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 4 of 6

Development of double blind gluten & casein free (GFCF) test foods for autism trial

Authors: Elaine McColl, Sandra Adams, Nicola Burton, Anna Cutress, Ashley Adamson, Gillian Baird, Anne O'Hare and Ann Le Couteur

Citation: Trials 2013 14(Suppl 1):P22

Content type: Poster presentation

Published on: 29 November 2013
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Parents' and child health professionals' attitudes to dietary interventions in autism spectrum disorder (ASD): findings from a UK survey

Authors: Elaine McColl, Ann Le Couteur, Sandra Adams, Helen McConachie, Paul Gringras, Gillian Baird, Anne O'Hare, David Wilson, Jeremy Parr, Elizabeth Winburn and Jenna Charlton

Citation: Trials 2013 14(Suppl 1):P23

Content type: Poster presentation

Published on: 29 November 2013
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Flexible trial design in a rare condition

Authors: Veronica Moroz, Keith Wheatley and Martin McCabe

Citation: Trials 2013 14(Suppl 1):P24

Content type: Poster presentation

Published on: 29 November 2013
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Modifying the multi-arm multi-stage (MAMS) design for use in a phase II tuberculosis trial in sub-Saharan Africa with a time-to-event primary outcome

Authors: Patrick Phillips, Michael Hoelscher, Daniel Bratton, Sunita Rehal, Norbert Heinrich, Georgette Plemper van Balen, Andrew Nunn, Rob Aarnoutse, Sonja Henne, Stephen Gillespie and Martin Boeree

Citation: Trials 2013 14(Suppl 1):P26

Content type: Poster presentation

Published on: 29 November 2013
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Recruitment challenges in surgical trials: lessons from the crisp trial

Authors: K Pike, GD Angelini, BC Reeves, DP Taggart and CA Rogers

Citation: Trials 2013 14(Suppl 1):P27

Content type: Poster presentation

Published on: 29 November 2013
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Overcoming the challenge of conducting a pragmatic randomised trial in premises licensed for the on-site sale and consumption of alcohol

Authors: Rebecca Playle, Simon Moore, Simon Murphy, Laurence Moore, Kerry Hood and Jonathan Shepherd

Citation: Trials 2013 14(Suppl 1):P28

Content type: Poster presentation

Published on: 29 November 2013
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Clinical development of nitisinone for alkaptonuria (developakure) - a rare disease clinical trials design

Authors: Eftychia Eirini Psarelli, Trevor Cox and Lakshminarayan Ranganath

Citation: Trials 2013 14(Suppl 1):P29

Content type: Poster presentation

Published on: 29 November 2013
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Methodological issues in the development of a prediction model for pre-eclampsia complications

Authors: Ewelina Rogozinska, Fiona Fong, Shakila Thangaratinam, John Allotey, Julie Dodds, Sally Kerry, Nadine Marlin and Khalid Khan

Citation: Trials 2013 14(Suppl 1):P30

Content type: Poster presentation

Published on: 29 November 2013
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Challenges in the design and analysis of surgical trials

Authors: Ines Rombach, David Beard, Andrew Carr, Jonathan Rees, Cushla Cooper and Naomi Cummings

Citation: Trials 2013 14(Suppl 1):P31

Content type: Poster presentation

Published on: 29 November 2013
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A framework to assess the added value of subgroup analyses when the overall treatment effect (TE) was significant

Authors: Hong Sun and Werner Vach

Citation: Trials 2013 14(Suppl 1):P32

Content type: Poster presentation

Published on: 29 November 2013
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Do participants in major, practice-changing breast cancer trials reflect the breast cancer patient population?

