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 1 of 6

The UK Medical Research Council and clinical trials, 1934-1960

Authors: Iain Chalmers

Citation: Trials 2013 14(Suppl 1):I1

Content type: Invited speaker presentation Published on: 29 November 2013
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Removing unnecessary obstacles to randomised trials

Authors: Rory Collins

Citation: Trials 2013 14(Suppl 1):I2

Content type: Invited speaker presentation Published on: 29 November 2013
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Data monitoring committees: history and their future

Authors: David L DeMets

Citation: Trials 2013 14(Suppl 1):I3

Content type: Invited speaker presentation Published on: 29 November 2013
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Using evidence from observational healthcare data to inform a trial design

Authors: Christian Holm Hansen, Gordon Murray and Michael Sharpe

Citation: Trials 2013 14(Suppl 1):O1

Content type: Oral presentation Published on: 29 November 2013
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Impact of lack-of-benefit stopping rules on treatment effect estimates of two-arm multi-stage (TAMS) trials with time to event outcome

Authors: Babak Choodari-Oskooei, Max KB Parmar, Patrick Royston and Jack Bowden

Citation: Trials 2013 14(Suppl 1):O2

Content type: Oral presentation Published on: 29 November 2013
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The need for a cultural shift from two-arm to multi-arm RCTS

Authors: Matthew R Sydes and Mahesh KB Parmar

Citation: Trials 2013 14(Suppl 1):O3

Content type: Oral presentation Published on: 29 November 2013
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Treatment selection in multi-arm, multi-stage clinical trials

Authors: Thomas Jaki, Dominic Magirr and Nigel Stallard

Citation: Trials 2013 14(Suppl 1):O4

Content type: Oral presentation Published on: 29 November 2013
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Efficient design of a phase III trial of competing tests for personalised cancer treatment in the absence of gold standard outcome data: challenges and potential solutions

Authors: Peter Hall, Christopher McCabe, Claire Hulme, Richard Edlin, Janet Dunn, David Cameron and Rob Stein

Citation: Trials 2013 14(Suppl 1):O5

Content type: Oral presentation Published on: 29 November 2013
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Evidence synthesis in trial design: an example from the neurosciences

Authors: Kieren Egan, Hanna Vesterinen, Emily Sena and Malcolm Macleod

Citation: Trials 2013 14(Suppl 1):O6

Content type: Oral presentation Published on: 29 November 2013
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When is a randomised controlled trial required: the theoretical domains framework approach

Authors: Marion Campbell, Jill Francis, Eilidh Duncan, Graeme MacLennan and Brian Cuthbertson

Citation: Trials 2013 14(Suppl 1):O7

Content type: Oral presentation Published on: 29 November 2013
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A series of decision-theoretic phase II trials of related treatments

Authors: Siew Wan Hee, Nicholas Parsons, Matthew Costa and Nigel Stallard

Citation: Trials 2013 14(Suppl 1):O8

Content type: Oral presentation Published on: 29 November 2013
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The risks and benefits of RTPA in acute ischemic stroke for patients at high risk of intracranial haemorrhage and poor functional outcome: a secondary analysis of the IST-3 trial and systematic review of prediction models

Authors: Douglas Thompson, Gordon Murray and William Whiteley

Citation: Trials 2013 14(Suppl 1):O9

Content type: Oral presentation Published on: 29 November 2013
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Who do treatments work for and why? Understanding treatment-effect mechanisms in stratified medicine

Authors: Richard Emsley, Hanhua Liu, Sabine Landau and Graham Dunn

Citation: Trials 2013 14(Suppl 1):O10

Content type: Oral presentation Published on: 29 November 2013
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Adaptive enrichment in biomarker-stratified clinical trial design

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

Citation: Trials 2013 14(Suppl 1):O11

Content type: Oral presentation Published on: 29 November 2013
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Using adaptive designs for decision making within the optima trial: optimal personalized treatment of early breast cancer using multi-parameter tests

Authors: Janet Dunn, Andrea Marshall, Amy Campbell, Nigel Stallard, Claire Hulme, Peter Hall, Helen Higgins, John Bartlett, Adrienne Morgan, Jenny Donovan, Andreas Makris, Luke Hughes-Davies and Rob Stein

Citation: Trials 2013 14(Suppl 1):O12

Content type: Oral presentation Published on: 29 November 2013
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Experiences of perceived vs actual time required for data management on electronic data capture clinical trials in a non commercial setting

Authors: Nancy Tappenden and Lindsey Masters

Citation: Trials 2013 14(Suppl 1):O13

Content type: Oral presentation Published on: 29 November 2013
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Clinical trials registries: is it viable for the inclusion of conduct, performance, analyses and cost of trials?

