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A framework for the design, conduct and interpretation of randomised controlled trials in the presence of treatment changes

When a randomised trial is subject to deviations from randomised treatment, analysis according to intention-to-treat does not estimate two important quantities: relative treatment efficacy and effectiveness in a setting different from that in the trial. Even in trials of a predominantly pragmatic nature, there may be numerous reasons to consider the extent, and impact on analysis, ...

A survey of facilitators and barriers to recruitment to the MAGNETIC trial

Background Recruitment to randomised controlled trials with children is challenging. It is imperative to understand the factors that boost or hinder recruitment of children to clinical trials. We conducted a survey of facilitators and barriers to recruitment to the MAGNETIC trial, using a previously developed web-based tool. Methods MAGNETIC is a multicentre randomised trial of ...

Core outcome sets and systematic reviews

Systematic reviews seek to bring together research evidence to answer the question for the review. The reviewers usually wish to compare, contrast and, if appropriate, combine the findings of the existing research studies. However, these intentions are often thwarted by inconsistencies in the outcomes that were measured and reported in the individual studies. This, in turn, makes ...

Modelling variable dropout in randomised controlled trials with longitudinal outcomes: application to the MAGNETIC study

Background Clinical trials with longitudinally measured outcomes are often plagued by missing data due to patients withdrawing or dropping out from the trial before completing the measurement schedule. The reasons for dropout are sometimes clearly known and recorded during the trial, but in many instances these reasons are unknown or unclear. Often such reasons for dropout are ...

Core outcome sets and trial registries

Some reasons for registering trials might be considered as self-serving, such as satisfying the requirements of a journal in which the researchers wish to publish their eventual findings or publicising the trial to boost recruitment. Registry entries also help others, including systematic reviewers, to know about ongoing or unpublished studies and contribute to reducing research ...

How to select outcome measurement instruments for outcomes included in a “Core Outcome Set” – a practical guideline

Background In cooperation with the Core Outcome Measures in Effectiveness Trials (COMET) initiative, the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) initiative aimed to develop a guideline on how to select outcome measurement instruments for outcomes (i.e., constructs or domains) included in a “Core Outcome Set” (COS). A COS is an agreed ...

Three nested randomized controlled trials of peer-only or multiple stakeholder group feedback within Delphi surveys during core outcome and information set development

Background Methods for developing a core outcome or information set require involvement of key stakeholders to prioritise many items and achieve agreement as to the core set. The Delphi technique requires participants to rate the importance of items in sequential questionnaires (or rounds) with feedback provided in each subsequent round such that participants are able to consider ...

The comet initiative

Paula Williamson 0 0 University of Liverpool , Liverpool , UK 2013 Williamson; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons

Development of a core outcome set for clinical trials in rosacea: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey

Background Rosacea is a chronic inflammatory disorder affecting millions of individuals worldwide. Diagnosis is based on signs and symptoms with management and treatment aimed to suppress inflammatory lesions, erythema, and telangiectasia. While many clinical trials of rosacea exist, the lack of consensus in outcome reporting across all trials poses a concern. Proper evaluation and ...

A core outcome set for neonatal abstinence syndrome: study protocol for a systematic review, parent interviews and a Delphi survey

Moulsdale Jodi Pereira Sarah Simpson Astrid Guttman Karel Allegaert Lisa Askie Henry Roukema Thierry Lacaze Jonathan M. Davis Loretta Finnegan Paula Williamson Martin Offringa Background: The prevalence of

The COMET initiative database: progress and activities update (2014)

The COMET Initiative database is a repository of studies relevant to the development of core outcome sets (COS). Use of the website continues to increase, with more than 16,500 visits in 2014 (36 % increase over 2013), 12,257 unique visitors (47 % increase), 9780 new visitors (43 % increase) and a rise in the proportion of visits from outside the UK (8565 visits; 51 % of all ...

Towards core outcome set (COS) development: a follow-up descriptive survey of outcomes in Cochrane reviews

Paula Williamson 4 Elizabeth Gargon 4 0 School of Nursing & Midwifery, Trinity College Dublin , 24 D'Olier Street, Dublin 2 , Ireland 1 All-Ireland Hub for Trials Methodology Research, Queens University

A multi-factorial analysis of response to warfarin in a UK prospective cohort

Background Warfarin is the most widely used oral anticoagulant worldwide, but it has a narrow therapeutic index which necessitates constant monitoring of anticoagulation response. Previous genome-wide studies have focused on identifying factors explaining variance in stable dose, but have not explored the initial patient response to warfarin, and a wider range of clinical and ...