Volume 14 Supplement 1

2nd Clinical Trials Methodology Conference: Methodology Matters

Meeting abstracts

Publication of this supplement was funded by the 2nd Clinical Trials Methodology Conference.

2nd Clinical Trials Methodology Conference: Methodology Matters. Go to conference site.

Edinburgh, UK18-19 November 2013

Page 2 of 6

A novel measure of treatment benefit for an ordinal scale: a case study of the IST-1 and the IST-3 stroke trials

Authors: Douglas Thompson, William Whiteley and Gordon Murray

Citation: Trials 2013 14(Suppl 1):O48

Content type: Oral presentation

Published on: 29 November 2013
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Behavioural recovery following treatments for varicose veins: developing a measure of outcome and process

Authors: Seonaidh Cotton, Jill Francis, Denise Bolsover, Maria Prior, Graeme MacLennan and Julie Brittenden

Citation: Trials 2013 14(Suppl 1):O49

Content type: Oral presentation

Published on: 29 November 2013
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Comparing sensitivity to change of two patient-reported outcome measures in a randomised trial of patients referred for physiotherapy services

Authors: Selman Mirza, Chris Salisbury, Cherida Hopper, Nadine Foster and Alan Montgomery

Citation: Trials 2013 14(Suppl 1):O50

Content type: Oral presentation

Published on: 29 November 2013
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Minimal important change or difference for the oxford hip and knee scores following joint replacement surgery

Authors: Kristina Harris, Andrew Price, Jill Dawson, Helen Doll, David Murray, Andrew Carr and David Beard

Citation: Trials 2013 14(Suppl 1):O51

Content type: Oral presentation

Published on: 29 November 2013
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What can qualitative research do for randomised controlled trials? A systematic mapping review

Authors: Alicia O'Cathain, Kate Thomas, Sarah Drabble, Anne Rudolph and Jenny Hewison

Citation: Trials 2013 14(Suppl 1):O52

Content type: Oral presentation

Published on: 29 November 2013
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The nuts and bolts of conducting an integrated process evaluation: a presentation on the role and methods of the process evaluation integrated into a trial of a complex educational intervention for young people with diabetes (CASCADE)

Authors: Mary Sawtell and Meg Wiggins

Citation: Trials 2013 14(Suppl 1):O53

Content type: Oral presentation

Published on: 29 November 2013
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‘Keep an open mind’: using qualitative research to make recruitment easier in the by-band randomised controlled trial

Authors: Sangeetha Paramasivan, Chris Rogers, Graziella Mazza, Jane Blazeby and Jenny Donovan

Citation: Trials 2013 14(Suppl 1):O54

Content type: Oral presentation

Published on: 29 November 2013
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Intervention vignettes as a qualitative tool to refine complex intervention design

Authors: Pat Hoddinott, Heather Morgan, Gill Thomson, Nicola Crossland, Leone Craig, Jane Britten, Shelley Farrar, Rumana Newlands, Kirsty Kiezebrink and Joanne Coyle

Citation: Trials 2013 14(Suppl 1):O55

Content type: Oral presentation

Published on: 29 November 2013
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Inconsistencies in quality of life data collection in clinical trials: a potential source of bias? Interviews with research nurses and trialists

Authors: Derek Kyte, Jonathan Ives, Heather Draper, Thomas Keeley and Melanie Calvert

Citation: Trials 2013 14(Suppl 1):O56

Content type: Oral presentation

Published on: 29 November 2013
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Designing the CORONIS trial. Why a non-regular fractional factorial design?

Authors: Pollyanna Hardy, Ed Juszczak and Barbara Farrell

Citation: Trials 2013 14(Suppl 1):O57

Content type: Oral presentation

Published on: 29 November 2013
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Using a Bayesian approach with reverse philosophy to design clinical trials in rare diseases

Authors: Lucinda Billingham, Emma Hall, Clare Cruickshank, Jim Barber and Steve Nicholson

Citation: Trials 2013 14(Suppl 1):O58

Content type: Oral presentation

Published on: 29 November 2013
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Opening research sites in multicentre clinical trials within the UK: a detailed analysis of delays

Authors: Paula Williamson, Carrol Gamble, Anna Kearney and Helen Hickey

Citation: Trials 2013 14(Suppl 1):O59

Content type: Oral presentation

Published on: 29 November 2013
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A survey of facilitators and barriers to recruitment to the magnetic trial

