Volume 12(Suppl 1); 2011

Invited Speaker Presentation

Adaptive designs: current status, future outlook

Andy Grieve

Trials. 2011; 12(Suppl 1): A1. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A1

PMCID:: PMC3287670

Article PDF–181K

Adverse effects

Stephen JW Evans

Trials. 2011; 12(Suppl 1): A9. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A9

PMCID:: PMC3287810

Article PDF–192K

Using biomarkers prospectively in adaptive clinical trials

Donald A Berry

Trials. 2011; 12(Suppl 1): A14. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A14

PMCID:: PMC3287715

Article PDF–149K

Statistical issues in the analysis of non-pharmacological therapy trials with clustering by care-provider or therapy group

Chris Roberts

Trials. 2011; 12(Suppl 1): A21. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A21

PMCID:: PMC3287735

Article PDF–187K

Equivalence and non inferiority trials

Ralph B D’Agostino, Sr

Trials. 2011; 12(Suppl 1): A28. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A28

PMCID:: PMC3287742

Article PDF–185K

Streamlining regulation of clinical trials – update on the Academy of Medical Sciences review and government’s response

Gary A Ford

Trials. 2011; 12(Suppl 1): A35. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A35

PMCID:: PMC3287750

Article PDF–151K

Using economic modelling to contribute to the prioritisation and design and clinical trials: ready for prime time

Mark Sculpher

Trials. 2011; 12(Suppl 1): A40. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A40

PMCID:: PMC3287756

Article PDF–149K

Strategies for handling missing data in randomised trials

Ian R White

Trials. 2011; 12(Suppl 1): A59. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A59

PMCID:: PMC3287776

Article PDF–190K

Patient reported outcomes: past, present, and future

Jane A Scott

Trials. 2011; 12(Suppl 1): A63. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A63

PMCID:: PMC3287781

Article PDF–183K

Identifying appropriate phase II trial designs

Sarah R Brown

Trials. 2011; 12(Suppl 1): A87. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A87

PMCID:: PMC3287807

Article PDF–188K

Statistical validation of surrogate outcome measures

Marc Buyse

Trials. 2011; 12(Suppl 1): A93. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A93

PMCID:: PMC3287814

Article PDF–155K

Investigator led trials: challenges and opportunities

Peter Sandercock

Trials. 2011; 12(Suppl 1): A94. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A94

PMCID:: PMC3287815

Article PDF–188K

Seven myths of randomisation in clinical trials

Stephen Senn

Trials. 2011; 12(Suppl 1): A95. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A95

PMCID:: PMC3287816

Article PDF–186K

Trials in rare diseases: the need to think differently

Lucinda Billingham, Kinga Malottki, Mark Pritchard, Neil Steven

Trials. 2011; 12(Suppl 1): A107. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A107

PMCID:: PMC3287679

Article PDF–152K

Recruitment to trials - why is it hard and how might we make it less so?

Shaun Treweek

Trials. 2011; 12(Suppl 1): A110. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A110

PMCID:: PMC3287683

Article PDF–151K

Survival analysis: coping with non proportional hazards in randomized trials

Patrick Royston, Mahesh KB Parmar

Trials. 2011; 12(Suppl 1): A136. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A136

PMCID:: PMC3287711

Article PDF–186K

Randomised controlled trials of complex interventions

John Norrie

Trials. 2011; 12(Suppl 1): A142. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A142

PMCID:: PMC3287718

Article PDF–186K

Oral Presentation

An adaptive seamless phase II/III clinical trial design incorporating short-term endpoint information

Nigel Stallard

Trials. 2011; 12(Suppl 1): A2. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A2

PMCID:: PMC3287733

Article PDF–152K

Flexible trial design in practice – dropping and adding arms in STAMPEDE: a multi-arm multi-stage randomised controlled trial

Matthew R Sydes, Nicholas D James, Malcolm D Mason, Noel W Clarke, Claire Amos, John Anderson, Johann de Bono, David P Dearnaley, John Dwyer, Gordana Jovic, Alastair Ritchie, Martin Russell, Karen Sanders, George Thalmann, Mahesh KB Parmar

Trials. 2011; 12(Suppl 1): A3. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A3

PMCID:: PMC3287744

Article PDF–196K

Optimal design for multi-arm multi-stage clinical trials

James MS Wason, Thomas Jaki

Trials. 2011; 12(Suppl 1): A4. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A4

PMCID:: PMC3287755

Article PDF–185K

Eliciting harms data from trial participants: how perceptions of illness and treatment mediate recognition of relevant information to report

Elizabeth N Allen, Karen I Barnes, Adiel Mushi, Isolide Massawe, Sarah G Staedke, Ushma Mehta, Lasse S Vestergaard, Martha M Lemnge, Clare I Chandler

Trials. 2011; 12(Suppl 1): A10. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A10

PMCID:: PMC3287671

Article PDF–193K

Anti-epileptic drug harms: issues for meta-analysis

Catrin Tudur Smith, Arif Shukralla, Sarah Donegan, Karla Hemming, Graham A Powell, Paula Williamson, Anthony Marson

