Volume 12 Supplement 1

Clinical Trials Methodology Conference 2011

Meeting abstracts

Edited by Stephanie McAvoy and Emily Crowe

This conference was sponsored by the Network of Hubs for Trials Methodology Research

Clinical Trials Methodology Conference 2011. Go to conference site.

Bristol, UK4-5 October 2011

Concatenated PDF 12S1

Page 3 of 4

Holding onto power: why confidence intervals are not (usually) the best basis for sample size calculations

Authors: Chris Metcalfe

Citation: Trials 2011 12(Suppl 1):A101

Content type: Oral presentation Published on: 13 December 2011
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Making the most of animal data – improving the prospect of success in pragmatic trials in the neurosciences

Authors: Kieren J Egan, Emily S Sena, Hanna M Vesterinen and Malcolm R Macleod

Citation: Trials 2011 12(Suppl 1):A102

Content type: Poster presentation Published on: 13 December 2011
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The CORONIS Trial: international study of caesarean section surgical techniques

Authors: Edmund Juszczak and Barbara Farrell

Citation: Trials 2011 12(Suppl 1):A103

Content type: Poster presentation Published on: 13 December 2011
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Randomised Evaluations of Accepted Choices in Treatment (REACT) trials: large-scale pragmatic trials within databases of routinely collected electronic healthcare records

Authors: Tjeerd-Pieter van Staa, Ben Goldacre, Martin Gulliford, Jackie Cassell, Munir Pirmohamed, Adel Taweel, Brendan Delaney and Liam Smeeth

Citation: Trials 2011 12(Suppl 1):A104

Content type: Poster presentation Published on: 13 December 2011
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QUEST Perspective Study (QPS) to measure the understanding by patients and healthcare professionals of surgical breast reconstruction clinical trials: QUEST Trials A & B

Authors: Zoe E Winters, Judith Mills, Marie Emson, Judith M Bliss and Rob Horne

Citation: Trials 2011 12(Suppl 1):A105

Content type: Poster presentation Published on: 13 December 2011
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Strategic use of new generation antidepressants for depression, SUN(^_^)D : study design and rationale

Authors: Naohiro Yonemoto, Tatsuo Akechi, Shinji Shimodera, Mitsuhiko Yamada, Kazuhira Miki, Norio Watanabe, Masatoshi Inagaki and Toshi A Furukawa

Citation: Trials 2011 12(Suppl 1):A106

Content type: Poster presentation Published on: 13 December 2011
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Trials in rare diseases: the need to think differently

Authors: Lucinda Billingham, Kinga Malottki, Mark Pritchard and Neil Steven

Citation: Trials 2011 12(Suppl 1):A107

Content type: Invited speaker presentation Published on: 13 December 2011
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Comparison of anticipated and actual control group outcome in randomised trials in paediatric oncology provides evidence that non-randomised studies are biased in favour of the novel treatment

Authors: Veronica Moroz, Jayne Wilson and Keith Wheatley

Citation: Trials 2011 12(Suppl 1):A108

Content type: Oral presentation Published on: 13 December 2011
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Recruitment into trials of rare conditions - experiences from the STOP GAP trial

Authors:

Citation: Trials 2011 12(Suppl 1):A109

Content type: Poster presentation Published on: 13 December 2011
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Recruitment to trials - why is it hard and how might we make it less so?

Authors: Shaun Treweek

Citation: Trials 2011 12(Suppl 1):A110

Content type: Invited speaker presentation Published on: 13 December 2011
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Investigating strategies to improve attendance at screening visits in a randomized trial

Authors: Fang Chen, K Rahimi, R Haynes, K Naessens, M Taylor-Clarke, C Murray and Jane Armitage

Citation: Trials 2011 12(Suppl 1):A111

Content type: Oral presentation Published on: 13 December 2011
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Rates of recruitment from systematic and opportunistic methods: preliminary results from the DDELPHI study

