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 5 of 7

“To have, to hold, from this day forward”: understanding current practice regarding the retention of trial participants

Authors: Anne Daykin, Athene Lane, Carrol Gamble, Anna Kearney, Jane Blazeby, Mike Clarke, Paula Williamson and Ali Heawood

Citation: Trials 2015 16(Suppl 2):P104

Content type: Poster presentation

Published on: 16 November 2015
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Innovative methods for optimising clinical trial recruitment and retention within primary care

Authors: Sarah Lawton and Simon Wathall

Citation: Trials 2015 16(Suppl 2):P105

Content type: Poster presentation

Published on: 16 November 2015
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The NICOLA recruitment trial (NICOLA-RT): can you improve recruitment by making zero cost amendments to the invitation letter?

Authors: Lisa Maguire, Frances Burns and Mike Clarke

Citation: Trials 2015 16(Suppl 2):P106

Content type: Poster presentation

Published on: 16 November 2015
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The NICOLA questionnaire trial (NICOLA-QT): a randomised trial of the effect of timing and mode of delivery on the completion and return of a self-assessment questionnaire

Authors: Lisa Maguire, Frances Burns and Mike Clarke

Citation: Trials 2015 16(Suppl 2):P107

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Published on: 16 November 2015
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Incentives and rewards: what do adult populations truly want? Insights from the physical activity loyalty (PAL) scheme

Authors: Helen McAneney, Ruth Hunter, Frank Kee and Mike Clarke

Citation: Trials 2015 16(Suppl 2):P108

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Published on: 16 November 2015
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Do people who choose their treatment in a large randomised trial with parallel preference groups differ at baseline from those who agree to random treatment allocation? Results from the protect study

Authors: Nicola Mills, Hanan Khazragui, Chris Metcalfe, Athene Lane, Michael Davis, Grace Young, David Neal, Freddie Hamdy and Jenny Donovan

Citation: Trials 2015 16(Suppl 2):P109

Content type: Poster presentation

Published on: 16 November 2015
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Under-representation of male patients in breast cancer studies

Authors: Pankaj Mistry, Louise Hiller, Gulnaz Iqbal and Janet Dunn

Citation: Trials 2015 16(Suppl 2):P110

Content type: Poster presentation

Published on: 16 November 2015
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Advance telephone notification of follow-up in the healthlines study: a nested study of patients with depression

Authors: Louisa Edwards, Chris Salisbury, Katy Garner, Kim Horspool, Alexis Foster and Alan Montgomery

Citation: Trials 2015 16(Suppl 2):P111

Content type: Poster presentation

Published on: 16 November 2015
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Reasons for non-participation in a randomised controlled trial and the effect of audiovisual material

Authors: Neil Nathwani, Amanda Davis, Evgenia Konstantakopoulou and Gus Gazzard

Citation: Trials 2015 16(Suppl 2):P112

Content type: Poster presentation

Published on: 16 November 2015
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Measuring patients’ experience of clinical trials: results of an exploratory review and stakeholder workshop

Authors: Claire Planner

Citation: Trials 2015 16(Suppl 2):P113

Content type: Poster presentation

Published on: 16 November 2015
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Review of an innovative approach to practical trials: the ‘cohort multiple RCT’ design

Authors: Clare Relton, Kate Thomas, Jon Nicholl and Rudolf Uher

Citation: Trials 2015 16(Suppl 2):P114

Content type: Poster presentation

Published on: 16 November 2015
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Equipoise in action: a qualitative investigation across six pragmatic randomised controlled trials (RCTs)

Authors: Leila Rooshenas, Daisy Townsend, Julia Wade, Caroline Wilson, Jane Blazeby and Jenny Donovan

Citation: Trials 2015 16(Suppl 2):P115

Content type: Poster presentation

Published on: 16 November 2015
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The trialists’ perspectives on the participant retention in mental health randomised controlled trials

Authors: Paulina Szymczynska and Stefan Priebe

Citation: Trials 2015 16(Suppl 2):P116

Content type: Poster presentation

Published on: 16 November 2015
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A systematic review of training programmes for recruiters to randomised clinical trials

Authors: Daisy Towsend, Nicola Mills, Jelena Savović and Jenny Donovan

Citation: Trials 2015 16(Suppl 2):P117

Content type: Poster presentation

Published on: 16 November 2015
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Evaluating informed consent during trial recruitment consultations: development and preliminary evaluation of a new method

Authors: Julia Wade, Daisy Townsend, Daisy Gaunt, Kerry Avery, Grace Young and Jenny Donovan

Citation: Trials 2015 16(Suppl 2):P118

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Published on: 16 November 2015
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Recruitment to oral steroids for the resolution of otitis media with effusion in children (OSTRICH) study: challenges of a randomised controlled trial in secondary care sites across Wales and England