Trials. 2011; 12(Suppl 1): A11. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A11

PMCID:: PMC3287682

Article PDF–195K

Data modeling methods in clinical trials: experiences from the clinical trial methods in neurodegenerative diseases project

Athanasios Anastasiou, Emmanuel Ifeachor, John Zajicek

Trials. 2011; 12(Suppl 1): A15. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A15

PMCID:: PMC3287726

Article PDF–192K

Stratified medicine in practice: review of predictive biomarkers in European Medicines Agency (EMA) indications

Kinga Malottki, Mousumi Biswas, Jon Deeks, Richard Riley, Charles Craddock, Lucinda Billingham

Trials. 2011; 12(Suppl 1): A16. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A16

PMCID:: PMC3287729

Article PDF–152K

Designing a preliminary adaptive study to inform a biomarker trial in Psoriasis

Andrew T Prevost, Jack Bowden

Trials. 2011; 12(Suppl 1): A17. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A17

PMCID:: PMC3287730

Article PDF–157K

Stratified randomisation: a hidden form of clustering?

Brennan C Kahan, Tim P Morris

Trials. 2011; 12(Suppl 1): A22. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A22

PMCID:: PMC3287736

Article PDF–185K

A review of methodology for sample size calculations in cluster randomised trials

Clare Rutterford, Sandra Eldridge, Andrew Copas

Trials. 2011; 12(Suppl 1): A23. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A23

PMCID:: PMC3287737

Article PDF–152K

Is there a danger of “biocreep” with non-inferiority trials?

Primrose Beryl, Werner Vach

Trials. 2011; 12(Suppl 1): A29. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A29

PMCID:: PMC3287743

Article PDF–199K

Choice of randomisation time-point in non-inferiority studies of reduced treatment duration: experience from the SCOT study

Jim Paul, Tim Iveson, Rachel Midgely, Andrea Harkin, Michelle Masterton, Laura Alexander, Jim Cassidy

Trials. 2011; 12(Suppl 1): A30. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A30

PMCID:: PMC3287745

Article PDF–193K

The evolution of and challenges in defining the clinical endpoint in tuberculosis treatment trials with non-inferiority designs

Patrick PJ Phillips, Angela Crook, Andrew J Nunn

Trials. 2011; 12(Suppl 1): A31. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A31

PMCID:: PMC3287746

Article PDF–154K

Challenges of defining a non-inferiority margin: a case study of non-inferiority randomized controlled trials of oral anti-thrombolytic agents for prophylaxis of venous thromboembolic events after orthopedic surgery

Grace Wangge, Olaf H Klungel, Kit CB Roes, Antonius de Boer, Arno W Hoes, Mirjam J Knol

Trials. 2011; 12(Suppl 1): A32. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A32

PMCID:: PMC3287747

Article PDF–192K

Interim reports for data monitoring committee review vs final reports for regulatory filing

KyungMann Kim

Trials. 2011; 12(Suppl 1): A36. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A36

PMCID:: PMC3287751

Article PDF–185K

A practical solution to ‘Continuing Care Site’ issues in neonatal clinical trials – a pragmatic approach to regulatory and research governance review

Kayleigh Morgan, Ed Juszczak, Ursula Bowler

Trials. 2011; 12(Suppl 1): A37. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A37

PMCID:: PMC3287752

Article PDF–155K

Exploring the ethical and practical challenges of conducting clinical trials in care home settings

Fiona Wood, Hayley Prout, Arun Acharjya, Jacqueline Nuttall, Kerry Hood, Christopher Butler

Trials. 2011; 12(Suppl 1): A38. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A38

PMCID:: PMC3287753

Article PDF–155K

Analysis of adverse events and quality of life data for an economic evaluation of adjuvant chemotherapy in colorectal cancer: when can we stop collecting?

Kathleen A Boyd, Andrew H Briggs, Jim Paul, Tim Iveson, Rachel Midgely, Andrea Harkin, Gaynor Bates, Laura Alexander, Jim Cassidy

Trials. 2011; 12(Suppl 1): A41. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A41

PMCID:: PMC3287757

Article PDF–194K

What is the value of collecting detailed costing data in clinical trials?

Helen Dakin, Giselle Abangma, Sarah Wordsworth

Trials. 2011; 12(Suppl 1): A42. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A42

PMCID:: PMC3287758

Article PDF–193K

Bayesian analysis of trial-based cost-effectiveness in the presence of missing data: effects of including covariates on efficiency of estimation in the ASTER trial

Linda Sharples, Christopher Jackson, Ella Wheaton, Robert Rintoul

Trials. 2011; 12(Suppl 1): A43. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A43

PMCID:: PMC3287759

Article PDF–193K

The influence of CONSORT on the quality of reporting of randomised controlled trials: an updated review

Lucy Turner, David Moher, Larissa Shamseer, Laura Weeks, Jodi Peters, Amy Plint, Douglas G Altman, Kenneth F Schulz

Trials. 2011; 12(Suppl 1): A47. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A47

PMCID:: PMC3287763

Article PDF–196K

What can available randomised controlled trials evaluating monitoring strategies tell us about the design and analysis of future trials?

