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 1 of 7

Content type: Invited speaker presentation

The madness of HIV prevention trials

Authors: S McCormack

Citation: Trials 2015 16(Suppl 2):I1

Published on: 16 November 2015
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Content type: Invited speaker presentation

Discussion session: biomarker trials

Authors:

Citation: Trials 2015 16(Suppl 2):I2

Published on: 16 November 2015
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Content type: Invited speaker presentation

Science in a crisis: conducting clinical trials in an emergency

Authors: P Horby

Citation: Trials 2015 16(Suppl 2):I3

Published on: 16 November 2015
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Content type: Oral presentation

Good practice principles for sharing individual participant data from publicly funded clinical trials

Authors: Catrin Tudur Smith, Carolyn Hopkins, Matt Sydes, Kerry Woolfall, Mike Clarke, Gordon Murray and Paula Williamson

Citation: Trials 2015 16(Suppl 2):O1

Published on: 16 November 2015
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Content type: Oral presentation

Reading or listening to review summaries - which method will produce greater understanding of the key outcomes in a cochrane review?

Authors: Lisa Maguire, Mike Clarke and Mark Tully

Citation: Trials 2015 16(Suppl 2):O2

Published on: 16 November 2015
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Content type: Oral presentation

How are systematic reviews used in the planning and design of health technology assessment funded trials?

Authors: Sheetal Bhurke, Andrew Cook, Anna Tallant, Amanda Young, Elaine Williams and James Raftery

Citation: Trials 2015 16(Suppl 2):O3

Published on: 16 November 2015
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Content type: Oral presentation

The value of evidence synthesis in randomised controlled trial (RCT) design, conduct and analysis: MRC clinical trials unit (CTU) at UCL experience

Authors: Jayne F Tierney, Sarah Burdett, Claire Vale, Larysa Rydzewska, Matthew R Sydes, Ruth E Langley, Richard S Kaplan and Mahesh KB Parmar

Citation: Trials 2015 16(Suppl 2):O4

Published on: 16 November 2015
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Content type: Oral presentation

Methods for selecting health concepts and domains from in-depth qualitative interviews for the development of patient reported outcome measures (PROMS): a case study

Authors: Jane Blazeby, Leila Rooshenas, Rhiannon Macefield, Daisy Townsend and Tom Milne

Citation: Trials 2015 16(Suppl 2):O5

Published on: 16 November 2015
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Content type: Oral presentation

Development of a single, practical measure of surgical site infection (SSI) for patient self-report and observer completion: a novel method of questionnaire design

Authors: Rhiannon Macefield, Alex Nicholson, Tom Milne, Thomas Pinkney, Melanie Calvert, Kerry Avery, Barnaby Reeves and Jane Blazeby

Citation: Trials 2015 16(Suppl 2):O6

Published on: 16 November 2015
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Content type: Oral presentation

Understanding patterns of adverse events after surgery and their impact on recovery

Authors: Rachel L Nash, Barnaby C Reeves, Gianni D Angelini and Chris A Rogers

Citation: Trials 2015 16(Suppl 2):O7

Published on: 16 November 2015
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Content type: Oral presentation

Ongoing validation of health-related quality of life instruments

Authors: Kim Cocks and Puvan Tharmanathan

Citation: Trials 2015 16(Suppl 2):O8

Published on: 16 November 2015
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Content type: Oral presentation

Trials within trials of interventions to improve recruitment and retention: the experience of York Trials Unit

Authors: David Torgerson and Caroline Fairhurst

Citation: Trials 2015 16(Suppl 2):O9

Published on: 16 November 2015
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Content type: Oral presentation

Assessing the effectiveness of a ‘site visit’ on recruitment rates in a multicentre randomised trial: SWAT-1

Authors: Valerie Smith, Mike Clarke, Cecily Begley and Declan Devane

Citation: Trials 2015 16(Suppl 2):O10

Published on: 16 November 2015
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Content type: Oral presentation

Scoop pen sub-study-a ‘trial within a trial’ of enclosing a pen in questionnaire mailings to increase response rate

