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

The COMET Handbook: version 1.0.

Author information

1
MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Block F Waterhouse Building, 1-5 Brownlow Street, Liverpool, L69 3GL, UK. prw@liv.ac.uk.
2
Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
3
MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Block F Waterhouse Building, 1-5 Brownlow Street, Liverpool, L69 3GL, UK.
4
MRC ConDuCT II Hub for Trials Methodology Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.
5
Centre for Public Health, Queen's University Belfast, Belfast, UK.
6
National University of Ireland Galway and HRB Trials Methodology Research Network, Galway, Ireland.
7
Department of Epidemiology and Biostatistics, EMGO+ Institute for Health and Care Research, VU University Medical Center, Amsterdam, The Netherlands.
8
Center for Evidence-based Healthcare, Medizinische Fakult├Ąt, Technische Univesit├Ąt Dresden, Dresden, Germany.

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

PMID:
28681707
PMCID:
PMC5499094
DOI:
10.1186/s13063-017-1978-4
[Indexed for MEDLINE]
Free PMC Article

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