Jacqueline Dinnes, Jenny Hewison, Doug Altman, Jon Deeks

Trials. 2011; 12(Suppl 1): A48. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A48

PMCID:: PMC3287764

Article PDF–194K

Cochrane systematic reviews as a source of information for practice and trials

Mike Clarke, Thomas T Clarke, Lorcan Clarke

Trials. 2011; 12(Suppl 1): A49. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A49

PMCID:: PMC3287765

Article PDF–160K

Biases in clinical trials with sequential monitoring

Manjula Schou, Ian C Marschner

Trials. 2011; 12(Suppl 1): A50. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A50

PMCID:: PMC3287767

Article PDF–186K

Making best use of existing evidence when planning trials

Verena Roloff, JPT Higgins

Trials. 2011; 12(Suppl 1): A51. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A51

PMCID:: PMC3287768

Article PDF–186K

Protecting intellectual property associated with health technology trials – another barrier to multi-centre trials?

Sue Ross, Laura Magee, Stephen Wood

Trials. 2011; 12(Suppl 1): A52. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A52

PMCID:: PMC3287769

Article PDF–199K

Using linear increment models for the imputation of missing composite outcomes in randomized trials

Aidan G O’Keeffe, Daniel M Farewell, Brian DM Tom, Vernon T Farewell

Trials. 2011; 12(Suppl 1): A60. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A60

PMCID:: PMC3287778

Article PDF–190K

CONSORT: missing missing data guidelines, the effects on HTA monograph reporting

Yvonne Sylvestre

Trials. 2011; 12(Suppl 1): A61. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A61

PMCID:: PMC3287779

Article PDF–150K

The effect of diabetes complications on health-related quality of life: estimating the bias due to unobserved heterogeneity using the UKPDS

Maria L Alva, Alastair Gray, Borislava Mihaylova, Philip Clarke

Trials. 2011; 12(Suppl 1): A64. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A64

PMCID:: PMC3287782

Article PDF–188K

Patient Reported Outcomes: misinference from ordinal scales?

Mike Horton, Alan Tennant

Trials. 2011; 12(Suppl 1): A65. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A65

PMCID:: PMC3287783

Article PDF–155K

Making continuous outcomes meaningful to clinicians

Janet L Peacock, Odile Sauzet, Sally M Kerry

Trials. 2011; 12(Suppl 1): A66. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A66

PMCID:: PMC3287784

Article PDF–153K

Efficiency gains resulting from the ordinal analysis of a functional outcome scale: a case study of a major phase III stroke trial

Gordon D Murray, Else Charlotte Sandset, Philip MW Bath, Eivind Berge

Trials. 2011; 12(Suppl 1): A67. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A67

PMCID:: PMC3287785

Article PDF–155K

Use of an objective measure of time to recovery after cardiac surgery – the STET randomised controlled trial

Chris A Rogers, Katie Pike, Gianni D Angelini, Barney C Reeves

Trials. 2011; 12(Suppl 1): A68. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A68

PMCID:: PMC3287786

Article PDF–152K

The win ratio: a new approach to the analysis of composite endpoints in clinical trials based on clinical priorities

Duolao Wang, Con Ariti, Tim Collier, Stuart Pocock

Trials. 2011; 12(Suppl 1): A69. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A69

PMCID:: PMC3287787

Article PDF–187K

The COMET (Core Outcome Measures in Effectiveness Trials) Initiative

Paula R Williamson, Doug G Altman, Jane M Blazeby, Mike Clarke, Elizabeth Gargon

Trials. 2011; 12(Suppl 1): A70. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A70

PMCID:: PMC3287789

Article PDF–154K

What have we learned from a decade of patient involvement in OMERACT and its effect on trial outcome assessments?

John R Kirwan, Maarten de Wit

Trials. 2011; 12(Suppl 1): A80. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A80

PMCID:: PMC3287800

Article PDF–191K

Consumer involvement at the MRC Clinical Trials Unit: results of a survey

Claire L Vale, Lindsay C Thompson, Silvia Forcat, Claire Murphy, Bec Hanley

Trials. 2011; 12(Suppl 1): A81. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A81

PMCID:: PMC3287801

Article PDF–188K

Phase II investigation of a PARP inhibitor (olaparib) in castration resistant prostate cancer (CRPC) which incorporates the possibility that treatment effect may be restricted to biomarker defined subgroups

Roger A’Hern, Johann DeBono, Shahneen Sandhu, Eletheria Kalaitzaki, Martine Usdin, Emma E Hall

Trials. 2011; 12(Suppl 1): A88. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A88

PMCID:: PMC3287808

Article PDF–193K

Design choices for small-scale phase II trials with non-inferiority (NI) intention

Hong Sun, Shu-Fang Hsu Schmitz

Trials. 2011; 12(Suppl 1): A89. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A89

PMCID:: PMC3287809

Article PDF–154K

A Bayesian dose-finding procedure applied to a seamless phase I/II trial in rheumatoid arthritis

Anne Whitehead, Helene Thygesen, Vladimir Dragalin, John Whitehead

Trials. 2011; 12(Suppl 1): A90. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A90