Authors: Melvyn Hillsdon

Citation: Trials 2011 12(Suppl 1):A112

Content type: Oral presentation Published on: 13 December 2011
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FARSITE: evaluation of an automated trial feasibility assessment and recruitment tool

Authors: Sarah Thew, Gary Leeming, John Ainsworth, Martin Gibson and Iain Buchan

Citation: Trials 2011 12(Suppl 1):A113

Content type: Oral presentation Published on: 13 December 2011
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Exploring meaning of participation in a clinical trial in a developing country setting: implications for recruitment

Authors: Joanna Reynolds, Peter Mangesho, Lasse S Vestergaard and Clare Chandler

Citation: Trials 2011 12(Suppl 1):A114

Content type: Oral presentation Published on: 13 December 2011
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Improving recruitment to clinical trials with a register of a million patients who agree to the use of their clinical records for research in the Scottish Health Research Register (SHARE)

Authors: Frank M Sullivan, Shaun Treweek, Anile Grant, Fergus Daly, Donald Nicolson, Brian McKinstry, Janet Hanley, Jenny Ure and Aziz Sheikh

Citation: Trials 2011 12(Suppl 1):A115

Content type: Oral presentation Published on: 13 December 2011
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What parents think about being approached about children’s trials, how this differs from what practitioners expect, and what this tells us about enhancing recruitment

Authors: Bridget Young, Valerie Shilling, Helen Hickey, Emma Sowden, Rosalind L Smyth and Paula R Williamson

Citation: Trials 2011 12(Suppl 1):A116

Content type: Oral presentation Published on: 13 December 2011
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Recruiting patients cost-effectively by mail

Authors: Theingi Aung, Helen Cowan, Richard Haynes, Louise Bowman and Jane Armitage

Citation: Trials 2011 12(Suppl 1):A117

Content type: Poster presentation Published on: 13 December 2011
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Analysis and validation of a Parkinson’s disease register as a recruitment tool for clinical studies

Authors: Camille B Carroll, Amy Palmer, Christine Cosby and John P Zajicek

Citation: Trials 2011 12(Suppl 1):A118

Content type: Poster presentation Published on: 13 December 2011
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Recruiting patients with advanced malignant and non-malignant disease: lessons learned from a palliative care RCT

Authors: Morag C Farquhar, Barbara Brafman-Kennedy, Irene J Higginson and Sara Booth

Citation: Trials 2011 12(Suppl 1):A119

Content type: Poster presentation Published on: 13 December 2011
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Recruitment to the pilot phase of Start2quit – lessons learned

Authors: Leanne M Gardner, Hazel Gilbert and Irwin Nazareth

Citation: Trials 2011 12(Suppl 1):A120

Content type: Poster presentation Published on: 13 December 2011
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Analysis of patient information leaflets (PILs), used in clinical trials using the Informed Consent Evaluation instrument (ICEi)

Authors: Katie Gillies, Wan Huang, Zoe Skea and Seonaidh Cotton

Citation: Trials 2011 12(Suppl 1):A121

Content type: Poster presentation Published on: 13 December 2011
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The complexities of maximising recruitment to complex intervention trials in child and adolescent mental health services

Authors: David Cottrell, Liz Graham and Amanda Farrin

Citation: Trials 2011 12(Suppl 1):A122

Content type: Poster presentation Published on: 13 December 2011
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Can we improve recruitment to trials and informed consent by improving participant information sheets? - A nested RCT

Authors: Peter Knapp, Natasha Mitchell, David K Raynor, Jonathan Silcock, Brian Parkinson, Janet Holt, Yvonne Birks and Simon Gilbody

Citation: Trials 2011 12(Suppl 1):A123

Content type: Poster presentation Published on: 13 December 2011
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Addressing patient treatment preferences at trial recruitment

Authors: Nicola Mills, Julia Wade, Athene J Lane, Freddie C Hamdy, David E Neal and Jenny L Donovan

Citation: Trials 2011 12(Suppl 1):A124

Content type: Poster presentation Published on: 13 December 2011
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Releasing interim results from a randomised clinical trial: an example from the QUARTZ trial

Authors: Matthew Nankivell, Richard Stephens, Cheryl Pugh, Paula Mulvenna, Rachael Barton, Ruth Langley and Mahesh Parmar

Citation: Trials 2011 12(Suppl 1):A125

Content type: Poster presentation Published on: 13 December 2011
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Recruiting ahead of target: What worked in the REEACT trial?