Authors: Geetinder Kaur, Rosalind Smyth, Colin Powell and Paula Williamson

Citation: Trials 2013 14(Suppl 1):O60

Content type: Oral presentation

Published on: 29 November 2013
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Systematic techniques for assisting recruitment to trials (START): developing the science of recruitment

Authors: Jo Rick, Peter Bower, David Collier, Sandra Eldridge, Jonathan Graffy, Anne Kennedy, Peter Knapp, Adwoa Hughes-Morley, Chris Salisbury, Nicola Small, David Torgerson, Shaun Treweek and Paul Wallace

Citation: Trials 2013 14(Suppl 1):O61

Content type: Oral presentation

Published on: 29 November 2013
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A simple technique to identify key recruitment issues in randomised controlled trials: Q-QAT - quanti-qualitative appointment timing

Authors: Sangeetha Paramasivan, Sean Strong, Caroline Wilson, Jane Blazeby and Jenny Donovan

Citation: Trials 2013 14(Suppl 1):O62

Content type: Oral presentation

Published on: 29 November 2013
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Recruiters to randomised trials can be trained to facilitate recruitment and informed consent by exploring patients’ treatment preferences

Authors: Nicola Mills, Jane Blazeby, Freddie Hamdy, David Neal, Bruce Campbell and Jenny Donovan

Citation: Trials 2013 14(Suppl 1):O63

Content type: Oral presentation

Published on: 29 November 2013
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Determining items for inclusion in a decision support intervention for clinical trial participation: a modified Delphi approach

Authors: Katie Gillies, Zoe Skea, Sara MacLennan, Craig Ramsay and Marion Campbell

Citation: Trials 2013 14(Suppl 1):O64

Content type: Oral presentation

Published on: 29 November 2013
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The comet initiative

Authors: Paula Williamson

Citation: Trials 2013 14(Suppl 1):O65

Content type: Oral presentation

Published on: 29 November 2013
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Has the rheumatoid arthritis (RA) core outcome set influenced the selection of study outcome measures?

Authors: Jamie Kirkham, Maarten Boers, Peter Tugwell, Mike Clarke and Paula Williamson

Citation: Trials 2013 14(Suppl 1):O66

Content type: Oral presentation

Published on: 29 November 2013
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Collating the knowledge base for the COMET (core outcome measures in effectiveness trials) initiative - a systematic review

Authors: Elizabeth Gargon, Binu Gurung and Paula Williamson

Citation: Trials 2013 14(Suppl 1):O67

Content type: Oral presentation

Published on: 29 November 2013
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Design considerations in the development of a core outcome set

Authors: Nicola Harman, Iain Bruce, Peter Callery, Stephanie Tierney, Kevin O'Brien and Paula Williamson

Citation: Trials 2013 14(Suppl 1):O68

Content type: Oral presentation

Published on: 29 November 2013
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Recruitment to trials: insights from a meta-ethnography of qualitative studies

Authors: Sharon McCann, Marion Campbell and Vikki Entwistle

Citation: Trials 2013 14(Suppl 1):O69

Content type: Oral presentation

Published on: 29 November 2013
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Evaluating best practice in informed consent discussions: a new method of evaluating information provision and patient understanding during trial recruitment consultations

Authors: Julia Wade, Jenny Donovan, Sangeetha Paramasivan, Athene Lane, David Neal and Freddie Hamdy

Citation: Trials 2013 14(Suppl 1):O70

Content type: Oral presentation

Published on: 29 November 2013
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Involving patients in optimising RCT participant information sheets and exploring patient acceptability of clinical trials

Authors: Alba Realpe, Peter Wall, Damian Griffin, Rachel Hobson, Jenny Donovan and Ann Adams

Citation: Trials 2013 14(Suppl 1):O71

Content type: Oral presentation

Published on: 29 November 2013
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What are parents’ priorities when being invited to enter their child into a clinical trial and how far do they voice their priorities?

