Objective
To assess the uptake of the rheumatoid arthritis core outcome set using a new assessment method of calculating uptake from data in clinical trial registry entries.
Design
Review of randomised trials.
Setting
ClinicalTrials.gov.
Subjects
273 randomised trials of drug interventions for the treatment of rheumatoid arthritis and registered in ClinicalTrials.gov between 2002 and 2016. Full publications were identified for completed studies from information in the trial registry or from an internet search using Google and the citation database Web of Science.
Main outcome measure
The percentage of trials reporting or planning to measure the rheumatoid arthritis core outcome set calculated from the information presented in the trial registry and compared with the percentage reporting the rheumatoid arthritis core outcome set in the resulting trial publications.
Results
The full rheumatoid arthritis core outcome set was reported in 81% (116/143) of trials identified on the registry as completed (or terminated) for which results were found in either the published literature or the registry. For trials identified on the registry as completed (or terminated), using information only available in the registry gives an estimate for uptake of 77% (145/189).
Conclusions
The uptake of the rheumatoid arthritis core outcome set in clinical trials has continued to increase over time. Using the information on outcomes listed for completed or terminated studies in a trial registry provides a reasonable estimate of the uptake of a core outcome set and is a more efficient and up-to-date approach than examining the outcomes in published trial reports. The method proposed may provide an efficient approach for an up-to-date assessment of the uptake of the 300 core outcome sets already published.
To assess the uptake of the rheumatoid arthritis core outcome set using a new assessment method of calculating uptake from data in clinical trial registry entries.
ContributorsJamie J Kirkham, Mike Clarke, Paula R Williamson
Disease Category: Other
Disease Name: N/A
Age Range: Unknown
Sex: Either
Nature of Intervention: Drug
- Commentary
- COS uptake study
- Systematic review
- Trial registry
We searched the trials registry ClinicalTrials.gov on 6 October 2016 to identify all phase III/IV drug clinical trials of rheumatoid arthritis that had been registered on the site. For each eligible trial registry entry, we extracted information on all planned trial outcomes and assessed whether the full rheumatoid arthritis core outcome set was listed.