Authors: Puvan Tharmanathan, Gwen Brierley, Elizabeth Littlewood, Phil Andersen and Simon Gilbody

Citation: Trials 2011 12(Suppl 1):A126

Content type: Poster presentation Published on: 13 December 2011
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Recruiting and retaining medical patients in trials of complex interventions: practical experience of challenges and solutions in three multi-centre trials

Authors: Jane Walker and Michael Sharpe

Citation: Trials 2011 12(Suppl 1):A127

Content type: Poster presentation Published on: 13 December 2011
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Strategies to reduce attrition in randomised trials

Authors: Valerie Brueton, Jayne Tierney, Sally Stenning, Irwin Nazareth, Sarah Meredith, Seeromanie Harding and Greta Rait

Citation: Trials 2011 12(Suppl 1):A128

Content type: Oral presentation Published on: 13 December 2011
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Departure from treatment protocol in published randomised controlled trials: a review

Authors: Susanna Dodd, Ian White and Paula Williamson

Citation: Trials 2011 12(Suppl 1):A129

Content type: Oral presentation Published on: 13 December 2011
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The use of the Medication Event Monitoring System (MEMS) for assessing medication adherence for chronic conditions: use and results from a 12 month trial of patients in remission with ulcerative colitis (UC)

Authors: David Gillespie, Kerenza Hood, Andrew Williams, Rachel Stenson, Christopher Probert and Antony Hawthorne

Citation: Trials 2011 12(Suppl 1):A130

Content type: Oral presentation Published on: 13 December 2011
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Adherence in a randomised controlled trial comparing liberal and restrictive red blood cell (RBC) transfusion protocols after cardiac surgery (TITRe2)

Authors: Katie Pike, Rachel Brierley, Chris A Rogers, Gavin J Murphy and Barney C Reeves

Citation: Trials 2011 12(Suppl 1):A131

Content type: Oral presentation Published on: 13 December 2011
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Complexities of retention in primary care randomised trials: A thematic analysis of in-depth interviews

Authors: Valerie Brueton, Fiona Stevenson, Claire Vale and Greta Rait

Citation: Trials 2011 12(Suppl 1):A132

Content type: Poster presentation Published on: 13 December 2011
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Maximising adherence to study protocol within pharmaco-rehabilitation clinical trials

Authors: Suzanne Hartley, Sharon Ruddock, Bipin Bhakta, John Pearn, Lorna Barnard, Alison Fergusson, Dean Langan and Amanda Farrin

Citation: Trials 2011 12(Suppl 1):A133

Content type: Poster presentation Published on: 13 December 2011
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Understanding factors influencing questionnaire response rates to maximise retention in a long term complex intervention trial

Authors: Athene J Lane, Liz Down, Julia Wade, David Neal, Freddie Hamdy and Jenny Donovan

Citation: Trials 2011 12(Suppl 1):A134

Content type: Poster presentation Published on: 13 December 2011
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A key risk indicator approach to central statistical monitoring in multicentre clinical trials: method development in the context of an ongoing large-scale randomized trial

Authors: Valdés-Márquez Elsa, Hopewell C Jemma, Landray Martin and Armitage Jane

Citation: Trials 2011 12(Suppl 1):A135

Content type: Poster presentation Published on: 13 December 2011
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Survival analysis: coping with non proportional hazards in randomized trials

