The COMET Handbook: version 1.0

• Published in: Current controlled trials in cardiovascular medicine Vol. 18; no. Suppl 3; pp. 280 - 50
• Main Authors: Williamson, Paula R, Altman, Douglas G, Bagley, Heather, Barnes, Karen L, Blazeby, Jane M, Brookes, Sara T, Clarke, Mike, Gargon, Elizabeth, Gorst, Sarah, Harman, Nicola, Kirkham, Jamie J, McNair, Angus, Prinsen, Cecilia A C, Schmitt, Jochen, Terwee, Caroline B, Young, Bridget
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 20-06-2017; BioMed Central; BMC
• Subjects: Biomarkers; Clinical outcomes; Clinical trial; Clinical trials; Clinical Trials as Topic - standards; COMET Initiative; Consensus; Core outcome set; Databases, Factual; Decision making; Endpoint Determination - standards; Evidence-Based Medicine - standards; Guideline Adherence - standards; Handbooks; Handbooks, vade-mecums, etc; Humans; Intervention; Laboratories; Management; Medical research; Medicine, Experimental; Outcome and process assessment (Health Care); Patients; Patients and the public; Practice Guidelines as Topic - standards; Records and correspondence; Research Design - standards; Review; Stakeholder Participation; Clinical trial; Patients and the public; Core outcome set; COMET Initiative
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-017-1978-4

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.