PMCID:: PMC3287811

Article PDF–188K

Screened selection design for randomised phase II oncology trials: an example in chronic lymphocytic leukaemia

Christina Yap, Lucinda Billingham, Andrew Pettitt

Trials. 2011; 12(Suppl 1): A91. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A91

PMCID:: PMC3287812

Article PDF–194K

Alternative approaches to tuberculosis treatment evaluation: the role of pragmatic trials

Daniel J Bratton, Andrew J Nunn

Trials. 2011; 12(Suppl 1): A96. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A96

PMCID:: PMC3287817

Article PDF–186K

Treatment success in pragmatic randomised controlled trials: a review of trials funded by the UK Health Technology Assessment programme

Louise Dent, James Raftery

Trials. 2011; 12(Suppl 1): A97. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A97

PMCID:: PMC3287818

Article PDF–201K

Pragmatic trials of non-NHS interventions: experiences from a Randomised Controlled Trial of the Strengthening Families 10-14 UK Programme (SFP10-14 UK)

Jo Holliday, J Segrott, H Rothwell, C Phillips, K Hood, Z Roberts, J Scourfield, S Murphy, D Foxcroft, P Daniels, L Moore

Trials. 2011; 12(Suppl 1): A98. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A98

PMCID:: PMC3287819

Article PDF–192K

Generalisability of trials of home blood pressure monitoring; a comparison of two UK primary care trials

Sally M Kerry, Hugh S Markus, Teck K Khong, Pippa Oakeshott

Trials. 2011; 12(Suppl 1): A99. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A99

PMCID:: PMC3287820

Article PDF–201K

Statistical issues in the design of randomised surgical trials: a practical example of the possible solutions

Helen Marshall, Ivana Holloway, Julia M Brown

Trials. 2011; 12(Suppl 1): A100. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A100

PMCID:: PMC3287672

Article PDF–187K

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

Chris Metcalfe

Trials. 2011; 12(Suppl 1): A101. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A101

PMCID:: PMC3287673

Article PDF–149K

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

Veronica Moroz, Jayne Wilson, Keith Wheatley

Trials. 2011; 12(Suppl 1): A108. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A108

PMCID:: PMC3287680

Article PDF–191K

Investigating strategies to improve attendance at screening visits in a randomized trial

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

Trials. 2011; 12(Suppl 1): A111. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A111

PMCID:: PMC3287684

Article PDF–156K

Rates of recruitment from systematic and opportunistic methods: preliminary results from the DDELPHI study

Melvyn Hillsdon

Trials. 2011; 12(Suppl 1): A112. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A112

PMCID:: PMC3287685

Article PDF–151K

FARSITE: evaluation of an automated trial feasibility assessment and recruitment tool

Sarah Thew, Gary Leeming, John Ainsworth, Martin Gibson, Iain Buchan

Trials. 2011; 12(Suppl 1): A113. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A113

PMCID:: PMC3287686

Article PDF–154K

Exploring meaning of participation in a clinical trial in a developing country setting: implications for recruitment

Joanna Reynolds, Peter Mangesho, Lasse S Vestergaard, Clare Chandler

Trials. 2011; 12(Suppl 1): A114. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A114

PMCID:: PMC3287687

Article PDF–194K

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)

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

Trials. 2011; 12(Suppl 1): A115. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A115

PMCID:: PMC3287688

Article PDF–276K

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

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

Trials. 2011; 12(Suppl 1): A116. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A116

PMCID:: PMC3287689

Article PDF–195K

Strategies to reduce attrition in randomised trials

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

Trials. 2011; 12(Suppl 1): A128. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A128

PMCID:: PMC3287702

Article PDF–159K

Departure from treatment protocol in published randomised controlled trials: a review

Susanna Dodd, Ian White, Paula Williamson

Trials. 2011; 12(Suppl 1): A129. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A129

PMCID:: PMC3287703

Article PDF–152K

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)

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

Trials. 2011; 12(Suppl 1): A130. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A130

PMCID:: PMC3287705

Article PDF–197K

Adherence in a randomised controlled trial comparing liberal and restrictive red blood cell (RBC) transfusion protocols after cardiac surgery (TITRe2)

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

Trials. 2011; 12(Suppl 1): A131. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A131

PMCID:: PMC3287706

Article PDF–193K

Crossing survival curves: alternatives to the log-rank test

George Bouliotis, Lucinda Billingham

Trials. 2011; 12(Suppl 1): A137. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A137

PMCID:: PMC3287712

Article PDF–154K

A new measure of predictive ability for survival models

Babak Choodari-Oskooei, Patrick Royston, Mahesh KB Parmar

Trials. 2011; 12(Suppl 1): A138. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A138

PMCID:: PMC3287713

Article PDF–154K

Evaluation of methods to adjust for treatment switching in clinical trials

Richard Fox, Lucinda Billingham, Keith Abrams

Trials. 2011; 12(Suppl 1): A139. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A139