Authors: Cherry-Ann Waldron, Emma Thomas-Jones, Debbie Harris, Vicky Shepherd, Rebecca Cannings-John, Kerry Hood, Nick Francis and Chris Butler

Citation: Trials 2015 16(Suppl 2):P119

Content type: Poster presentation

Published on: 16 November 2015
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Projection of participant recruitment to primary care research

Authors: David White and Daniel Hind

Citation: Trials 2015 16(Suppl 2):P120

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Published on: 16 November 2015
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Recruiting to an infant formula-milk feeding trial: lessons from the baby milk trial

Authors: F Whittle, K K Ong, S J Griffin and R Lakshman

Citation: Trials 2015 16(Suppl 2):P121

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Published on: 16 November 2015
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Methodology for UK recruitment into a large-scale international clinical trial

Authors: Elizabeth Wincott, Rejive Dayanandan, Richard Haynes, Michael Lay, Martin Landray and Jane Armitage

Citation: Trials 2015 16(Suppl 2):P122

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Published on: 16 November 2015
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Strategies to improve response rates to patient reported outcome measures in a surgical RCT

Authors: Jessica Wood, Hanne Bruhn, Jonathan A Cook, Alison McDonald, John Norrie and Angus J M Watson

Citation: Trials 2015 16(Suppl 2):P123

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Published on: 16 November 2015
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Calculating the design effect for a cluster stepped-wedge trial with varying cluster size; a case study from a trial in type 2 diabetes

Authors: Nuzhat Ashra, Melanie Davies, Kamlesh Khunti and Laura Gray

Citation: Trials 2015 16(Suppl 2):P124

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Published on: 16 November 2015
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Randomised controlled trials of group interventions with an individual level comparator: are appropriate statistical methods being used?

Authors: Lucy Bradshaw and Alan Montgomery

Citation: Trials 2015 16(Suppl 2):P125

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Published on: 16 November 2015
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Analysis of repeated measures of multiple surgical sites within a factorial randomised controlled trial

Authors: Gemma Clayton, Katie Pike, Gianni D Angelini and Chris A Rogers

Citation: Trials 2015 16(Suppl 2):P126

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Published on: 16 November 2015
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Variance estimation in reference based sensitivity analysis for longitudinal trials with protocol deviation

Authors: Suzie Cro, Michael Kenward and James Carpenter

Citation: Trials 2015 16(Suppl 2):P127

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Published on: 16 November 2015
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Interim sample size re-estimation in the IIVOP trial

Authors: Sarah Dawson, Mike Lee and Simon Bond

Citation: Trials 2015 16(Suppl 2):P128

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Published on: 16 November 2015
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The use of randomisation-based efficacy estimators in non-inferiority trials

Authors: David Gillespie, Kerenza Hood, Daniel Farewell, Antony Hawthorne, Chris Probert, Rachel Stenson, Peter Barrett-Lee, Angela Casbard and Nick Murray

Citation: Trials 2015 16(Suppl 2):P129

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Published on: 16 November 2015
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Analysis of the modified rankin scale in randomised controlled trials in acute stroke: a systematic review

Authors: Aimie Nunn and Laura Gray

Citation: Trials 2015 16(Suppl 2):P130

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Published on: 16 November 2015
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Identification and evaluation of novel methods for the analysis of ordinal data in acute stroke trials in comparison to ordinal logistic regression

Authors: Aimie Nunn and Laura Gray

Citation: Trials 2015 16(Suppl 2):P131

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Published on: 16 November 2015
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Stepped-wedge cluster randomised trials: where, when and why?

Authors: Michael Grayling, James Wason and Adrian Mander

Citation: Trials 2015 16(Suppl 2):P132

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Published on: 16 November 2015
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A flexible method for determining a biomarker positive population based on an efficacy target within a confirmatory study

Authors: Chris Harbron

Citation: Trials 2015 16(Suppl 2):P133

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Published on: 16 November 2015
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Assessing violations of the proportional hazards assumption in Cox regression: does the chosen method matter?

Authors: Louise Hiller, Andrea Marshall and Janet Dunn

Citation: Trials 2015 16(Suppl 2):P134

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Published on: 16 November 2015
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Practical barriers and corresponding solutions in applying interrupted time series to PUMA

Authors: Chao Huang, Colin Powell, Davina Allen, Kerry Hood, Emma Thomas-Jones, Nina Jacob, Yvonne Moriarty and Fiona Lugg

Citation: Trials 2015 16(Suppl 2):P135

Content type: Poster presentation

Published on: 16 November 2015
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An empirical evaluation of the impact of missing data on treatment effect

Authors: Royes Joseph, Julius Sim, Reuben Ogollah and Martyn Lewis

Citation: Trials 2015 16(Suppl 2):P136

Content type: Poster presentation

Published on: 16 November 2015
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Statistical inference in randomized consent designs in the presence of Hawthorne

Authors: Kyungmann Kim

Citation: Trials 2015 16(Suppl 2):P137

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Published on: 16 November 2015
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Time-to-event studies: how robust are inferences when the assumption of independent censoring is in doubt?

