Volume 16 Supplement 2

3rd International Clinical Trials Methodology Conference

Meeting abstracts

Publication of this supplement was funded by the 3rd Clinical Trials Methodology Conference.

3rd International Clinical Trials Methodology Conference. Go to conference site.

Glasgow, UK16-17 November 2015

Concatenated PDF V16 S2

Page 4 of 7

Minimal clinically important difference (MCID) of the SCL-20 measure of depression severity in patients with cancer and major depression

Authors: Bethan Copsey, Jane Walker, Susan Dutton, Rebecca Fisher and Michael Sharpe

Citation: Trials 2015 16(Suppl 2):P54

Content type: Poster presentation

Published on: 16 November 2015
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Core harm outcome sets developed by drug are needed to allow informed risk-benefit decision making

Authors: Victoria Cornelius, Kun Liu, Janet Peacock and Odile Sauzet

Citation: Trials 2015 16(Suppl 2):P55

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Published on: 16 November 2015
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Modifying a validated instrument: the Aberdeen varicose vein questionnaire

Authors: Aleksandra Staniszewska, Seonaidh Cotton, Graeme MacLennan and Julie Brittenden

Citation: Trials 2015 16(Suppl 2):P56

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Published on: 16 November 2015
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Choosing outcomes for a core outcome set: does provision of feedback between delphi survey rounds help prioritise items?

Authors: Karen Coulman, Sara Brookes, Katy Chalmers, James Hopkins, Noah Howes, Alex Nicholson, Amanda Owen-Smith, Katie Whale and Jane Blazeby

Citation: Trials 2015 16(Suppl 2):P57

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A comparison of an objective and subjective test of stress urinary incontinence (SUI) and their acceptability to participants

Authors: Tracey Davidson, Alison McDonald, Gladys McPherson and John Norrie

Citation: Trials 2015 16(Suppl 2):P58

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Using a consensus technique for improving the methodology of clinical trials assessing treatments for Cutaneous Leishmaniasis

Authors: Astrid Erber, Liliana Lopez-Carvajal, Byron Arana, Trudie Lang and Piero Olliaro

Citation: Trials 2015 16(Suppl 2):P59

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A mixed methods study of researchers’ experiences of developing core outcome sets

Authors: Elizabeth Gargon, Bridget Young and Paula Williamson

Citation: Trials 2015 16(Suppl 2):P60

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Can vascular mortality be reliably ascertained from the underlying cause of death recorded on a medical death certificate? Evidence from 2800 adjudicated heart protection study (HPS) deaths

Authors: William Herrington, Karl Wallendszus, Louise Bowman, Martin Landray and Jane Armitage

Citation: Trials 2015 16(Suppl 2):P61

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Analysis of continuous biochemical parameters in long-term trials of chronic disease where outcomes could be affected by further intervention

Authors: Natalie Ives, Samir Mehta, Elizabeth Brettell, Marie Valente and Sunil Bhandari

Citation: Trials 2015 16(Suppl 2):P62

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Published on: 16 November 2015
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Improving phase ii oncology trial using best observed RECIST response as an endpoint by modelling continuous tumour measurements

Authors: Chien-Ju Lin and James Wason

Citation: Trials 2015 16(Suppl 2):P63

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Published on: 16 November 2015
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Are patients and health care professionals influenced by each other's’ opinions about the outcomes to measure in localised prostate cancer effectiveness trials?

Authors: Steven MacLennan, Thomas Lam and Paula Williamson

Citation: Trials 2015 16(Suppl 2):P64

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Core outcomes for randomized trials and core information for clinical decision-making: implications for outcome selection

Authors: Angus McNair, Robert Whistance, Rachel Forsythe, Rhiannon Macefield, Sara Brookes and Jane Blazeby

Citation: Trials 2015 16(Suppl 2):P65

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Exploring the reasons for the sensitivity to change of a patient preference measure, compared with the KOOS questionnaire in patellofemoral osteoarthritis

Authors: Matthew Parkes, Michael Callaghan and David Felson

Citation: Trials 2015 16(Suppl 2):P66

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Published on: 16 November 2015
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The current practice of handling and reporting missing outcome data in eight widely-used PROMS in RCT publications: are we doing well?

