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 3 of 6

A comparison of multiple imputation methods for bivariate hierarchical data: an application to cost-effectiveness analyse

Authors: K Diaz-Ordaz, M Gomes, R Grieve and MG Kenward

Citation: Trials 2013 14(Suppl 1):O98

Content type: Oral presentation Published on: 29 November 2013
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Simplification or simulation: some unclear issues in sample size calculation

Authors: Chao Huang

Citation: Trials 2013 14(Suppl 1):O100

Content type: Oral presentation Published on: 29 November 2013
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A framework to assess the impact of applying formal criteria to check clinical relevance on top of statistical significance

Authors: Werner Vach and Beryl Primrose Gladstone

Citation: Trials 2013 14(Suppl 1):O101

Content type: Oral presentation Published on: 29 November 2013
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Statistical analysis plans (SAPS) for academic clinical trials at the edinburgh clinical trials unit: what should they contain?

Authors: Aryelly Rodriguez, Steff Lewis, Gordon Murray, Ashma Krishan, Isabella Butcher and Christopher Weir

Citation: Trials 2013 14(Suppl 1):O102

Content type: Oral presentation Published on: 29 November 2013
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An adaptive biomarker strategy clinical trial design

Authors: James Wason, Nigel Stallard, Janet Dunn and Rob Stein

Citation: Trials 2013 14(Suppl 1):O103

Content type: Oral presentation Published on: 29 November 2013
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Risk stratification in clinical trials: a subgroup to be encouraged

Authors: Tim Clayton and Stuart Pocock

Citation: Trials 2013 14(Suppl 1):O104

Content type: Oral presentation Published on: 29 November 2013
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Level of evidence for promising subgroup findings in a negative trial

Authors: Julien Tanniou, Ingeborg van der Tweel and Kit Roes

Citation: Trials 2013 14(Suppl 1):O105

Content type: Oral presentation Published on: 29 November 2013
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Simulation modelling to identify optimal monitoring strategies: the use of the elf biomarker in liver disease monitoring

Authors: Alice Sitch, Jac Dinnes, Julie Parkes, Walter Gregory, Jenny Hewison, Doug Altman and Jon Deeks

Citation: Trials 2013 14(Suppl 1):O106

Content type: Oral presentation Published on: 29 November 2013
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Follow up after sample size re-estimation in a breast cancer trial for time to recurrence

Authors: Erinn Hade, Gregory Young, David Jarjoura and Richard Love

Citation: Trials 2013 14(Suppl 1):O107

Content type: Oral presentation Published on: 29 November 2013
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Sample size formula for joint modelling of longitudinal and time-to-event data in clinical trials

Authors: Matthew Powney, Paula Williamson and Ruwanthi Kolamunnage-Dona

Citation: Trials 2013 14(Suppl 1):O108

Content type: Oral presentation Published on: 29 November 2013
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A nested randomised controlled trial of a leaflet, containing information on research, to increase the recruitment rate of reform (reducing falls with orthoses and a multifaceted podiatry) trial participants

Authors: Catherine Arundel, David Torgerson, Laura Jefferson and Sarah Cockayne

Citation: Trials 2013 14(Suppl 1):O109

Content type: Oral presentation Published on: 29 November 2013
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Trainee led research networks in the implementation and delivery of multicentre randomised trials: a model from the west midlands research collaborative

Authors: Aneel Bhangu, Thomas Pinkney, Laura Magill and Dion Morton

Citation: Trials 2013 14(Suppl 1):O110

Content type: Oral presentation Published on: 29 November 2013
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Approaches to participant recruitment and predictors of retention in a large community based public health trial: findings from the building blocks trial

Authors: Eleri Owen-Jones, Mike Robling, Julia Sanders, Rebecca Cannings-John and Gwenllian Moody

Citation: Trials 2013 14(Suppl 1):O111

Content type: Oral presentation Published on: 29 November 2013
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Comparison of recruitment yield in prevention and therapy trials

