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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.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 .
dc.identifier.otherPURE: 250566408
dc.identifier.otherPURE UUID: 02f0c7d8-ac7b-4b93-aacb-45ca56f7ebe7
dc.identifier.otherRIS: urn:7A34E1580A997B17227EB3F2B1FFDDA6
dc.identifier.otherScopus: 85021755873
dc.identifier.otherWOS: 000411916500015
dc.identifier.otherORCID: /0000-0002-6623-4964/work/35609724
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.relation.ispartofJournal of Clinical Epidemiologyen
dc.rights© 2017, Elsevier. This work has been made available online in accordance with the publisher’s policies. This is the author created, accepted version manuscript following peer review and may differ slightly from the final published version. The final published version of this work is available at /
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.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.description.statusPeer revieweden

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