Volume 16 Supplement 2

3rd International Clinical Trials Methodology Conference

Meeting abstracts

Publication of this supplement was funded by the 3rd Clinical Trials Methodology Conference.

3rd International Clinical Trials Methodology Conference. Go to conference site.

Glasgow, UK16-17 November 2015

Concatenated PDF V16 S2

Page 2 of 7

Is over recruitment to a single site problematic for surgical trials?

Authors: David Beard, Andrew Price, David Murray, Loretta Davies, Cushla Cooper and Jonathan Cook

Citation: Trials 2015 16(Suppl 2):O48

Content type: Oral presentation

Published on: 16 November 2015
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Improving efficiency of on-site monitoring in multicentre clinical trials by targeting visits

Authors: Carol Knott, Elsa Valdes-Marquez, Martin Landray, Jane Armitage and Jemma Hopewell

Citation: Trials 2015 16(Suppl 2):O49

Content type: Oral presentation

Published on: 16 November 2015
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The role of an in-house audit group as an innovative tool to review clinical trials

Authors: Shivali Trivedi, Krishna Hathi, Natasha Aslam, Nausheen Saleem, Kylie Gyertson and Jeremy Whelan

Citation: Trials 2015 16(Suppl 2):O50

Content type: Oral presentation

Published on: 16 November 2015
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Blindingly obvious (once revealed): a novel approach to blinding medicinal products for injection

Authors: Julia Sanders, Julia Townson and Nadine Aawar

Citation: Trials 2015 16(Suppl 2):O51

Content type: Oral presentation

Published on: 16 November 2015
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How was it for you? - obtaining feedback from staff at study sites for the HPS2-thrive trial

Authors: Christopher Bray, Elizabeth Wincott, Carol Knott, Martin Landray and Jane Armitage

Citation: Trials 2015 16(Suppl 2):O52

Content type: Oral presentation

Published on: 16 November 2015
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Investigation of the shortcomings of the consort 2010 statement for the reporting of group sequential randomised controlled trials

Authors: Munyaradzi Dimairo, Abigail Stevely, Susan Todd, Steven Julious, Jonathan Nicholl, Daniel Hind and Cindy Cooper

Citation: Trials 2015 16(Suppl 2):O53

Content type: Oral presentation

Published on: 16 November 2015
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Methods for evaluating innovative surgery: a nested ideal phase 2 study within an external randomised pilot (the ROMIO trial)

Authors: Jane Blazeby, Richard Berrisford, Dan Titcomb, Andrew Hollowood, Grant Sanders, Christopher Streets, Tim Wheatley, Kerry Avery, George Hanna, Chris Metcalfe and Paul Barham

Citation: Trials 2015 16(Suppl 2):O54

Content type: Oral presentation

Published on: 16 November 2015
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A systematic review of the use of an expertise-based randomised trial design

Authors: Jonathan Cook, Andrew Elders, Charles Boachie, Ted Bassigna, Cynthia Fraser, Doug Altman, Isabelle Boutron, Craig Ramsay and Graeme Maclennan

Citation: Trials 2015 16(Suppl 2):O55

Content type: Oral presentation

Published on: 16 November 2015
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A framework for the design and analysis of phase III randomised trials in uncommon diseases

Authors: Mahesh Parmar, Tim Morris and Matthew Sydes

Citation: Trials 2015 16(Suppl 2):O56

Content type: Oral presentation

Published on: 16 November 2015
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Design of the myechild trial, an international randomised phase III clinical trial in children with acute myeloid leukaemia incorporating an embedded dose finding study

Authors: Aimee Houlton, Brenda Gibson and Keith Wheatley

Citation: Trials 2015 16(Suppl 2):O57

Content type: Oral presentation

Published on: 16 November 2015
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Comparison of a frequentist and Bayesian response-adaptive randomisation approach in multi-stage phase II selection trials with multiple experimental arms

Authors: Christina Yap, Xuejing Lin and Ken Cheung

Citation: Trials 2015 16(Suppl 2):O58

Content type: Oral presentation

Published on: 16 November 2015
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Introducing personalised risk based intervals in screening for diabetic retinopathy: development, implementation and assessment of safety, cost-effectiveness and patient experience (ISDR): a case study in the use of automated systems in trials

