Core Outcome Measures in Effectiveness Trials

Choosing Important Health Outcomes for Comparative Effectiveness Research: An Updated Review and User Survey

General Information

Abstract:
Background: A 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.

Methods: A 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.

Results: Thirty-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.

Conclusions: This 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.

Aim:
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.

Authors:
Gorst SL, Gargon E, Clarke M, Blazeby JM, Altman DG, Williamson PR

Publication

Journal:
PLoS ONE
Volume:
11
Issue:
1
Pages:
e0146444 -
Year:
2016
DOI:
Further Study Information

Date:
August 2013 - January 2015
Funding source(s):
This work was funded by the NIHR (National Institute for Health Research), grant number NF-SI_0513-10025.

Health Area

Disease Category

Disease Name
N/A

Target Population

Age Range
-

Sex
Either


Nature / type of Intervention
Any

Method(s)

Survey
Systematic review

A systematic reviews using a multi-faceted search strategy was conducted, 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.


Stakeholders Involved

Clinical experts
Researchers
Statisticians

Study Type

Systematic review of core outcome sets

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