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dc.contributor.authorLoudon, Kirsty
dc.contributor.authorZwarenstein, Merrick
dc.contributor.authorSullivan, Frank M.
dc.contributor.authorDonnan, Peter T.
dc.contributor.authorGágyor, Ildikó
dc.contributor.authorHobbelen, Hans J. S. M.
dc.contributor.authorAlthabe, Fernando
dc.contributor.authorKrishnan, Jerry A.
dc.contributor.authorTreweek, Shaun
dc.date.accessioned2018-06-08T23:31:54Z
dc.date.available2018-06-08T23:31:54Z
dc.date.issued2017-08
dc.identifier250566408
dc.identifier02f0c7d8-ac7b-4b93-aacb-45ca56f7ebe7
dc.identifier85021755873
dc.identifier000411916500015
dc.identifier.citationLoudon , K , Zwarenstein , M , Sullivan , F M , Donnan , P T , Gágyor , I , Hobbelen , H J S M , Althabe , F , Krishnan , J A & Treweek , S 2017 , ' The PRECIS-2 tool has good interrater reliability and modest discriminant validity ' , Journal of Clinical Epidemiology , vol. 88 , pp. 113-121 . https://doi.org/10.1016/j.jclinepi.2017.06.001en
dc.identifier.issn0895-4356
dc.identifier.otherRIS: urn:7A34E1580A997B17227EB3F2B1FFDDA6
dc.identifier.otherORCID: /0000-0002-6623-4964/work/35609724
dc.identifier.urihttps://hdl.handle.net/10023/13867
dc.descriptionThis work was supported by the Chief Scientist Office (CSO) of Scotland grant CZH/4/773 , the UK Medical Research Council, and the University of Dundee work through the provision of a stipend for K.L. and from the Health Services Research Unit at the University of Aberdeen, which is core funded by the CSO of the Scottish Government Health Directories.en
dc.description.abstractObjectives : PRagmatic Explanatory Continuum Indicator Summary (PRECIS)-2 is a tool that could improve design insight for trialists. Our aim was to validate the PRECIS-2 tool, unlike its predecessor, testing the discriminant validity and interrater reliability. Study Design and Setting : Over 80 international trialists, methodologists, clinicians, and policymakers created PRECIS-2 helping to ensure face validity and content validity. The interrater reliability of PRECIS-2 was measured using 19 experienced trialists who used PRECIS-2 to score a diverse sample of 15 randomized controlled trial protocols. Discriminant validity was tested with two raters to independently determine if the trial protocols were more pragmatic or more explanatory, with scores from the 19 raters for the 15 trials as predictors of pragmatism. Results : Interrater reliability was generally good, with seven of nine domains having an intraclass correlation coefficient over 0.65. Flexibility (adherence) and recruitment had wide confidence intervals, but raters found these difficult to rate and wanted more information. Each of the nine PRECIS-2 domains could be used to differentiate between trials taking more pragmatic or more explanatory approaches with better than chance discrimination for all domains. Conclusion: We have assessed the validity and reliability of PRECIS-2. An elaboration study and web site provide guidance to help future users of the tool which is continuing to be tested by trial teams, systematic reviewers, and funders.
dc.format.extent373803
dc.language.isoeng
dc.relation.ispartofJournal of Clinical Epidemiologyen
dc.subjectRandomized controlled trialsen
dc.subjectClinical trial methodologyen
dc.subjectValidity and reliabilityen
dc.subjectFace validityen
dc.subjectPragmatic clinical trialen
dc.subjectTrial designen
dc.subjectR Medicineen
dc.subjectNDASen
dc.subject.lccRen
dc.titleThe PRECIS-2 tool has good interrater reliability and modest discriminant validityen
dc.typeJournal articleen
dc.contributor.institutionUniversity of St Andrews. School of Medicineen
dc.identifier.doi10.1016/j.jclinepi.2017.06.001
dc.description.statusPeer revieweden
dc.date.embargoedUntil2018-06-08
dc.identifier.urlhttp://www.jclinepi.com/article/S0895-4356(16)30601-1/abstracten


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