Authors: Duncan Appelbe, Deborah Broadbent, Mehrdad Mobayen-Rahni, Antonio Eleuteri, Abigail Bennett, Tracy Moitt, Amu Wang, Marta García-Fiñana, Anthony Fisher and Simon Harding

Citation: Trials 2015 16(Suppl 2):O59

Content type: Oral presentation

Published on: 16 November 2015
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Video adjudication in clinical trials: enabling distribution of expertise and accurate scoring

Authors: Alan Stevenson, Sharon Kean and David Cowan

Citation: Trials 2015 16(Suppl 2):O60

Content type: Oral presentation

Published on: 16 November 2015
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Experience from creating electronic systems with generic endpoint review and adjudication flows

Authors: Jane Aziz, Sharon Kean, Ernest Edifor and Eleanor Dinnett

Citation: Trials 2015 16(Suppl 2):O61

Content type: Oral presentation

Published on: 16 November 2015
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Design, validity and clinical utility of smartphone app to assess short-term pain trajectories

Authors: John Bedson, Kate Dunn, Stephen Dent and Danielle van der Windt

Citation: Trials 2015 16(Suppl 2):O62

Content type: Oral presentation

Published on: 16 November 2015
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A better participant experience using sms for real time data collection

Authors: Jamie Garner and Rhiannon Whitaker

Citation: Trials 2015 16(Suppl 2):O63

Content type: Oral presentation

Published on: 16 November 2015
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Development and evaluation of an electronic diary for recording patient reported outcomes in the overt study

Authors: Duncan Appelbe, Oluseun Adeogun, Nicholas Webb, Rabiya Majeed, Malcom Lewis and Paula Williamson

Citation: Trials 2015 16(Suppl 2):O64

Content type: Oral presentation

Published on: 16 November 2015
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Evaluating the use of real-time data collection using SMS texts in the SIMS study

Authors: Tracey Davidson, Alison McDonald, Gladys McPherson and John Norrie

Citation: Trials 2015 16(Suppl 2):O65

Content type: Oral presentation

Published on: 16 November 2015
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Data sharing in clinical trials - practical guidance on anonymising trial datasets

Authors: Christopher Tuck, Steff Lewis, Garry Milne, Sandra Eldridge and Neil Wright

Citation: Trials 2015 16(Suppl 2):O66

Content type: Oral presentation

Published on: 16 November 2015
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Supporting clinical trials through healthcare informatics

Authors: Claire Jones, Emily Jefferson, Fiona Hogarth, Roberta Littleford and Margaret Band

Citation: Trials 2015 16(Suppl 2):O67

Content type: Oral presentation

Published on: 16 November 2015
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Challenges of linking to routine healthcare records in UK Biobank

Authors: Ligia Adamska, Naomi Allen, Robin Flaig, Cathie Sudlow, Michael Lay and Martin Landray

Citation: Trials 2015 16(Suppl 2):O68

Content type: Oral presentation

Published on: 16 November 2015
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Are we getting the whole picture? Measuring outcomes using routinely collected data in long term follow-up: an example from BB:2-6

Authors: Rebecca Cannings-John, Fiona Lugg, Michael Robling and Gwenllian Moody

Citation: Trials 2015 16(Suppl 2):O69

Content type: Oral presentation

Published on: 16 November 2015
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Managing the morass. Lessons learned from establishing a data linkage model for long-term follow up of a trial cohort using routine health and education data

Authors: Fiona Lugg, Rebecca Cannings-John, Gwenllian Moody and Mike Robling

Citation: Trials 2015 16(Suppl 2):O70

Content type: Oral presentation

Published on: 16 November 2015
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Can we reduce bias in open-label trials when blinded outcome assessment is not possible? An example from the trigger trial

Authors: Brennan Kahan and Vipul Jairath

Citation: Trials 2015 16(Suppl 2):O71

Content type: Oral presentation

Published on: 16 November 2015
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Selective reporting in clinical trials - an examination of discrepancy rates in pre-specified and reported outcomes in articles submitted to the BMJ

Authors: Jennifer Weston, Kerry Dwan, Douglas Altman, Mike Clarke, Carrol Gamble, Trish Groves, Sara Schroter, Paula Williamson and Jamie Kirkham

Citation: Trials 2015 16(Suppl 2):O72

Content type: Oral presentation

Published on: 16 November 2015
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What is the effect of patient-reported outcome (PRO) item order on prioritisation of PROs in the development of a core outcome set?