Authors: Cindy Cooper, Adjoa Asante, Danny Hind and Stephen Walyers

Citation: Trials 2013 14(Suppl 1):O112

Content type: Oral presentation Published on: 29 November 2013
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Recruitment and retention in internet based randomised trials

Authors: Gillian W Shorter and Finola Ferry

Citation: Trials 2013 14(Suppl 1):O113

Content type: Oral presentation Published on: 29 November 2013
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Can we recruit to expertise trials? Experience from the total or partial knee arthroplasty trial (TOPKAT)

Authors: Loretta Davies, Cushla Cooper and David Beard

Citation: Trials 2013 14(Suppl 1):O114

Content type: Oral presentation Published on: 29 November 2013
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Covariance modelling for randomised controlled trials

Authors: Gilbert MacKenzie

Citation: Trials 2013 14(Suppl 1):O115

Content type: Oral presentation Published on: 29 November 2013
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Using continuous data on tumour measurements to improve inference in phase II cancer studies

Authors: James Wason and Shaun Seaman

Citation: Trials 2013 14(Suppl 1):O116

Content type: Oral presentation Published on: 29 November 2013
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Comparing active treatments at phase II: using multiple criteria to find the optimal treatment to take forward to phase III

Authors: Michael Sweeting and Martin Law

Citation: Trials 2013 14(Suppl 1):O117

Content type: Oral presentation Published on: 29 November 2013
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Using meta-analysis of Phase II trials to predict Phase III trial results

Authors: Danielle Burke, Lucinda Billingham, Alan Girling and Richard Riley

Citation: Trials 2013 14(Suppl 1):O118

Content type: Oral presentation Published on: 29 November 2013
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Trichotomous prognosis-based outcome analysis: an efficient and clinically relevant method for analysis of acute stroke trials

Authors: David Barer, Eivind Berge and Else Charlotte Sandset

Citation: Trials 2013 14(Suppl 1):O119

Content type: Oral presentation Published on: 29 November 2013
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Modelling residual disease volume and re-growth rates from response durations to aid in cancer trial design, interpretation and analysis, with a particular focus on breast cancer

Authors: Walter Gregory, Helen Marshall, David Cameron, Christopher Twelves, Richard Bell and Robert Coleman

Citation: Trials 2013 14(Suppl 1):O120

Content type: Oral presentation Published on: 29 November 2013
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Trial forge: a systematic approach to making trials more efficient

Authors: Shaun Treweek

Citation: Trials 2013 14(Suppl 1):O121

Content type: Oral presentation Published on: 29 November 2013
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A systematic review of methods for specifying the target difference in randomised controlled trials (delta review)

Authors: Jonathan Cook, Jenni Hislop, Temitope Adewuyi, Kirsten Harrild, Cynthia Fraser, Doug Altman, Craig Ramsay, Peter Fraser, Andrew Briggs, John Norrie, Ian Harvey, Brian Buckley and Luke Vale

Citation: Trials 2013 14(Suppl 1):O122

Content type: Oral presentation Published on: 29 November 2013
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Design, analysis and reporting of active-control randomised trials: a systematic review

Authors: Lang'o Odondi, Chris Metcalfe and Jonathan Sterne

Citation: Trials 2013 14(Suppl 1):O123

Content type: Oral presentation Published on: 29 November 2013
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Methodological, planning and implementation challenges for rcts evaluating group interventions

Authors: Daniel Hind, Chris Roberts, Kirsty Sprange, Rebecca Gossage-Worrall, Cindy Cooper and Stephen Walters

Citation: Trials 2013 14(Suppl 1):O124

Content type: Oral presentation Published on: 29 November 2013
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Methodological challenges designing pragmatic, multi-centre randomised controlled trials in critical care