Authors: Amanda Young, James Raftery, Louise Stanton, Andrew Cook, Peter Davidson, Ruairidh Milne and David Turner

Citation: Trials 2013 14(Suppl 1):O14

Content type: Oral presentation Published on: 29 November 2013
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Incorporation of text recognition into trial it systems to safeguard against enrolment of ineligible patients or inappropriate reporting of adverse events

Authors: Martin Dennis, Rustam Salman, Gillian Mead, Connor McGill and David Perry

Citation: Trials 2013 14(Suppl 1):O15

Content type: Oral presentation Published on: 29 November 2013
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Using linked healthcare data to create a randomised controlled trial: the rapid trial (reducing antibiotic prescribing in dentistry)

Authors: Paula Elouafkaoui, Andrew Elders, Jan Clarkson, Eilidh Duncan, Maria Prior, Craig Ramsay and Linda Young

Citation: Trials 2013 14(Suppl 1):O16

Content type: Oral presentation Published on: 29 November 2013
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Optimising the design and evaluation of pilot work to inform the main trial: a review of current evidence and consideration of future practices

Authors: Elaine O'Connell Francischetto, Kerry Avery, Chris Metcalfe, Paula Williamson, Carrol Gamble and Jane Blazeby

Citation: Trials 2013 14(Suppl 1):O17

Content type: Oral presentation Published on: 29 November 2013
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Definition and reporting of pilot and feasibility studies

Authors: Sandra Eldridge, Christine Bond, Mike Campbell, Gill Lancaster, Lehana Thabane and Sally Hopwell

Citation: Trials 2013 14(Suppl 1):O18

Content type: Oral presentation Published on: 29 November 2013
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ADePT (algorithm for decision-making after pilot and feasibility trials): a decision aid for progression from feasibility study to main trial

Authors: Carol Bugge, Brian Williams and Suzanne Hagen

Citation: Trials 2013 14(Suppl 1):O19

Content type: Oral presentation Published on: 29 November 2013
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Designing and analysing feasibility studies of complex interventions: challenges related to assessing stop/go criteria

Authors: Michelle Collinson, Shamaila Anwar, Liz Graham, Kayleigh Burton, Tamar Pincus, David Owens and Amanda Farrin

Citation: Trials 2013 14(Suppl 1):O20

Content type: Oral presentation Published on: 29 November 2013
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Sample size requirements for pilot randomised controlled trials with binary outcomes: a simulation study

Authors: Dawn Teare, Munya Dimairo, Alexandra Hayman, Neil Shephard, Amy Whitehead and Stephen Walters

Citation: Trials 2013 14(Suppl 1):O21

Content type: Oral presentation Published on: 29 November 2013
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Review of the use of resource use instruments based on patient recall in relation to other methods of resource use estimation

Authors: Colin Ridyard and Dyfrig Hughes

Citation: Trials 2013 14(Suppl 1):O22

Content type: Oral presentation Published on: 29 November 2013
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A non-linear beta-binomial regression model for mapping qlqc-30 to the eq-5d in lung cancer patients: a comparison with existing approaches

Authors: Iftekhar Khan, Shah-Jalal Sarker and Steven Morris

Citation: Trials 2013 14(Suppl 1):O23

Content type: Oral presentation Published on: 29 November 2013
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Developing a lifetime disease model from RCT data using parametric models with time-updated covariates

Authors: Iryna Schlackow and Borislava Mihaylova

Citation: Trials 2013 14(Suppl 1):O24

Content type: Oral presentation Published on: 29 November 2013
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Fast efficient computation of expected value of sample information from a probabilistic sensitivity analysis sample: a non-parametric regression approach

Authors: Mark Strong, Alan Brennan and Jeremy Oakley

Citation: Trials 2013 14(Suppl 1):O25

Content type: Oral presentation Published on: 29 November 2013
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A comparison of four different approaches to measuring health utility in depressed patients

Authors: Nicholas Turner, John Campbell, Tim Peters, Nicola Wiles and Sandra Hollinghurst

Citation: Trials 2013 14(Suppl 1):O26

Content type: Oral presentation Published on: 29 November 2013
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The completeness of intervention descriptions in published NIHR HTA funded trials: a cross sectional study

Authors: Lisa Douet, Ruairidh Milne, Sydney Anstee, Fay Habens, Amanda Young and David Wright

Citation: Trials 2013 14(Suppl 1):O27

Content type: Oral presentation Published on: 29 November 2013
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PRECIS-2: a tool to improve the applicability of randomised controlled trials

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

Citation: Trials 2013 14(Suppl 1):O28

Content type: Oral presentation Published on: 29 November 2013
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Remits, roles and working models for trial steering committees and data monitoring committees in studies evaluating diagnostic tests: a survey of current practice

Authors: Lavinia Ferrante di Ruffano, Jac Dinnes, Jane Daniels, Richard Riley, Nick Hicks, Richard Kaplan and Jon Deeks

Citation: Trials 2013 14(Suppl 1):O29

Content type: Oral presentation Published on: 29 November 2013
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Evaluation of a site selection questionnaire for the recruitment of trial sites into multi-centre trials: experiences from the nottingham clinical trials unit

Authors: Diane Whitham and Lelia Duley

Citation: Trials 2013 14(Suppl 1):O30

Content type: Oral presentation Published on: 29 November 2013
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A research methodology study to map the process of initiating and operating a randomised controlled trial of podoconiosis treatment in Northern Ethiopia

