Core Outcome Measures in Effectiveness Trials

Choosing Important Health Outcomes for Comparative Effectiveness Research: A Systematic Review

General Information

Abstract:
BACKGROUND: A core outcome set (COS) is a standardised set of outcomes which should be measured and reported, as a minimum, in all effectiveness trials for a specific health area. This will allow results of studies to be compared, contrasted and combined as appropriate, as well as ensuring that all trials contribute usable information. The COMET (Core Outcome Measures for Effectiveness Trials) Initiative aims to support the development, reporting and adoption of COS. Central to this is a publically accessible online resource, populated with all available COS. The aim of the review we report here was to identify studies that sought to determine which outcomes or domains to measure in all clinical trials in a specific condition and to describe the methodological techniques used in these studies.

METHODS: We developed a multi-faceted search strategy for electronic databases (MEDLINE, SCOPUS, and Cochrane Methodology Register). We included studies that sought to determine which outcomes/domains to measure in all clinical trials in a specific condition.

RESULTS: A total of 250 reports relating to 198 studies were judged eligible for inclusion in the review. Studies covered various areas of health, most commonly cancer, rheumatology, neurology, heart and circulation, and dentistry and oral health. A variety of methods have been used to develop COS, including semi-structured discussion, unstructured group discussion, the Delphi Technique, Consensus Development Conference, surveys and Nominal Group Technique. The most common groups involved were clinical experts and non-clinical research experts. Thirty-one (16%) studies reported that the public had been involved in the process. The geographic locations of participants were predominantly North America (n = 164; 83%) and Europe (n = 150; 76%).

CONCLUSIONS: This systematic review identified many health areas where a COS has been developed, but also highlights important gaps. It is a further step towards a comprehensive, up-to-date database of COS. In addition, it shows the need for methodological guidance, including how to engage key stakeholder groups, particularly members of the public.

Authors:
Gargon, E. Gurung, B. Medley, N. Altman, D. G. Blazeby, J. M. Clarke, M. & Williamson, P. R.

Publication

Journal:
PLoS ONE
Volume:
9
Issue:
6
Pages:
e99111 -
Year:
2014
DOI:
Further Study Information

Date:
August 2012 - December 2013
Funding source(s):
This work was funded by the MRC MRP (Medical Research Council Methodology Research Panel), grant number MR/J004847/1; and European Union Seventh Framework Programme ([FP7/2007-2013] [FP7/2007-2011]) under grant agreement n° 305081.

Health Area

Disease Category

Disease Name
N/A

Target Population

Age Range
-

Sex
Unknown


Nature / type of Intervention
Any

Method(s)

Systematic review

Stakeholders Involved

Clinical experts
Researchers
Statisticians

Study Type

Systematic review of core outcome sets

The site uses cookies, some may have been set already. Please refer to our privacy policy & cookie usage statement.
If you continue to use the site we'll assume you're happy to accept the cookies.