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. 2014 Jun 16;9(6):e99111.
doi: 10.1371/journal.pone.0099111. eCollection 2014.

Choosing important health outcomes for comparative effectiveness research: a systematic review

Elizabeth Gargon  1 , Binu Gurung  1 , Nancy Medley  1 , Doug G Altman  2 , Jane M Blazeby  3 , Mike Clarke  4 , Paula R Williamson  1
Affiliations

Choosing important health outcomes for comparative effectiveness research: a systematic review

Elizabeth Gargon et al. PLoS One. .

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.

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Conflict of interest statement

Competing Interests: DGA, JB, MC and PRW are members of the COMET Management Group and co-applicants on grants to support COMET and related work. EG is a member of the COMET Management Group and is the COMET Project Co-ordinator. This does not alter the authors' adherence to PLOS ONE policies on sharing data and materials.

Figures

Figure 1
Figure 1. Identification of studies.
Figure 2
Figure 2. Year of first publication of each study (N = 198).
See this image and copyright information in PMC

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