Authors: Trudie Lang, Mike Clarke, Melanie Newport, Fikre Enquoselassie, Francois van Loggerenberg, Sam Franzen, Tamzin Furtado, Patricia Njuguna, Greg Fegan and Gail Davey

Citation: Trials 2013 14(Suppl 1):O31

Content type: Oral presentation Published on: 29 November 2013
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Feeding back the results of trials to the families of participants who have died: methodological considerations 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):O32

Content type: Oral presentation Published on: 29 November 2013
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Using discrete choice experiments to define patient preferences for outcomes in trials

Authors: Emily Fargher, Dyfrig Hughes, Adele Ring, Ann Jacoby, Margaret Rawnsley and Anthony Marson

Citation: Trials 2013 14(Suppl 1):O33

Content type: Oral presentation Published on: 29 November 2013
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Evidence base for patient and public involvement in clinical trials (EPIC)

Authors: Carrol Gamble, Louise Dudley and Jennifer Newman

Citation: Trials 2013 14(Suppl 1):O34

Content type: Oral presentation Published on: 29 November 2013
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Service user groups as co-applicants on a platform study for a trial

Authors: Heather Morgan, Pat Hoddinott, Gill Thomson, Nicola Crossland, Fiona Dykes, Sharon McCann and Marion Campbell

Citation: Trials 2013 14(Suppl 1):O35

Content type: Oral presentation Published on: 29 November 2013
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Patient involvement in clinical research: a qualitative evaluation of impact

Authors: Rachael Gooberman-Hill, Amanda Burston, Erik Lenguerrand, Emma Clark and Emma Johnson

Citation: Trials 2013 14(Suppl 1):O36

Content type: Oral presentation Published on: 29 November 2013
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Adjusting for treatment changes in epilepsy: causal analysis of randomised controlled trial survival outcomes in the presence of departure from randomised treatment

Authors: Susanna Dodd, Paula Williamson, Ruwanthi Kolamunnage Dona, Marta Van der Hoek and Ian White

Citation: Trials 2013 14(Suppl 1):O37

Content type: Oral presentation Published on: 29 November 2013
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Analysis of survival data from trials with non-proportional hazards: an empirical comparison of methods

Authors: Patrick Royston, Yinghui Wei, Jayne Tierney and Mahesh Parmar

Citation: Trials 2013 14(Suppl 1):O38

Content type: Oral presentation Published on: 29 November 2013
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Modelling of longitudinal outcomes with highly skewed distributions: applications in the IVAN trial

Authors: R Nash, L Scott, U Chakravarthy, SP Harding, BC Reeves and CA Rogers

Citation: Trials 2013 14(Suppl 1):O39

Content type: Oral presentation Published on: 29 November 2013
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Rasch analysis of the PedsQL 3.0 diabetes module

Authors: Tim Pickles, Rebecca Playle, Kerenza Hood, Jonathan Gillard and Michael Robling

Citation: Trials 2013 14(Suppl 1):O40

Content type: Oral presentation Published on: 29 November 2013
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The implications of differential clustering for analysis of binary outcomes

Authors: Chris Roberts, Steve Roberts and Eva Batistatou

Citation: Trials 2013 14(Suppl 1):O41

Content type: Oral presentation Published on: 29 November 2013
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Bridging the gap: a review of dose-investigation studies in paediatric investigation plans

Authors: Lisa Hampson, Martin Posch, Julia Saperia and Anne Whitehead

Citation: Trials 2013 14(Suppl 1):O42

Content type: Oral presentation Published on: 29 November 2013
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Methodological considerations for neonatal trials involving multiples: lessons 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):O43

Content type: Oral presentation Published on: 29 November 2013
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The reform study: a cohort multiple randomised controlled trial

Authors: Sarah Cockayne, Joy Adamson, Catherine Hewitt, Robin Hull, Anne-Maree Keenan, Antony Redmond, Sallie Lamb, Caroline McIntosh, Hylton Menz, Wesley Vernon, Judith Watson and David Torgerson

Citation: Trials 2013 14(Suppl 1):O44

Content type: Oral presentation Published on: 29 November 2013
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Comparative study of new imaging technologies for the diagnosis of glaucoma: design and conduct of a multi-centre diagnostic accuracy study

Authors: Katie Banister, Jonathan Cook, Craig Ramsay, Jennifer Burr, Rodolfo Hernández, Kirsty McCormack, Rupert Bourne, Mark Batterbury, David Garway-Heath and Augusto Azuara-Blanco

Citation: Trials 2013 14(Suppl 1):O45

Content type: Oral presentation Published on: 29 November 2013
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Comparative evaluation of the stepped wedge design efficiency

Authors: Gianluca Baio, Rumana Omar and Gareth Ambler

Citation: Trials 2013 14(Suppl 1):O46

Content type: Oral presentation Published on: 29 November 2013
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A win ratio approach to comparing ordinal or non-normal outcomes in clinical trials

Authors: Duolao Wang and Stuart Pocock

Citation: Trials 2013 14(Suppl 1):O47

Content type: Oral presentation Published on: 29 November 2013
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