Authors: Katy Chalmers, Kerry Avery, Karen Coulman, Natalie Blencowe, Rhiannon Macefield, Chris Metcalfe, Jane Blazeby and Sara Brookes

Citation: Trials 2015 16(Suppl 2):O73

Content type: Oral presentation

Published on: 16 November 2015
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Using existing trial data to inform the development of core outcome sets and improve efficiencies in research

Authors: Kim S Thomas, Lucy Bradshaw, Alan A Montgommery, Nick A Francis, Matthew J Ridd and Miriam Santer

Citation: Trials 2015 16(Suppl 2):O74

Content type: Oral presentation

Published on: 16 November 2015
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Rapid recruitment of large cohort to support trials in general practice: the role of FARSITE

Authors: Peter Bower, Kelly Howells, Sheila McCorkindale, Lucy Bridges and Mark Sidaway

Citation: Trials 2015 16(Suppl 2):O75

Content type: Oral presentation

Published on: 16 November 2015
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Optimising participation and generalisability: the use of opt-out recruitment for an implementation trial in primary care

Authors: Suzanne Hartley, Paul Carder, Robbie Foy, Peter Heudtlass, Liz Glidewell, Emma Ingleson, Stella Johnson, Paul Lord, Tom Willis and Amanda Farrin

Citation: Trials 2015 16(Suppl 2):O76

Content type: Oral presentation

Published on: 16 November 2015
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Recruitment to clinical trials - the use of social media

Authors: Will Storrar, Thomas Brown, Lara Balls, Anoop Chauhan and Carole Fogg

Citation: Trials 2015 16(Suppl 2):O77

Content type: Oral presentation

Published on: 16 November 2015
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Randomized controlled trials: who fails run-in?

Authors: Judy R Rees, Leila A Mott, Elizabeth L Barry, John A Baron and Janet L Peacock

Citation: Trials 2015 16(Suppl 2):O78

Content type: Oral presentation

Published on: 16 November 2015
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Testosterone replacement in young male cancer survivors (TRYMS) - pragmatic adaptation of trial design for a trial struggling with recruitment

Authors: Isabelle Smith, Jayne Swain, Helen Marshall, Alexandra Smith, Jennifer Walsh, Richard Ross and Sarah Brown

Citation: Trials 2015 16(Suppl 2):O79

Content type: Oral presentation

Published on: 16 November 2015
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Learning more from exploratory trials of complex interventions: exploiting the complexity of complex interventions to empirically optimise the content and delivery of intervention packages for evaluation in a confirmatory trial

Authors: Rebecca Walwyn, Steven Gilmour, Amanda Farrin and Allan House

Citation: Trials 2015 16(Suppl 2):O80

Content type: Oral presentation

Published on: 16 November 2015
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Do pragmatic trials trade-off internal validity for external validity?

Authors: Kirsty Loudon, Merrick Zwarenstein, Frank Sullivan, Peter Donnan and Shaun Treweek

Citation: Trials 2015 16(Suppl 2):O81

Content type: Oral presentation

Published on: 16 November 2015
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Designing, implementing and analysing a virtual trial

Authors: Lauren J Scott, Barnaby C Reeves, Usha Chakravarthy and Chris A Rogers

Citation: Trials 2015 16(Suppl 2):O82

Content type: Oral presentation

Published on: 16 November 2015
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Evaluating statistical characteristics of biomarker-guided trial designs

Authors: Miranta Antoniou, Andrea Jorgensen and Ruwanthi Kolamunnage-Dona

Citation: Trials 2015 16(Suppl 2):O83

Content type: Oral presentation

Published on: 16 November 2015
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Type I error control in biomarker-stratified clinical trials

Authors: Deepak Parashar, Jack Bowden, Colin Starr, Lorenz Wernisch and Adrian Mander

Citation: Trials 2015 16(Suppl 2):O84

Content type: Oral presentation

Published on: 16 November 2015
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Combining multiple predictive markers in stratified medicine

Authors: Richard Emsley, Matthias Pierce and Graham Dunn

Citation: Trials 2015 16(Suppl 2):O85

Content type: Oral presentation

Published on: 16 November 2015
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Prediction of treatment benefit in high-dimensional cox models via gene signatures in randomized clinical trials

