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PIMS (Positioning In Macular hole Surgery) trial – a multicentre interventional comparative randomised controlled clinical trial comparing face-down positioning, with an inactive face-forward position on the outcome of surgery for large macular holes: study protocol for a randomised controlled trial

Idiopathic macular holes are an important cause of blindness. They have an annual incidence of 8 per 100,000 individuals, and prevalence of 0.2 to 3.3 per 1000 individuals with visual impairment. The condition...

Authors: Saruban Pasu, Catey Bunce, Richard Hooper, Ann Thomson and James Bainbridge

Citation: Trials 2015 16:527

Content type: Study protocol Published on: 17 November 2015
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Cognitive behavioural treatment for mild Alzheimer’s patients and their caregivers (CBTAC): study protocol for a randomized controlled trial

About 90 % of all persons with mild Alzheimer’s disease experience neuropsychiatric symptoms, most frequently apathy, depression, anxiety and irritability. These symptoms are associated with greater morbidity,...

Authors: Simon Forstmeier, Andreas Maercker, Egemen Savaskan and Tanja Roth

Citation: Trials 2015 16:526

Content type: Study protocol Published on: 17 November 2015
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Comparative effectiveness of electro-acupuncture plus lifestyle modification treatment for patients with simple obesity and overweight: study protocol for a randomized controlled trial

Acupuncture is considered to be an effective and safe treatment for obese and overweight patients, although high-quality evidence regarding the effects of acupuncture on obesity are not conclusive. The aim of ...

Authors: Zishan Gao, Zhi Yu, Zhi-Xiu Song, Cai-Rong Zhang, Yao-Shuai Wang, Yun-Feng Wu, Bei Zhou, Shu-Ping Fu, Hao Chen, Ying Xiong, Yi Yang, Bing-Mei Zhu and Bin Xu

Citation: Trials 2015 16:525

Content type: Study protocol Published on: 17 November 2015
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Involuntary reflexive pelvic floor muscle training in addition to standard training versus standard training alone for women with stress urinary incontinence: study protocol for a randomized controlled trial

Pelvic floor muscle training is effective and recommended as first-line therapy for female patients with stress urinary incontinence. However, standard pelvic floor physiotherapy concentrates on voluntary cont...

Authors: Helena Luginbuehl, Corinne Lehmann, Jean-Pierre Baeyens, Annette Kuhn and Lorenz Radlinger

Citation: Trials 2015 16:524

Content type: Study protocol Published on: 17 November 2015
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Dichotomizing partial compliance and increased participant burden in factorial designs: the performance of four noncompliance methods

Noncompliance to treatment assignment is an inevitable occurrence in randomized clinical trials (RCTs). Intention to treat (ITT) is generally considered the best method for addressing noncompliance in RCTs. Al...

Authors: Peter D. Merrill and Leslie A. McClure

Citation: Trials 2015 16:523

Content type: Research Published on: 17 November 2015
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Comparison of analysis approaches for multi-level vascular imaging data

Authors: Julia Forman, Marie Fisk, Joseph Cheriyan, Simon Bond and Ian Wilkinson

Citation: Trials 2015 16(Suppl 2):P237

Content type: Poster presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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Addressing the barriers to implementing model based designs in dose escalation studies

Authors: Victoria Cornelius and Simon Bond

Citation: Trials 2015 16(Suppl 2):P235

Content type: Poster presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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A toxicity-dependent feasibility bound for the escalation with overdose control approach in phase I cancer trials

Authors: Graham Wheeler, Michael Sweeting and Adrian Mander

Citation: Trials 2015 16(Suppl 2):P233

Content type: Poster presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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Determining the sample size for a cluster-randomised trial: Bayesian hierarchical modelling of the ICC estimate

Authors: Svetlana Tishkovskaya, Chris Sutton, Lois Thomas, Michael Leathley and Caroline Watkins

Citation: Trials 2015 16(Suppl 2):P229

Content type: Poster presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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Innovative considerations on a phase 2a dose-finding strategy using Bayesian methods and MCP-MOD

