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Review
. 2017 Jun 20;18(Suppl 3):280.
doi: 10.1186/s13063-017-1978-4.

The COMET Handbook: version 1.0

Paula R Williamson  1 , Douglas G Altman  2 , Heather Bagley  3 , Karen L Barnes  3 , Jane M Blazeby  4 , Sara T Brookes  4 , Mike Clarke  5   6 , Elizabeth Gargon  3 , Sarah Gorst  3 , Nicola Harman  3 , Jamie J Kirkham  3 , Angus McNair  4 , Cecilia A C Prinsen  7 , Jochen Schmitt  8 , Caroline B Terwee  7 , Bridget Young  3
Affiliations
Review

The COMET Handbook: version 1.0

Paula R Williamson et al. Trials. .

Abstract

The selection of appropriate outcomes is crucial when designing clinical trials in order to compare the effects of different interventions directly. For the findings to influence policy and practice, the outcomes need to be relevant and important to key stakeholders including patients and the public, health care professionals and others making decisions about health care. It is now widely acknowledged that insufficient attention has been paid to the choice of outcomes measured in clinical trials. Researchers are increasingly addressing this issue through the development and use of a core outcome set, an agreed standardised collection of outcomes which should be measured and reported, as a minimum, in all trials for a specific clinical area.Accumulating work in this area has identified the need for guidance on the development, implementation, evaluation and updating of core outcome sets. This Handbook, developed by the COMET Initiative, brings together current thinking and methodological research regarding those issues. We recommend a four-step process to develop a core outcome set. The aim is to update the contents of the Handbook as further research is identified.

Keywords: COMET Initiative; Clinical trial; Core outcome set; Patients and the public.

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Figures

Fig. 1
Fig. 1
The core outcome set (COS) development process
Fig. 2
Fig. 2
An outcome from a round-2 questionnaire for surgery for colorectal cancer presenting the mean score for round-1 for patients and health professionals separately
Fig. 3
Fig. 3
An outcome from a round-2 questionnaire presenting the percentage distribution of scores across all stakeholder groups with options for participants to review their previous round score and re-score (taken from DelphiManager)
Fig. 4
Fig. 4
Average scores in round 1 across all outcomes for (a) stakeholder group 1 and (b) stakeholder group 2. Shaded bars represent those who provided scores in round 1 only; open bars represent those scoring in both rounds 1 and 2
Fig. 5
Fig. 5
Percentage of scores changed between rounds 1 and 2 after viewing the results by stakeholder group
See this image and copyright information in PMC

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