The PRECIS-2 tool: designing trials that are fit for purpose. (8th May 2015)

• Record Type: Journal Article
• Authors: Loudon, Kirsty; Treweek, Shaun; Sullivan, Frank; Donnan, Peter; Thorpe, Kevin E; Zwarenstein, Merrick
• Is Part Of: BMJ. Volume 350(2015)
• Publication Date: 2015-05-08
• Subjects: Medicine -- Periodicals; Medicine -- Periodicals; Medicine; Periodicals; 610
• DOI: 10.1136/bmj.h2147
• Languages: English
• ISSNs: 0007-1447

Abstract

Abstract : PRECIS is a tool to help trialists make design decisions consistent with the intended purpose of their trial. This paper gives guidance on how to use an improved, validated version, PRECIS-2, which has been developed with the help of over 80 international trialists, clinicians, and policymakers. Keeping the original simple wheel format, PRECIS-2 has nine domains—eligibility criteria, recruitment, setting, organisation, flexibility (delivery), flexibility (adherence), follow-up, primary outcome, and primary analysis—scored from 1 (very explanatory) to 5 (very pragmatic) to facilitate domain discussion and consensus. It is hoped PRECIS-2 will be valuable in supporting the explicit matching of design decisions to how the trial results are intended to be used