Authors: Alun Bedding and Julian Zhou

Citation: Trials 2015 16(Suppl 2):P204

Content type: Poster presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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Establishing a journal club to promote professional development within a trials unit

Authors: Fiona Strachan, Chris Tuck, Gina Cranswick and Lorraine Smith

Citation: Trials 2015 16(Suppl 2):P202

Content type: Poster presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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TRYMS: the ethical and practical considerations of a double-blind placebo controlled randomised clinical trial

Authors: Jayne Swain, Isabelle Smith, Alexandra Smith, Jennifer Walsh, Richard Ross and Helen Marshall

Citation: Trials 2015 16(Suppl 2):P200

Content type: Poster presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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The impact of a delayed consent model on trial recruitment - the cream study (children with eczema antibiotic management study)

Authors: Victoria Shepherd, Emma Thomas-Jones, Katy Addison, Matthew Ridd, Christopher Butler, Kerenza Hood and Nick Francis

Citation: Trials 2015 16(Suppl 2):P199

Content type: Poster presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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The research registry - answering the call to register every research study involving human participants

Authors: Riaz Agha, Katharine Whitehurst and Harkiran K Sagoo

Citation: Trials 2015 16(Suppl 2):P197

Content type: Poster presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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Does ‘mapping’ the evidence usefully inform the research question prioritisation process in systematic reviews?

Authors: Caroline Main, Jayne Wilson, Martin English, Pamela Kearns, Bob Phillips, Barry Pizer, Sophie Wilne and Keith Wheatley

Citation: Trials 2015 16(Suppl 2):P170

Content type: Poster presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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The challenges of estimating the prevalence of child maltreatment

Authors: Gwenllian Moody, Michael Robling, Kerenza Hood, Rebecca Cannings-John and Alison Kemp

Citation: Trials 2015 16(Suppl 2):P166

Content type: Poster presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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Systematic review of randomised and observational evidence of effects of treatments of carotid stenosis to prevent stroke

Authors: Kusal Lokuge, Alison Halliday, Richard Bulbulia, Alastair Gray and Borislava Mihaylova

Citation: Trials 2015 16(Suppl 2):P164

Content type: Poster presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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A novel approach to understanding outcome selection and reporting during the evaluation of innovative surgery from first in human to pragmatic RCT: an evolution review

Authors: Noah Howes, Jelena Savovic, Julian Higgins and Jane Blazeby

Citation: Trials 2015 16(Suppl 2):P162

Content type: Poster presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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Identification of strata for a trial of a targeted multimodal physiotherapy intervention in patellofemoral pain patients

Authors: Chris Sutton, Paola Dey, Jessie Janssen, Michael Callaghan, Jim Richards, Maria Stokes, Denis Martin, John Dixon, Erik Witvrouw, Russell Hogarth, Vasilios Baltzopoulos, Elizabeth Ritchie, Nigel Arden, Rich Masters, Remco Polman, David Turner…

Citation: Trials 2015 16(Suppl 2):P158

Content type: Poster presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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A flexible method for determining a biomarker positive population based on an efficacy target within a confirmatory study

Authors: Chris Harbron

Citation: Trials 2015 16(Suppl 2):P133

Content type: Poster presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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Identification and evaluation of novel methods for the analysis of ordinal data in acute stroke trials in comparison to ordinal logistic regression

Authors: Aimie Nunn and Laura Gray

Citation: Trials 2015 16(Suppl 2):P131

Content type: Poster presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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The use of randomisation-based efficacy estimators in non-inferiority trials

Authors: David Gillespie, Kerenza Hood, Daniel Farewell, Antony Hawthorne, Chris Probert, Rachel Stenson, Peter Barrett-Lee, Angela Casbard and Nick Murray

Citation: Trials 2015 16(Suppl 2):P129

Content type: Poster presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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Variance estimation in reference based sensitivity analysis for longitudinal trials with protocol deviation

Authors: Suzie Cro, Michael Kenward and James Carpenter

Citation: Trials 2015 16(Suppl 2):P127

Content type: Poster presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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Randomised controlled trials of group interventions with an individual level comparator: are appropriate statistical methods being used?