Authors: Ines Rombach, Oliver Rivero-Arias, Crispin Jenkinson, Alastair Gray and Órlaith Burke

Citation: Trials 2015 16(Suppl 2):P67

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Validation of the Vitiligo noticeability scale: a patient-reported outcome measure of Vitiligo treatment success

Authors: Jonathan Batchelor, Wei Tan, Selina Tour, Andrian Yong, Alan Montgomery and Kim Thomas

Citation: Trials 2015 16(Suppl 2):P68

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The core outcome measures in effectiveness trials (COMET) initiative: five years on

Authors: Paula Williamson, Douglas Altman, Jane Blazeby, Michael Clarke, Elizabeth Gargon, Sarah Gorst and Sean Tunis

Citation: Trials 2015 16(Suppl 2):P69

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Clinicians’ and womens’ experiences of two consent pathways in a trial of timing of clamping at very preterm birth: a qualitative study

Authors: Susan Ayers, Alex Sawyer, Celine Chhoa, Angela Pushpa-Rajah and Lelia Duley

Citation: Trials 2015 16(Suppl 2):P70

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The treatment preferences of adolescents and their parents, what has the smile RCT shown us? Smile: specialist medical intervention and lightning evaluation

Authors: Lucy Beasant, Nicola Mills and Esther Crawley

Citation: Trials 2015 16(Suppl 2):P71

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Patient and health professionals’ perspectives on the use of ciclosporin and infliximab when treating acute severe ulcerative colitis: an added dimension to the construct trial

Authors: Clare Clement and Frances Rapport

Citation: Trials 2015 16(Suppl 2):P72

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Early qualitative analysis to enhance trial processes

Authors: Will Storrar, Ann Dewey, Anoop Chauhan, Carole Fogg, Ellie Lanning, Thomas Brown and Lara Balls

Citation: Trials 2015 16(Suppl 2):P73

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Using qualitative interviews with nihr crn research midwives to refine trial recruitment methods

Authors: Katharine Foster, Katharine Bowker, Sophie Orton, Felix Naughton, Sue Cooper and Tim Coleman

Citation: Trials 2015 16(Suppl 2):P74

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Qualitative methods and patient and public involvement in trials: opportunities and pitfalls

Authors: Pat Hoddinott, Alicia O'Cathain, Isabel Boyer and Sandy Oliver

Citation: Trials 2015 16(Suppl 2):P75

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Q methodology with cognitive interviewing to rank the importance of informational items in a patient information leaflet

Authors: Karen Innes, Katie Gillies, Seonaidh Cotton and Marion Campbell

Citation: Trials 2015 16(Suppl 2):P76

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Using conversation analytic methods to explore the content, delivery and receipt of complex healthcare interventions

Authors: Rebecca K Barnes, Marcus Jepson and Alison Heawood

Citation: Trials 2015 16(Suppl 2):P77

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Published on: 16 November 2015
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Enhancing public involvement in trial oversight committees through qualitative research with eight trials facing challenges

Authors: A Nicholson, A Daykin, R Macefield, S McCann, G Shorter, M Sydes, C Gamble, A Shaw and JA Lane

Citation: Trials 2015 16(Suppl 2):P78

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What do young people really understand when completing questionnaires? Lessons learnt from developing a questionnaire to measure behavioural outcomes in a sexual health trial

Authors: Lisa Maguire, Aine Aventin, Maria Lohan and Mike Clarke

Citation: Trials 2015 16(Suppl 2):P79

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Defining usual care: do we need to think beyond clinical equipoise? A synthesis and secondary analysis of multiple qualitative data sets

