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Do trial managers know when sites will fail to recruit? Preliminary results from the estimating site performance (ESP) study

Seonaidh Cotton 0 Shaun Treweek 0 0 University of Aberdeen , Aberdeen , UK © 2015 Shearer et al. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http

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

Gladys McPherson 0 Mark Forrest 0 Seonaidh Cotton 0 0 University of Aberdeen , Aberdeen , UK © 2015 Starr et al. This is an Open Access article distributed under the terms of the Creative Commons

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

Background Patient-reported outcomes are vital in informing randomised controlled trials (RCTs) and health-care interventions and policies from the patient’s perspective. However, participant non-response may introduce bias and can affect the generalisability of the trial. This study evaluates two interventions aimed at increasing response rates to postal questionnaires within a...

An Open-Label Investigation of the Pharmacokinetics and Tolerability of Oral Cysteamine in Adults with Cystic Fibrosis

Background and Objective Cysteamine is licensed for use in nephropathic cystinosis but preclinical data suggest a role in managing cystic fibrosis (CF). This study aimed to determine whether oral cysteamine is absorbed in adult CF patients and enters the bronchial secretions. Tolerability outcomes were also explored. Methods Patients ≥18 years of age, weighing >50 kg with stable...

File notes and breach reports: when are they appropriate?

Alison McDonald 0 Seonaidh Cotton 0 John Norrie 0 0 University of Aberdeen , Aberdeen , UK From 2nd Clinical Trials Methodology Conference: Methodology Matters Edinburgh, UK. 18-19 November 2013

Patient information leaflets (PILs) for UK randomised controlled trials: a feasibility study exploring whether they contain information to support decision making about trial participation

Background Informed consent is regarded as a cornerstone of ethical healthcare research and is a requirement for most clinical research studies. Guidelines suggest that prospective randomised controlled trial (RCT) participants should understand a basic amount of key information about the RCTs they are being asked to enrol in in order to provide valid informed consent. This...

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

Seonaidh Cotton 1 0 Academic Urology Unit, University of Aberdeen , Aberdeen, AB25 2ZB , UK 1 Health Services Research Unit, University of Aberdeen , Aberdeen, AB25 2ZB , UK - Background Informed consent

Psychosocial Impact of Alternative Management Policies for Low-Grade Cervical Abnormalities: Results from the TOMBOLA Randomised Controlled Trial

, Katrina Brown (deceased), Joe Brown, Kheng Chew, Claire Cochran, Seonaidh Cotton, Jeannie Dean, Kate Dunn, Jane Edwards, David Evans, Julie Fenty, Al Finlayson, Marie Gallagher, Nicola Gray, Maureen Heddle ... Prabhakaran, John Rippin, Rose Thompson, Elizabeth Williams, Claire Woolley Statistical analysis: Massoud Boroujerdi, Seonaidh Cotton, Kirsten Harrild, John Norrie, Linda Sharp External Trial Steering

Use of low-dose oral theophylline as an adjunct to inhaled corticosteroids in preventing exacerbations of chronic obstructive pulmonary disease: study protocol for a randomised controlled trial

controlled trial Graham Devereux 0 Seonaidh Cotton 2 Peter Barnes 1 Andrew Briggs 7 Graham Burns 6 Rekha Chaudhuri 5 Henry Chrystyn 4 Lisa Davies 9 Anthony De Soyza 8 Shona Fielding 3 Simon Gompertz 12 John

Making randomised trials more efficient: report of the first meeting to discuss the Trial Forge platform

Randomised trials are at the heart of evidence-based healthcare, but the methods and infrastructure for conducting these sometimes complex studies are largely evidence free. Trial Forge (www.trialforge.org) is an initiative that aims to increase the evidence base for trial decision making and, in doing so, to improve trial efficiency. This paper summarises a one-day workshop held...