title: Developing core outcome sets for clinical trials: issues to consider.
abstract: The selection of appropriate outcomes or domains is crucial when designing clinical trials in order to compare directly the effects of different interventions in ways that minimize bias. If the findings are to influence policy and practice then the chosen 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. There is a growing recognition that insufficient attention has been paid to the outcomes measured in clinical trials. These issues could be addressed through the development and use of an agreed standardized collection of outcomes, known as a core outcome set, 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 general guidance on the development of core outcome sets. Key issues to consider in the development of a core outcome set include its scope, the stakeholder groups to involve, choice of consensus method and the achievement of a consensus.
authors.affiliation: Department of Biostatistics, University of Liverpool, Shelley's Cottage, Brownlow Street, Liverpool, L69 3GS, UK. prw@liv.ac.uk
authors.forename: Paula R
authors.initials: PR
authors.lastname: Williamson
authors.forename: Douglas G
authors.initials: DG
authors.lastname: Altman
authors.forename: Jane M
authors.initials: JM
authors.lastname: Blazeby
authors.forename: Mike
authors.initials: M
authors.lastname: Clarke
authors.forename: Declan
authors.initials: D
authors.lastname: Devane
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Gargon
authors.forename: Peter
authors.initials: P
authors.lastname: Tugwell
mesh_terms: D015982:Bias; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards; D032921:Consensus; D023381:Endpoint Determination / Q000592:standards; D019317:Evidence-Based Medicine; D019983:Guideline Adherence; D017408:Guidelines as Topic; D006801:Humans; D012107:Research Design / Q000592:standards; D016896:Treatment Outcome