Authors: Caroline Fairhurst, Kerry Bell, Laura Clark, Natasha Mitchell, Elizabeth Lenaghan, Jeanette Blacklock, Lee Shepstone and David Torgerson

Citation: Trials 2015 16(Suppl 2):O11

Published on: 16 November 2015
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Content type: Oral presentation

Developing guidelines for reporting embedded recruitment trials

Authors: Vichithranie W Madurasinghe, Sandra Eldridge and Gordon Forbes

Citation: Trials 2015 16(Suppl 2):O12

Published on: 16 November 2015
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Content type: Oral presentation

Dose transition pathways: a design, analysis and operational tool for dose-finding trials using model-based designs

Authors: Christina Yap, Lucinda Billingham, Charles Craddock and John O'Quigley

Citation: Trials 2015 16(Suppl 2):O13

Published on: 16 November 2015
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Content type: Oral presentation

Conducting a randomised trial during an influenza pandemic: an example of a trial set up and ‘hibernated’ ready to activate and recruit within 4 weeks

Authors: Clare Brittain, Garry Meakin, Margo Childs, Lelia Duley and Wei Shen Lim

Citation: Trials 2015 16(Suppl 2):O14

Published on: 16 November 2015
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Content type: Oral presentation

Using the UK renal registry for a clinical trial in dialysis patients: the example of SIMPLIFIED

Authors: Simon Bond, Rupert Payne, Edward Wilson, Afzal Chowdry, Fergus Caskey, David Wheeler and Thomas Hiemstra

Citation: Trials 2015 16(Suppl 2):O15

Published on: 16 November 2015
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Content type: Oral presentation

The design of a multi-arm multi-stage (MAMS) phase III randomised controlled trial comparing alternative regimens for escalating (COMPARE) treatment of intermediate and high-risk oropharyngeal cancer with reflections on the complications of introducing a new experimental ARM

Authors: Piers Gaunt, Hisham Mehanna and Christina Yap

Citation: Trials 2015 16(Suppl 2):O16

Published on: 16 November 2015
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Content type: Oral presentation

Progression from an internal pilot of a main trial including adaptation from a two to three group study - straightforward to do?

Authors: Danielle Edwards, Graziella Mazza, Rachael Heys, Caroline Wilson, Jane Blazeby and Chris Rogers

Citation: Trials 2015 16(Suppl 2):O17

Published on: 16 November 2015
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Content type: Oral presentation

Adapting a trial design based on feasibility of recruitment where several treatment groups are possible and the outcome is long-term: pre-empt flexible-entry internal pilot study

Authors: Lee Middleton, Jane Daniels, Kostas Tryposkiadis, Laura Gennard, Lisa Leighton and Siladitya Bhattacharya

Citation: Trials 2015 16(Suppl 2):O18

Published on: 16 November 2015
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Content type: Oral presentation

The use of early decision modelling and value of information analysis in an adaptive trial design: results from the OPTIMA preliminary study

Authors: Peter Hall, Alison Smith, Claire Hulme, Armando Vargas-Palacios, Janet Dunn, Andrea Marshall, John Bartlett, Rob Stein, David Cameron and Christopher McCabe

Citation: Trials 2015 16(Suppl 2):O19

Published on: 16 November 2015
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Content type: Oral presentation

Meandering journey towards routine trial adaptation: survey results on barriers to use of adaptive designs in confirmatory trials

Authors: Munyaradzi Dimairo, Steven Julious, Susan Todd and Jonathan Nicholl

Citation: Trials 2015 16(Suppl 2):O20

Published on: 16 November 2015
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Content type: Oral presentation

What does a good RCT recruitment consultation look like? A new simple six-step model to promote information sharing and recruitment to RCTs

Authors: Alba Realpe, Ann Adams, Peter Wall, Damian Griffin and Jenny L Donovan

Citation: Trials 2015 16(Suppl 2):O21

Published on: 16 November 2015
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Content type: Oral presentation

Using vignettes to understand variations in patient screening and recruitment

Authors: Elaine McColl, Paul Hilton and Cath Brennand

Citation: Trials 2015 16(Suppl 2):O22

Published on: 16 November 2015
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Content type: Oral presentation