Authors: Martin Law and Dan Jackson

Citation: Trials 2015 16(Suppl 2):P138

Content type: Poster presentation

Published on: 16 November 2015
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Analysis and reporting of individually randomised controlled trials with clustering in one arm only: how should we do it?

Authors: Stephen Walters, Ellen Lee, Laura Flight, Laura Mandefield, Munya Dimario and Annabel Allison

Citation: Trials 2015 16(Suppl 2):P139

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Published on: 16 November 2015
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Bias of complete-case analysis of williams square crossover designs when data are missing not at random

Authors: Sofia Bazakou, Robin Henderson, Linda Sharples and John Matthews

Citation: Trials 2015 16(Suppl 2):P140

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Published on: 16 November 2015
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Analysis techniques in the presence of non-proportional hazards (PH); application to an ovarian cancer RCT with long-term follow-up

Authors: James Morden, Judith Bliss and Rosalind Eeles

Citation: Trials 2015 16(Suppl 2):P141

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Published on: 16 November 2015
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Mixed effects approach to the analysis of the stepped wedge cluster randomised trial - accounting for the confounding effect of time

Authors: Alecia Nickless, Merryn Voysey and Ly-Mee Yu

Citation: Trials 2015 16(Suppl 2):P142

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Published on: 16 November 2015
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The use of multiple imputation (MI) in cluster randomised trials with suspected missing not at random (MNAR) outcome

Authors: Rebecca Playle, Elinor Coulman, Dunla Gallagher and Sharon Simpson

Citation: Trials 2015 16(Suppl 2):P143

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Published on: 16 November 2015
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Dynamic prediction methods in the BC2001 clinical trial

Authors: Nuria Porta, M Luz Calle, Rebecca Lewis, Michelle Snape, Carey Hendron, Nicholas James, Robert Huddart and Emma Hall

Citation: Trials 2015 16(Suppl 2):P144

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Published on: 16 November 2015
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Correcting for selection bias in two-stage trials with multiple correlated outcomes: application to seamless phase ii/iii clinical trials

Authors: David Robertson, A Toby Prevost and Jack Bowden

Citation: Trials 2015 16(Suppl 2):P145

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Published on: 16 November 2015
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A novel approach for obtaining a near complete dataset for time-to-event outcomes in the bronchiolitis of infancy discharge study (BIDS) using an informed multiple imputation technique

Authors: Aryelly Rodriguez and Steff Lewis

Citation: Trials 2015 16(Suppl 2):P146

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Published on: 16 November 2015
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Estimating the effect of “treatment in the treated” - instrumental variable analysis vs conventional regression methods in the titre-2 trial in cardiac surgery

Authors: Chris Rogers, Katie Pike, Jonathan Sterne and Barney Reeves

Citation: Trials 2015 16(Suppl 2):P147

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Published on: 16 November 2015
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Adaptive designs for phase II cross-over dose-finding trials using Bayesian model averaging

Authors: Sarah Simpson, Lisa Hampson, Thomas Jaki and Byron Jones

Citation: Trials 2015 16(Suppl 2):P148

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Published on: 16 November 2015
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Challenges in the design and analysis of a factorial-design cluster randomised trial

Authors: Jacqueline Stephen, Robert Lee, Kalliopi Kydonaki, Jean Antonelli, Timothy S Walsh and Christopher J Weir

Citation: Trials 2015 16(Suppl 2):P149

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Published on: 16 November 2015
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Managing non-proportionality of hazards (PH) within TNT: a randomised phase III trial of carboplatin compared to docetaxel for patients with metastatic or recurrent locally advanced triple negative (TN) or brca1/2 breast cancer (BC)

Authors: Holly Tovey, Judith Bliss, Andrew Tutt, James Morden, Katy Jarman, Sue Martin, Sarah Kernaghan, Christy Toms and Lucy Kilburn

Citation: Trials 2015 16(Suppl 2):P150

Content type: Poster presentation

Published on: 16 November 2015
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The potential of the multivariate multilevel model for analysing correlated multiple outcomes: a simulation study

Authors: Victoria Vickerstaff, Gareth Ambler and Rumana Z Omar

Citation: Trials 2015 16(Suppl 2):P151

Content type: Poster presentation

Published on: 16 November 2015
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Structured exploration of clinical trials data - finding the middle way

Authors: James Weatherall

Citation: Trials 2015 16(Suppl 2):P152

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Published on: 16 November 2015
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Handling drop-outs which imply a change of treatment: an evaluation of reference-based imputation

Authors: Ian White, Royes Joseph and Nicky Best

Citation: Trials 2015 16(Suppl 2):P153

Content type: Poster presentation

Published on: 16 November 2015
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