Authors: Bridget Young, Kerry Woolfall and Paula Williamson

Citation: Trials 2013 14(Suppl 1):O72

Content type: Oral presentation

Published on: 29 November 2013
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A multi-arm multi-stage design for binary outcomes and application to tuberculosis

Authors: Daniel Bratton, Patrick Phillips and Mahesh Parmar

Citation: Trials 2013 14(Suppl 1):O73

Content type: Oral presentation

Published on: 29 November 2013
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An integrated approach to the development of a Bayesian response-adaptive dose-finding study using sas and winbugs

Authors: Christian Holm Hansen, Christopher Weir, Pamela Warner and Hilary Critchley

Citation: Trials 2013 14(Suppl 1):O74

Content type: Oral presentation

Published on: 29 November 2013
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Implementation of adaptive dose-finding designs in two early phase haematological trials: clinical, operational, and methodological challenges

Authors: Christina Yap, Charlie Craddock, Graham Collins, Josephine Khan, Shamyla Siddique and Lucinda Billingham

Citation: Trials 2013 14(Suppl 1):O75

Content type: Oral presentation

Published on: 29 November 2013
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Prediction of recurrent stroke and myocardial infarction after stroke: a systematic review of clinical prediction models

Authors: Douglas Thompson, Gordon Murray and William Whiteley

Citation: Trials 2013 14(Suppl 1):O76

Content type: Oral presentation

Published on: 29 November 2013
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A novel adaptive trial design: randomised evaluation of molecular guided therapy for diffuse large b-cell lymphoma with bortezomib (REMODL-B) with two interim analyses to explore safety and efficacy

Authors: Tom Maishman, Louise Stanton, Andy Davies, Sharon Barrans, Lisa Worrillow, Christoph Mamot, Matt Care, Tikki Immins, Debbie Hamid, Andrew McMillan, Paul Fields, Andrew Jack and Peter Johnson

Citation: Trials 2013 14(Suppl 1):O77

Content type: Oral presentation

Published on: 29 November 2013
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Adaptive dose-finding designs to identify multiple doses that achieve multiple response targets

Authors: Simon Bond, Adrian Mander, John Todd, Linda Wicker and Frank Waldron-Lynch

Citation: Trials 2013 14(Suppl 1):O78

Content type: Oral presentation

Published on: 29 November 2013
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An ethnographic study of group decision making to understand and improve how trial steering committees contribute to trial conduct

Authors: Anne Daykin, Ali Heawood, Athene Lane, Rhiannon Macefield, Carrol Gamble, Sharon McCann, Gillian Shorter and Matthew R Sydes

Citation: Trials 2013 14(Suppl 1):O79

Content type: Oral presentation

Published on: 29 November 2013
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Evaluation of source data verification in a multicentre cancer trial (PROTECT)

Authors: J Athene Lane, Michael Davis, Elizabeth Down, Rhiannon Macefield, David Neal, Freddie Hamdy, Jenny Donovan and Hilary Taylor

Citation: Trials 2013 14(Suppl 1):O80

Content type: Oral presentation

Published on: 29 November 2013
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Should involvement in a trial be discussed at a bereavement follow up visit? Views of clinicians and bereaved parents from the bracelet study (bereavement and randomised controlled trials)

Authors: Claire Snowdon, Peter Brocklehurst, Robert Tasker, Martin Ward Platt and Diana Elbourne

Citation: Trials 2013 14(Suppl 1):O81

Content type: Oral presentation

Published on: 29 November 2013
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Issues in the design and conduct of a multicentre trial in UK ambulance services

Authors: Simon Gates, Jessica Horton, Susie Hennings and Gavin Perkins

Citation: Trials 2013 14(Suppl 1):O82

Content type: Oral presentation

Published on: 29 November 2013
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Ensuring a high response rate to patient reported outcomes in surgical trials using incentives - a trial manager perspective

Authors: Hanne Bruhn, Alison McDonald, Angus Watson and John Norrie

Citation: Trials 2013 14(Suppl 1):O83

Content type: Oral presentation

Published on: 29 November 2013
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Long-term post-trial follow-up of participants in randomised trials: lessons learned from the mrc / bhf heart protection study (HPS)

Authors: Theingi Aung, Richard Bulbulia, Louise Bowman and Jane Armitage

Citation: Trials 2013 14(Suppl 1):O84

Content type: Oral presentation

Published on: 29 November 2013
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Tailoring study design to each stage of surgical innovation: the ideal recommendations

Authors: Allison Hirst, Jonathan A Cook, Peter McCulloch, Douglas G Altman, Carl Heneghan, Markus K Diener, Patrick L Ergina, Jeffrey S Barkun, Jane M Blazeby, David J Beard, Danica Marinac-Dabic and Art Sedrakyan

