The COMET Handbook: Version 1.0

Overview

Journal Trials

Publisher Biomed Central

Specialties General Medicine
Pharmacology

Date 2017 Jul 7

PMID 28681707

Citations 690

Authors

Paula R Williamson

Douglas G Altman

Heather Bagley

Karen L Barnes

Jane M Blazeby

Sara T Brookes

Mike Clarke

Elizabeth Gargon

Sarah Gorst

Nicola Harman

Jamie J Kirkham

Angus McNair

Cecilia A C Prinsen

Jochen Schmitt

Caroline B Terwee

Bridget Young

Affiliations

Soon will be listed here.

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.

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