Exploring challenges of RCTs in the emergency and critical care setting

Authors: Paul Mouncey, Sarah Power, David Harrison, Sheila Harvey and Kathryn Rowan

Citation: Trials 2015 16(Suppl 2):O23

Published on: 16 November 2015
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Content type: Oral presentation

Use of home visits increases data completion and retention in studies involving family members

Authors: Katie Biggs and Cindy Cooper

Citation: Trials 2015 16(Suppl 2):O24

Published on: 16 November 2015
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Content type: Oral presentation

Can using a resource use log in an economic evaluation alongside a randomised controlled trial reduce the amount of recall bias?

Authors: Sian Noble, Isobel Tudge, Vikki Wylde, Erik Lenguerrand and Elsa Marques

Citation: Trials 2015 16(Suppl 2):O25

Published on: 16 November 2015
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Content type: Oral presentation

Identification of items for a standardised resource-use measure: review of current instruments

Authors: Joanna Thorn, Colin Ridyard, Ruth Riley, Sara Brookes, Dyfrig Hughes, Sarah Wordsworth, Sian Noble and William Hollingworth

Citation: Trials 2015 16(Suppl 2):O26

Published on: 16 November 2015
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Content type: Oral presentation

Modelling cost-effectiveness and value of information in clinical trials to inform stop go decisions: results from the arctic study

Authors: Alison Smith, Peter Hall, John O'Dwyer, Claire Hulme, Dena Cohen and Walter Gregory

Citation: Trials 2015 16(Suppl 2):O27

Published on: 16 November 2015
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Content type: Oral presentation

The use of hospital episode statistics (HES) records alongside clinical trials

Authors: Belen Corbacho, Kerry Bell, Rita Santos and David Torgerson

Citation: Trials 2015 16(Suppl 2):O28

Published on: 16 November 2015
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Content type: Oral presentation

Researchers' experiences of optimising complex health interventions before full-scale RCTs: results from an exploratory multiple case study

Authors: Sara Levati, Suzanne Hagen, Cam Donaldson and Mary Wells

Citation: Trials 2015 16(Suppl 2):O29

Published on: 16 November 2015
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Content type: Oral presentation

Barriers to blinding: an analysis of the feasibility of blinding in test-treatment RCTS

Authors: Lavinia Ferrante di Ruffano and Jon Deeks

Citation: Trials 2015 16(Suppl 2):O30

Published on: 16 November 2015
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Content type: Oral presentation

Can we implement findings from RCTs of diagnostic tests? A review of reporting of test-treat interventions

Authors: Lavinia Ferrante di Ruffano, Jac Dinnes, Sian Phillips-Taylor, Clare Davenport, Chris Hyde and Jon Deeks

Citation: Trials 2015 16(Suppl 2):O31

Published on: 16 November 2015
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Content type: Oral presentation

Complex considerations for randomisation across linked randomised trials of complex interventions: illustration from the affinitie programme

Authors: Robert Cicero, Rebecca Walwyn, Amanda Farrin, Robbie Foy, Jillian Francis, Natalie Gould, Fabiana Lorencatto and Simon Stanworth

Citation: Trials 2015 16(Suppl 2):O32

Published on: 16 November 2015
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Content type: Oral presentation

Impact of timing of follow-up upon outcome in the TOPKAT trial

Authors: Jonathan Cook, Graeme MacLennan, David Murray, Andrew Price, Ray Fitzpatrick, Andrew Carr, Marion Campbell, Helen Campbell, Nigel Arden, Cushla Cooper, Loretta Davies and David Beard

Citation: Trials 2015 16(Suppl 2):O33

Published on: 16 November 2015
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Content type: Oral presentation

Methods for standardising and monitoring surgical interventions in RCTs

Authors: Natalie Blencowe, Nicola Mills, Jenny Donovan and Jane Blazeby

Citation: Trials 2015 16(Suppl 2):O34

Published on: 16 November 2015
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Content type: Oral presentation

How pre-trial qualitative research can change proposed RCT design: a case study and implications for future research