Citation: Trials 2013 14(Suppl 1):O85

Content type: Oral presentation

Published on: 29 November 2013
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Accounting for intervention complexity in rcts in surgery: new approaches for intervention definition and methods for monitoring fidelity

Authors: Natalie Blencowe, Alex Boddy, Alexander Harris, Tom Hanna, Penny Whiting, Jonathan Cook and Jane Blazeby

Citation: Trials 2013 14(Suppl 1):O86

Content type: Oral presentation

Published on: 29 November 2013
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Pro’s and con’s of the stepped wedge design in cluster randomised trials of quality improvement interventions: two current examples

Authors: Tobias Dreischulte, Aileen Grant, Peter Donnan and Bruce Guthrie

Citation: Trials 2013 14(Suppl 1):O87

Content type: Oral presentation

Published on: 29 November 2013
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Parallel process evaluation using a proposed framework for the design and reporting of process evaluations for cluster-randomised trials of complex interventions

Authors: Aileen Grant, Tobias Dreischulte and Bruce Guthrie

Citation: Trials 2013 14(Suppl 1):O88

Content type: Oral presentation

Published on: 29 November 2013
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Estimating effect of intervention delivery in the evaluation of complex intervention with various levels of compliance

Authors: Baptiste Leurent, Mike Crawford, Kalaitzaki Eleftheria and Irwin Nazareth

Citation: Trials 2013 14(Suppl 1):O89

Content type: Oral presentation

Published on: 29 November 2013
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Icons: identifying continence options after stroke trial: utility of a logic model in the design and implementation of a process evaluation

Authors: Lois Thomas, Christopher Burton, Beverley French, Michael Leathley, Denise Forshaw, Christopher Sutton, Brenda Roe, Brigit Chesworth and Caroline Watkins

Citation: Trials 2013 14(Suppl 1):O90

Content type: Oral presentation

Published on: 29 November 2013
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Guidance to detect, evaluate and prevent the problem of selective reporting in trial publications

Authors: Kerry Dwan, Paula R Williamson, Carrol Gamble, Julian Higgins, Jonathan Sterne, Douglas G Altman, Mike Clarke and Jamie J Kirkham

Citation: Trials 2013 14(Suppl 1):O91

Content type: Oral presentation

Published on: 29 November 2013
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The use of systematic reviews in the planning, design and conduct of randomised trials: a retrospective cohort of NIHR HTA funded trials

Authors: Ashley Jones, Elizabeth Conroy, Paula Williamson, Mike Clarke and Carrol Gamble

Citation: Trials 2013 14(Suppl 1):O92

Content type: Oral presentation

Published on: 29 November 2013
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Assessing and improving the reliability of meta-analyses of hazard ratios derived from published time-to-event data

Authors: Jayne Tierney, David Fisher, Sarah Burdett, Lesley Stewart and Mahesh Parmar

Citation: Trials 2013 14(Suppl 1):O93

Content type: Oral presentation

Published on: 29 November 2013
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How systematic reviews and meta-analyses based on individual participant data can inform trial design and conduct

Authors: Jayne Tierney, Claire Vale, Jean-Pierre Pignon, Francois Gueffyier, Lisa Askie and Mike Clarke

Citation: Trials 2013 14(Suppl 1):O94

Content type: Oral presentation

Published on: 29 November 2013
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Randomised trial reports continue to be islands of evidence, with few continents in sight

Authors: Michael Clarke and Sally Hopewell

Citation: Trials 2013 14(Suppl 1):O95

Content type: Oral presentation

Published on: 29 November 2013
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Assessing the presence of selection bias in meta-analyses of randomised trials using baseline heterogeneity

Authors: Laura Clark, Caroline Fairhurst, Catherine Hewitt, Yvonne Birks, Sally Brabyn, Sarah Cockayne, Sara Rodgers, Katherine Hicks, Robert Hodgson, Elizabeth Littlewood and David Torgerson

Citation: Trials 2013 14(Suppl 1):O96

Content type: Oral presentation

Published on: 29 November 2013
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Sensitivity analyses for trials with missing data, assuming missing not at random mechanisms

Authors: Baptiste Leurent, Mike Crawford, Hazel Gilbert, Richard Morris, Mike Sweeting and Irwin Nazareth

Citation: Trials 2013 14(Suppl 1):O97

Content type: Oral presentation

Published on: 29 November 2013
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