MRC ConDuCT-II Hub for Trials Methodology Research, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom, 2Health Economics at Bristol, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom

PS2A - O2 Development of a standardised set of metrics for monitoring site performance in multicentre randomised trials: a Delphi study
Julie Turzanski1 , Diane Whitham1 , Lucy Bradshaw1 , Mike Clarke2 , Lucy Culliford3 , Lelia Duley1 , Lisa Shaw4 , Zoe Skea5 , Shaun P Treweek5 , Kate Walker1 , Paula R Williamson6 , Alan A Montgomery1 , On behalf of the Site Performance Metrics for Multicentre Randomised Trials Collaboration
1University of Nottingham, United Kingdom, 2Queen's University Belfast, United Kingdom, 3University of Bristol, United Kingdom, 4Newcastle University, United Kingdom, 5University of Aberdeen, United Kingdom, 6University of Liverpool, United Kingdom

PS3A - O3 Challenges to and facilitators of recruitment to an Alzheimer's Disease Clinical Trial: Findings and recommendations from a qualitative interview study
Ms Clare Clement1,2, Dr Lucy Selman1,2, Prof Patrick Keyhoe3 , Ms Beth Howden2 , Dr Athene Lane1,2, Dr Jeremy Horwood1,2
1Bristol Trials Centre, Bristol Medical School, University of Bristol, United Kingdom, 2Population Health Sciences, Bristol Medical School, University of Bristol, United Kingdom, 3Dementia Research Group, Translational Health Sciences, Bristol Medical School, University of Bristol, United Kingdom

PS3B - O1 DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial
Prof Jonathan A. Cook1 , Prof Steven A. Julious2 , Dr William Sones1 , Dr Lisa V. Hampson3,4, Prof Catherine Hewitt11, Dr Jesse A. Berlin5 , Prof Deborah Ashby6 , Prof Richard Emsley7 , Prof Dean A. Fergusson8 , Prof Stephen J. Walters2 , Dr Edward Wilson9 , Prof Graeme MacLennan10, Prof Nigel Stallard15, Dr Joanne C. Rothwell2 , Prof Martin Bland11, Dr Louise Brown12, Prof Craig R. Ramsay10, Dr Andrew Cook13 , Prof David Armstrong7 , Prof Doug G. Altman1 , Prof Luke D. Vale14
1University Of Oxford, Oxford, United Kingdom, 2University of Sheffield, Sheffield, United Kingdom, 3Novartis, Basel, Switzerland, 4 Lancaster University, Lancaster, United Kingdom, 5 Johnson & Johnson, Titusville, United States, 6 Imperial College London, London, United Kingdom, 7King’s College London, London, United Kingdom, 8Ottawa Hospital Research Institute, Ottawa, Canada, 9University of Cambridge, Cambridge, United Kingdom, 10University of Aberdeen, Aberdeen, United Kingdom, 11University of York, York, United Kingdom, 12UCL, London, United Kingdom, 13University of Southampton, Southampton, United Kingdom, 14Newcastle University, Newcastle, United Kingdom, 15Warwick University, Coventry, United Kingdom

PS4C - O1 Application of a Sequential Multiple Assignment Randomized Trial (SMART) Design in Older Patients with Chronic Lymphocytic Leukemia
Prof Sumithra Mandrekar1 , Dr Amy S. Ruppert2
1Mayo Clinic, Rochester, United States, 2The Ohio State University, Columbus, United States

PS7A - O1 Monitoring performance of sites within multicentre randomised trials: a systematic review of performance metrics
Kate Walker1 , Julie Turzanski1 , Diane Whitham1 , Alan Montgomery1 , Lelia Duley1
1University of Nottingham, United Kingdom

PS7A - O4 Development of a framework to improve the process of recruitment to randomised controlled trials (RCTs): the SEAR (Screened, Eligible, Approached, Randomised) framework
Dr Caroline Wilson1 , Dr Leila Rooshenas1 , Dr Sangeetha Paramasivan1 , Dr Daisy Elliott1 , Dr Marcus Jepson1 , Dr Sean Strong1 , Dr Alison Birtle2 , Dr David Beard3 , Prof Alison Halliday4 , Prof Freddie Hamdy4 , Ms Rebecca Lewis5 , Prof Chris Metcalfe1 , Prof Chris Rogers1 , Prof Rob Stein6 , Prof Jane Blazeby1 , Prof Jenny Donovan1
1Bristol Medical School, University of Bristol, Bristol, United Kingdom, 2Rosemere Cancer Centre, Royal Preston Hospital , Preston , UK, 3Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford , Oxford, UK, 4Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK, 5 Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU), Institute of Cancer Research, Sutton, London, UK, 6NIHR University College London Hospitals Biomedical Research Centre, London, UK

PS7C - O2 Introducing the extension of the CONSORT 2010 Statement for the reporting of multi-arm parallel-group randomised controlled trials
Associate Prof Ed Juszczak1 , Prof Douglas G Altman2 , Dr Sally Hopewell2 , Dr Kenneth Schulz3,4
1National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University Of Oxford, Oxford, United Kingdom, 2Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom, 3 FHI 360, Durham, USA, 4The University of North Carolina at Chapel Hill, School of Medicine, Chapel Hill, USA

PS8B - O3 Methods to Evaluate the Benefit-Risk Trade-Off in Individual Patients
Ms Ruth Owen1 , Dr John Gregson1 , Dr Shahrul Mt-Isa2 , Dr Richard Baumgartner3 , Dr Philip Urban4 , Prof. Stuart Pocock1
1Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom, 2Biostatistics and Research Decision Sciences, MSD Research Laboratories, London, United Kingdom, 3Biostatistics and Research Decision Sciences, MSD Research Laboratories, Rahway, USA, 4Division of Cardiology, Hopital de la Tour, Geneva, Switzerland

PS9A - O2 Estimating site performance (ESP): can trial managers predict which trial sites will fail to recruit? Results from an exploratory study
Dr Hanne Bruhn1 , Prof Shaun Treweek1 , Dr Anne Duncan1 , Dr Kirsty Shearer2 , Ms Karen Campbell1 , Ms Karen Innes1 , Ms Dawn McRae1 , Dr Seonaidh Cotton1
1University Of Aberdeen, Aberdeen, United Kingdom, 2NHS Grampian, Aberdeen, United Kingdom

PS9A - O5 Developing an approach to evaluate bias, conflicts of interest, and spin in clinical trials of breastmilk substitutes
Dr Bartosz Helfer1 , Dr Despo Ierodiakonou1 , Dr Vanessa Garcia-Larsen1,4, Dr Cynthia M Kroeger2 , Dr Zhaoli Dai2 , Dr Katharine Jarrold1 , Prof. Lisa Bero2 , Prof. Jo Leonardi-Bee3 , Dr Robert J Boyle1
1 Imperial College London, London, United Kingdom, 2The University of Sydney, Sydney, Australia, 3University of Nottingham, Nottingham, United Kingdom, 4 Johns Hopkins Bloomberg School of Public Health, Baltimore, United States of America

PS10C - O5 The value of including recurrent events in the analysis of cardiovascular outcomes trials
Dr John Gregson1 , Prof. Deepak Bhatt2 , Dr Lixia Jiao3 , Prof. Gregg Stone4,5, Prof. Stuart Pocock1
1Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom, 2Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, USA, 3Amarin Corporation, Bedminster, USA, 4Division of Cardiology, Columbia University Medical Center, New York, USA, 5Cardiovascular Research Foundatio, New York, USA


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