PMCID:: PMC3287714

Article PDF–194K

Designing trials of complex interventions for efficacy and mechanisms evaluation

Richard A Emsley, Jonathan Green, Graham Dunn

Trials. 2011; 12(Suppl 1): A143. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A143

PMCID:: PMC3287719

Article PDF–153K

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

Kimberley Goldsmith, Trudie Chalder, Peter White, Michael Sharpe, Andrew Pickles

Trials. 2011; 12(Suppl 1): A144. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A144

PMCID:: PMC3287720

Article PDF–187K

Statistical design of mental health complex intervention trials

Sabine Landau

Trials. 2011; 12(Suppl 1): A145. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A145

PMCID:: PMC3287721

Article PDF–190K

Modelling multiple outcomes to improve the detection of causal mediation effects in complex intervention trials

Neil Casey, Simon Thompson, Andrew T Prevost

Trials. 2011; 12(Suppl 1): A146. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A146

PMCID:: PMC3287722

Article PDF–196K

MATRICS: A Method for Aggregating The Reporting of Interventions in Complex Studies

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

Trials. 2011; 12(Suppl 1): A147. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A147

PMCID:: PMC3287723

Article PDF–200K

Poster Presentation

Model selection and sample size adaptation: HYPAZ trial

Simon Bond, Adrian Mander, Duncan Jodrell, Joseph Cheryian

Trials. 2011; 12(Suppl 1): A5. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A5

PMCID:: PMC3287766

Article PDF–187K

How Cancer Research UK is adapting to adaptive designs

Julie Hearn, Nicola Keat, Kate Law, Rowena Sharpe

Trials. 2011; 12(Suppl 1): A6. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A6

PMCID:: PMC3287777

Article PDF–191K

The importance of planning for a seamless transition in an adaptive phase II randomised trial

Andrea Marshall, Janet A Dunn, Julie Fletcher, Helen B Higgins, Christopher J Poole

Trials. 2011; 12(Suppl 1): A7. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A7

PMCID:: PMC3287788

Article PDF–151K

Software tools for implementing simulation studies in adaptive seamless designs: introducing R package ASD

Nick Parsons, Tim Friede, Susan Todd, Nigel Stallard

Trials. 2011; 12(Suppl 1): A8. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A8

PMCID:: PMC3287799

Article PDF–191K

Adverse event reporting in randomised trials of neuropathic pain: challenges for clinical usefulness of safety data

Victoria R Cornelius, Odile Sauzet, Salma Ayis, Joy Ross, Paul Farquhar-Smith, Ruth A Branford, John E Williams, Janet L Peacock

Trials. 2011; 12(Suppl 1): A12. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A12

PMCID:: PMC3287693

Article PDF–198K

Documentation of adverse events in non-commercial trials of intravitreal injection of anti-VEGF drugs to treat wet age-related macular degeneration (AMD)

Barnaby C Reeves, Wendy Underwood, Heike Cappel-Porter, Sarah Baos, Chris A Rogers, Michael Arnott, Simon P Harding, Usha Chakravarthy, Alex E Foss

Trials. 2011; 12(Suppl 1): A13. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A13

PMCID:: PMC3287704

Article PDF–193K

Selection of subjects for clinical trials in Alzheimer’s disease and mild cognitive impairment with machine learning analysis of MRI and CSF biomarkers

Javier Escudero, John P Zajicek, Emmanuel Ifeachor

Trials. 2011; 12(Suppl 1): A18. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A18

PMCID:: PMC3287731

Article PDF–207K

Comparing diagnostic tests and biomarkers: trials in people with discordant test results

Richard Hooper, Karla Díaz-Ordaz, Andrea Takeda, Khalid Khan

Trials. 2011; 12(Suppl 1): A19. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A19

PMCID:: PMC3287732

Article PDF–188K

Choice of transformation for modelling non-linear continuous biomarkers

Deborah D Stocken, Lucinda J Billingham, Philip J Johnson, Nick Freemantle

Trials. 2011; 12(Suppl 1): A20. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A20

PMCID:: PMC3287734

Article PDF–149K

Clustering in surgical trials – database of intra-cluster correlations

Jonathan A Cook, Thomas Bruckner, Graeme S MacLennan, Christoph M Seiler

Trials. 2011; 12(Suppl 1): A24. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A24

PMCID:: PMC3287738

Article PDF–153K

Sample size in cluster randomised trials with unequal clusters

Ivana Holloway, Amanda Farrin

Trials. 2011; 12(Suppl 1): A25. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A25

PMCID:: PMC3287739

Article PDF–186K

Sample size determination through power simulation; practical lessons from a stepped wedge cluster randomised trial (SW CRT)

Munyaradzi Dimairo, Mike Bradburn, Stephen J Walters

Trials. 2011; 12(Suppl 1): A26. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A26

PMCID:: PMC3287740

Article PDF–152K

Coping with clustering in sample size calculations

Rebecca Playle, Mark Kelly, Robert Newcombe, Kerry Hood

Trials. 2011; 12(Suppl 1): A27. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A27

PMCID:: PMC3287741

Article PDF–188K

The STAR trial: can quality of life benefit offset any survival detriment?