Authors: Graeme MacLennan, Marion Campbell and John Norrie

Citation: Trials 2013 14(Suppl 1):O125

Content type: Oral presentation Published on: 29 November 2013
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Measuring the impact of methodological research at the medical research council clinical trials unit hub for trials methodology research

Authors: Valerie Brueton, Claire Vale, Rachel Jinks, Babak Oskooei and Jayne Tierney

Citation: Trials 2013 14(Suppl 1):O126

Content type: Oral presentation Published on: 29 November 2013
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Simulation as a practical and versatile tool for sample size calculation

Authors: Richard Hooper

Citation: Trials 2013 14(Suppl 1):O99

Content type: Oral presentation Published on: 29 November 2013
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Is innovation in surgery less than ideal? A case study of acellular dermal matrix assisted prosthetic breast reconstruction

Authors: Shelley Potter, Danielle Browning, Jelena Savovic, Rob Warr, Simon Cawthorn and Jane Blazeby

Citation: Trials 2013 14(Suppl 1):P1

Content type: Poster presentation Published on: 29 November 2013
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Time to be brave: is educating surgeons the key to unlocking the potential of randomized clinical trials in surgery? A qualitative study

Authors: Shelley Potter, Nicola Mills, Simon Cawthorn and Jane Blazeby

Citation: Trials 2013 14(Suppl 1):P2

Content type: Poster presentation Published on: 29 November 2013
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Understanding the complexity of surgical interventions in rcts: the role of process evaluation in the operating theatre

Authors: Natalie Blencowe, Nicola Mills, Jenny Donovan and Jane Blazeby

Citation: Trials 2013 14(Suppl 1):P3

Content type: Poster presentation Published on: 29 November 2013
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Assessing fidelity to complex interventions: the icons experience

Authors: Brigit Chesworth, Michael Leathley, Lois Thomas, Denise Forshaw, Chris Sutton, Bev French, Chris Burton, David Britt, Brenda Roe, Francine Cheater and Caroline Watkins

Citation: Trials 2013 14(Suppl 1):P4

Content type: Poster presentation Published on: 29 November 2013
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Multi-level case studies in development of complex interventions: an example of the good goals intervention

Authors: Niina Kolehmainen, Graeme MacLennan, Laura Ternent, Edward AS Duncan, Eilidh M Duncan, Stephen B Ryan, Lorna McKee and Jill Francis

Citation: Trials 2013 14(Suppl 1):P5

Content type: Poster presentation Published on: 29 November 2013
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Causal inference techniques for trials of complex interventions

Authors: Sabine Landau

Citation: Trials 2013 14(Suppl 1):P6

Content type: Poster presentation Published on: 29 November 2013
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Defining ‘usual care' in trials of complex interventions

Authors: Julia Sanders, Marie-Jet Bekkers, Rebecca Cannings-John, Sue Channon and Mike Robling

Citation: Trials 2013 14(Suppl 1):P7

Content type: Poster presentation Published on: 29 November 2013
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Developing an intervention to support lung cancer patients and their clinicians when considering systemic anti-cancer therapy: pact study

Authors: Annmarie Nelson, Stephanie Sivell, Simon Noble, Anthony Byrne and Jason Lester

Citation: Trials 2013 14(Suppl 1):P8

Content type: Poster presentation Published on: 29 November 2013
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‘Once I knew there was a choice, I wanted to exercise that choice': using qualitative methods to understand why patients decline surgical trials

Authors: Emily Harrop, John Kelly, David Neal, Prokar Dasgupta, Gillian Basnett, Robert Huddart, Allan Barham, Colin Thompson, Angela Casbard, Hala Jundi, Gareth Griffiths and Annmarie Nelson

Citation: Trials 2013 14(Suppl 1):P9

Content type: Poster presentation Published on: 29 November 2013
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Effects of an optimised POCT guided diagnostic and treatment strategy for symptoms of uncomplicated UTI on use of appropriate antibiotics and uptake into primary care practice

Authors: Janine Bates, Emma Thomas-Jones, Nigel Kirby, Tim Pickles, Rhys Thomas, Emily Bongard, Micaela Gal, Paul Little, Theo Verheij, Carlos Llor, David Cohen, Nick Francis, Kerry Hood and Christopher Butler

Citation: Trials 2013 14(Suppl 1):P10

Content type: Poster presentation Published on: 29 November 2013
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Accounting for the placebo effect of surgery in surgical trials?