Authors: Nils Ternès, Federico Rotolo, Georg Heinze and Stefan Michiels

Citation: Trials 2015 16(Suppl 2):O86

Content type: Oral presentation

Published on: 16 November 2015
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Defining feasibility and pilot studies in preparation for randomised controlled trials: using consensus methods and validation to develop a conceptual framework

Authors: Sandra Eldridge, Christine Bond, Mike Campbell, Sally Hopewell, Lehana Thabane, Gill Lancaster and Claire Coleman

Citation: Trials 2015 16(Suppl 2):O87

Content type: Oral presentation

Published on: 16 November 2015
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Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers

Authors: Alicia O'Cathain, Pat Hoddinott, Simon Lewin, Kate Thomas, Bridget Young, Joy Adamson, Yvonne Jansen, Nicola Mills, Graham Moore and Jenny Donovan

Citation: Trials 2015 16(Suppl 2):O88

Content type: Oral presentation

Published on: 16 November 2015
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Recruitment progression rules for internal pilot studies monitoring recruitment

Authors: Lisa Hampson, Paula Williamson, Martin Wilby and Thomas Jaki

Citation: Trials 2015 16(Suppl 2):O89

Content type: Oral presentation

Published on: 16 November 2015
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Statistical challenges in assessing potential efficacy of complex interventions in pilot or feasibility studies

Authors: Duncan T Wilson, Rebecca E A Walwyn, Julia Brown, Amanda J Farrin and Sarah R Brown

Citation: Trials 2015 16(Suppl 2):O90

Content type: Oral presentation

Published on: 16 November 2015
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Assessing the impact of patient and public involvement on recruitment and retention in clinical trials: a systematic review

Authors: Joanna Crocker, Adwoa Hughes-Morley, Sophie Petit-Zeman and Sian Rees

Citation: Trials 2015 16(Suppl 2):O91

Content type: Oral presentation

Published on: 16 November 2015
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Developing a toolkit for patient and public involvement in a clinical trials unit

Authors: Heather Bagley, Nicola Harman, Kerry Woolfall, Bridget Young, Hannah Short, Helen Hickey and Paula Williamson

Citation: Trials 2015 16(Suppl 2):O92

Content type: Oral presentation

Published on: 16 November 2015
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Realising the potential of patient and public involvement to make a difference: what can trial teams do?

Authors: Bridget Young, Louise Dudley, Paula Williamson and Carrol Gamble

Citation: Trials 2015 16(Suppl 2):O93

Content type: Oral presentation

Published on: 16 November 2015
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Novel patient engagement and recruitment strategies for an RCY of two NHS treatments for ankle osteoarthritis - total ankle replacement versus arthrodesis - the TARVA trial

Authors: Andy Goldberg, Claire Thomson, Deirdre Brooking, Elin Rees, Marion Cumbers, Michelle Tetlow, Simon Skene and Suzie Cro

Citation: Trials 2015 16(Suppl 2):O94

Content type: Oral presentation

Published on: 16 November 2015

The Erratum to this article has been published in Trials 2016 17:109
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Improving health in children with disabilities: an intervention-development study to support participation in leisure in 8-12 year olds with communication and mobility limitations

Authors: Jennifer McAnuff, Allan Colver, Tim Rapley and Niina Kolehmainen

Citation: Trials 2015 16(Suppl 2):P1

Content type: Poster presentation

Published on: 16 November 2015
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Using results from a UK-wide survey to justify choice of comparator for the treatment of severe chronic hand eczema

Authors: Isabelle Smith, Sarah Brown, Jane Nixon and Miriam Wittmann

Citation: Trials 2015 16(Suppl 2):P2

Content type: Poster presentation

Published on: 16 November 2015
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What can we learn from experience? Impact of healthcare provider effects in the total or partial knee arthroplasty trial (TOPKAT)

Authors: Jonathan Cook, Graeme MacLennan, David Murray, Andrew Price, Ray Fitzpatrick, Andrew Carr, Marion Campbell, Helen Campbell, Nigel Arden, Cushla Cooper, Loretta Davies and David Beard

Citation: Trials 2015 16(Suppl 2):P3

Content type: Poster presentation

Published on: 16 November 2015
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