Authors: Leila Rooshenas, Christel Mcmullen, Jonathan Mathers, Daisy Townsend, Jenny Donovan and Jane Blazeby

Citation: Trials 2015 16(Suppl 2):O35

Published on: 16 November 2015
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Content type: Oral presentation

“It's what we call a randomised control trial” exploring how randomisation is presented by recruiters in RCTs

Authors: Marcus Jepson, Daisy Townsend, Julia Wade, Carmel Conefrey and Jenny Donovan

Citation: Trials 2015 16(Suppl 2):O36

Published on: 16 November 2015
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Content type: Oral presentation

The importance of rapport and relationship building when recruiting to clinical trials: a qualitative investigation of trial recruitment consultations in a surgical RCT

Authors: Lynda Constable, Danielle Pirie, Katie Gillies, Sharon McCann, Suzanne Breeman and Cathryn Glazener

Citation: Trials 2015 16(Suppl 2):O37

Published on: 16 November 2015
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Content type: Oral presentation

“You have to keep your nerve on a DMC.” Challenges for data monitoring committees in neonatal intensive care trials: qualitative accounts from the bracelet study

Authors: Claire Snowdon, Diana Elbourne, Peter Brocklehurst, Martin Ward Platt and Robert Tasker

Citation: Trials 2015 16(Suppl 2):O38

Published on: 16 November 2015
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Content type: Oral presentation

Using qualitative research to understand what outcomes matter to patients: direct and indirect approaches to outcome elicitation

Authors: Jonathan Mathers, Thomas Keeley, Laura Jones, Melanie Calvert, Paula Williamson, Janet Jones, Christel McMullan, Susan Wright and Bridget Young

Citation: Trials 2015 16(Suppl 2):O39

Published on: 16 November 2015
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Content type: Oral presentation

Synthesising participants’ accounts from different mental health trials: the stride study

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

Citation: Trials 2015 16(Suppl 2):O40

Published on: 16 November 2015
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Content type: Oral presentation

Development of guidance for statistical analysis plans (SAPs) for clinical trials

Authors: Ashma Krishan, Deborah Stocken, Steff Lewis, Ed Juszczak, Caroline Dore, Paula Williamson, Doug Altman, Alan Montgomery, Mike Clarke and Carrol Gamble

Citation: Trials 2015 16(Suppl 2):O41

Published on: 16 November 2015
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Content type: Oral presentation

Beyond total treatment effects in RCTs: why we need to measure outcomes at baseline when investigating mediation

Authors: Sabine Landau, Richard Emsley and Graham Dunn

Citation: Trials 2015 16(Suppl 2):O42

Published on: 16 November 2015
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Content type: Oral presentation

Longitudinal mediation in the PACE randomised clinical trial of rehabilitative treatments for chronic fatigue syndrome: modelling and design considerations

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

Citation: Trials 2015 16(Suppl 2):O43

Published on: 16 November 2015
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Content type: Oral presentation

Complier-average causal effects for multivariate outcomes: an instrumental variable approach with application to health economics

Authors: Karla DiazOrdaz, Angelo Franchini and Richard Grieve

Citation: Trials 2015 16(Suppl 2):O44

Published on: 16 November 2015
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Content type: Oral presentation

Considering the design effect for the stepped wedge trial: what can it tell us?

Authors: Jennifer Thompson, Katherine Fielding, James Hargreaves and Andrew Copas

Citation: Trials 2015 16(Suppl 2):O45

Published on: 16 November 2015
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Content type: Oral presentation

Assessing sensitivity to assumptions in mixed effects analyses of stepped-wedge trials

Authors: Calum Davey and Jennifer A Thompson

Citation: Trials 2015 16(Suppl 2):O46

Published on: 16 November 2015
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Content type: Oral presentation

Trials recruiting patients in the acute NHS setting: trial management challenges

Authors: Seonaidh Cotton, Ruth Thomas, Sarah Cameron, Anne Duncan, Tracey Davidson and Kirsty McCormack

Citation: Trials 2015 16(Suppl 2):O47

Published on: 16 November 2015
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