Authors: Katrina Turner, John Percival, Jenny Donovan and David Kessler

Citation: Trials 2015 16(Suppl 2):P80

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Recruiting schools, adolescents and parents to a sexual-health trial: experiences, challenges and lessons learned from the Jack Trial (NCT02092480)

Authors: Aine Aventin, Lisa Maguire, Mike Clarke and Maria Lohan

Citation: Trials 2015 16(Suppl 2):P81

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Understanding the role of teamwork in recruitment to randomised controlled trials in surgical oncology-results from an exploratory study

Authors: Sean Strong, Sangeetha Paramasivan, Caroline Wilson, Nicola Mills, Jenny Donovan and Jane Blazeby

Citation: Trials 2015 16(Suppl 2):P82

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A poetic story: lessons learnt from the world's largest breast cancer window of opportunity study

Authors: Judith Bliss, Alexa Gillman, Lucy Kilburn, James Morden, Kally Sidhu, Maggie Wilcox, Abigail Evans, Christopher Holcombe, Kieran Horgan, Anthony Skene, Raghavan Vidya, John Robertson, Mitch Dowsett and Ian Smith

Citation: Trials 2015 16(Suppl 2):P83

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Testing the effectiveness of user-tested patient information on recruitment rates across multiple trials: meta-analysis of data from the start programme

Authors: Peter Bower, Jo Rick, Anne Kennedy, Chris Salisbury, David Collier, David Torgerson, Jonathan Graffy, Shaun Treweek, Sandra Eldridge, Vichithranie Madurasinghe, Peter Knapp, Adwoa Hughes-Morley and Nicola Small

Citation: Trials 2015 16(Suppl 2):P84

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Published on: 16 November 2015
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Modelling clinical trial recruitment using poisson processes

Authors: Kristian Brock, Christina Yap, Gary Middleton and Lucinda Billingham

Citation: Trials 2015 16(Suppl 2):P85

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People with Parkinson's design clinical trials charter to improve communication about, recruitment to and retention in Parkinson's clinical trials

Authors: Jon Stamford, Tom Isaacs and Camille Carroll

Citation: Trials 2015 16(Suppl 2):P86

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Published on: 16 November 2015
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The reform patient information sheet sub study - an embedded trial evaluating the enhancement of patient information sheets to improve recruitment

Authors: Sarah Cockayne, Joy Adamson, Peter Bower, Belen Corbacho, Caroline Fairhurst, Lisa Farndon, Kate Hicks, Anne-Maree Keenan, Peter Knapp, Sally Lamb, Lorraine Loughrey, Caroline McIntosh, Hylton Menz, Anthony Redmond, Jo Rick, Sara Rodgers…

Citation: Trials 2015 16(Suppl 2):P87

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SMS text pre-notification and delivery of reminder e-mails to increase response rates to postal questionnaires: a factorial design, randomised, controlled trial

Authors: Kath Starr, Gladys McPherson, Mark Forrest and Seonaidh Cotton

Citation: Trials 2015 16(Suppl 2):P88

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Published on: 16 November 2015
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Developing a patient and public involvement intervention to enhance recruitment and retention in surgical trials (PIRRIST): study protocol

Authors: Joanna Crocker, Sian Rees, Louise Locock, Sophie Petit-Zeman, Alan Chant, Shaun Treweek, Jonathan Cook, Nicola Farrar, Kerry Woolfall and Richard Bulbulia

Citation: Trials 2015 16(Suppl 2):P89

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Just a simple observational follow-up study?