Authors: Shaun Treweek, Ruth Dryden, Colin McCowan, Alison Harrow and Alastair Thompson

Citation: Trials 2013 14(Suppl 1):P33

Content type: Poster presentation

Published on: 29 November 2013
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Clinical trials in rare diseases: a review of practice

Authors: Stuart Bell, Paula Williamson, Simon Day, Keith Wheatley, John Whitehead and Catrin Tudur Smith

Citation: Trials 2013 14(Suppl 1):P34

Content type: Poster presentation

Published on: 29 November 2013
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Introducing 'global health methodology research' a knowledge sharing platform open to all

Authors: Francois van Loggerenberg, Mike Clarke, Tamzin Furtado, Liam Boggs, Nicola McHugh, Samuel Franzen and Trudie Lang

Citation: Trials 2013 14(Suppl 1):P35

Content type: Poster presentation

Published on: 29 November 2013
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Revisiting the multi-armed bandit model for the optimal design of clinical trials: benefits and drawbacks

Authors: Sofia S Villar, Jack Bowden and James Wason

Citation: Trials 2013 14(Suppl 1):P36

Content type: Poster presentation

Published on: 29 November 2013
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Recruitment to diagnosis of urinary tract infections in young children (DUTY) study: an evaluation of the successful methods used in a primary care, prospective cohort study

Authors: Cherry-Ann Waldron, Emma Thomas-Jones, Timothy Pickles, Kerry Hood, Kim Harman, Harriet Downing, Kate Martinson, Marilyn Peters, Alastair D Hay and Christopher C Butler

Citation: Trials 2013 14(Suppl 1):P37

Content type: Poster presentation

Published on: 29 November 2013
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The use of placebo in randomised surgical clinical trials

Authors: Karolina Wartolowska, Andrew Judge, Benjamin Dean, Ines Rombach, Julian Savulescu, David Beard and Andrew Carr

Citation: Trials 2013 14(Suppl 1):P38

Content type: Poster presentation

Published on: 29 November 2013
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Benefits and harms of placebo in surgical randomised clinical trials: a systematic review

Authors: Karolina Wartolowska, Andrew Judge, Benjamin Dean, Ines Rombach, Julian Savulescu, David Beard and Andrew Carr

Citation: Trials 2013 14(Suppl 1):P39

Content type: Poster presentation

Published on: 29 November 2013
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A comparison of bayesian adaptive randomization and multi-stage designs for multi-arm clinical trials

Authors: James Wason and Lorenzo Trippa

Citation: Trials 2013 14(Suppl 1):P40

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Published on: 29 November 2013
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A novel Bayesian method for dual-agent Phase I dose-escalation studies using penalized D-optimality

Authors: Graham Wheeler

Citation: Trials 2013 14(Suppl 1):P41

Content type: Poster presentation

Published on: 29 November 2013
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Randomised trials during a public health crisis, such as pandemic flu: a case study for a model of ‘off the shelf' ready-to-go trials

Authors: Diane Whitham, Clare Brittain, Lelia Duley and Wei-Shen Lim

Citation: Trials 2013 14(Suppl 1):P42

Content type: Poster presentation

Published on: 29 November 2013
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External validation of a prognostic index

Authors: Laura Bonnett, Anthony Marson, Tony Johnson, Lois Kim, Ley Sander, Nicholas Lawn, Ettore Beghi, Maurizio Leone and Catrin Tudur Smith

Citation: Trials 2013 14(Suppl 1):P43

Content type: Poster presentation

Published on: 29 November 2013
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Short- versus long-term outcomes after treatment for tuberculosis

Authors: Laura Bonnett and Gerry Davies

Citation: Trials 2013 14(Suppl 1):P44

Content type: Poster presentation

Published on: 29 November 2013
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Biochemical efficacy and safety trial of vitamin D (BEST-D): finding an appropriate dose to test in a large randomized trial

Authors: Jane Armitage, Harold Hin, Joseph Tomson, Mike Lay, Mike Hill and Robert Clarke

Citation: Trials 2013 14(Suppl 1):P45

Content type: Poster presentation

Published on: 29 November 2013
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Sample size requirements for pilot randomised controlled trials with continuous outcomes: a simulation study