Authors: Lucy Bradshaw and Alan Montgomery

Citation: Trials 2015 16(Suppl 2):P125

Content type: Poster presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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Novel patient engagement and recruitment strategies for an RCY of two NHS treatments for ankle osteoarthritis - total ankle replacement versus arthrodesis - the TARVA trial

Authors: Andy Goldberg, Claire Thomson, Deirdre Brooking, Elin Rees, Marion Cumbers, Michelle Tetlow, Simon Skene and Suzie Cro

Citation: Trials 2015 16(Suppl 2):O94

Content type: Oral presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2

The Erratum to this article has been published in Trials 2016 17:109
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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

Content type: Poster presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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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

Content type: Poster presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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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

Content type: Poster presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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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

Content type: Poster presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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Evaluating the use of real-time data collection using SMS texts in the SIMS study

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

Citation: Trials 2015 16(Suppl 2):O65

Content type: Oral presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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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

Content type: Poster presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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A better participant experience using sms for real time data collection

Authors: Jamie Garner and Rhiannon Whitaker

Citation: Trials 2015 16(Suppl 2):O63

Content type: Oral presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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Experience from creating electronic systems with generic endpoint review and adjudication flows

Authors: Jane Aziz, Sharon Kean, Ernest Edifor and Eleanor Dinnett

Citation: Trials 2015 16(Suppl 2):O61

Content type: Oral presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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Introducing personalised risk based intervals in screening for diabetic retinopathy: development, implementation and assessment of safety, cost-effectiveness and patient experience (ISDR): a case study in the use of automated systems in trials

Authors: Duncan Appelbe, Deborah Broadbent, Mehrdad Mobayen-Rahni, Antonio Eleuteri, Abigail Bennett, Tracy Moitt, Amu Wang, Marta García-Fiñana, Anthony Fisher and Simon Harding

Citation: Trials 2015 16(Suppl 2):O59

Content type: Oral presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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Design of the myechild trial, an international randomised phase III clinical trial in children with acute myeloid leukaemia incorporating an embedded dose finding study

Authors: Aimee Houlton, Brenda Gibson and Keith Wheatley

Citation: Trials 2015 16(Suppl 2):O57

Content type: Oral presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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A web and telephone randomisation service in one hour – the benefits and challenges of delivering a configurable randomisation system

Authors: John Turgoose and Will Crocombe

Citation: Trials 2015 16(Suppl 2):P40

Content type: Poster presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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A review of the online prognositc model predict using the POSH cohort (women aged ≤40 years at breast cancer diagnosis)

Authors: Tom Maishman, Ellen Copson, Louise Stanton, Sue Gerty, Ed Dicks, Lorraine Durcan, Gordon Wishart, Paul Pharoah and Diana Eccles

Citation: Trials 2015 16(Suppl 2):P36

Content type: Poster presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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Software for spatial analysis and visualisation of cluster randomised trials - a review of available tools

Authors: Christopher Jarvis, Gian Luca Di Tanna, Neal Alexander, Karim Anaya-Izquierdo and James Carpenter

Citation: Trials 2015 16(Suppl 2):P34

Content type: Poster presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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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

Content type: Oral presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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Introducing framework for analyzing non-adherence (FAN)

Authors: Ernest Edifor, Sharon Kean and Jane Aziz

Citation: Trials 2015 16(Suppl 2):P32

Content type: Poster presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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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

Content type: Oral presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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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

Content type: Oral presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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Using primary care data to evaluate the 10-year cost-effectiveness of cardiovascular disease risk algorithms in patients with serious mental illness: a patient level simulation

Authors: Ella Zomer, Rachael Hunter, Irwin Nazareth and David Osborn

Citation: Trials 2015 16(Suppl 2):P28

Content type: Poster presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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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

Content type: Oral presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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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

Content type: Oral presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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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

Content type: Oral presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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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

Content type: Oral presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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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

Content type: Oral presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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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

Content type: Oral presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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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

Content type: Oral presentation Published on: 16 November 2015

This article is part of a Supplement: Volume 16 Supplement 2
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