Authors: David Beard, Cushla Cooper, Ines Rombach, Jon Rees, Karolina Wartolowska, Naomi Cummings and Andrew Carr

Citation: Trials 2013 14(Suppl 1):P11

Content type: Poster presentation Published on: 29 November 2013
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Potential role of “the compensating benefit” in claiming non-inferiority

Authors: Primrose Beryl and Werner Vach

Citation: Trials 2013 14(Suppl 1):P12

Content type: Poster presentation Published on: 29 November 2013
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The process of stopping recruitment and trial treatment in a trial of a psychological therapy for people with personality disorder following a safety alert

Authors: Florence Day, Mary McMurran and Lelia Duley

Citation: Trials 2013 14(Suppl 1):P13

Content type: Poster presentation Published on: 29 November 2013
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How well documented are testing strategies and outcome measurement methods in trials of tests? A comparison of reporting quality in test-treatment and monitoring RCTS

Authors: Jac Dinnes, Lavinia Ferrante di Ruffano, Alice Sitch, Julie Parkes, Jenny Hewison, Doug Altman and Jon Deeks

Citation: Trials 2013 14(Suppl 1):P14

Content type: Poster presentation Published on: 29 November 2013
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Stepped-wedge cluster randomised controlled trials: some variations on the common design

Authors: Karla Hemming and Alan Girling

Citation: Trials 2013 14(Suppl 1):P15

Content type: Poster presentation Published on: 29 November 2013
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The dog-leg design that can give clinical trials more power to their elbow

Authors: Richard Hooper and Liam Bourke

Citation: Trials 2013 14(Suppl 1):P16

Content type: Poster presentation Published on: 29 November 2013
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Preventing and lessening exacerbations of asthma in school age children associated with a new term: pleasant

Authors: Steven Julious and Michelle Horspool

Citation: Trials 2013 14(Suppl 1):P17

Content type: Poster presentation Published on: 29 November 2013
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Seal or varnish? Overcoming the challenges of conducting a CTIMP in a research naive, primary-school based environment through a risk-adapted approach

Authors: Simon Hutchings, Ivor Chestnutt, Barbara Chadwick, Jacqui Nuttall, Rebecca Playle and Kerenza Hood

Citation: Trials 2013 14(Suppl 1):P18

Content type: Poster presentation Published on: 29 November 2013
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A pragmatic cluster randomised controlled trial of an oral health intervention for people with serious mental illness (three shires early intervention dental trial)

Authors: Hannah Jones, Clive Adams, Andrew Clifton, Patrick Callaghan, Peter Liddle, Heather Buchanan and Vishal Aggarwal

Citation: Trials 2013 14(Suppl 1):P19

Content type: Poster presentation Published on: 29 November 2013
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Practical implementation of an adaptive phase I/II design in chronic myeloid leukaemia: evaluating both efficacy and toxicity using the EffTox design

Authors: Josephine Khan, Christina Yap, Richard Clark, Nicola Fenwick and David Marin

Citation: Trials 2013 14(Suppl 1):P20

Content type: Poster presentation Published on: 29 November 2013
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A multi-centre randomised Phase III trial of radioembolisation (RE) combined with oxmdg compared with oxmdg alone as first-line therapy for unresectable liver-only or liver-dominant metastatic colorectal cancer (CRC)

Authors: Nicola Maycock, Susan Dutton and Ricky Sharma

Citation: Trials 2013 14(Suppl 1):P21

Content type: Poster presentation Published on: 29 November 2013
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