Fiona Collinson, Janet Brown, Christopher McCabe, Julia Brown, Sandy Tubeuf, Barbara Potrata, Jenny Hewison, Ines Rombach, Peter Selby, Catherine Olivier, Helen Howard, Walter Gregory

Trials. 2011; 12(Suppl 1): A33. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A33

PMCID:: PMC3287748

Article PDF–186K

The ABC of non-inferiority margin setting: an investigation of approaches

Steven A Julious

Trials. 2011; 12(Suppl 1): A34. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A34

PMCID:: PMC3287749

Article PDF–153K

Risk-adapted approaches to the management of clinical trials: guidance from the Department of Health (DH)/Medical Research Council(MRC)/Medicines and Healthcare Products Regulatory Agency (MHRA) Clinical Trials Working Group

Sarah Meredith, Martyn Ward, Gillian Booth, Andrew Fisher, Carrol Gamble, Heather House, Martin Landray

Trials. 2011; 12(Suppl 1): A39. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A39

PMCID:: PMC3287754

Article PDF–192K

HERALD (Health Economics using Routine Anonymised Linked Data)

Muhammad J Husain, Sinead Brophy, Steven Macey, Leila M Pinder, Mark D Atkinson, Roxanne Cooksey, Ceri J Phillips, Stefan Siebert

Trials. 2011; 12(Suppl 1): A44. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A44

PMCID:: PMC3287760

Article PDF–197K

Estimation of cost-effectiveness in randomised controlled trials when not all participants allocated to active intervention receive it

Chris Metcalfe

Trials. 2011; 12(Suppl 1): A45. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A45

PMCID:: PMC3287761

Article PDF–151K

How best to handle the evidence in a cost-effectiveness analysis of TAVI in the UK

Aileen Murphy, Elizabeth Fenwick, Andrew Briggs, Matthew Neilson

Trials. 2011; 12(Suppl 1): A46. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A46

PMCID:: PMC3287762

Article PDF–153K

Stopping clinical trials early for futility: retrospective analysis of several randomised clinical studies

Mark Jitlal, Iftekhar Khan, Siow Ming Lee, Allan Hackshaw

Trials. 2011; 12(Suppl 1): A53. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A53

PMCID:: PMC3287770

Article PDF–154K

The use of systematic reviews in the design of randomised trials

Ashley P Jones, Carrol Gamble, Mike Clarke, Paula R Williamson

Trials. 2011; 12(Suppl 1): A54. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A54

PMCID:: PMC3287771

Article PDF–188K

Central statistical monitoring in clinical trials

Amy A Kirkwood, Allan Hackshaw

Trials. 2011; 12(Suppl 1): A55. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A55

PMCID:: PMC3287772

Article PDF–296K

Feasibility of establishing a central repository for the individual participant data from research studies

Catrin Tudur Smith, Kerry Dwan, Mike Clarke, Richard Riley, Douglas Altman, Paula Williamson

Trials. 2011; 12(Suppl 1): A56. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A56

PMCID:: PMC3287773

Article PDF–187K

Individual participant data meta-analyses compared with meta-analyses based on aggregate data

Catrin Tudur Smith, James Oyee, Maura Marcucci, Maroeska Rovers, Alfonso Iorio, Richard Riley, Paula Williamson, Mike Clarke

Trials. 2011; 12(Suppl 1): A57. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A57

PMCID:: PMC3287774

Article PDF–198K

What are the characteristics of an application (or team) which are associated with success or failure of an application to the NIHR HTA programme for research funding?

Sheila Turner, Peter Davidson, Louise Dent, Elke Streit, Victoria Bowness

Trials. 2011; 12(Suppl 1): A58. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A58

PMCID:: PMC3287775

Article PDF–191K

Simulation study - handling missing covariates in the context of external validation

Laura J Bonnett, Tony G Marson, Paula R Williamson, Catrin Tudur-Smith

Trials. 2011; 12(Suppl 1): A62. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A62

PMCID:: PMC3287780

Article PDF–153K

A mixed methods approach to assess the reliability of a test for the success of blinding in a surgical randomised controlled trial (RCT)

Caroline E Boulind, Kerry Avery, Chris Metcalfe, Nader K Francis, Jane M Blazeby

Trials. 2011; 12(Suppl 1): A71. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A71

PMCID:: PMC3287790

Article PDF–153K

Patient reported clinical outcomes: the challenges and implications for randomised controlled trials

Suzanne Breeman, Alison McDonald, Gladys McPherson, Graeme MacLennan, Marion Campbell, Kath Starr, Seonaidh Cotton

Trials. 2011; 12(Suppl 1): A72. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A72

PMCID:: PMC3287791

Article PDF–151K

Treatment effect bias in randomised controlled trials using surrogate outcomes: a preliminary cohort study analysis

Oriana Ciani, Rod S Taylor

Trials. 2011; 12(Suppl 1): A73. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A73

PMCID:: PMC3287792

Article PDF–207K

Optimising patient recall of adverse events over prolonged time periods

Louise Hiller, Janet A Dunn, Helen B Higgins, Emma Ogburn-Storey, Shrushma Loi, Anne-Laure Vallier, Helena M Earl