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

Citation: Trials 2013 14(Suppl 1):P46

Content type: Poster presentation

Published on: 29 November 2013
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Eligibility for randomized trials of treatments specifically for intracerebral hemorrhage: community-based study

Authors: Arthur Fonville, Neshika Samarasekera, Yvo Roos and Rustam Al-Shahi Salman

Citation: Trials 2013 14(Suppl 1):P47

Content type: Poster presentation

Published on: 29 November 2013
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Formal consensus method for the development of a primary outcome measure to assess the clinical and cost-effectiveness of cardiac magnetic resonance imaging after primary percutaneous coronary intervention pathway activation (PIPA feasibility study)

Authors: Maria Pufulete, Chiara Bucciarelli-Ducci, Rachel Brierley, Chris Rogers, Jessica Harris and Barney Reeves

Citation: Trials 2013 14(Suppl 1):P48

Content type: Poster presentation

Published on: 29 November 2013
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Sample size in a prognostic study: prep (prediction of risks in early onset pre-eclampsia)

Authors: John Allotey, Julie Dodds, Sally Kerry and Shakila Thangaratinam

Citation: Trials 2013 14(Suppl 1):P49

Content type: Poster presentation

Published on: 29 November 2013
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Development of maternal and neonatal composite outcomes for trials evaluating timing of delivery in women with pre-eclampsia

Authors: Fiona Fong, Ewelina Rogozinska, John Allotey, Steve Kempley, Divyen Shah and Shakila Thangaratinam

Citation: Trials 2013 14(Suppl 1):P50

Content type: Poster presentation

Published on: 29 November 2013
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Expected value of information in the case of mixed strategies

Authors: Gianluca Baio

Citation: Trials 2013 14(Suppl 1):P51

Content type: Poster presentation

Published on: 29 November 2013
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Research into biomarkers to facilitate the early identification of Parkinson's disease: a decision analytic model to determine the feasibility and value

Authors: Rachael Hunter, Gordon Proctor, Alastair Noyce, Anette Schrag, Elaine Ward and John Galloway

Citation: Trials 2013 14(Suppl 1):P52

Content type: Poster presentation

Published on: 29 November 2013
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The use of historical priors to improve the efficiency of phase II clinical trials with time-to-event endpoints

Authors: Richard Jackson, Trevor Cox and Catrin Tudur-Smith

Citation: Trials 2013 14(Suppl 1):P53

Content type: Poster presentation

Published on: 29 November 2013
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Designing clinical research into the treatment of breast cancer in the elderly - the advantages and challenges of a value of information approach

Authors: Paul Richards and Alan Brennan

Citation: Trials 2013 14(Suppl 1):P54

Content type: Poster presentation

Published on: 29 November 2013
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Empirical evidence for the validity and reliability of resource-use measures based on patient recall: a systematic review

Authors: Joanna Thorn, Sian Noble, Theresa Moore and William Hollingworth

Citation: Trials 2013 14(Suppl 1):P55

Content type: Poster presentation

Published on: 29 November 2013
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Utilising fax to PDF technology to increase security, confidentiality, protocol adherence, follow-up and ease of monitoring in multicentre randomised trials

Authors: Martin Dennis, Rustam Al-Shahi Salman, Gillian Mead, Christopher Matthews, Jonathan Drever and David Perry

Citation: Trials 2013 14(Suppl 1):P56

Content type: Poster presentation

Published on: 29 November 2013
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On-line training and testing of knowledge of trial protocols to facilitate centre start-up and reduce protocol deviations

Authors: Martin Dennis, Rustam Al Shahi Salman, Gillian Mead and David Perry

Citation: Trials 2013 14(Suppl 1):P57

Content type: Poster presentation

Published on: 29 November 2013
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Developing easy access patient information booklets and consent forms for use in multicentre stroke trials

Authors: Gillian Mead, Martin Dennis and Marian Brady

Citation: Trials 2013 14(Suppl 1):P58

Content type: Poster presentation

Published on: 29 November 2013
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Database development to maximise recruitment in a busy cardiac surgery department

Authors: Lucy Dreyer, Katie Pike, Neil Smith and Lucy Culliford

Citation: Trials 2013 14(Suppl 1):P59

Content type: Poster presentation

Published on: 29 November 2013
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Minimising paper: electronic data capture methods in the 3c study

Authors: Richard Haynes

Citation: Trials 2013 14(Suppl 1):P60

Content type: Poster presentation

Published on: 29 November 2013
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Clinical trials software: commercial system or build your own?