Authors: Lucy Culliford, Tracy Harris, Vhris Rogers, Usha Chakravarthy and Barney Reeves

Citation: Trials 2015 16(Suppl 2):P90

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Published on: 16 November 2015
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Does size matter? Trial management strategies to increase response rates. The assessment of physical questionnaire size on response rates (APS) sub-study

Authors: Tracey Davidson, Gladys McPherson, Alison McDonald and John Norrie

Citation: Trials 2015 16(Suppl 2):P91

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Published on: 16 November 2015
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Improving trial questionnaire response rates using behaviour change theory

Authors: Anne Duncan, Debbie Bonetti, Jan Clarkson and Craig Ramsay

Citation: Trials 2015 16(Suppl 2):P92

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Published on: 16 November 2015
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Conducting complex intervention trials in populations at risk of diminished capacity

Authors: Amanda Farrin, Suzanne Hartley, Liz Graham, Rachael Kelley, Claire Surr, Alys Griffiths and Louise Bryant

Citation: Trials 2015 16(Suppl 2):P93

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Published on: 16 November 2015
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Specialist nurses’ perceptions of the barriers and facilitators to inviting adult NHS patients to participate in clinical research studies: a qualitative descriptive study

Authors: Caroline French and Charitini Stavropoulou

Citation: Trials 2015 16(Suppl 2):P94

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Published on: 16 November 2015
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Recruitment challenges in physiotherapy trials

Authors: Varsha Gandhi, Cushla Cooper and Karen Barker

Citation: Trials 2015 16(Suppl 2):P95

Content type: Poster presentation

Published on: 16 November 2015
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Complexities of trial recruitment in the care home setting: an illustration via the DCM™epic (dementia care mapping™: to enable person-centred care in care homes) trial

Authors: Claire Surr, Amanda Lilley-Kelly, Liz Graham, Rebecca Walwyn, Robert Cicero, Alys Griffiths, Byron Creese and Lucy Garrod

Citation: Trials 2015 16(Suppl 2):P96

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Published on: 16 November 2015
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Evaluation of the effects of an offer of an incentive on the rate of questionnaire return: a nested RCT

Authors: Pollyanna Hardy and Peter Brocklehurst

Citation: Trials 2015 16(Suppl 2):P97

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Published on: 16 November 2015
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Development of an online resource for recruitment research in clinical trials (ORRCA)

Authors: Nicola Harman, Shaun Treweek, Mike Clarke, Paula Williamson, Pete Bower and Carrol Gamble

Citation: Trials 2015 16(Suppl 2):P98

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Published on: 16 November 2015
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Use of a mobile workforce to improve recruitment across multiple sites within a local clinical research network

Authors: Robert Hughes, Dawn Beaumont-Jewell, Rachel Taylor and Kylie Gyertson

Citation: Trials 2015 16(Suppl 2):P99

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Published on: 16 November 2015
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Advertising patient and public involvement in trials as a way of improving participant recruitment: development of an intervention and its evaluation

Authors: Adwoa Hughes-Morley, Bridget Young, Mark Hann and Waquas Waheed

Citation: Trials 2015 16(Suppl 2):P100

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Published on: 16 November 2015
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Reported reasons for missing data and the interplay with trial setting

Authors: Anna Kearney, Naomi Bacon, Anna Rosala-Hallas, Anne Daykin, Ali Heawood, Athene Lane, Jane Blazeby, Mike Clarke, Paula Williamson and Carrol Gamble

Citation: Trials 2015 16(Suppl 2):P101

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Published on: 16 November 2015
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Post-it notes to improve questionnaire response rates in RCTs - findings from a randomised sub-study

Authors: Ada Keding, Helen Lewis, Kate Bosanquet, Simon Gilbody, Hannah Buckley, Helen Tilbrook and David Torgerson

Citation: Trials 2015 16(Suppl 2):P102

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Published on: 16 November 2015
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Text message reminders to improve questionnaire response rates in RCTs: findings from three randomised sub-studies

Authors: Ada Keding, Sally Brabyn, Hugh MacPherson, Stewart Richmond and David Torgerson

Citation: Trials 2015 16(Suppl 2):P103

Content type: Poster presentation

Published on: 16 November 2015
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