Trials. 2011; 12(Suppl 1): A74. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A74

PMCID:: PMC3287793

Article PDF–154K

Applying Rasch analysis to the SF-36 physical function scale: effect of dependent items

Mike Horton, Alan Tennant

Trials. 2011; 12(Suppl 1): A75. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A75

PMCID:: PMC3287794

Article PDF–191K

Incorporating patient reported outcomes (PROs) in gastro-intestinal (GI) cancer randomised controlled trials (RCTs): the need for adequate rationale and integrated reporting

Rhiannon C Macefield, Angus GK McNair, Natalie S Blencowe, Sara T Brookes, Jane M Blazeby

Trials. 2011; 12(Suppl 1): A76. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A76

PMCID:: PMC3287795

Article PDF–154K

The case for a HRQL core outcome set: outcome reporting bias in oesophageal cancer studies

Rhiannon C Macefield, Marc Jacobs, Natalie S Blencowe, Ida J Korfage, Joanna Nicklin, Sara T Brookes, Mirjam A Sprangers, Jane M Blazeby

Trials. 2011; 12(Suppl 1): A77. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A77

PMCID:: PMC3287796

Article PDF–155K

Optimising trial monitoring on the AZURE trial

Geraldine A Matthews, Roger Burkinshaw, Claire Davies, Vicky Hiley, Helen C Marshall, Robert E Coleman

Trials. 2011; 12(Suppl 1): A78. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A78

PMCID:: PMC3287797

Article PDF–154K

Pain assessment: the relationship between pain thresholds and pain severity in osteoarthritis

Vikki Wylde, Shea Palmer, Ian D Learmonth, Paul Dieppe

Trials. 2011; 12(Suppl 1): A79. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A79

PMCID:: PMC3287798

Article PDF–154K

Public involvement in the design and conduct of clinical trials: a narrative review of case examples

Jonathan Boote, Wendy Baird, Anthea Sutton

Trials. 2011; 12(Suppl 1): A82. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A82

PMCID:: PMC3287802

Article PDF–203K

Including service users in trials and rigorous studies in health and social care: developing a standard operating procedure for researchers

Bridie Angela Evans, Emma Bedson, Philip Bell, Hayley Hutchings, Lesley Lowes, David Rea, Anne Seagrove, Stefan Siebert, Graham Smith, Helen Snooks, Marie Thomas, Kym Thorne, Ian Russell

Trials. 2011; 12(Suppl 1): A83. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A83

PMCID:: PMC3287803

Article PDF–195K

Self-help therapy and recovery in psychosis: methodological considerations and service user involvement in a partially randomised preference trial

Samantha Hartley, Gillian Haddock

Trials. 2011; 12(Suppl 1): A84. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A84

PMCID:: PMC3287804

Article PDF–151K

The development of a DVD to aid patients’ understanding of surgical breast reconstruction clinical trials: QUEST Trials A & B

Judith Mills, Maria Emson, Judith M Bliss, Zoe E Winters

Trials. 2011; 12(Suppl 1): A85. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A85

PMCID:: PMC3287805

Article PDF–152K

Research to meet the needs of the NHS: a review of published NIHR HTA clinical trials

Amanda Young, Ruairidh Milne, James Raftery, Louise Dent, David Turner, Peter Davidson, Andrew Cook

Trials. 2011; 12(Suppl 1): A86. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A86

PMCID:: PMC3287806

Article PDF–205K

Experiences in the design and implementation of phase II trials in CLL

Dena R Cohen, Peter Hillmen, Julia M Brown, Walter M Gregory

Trials. 2011; 12(Suppl 1): A92. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A92

PMCID:: PMC3287813

Article PDF–189K

Making the most of animal data – improving the prospect of success in pragmatic trials in the neurosciences

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

Trials. 2011; 12(Suppl 1): A102. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A102

PMCID:: PMC3287674

Article PDF–153K

The CORONIS Trial: international study of caesarean section surgical techniques

Edmund Juszczak, Barbara Farrell

Trials. 2011; 12(Suppl 1): A103. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A103

PMCID:: PMC3287675

Article PDF–196K

Randomised Evaluations of Accepted Choices in Treatment (REACT) trials: large-scale pragmatic trials within databases of routinely collected electronic healthcare records

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

Trials. 2011; 12(Suppl 1): A104. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A104

PMCID:: PMC3287676

Article PDF–154K

QUEST Perspective Study (QPS) to measure the understanding by patients and healthcare professionals of surgical breast reconstruction clinical trials: QUEST Trials A & B

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

Trials. 2011; 12(Suppl 1): A105. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A105

PMCID:: PMC3287677

Article PDF–154K

Strategic use of new generation antidepressants for depression, SUN(^_^)D : study design and rationale

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

Trials. 2011; 12(Suppl 1): A106. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A106

PMCID:: PMC3287678

Article PDF–195K

Recruitment into trials of rare conditions - experiences from the STOP GAP trial

Trials. 2011; 12(Suppl 1): A109. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A109

