The PRECIS-2 tool: designing trials that are fit for purpose

Kirsty Loudon, Shaun Treweek, Frank Sullivan, Peter Donnan, Kevin E Thorpe, Merrick Zwarenstein

Research output: Contribution to journalArticlepeer-review

1178 Citations (Scopus)

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.
Original languageEnglish
Article numberh2147
JournalBritish Medical Journal
Volume350
DOIs
Publication statusPublished - 8 May 2015

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