Abstract
BackgroundA COS represents an agreed minimum set of outcomes that should be measured and reported in all trials of a specific condition. The COMET (Core Outcome Measures in Effectiveness Trials) initiative aims to collate and stimulate the development and application of COS, by including data on relevant studies within a publically available internet-based resource. In recent years, there has been an interest in increasing the development of COS. Therefore, this study aimed to provide an update of a previous review, and examine the quality of development of COS. A further aim was to understand the reasons why individuals are searching the COMET database.MethodsA multi-faceted search strategy was followed, in order to identify studies that sought to determine which outcomes/domains to measure in clinical trials of a specific condition. Additionally, a pop up survey was added to the COMET website, to ascertain why people were searching the COMET database.ResultsThirty-two reports relating to 29 studies were eligible for inclusion in the review. There has been an improvement in the description of the scope of a COS and an increase in the proportion of studies using literature/systematic reviews and the Delphi technique. Clinical experts continue to be the most common group involved in developing COS, however patient and public involvement has increased. The pop-up survey revealed the most common reasons for visiting the COMET website to be thinking about developing a COS and planning a clinical trial.ConclusionsThis update demonstrates that recent studies appear to have adopted a more structured approach towards COS development and public representation has increased. However, there remains a need for developers to adequately describe details about the scope of COS, and for greater public engagement. The COMET database appears to be a useful resource for both COS developers and users of COS.
Highlights
When designing clinical trials, it is important to measure appropriate outcomes, so that the results can be compared with other trials and will be as useful as possible to decision makers
There has been an improvement in the description of the scope of a core outcome sets (COS) and an increase in the proportion of studies using literature/systematic reviews and the Delphi technique
Clinical experts continue to be the most common group involved in developing COS, patient and public involvement has increased
Summary
It is important to measure appropriate outcomes, so that the results can be compared with other trials and will be as useful as possible to decision makers. Many studies which explore the effects of the same intervention on a specific health condition measure and report different outcomes, making it difficult to compare, contrast or combine their findings. This causes problems for people trying to use healthcare research. Inconsistency in outcome measurement and outcome reporting bias have led to avoidable waste in the production and reporting of research [1,2] These issues could be reduced through the development and application of core outcome sets (COS). A further aim was to understand the reasons why individuals are searching the COMET database.
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