title: Core outcome sets and trial registries.
abstract: Some reasons for registering trials might be considered as self-serving, such as satisfying the requirements of a journal in which the researchers wish to publish their eventual findings or publicising the trial to boost recruitment. Registry entries also help others, including systematic reviewers, to know about ongoing or unpublished studies and contribute to reducing research waste by making it clear what studies are ongoing. Other sources of research waste include inconsistency in outcome measurement across trials in the same area, missing data on important outcomes from some trials, and selective reporting of outcomes. One way to reduce this waste is through the use of core outcome sets: standardised sets of outcomes for research in specific areas of health and social care. These do not restrict the outcomes that will be measured, but provide the minimum to include if a trial is to be of the most use to potential users. We propose that trial registries, such as ISRCTN, encourage researchers to note their use of a core outcome set in their entry. This will help people searching for trials and those worried about selective reporting in closed trials. Trial registries can facilitate these efforts to make new trials as useful as possible and reduce waste. The outcomes section in the entry could prompt the researcher to consider using a core outcome set and facilitate the specification of that core outcome set and its component outcomes through linking to the original core outcome set. In doing this, registries will contribute to the global effort to ensure that trials answer important uncertainties, can be brought together in systematic reviews, and better serve their ultimate aim of improving health and well-being through improving health and social care.
authors.affiliation: Northern Ireland Network for Trials Methodology Research, Centre for Public Health, Institute of Clinical Sciences, Block B, Queens University Belfast, Royal Hospitals, Grosvenor Road, Belfast, BT12 6BJ, UK. m.clarke@qub.ac.uk.
authors.forename: Mike
authors.initials: M
authors.lastname: Clarke
authors.affiliation: Department of Biostatistics, University of Liverpool, 1st floor Duncan Building, Daulby Street, Liverpool, L69 3GA, UK. p.r.williamson@liverpool.ac.uk.
authors.forename: Paula
authors.initials: P
authors.lastname: Williamson
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards; D023381:Endpoint Determination / Q000592:standards; D006801:Humans; D017410:Practice Guidelines as Topic; D012042:Registries / Q000592:standards; D012107:Research Design / Q000592:standards; D016896:Treatment Outcome