Year-end Sale % OFF 
Abstract
BackgroundThe development and application of standardised sets of outcomes to be measured and reported in clinical trials have the potential to increase the efficiency and value of research. One of the most notable of the current outcome sets began nearly 20 years ago: the World Health Organization and International League of Associations for Rheumatology core set of outcomes for rheumatoid arthritis clinical trials, originating from the OMERACT (Outcome Measures in Rheumatology) Initiative. This study assesses the use of this core outcome set by randomised trials in rheumatology.MethodsAn observational review was carried out of 350 randomised trials for the treatment of rheumatoid arthritis identified through The Cochrane Library (up to and including September 2012 issue). Reports of these trials were evaluated to determine whether or not there were trends in the proportion of trials reporting on the full set of core outcomes over time. Researchers who conducted trials after the publication of the core set were contacted to assess their awareness of it and to collect reasons for non-inclusion of the full core set of outcomes in the study.ResultsSince the introduction of the core set of outcomes for rheumatoid arthritis, the consistency of measurement of the core set of outcomes has improved, although variation in the choice of measurement instrument remains. The majority of trialists who responded said that they would consider using the core outcome set in the design of a new trial.ConclusionsThis observational review suggests that a higher percentage of trialists conducting trials in rheumatoid arthritis are now measuring the rheumatoid arthritis core outcome set. Core outcome sets have the potential to improve the evidence base for health care, but consideration must be given to the methods for disseminating their availability amongst the relevant communities.
Highlights
The development and application of standardised sets of outcomes to be measured and reported in clinical trials have the potential to increase the efficiency and value of research
In this paper we investigate whether outcome selection in rheumatoid arthritis (RA) trials has changed over time, in particular whether the RA core outcome set (COS) is more frequently measured since the introduction of the core set of outcomes for RA and the publication of relevant regularity guidance for RA
Reporting of the rheumatoid core outcome set The reporting of the full RA COS over time is illustrated for both pharmacological and non-pharmacological intervention types in Figure 3, where a clear upward trend in the proportion of trials reporting on the full RA COS is observed
Summary
The development and application of standardised sets of outcomes to be measured and reported in clinical trials have the potential to increase the efficiency and value of research. This study assesses the use of this core outcome set by randomised trials in rheumatology. Research has shown that outcome reporting bias, that is, resultsbased selection for publication of a subset of the original outcome variables, is a major problem in randomised trials [1]. In rheumatoid arthritis (RA), it has been common practice since the 1950s to use a selection of traditional measures to define the endpoints of most clinical trials, usually including measures based on the clinician’s physical examination, global assessment, laboratory measurements and sometimes radiographs. It was notable that the choice of outcomes was variable between trials: for instance, clinical trials of patients with RA in the USA measured different outcomes to those conducted in Europe [6]
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
