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dc.contributor.authorCook, Jonathan A
dc.contributor.authorJulious, Steven A
dc.contributor.authorSones, William
dc.contributor.authorHampson, Lisa V
dc.contributor.authorHewitt, Catherine
dc.contributor.authorBerlin, Jesse A
dc.contributor.authorAshby, Deborah
dc.contributor.authorEmsley, Richard
dc.contributor.authorFergusson, Dean A
dc.contributor.authorWalters, Stephen J
dc.contributor.authorWilson, Edward CF
dc.contributor.authorMaclennan, Graeme
dc.contributor.authorStallard, Nigel
dc.contributor.authorRothwell, Joanne C
dc.contributor.authorBland, Martin
dc.contributor.authorBrown, Louise
dc.contributor.authorRamsay, Craig R
dc.contributor.authorCook, Andrew
dc.contributor.authorArmstrong, David
dc.contributor.authorAltman, Doug
dc.contributor.authorVale, Luke D
dc.date.accessioned2018-11-07T07:02:35Z
dc.date.available2018-11-07T07:02:35Z
dc.date.issued2018-11-05
dc.identifier.citationTrials. 2018 Nov 05;19(1):606
dc.identifier.issn1745-6215
dc.identifier.urihttps://www.repository.cam.ac.uk/handle/1810/284717
dc.description.abstractBACKGROUND: A key step in the design of a RCT is the estimation of the number of participants needed in the study. The most common approach is to specify a target difference between the treatments for the primary outcome and then calculate the required sample size. The sample size is chosen to ensure that the trial will have a high probability (adequate statistical power) of detecting a target difference between the treatments should one exist. The sample size has many implications for the conduct and interpretation of the study. Despite the critical role that the target difference has in the design of a RCT, the way in which it is determined has received little attention. In this article, we summarise the key considerations and messages from new guidance for researchers and funders on specifying the target difference, and undertaking and reporting a RCT sample size calculation. This article on choosing the target difference for a randomised controlled trial (RCT) and undertaking and reporting the sample size calculation has been dual published in the BMJ and BMC Trials journals METHODS: The DELTA2 (Difference ELicitation in TriAls) project comprised five major components: systematic literature reviews of recent methodological developments (stage 1) and existing funder guidance (stage 2); a Delphi study (stage 3); a two-day consensus meeting bringing together researchers, funders and patient representatives (stage 4); and the preparation and dissemination of a guidance document (stage 5). RESULTS AND DISCUSSION: The key messages from the DELTA2 guidance on determining the target difference and sample size calculation for a randomised caontrolled trial are presented. Recommendations for the subsequent reporting of the sample size calculation are also provided.
dc.publisherSpringer Science and Business Media LLC
dc.titleDELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial.
dc.typeJournal Article
dc.date.updated2018-11-07T07:02:28Z
dc.language.rfc3066en
dc.rights.holderThe Author(s).
prism.publicationNameTrials
dc.identifier.doi10.17863/CAM.32089
dcterms.dateAccepted2018-08-29
rioxxterms.versionofrecord10.1186/s13063-018-2884-0
dc.contributor.orcidCook, Jonathan A [0000-0002-4156-6989]
dc.identifier.eissn1745-6215
cam.issuedOnline2018-11-05


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