Authors: Patrick Royston and Mahesh KB Parmar

Citation: Trials 2011 12(Suppl 1):A136

Content type: Invited speaker presentation Published on: 13 December 2011
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Crossing survival curves: alternatives to the log-rank test

Authors: George Bouliotis and Lucinda Billingham

Citation: Trials 2011 12(Suppl 1):A137

Content type: Oral presentation Published on: 13 December 2011
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A new measure of predictive ability for survival models

Authors: Babak Choodari-Oskooei, Patrick Royston and Mahesh KB Parmar

Citation: Trials 2011 12(Suppl 1):A138

Content type: Oral presentation Published on: 13 December 2011
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Evaluation of methods to adjust for treatment switching in clinical trials

Authors: Richard Fox, Lucinda Billingham and Keith Abrams

Citation: Trials 2011 12(Suppl 1):A139

Content type: Oral presentation Published on: 13 December 2011
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Impact of the censoring distribution on time-to-event problems in the presence of competing risks

Authors: Mark W Donoghoe and Val Gebski

Citation: Trials 2011 12(Suppl 1):A140

Content type: Poster presentation Published on: 13 December 2011
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A robust parameterisation for the analysis of survival data in the presence of covariates with extreme value observations

Authors: Richard Jackson and Trevor Cox

Citation: Trials 2011 12(Suppl 1):A141

Content type: Poster presentation Published on: 13 December 2011
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Randomised controlled trials of complex interventions

Authors: John Norrie

Citation: Trials 2011 12(Suppl 1):A142

Content type: Invited speaker presentation Published on: 13 December 2011
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Designing trials of complex interventions for efficacy and mechanisms evaluation

Authors: Richard A Emsley, Jonathan Green and Graham Dunn

Citation: Trials 2011 12(Suppl 1):A143

Content type: Oral presentation Published on: 13 December 2011
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How do treatments for chronic fatigue syndrome work? Exploration of instrumental variable methods for mediation analysis in PACE – a randomised controlled trial of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care

Authors: Kimberley Goldsmith, Trudie Chalder, Peter White, Michael Sharpe and Andrew Pickles

Citation: Trials 2011 12(Suppl 1):A144

Content type: Oral presentation Published on: 13 December 2011
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Statistical design of mental health complex intervention trials

Authors: Sabine Landau

Citation: Trials 2011 12(Suppl 1):A145

Content type: Oral presentation Published on: 13 December 2011
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Modelling multiple outcomes to improve the detection of causal mediation effects in complex intervention trials

Authors: Neil Casey, Simon Thompson and Andrew T Prevost

Citation: Trials 2011 12(Suppl 1):A146

Content type: Oral presentation Published on: 13 December 2011
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MATRICS: A Method for Aggregating The Reporting of Interventions in Complex Studies

Authors: Kymberley Thorne, Gabi S Jerzembek, Wai-Yee Cheung, David Cohen, Hayley A Hutchings, Frances L Rapport, Anne C Seagrove, John G Williams and Ian T Russell

Citation: Trials 2011 12(Suppl 1):A147

Content type: Oral presentation Published on: 13 December 2011
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Understanding the complexity of surgical procedures in RCTs: a pilot study to test the application of the MRC framework for evaluating complex healthcare interventions in the operating theatre

Authors: Mark O Eveleigh, Natalie S Blencowe, Nicola Mills and Jane M Blazeby

Citation: Trials 2011 12(Suppl 1):A148

Content type: Poster presentation Published on: 13 December 2011
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Designing and analysing pragmatic clinical trials of complex interventions in mental health: challenges and solutions

Authors: Amanda J Farrin and Michelle Collinson

Citation: Trials 2011 12(Suppl 1):A149

Content type: Poster presentation Published on: 13 December 2011
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A pilot factorial randomised cohort trial of manual therapy or acupuncture for low back pain

Authors: Vivienne C Dascanio, Yvonne Birks and David Torgerson

Citation: Trials 2011 12(Suppl 1):A150

Content type: Poster presentation Published on: 13 December 2011
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