Authors: Gladys McPherson, Mark Forrest and Sazid Mohammed

Citation: Trials 2013 14(Suppl 1):P61

Content type: Poster presentation

Published on: 29 November 2013
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Data entry checking - is it necessary?

Authors: Gladys McPherson

Citation: Trials 2013 14(Suppl 1):P62

Content type: Poster presentation

Published on: 29 November 2013
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KCTU randomisation and IMP management system

Authors: Caroline Murphy, Joanna Kelly, John Hodsoll, Andrew Pickles, Evangelos Georgiou and PL Morgan

Citation: Trials 2013 14(Suppl 1):P63

Content type: Poster presentation

Published on: 29 November 2013

The Erratum to this article has been published in Trials 2015 16:338
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Use of an online e-learning module to standardise the assessment and reporting of a subjective endpoint in a multicentre rct

Authors: Thomas Pinkney, David Bartlett, Adrian Gheorghe, George Dowswell, Dion Morton and Melanie Calvert

Citation: Trials 2013 14(Suppl 1):P64

Content type: Poster presentation

Published on: 29 November 2013
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Comparing the use of traditional and agile development methodologies in a clinical trials environment

Authors: Mary Rauchenberger, Emma Little and Carlos Diaz Montana

Citation: Trials 2013 14(Suppl 1):P65

Content type: Poster presentation

Published on: 29 November 2013
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Development of the "GeneSYS" database system to support trial data capture and conduct

Authors: D Hutton, N Smith, H Cappel-Porter, C Saw and CA Rogers

Citation: Trials 2013 14(Suppl 1):P66

Content type: Poster presentation

Published on: 29 November 2013
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Integrating qualitative research in a multi-centre trial - the clinical trials unit perspective

Authors: CA Rogers, G Mazza, S Paramasivan, N Smith, R Nash, JM Blazeby and J Donovan

Citation: Trials 2013 14(Suppl 1):P67

Content type: Poster presentation

Published on: 29 November 2013
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Pressure relieving support surfaces: a randomised evaluation 2 (PRESSURE 2)

Authors: Sarah Brown, Isabelle Smith, Julia Brown, Claire Hulme and Jane Nixon

Citation: Trials 2013 14(Suppl 1):P68

Content type: Poster presentation

Published on: 29 November 2013
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Time to publication for NIHR HTA programme-funded studies

Authors: Fay Chinnery, Amanda Young, Jennie Goodman, Ruairidh Milne and Martin Ashton-Key

Citation: Trials 2013 14(Suppl 1):P69

Content type: Poster presentation

Published on: 29 November 2013
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A discussion of an issue relating to sample sizes of exact phase II trial designs

Authors: Andrew Howman

Citation: Trials 2013 14(Suppl 1):P70

Content type: Poster presentation

Published on: 29 November 2013
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A framework for the development and appraisal of diet and eating behaviour outcome measures

Authors: Dianne Ward, Maria Bryant, Claudia Gorecki, Amber Vaughn, Rachel Tabak, June Stevens, Jane Nixon, Susan Jebb, Kath Roberts, Judy Wright and Julia Brown

Citation: Trials 2013 14(Suppl 1):P71

Content type: Poster presentation

Published on: 29 November 2013
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The application of standardised diagnostic criteria in RCTS in depression

Authors: Finola Ferry, Gillian Shorter and Mike Clarke

Citation: Trials 2013 14(Suppl 1):P72

Content type: Poster presentation

Published on: 29 November 2013
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