PMCID:: PMC3287681

Article PDF–189K

Recruiting patients cost-effectively by mail

Theingi Aung, Helen Cowan, Richard Haynes, Louise Bowman, Jane Armitage

Trials. 2011; 12(Suppl 1): A117. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A117

PMCID:: PMC3287690

Article PDF–198K

Analysis and validation of a Parkinson’s disease register as a recruitment tool for clinical studies

Camille B Carroll, Amy Palmer, Christine Cosby, John P Zajicek

Trials. 2011; 12(Suppl 1): A118. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A118

PMCID:: PMC3287691

Article PDF–194K

Recruiting patients with advanced malignant and non-malignant disease: lessons learned from a palliative care RCT

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

Trials. 2011; 12(Suppl 1): A119. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A119

PMCID:: PMC3287692

Article PDF–152K

Recruitment to the pilot phase of Start2quit – lessons learned

Leanne M Gardner, Hazel Gilbert, Irwin Nazareth

Trials. 2011; 12(Suppl 1): A120. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A120

PMCID:: PMC3287694

Article PDF–152K

Analysis of patient information leaflets (PILs), used in clinical trials using the Informed Consent Evaluation instrument (ICEi)

Katie Gillies, Wan Huang, Zoe Skea, Seonaidh Cotton

Trials. 2011; 12(Suppl 1): A121. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A121

PMCID:: PMC3287695

Article PDF–196K

The complexities of maximising recruitment to complex intervention trials in child and adolescent mental health services

David Cottrell, Liz Graham, Amanda Farrin

Trials. 2011; 12(Suppl 1): A122. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A122

PMCID:: PMC3287696

Article PDF–154K

Can we improve recruitment to trials and informed consent by improving participant information sheets? - A nested RCT

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

Trials. 2011; 12(Suppl 1): A123. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A123

PMCID:: PMC3287697

Article PDF–194K

Addressing patient treatment preferences at trial recruitment

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

Trials. 2011; 12(Suppl 1): A124. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A124

PMCID:: PMC3287698

Article PDF–153K

Releasing interim results from a randomised clinical trial: an example from the QUARTZ trial

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

Trials. 2011; 12(Suppl 1): A125. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A125

PMCID:: PMC3287699

Article PDF–153K

Recruiting ahead of target: What worked in the REEACT trial?

Puvan Tharmanathan, Gwen Brierley, Elizabeth Littlewood, Phil Andersen, Simon Gilbody

Trials. 2011; 12(Suppl 1): A126. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A126

PMCID:: PMC3287700

Article PDF–196K

Recruiting and retaining medical patients in trials of complex interventions: practical experience of challenges and solutions in three multi-centre trials

Jane Walker, Michael Sharpe

Trials. 2011; 12(Suppl 1): A127. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A127

PMCID:: PMC3287701

Article PDF–152K

Complexities of retention in primary care randomised trials: A thematic analysis of in-depth interviews

Valerie Brueton, Fiona Stevenson, Claire Vale, Greta Rait

Trials. 2011; 12(Suppl 1): A132. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A132

PMCID:: PMC3287707

Article PDF–194K

Maximising adherence to study protocol within pharmaco-rehabilitation clinical trials

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

Trials. 2011; 12(Suppl 1): A133. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A133

PMCID:: PMC3287708

Article PDF–193K

Understanding factors influencing questionnaire response rates to maximise retention in a long term complex intervention trial

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

Trials. 2011; 12(Suppl 1): A134. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A134

PMCID:: PMC3287709

Article PDF–192K

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

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

Trials. 2011; 12(Suppl 1): A135. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A135

PMCID:: PMC3287710

Article PDF–151K

Impact of the censoring distribution on time-to-event problems in the presence of competing risks

Mark W Donoghoe, Val Gebski

Trials. 2011; 12(Suppl 1): A140. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A140

PMCID:: PMC3287716

Article PDF–153K

A robust parameterisation for the analysis of survival data in the presence of covariates with extreme value observations

Richard Jackson, Trevor Cox

Trials. 2011; 12(Suppl 1): A141. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A141

PMCID:: PMC3287717

Article PDF–161K

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

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

Trials. 2011; 12(Suppl 1): A148. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A148

PMCID:: PMC3287724

Article PDF–192K

Designing and analysing pragmatic clinical trials of complex interventions in mental health: challenges and solutions

Amanda J Farrin, Michelle Collinson

Trials. 2011; 12(Suppl 1): A149. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A149

PMCID:: PMC3287725

Article PDF–155K

A pilot factorial randomised cohort trial of manual therapy or acupuncture for low back pain

Vivienne C Dascanio, Yvonne Birks, David Torgerson

Trials. 2011; 12(Suppl 1): A150. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A150

PMCID:: PMC3287727

Article PDF–197K

Practical and methodological challenges in the design and implementation of a cluster-randomised feasibility trial of the management of urinary incontinence after stroke

Chris J Sutton, Lois Thomas, Denise Forshaw, Caroline L Watkins

Trials. 2011; 12(Suppl 1): A151. Published online 2011 Dec 13. doi: 10.1186/1745-6215-12-S1-A151

PMCID:: PMC3287728

Article PDF–194K

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